Systems and methods for ablation visualization and treatment confirmation

Abstract

Examples described herein include visualization techniques for ablation. In some examples, the ablation includes a combination of electrolysis and electroporation. A target region is treated using intraluminal or other ablation to tissue within a zone of the target region. An imaging device can be used to image the zone to identify treated regions within the zone by observing treated tissue that changes color. In some examples, imaging can be performed before, during, and after treatment. Treatment can be confirmed by observing the coloration of treated tissue in the images. Untreated or insufficiently treated regions of tissue can be identified by different coloration compared to treated regions. Based on the location of treated regions, additional intraluminal ablation can be performed to selected additional regions within the zone that were missed using manual techniques or partially or fully automated techniques.

Description

[0001] Cross-references to related applications This application claims priority to U.S. Provisional Application No. 63 / 598,893, filed November 14, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure generally relates to the field of visualization and confirmation of medical procedures. The described examples utilize visualization of the intraluminal ablation zone to plan and confirm tissue treatment. Background Technology

[0003] Soft tissue ablation, especially the ablation of luminal structures, has been used in a variety of clinical applications, including endovascular treatment of varicose veins, gastrointestinal (GI) ablation for Barrett's esophagus and insulin resistance, and lung ablation for chronic obstructive pulmonary disease.

[0004] Regarding the small intestine, the duodenum plays a fundamental role in glucose homeostasis and metabolic disorders, as evidenced by improved glycemic control in patients undergoing gastric bypass surgery. An emerging investigational surgical procedure, duodenal mucosal remodeling (DMR), has shown promising efficacy in patients with diabetes and fatty liver disease. Despite good glycemic control, safety concerns exist regarding thermal ablation for early cases of duodenal and duodenal strictures. Ablation can be performed within the duodenum using various energy modalities. A caveat accompanying thermal ablation is the necessity to protect the underlying muscular layer, as thermal damage to the muscle can lead to intestinal stricture during postoperative tissue recovery and healing. Therefore, thermal ablation has been combined with submucosal injection to provide buffering and thus this protection. Ablation using thermal risk mitigation energy methods (such as pulsed field ablation, including irreversible electroporation (IRE), high-frequency irreversible electroporation (H-FIRE), electroporation, and electrolysis (E2)) may eliminate the need for submucosal elevation, as the ablation depth can be modeled and controlled to perform transmucosal ablation in the duodenum to treat duodenal lesions that directly cause insulin resistance in patients.

[0005] Regarding the lungs, the endothelium plays a fundamental role in overall lung function. Goblet cells, present in the endothelium of the bronchi, secrete mucin and form a protective mucus layer that helps trap microorganisms. In chronic obstructive pulmonary disease (COPD), chronic bronchitis (CB), inflammation within the airway walls leads to excessive mucus secretion due to goblet cell overgrowth. Potentially, energy-based methods, including thermal methods (thermal vapor ablation) and thermal relief methods (such as pulsed ablation, e.g., IRE and H-FIRE), can be applied to ablate the endothelium of the lungs to reduce the number of goblet cells, thereby reducing mucus secretion and improving lung function in the process.

[0006] While thermal relief energy (IRE) approaches show promise for small bowel and lung ablation, the process is not yet fully optimized. A known drawback of using specific IRE parameters for small bowel and lung mucosal ablation is the inability to visualize the location of treatment applied due to reliance on IRE as the treatment modality. This leads to a frustrating initial experience for medical practitioners who are unaware of the treated area, extent of treatment, potential gaps or omissions in the treatment, and the degree of treatment to determine over- or under-ablation of the treated area. Summary of the Invention

[0007] This document describes method examples. One example method may include ablation of tissue within a target region using an ablation device, the ablation comprising applying electroporation energy, imaging the region to identify treated areas within the region, and performing additional ablation by the ablation device in selected additional areas within the region based on the location of the treated areas.

[0008] Some example methods also include delivering the drug to the treated area based on its appearance.

[0009] In some example methods, ablation includes a combination of electroporation and electrolysis. Some example methods also include imaging the area using a white light endoscope, wherein the treated area has a different visual appearance than the untreated area. In some example methods, the treated area is discolored (e.g., white). Some example methods also include determining the degree of ablation of the treated area through image recognition or visual assessment, and adjusting additional ablation of selected additional areas based on the degree of ablation of the treated area. In some example methods, adjusting the additional ablation includes controlling at least one of the following: pulse duration, applied current, applied charge, applied voltage, number of pulses, or combinations thereof.

[0010] Some example methods further include marking at least one of the leading or trailing edges of the region to mark the tissue before processing it. In some example methods, marking the region includes applying energy to the region. In some example methods, marking the region includes applying a combination of electroporation and electrolysis. In some example methods, marking includes applying a first amount of energy to the region, and the processing includes applying a second amount of energy to the region, wherein the first amount is less than the second amount.

[0011] Some example methods also include identifying portions of the image generated from the imaging to identify the selected additional region. Some example methods also include comparing the identification with kinematic data of a robotic system used for ablation, and generating location data for the selected additional region based on the comparison. In some example methods, performing additional ablation includes using the location data to position the robotic system to process the selected additional region.

[0012] This article describes method examples. One example method may include treating tissue within a region of a target area using ablation that combines electroporation and electrolysis, imaging the region, and identifying treated areas within the region based on the imaging.

[0013] In some example methods, the imaging uses white light endoscopy, narrow-band imaging (NBI), fluorescence, chromoendoscopy, or a combination thereof. In some example methods, the identification includes using image recognition, kinematics, shape sensing, and / or visual evaluation to determine whether the treated area is visually different from at least one untreated area. Some example methods also include determining the degree of ablation of the treated area via image recognition or visual evaluation.

[0014] In some example methods, tissue treatment is performed using an ablation device, and prior to tissue treatment, at least one of the leading or trailing edges of the region is marked using the ablation device to label the tissue. Some example methods also include comparing the leading, trailing, and / or overlapping edges with at least one of shape sensing data, kinematic data, or location data, and positioning the ablation device between the leading and trailing edges for ablation based on at least one of the shape sensing data, kinematic data, or location data. Some example methods also include marking the trailing edge, moving the imaging device to the trailing edge, identifying a marker or electrolytic marker within the region to identify the leading edge, moving the imaging device to the proximal portion of the treatment region to measure the travel distance from the trailing edge to the marker or electrolytic marker, moving the imaging device to the leading edge, pre-mapping a map including the region, planning one or more treatment segments in the map based on a predetermined length within the treatment region, treatment location, travel distance, or a combination thereof, and moving the ablation device to one or more planned treatment segments. In some example methods, the pre-mapping map includes anatomical localization. Some example methods also include dynamically adjusting one or more positions of one or more treatment segments to update the planned one or more treatment segments.

[0015] This document describes system examples. One example system includes an ablation device comprising multiple electrodes that contact and ablate the contacted tissue, wherein ablation includes applying electroporation energy; an imaging device proximal to the ablation device that images a region of the target area; and a controller coupled to the ablation device and the imaging device that controls the ablation device to use the tissue within the ablated labeled area by controlling the charge applied to the multiple electrodes, and controls the imaging device to image the area to visualize the labeled area. In some example systems, ablation includes a combination of electroporation and electrolysis. In some example systems, controlling the ablation device to label the tissue includes applying energy including a combination of electroporation and electrolysis. In some example systems, visualizing the labeled area includes imaging the area using a white light endoscope, and the labeled area has a different visual appearance than unlabeled areas.

[0016] Some example systems also include an elongated flexible device. In some example systems, the plurality of electrodes includes at least one electrode inserted through a working channel of the elongated flexible device. In some example systems, the elongated flexible device has at least one expandable member at its distal end.

[0017] In some example systems, the imaging device includes an ultrasound imaging sensor and a light source. In some example systems, the imaging device performs white light endoscopy, NBI, fluorescence, or a combination thereof.

[0018] Some example systems also include an elongated flexible device containing an imaging apparatus, wherein multiple electrodes are attached distally to the elongated flexible device.

[0019] Some example systems also include a processor that receives data from an imaging device and performs image recognition to identify a marked region. In some example systems, the processor further determines the degree of ablation of the marked region based on data from the imaging device, and a controller further controls the charge applied to the marked region based on the degree of ablation by selecting a duration, voltage or voltage range, multiple pulses, or a combination thereof. Some example systems also include a robotic system that robotically actuates the ablation device and the imaging device, wherein the processor further determines a region within the area, and wherein the controller causes the robotic system to position the ablation device and the imaging device at that region within the area. In some example systems, the controller further identifies portions of one or more images generated by the imaging device to compare the identified portions of one or more images with at least one of shape sensing data, kinematic data, or position data, and based on at least one of the shape sensing data, kinematic data, or position data, the controller positions the ablation device near that region within the area.

[0020] Some example systems also include a display showing one or more images generated by the imaging device, and the controller also allows the user to visually assess and determine the degree of ablation in the marked area. In some example systems, the controller also allows the user to control, based on the marked area, at least one of the following: the duration, voltage, or number of pulses applied to perform additional ablation on the treated area, or the position of the ablation device and imaging device to be located within the area.

[0021] This document describes an example of a non-transitory computer-readable storage medium that may be encoded with instructions, which, when executed by a controller, cause the controller to control an ablation apparatus to ablate tissue within a target region by controlling the charge applied to a plurality of electrodes of the ablation apparatus, wherein ablation includes applying electroporation energy; to control an imaging apparatus to image the region to generate one or more images; and, based on the location of the treated region determined according to the one or more images, to control the ablation apparatus to perform additional ablation on selected additional regions within that region.

[0022] This article describes method examples. One example method involves positioning an electrolysis device near a tissue region and performing electrolysis to discolor the tissue region and provide a visual marker.

[0023] Example methods may also include location-based delivery of processing energy based on visual markers. In some example methods, electrolysis of tissue includes avoiding complete ablation of tissue regions.

[0024] Some example methods also include partially visually-based navigation of the processing apparatus to the processing location. Example methods may also include electroporation using an electrolytic device positioned at the processing location. In some example methods, the same electrodes are used for both electrolysis and electroporation. Attached Figure Description

[0025] Figure 1A This is a schematic diagram of a medical procedure visualization system based on some examples.

[0026] Figure 1B This is a schematic diagram of an ablation device based on some examples.

[0027] Figure 2 This is a schematic diagram of the ablation device and imaging device according to the example described herein.

[0028] Figure 3 This is a flowchart of the method for visualizing medical procedures using the medical procedure visualization system shown in Figure 1.

[0029] Figure 4 This is a flowchart of the method for visualizing medical procedures using the medical procedure visualization system shown in Figure 1.

[0030] Figure 5 This is a schematic diagram of the anatomical structure arranged according to the example described in this article.

[0031] Figure 6A This is a schematic diagram of an electrode used as the anode in the example described in this article.

[0032] Figure 6B This is a schematic diagram of an electrode used as the cathode, based on the example described in this article.

[0033] Figure 7A These are example images of a medical procedure using an ablation device to visualize the treated area, based on the examples described in this article.

[0034] Figure 7B These are example images of a medical procedure using an ablation device to visualize the treated area, based on the examples described in this article.

[0035] Figure 8A This includes example images of the treated area examined using white light endoscopy according to the examples described herein.

[0036] Figure 8B These are example images of processed areas using narrow-band imaging (NBI) based on the examples described in this article.

[0037] Figure 8C These are example images of the treatment sites based on the examples described in this article, histologically showing mucosal rash areas associated with electrode placement.

[0038] Figures 9A-9C These are example images of the post-ablation treatment site of pig small intestine examined using a white light endoscope, based on the examples described in this article.

[0039] Figures 10A-10D These are example images of the post-ablation treatment site of pig small intestine examined using a white light endoscope, based on the examples described in this article.

[0040] Figure 11 These are schematic diagrams of robot-assisted servo mechanisms based on some examples.

[0041] Figure 12A This is a schematic diagram of the instrument system based on the example described in this article.

[0042] Figure 12B The examples described in this article are shown. Figure 12A The remote portion of the instrument system has an extension instance of the instrument.

[0043] Figure 13 This is a perspective view of the manipulator system based on the example described in this article.

[0044] Figure 14 This is a top view of the manipulator system based on the example described in this article. Detailed Implementation

[0045] Certain details are set forth below to provide a thorough understanding of embodiments of this disclosure. However, it will be apparent to those skilled in the art that embodiments of this disclosure may be practiced without these specific details. Furthermore, the specific embodiments of this disclosure described herein are provided by way of example only and should not be construed as limiting the scope to these specific embodiments. In other instances, well-known materials, components, processes, controller components, software, circuits, timing diagrams, and / or anatomy are not described in detail or shown to avoid unnecessarily obscuring the embodiments.

[0046] Processing diagrams (e.g., visualizing the treated area) can be advantageous during and / or after ablation procedures. For example, ablation procedures in the lungs, intestines, and other tissues can benefit from visualization of the processing. The examples described herein provide systems and methods that allow visualization of treated tissue in luminal and other ablation procedures. The examples of systems and methods described herein can be used to perform ablation and / or adjust ablation or other treatments based on visualization of the treated tissue.

[0047] For example, given the known dose-dependent relationship between ablation and a decrease in blood glucose level (A1C) in DMR using thermal and IRE methods, and the dose-dependent relationship between lung function and an excess of goblet cells in CB, a technique for mapping the surface area of ​​the treatment zone is desirable in order to ablate as many duodenal lesions as possible, allowing users to confidently determine where to begin new or additional treatment zones.

[0048] The systems and methods described herein can be used in ablation techniques, such as endoluminal ablation procedures. In some instances, non-thermal endoluminal tissue ablation techniques employing a combination of electroporation and electrolysis (E2) can be used. Given that this technique enables normal tissue regeneration without collagen band formation, scarring, stenosis (particularly in the small intestine), or ulceration, and allows for overlapping ablation zones without damaging underlying muscle, using E2 for CB with lung treatment mapping or duodenal mucosal regeneration (DMRe) via duodenal treatment may be advantageous as an endoscopic approach to endoluminal soft tissue ablation.

[0049] The examples described herein involve endoluminal ablation, such as treating target tissues in the GI tract (e.g., the duodenum). However, it should be understood that the ablation methods described herein, employing a combination of electroporation and electrolysis with processing feedback and / or visualization, can treat a wide variety of target tissues, such as the intestine, duodenum, stomach, bladder, uterus, endometrium, ovary, colon, rectum, sinuses, ducts, ureters, prostate, skin, muscle, nerves, diaphragm, omentum, kidney, follicle, brain, lymphatic vessels, breast, esophagus, lung, liver, kidney, lymph nodes, lymph node drainage areas, and / or heart or other target tissues.

[0050] Examples described herein include visualization techniques for tissue ablation, such as for endoluminal ablation or other target tissues. In some embodiments, ablation may include a combination of electrolysis and electroporation. Treated tissue may have different visual appearances when different charge densities are used during ablation application, including ablation using electroporation combined with electrolysis. For example, tissue shortly after treatment with electroporation combined with electrolysis, particularly near the anode, may exhibit discoloration. In some instances, tissue treated in this way may appear white and / or a lighter color than before treatment. When tissue within a target region is treated with electroporation and electrolysis ablation, the treated tissue may change color over time, for example, from white to red. Imaging devices may be used to image the region to identify the treated area within the region by observing the treated tissue. In some embodiments, white light endoscopy may be used to image the region, and the treated area may exhibit discoloration (e.g., white) shortly after treatment. In some embodiments, imaging may be performed before, during, and after treatment. Treatment confirmation can be obtained by observing the coloration of the treated tissue in the image. Untreated or undertreated tissue areas can be identified by their different coloration compared to treated areas. Based on the location of treated areas, additional ablation can be performed on selected additional areas within the treated area using manual or partially or fully automated techniques. Note that the tissue color changes caused by energy application described herein may not be due to harmful effects such as carbonization or other undesirable side effects. In some instances, delivering energy to tissue at levels suitable for electroporation and electrolysis can cause the tissue color changes described herein. For example, in some tissue ablation applications, radiofrequency ablation (RFA) can be used to thermally alter tissue color to induce protein denaturation. However, in some sensitive organs, such as the duodenum or lung, the introduction of heat energy, even for labeling purposes only, can lead to thermal diffusion that can propagate transmurally through the intestinal or bronchial walls, causing fibrotic scarring, loss of local compliance, and / or stenosis or perforation. For such organs, non-thermal ablation methods (such as electrolysis) can be used for tissue labeling because of their ability to control the depth of ablation. Because it is produced by chemical effects, electrolytic staining (such as labeling) can be performed with or without extensive cell death. In some instances, electrolytic labeling can be performed at a specific electrode (anode) within a bipolar device with a unique mechanism. For these reasons, electrolytic staining can be used in the duodenum, lungs, or any instance where there is a risk of thermal energy exposure.

[0051] In some implementations, the degree of ablation of the treated area can be determined by one or more of image recognition, kinematic data, shape sensing data, and / or visual assessment. Additional ablation treatment at the treated area can be adjusted based on the degree of ablation determined in the treated area. Adjustment of the electroporation and / or electrolysis energy used for additional ablation may include controlling at least one of the following: the duration of the applied energy (e.g., pulses), the applied current, the applied charge (e.g., electric field strength), the applied voltage, the number of pulses, or combinations thereof. Optionally, in some instances, drug delivery may be performed to the treated area, including providing drug substance to or near the treated area. Drug delivery during treatment may be adjusted based on the appearance and location of the treated tissue.

[0052] The systems and methods described herein can be used for treatment planning of desired areas of target tissue. In some instances, the treatment area can be identified by creating physical markers by marking the leading and / or trailing edges of the treatment area using an ablation device. The ablation device can be used to apply energy of sufficient intensity, in the form of electrolysis (with or without electroporation), to induce physical marking without causing complete ablation in the marked area. In other embodiments, the ablation device can apply other types of energy or other ablation sufficient to induce marking. For example, the ablation device can apply energy at the leading edge of the area. This energy application marks the leading edge of the area by altering the appearance of the tissue at the leading edge. The ablation device can move to the trailing edge of the area and apply energy there. This energy application marks the trailing edge of the area by altering the appearance of the tissue at the trailing edge. In some instances, the energy application used for marking the area can utilize energy sufficient to treat the tissue (e.g., ablation of the tissue to a specific depth using electroporation and electrolysis). In some instances, the energy application used for marking can utilize less energy than the energy applied subsequently for treating the tissue within the area. In some embodiments, the leading and trailing edges can be imaged using a white light endoscope and NBI for planning purposes. The leading and trailing edges can be compared with at least one of shape sensing data, kinematic data, or positional data. Based on this comparison, a treatment plan can be generated, and the ablation device can be positioned between the leading and trailing edges for ablation based on at least one of the shape sensing data, kinematic data, or positional data. In some embodiments, the ablation device can be positioned such that one electrode (e.g., the distal electrode) is positioned at the leading edge, and another electrode (e.g., the proximal electrode) is positioned at the trailing edge to provide an ablation edge indicating the termination of the treatment area and the location where treatment is applied. Other electrodes (including anodes and cathodes) can be arranged in layers between the leading and trailing edges.

[0053] In some implementations, an initial scan of the target region can be performed using an imaging device to survey the target area. Proximal and distal markers can be set to indicate the area (e.g., zone) to be ablated. The markers can be virtually set in the image of the user interface, or the markers can be set as leading and trailing edges provided by energy application or other physical markers, as described herein. Energy application for marking can be performed using a manually operated delivery device (e.g., a guidewire catheter) to deliver the ablation device to the target tissue. Alternatively, energy application can be performed using a robot-assisted parent-child servo mechanism manipulation system to deliver the ablation device to the target tissue. Ablation can then be performed based on visual feedback by having the user move the ablation device to the target location (the device can be delivered manually or under robot-assisted control), or fully automatically in robot-assisted surgery where servo mechanisms and / or a computer processor use markers as start and stop positions to control the process, or semi-automatically in robot-assisted surgery where the processor can use markers as the start position and the user's input as the desired processing length, or the user can select a start position without applying a specific marker, and the processor can perform an ablation-imaging loop until the system reaches a stop marker, etc. After the process is applied, a post-processing scan can be performed via imaging to identify any gaps or under-processed areas, which can then be reprocessed by having the user move the ablation device (manually or under robot-assisted control) or by using the system's automatic movement.

[0054] For example, a controller in a robot-assisted servo system can be used to position an imaging device at the leading edge and image the leading edge of the treatment area. A computing system can identify the leading edge of the area, for example, by identifying markers or applied physical markings (e.g., electrolytic markings) at the leading edge of the area based on images from the imaging device. The trailing edge of the area can be identified in a similar manner. The computing system and / or controller can further control the imaging device to move to the proximal portion of the area to measure the distance traveled from the trailing edge to the leading edge (e.g., markers or electrolytic markings). The computing system can generate a map including the area and plan one or more treatment segments within the area based on the location within the area, the treatment location, the distance traveled, or a combination thereof. In some embodiments, map generation may include anatomical localization. In medical procedures performed based on the map, the computing system can be used to control the movement of an ablation device to one or more planned treatment segments and / or along one or more planned treatment segments. During the medical procedure, the computing system can dynamically adjust the location of one or more treatment segments based on images of the area to update the planned one or more treatment segments. Therefore, automated preoperative planning and automated processing are possible.

[0055] In some instances, automated preoperative planning and automated processing using robot-assisted servo systems can be based on a linear traveling reference that provides anatomical localization for mapping, planning, confirmation, and / or dynamic adjustment and updating. This linear traveling reference can be obtained in some instances using one or more computer vision algorithms that use image analysis to identify the treated area. Because the ablation examples described herein alter the appearance of the treated tissue in real time during tissue processing, computer vision can be used to identify locations and / or treatment sites within the treated area. In some instances, system and method examples can utilize computer vision and proximal and / or distal markers identifiable in the target area for ablation between proximal and distal markers. In some instances, the systems and methods described herein can perform endoluminal ablation. In some instances, the endoluminal energy application used can include a combination of electrolysis, electroporation, and electrolysis, or other energy application or ablation types that can mark tissue to establish proximal and distal markers.

[0056] For example, energy can be applied using an intraluminal ablation device to mark the anterior and / or posterior edges of the treatment area, creating visible markers of the treated tissue (e.g., using electrolysis with or without electroporation). Alternatively or additionally, characteristic markers can be identified in the target area for use as proximal and / or distal markers. Alternatively or additionally, physical markers can be established by applying other energy types (e.g., RF or thermal energy) or physical notching. Anatomical localization can be performed using one or more computer vision algorithms, such as Visual Simultaneous Localization and Mapping (SLAM) and / or You Only Look Once (YOLO), to map the target area using the markers. In some instances, such imaging can be aided by introducing an imaging reference frame. For example, in some instances, an ablation device or catheter with centimeter or millimeter markers can be imaged and used as a reference frame. In this way, one or more images can include a known reference scale that can be used as a registration marker to measure the movement of the ablation device, including slender, flexible devices such as endoscopes and / or catheters. Based on images including a scale bar, the movement of the lumen or ablation device within the lumen can be visualized as length.

[0057] In some instances, artificial intelligence (AI) and / or machine learning (ML) (e.g., SLAM and / or YOLO) can be used to train algorithms and software to perform treatment on disease areas. For example, a computational system can create a model for a target disease and / or treatment (e.g., DMR). Training this model may include training the AI ​​and / or ML model using images of treated areas from a patient population with annotated location and / or kinematic data or other clinical data relevant to the target disease and / or treatment. In this way, the trained model can be trained to recognize tissue changes that occur in response to endoluminal ablation in a specific disease and / or treatment. Planning the ablation procedure using a trained procedure or algorithm with the model can utilize images from the target patient with location and / or kinematic data or any clinical data. Therefore, the ablation device can be positioned within the treatment area.

[0058] Examples of systems disclosed herein may include an ablation device comprising electrodes that contact and / or are positioned near the tissue. The ablation device can ablate the tissue. Examples of systems may include an imaging device near the ablation device that images the area to identify treated and / or marked regions within that area. The imaging device can generally be implemented using any imaging system, including those utilizing white light endoscopy, NBI, fluorescence, chromoendoscopy, optical coherence tomography (OCT), or radial ultrasound, or combinations thereof. In some embodiments, the imaging device may include an ultrasound imaging sensor and a light source. In some embodiments, examples of systems may include an endoscope containing the imaging device. Electrodes may be distally attached to the endoscope.

[0059] Examples of the systems disclosed herein may include a controller coupled to an ablation device and optionally coupled to an imaging device. The controller can control the ablation device to treat tissue within a treatment area by controlling the charge applied to multiple electrodes, control the imaging device to image the area, and control the ablation device to perform additional ablation in selected additional areas within the area based on the location of the treated area determined from the imaging of the area. In some embodiments, at least one electrode may be inserted through a working channel of an endoscope. Examples of the systems disclosed herein may include a catheter and an expandable member of the distal portion of the catheter. The example systems and methods can be applied to intraluminal ablation application or other body tissues.

[0060] The system examples disclosed herein may include a computing system that may include at least one processor. The computing system may receive data including images from an imaging device and perform image recognition to identify processed regions. The processor may identify portions of the image to select additional regions to be processed. For example, the identified portions may be compared (by the computing system) with kinematic data of a robotic system used for ablation, and the processor may generate positional data of the selected additional regions based on the comparison. The processor may control the controller to perform additional ablation. The processor may use the positional data to position the robotic system to process the selected additional regions. In some instances, the processor may compare leading and / or trailing edges with at least one of shape sensing data, kinematic data, or positional data, and position the ablation device between the leading and trailing edges for ablation based on at least one of the shape sensing data, kinematic data, or positional data. While a single computing system and / or processor may be described in some instances, it should be understood that the implementation is very flexible and any number of computing systems and / or processors may be used. In some instances, the computing system and / or processor may be communicatively coupled to perform the actions described herein.

[0061] The system examples disclosed herein may include a display configured to display one or more images generated by an imaging device, and a controller that allows a user to perform a visual assessment to determine the degree of ablation of the treated area and / or the location of the treated area.

[0062] In some instances, imaging of the treated area can lead to the computational system and / or visual observer guiding the ablation device to perform additional ablation on untreated and / or undertreated areas. The staining resulting from the reaction of tissue with the electrode material can, in some instances, be observed during and / or immediately after treatment using the imaging techniques described herein. Furthermore, the application of energy can be used to mark areas on the tissue for preoperative planning of treatment sites, followed by treatment and feedback on the resulting staining for further processing. Visualization and identification of treated areas using energy application and ablation techniques can provide treatment confirmation and planning.

[0063] Figure 1A This is a schematic diagram of a system 100 used to provide visualization and ablation of medical procedures, based on some examples. Figure 1B This is a schematic diagram of an ablation device 120 in a system 100 based on some examples. Typically, the system examples described herein may include a controller and an ablation device. Figure 1A In one example, system 100 includes a controller 104, an ablation device 120, and an elongated flexible device 130 (e.g., a catheter or endoscope) that can be coupled to the ablation device 120. In some embodiments, the controller 104 can be coupled to the elongated flexible device 130. Examples of ablation devices 200 will be discussed in the section on... Figure 2 The description provides further details. In some instances, the elongated flexible device 130 is a hand-actuated manual guidewire catheter. In other instances, the elongated flexible device 130 is a flexible catheter, endoscope, duodenoscope, or other robot-driven device, for example, via... Figures 11-12B A robot-assisted servo mechanism system is described in further detail to drive the device. In such a system, an elongated flexible device 130 (e.g., a flexible catheter or endoscope) is coupled to a drive unit (e.g., drive unit 1204) that receives actuation force from a manipulator assembly (e.g., manipulator assembly 1102). The ablation device 120 may be an end effector of a flexible ablation instrument (e.g., instrument 1226) that extends through or along the working channel of the elongated flexible device 130. In some embodiments, optionally, the ablation device 120 may be a detachable attachment coupled to the distal end of the elongated flexible device 130.

[0064] The ablation device 120 includes one or more electrode members 15 and optionally one or more expandable members 14 (e.g., balloons). In some instances, the ablation device 120 may include an imaging device 18. In some instances, the imaging device 18 may be implemented as part of an elongated flexible device 130 (e.g., a catheter or endoscope), as part of the ablation device 120, or as part of a separate instrument. The imaging device 18 may follow the ablation device 120 after it has been introduced into the target tissue 10 (e.g., small intestinal tissue or other tissue). In some instances, the imaging device 18 may advance to the target tissue 10, and the ablation device 120 may be controlled to follow the imaging device 18. In some instances, the electrode members 15 may surround the expandable members 14. The expandable members 14 may be used to provide outward tissue contact force to the electrode members 15 to ensure sufficient contact between the electrode members 15 and the target tissue, thereby allowing the electrolytic products to diffuse into the target tissue. The electrode members 15 may include one or more electrodes 16 disposed on the distal and proximal portions of the electrode members 15. The one or more electrodes 16 can be used to provide ablation, such as simultaneously providing electroporation and electrolysis in some instances. An ablation device 120 coupled to the elongated flexible device 130 can be introduced into the target tissue for ablation, delivery of electrolytic products, and regeneration, for example, into the lumen 12 of the tissue 10 in a patient's luminal region. An expandable member 14 can press against the tissue 10, and the one or more electrodes 16 can be ablated. Although the electrode member 15 is shown disposed within the lumen 12 of the tissue 10, the electrode member 15 can be located on the surface of the tissue 10, inside the tissue 10, and / or near the tissue 10. Furthermore, although the elongated flexible device 130 is shown for positioning one or more electrodes for permeation and / or electrolytic product generation, in other embodiments, other ablation devices can be used, and / or the electrodes can be positioned near the tissue in other ways—for example, by contacting the tissue with the electrodes or by using probes, pads, needle electrodes, flexible laparoscopic electrodes, or another device coupled to the one or more electrodes.

[0065] The controller 104 may include one or more processors 106, computer-readable medium 108 (e.g., memory), and other computing system components, such as one or more input devices, output devices, sensors, and / or communication devices in some instances. Additional, fewer, and / or different components may be used in other instances. The computer-readable medium 108 includes executable instructions 110 for ablation, such as electroporation and electrolysis using one or more electrodes 16. In some embodiments, the executable instructions 110 for ablation may include controlling electrode members 15 to treat tissue within a region of target tissue using intraluminal ablation by controlling the charge applied to one or more electrodes 16. The computer-readable medium 108 may include parameters 114 selectable during the control of electrode members 15. For example, parameter 114 may include duration, voltage or voltage range, number of pulses, or combinations thereof, applied to the treated area based on the degree of ablation to control the charge on one or more electrodes 16. In some instances, electric field strength, current level, capacitance, waveform shape, etc., may also be selected.

[0066] Computer-readable medium 108 includes executable instructions 112 for imaging. The executable instructions 112 for imaging may include controlling imaging device 18 to image a region of target tissue. In some embodiments, imaging device 18 may be included in ablation device 120. In some embodiments, imaging device 18 may be an endoscope following ablation device 120. In some embodiments, imaging may use white light endoscopy, NBI, fluorescence, chromoendoscopy, OCT, or radial ultrasound, or a combination thereof. For white light endoscopy, NBI, and / or fluorescence, imaging device 18 may be non-contact, provided that the wavelength of the light source of imaging device 18 is configured for color recognition. Imaging device 18 using OCT or radial ultrasound for depth mapping may be included in ablation device 120 to contact the treated area.

[0067] The controller 104 can 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 can be handheld and may also have other uses.

[0068] Controller 104 may include one or more processors, such as processor 106. Any type or number of processors may be present, including one or more central processing units (CPUs) and / 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)).

[0069] The controller 104 described herein may include a computer-readable medium 108, 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 Figure 1A The computer-readable medium 108 is schematically depicted as a single box, but any number of computer-readable medium 108 devices may be present. The computer-readable medium 108 may communicate with the processor 106 (e.g., via an electrical connection).

[0070] Computer-readable medium 108 may store executable instructions for processor 106 to execute, such as executable instructions 110 for ablation using electrode member 15, which utilizes stored parameters 114 to charge one or more electrodes 16. In this way, techniques for applying E2 to tissue may be implemented wholly or partially in software herein. The executable instructions may include instructions for controlling the charge delivered to the electrodes (e.g., electrodes 16 of electrode member 15). Thus, controller 104 may induce a voltage difference across the target tissue to generate an electric field that causes permeation of cells in the tissue region to be treated. Executable instructions 110 for ablation may also include instructions for controlling the ablation apparatus to perform additional intraluminal ablation in selected additional areas within the treated region, based on the location of the treated region determined by imaging of the region.

[0071] Typically, the electrodes used in the examples herein can be used in monopolar, bipolar, or combinations thereof. A typical monopolar configuration may include an active electrode (e.g., an electrode on or within the surgical field of view) and a return electrode. In some embodiments, the active electrode may be an anode. In some instances, the return electrode may be placed outside the surgical field of view but in contact with the patient (e.g., using a pad with electrodes). In this way, one polarity (e.g., the polarity of the active electrode) is within the surgical field of view. Therefore, a monopolar configuration of the electrode may include a pair of electrodes—one of which is powered, and the other serves as the return electrode. The return electrode may be located on a different device than the powered electrode. For example, the return electrode may be located on a pad placed on the patient's skin. In a bipolar configuration, current may flow from one electrode in a pair of electrodes to the other electrode in the pair. The electrodes in the pair of electrodes may therefore be referred to as having opposite polarities. Multiple pairs of electrodes may be used. In some instances, a monopolar configuration of the electrode may include any combination of active and return electrodes, including different numbers of active and return electrodes. For example, the number of active electrodes may be greater than the number of return electrodes, or vice versa. Typically, a unipolar configuration refers to the use of one or more effective electrodes (e.g., positioned near the tissue to be treated) powered relative to one or more distal electrodes (e.g., placed externally to the patient being treated). In a unipolar configuration, in some instances, multiple effective electrodes may be present and current may be conducted through a shared return electrode, or in other instances, current may be conducted through individual return electrodes. In a bipolar configuration, in some instances, current may be conducted through multiple pairs of electrodes. In some instances, a distally positioned electrode may be used as an anode and a proximally positioned electrode may be used as a cathode. In some instances, a distally positioned electrode may be used as a cathode and a proximally positioned electrode may be used as an anode. In some instances, a bipolar configuration of electrodes may include any combination of anodes and cathodes, including different numbers of anodes and cathodes. For example, the number of anodes may be greater than the number of cathodes, or vice versa. In some instances, the electrodes used in the examples herein may include treatment electrodes and electrodes for creating visual markings. These treatment electrodes and marking electrodes may be independent of each other (i.e., treatment electrodes and marking electrodes are separate), electrodes may be used for both treatment and marking, or some electrodes may contribute to both treatment and marking simultaneously, while others are used only for treatment or only for marking. For example, a bipolar configuration can be used for ablation, followed by a monopolar configuration and the same end effector for tissue marking. Alternatively, the reverse may also be true. Or, after ablation using a bipolar or monopolar configuration, the anode and cathode can be altered in some way to deliver visualization pulses. In further examples, separate electrodes on a common end effector can be used for marking rather than treatment, or the first end effector applies marking while the second end effector applies treatment.

[0072] Controller (e.g.) Figure 1A The controller 104 can activate one or more selected electrodes to provide an electric field, as described herein. In some instances, the controller 104 can activate an electrode that can be used as an anode. The controller 104 can alternately or otherwise select the mode of electrode activation (e.g., sequentially activating pairs of electrodes) to form or deliver a specific electric field. In some embodiments, one or more electrodes used to apply electroporation can also be used to generate electrolysis products (e.g., some or all electrodes can be used for both electroporation and electrolysis), while in other embodiments, the electrodes used to apply electroporation can be different from the electrodes used to generate electrolysis products. Generally, electrodes of any shape can be used, including circular, square, rectangular, or other shapes. In some instances, the shape of the electrodes can be determined based on the shape of the region to be visualized. The controller 104 can also be used to induce a current through tissue (e.g., between electrodes) to generate electrolysis products. Electrolysis products can lead to the ablation of permeable cells. Electrolysis products may not be sufficient to destroy the extracellular matrix in the region of permeable cells, so the permeable cells can be ablated while leaving the extracellular matrix in that region intact. Intact extracellular matrix allows for tissue staining and further tissue engineering.

[0073] In some embodiments, one or more electrodes 16 used in the examples may include an anode. When the imaging device 18 (e.g., an endoscope) images the treated area, the treated area near the anode after ablation may appear discolored (e.g., white) compared to the untreated area for a short period after treatment. In some instances, the treated area near the anode may change color from untreated tissue to white. Using white light endoscopy, the treated area can be effectively visualized through color changes and color change gradients. In some instances, other imaging techniques (e.g., NBI, fluorescence, chromoendoscopy, OCT, and / or radial ultrasound) can be used to visualize the treated area as well as the untreated or undertreated area to visualize different tinting and gradients.

[0074] System 100 may include a power supply 102. Power supply 102 may be coupled to controller 104. Power supply 102 may be implemented using one or more AC power supplies, DC power supplies, batteries, and / or waveform generators. Power supply 102 may supply power to one or more electrodes 16 to generate voltage and / or current, thereby generating an electric field and / or electrolytic products in tissue. In some instances, power supply 102 may be implemented using a signal generator, such as an exponentially decaying wave generator (for example, the Harvard Apparatus BTX 630); however, this disclosure is not limited to or not limited thereto. In some instances, the signal generator may include a set of capacitors for selection as controlled by controller 104. The signal generator may allow selection of a specific charge (e.g., capacitance) applied for each charge.

[0075] The controller 104 can control the timing, intensity, and duration of the electric field and / or electrolytic products provided by the electrode member 15. For example, the controller 104 can be programmed to provide electronic signals to the electrode member 15 via an elongated flexible device 130. These electronic signals can indicate the treatment dose, such as the dose of the electrolytic products. The electronic signals can control the timing and magnitude of the current generated by one or more electrodes 16 of the electrode member 15 to generate an electric field. This allows a user to customize the treatment of tissue 10. In some embodiments, the controller is coupled to a power source 102. In some embodiments, the power source 102 may be included in the medical procedure visualization system 100. In some embodiments, the power source 102 is integrated with the controller 104.

[0076] Although shown as a separate component coupled to the ablation device 120 via an elongated flexible device 130, in some embodiments, the controller 104 may be integrated into the ablation device 120. In some embodiments, the controller 104 may include programmable circuitry coupled to the ablation device 120. The controller 104 may be coupled via wires or communicate wirelessly with the ablation device 120.

[0077] In some embodiments, controller 104 may be programmed to provide electronic signals indicating the dosage of electrolytic products and / or the level of cell permeability. For example, controller 104 may include such a program, or include one or more processing means (e.g., a processor) coupled to computer-readable medium 108, which is encoded with executable instructions 110 for ablation.

[0078] Examples of voltage, current, duration and / or time constant, electric field strength, capacitance and / or number of pulses can be calculated and / or determined according to the methods described herein. In some instances, parameters (e.g. Figure 1A The parameters (114) can be determined based on measurements performed in the tissue of interest, or different samples of similar tissue from the same patient or different patients. For example, measurements can be performed at different voltage levels with a specific electrode configuration, and the voltage levels, currents, pulse patterns, time constants, and other factors that lead to reversible electroporation and delivery of electrolytes to cause death of permeable cells can be identified. Typically, an electric field can be generated in the tissue that can cause reversible electroporation of cells in the target ablation region. Electrolytes can be generated and diffused over a period of time to induce ablation of permeable cells, but leave the extracellular matrix intact in the region of ablated cells.

[0079] Examples of usable parameters include delivering 1 to 10 or more voltage pulses, ranging from 10 V to 5,000 V. In some instances, the parameter range may depend on the target tissue and end effector design. In some instances, these pulses can be delivered in systems with capacitors selected by the signal generator ranging from 1 μF to 1500 μF. In some instances, other capacitance values ​​can be used. For example, in some instances, pulses can be delivered using resistors of 15-20 ohms. In other instances, other resistance values ​​can be used. In some instances, an electric field ranging from approximately 1,500 V / cm to approximately 0 V / cm can be generated in the tissue. The amount of electrolytic products generated may be related to the delivered charge in coulombs. There are several methods for calculating the delivered charge. For example, the charge Q (in coulombs, abbreviated as C) stored in a capacitor is generally equal to the product of the capacitor's capacitance C (in farads, abbreviated as F) and the voltage across its terminals V (in volts, abbreviated as V). That is, Q = C·V. The stored charge is typically equal to the product of the current I (in amperes, abbreviated as A) and the time t (in seconds, abbreviated as s). That is, Q = I·t (for example, when the pulse is a constant current pulse) or By defining the capacitance and the voltage across the capacitor, the charge can be defined, thus determining the electrolytic performance. When a capacitor discharges, it generates a current, and this current multiplied by time must equal the total charge in the capacitor. While the capacitor is discharging, the current is not constant—it decays exponentially. Therefore, the time measure is given by the exponentially decaying time constant, and the current measure is given by the peak current at the moment the discharge begins. The capacitor controlling the time constant is typically obtained from the power source (e.g., in the examples described herein). Figure 1A The capacitor contained in the power supply 102 is used to obtain the power. Therefore, the time constant (e.g., the exponential decay time constant of capacitor discharge) can be controlled.

[0080] In some instances, the parameters used to ablate tissue using the electroporation and electrolysis techniques described herein allow for significantly less charge per volume of tissue to be treated compared to ablation using electrolysis alone (furthermore, electrolysis alone may result in scarring and / or other tissue regeneration impairment). Additionally, the parameters used to ablate tissue using the electroporation and electrolysis techniques described herein allow for significantly lower targeted electric field strengths compared to treatment performed using IRE ablation.

[0081] In some instances, energy delivery (e.g., via electrolysis, with or without electroporation) can provide a sufficient dose and sufficient time to allow staining (e.g., discoloration) of areas permeable to cells, thereby providing physical labeling to the tissue without causing complete ablation of the tissue to be treated. In some instances, the energy used to provide labeling may be insufficient to damage the extracellular matrix in areas where cells have been ablated. Therefore, it may be possible to apply energy to the tissue to label it as an indication of the treatment plan described herein, without completely treating the tissue (e.g., by ablation of tissue volume). Thus, energy delivery can be provided to the tissue for ablation, labeling, or both. An electrolytic device (e.g., a device capable of performing electrolysis) can be positioned near the tissue area for visual labeling. Electrolysis can be performed to alter the visual appearance of the tissue (e.g., to discolor the tissue), thereby creating a visual label. Labeling under incomplete tissue treatment can be achieved through various energy delivery parameters, such as ablation with shorter duration and relatively high amplitude pulses, or ablation with longer duration and lower amplitude pulses, adjusting the delivery parameters in each case to avoid complete ablation of the target area. Tissue labeling can occur through electrochemical processes. In some instances, electrochemical interactions may depend on the total amount of electrons supplied or removed at the electrode-tissue electrolyte interface. The degree of reactivity of the electrochemical interaction can be controlled by manipulating the amount of charge delivered through a specified controlled volume of tissue and / or the electrode surface area. In some instances, ablation can be performed using a threshold electric field of hundreds of V / cm and additional electrolysis (charge). In some instances, labeling tissue to provide visual marking can be performed by individually passing sufficient charge through the tissue at a designated location at a low voltage, without causing significant tissue damage due to the absence of electroporation. Thus, transient visual marking can be provided at the electrode-tissue interface without inducing volumetric cell death. Such transient visual marking techniques may be useful when the user wants to create guiding marks that are not exactly at the boundary of the ablated area, for example, to provide a buffer of untreated tissue between subsequent ablations. Transient visual marking techniques also allow users to create marks before delivering ablation energy to visually test whether the electrode is in the desired location and to adjust the electrode position without ablation. In some instances, ablation can be performed using charge-balanced (e.g., biphasic) waveforms in both electroporation and electrolysis without producing discoloration. Following ablation, low-voltage, high-charge waveforms can be delivered to visualize the electrode contact area without causing further cell damage, allowing users to infer the ablation zone. Transient visual labeling offers many other advantages, not limited to the examples described herein.

[0082] While examples of electroporation and electrolysis are described as ablation techniques relevant to the visualization described herein, other intraluminal ablation techniques, including electrolysis, electroporation, thermal ablation, or other ablation techniques, may be used in other instances.

[0083] The parameter may be stored as parameter 114 in computer-readable medium 108. In some instances, controller 104 may be used to calculate parameter 114. In other instances, the parameter may be calculated by another system and may be provided to controller 104 and / or stored by controller 104.

[0084] System 100 may also include one or more sensors (not shown) for measuring pH, electric field strength, and / or other properties of tissue 10. For example, a pH sensor may be provided. In some instances, the pH sensor may be located on and / or attached to the delivery system, for example... Figure 1A and Figure 1B The ablation device 120. In some instances, the pH sensor may be located near the electrodes of the delivery system, for example... Figure 1A and Figure 1B The pH sensor is located near one or more electrodes 16. Therefore, the pH value near one or more electrodes can be detected. In some instances, one or more electrodes 16 may function as an anode, exhibiting acidity with a pH value less than 7. In some instances, one or more electrodes 16 may function as a cathode, exhibiting alkalinity with a pH value greater than 7. The pH sensor may be coupled to the controller 104, and the detected pH value is provided to the controller 104. Alternatively or additionally, a pH sensor may be provided at the outer edge of the target area of ​​the tissue. The pH sensor may be coupled to the controller 104, and the detected pH value is provided to the controller 104. Alternatively or additionally, a pH sensor may be provided at a specific site within the tissue to detect the pH at that specific location, such as a site where tissue damage is not desired. The pH sensor may be coupled to the controller 104, and the detected pH value is provided to the controller 104. The controller 104 may utilize one or more received pH values ​​as an indication of tissue ablation and / or potentially harmful pH levels that may lead to or are close to causing tissue damage. The controller 104 may combine pH values ​​in any manner. For example, controller 104 may take the difference between received pH values ​​(e.g., the pH value near the edge of the target tissue region versus the pH value near the electrode). Controller 104 may adjust the voltage, current, and / or electric field applied to the tissue based on the pH level or a combination of pH levels. For example, if the pH value at a location where tissue damage is not expected is at or above a tissue damage threshold, controller 104 may reduce the electric field amplitude or the duration between pulses, or stop applying the electric field. In some instances, if the pH value in the area where tissue ablation is desired is at or above a tissue ablation threshold, controller 104 may immediately stop applying current through the electrode and / or stop the electrolysis process after the desired electrolysis time has elapsed.

[0085] Furthermore, resistivity meters can be used to determine the resistance of target tissue. For example, a resistivity meter can be mounted on or otherwise coupled to a delivery system. Figure 1AThe controller 104 and / or power supply 102 can provide impedance measurements. Impedance measurements determine the resistivity of the tissue contacted by the electrodes 16 of the ablation device 120. For example, the controller 104 and / or power supply 102 can provide a nominal amount of current (e.g., DC current) through the tissue and receive resistivity measurements and / or calculate the resistivity of the tissue. In some instances, the applied voltage, current, capacitance, and / or electric field can be selected, determined, and / or allowed based on the measured resistance of the tissue. In some instances, the number of pulses for applying the voltage can be selected, determined, and / or otherwise used based on the measured resistance of the tissue. In some instances, the number of pulses can be from 1 to 10, 20, or 30.

[0086] The number of pulses can be selected to provide a specific dose (e.g., surface charge), which controls the ablation depth and / or circumferential ablation ratio (e.g., the ablation amount within a specific circumference can be increased). For example, the delivered charge of the number of pulses can be calculated. For instance, the charge Q (in coulombs, abbreviated C) delivered from the capacitor by the number of pulses is typically equal to the product of the capacitor's capacitance C (in farads, abbreviated F), its voltage V (in volts, abbreviated V), and the number of pulses N (in some instances, a natural number from 1 to 10, 20, or 30 or more). That is, Q = The ablation depth and / or circumferential ablation ratio can be controlled by selecting the number of pulses. The device described herein can control the number of pulses delivered (e.g., voltage pulses) based on a specific depth and / or circumferential ablation ratio. Typically, the amount of tissue perimeter affected by ablation can increase with increasing number of applied pulses. Despite the increase in ablation, heat generation can be reduced and / or avoided by using a combination of reversible electroporation and electrolysis. The applied surface charge can be only a fraction of the surface charge typically used when ablation is achieved using electrolysis alone.

[0087] In some instances, sensors can be used to detect and / or determine the electric field strength. The electric field strength at any point is obtained by measuring the potential difference between adjacent equipotential lines and dividing by the distance between them. The distance between equipotential lines is measured along the direction of the electric field lines perpendicular to the equipotential lines. In some instances, a gaussmeter and / or a teslameter can be used for this purpose.

[0088] During the procedure, electrode 16 can be brought to the vicinity of tissue. The electrode can contact tissue, be implanted within tissue, or be positioned on, beside, or near tissue. For example, an ablation device 120 including electrode 16 can be delivered to the patient to bring the electrode to the vicinity of tissue.

[0089] In some implementations, visualization of the tissue area, delivery of electrode 16 to the vicinity of the tissue, and treatment of the tissue area can be performed manually using system 100. For example, a user (e.g., a clinician) using ablation device 120 can directly visualize the area via imaging device 18 during the procedure. The user can manually advance and place ablation device 120 under direct vision to treat skip lesions and / or avoid overlapping ablation areas. When the user notices a skip lesion, the user can reposition the delivery system to perform additional ablation to treat the skip lesion.

[0090] In some instances, users can map the treatment based on direct observation of the area throughout the procedure to better plan intraoperatively, such as performing additional ablation on tissue outside the treated area. In some implementations, preoperative planning can also be achieved by screening endoscopy to identify duodenal lesions to identify patients who are likely to respond best to treatment.

[0091] In some implementations, visualization of tissue regions, delivery of electrode 16 to the vicinity of the tissue, and partial or complete treatment of tissue regions can be performed under robot-assisted control. In some instances, a user can utilize direct visualization of the region to actuate the ablation device 120 using user input coupled to a servo mechanism component (e.g., operator input system 1106), moving the ablation device 120 (which includes the imaging device 18, electrode member 15, and / or elongated flexible device 130) to the ablation area with robot assistance to achieve precision and avoid treatment gaps or overlap of ablation areas. In some instances, processor 106 or an external computing device coupled to controller 104 can automatically perform visualization of the region using, for example, image recognition, and can automatically control the movement of the elongated flexible device 130 based on the output of image recognition. For example, image recognition can output identification of missed areas, and the external computing device can control the elongated flexible device 130 to move to the missed areas to allow treatment of the missed areas.

[0092] In some implementations, visualization and positioning of the elongated flexible device 130 may be based on shape sensing, kinematic data, and / or positional data of the elongated flexible device 130 and / or devices within the treatment area to precisely place and abut the electrode 16 for endoluminal ablation. A robotic system (e.g., processor 106 or an external computing device coupled to controller 104) may execute planning software to construct a two-dimensional (2D) and / or three-dimensional (3D) region of the duodenal lesion using screening data (obtainable via screening endoscopy and / or via mapping during surgery using the elongated flexible device 130 to map the target tissue). The robotic system may use kinematic and / or positional data in real time to track the treatment area and treatment progress to improve real-time effectiveness. In some instances, the robotic system may generate reports for the user regarding a portion or total area or volume of treated tissue (e.g., duodenal lesion). These reports may be used to correlate the total treated area or volume (e.g., duodenal lesion) with dosimetric treatment with outcomes (e.g., A1C reduction and / or improved glycemic control through continuous glucose monitoring and time-range indicators).

[0093] Using positional and kinematic data, combined with intraoperative duodenal diameter mapping and total desired ablation length, a program executed by processor 106 or an external computing device coupled to controller 104 can provide feedback to the user to control the system with robot assistance. In some embodiments, the robotic system can automatically move the robot-actuated elongated flexible device 130 to each planned treatment area. Processor 106 or the external computing device can calculate the distance to move the robot-actuated elongated flexible device 130 based on at least some of the positional, kinematic, and shape-sensing data, combined with intraoperative mapping. Processor 106 or the external computing device can provide the calculated distance to the user to assist in the accurate placement and repositioning of the elongated flexible device 130 in some instances. For example, instead of automatically moving the elongated flexible device 130 via a controller, the user can control the movement of the robot-actuated elongated flexible device 130 using operator input system 1106 to perform ablation. The processor 106 or an external computing device can also provide information about the movement and contact of the robot-actuated elongated flexible device 130 to inform axial or rotational deployment, achieving optimal circumferential ablation and treatment zones to assist user control.

[0094] In some instances, processor 106 or an external computing device may use an image to perform one or more of the following operations: identifying untreated areas, providing feedback to a user about untreated or undertreated areas, and / or performing treatment by ablating untreated areas, imaging tissue within the area, acquiring a reconstructed 2D or 3D area, and acquiring a side view of the ablated tissue within the area from the reconstructed 2D or 3D area. Processor 106 or the external computing device may identify treated areas in the image and mark undertreated or untreated areas within the image. For example, the color associated with a treated area may differ from the color associated with an untreated area. In some instances, the color difference may be time-based. For example, within a specific time after treatment, tissue areas treated with electroporation and electrolytic ablation may appear discolored, while untreated tissue appears pink. Longer after treatment, ablated tissue areas may appear a deeper red than untreated tissue. Therefore, processor 106 may execute instructions to identify tissue areas with a different color from other tissue areas. Tissue areas with a whiter and / or deeper red appearance may be identified as treated areas. The processor 106 or external computing device can correlate or associate image identification information (e.g., locations marked in the image) with location and kinematic data, combined with intraoperative mapping of the duodenal diameter and the total desired ablation length, and automatically move the electrode assembly 15 using axial or rotational deployment by controlling the movement and contact of the robot-actuated elongated flexible device 130 to achieve optimal circumferential ablation and treatment area. In some instances, optionally, the processor 106 or external computing device can automatically control initial imaging and initial processing. After initial processing, the processor 106 or external computing device can continue to use the image to identify unprocessed areas, followed by a feedback loop for further processing of the unprocessed areas until the entire area has been processed.

[0095] In some instances, AI and / or ML, such as SLAM and / or YOLO, can be used to train algorithms and software executed by processor 106 or an external computing device to treat disease areas. For example, AI and / or ML models can be trained using images of treated areas from a patient population (with location and / or kinematic data or any clinical data relevant to the target disease being treated) to create a model of the target disease. Processor 106 or an external computing device executing the training program or algorithm with the model can use images from target patients with location and / or kinematic data or any clinical data to plan the ablation procedure. Thus, the ablation device 120 can be positioned in the treatment area using the medical procedure visualization system 100.

[0096] When the ablation device 120 is positioned in the treatment area, an electric field can be applied to the target anatomy via one or more electrodes 16 to provide precise, accurate, and repeatable ablation in open, laparoscopic, thoracoscopic, and / or robot-assisted procedures. For gastrointestinal applications, the ablation device 120 can be delivered intraluminally via a manual or robotic delivery device through an oral, anal, or abdominal route, using an integrated bipolar instrument, delivery probe, or catheter. For urological applications, the ablation device 120 can be delivered intraluminally via a manual or robotic delivery device through a urethral, ​​perineal, preperitoneal, or abdominal route, using an integrated bipolar instrument, delivery probe, or catheter. For gynecological applications, the ablation device 120 can be delivered intraluminally via a manual or robotic delivery device through a vaginal, perineal, or abdominal route, using an integrated bipolar instrument, delivery probe, or catheter. For hepatobiliary applications, the ablation device 120 can be delivered intraluminally to the ampulla of Vater via a manual or robotic delivery device via the oral route, using an integrated bipolar instrument, delivery probe, or catheter, or via a transgastric or transabdominal route to access the liver. For neurovascular applications, the ablation device 120 can be delivered intravascularly via a manual or robotic delivery device or via keyhole craniotomy, using an integrated bipolar instrument, delivery probe, or catheter. For cardiac applications, the ablation device 120 can be delivered intravascularly or transthoracically via a manual or robotic delivery device, using an integrated bipolar instrument, delivery probe, or catheter. For endobronchial ablation of the lungs to treat chronic obstructive pulmonary disease (e.g., chronic bronchitis and emphysema), the ablation device 120 can be delivered intraluminally via a manual or robotic delivery device via the nasal or oral route, using an integrated bipolar instrument, delivery probe, or catheter.

[0097] The process of applying an electric field to control ablation (e.g., inducing permeation and performing electrolysis) can be controlled by the computational system described herein, for example... Figure 1AThe controller 104 is controlled according to executable instructions 110 for ablation. An electric field can be applied to at least a portion of the tissue using electrode 16. For example, the controller 104 can apply a voltage to electrode 16 to apply an electric field. In some instances, liquids or other substances can be injected, contacted, or otherwise placed in or around the tissue to help shape the electric field generated in the tissue. The strength of the electric field in the tissue can cause reversible electroporation of the ablation target cell region. Thus, cell membranes in the ablation target tissue region can be permeated. In some instances, the electric field can be kept constant for a period of time and / or can be pulsed. The electric field pulse can have any of a variety of shapes (e.g., square wave pulse, triangular wave pulse, sine wave pulse, shock pulse, and / or exponentially decaying pulse). Electrolysis can be performed to generate electrolysis products. For example, the electrolysis products can be generated from the ions and molecules of an aqueous solution. The aqueous solution can be a solution of a naturally occurring physiological concentration present in the tissue. The ionic composition of the body fluid can be used as an ionicly conductive medium to induce an electrochemical reaction, forming the basis for electrolysis and / or can be introduced (e.g., injected) into the tissue during the methods described herein. Electrolysis products can be obtained by using the electrodes described herein (e.g. Figure 1B Electrode 16) generates an electric current through the tissue. The electrolysis products can diffuse within the tissue and ablate permeable cells. The time period for performing electrolysis and / or generating the amount of electrolysis products can be set herein such that the electrolysis products cause ablation of permeable cells but not of non-permeable cells. Furthermore, the time period and / or the amount of electrolysis products can be set to keep the extracellular matrix of permeable cells intact, which can promote regeneration of the ablated tissue area.

[0098] Various tissues can be treated using the systems and examples described herein. Typically, systems can be used to treat tissues of luminal organs when tissue regeneration is desired, or when it is desired to replace one cell type with another. Examples include the intestine, duodenum, stomach, bladder, uterus, endometrium, bronchial lining, ovary, colon, rectum, sinuses, ducts, ureters, prostate, skin, muscle, nerves, diaphragm, kidney, follicle, brain, lymphatic vessels, blood vessels, breast, esophagus, lung, liver, kidney, lymph nodes, lymph node regions, and / or heart. Generally, any luminal structure can be treated using the systems, devices, and techniques described herein. Replacement of one tissue type with another can be performed in fibrotic areas, where it is desired to replace fibrotic cells with stem cells capable of remodeling that area, or when islet portions are injected into the liver to generate a new source of insulin. Other tissues can be treated in other examples.

[0099] Figure 2 This is a schematic diagram of an ablation device 200 including an imaging device 28 according to the examples described herein. In some embodiments, the ablation device 200 may be... Figure 1A and Figure 1BThe ablation device 120. In some instances, the imaging device 28 may be the imaging device 18 that follows the ablation device 200.

[0100] The ablation device 200 may include one or more expandable members 24, one or more electrodes 262, and an elongated flexible device 22. In some embodiments, the elongated flexible device 22 may be... Figure 1A and Figure 1B The elongated flexible device 130. The elongated flexible device 22 may include an elongated member having a tubular shape. The distal end of the elongated flexible device 22 may be introduced into the tissue 10 of an organ within the lumen, such as an organ in the digestive pathway. The expandable member 24 is optional and may be omitted in some embodiments. In some embodiments, the ablation device 200 may be the end effector of a flexible ablation instrument that extends through or along the working channel of the elongated flexible device 130. In some embodiments, optionally, the ablation device 200 may be a detachable attachment coupled to the distal end of the elongated flexible device 130.

[0101] The ablation device 200 may include one or more expandable members 24. In the illustrated embodiment, the one or more expandable members 24 may be balloons. Other expandable members, such as meshes, may be used in other instances. The one or more expandable members 24 may expand in a variety of different ways. In some embodiments, the one or more expandable members 24 may be expanded with a fluid (e.g., air, saline, contrast agent solution, etc.). The fluid may be introduced into the one or more expandable members 24 through an elongated flexible device 22. The one or more expandable members 24 may have a length of 4 to 5 cm and may expand to a diameter between 2 cm and 4 cm. However, the length and expandable diameter of the expandable members 24 may vary depending on the tissue to be treated. In other instances, the expandable members 24 may expand in other ways (e.g., coiling, unfolding, advancing).

[0102] The ablation device 200 includes one or more electrodes 262 that provide electrolysis and electroporation processes according to embodiments of the present disclosure. The one or more electrodes 262 can be used to simultaneously provide electrolysis and electroporation to target tissue. While multiple electrodes 262 are shown, in some instances, multiple pairs of electrodes, including an anode and a cathode, may be used. In some instances, one electrode (e.g., an anode or cathode) may be used in conjunction with a return electrode (e.g., in a monopolar configuration). In some instances, the electrodes may be positioned and / or spaced to create and / or facilitate a uniform electric field. In some instances, one or more electrodes may be physically connected to one or more other electrodes (e.g., using a mesh or other connecting material portion) to create a fixed spacing between the electrodes. In the illustrated embodiment, multiple electrodes 262 may be disposed on the surface of the expandable member 24 to provide circumferential ablation. In some embodiments, the multiple electrodes 262 have a circular cross-section. The multiple electrodes 262 may alternate between anode and cathode arrangements. The anodes and cathodes of the multiple electrodes 262 may be dielectrically separated at any point where they intersect.

[0103] The anode and cathode can be made of any conductive material, such as stainless steel, titanium, gold, copper, graphene, graphite, etc. Typically, the electrode material is selected in part based on the application. For example, electrode materials can be selected to minimize ion transfer from the electrode material to the target tissue. For example, steel may not be preferred. Titanium and gold may participate in the electrolysis process to some extent; however, they may not generate toxic residues and can be used in some instances. In some instances, titanium can be used and may be preferred. In some instances, stainless steel can be used. In some instances, two separate metals (e.g., zinc and aluminum) can be used, which generate a current when placed close together, thereby generating electrolytic products. In some instances, the spacing between adjacent electrodes 262 can be approximately 3 mm, although other spacings can be used.

[0104] In some instances, the user can move the ablation device 200 and the imaging device 28 as follows: the imaging device 28 can follow the ablation device 200. The user can observe a white ring or line on the treated area immediately after ablation by viewing real-time images from the imaging device 28. The user can move the ablation device 200 as follows: at least one anode can be positioned near the undertreated area or near the area marked for ablation.

[0105] In some instances, the user can move the ablation device 200 and the imaging device 28 to mark the leading and / or trailing edges of the treatment area using the ablation device 200 as described herein. After marking the leading and / or trailing edges, the user can move the ablation device 200 based on the marked leading and / or trailing edges (e.g., between edges when both are present, or across an edge of a desired length, or toward a desired marker where an edge is present) to perform ablation.

[0106] One or more electrodes 262 may be attached to two or more wires extending along the elongated member of the elongated flexible device 22, providing electrical signals (e.g., voltage and / or current) to the one or more electrodes 262. These wires extend downwards along the length of the elongated member to a controller 104 and / or a power source 102 generator, which may be located externally. Once the one or more expandable members 24 are in place and expanded into an expandable configuration, and the one or more expandable members 24 are pressed against the gastrointestinal wall, current flows through the electrodes, inducing an electrolytic and electroporation field. The applied electric field may be from 10 V / cm to 2,500 V / cm. Subsequently, the one or more expandable members 24 may be deflated.

[0107] For example, one or more electrodes 262 may be made of piezoelectric and / or thermoelectric materials that can generate electricity over time. In some instances, the power source may be placed within tissue, such as a battery. In some instances, microbatteries may be used, which may include one or more electrodes described herein, or other electrodes. In some instances, microbatteries may be charged using microcurrents in tissue (e.g., bodily microcurrents). For example, a scaffold with such microbatteries may be used.

[0108] In some instances, the ablation device 200 may be used or coupled with the imaging device 28 in such a way that the imaging device 28 can follow the ablation device 200. In some instances, a user can observe a white ring or line on the treated area immediately after ablation by viewing a real-time image from the imaging device 28, and the user can move the ablation device 200 in such a way that at least one anode can be positioned near the undertreated area or near the marked ablation area. Optionally, a computing device (e.g., processor 106 or coupled to...) may be used in conjunction with the imaging device 28. Figure 1A The external computing device of the controller 104 can perform visualization of the area based on the image from the imaging device 28 using image recognition and other methods, and automatically actuate the ablation device 200 to the ablation area to achieve better accuracy, avoid processing gaps or overlap of ablation areas, or provide guidance to the user on the positioning of the ablation device 200.

[0109] In some instances, a user can move the ablation device 200 to mark the leading and / or trailing edges of the treatment area to induce energy delivery. After marking the leading and / or trailing edges, the user can move the ablation device 200 based on the leading and / or trailing edges to perform ablation. In some instances, a computing device can use the ablation device 200 to mark the leading and / or trailing edges of the treatment area. The computing device can further control the imaging device to move to the leading edge and image the area, and based on the image from the imaging device, identify markers or electrolytic markers within the area; move the imaging device to a proximal portion of the treatment area to measure the travel distance from the trailing edge to the markers or electrolytic markers; move the imaging device to the leading edge to pre-map the area, plan one or more treatment segments in the map based on a predetermined length, treatment location, travel distance, or a combination thereof within the treatment area; and move the ablation device to one or more planned treatment segments. Thus, by including the imaging device 28 in the ablation device 200, automated processing can be performed.

[0110] Figure 3 Is using Figure 1A The flowchart illustrates a method 300 for visualizing a medical procedure using system 100. Method 300 may begin at operation 302, where an ablation device (e.g., electrode component 15 of the medical procedure visualization system 100) treats tissue within a treatment area using endoluminal ablation. In some instances, ablation includes a combination of electroporation and electrolysis, which can cause a change in tissue color. Method 300 may proceed to operation 304, where a processor (e.g., processor 106 in controller 104 or an external computing device coupled to controller 104) controls an imaging device (e.g., imaging device 18) to image the area to identify treated regions within it. In some embodiments, such imaging control may be performed manually by a user (e.g., via manual movement or under robotic guidance, e.g., via operator input system 1106). In some embodiments, the processor may perform imaging automatically. Imaging may be performed using white light endoscopy, NBI, fluorescence, chromoendoscopy, OCT, or radial ultrasound, or combinations thereof. In some embodiments, white light endoscopy may be used to image the area, where treated areas appear discolored (e.g., white). White light endoscopy can be used to confirm processed areas in real time because the discolored processed areas in the post-ablation image are presented relatively instantly. For example, tissue whitening may be part of a visual change (such as discoloration) that occurs during treatment. In some instances, the entire tissue may undergo a discoloration change that the eye can perceive in the white light spectrum. In some instances, blue light optical filters can be used to observe the tissue, making the discoloration change more clearly visible.

[0111] Method 300 can proceed to operation 306 and identify ablated portions within the region in the post-ablation image. In some instances, the user may manually identify the ablated portions. In some instances, the processor may perform image recognition to identify the ablated portions. Once the ablated portions within the region are identified, one or more untreated or undertreated regions within the region can be identified. In some instances, the degree of intraluminal ablation of the treated region can be determined through visual assessment by the user or image recognition by the processor. Once the degree of intraluminal ablation is determined, additional ablation can be performed in selected additional regions within the target region. Such additional ablation can be used to treat untreated or undertreated target regions. The energy applied for additional intraluminal ablation at the target region can be adjusted based on the degree of intraluminal ablation. In some embodiments, adjusting the energy applied for additional ablation may include controlling at least one of the following: pulse duration, applied current, applied charge (e.g., electric field strength), applied voltage, number of pulses, or combinations thereof. Optionally, in some instances, a drug may be delivered to the treatment region, including providing a drug substance to or near the treatment region.

[0112] Method 300 can proceed to operation 308, performing additional intraluminal ablation in a selected additional region within the zone based on the location of the treated region. In some embodiments, the additional ablation may be delivered to the zone based on the appearance of the treated region. The zone may include one or more untreated or undertreated regions. In some embodiments, untreated or undertreated regions may be identified in the post-ablation image by marking the image portion outside the treated region within the zone. In some embodiments, such marking may be performed via image recognition. In some embodiments, the marking in the post-ablation image may be compared with kinematic data of a robotic system that controls the ablation device 120 to actuate. Based on this comparison, location data of the additional region may be generated. The additional intraluminal ablation may be performed using the location data to position the robotic system to treat the selected additional region.

[0113] The operation of method 300 may be performed in a sequence different from that shown. The operation of method 300 may include further operations. In some instances, region identification may be performed prior to method 300. For example, the anterior and / or posterior edges of the region may be marked using the endovascular ablation device in method 300. In some embodiments, the anterior and / or posterior edges may be visualized under a white light endoscope in such a way that ablation can be performed immediately after the edges are marked. Ablation may be performed by manually, robotically assisted, or automatically moving the ablation device 120 to place the electrode near the undertreated or untreated area and apply treatment until no skip lesions are found between the anterior and posterior edges.

[0114] Figure 4 Is using Figure 1AA flowchart of a method 400 for visualizing a medical procedure using a medical procedure visualization system 100. Method 400 may begin at operation 402, where an ablation device (e.g., electrode component 15 of the medical procedure visualization system 100) can be used to ablate tissue within a target region via an intraluminal ablation process, including a combination of electroporation and electrolysis. Electroporation and electrolysis can cause tissue staining. Method 400 may proceed to operation 404, where a processor (e.g., processor 106 in controller 104 or an external computing device coupled to controller 104) controls an imaging device (e.g., imaging device 18) to image the region to identify the treated area. In some embodiments, such imaging control may be performed manually by a user or under robot guidance, for example via operator input system 1106. In some embodiments, the processor may perform imaging automatically. Imaging may be performed using white light endoscopy, NBI, fluorescence, chromoendoscopy, OCT, or radial ultrasound, or a combination thereof. In some embodiments, white light endoscopy may be used to image the region, where the treated area appears discolored (e.g., white). White light endoscopy can be used to confirm the processed area in real time because the discolored processed area in the ablation image is presented relatively instantly.

[0115] Method 400 may proceed to operation 406 and identify the ablated portion within the region in the post-ablation image. In some instances, the user may manually identify the ablated portion. In some instances, the processor may perform image recognition to identify the ablated portion. In some instances, it may be determined whether the treated region differs visually from at least one untreated region to identify the ablated portion using image recognition, kinematic data, shape sensing data, and / or visual evaluation. In some instances, the degree of ablation of the treated region may be determined through image recognition, kinematic data, shape sensing data, and / or visual evaluation. The operations of method 400 may be performed in a sequence different from that shown.

[0116] The operation of method 400 may include further operations for preoperative planning. In some instances, method 400 may be used to identify the region. For example, the leading and trailing edges of the region may be marked by the ablation device before complete ablation is performed on the target region. As described above, the ablation device may deliver energy (e.g., electrolysis with or without electroporation) or other markers, with a dose and time sufficient to stain the region to provide physical marking to the tissue without causing complete ablation of the tissue to be treated. In some embodiments, the leading and / or trailing edges may be visualized using white light endoscopy and NBI imaging for planning purposes. The leading, trailing, and / or overlapping edges may be compared with at least one of shape sensing data, kinematic data, or positional data. Based on this comparison, a treatment plan may be generated, and the ablation device may be positioned between the leading and trailing edges based on at least one of shape sensing data, kinematic data, or positional data to perform ablation. In some embodiments, the ablation device may be positioned such that an electrode (e.g., the distal electrode) in the electrode 16 of electrode member 15 is positioned at the leading edge to mark the leading edge. The electrodes in the electrodes 16 of the electrode assembly 15 (e.g., the nearest-side electrode) can be positioned at the trailing edge to mark the trailing edge. Depending on the total desired processing length, the leading and trailing edges can be marked at the same time / position, or marked at different times / positions by moving the electrode assembly 15 between positions. During marking, other electrodes (including anodes and cathodes) can be positioned between the leading and trailing edges.

[0117] In some instances, the imaging device (e.g.) can be controlled. Figure 1BThe imaging device 18) moves to the leading edge and images the region. The processor can identify markers or one or more electrolytic shape forms within the region based on the image from the imaging device, such as circles, squares, dots, hexagons, trapezoids, custom shapes, etc., or any combination thereof, and further control the movement of the imaging device to a proximal portion of the treatment region (e.g., a lumen or lumen length) to measure the travel distance from the trailing edge to the marker or electrolytic mark, and further control the movement of the imaging device to the leading edge. The processor can pre-map the region and plan one or more treatment segments in the map based on a predetermined length, treatment position, travel distance, or a combination thereof within the treatment region. In some embodiments, pre-mapping includes anatomical localization. In a medical procedure executed according to the pre-mapped map, the processor can move the ablation device to one or more planned treatment segments. During the medical procedure, the processor can dynamically adjust one or more positions of one or more treatment segments based on images to update the planned one or more treatment segments. Therefore, automated preoperative planning and automated processing can be performed. In some instances, automated preoperative planning and automated processing can be based on linear traveling references that provide anatomical localization for mapping, planning, confirmation, and dynamic adjustment and updating. These linear traveling references can be obtained through computer vision algorithms. In some instances, anatomical localization (e.g., marker recognition) can utilize YOLO neural networks or attention networks. For example, highlighting regions as markers in an image can easily indicate the relationship between the image and the region in the actual tissue. After marker classification, the processor can determine the corresponding depth value associated with the relevant portion of the image or, for example, the entire image as identified by a YOLO network, and label the corresponding tissue portion representing the positional relationship between the region and the marker or map. In some instances, computer vision algorithms for the position and orientation of visual SLAM or other computationally comprehensible imaging devices relative to their surrounding environment, including the tissue, can be used for anatomical localization.

[0118] In some instances, computer vision algorithms can be used to create mosaics or composite views of the treated anatomical region. An imaging device can be controlled to capture a series of images of the treated region, and a mosaicking algorithm can stitch these images together to form a composite view of the treated region. Composite views can be captured at various stages of the procedure and can be generated or updated multiple times before, during, or after the procedure. For example, a composite view can be generated before treatment for preoperative planning. This may be part of the initial scan of the target region described herein. Areas to be labeled and / or treated can be identified in the preoperative planning composite view. After the composite view is created, the user can then optionally perform labeling on the tissue using the ablation device described herein. In some implementations, labeling can be omitted. Ablation can then be performed using the ablation device. Labeling and / or ablation can be performed manually under visualization, with robot assistance, or automatically as described herein. Optionally, the composite view can be displayed simultaneously with the labeling and / or ablation steps, and the composite view can be updated based on the position and orientation of the ablation device relative to the anatomical structure. After treatment, the treated tissue can be identified by color changes described herein. Further composite views can optionally be generated or updated to depict the amount of treated tissue. Additional processing can be performed, as described herein, and composite views can be further generated or updated based on this additional processing. Further details of the image mosaicking are found in U.S. Patent No. 10,695,136, which is incorporated herein by reference.

[0119] In some instances, imaging can be aided by introducing an imaging reference frame. For example, an ablation device or catheter marked in cm or mm. Thus, the image can include a known reference scale that can be used as a registration marker to measure the movement of the ablation device, including the electrode components. Based on the image including the scale, the movement of the ablation device within the treatment area (e.g., a lumen or cavity) can be visualized as length.

[0120] In some implementations, an initial scan of the target region can be performed using an imaging device to survey the target area. Proximal and distal markers can be set to indicate the areas to be ablated. The markers can be set virtually in the image on the user interface, or they can be set as leading and / or trailing edges provided by the ablation device (e.g., electroporation and electrolysis energy application or other markers induced by the ablation device). The ablation process can then be performed manually based on visual feedback if the user applies ablation, or under robot-assisted guidance via user input, or fully automatically if the processor controls the process using markers as start and stop positions, or semi-automatically if the processor can use markers as a start position and the user inputs the desired treatment length, or if the user can select a start position without applying a specific marker, and the processor can execute an ablation-imaging loop until the system reaches a stop marker, etc. After treatment is applied, a post-treatment scan can be performed via imaging to identify any gaps or undertreated areas, which can then be reprocessed manually or automatically by the system.

[0121] In some instances, AI and / or ML can be used to train algorithms and software for treating disease areas, executed by processor 106 or an external computing device. For example, creating a target disease model may include training AI and / or ML models (e.g., SLAM and / or YOLO), or may use images of treated areas from a patient population (with location and / or kinematic data or any clinical data relevant to the target disease being treated). Ablation treatment planning via a training procedure or algorithm with a model can use images from target patients with location and / or kinematic data or any clinical data. Thus, the localization of the ablation device 120 in the treatment area can be performed using the medical procedure visualization system 100.

[0122] The examples described in this article, including references Figure 3 and Figure 4 The described methods may involve treating and imaging tissue within a treatment area. However, it should be understood that in some instances, treating tissue may simply refer to labeling tissue, and not necessarily providing ablation or significant ablation. The controller described herein may provide one or more pulses or other waveforms to an electrode positioned near the tissue, wherein the pulse amplitude, number, and / or duration are set for labeling the tissue. For example, the tissue may change color in response to the generation of certain substances at the electrode. In some instances, tissue labeling may occur without causing tissue volume ablation or significant tissue ablation. In some instances, tissue labeling using electrodes as described herein may be performed by using electrolysis alone and / or primarily using electrolysis. In some instances, such tissue labeling may be used to apply subsequent voltage and / or current pulses to further induce ablation.

[0123] Therefore, in some instances, one or more electrodes can be activated to label tissue, which can be performed simultaneously with or separately from significant tissue ablation. For example, in Figure 3 Box 302 and / or Figure 4 Within box 402, tissue can be labeled. Tissue imaging (such as...) Figure 3 Box 304 and / or Figure 4 Box 404 may accordingly allow the marker to be visualized (by a human user and / or an automated image analysis system). Tissue processing can then be performed, where the ablation location is determined based on the location of the marker. Tissue processing may include ablation.

[0124] Therefore, the control system (e.g., a controller) described herein can provide a first set of waveforms to the electrodes, wherein the first set of waveforms provides sufficient energy to the tissue for marking. Based on the location of the visual markings, the electrodes can be positioned in the treatment area, and the control system can provide a second set of waveforms to the electrodes, wherein the second set of waveforms provides sufficient energy to the tissue for ablation (e.g., using electroporation and electrolysis).

[0125] Furthermore, it should be understood that the size, shape, and positioning of the electrodes can vary. Although Figure 1B and Figure 2 Electrodes are depicted that can access the full circumference of tissue (e.g., gastrointestinal tissue), but in some instances, only a portion of the tissue circumference can be processed and / or marked. For example, the electrodes may be sized and / or positioned to access only a portion of the tissue circumference. In some instances, after marking and / or processing a portion of the circumference, the device may be rotated to place the electrodes near an unprocessed or unmarked portion of the circumference, and the unprocessed or unmarked portion may be processed and / or marked.

[0126] Figure 5 This is a schematic diagram of the anatomical structure arranged according to the example described herein. The anatomical structure includes the liver 502, stomach 504, pancreas 506, duodenum 508, and jejunum 510. The ablation device example described herein can deliver an electric field to the duodenum 508 and / or jejunum 510 to perform electroporation and electrolysis.

[0127] Figure 6A This is a schematic diagram of an electrode used as the anode in the example described in this article. Figure 6B This is a schematic diagram of an electrode used as the cathode, based on the example described in this article.

[0128] In response to the charge transport waveform in the duodenum 508 and contact with aqueous secretions of the lining, destructive acidic hydrogen ions are significantly generated at the anode, while destructive alkaline hydroxides are generated at the cathode. In some instances, the aqueous reaction at the anode produces oxygen, acidic hydrogen ions, and electrons. The sodium chloride reaction at the anode produces chlorine gas that attacks carbon, and electrons. The localization of chlorine and chloride ions at the anode can lead to the formation of known decolorizing chemicals such as chlorite ions (ClO2). - The process involves the generation of sodium hypochlorite (NaOCl) and / or other substances. In some instances, the water reaction at the cathode produces hydrogen gas and basic hydroxide ions. The sodium reaction at the cathode can produce trace amounts of solid sodium. With the interaction of ionic substances, acidic substances, such as hydrochloric acid (HCl), are generated at the anode, and basic substances, such as sodium hydroxide (NaOH), are generated at the cathode. These products from the anode and cathode can be used to discolor tissue without causing significant damage, or, in some instances described herein, can be used in conjunction with electroporation to further promote mucosal ablation of the electroporated cell area. In some embodiments, the electrolyzed products can be used in the tissue staining process as well as to prolong electroporation-mediated tissue ablation.

[0129] When an electrode applies current through tissue in contact with or near the electrode, acidic and basic substances can be generated at the anode and cathode, respectively. These substances can penetrate the tissue and may cause tissue discoloration (e.g., whitening). Initially, the anode may provide significant discoloration. Over time, relatively uniform ablation can be observed near the anode and cathode. In some embodiments, the amount of discoloring substance generated can be controlled as a function of charge density to control ablation. Charge density can be adjusted by controlling end-effector size, current delivery, capacitance, duration, or number of pulses or other generator control parameters. In this way, the luminal ablation described herein produces a color change in the treated tissue. As described herein, this color change can be used to adjust and / or plan the treatment. In some instances, the color change may occur to varying degrees at locations corresponding to electrode positions and / or specific electrode locations. Therefore, treatment planning and / or treatment adjustment herein may refer to positioning the treatment apparatus based on imaging to place the electrodes in specific locations.

[0130] Figure 7A This is an example image 70 of a medical procedure using an ablation device 72 to visualize the treated site, according to the examples described herein. The ablation device 72 may include one or more expandable members 74 and an ablation apparatus including one or more electrodes 76. In some instances, the ablation device 72 may be an ablation device 120.

[0131] The ablation device 72 can be introduced into the patient's small intestine, while an expandable member 74 (e.g., expandable member 74) assists in expanding a flexible electrode assembly with multiple electrodes 76 to contact the target tissue. Once the ablation device 72 reaches the target treatment site and the expandable member 74 and electrodes 76 have expanded to contact the tissue, ablation using electroporation and / or electrolysis is performed at the desired treatment location. After treatment, the expandable member 74 and electrodes 86 can be compressed. An imaging device (not shown) (e.g., imaging device 18) of an elongated flexible device (e.g., a monocular or binocular camera on an endoscope) can image the treatment site. Imaging can be performed immediately after ablation.

[0132] Figure 7B This is an example image 70 of a medical procedure using an ablation device 72 to visualize the treated area according to the examples described herein. Once tissue within the treated area is treated using an ablation device including electrode 76 (e.g., electrode component 15 of ablation device 120), white rings 702 and 704 immediately appear as ablation marks on the treated area of ​​the tissue. An imaging device can image this area using significant visualization (e.g., monocular visualization with white light endoscopy). The treated area can be identified by recognizing the white rings 702 and 704. In some instances, immediately after ablation, the white ring 702 of the treated area above the electrode operating as the anode is whiter and more prominent than the white ring 704 of the treated area above the electrode operating as the cathode. In some instances, immediately after ablation, the white ring 704 of the treated area above the electrode operating as the cathode is redder and paler than the white ring 702 of the treated area above the electrode operating as the anode. Several hours after ablation, the rings 702 and 704 of the treated area become equally prominent red.

[0133] Example Duodenum 508 and distal jejunum 510 were selected as models to demonstrate the ability of the medical procedure visualization system 100 to visualize the ablation zone and identify the treated area. These embodiments are provided to demonstrate examples of parameters for electroporation combined with electrolysis that allow visualization of the treated area and demonstrate that electroporation and electrolysis can be precisely delivered.

[0134] Minimally invasive ablation using electroporation (reversible electroporation and electrolysis) was performed in the duodenal and jejunal mucosa as an example of an ablation modality where electroporation is controlled to promote staining of the ablated tissue.

[0135] The goal of these embodiments is to verify that electroporation can ablate tissue regions within the ablation zone in order to identify the area and extent of electroporation ablation. To explore these aspects of electroporation ablation, duodenal and distal jejunal mucosa from one or more pigs were used as experimental models.

[0136] A series of acute studies were conducted to evaluate the ability of electroporation ablation to induce tissue staining and to investigate the effects of various treatment parameters on the extent of tissue staining induced by ablation. Histological specimens were taken six to eight hours post-ablation to follow up on the treatment results and to verify the regenerative capacity of tissues ablated using electroporation.

[0137] Example 1 The treatment site is located in duodenum 508. Figure 8A This includes example images of treatment sites using a white light endoscope, as described in this document. The ablation ring 802 corresponding to the anode is visually more prominent than the ablation ring 804 corresponding to the cathode. Therefore, these rings can indicate treatment information, such as the actual treated area within the treatment zone and the type of electrode (either anode or cathode) used to ablate the treated area. This information helps identify the exact location of the electrodes and the corresponding treated areas, and allows for the planning of additional ablation.

[0138] The ablated "white" ring then turned red over time, and one hour after ablation, the ablation area directly above the electrode had a distinct red ablation appearance. Figure 8B These are example images of the treatment site using NBI, based on the examples described in this article. The treatment site is located in the duodenum at 508. The area shown in ring 806 was subsequently further visualized using NBI, with the ablation directly above the electrode being more prominent in NBI mode.

[0139] Using white light endoscopy and NBI images, the user or robotic system can map the surface area of ​​the treatment zone and determine the start and end points of the new treatment zone in order to ablate as many duodenal lesions as possible, since a dose-dependent relationship between ablation and A1C reduction is known in DMR using thermal methods.

[0140] Six to eight hours after tissue ex vivo and analysis, histological results can be obtained at the electrode (cathode and anode) sites, which show mucosal rash areas indicating complete ablation and apoptosis (transmucosal ablation). Figure 8CThese are example images of the treatment site according to the embodiments described herein, histologically showing the mucosal rash area in relation to the electrode placement. Alkaline damage is known to be more corrosive, for example, due to alkaline substances present in esophageal injuries. The higher surface tension of alkalis allows for longer contact time with esophageal tissue, explaining the greater severity of esophageal injuries. Corrosive damage leads to coagulative or liquefactive necrosis, loss of both intracellular and extracellular structures, such as ablation of the extracellular matrix, and at high concentrations can cause damage to underlying muscle layers, resulting in scarring, stenosis, and in the worst case, perforation. Therefore, severe corrosive damage due to high-concentration contact areas on sensitive organs is extremely dangerous and undesirable. During E2 ablation, the charge generated on the electrode surface produces moderate, transient amounts of ionic material and corrosive byproducts. Therefore, the ionic material generated by electrolysis can diffuse into intracellular regions of cells and induce apoptosis, where electroporation (cell perforation) occurs in the electric field locally applied to the target area, thereby achieving controlled ablation depth without significant damage to the extracellular matrix, as shown in the provided histological examples. Therefore, cell death can be achieved within the electroporation target area without damaging the surrounding extracellular matrix. Visualization of the treatment site allows for control of the ablation depth to preserve the extracellular scaffold that promotes faster tissue regeneration without scarring, fibrosis, stenosis, or ulceration, and to protect the underlying muscular layer of the intestinal wall. In cases of DMR or endobronchial ablation for chronic bronchitis, it is preferable to adjust the energy to achieve complete cell ablation with minimal / no damage to the ECM. However, in some applications, it may be necessary to generate sufficient charge to intentionally damage the ECM through corrosive and acidic processes. For example, when intentionally ablating nerves or coagulating blood vessels using E2 (or in various other embodiments), it may be desirable to locally disrupt ECM components in addition to ablating cells by generating excessive amounts of electrolytic products that induce a local ablation effect independently of the electric field applied to the target area. In these cases, the ablation energy can be adjusted to provide a higher amount of local charge, using only electrolysis to generate higher concentrations of corrosive and / or acidic products that denature proteins in the target area.

[0141] White light visualization of the ablation zone is readily visible under direct vision for a relatively short time post-ablation. NBI images of the treated area become visually more pronounced over time. White light can be used to confirm ablation, adherence, and successful treatment for a relatively short time post-ablation, while NBI significantly improves capillary pattern contrast and is an in vivo method for visualizing microvascular morphological changes in mucosal tissue. Therefore, NBI can better assess mucosal and vascular patterns. Vascular occlusion occurs at the site of the applied electroporation field after ablation. It is presumably that NBI more easily defines the ablation area and acts as a filter to make lesions appear more prominent. Furthermore, other methods such as fluorescence, chromoendoscopy, OCT, or radial ultrasound can be used to visualize and confirm the ablation area. In some embodiments, the single field of view of direct visualization makes it suitable for surface area mapping, while a stereoscopic field of view can provide more robust and accurate surface area mapping of the treated area as well as potential volumetric measurements of the total ablation area. OCT and radial ultrasound can identify the ablation area and provide corresponding areas of volumetric ablation and depth. In some embodiments, AI and ML neural networks and recognizers (such as SLAM and / or YOLO) can be used to train single-field and stereoscopic field-of-view videos and images to accurately overlay the location of ablation, track the ablation zone, and calculate ablation information (such as total treated area and / or volume), providing the user with videos and / or images showing the overlay, tracking, and calculated ablation information of the ablation area. In some implementations, AI and ML can also be used to map the entire duodenal lesion area and track the ablation area, thereby providing the user with a "tracking / progress bar" related to the total surface area and / or volume of the applied treatment to ensure the maximum possible efficacy and safety of DMRe treatment.

[0142] In Examples 2 and 3, an ablation device with a full-size DMR catheter having circumferential electrode wiring was used.

[0143] Example 2 The treatment site is located in the distal jejunum 510. In this embodiment, ablation is applied via capacitive discharge at a voltage of 300V and a capacitance of 400 µF, resulting in a charge per unit surface area (Q / SA) of 3.37 x 10⁻⁶. -4 C / mm 2 It can calculate the electric field strength when a 300 V voltage is applied to a 3 mm gap. The balloon diameter is 29 mm and the length is 40 mm. The balloon pressure is 2.5 psi.

[0144] Figures 9A-9C These are example images of the ablation-treated areas of pig small intestine observed using a white light endoscope according to the embodiments described herein. Figure 9A Shows the appearance four minutes after processing. Figure 9B Shows the appearance seven minutes after processing. Figure 9C Shows the appearance 160 minutes after processing.

[0145] Four minutes after treatment, a very faint circumferential white line 902 was observed on the corresponding anode electrode. Figure 9A As shown. Three minutes later, with Figure 9A Compared to the white line 902 in the middle, Figure 9B The white line 902 becomes more prominent. For example... Figure 9C As shown, the white line 902 disappeared 160 minutes after the treatment.

[0146] Example 3 The treatment site is located in the distal jejunum 510. In this embodiment, ablation is applied via capacitor discharge at a voltage of 300V, a capacitance of 800 µF, and a Q / SA of 6.37 x 10⁻⁶. -4 C / mm 2 The electric field strength when a 300 V voltage is applied to a 3 mm gap can be calculated. The balloon diameter is 29 mm and the length is 40 mm. The balloon pressure is 2.5 psi.

[0147] Figures 10A-10D These are example images of the ablation-treated areas of pig small intestine observed using a white light endoscope according to the embodiments described herein. Figure 10A Shows the appearance three minutes after processing. Figure 10B Shows the appearance eight minutes after processing. Figure 10C Shows the appearance 45 minutes after processing. Figure 10D Shows the appearance 130 minutes after processing.

[0148] Three minutes after processing, a distinct solid white line 1002 was observed on the corresponding anode electrode, as shown. Figure 10A As shown. The outer white line 1002 breaks at the top and does not form a complete circumferential loop. Eight minutes after treatment, a fine white line 1004 corresponding to the cathode electrode was observed, as shown. Figure 10B As shown. 45 minutes after treatment, white lines 1002 and 1004 had the same whiteness level. White line 1004 may have become more prominent between 8 and 45 minutes due to ablation over time. These white lines 1002 and 1004... Figure 10C They are visible at similar levels of whiteness. For example... Figure 10D As shown, white line 1002 begins to show red coloring 1008 in its upper left portion approximately 160 minutes after processing.

[0149] Based on the results of Examples 2 and 3, a rapid whitening effect was observed within three minutes after ablation in the treated areas corresponding to the anode electrode (acidic, low pH, positive polarity lead). In the treated areas corresponding to the cathode electrode (alkaline, high pH, ​​negative polarity lead), a delayed whitening effect was observed 3 to 10 minutes after ablation. Over time, approximately 45 minutes after ablation, all treated areas began to show similar levels of whitening. After 2 to 6 hours, the color changed from white to dark red. The comparative results of Examples 2 and 3 indicate that the whitening effect can be determined by charge titration. For example, under the same electric field strength, applying a lower charge as shown in Example 2 resulted in less whitening, while applying a higher charge as shown in Example 3 resulted in more whitening.

[0150] As can be seen from the above embodiments, visual coloring can be controlled, for example, by the positioning of the anodic / cathode electrodes, the passage of time after ablation, electrically or chemically controlled ablation dosage, and / or imaging techniques. White coloring of the treated area can appear immediately after ablation. Red coloring appears over time, approximately one to several hours later.

[0151] In some embodiments, the charge applied to the treatment area may be optimized based on a pattern. In some embodiments, the area may be divided into circumferential portions, such as quadrants or three portions. Charge may be applied to ablate undertreated areas within the circumferential region that matches the partitioned area, thereby improving treatment fit. For example, ablation at the corner of a luminal organ may fail due to partial electrode incomplete contact. In some embodiments, the medical procedure visualization system 100 may detect such failures and notify the user to perform additional ablation reprocessing by moving the electrode closer to the undertreated area or to automatically reprocess the undertreated area. In some embodiments, the medical procedure visualization system 100 may detect such failures and change the activated portion of the electrode to reprocess the undertreated area. In some embodiments, the white ring width may be widened by activating a wider electrode region. In some embodiments, the salience of the white or red ring may be adjusted by adjusting voltage, electric field, capacitance, current amplitude, duration, number of pulses per unit time, etc. In some embodiments, the medical procedure visualization system 100 may detect the salience of the white or red ring and adjust the dose. In some embodiments, approximately 10 pulses may be applied to each area. In other embodiments, a smaller number (e.g., 5) of initial pulses may be applied, and the medical procedure visualization system 100 may examine the salience of the white lines and determine whether further pulses should be applied in the area between electrodes or outside the electrode contact area, or in the same area, to optimize the bleaching effect.

[0152] In some embodiments, the medical procedure visualization system 100 may also notify of treatment and / or drug dosage. In some embodiments, the intestine may move during / under treatment. The medical procedure visualization system 100 may notify the dosage of muscle paralyzing agents and / or anti-peristaltic agents based on observed movement, thereby enabling real-time drug delivery.

[0153] The aspects of this disclosure may be part of a computer-aided remote-operated manipulator system, sometimes referred to as a robot-assisted manipulator system or a robot system. The manipulator system may include one or more manipulators that can operate with the assistance of an electronic controller (e.g., a computer) to move and control the functions of one or more instruments when coupled to the manipulator.

[0154] Figure 11 An embodiment of a robot-assisted manipulator system (also known as a robot-assisted servo mechanism system) for use in the system described herein is shown. This manipulator system can be used for, for example, surgical, diagnostic, therapeutic, biopsy, or non-medical procedures, and is generally indicated by reference numeral 1100. Figure 11 As shown, the robot-assisted servo system 1100 may include one or more manipulator components 1102 for operating one or more medical instrument systems 1104 to perform various procedures on a patient P located on an operating table T in a medical environment 1101. For example, the manipulator component 1102 may drive catheter or end effector movement, apply treatment to target tissue, and / or manipulate control components. For example, the manipulator component 1102 may drive one or more catheters and / or assist described herein. Figure 1APositioning of the various parts of the system 100. The manipulator assembly 1102 can be a remotely operated, non-remotely operated, or hybrid remotely and non-remotely operated assembly, wherein selected degrees of freedom of motion are electrically powered and / or remotely operated, and selected degrees of freedom of motion are non-electrically powered and / or non-remotely operated. The operator input system 1106 may be located inside or outside the medical environment 1101 and typically includes one or more control devices for controlling the manipulator assembly 1102. The manipulator assembly 1102 supports the medical instrument system 1104 and may optionally include multiple actuators or motors that drive inputs on the medical instrument system 1104 in response to commands from the control system 1112. The actuators may optionally include a drive system that, when coupled to the medical instrument system 1104, can advance the medical instrument system 1104 into naturally or surgically created anatomical channels. Other actuation systems may enable the distal end of the medical instrument system 1104 to move in multiple degrees of freedom, including three linear degrees of freedom (e.g., linear motion along the X, Y, and Z Cartesian axes) and three rotational degrees of freedom (e.g., rotation about the X, Y, and Z Cartesian axes). The manipulator assembly 1102 may support various other systems for perfusion, treatment, or other purposes. Such systems may include fluid systems (e.g., including reservoirs, heating / cooling elements, pumps, and valves), generators, lasers, interrogators, and ablation components.

[0155] The robot-assisted servo system 1100 also includes a display system 1110 for displaying images or diagrams of the surgical site and medical instrument system 1104 generated by imaging system 1109, which may include an imaging system such as an endoscopic imaging system. The display system 1110 and operator input system 1106 are configured to enable operator O to control the medical instrument system 1104 and operator input system 1106 with a remote sense of presence. A graphical user interface may be displayed on the display system 1110 and / or on the display system of a standalone planning workstation.

[0156] In some embodiments, the endoscopic imaging system components of imaging system 1109 may be integrally coupled to or detachably coupled to medical instrument system 1104. However, in some embodiments, a separate imaging device (e.g., an endoscope) attached to a separate manipulator assembly may be used in conjunction with medical instrument system 1104 to image the surgical site. Endoscopic imaging system 1109 may be implemented as hardware, firmware, software, or a combination thereof, interacting with or being executed by one or more computer processors, and may include the processor of control system 1112.

[0157] The robot-assisted servo system 1100 may also include a sensor system 1108. The sensor system 1108 may include a position / positioning 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 position, orientation, speed, rate, attitude, and / or shape of the medical instrument system 1104. The sensor system 1108 may also include temperature, pressure, force, or contact sensors, etc.

[0158] The robot-assisted servo system 1100 may also include a control system 1112. The control system 1112 includes at least one memory 1116 and at least one computer processor 1114 for controlling the medical instrument system 1104, the operator input system 1106, the sensor system 1108, and the display system 1110. The control system 1112 also includes programming instructions (e.g., a non-transitory machine-readable medium storing the instructions) to execute programs using the robot-assisted servo system, including navigation, steering, imaging, deployment or retraction of engagement features, application of treatment to target tissue (e.g., by applying energy), etc.

[0159] The control system 1112 may optionally further include a virtual visualization system to provide navigation assistance to the operator O controlling the medical instrument system 1104 during image-guided surgery. Virtual navigation using the virtual visualization system may be based on a reference to a dataset acquired preoperatively or intraoperatively of the 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), fluoroscopy, thermography, ultrasound, OCT, thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, etc. The control system 1112 may use preoperative images to locate the target tissue (using visual imaging techniques and / or by receiving user input) and create a preoperative plan, including the optimal initial location for performing the procedure. The preoperative plan may include, for example, predetermined dimensions of the expandable device, the duration of the procedure, the temperature of the procedure, and / or multiple deployment locations.

[0160] Figure 12A A medical instrument system 1200 according to some embodiments is illustrated. In some embodiments, the medical instrument system 1200 can be used for image-guided medical procedures. In some embodiments, the medical instrument system 1200 can be used for non-remotely operated exploration procedures, or procedures involving conventionally manually operated medical instruments (such as endoscopes). In some embodiments, the medical instrument system 1200 can be used with... Figure 11 The medical instrument system 1104 may be interchangeable with, or a variation thereof. For example, the medical instrument system 1200 may include one or more catheters and / or endoscopes as described herein, and / or assistive devices. Figure 1A Positioning of each part of the system 100.

[0161] Medical instrument system 1200 includes an elongated flexible device 1202, such as a flexible catheter or endoscope (e.g., a gastroscope, bronchoscope), coupled to a drive unit 1204. The elongated flexible device 1202 includes a flexible body 1216 having a proximal end 1217 and a distal or tip portion 1218. In some embodiments, the outer diameter of the flexible body 1216 is approximately 114-20 mm. Other flexible bodies may have larger or smaller outer diameters. The flexible body 1216 may have an appropriate length to reach portions of anatomical structures, such as the lungs, sinuses, pharynx, or upper / lower gastrointestinal tract, when inserted into a patient's mouth or nasal cavity.

[0162] The medical instrument system 1200 optionally includes a tracking system 1230 for determining the position, orientation, velocity, rate, attitude, and / or shape of one or more segments 1224 on the distal end 1218 and / or the flexible body 1216 using one or more sensors and / or imaging devices. The entire length of the flexible body 1216, between the distal end 1218 and the proximal end 1217, can be effectively divided into segments 1224. The tracking system 1230 may optionally be implemented as hardware, firmware, software, or a combination thereof, and may interact with or be implemented by one or more computer processors, and may include... Figure 11 The processor of the central control system 1112.

[0163] Tracking system 1230 may optionally use shape sensor 1222 to track distal end 1218 and / or one or more segments 1224. In some embodiments, tracking system 1230 may optionally and / or additionally use position sensor system 1220 (e.g., electromagnetic (EM) sensor system) to track distal end 1218. In some embodiments, position sensor system 1220 may be configured and positioned to measure six degrees of freedom, such as three position coordinates X, Y, Z and three indicator base points pitch, yaw, and roll direction angles, or five degrees of freedom, such as three position coordinates X, Y, Z and two indicator base points pitch and yaw direction angles.

[0164] The flexible body 1216 includes one or more channels 1221, which are sized and shaped to receive one or more medical instruments 1226 (e.g., ablation device 120 or ablation device 200). In some embodiments, the flexible body 1216 includes two channels 1221 for a single instrument 1226; however, a different number of channels 1221 may be provided. Figure 12BThis is a simplified schematic diagram of a flexible body 1216 according to some embodiments, wherein a medical instrument 1226 extends. In some embodiments, the medical instrument 1226 can be used for procedures and procedural aspects, such as surgery, biopsy, ablation, mapping, imaging, illumination, perfusion, or aspiration. The medical instrument 1226 can be deployed through a channel 1221 of the flexible body 1216 and used at a target site within an anatomical structure. The medical instrument 1226 may include, for example, an image capturing device, a biopsy instrument, an ablation instrument, a catheter, laser ablation fibers, and / or other surgical, diagnostic, or therapeutic tools. Medical tools may include end effectors with a single working component, such as scalpels, blunt blades, lenses, optical fibers, electrodes, etc. Other end effectors may include, for example, forceps, grasping forceps, balloons, needles, scissors, applicators, etc. Other end effectors may also include electrically activated end effectors, such as electrosurgical electrodes, transducers, sensors, imaging devices, etc. The medical instrument 1226 may be advanced from an opening in the channel 1221 to perform a procedure and then retracted into the channel after the procedure is completed. The medical instrument 1226 can be removed from the proximal end 1217 of the flexible body 1216 or from another optional instrument port (not shown) on the flexible body 1216. The medical instrument 1226 can be used with an image capturing device (e.g., an endoscope camera) also located within the elongated flexible device 1202. Alternatively, the medical instrument 1226 itself can be an image capturing device.

[0165] The medical instrument 1226 may also accommodate cables, links, or other actuation control devices (not shown) extending between its proximal and distal ends to controllably bend the distal end of the medical instrument 1226. The flexible body 1216 may also accommodate cables, links, or other steering control devices (not shown) extending between the drive unit 1204 and the distal end 1218 to controllably bend the distal end 1218, for example, as shown by the dashed line depiction 1219 of the distal end 1218. In some embodiments, at least four cables are used to provide independent "up / down" steering to control the pitch motion of the distal end 1218 and "left / right" steering to control the yaw motion of the distal end 1218. In embodiments where the medical instrument system 1200 is actuated by a robot-assisted component, the drive unit 1204 may include a drive input detachably coupled and receiving power from a drive element (e.g., an actuator) of a remotely operated component. In some embodiments, the medical instrument system 1200 may include gripping features, manual actuators, or other components for manually controlling the movement of the medical instrument system 1200. Information from the tracking system 1230 can be sent to the navigation system 1232, where it is combined with information from the visualization system 1231 and / or the preoperative acquisition model to provide real-time location information to the doctor or other operator.

[0166] Other configurations of the remote-operated manipulator system have also been considered, such as systems configured for multi-port or single-port procedures. For example, the implementations described herein can be used with da Vinci® surgical systems, such as the da Vinci X®, Xi®, or SP® surgical systems, all of which are commercialized by Intuitive Surgical, Inc., Sunnyvale, California.

[0167] Figure 13 An example embodiment of a drive unit 1204 that can be used as part of a manipulator system 1100 is shown. The manipulator system 1300 includes a base 1320, a main column 1340, and a main frame 1360 connected to the main column 1340. The manipulator system 1300 also includes a plurality of manipulator arms 1310, 1311, 1312, and 1313, each connected to the main frame 1360. The manipulator arms 1310, 1311, 1312, and 1313 can be used as manipulator components 1102. Each of the manipulator arms 1310, 1311, 1312, and 1313 includes an instrument mounting portion 1322 to which an instrument 1330 can be mounted, illustrated as being attached to the manipulator arm 1310. While the manipulator system 1300 depicts four manipulator arms, various embodiments may include more or fewer manipulator arms.

[0168] According to one embodiment, the instrument mounting portion 1322 may include a drive assembly 1323 and a sleeve mounting base 1324, through which the transmission mechanism 1334 of the instrument 1330 is connected to the drive assembly 1323. The sleeve mounting base 1324 is configured to hold a sleeve 1336 through which the shaft 1332 of the instrument 1330 can extend to the surgical site during surgery. The drive assembly 1323 includes various controlled drive mechanisms and other mechanisms to respond to input commands at the operator input system 1106 and to transmit force to the transmission mechanism 1334 to actuate the instrument 1330. Although Figure 13 The implementation shows that the instrument 1330 is only attached to the manipulator arm 1310 for easy viewing, but the instrument can be attached to any and each of the manipulator arms 1310, 1311, 1312, and 1313.

[0169] Figure 14 An example embodiment of a manipulator system 1400 that can be used as part of a manipulator system 1100 is shown. Figure 14 The image shows a portion of the manipulator arm 1440 of the manipulator system 1400, with two instruments 1408 and 1410 in the mounting position. Figure 14The schematic diagram depicts only two instruments for simplification, but as those skilled in the art will recognize, more than two instruments may be mounted at the mounting location of the manipulator system 1400. Each instrument 1408, 1410 includes shafts 1420, 1430, with a movable end effector or endoscope, camera or other sensing device at its distal end, and may or may not include a wrist mechanism (not shown) to control the movement of the distal end.

[0170] exist Figure 14 In this embodiment, the distal portions of instruments 1408 and 1410 are received via a single port structure 1480 for introduction into the patient. As shown, the port structure includes a cannula and an instrument entry guide inserted into the cannula. A single instrument is inserted into the entry guide to reach the surgical site.

[0171] Transmission mechanisms 1485 and 1490 are disposed at the proximal portions of each shaft 1420 and 1430 and are connected to drive assemblies 1470 and 1475 via sterile adapters 1450 and 1460. The drive assemblies contain various internal mechanisms (not shown) controlled by a controller (e.g., at the control trolley of the surgical system) to transmit force to the force transmission mechanisms 1485 and 1490 to actuate instruments 1408 and 1410 in response to input commands from the surgeon's side console of the surgical system.

[0172] The control system described in this article is not limited to Figure 11 , Figures 12A-12B , Figure 13 and Figure 14 Various other remote operation and computer-aided servo mechanism configurations can be used in conjunction with the embodiments described herein. The diameters of the instrument shafts and end effectors are typically selected based on the cannula size to be used with the instrument and the surgical procedure to be performed.

[0173] The visualization techniques described in this article can be used for confirmation and can be further extended to preoperative treatment planning to treat stem cells, molecules, genetic material, organoids or other desired cells in electroporation-ablated tissue before and during the ablation-to-regeneration period.

[0174] The system visualizations and clinical application examples provided in this article are not limitations on the use of electroporation and electrolysis combinations within luminal vessels. Numerous configurations of ablation devices exist, as well as applications that will benefit from the techniques described herein.

[0175] It should be understood that, according to this system, apparatus and method, any of the above-described embodiments or processes may be combined with one or more other embodiments and / or processes, or may be separated and / or performed in a separate apparatus or apparatus portion.

[0176] Finally, the foregoing discussion 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. Therefore, while this disclosure has been described in particular detail with reference to exemplary embodiments, it should be recognized that many modifications and alternative embodiments may be practiced without departing from the broader and contemplated spirit and scope of this disclosure as set forth in the appended claims. Consequently, the specification and drawings should be considered illustrative and not intended to limit the scope of the appended claims.

Claims

1. A method comprising: Tissue within a target region is treated by ablation using an ablation device, the ablation comprising applying electroporation energy; Image the area to identify the processed regions within it; and Based on the location of the already treated area, the ablation device performs additional ablation on selected additional areas within the treated area.

2. The method of claim 1, further comprising delivering a drug to the treated area based on the appearance of the treated area.

3. The method of claim 1, wherein the ablation comprises a combination of electroporation and electrolysis.

4. The method of claim 3, further comprising imaging the region using a white light endoscope, wherein the processed region has a different visual appearance than the unprocessed region.

5. The method of claim 4, wherein the treated area exhibits a color change.

6. The method according to claim 4, further comprising: The degree of ablation at the treated area is determined by image recognition or visual assessment. and The additional ablation at the selected additional region is adjusted based on the degree of ablation at the already processed region.

7. The method of claim 6, wherein adjusting the additional ablation comprises controlling at least one of the following: pulse duration, applied current, applied charge, applied voltage, number of pulses, or combinations thereof.

8. The method according to claim 1, further comprising: Before processing the tissue, at least one of the leading or trailing edges of the region is marked using the ablation device to mark the tissue.

9. The method of claim 8, wherein marking the region comprises applying energy to the region.

10. The method of claim 9, wherein marking the region comprises applying a combination of electroporation and electrolysis.

11. The method of claim 10, wherein the marking includes applying a first amount of energy to the region, and wherein the processing includes applying a second amount of energy to the region, wherein the first amount is less than the second amount.

12. The method of claim 1, further comprising identifying portions of the image generated by the imaging to identify the selected additional region.

13. The method of claim 12, further comprising: The identifier is compared with kinematic data from the robotic system used to perform the ablation; and Based on the comparison, location data for the selected additional region is generated, and the additional ablation includes using the location data to locate the robotic system to process the selected additional region.

14. A method comprising: Ablation, which combines electroporation and electrolysis, is used to treat tissue within the target area; Image the region; and Based on the imaging, the processed areas within the region are identified.

15. The method of claim 14, wherein the imaging uses white light endoscopy, narrow-band imaging (NBI), fluorescence, chromoendoscopy, or a combination thereof.

16. The method of claim 15, wherein the identification comprises using image recognition, kinematics, shape sensing and / or visual evaluation to determine whether the processed region is visually different from at least one unprocessed region.

17. The method of claim 16, further comprising determining the degree of ablation at the treated area by image recognition or visual assessment.

18. The method of claim 14, wherein the tissue is treated with an ablation device, and prior to treating the tissue, at least one of the leading or trailing edges of the region is marked using the ablation device to mark the tissue.

19. The method of claim 18, further comprising: The leading edge, trailing edge, and / or overlapping edge are compared with at least one of shape sensing data, kinematic data, or position data; and The ablation device is positioned between the leading and trailing edges to perform the ablation based on at least one of shape sensing data, kinematic data, or position data.

20. The method of claim 19, further comprising: Mark the trailing edge; Move the imaging device to the trailing edge; Identify markers or electrolytic marks in the region to identify the leading edge; The imaging device is moved to the proximal portion of the processing area to measure the travel distance from the trailing edge to the marker or the electrolytic marker; Move the imaging device to the leading edge; A map including the area was drawn in advance; Based on the predetermined length of the area, the processing location, the travel distance, or a combination thereof, one or more processing segments are planned in the map; and Move the ablation device to one or more planned processing sections.

21. The method of claim 20, wherein the pre-drawn map includes anatomical localization.

22. The method of claim 20, further comprising dynamically adjusting one or more positions of the one or more processing segments to update the planned one or more processing segments.

23. A system comprising: An ablation device comprising a plurality of electrodes configured to contact tissue, the ablation device being configured to ablate the contacted tissue, the ablation comprising applying electroporation energy; An imaging device, located near the ablation device, is configured to image a region of the target area; and A controller, coupled to the ablation device and the imaging device, is configured to: The ablation device is controlled to mark tissue within the region by controlling the charge applied to the plurality of electrodes; and The imaging device is controlled to image the region so that the marked region is visualized.

24. The system of claim 23, wherein the controller is further configured to: control the ablation device to ablate a region within the region based on the location of the marked region determined from imaging of the region.

25. The system of claim 24, wherein the ablation comprises a combination of electroporation and electrolysis.

26. The system of claim 23, wherein controlling the ablation device to mark tissue comprises applying energy, the energy comprising a combination of electroporation and electrolysis.

27. The system of claim 26, wherein visualizing the marked region comprises imaging the region using a white light endoscope, and wherein the marked region has a different visual appearance than the unmarked region.

28. The system of claim 23 further includes an elongated flexible device, wherein the plurality of electrodes includes at least one electrode inserted through a working channel of the elongated flexible device.

29. The system of claim 23, further comprising: Slender and flexible device; and At least one expandable member at the distal portion of the elongated flexible device.

30. The system of claim 23, wherein the imaging device comprises an ultrasonic imaging sensor and a light source.

31. The system of claim 23, wherein the imaging device is configured to perform white light endoscopy, NBI, fluorescence, or a combination thereof.

32. The system of claim 23 further includes an elongated flexible device, the elongated flexible device including the imaging device, wherein the plurality of electrodes are attached distally to the elongated flexible device.

33. The system of claim 23 further includes a processor configured to receive data from the imaging device, the processor being configured to perform image recognition to identify the marked region.

34. The system of claim 33, wherein the processor is further configured to determine the degree of ablation at the treated area based on data from the imaging device, and The controller is further configured to control the charge applied to the treated area based on the degree of ablation by selecting a duration, voltage or voltage range, multiple pulses or a combination thereof.

35. The system of claim 34, further comprising a robotic system configured to robotically actuate the ablation device and the imaging device. The processor is further configured to determine regions within the region, and The controller is configured to enable the robotic system to position the ablation device and the imaging device within the area.

36. The system of claim 35, wherein the controller is further configured to identify portions of one or more images generated by the imaging device, to compare the identified portions of the one or more images with at least one of shape sensing data, kinematic data, or position data, and The controller is configured to position the ablation device near the region within the area based on at least one of shape sensing data, kinematic data, or position data.

37. The system of claim 24, further comprising a display configured to display one or more images generated by the imaging device. The controller is also configured to allow users to visually assess and determine the degree of ablation in the treated area.

38. The system of claim 37, wherein the controller is further configured to allow a user to control at least one of the following based on the treated area: the duration, voltage, or number of pulses applied to perform additional ablation on the treated area, or the position of the ablation device and the imaging device at the area within the region.

39. A non-transient computer-readable storage medium, the computer-readable storage medium comprising instructions that, when executed by a controller, cause the controller to: The ablation device is controlled by controlling the charge applied to multiple electrodes of the ablation device to treat tissue within a target region using ablation, the ablation including the application of electroporation energy; The imaging device is controlled to image the area to generate one or more images; and The ablation device is controlled to perform additional ablation at selected additional areas within the area, based on the location of the processed region determined from the one or more images.

40. The non-transient computer-readable storage medium of claim 39, wherein the ablation comprises a combination of electroporation and electrolysis.

41. A method comprising: Position the electrolysis device near the tissue area; and Electrolysis is performed to discolor the tissue area and provide visual markings.

42. The method of claim 41, further comprising delivering energy for processing based on the location of the visual marker.

43. The method of claim 41, wherein the electrolysis on the tissue comprises avoiding complete ablation of the tissue region.

44. The method of claim 41, further comprising navigating the processing device to the processing location in part based on the visual markers.

45. The method of claim 44, further comprising performing electroporation using the electrolysis apparatus located at the processing position.

46. ​​The method of claim 45, wherein the same electrodes are used in the electrolysis and the electroporation.

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