System for planning and providing navigational guidance for anatomical lumen therapy
By generating anatomical models and optimizing ablation device movement using a robot assisted manipulator, the problem of poor contact between the ablation treatment device and the lumen wall in minimally invasive medical technology is solved, achieving more efficient and precise therapeutic effects.
Patent Information
- Application Number
- CN202380041963.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-08-03
- Filing Date
- 2023-03-21
- Publication Date
- 2025-01-07
AI Technical Summary
Existing minimally invasive medical technologies are difficult to effectively control the contact between the therapeutic device and the lumen wall when performing ablation therapy, resulting in overlapping ablation injuries and inefficient treatment, especially in the presence of challenges in navigation and delivery of treatment in complex anatomical structures.
By generating anatomical models using processor and computer-readable instructions, identifying gaps in the anatomical channels and generating bridge segments, providing navigation guidance and treatment plans, combining robot-assisted manipulators and sensor systems, optimizing movement and energy delivery of the ablation device to Achieve more precise treatments.
It improves the accuracy and efficiency of ablation treatment, reduces overlapping damage in the treatment area, optimizes the contact between the device and the lumen wall, and improves the treatment effect and patient recovery time.
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Figure CN119278002A_ABST
Abstract
Description
[0001] Cross-referenced applications
[0002] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 323,457, filed on March 24, 2022, entitled “Systems and Methods for the Planning, Navigation, and / or Delivery of an Anatomic Lumen Treatment,” U.S. Provisional Application No. 63 / 394,871, filed on August 3, 2022, entitled “Systems and Methods for the Planning, Navigation, and / or Delivery of an Anatomic Lumen Treatment,” and U.S. Provisional Application No. 63 / 394,873, filed on August 3, 2022, entitled “Systems and Methods for Planning and Providing Navigation Guidance for Anatomic Lumen Treatment,” which are incorporated herein by reference in their entirety. Technical Field
[0003] Examples described herein relate to systems and methods for intraluminal treatment. More particularly, examples may relate to planning, navigation, and delivery of ablation treatments within anatomical lumens. Background Art
[0004] Minimally invasive medical techniques may generally be intended to reduce the amount of tissue damaged during a medical procedure, thereby reducing patient recovery time, discomfort, and harmful side effects. Such minimally invasive techniques may be performed through natural orifices in the patient's anatomy or through one or more surgical incisions. Through these natural orifices or incisions, an operator may insert minimally invasive medical instruments, such as therapeutic instruments, diagnostic instruments, imaging instruments, and surgical instruments. Some minimally invasive medical instruments may be used to perform ablation. Improved systems and methods for planning ablation therapy, navigating instruments to the treatment area, and delivering ablation therapy are needed to control the lumen surface area for treatment, achieve good contact between the instrument and the lumen wall, and minimize overlap of ablation lesions. Summary of the invention
[0005] Embodiments of the invention are best summarized by the claims that follow the description.
[0006] In one example, a system may include a processor and a memory having computer readable instructions stored thereon. The computer readable instructions, when executed by the processor, may cause the system to receive anatomical image data of an anatomical region, and to segment the anatomical image data to identify an anatomical passage in the anatomical region. The computer readable instructions may also cause the system to identify a gap between a first segment and a second segment of the segmented anatomical image data, generate a bridging segment to bridge the gap, and generate an anatomical model of a diseased lung including the first segment, the second segment, and the bridging segment.
[0007] In another example, a system may include a processor and a memory having computer readable instructions stored thereon. The computer readable instructions, when executed by the processor, may cause the system to generate an ablation treatment plan, provide navigation guidance to perform ablation treatment according to the ablation treatment plan, and generate a treatment report after performing ablation treatment according to the ablation treatment plan.
[0008] In another example, a system may include a robot-assisted manipulator, an ablation device configured to be coupled to the robot-assisted manipulator, and a control system coupled to the robot-assisted manipulator. The control system may be configured to determine a first ablation therapy according to a first treatment mode at a first intracavitary location, receive anatomical information about a second intracavitary location, and determine a second ablation therapy according to a second treatment mode at the second intracavitary location based on the anatomical information.
[0009] In another example, a system may include a robot-assisted manipulator, an elongated instrument configured for manipulation by the robot-assisted manipulator, an ablation device coupled to a distal portion of the elongated instrument, a sensor system coupled to the elongated instrument, and a control system coupled to the robot-assisted manipulator. The control system may be configured to actuate the robot-assisted manipulator to move the ablation device from a first intracavitary position in an anatomical channel to a second intracavitary position in the anatomical channel. An expected rate of movement of the ablation device may be associated with actuation of the robot-assisted manipulator. The control system is also configured to receive sensor data from the sensor system while actuating the robot-assisted manipulator, deliver ablation therapy to the anatomical channel while actuating the robot-assisted manipulator, and evaluate contact of the ablation device with the anatomical channel based on the received sensor data and the expected rate of movement of the ablation device.
[0010] It should be understood that both the foregoing general description and the following detailed description are illustrative and explanatory in nature, and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In this regard, additional aspects, features and advantages of the present disclosure will be apparent to those skilled in the art from the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Figure 1A is a simplified diagram of a patient's anatomy according to some examples.
[0012] Figure 1B Explained Figure 1A Detailed portion of the diagram.
[0013] Figure 2 is a flow chart illustrating a method for generating an anatomical model.
[0014] Figure 3 A flow chart illustrating a method for performing a therapy, such as an ablation therapy, is provided.
[0015] Figure 4 Schematic illustration of the parameters used for treatment planning.
[0016] Figure 5 A graphical user interface is described for providing navigation guidance.
[0017] Figure 6 A graphical user interface is described for providing navigation guidance.
[0018] Figure 7 A flow chart illustrating a method for using anatomical information to determine a treatment mode for an ablation device.
[0019] Figure 8 A flow chart illustrating a method for evaluating the efficacy of an ablation procedure.
[0020] Fig. 9 A robot-assisted medical system according to some examples.
[0021] Examples of the present disclosure and its advantages are best understood by referring to the following detailed description. It should be understood that the same reference numerals are used to identify the same elements illustrated in one or more of the accompanying drawings, wherein the illustrations therein are for illustrating examples of the present disclosure and not for limiting thereof. DETAILED DESCRIPTION
[0022] The technology described herein provides technology and treatment systems for luminal treatment of diseased tissue. Although the examples provided herein may relate to the treatment of lung tissue and lung disease, it should be understood that the described technology can be used to treat artificially created lumens or any intraluminal or vascular passage or cavity including in a patient's trachea, colon, intestines, stomach, liver, kidney and calyces, brain, heart, circulatory system including vasculature, fistula, etc. In some examples, the treatments described herein can be used in procedures for treating lung tumors, asthma and / or chronic obstructive pulmonary disease (COPD), which can include one or more of a variety of disease conditions including chronic bronchitis, emphysema, asthma, and bronchiectasis.
[0023] For example, chronic bronchitis involves long-term inflammation of the bronchi in the diseased lung, which can be treated by endoluminally accessing the airways and ablating the outer mucosal layer of the airway wall to destroy the proliferating goblet cells and reduce mucus secretions. In some examples involving the use of minimally invasive ablation devices, the goal of treatment may be to ablate as much of the lung as possible, targeting goblet cells at a depth of approximately 0.1-0.5 mm without over-ablating and without repeatedly ablating any area. Some techniques may require multiple treatments performed in separate procedures over days, weeks, or months.
[0024] Figure 1A and Figure 1B An elongated medical device system 100 is illustrated extending within a branched anatomical passage (e.g., airway) 102 of an anatomical structure 104. In some examples, the anatomical structure 104 may be a lung, and the passage 102 may include a trachea 106, primary bronchi 108, secondary bronchi 110, and tertiary bronchi 112. The anatomical structure 104 has an anatomical reference frame (X A , Y A , Z A ). The distal portion 118 of the medical device system 100 can be advanced into an anatomical opening (e.g., a patient's mouth) and through the anatomical passage 102 to perform a medical procedure, such as endoluminal ablation therapy, at or near a target tissue located in a region 113 of the anatomical structure 104. In some examples, the movement and other operations of the elongated medical device system 100 can be controlled by a control system (e.g., control system 812) of a robotic-assisted medical system (e.g., medical system 800).
[0025] In some examples, the elongated medical device system 100 may include a delivery catheter 120 through which an ablation system 122 for ablating diseased tissue extends. An example device system may be a robotic assisted bronchoscope of the ion platform provided by Intuitive Surgical Operations, Inc. The ablation system 122 may include an ablation device 124 located at the distal portion of the elongated shaft 126. The ablation device 124 may contact the wall of the anatomical passage 102 to perform ablation. In some examples, the ablation device 124 may be expandable, such as a heated balloon, equipped with one or more ablation electrodes, or configured to deliver cryotherapy. In other examples, the ablation device may include a stent-like cage, an expandable helical structure, or other structures that are heated or include electrodes for delivering energy to adjacent tissues. Ablation may be performed using any of various forms of energy including radiofrequency, microwaves, cryo, electroporation (reversible, irreversible, thermal or non-thermal), electrical pulses, ultrasound, direct heating, etc.
[0026] The ablation system 122 may also include a sensor system 128 for determining the position, orientation, speed, velocity, posture, shape and / or force at the distal end and / or along one or more segments of the ablation system 122. For example, the sensor system may include a position / location sensor system (e.g., an electromagnetic (EM) sensor system), a shape sensor system (e.g., an optical fiber shape sensor), and / or a force sensor system. The movement and / or operation of the delivery catheter 120, the elongated shaft 126, and / or the ablation device 124 may be manually controlled by operator manipulation and / or by a control system (e.g., control system 812). During ablation, epithelial and sub-epithelial cell and structural changes may be induced. Ablation may result in tissue reduction, including destruction of goblet cells and cilia in lung tissue. In some examples, the cell matrix may be retained to allow for later regeneration of healthy cells. In some examples, tissue reactions may occur entirely during energy application, and in other examples, tissue damage may develop over a period of time as the anatomical structure responds to damage caused by energy. In the lungs, ablation can be used to treat a variety of lung conditions, including lung tumors, asthma, chronic obstructive pulmonary disease, chronic bronchitis, emphysema, and bronchiectasis.
[0027] The instrument system 100 may also include a suction system including a suction lumen and a vacuum source for suctioning through the suction lumen. The suction system can be used to drain mucus from the patient's anatomical structure. The instrument system 100 may also include an endoscopic imaging system including an imaging probe that captures images of anatomical passages. The instrument system 100 may be coupled to and actuated by a manipulator (e.g., manipulator assembly 802). The instrument system or manipulator may include an actuator for controlling insertion, retraction, and optional rotation or other degrees of freedom of motion of the instrument system 100 to articulate the instrument system 100.
[0028] In some examples, the instrument system may include a robotically controlled delivery device (e.g., a robotically controlled catheter), such as delivery catheter 120, which can deliver a passive instrument, such as passive ablation system 122. The passive instrument can be replaced with a suction device, or the passive instrument can include a suction port for aspirating mucus. The passive instrument can be replaced with an imaging probe of an endoscopic imaging system, which is used to visualize the anatomical passage during insertion of the instrument. In other examples, the instrument (e.g., ablation system 122) delivered by the robotically controlled delivery device (e.g., delivery catheter 120) can itself be robotically controlled and delivered by the robotically controlled delivery device. In other examples, the robotically controlled instrument (e.g., ablation system 122) can be delivered directly without a delivery system, or can be delivered by a passive sheath or other passive delivery system.
[0029] In some examples, the distal portion 118 of the elongated medical device system 100 can be driven to a lung region starting from the most distal position within the branch to be treated, ablation therapy can be performed, the device can be retracted, and ablation therapy can be performed at a new, more proximal position. In some procedures, an expandable device is used so that the device is placed at a distal position in the lung, expanded, ablative energy is delivered, the device is retracted, retracted to a different position, and the process is repeated until as much of the lung as desired is ablated. In other procedures, the expandable device is placed at a distal position in the lung, expanded, ablative energy is delivered, the device is retracted a distance to a different position during ablative energy delivery, and ablation energy delivery is stopped. This process can be repeated for different segments of the branch. The sequence from distal to proximal can be repeated and can be performed in consecutive branches so that areas that have been previously ablated do not undergo additional ablation. In alternative examples, a similar process can be performed from proximal to distal to provide insertion of the expandable device, depending on the patient's disease state. These techniques may be effective because the absence of an airway or an area along an airway may have minimal impact on the effectiveness of the treatment. The effectiveness of the treatment may also depend on the creation of an airway that has been treated.
[0030] Diagnostic techniques for assessing lung conditions may include pulmonary tests (e.g., functional tests), X-rays, and / or CT images of anatomical structures. In some embodiments, computer software, alone or in combination with manual input, is used to convert image data into a two-dimensional or three-dimensional composite representation or model of a segmentation of a portion or entire anatomical organ or anatomical region. The model may describe the various locations and shapes of anatomical pathways and their connectivity. More specifically, during the segmentation process, pixels or voxels may be divided into segments or elements, or may be labeled to indicate that they share certain characteristics or calculated properties, such as color, density, intensity, and texture. In some embodiments, segmented image data may include components selected to be associated with certain objects or tissue types. Anatomical passages (e.g., airways) in the lungs may be segmented based on their shared characteristics. Airways containing mucus may be incorrectly classified due to their altered characteristics, and may therefore be incorrectly interpreted as disconnections between airways.
[0031] Ablation therapy parameters (e.g., power, duration) may be device dependent, with each therapy device having a therapy chart with recommended settings. In some examples, ablation therapy is open loop, with no feedback, sensing, or other analysis to compare the intended therapy to the actual therapy. Instead, therapy may be delivered at one location for a predetermined amount of time, and then the ablation device may be moved to another location for a predetermined amount of time.
[0032] In some examples, ablation therapy can be performed by manually moving or manipulating the ablation device, but manual control may not always achieve the best results. For example, manually dragging the ablation device along the airway wall can achieve ablation of a large surface area, but dragging can be difficult to control manually. The diameter of the airway can vary along the length of the airway, so it may be necessary to change the size of the expandable device by manual manipulation to achieve good contact when the device is retracted. It may be difficult for the operator to estimate to what extent the device should be expanded or contracted in order to still achieve sufficient contact with the airway wall. In some examples, it is preferred to avoid overlap of ablation lesions, but under manual operation, it may be difficult to determine the location where the ablation lesion has been formed. In some examples, the operator manually moves the ablation device using only endoscopic and / or fluoroscopic imaging guidance, where the ablation lesions are difficult or impossible to visualize, and the location of the ablation device in the lungs is difficult to understand. Therefore, the operator may be uncertain where to perform subsequent ablations in order to treat sufficient tissue areas without overlapping any lesions.
[0033] Patient treatment within anatomical passages, such as ablation therapy, may be performed using an ablation system, such as instrument system 100. For example, treatment may be performed in a lung suffering from chronic bronchitis. Figure 2 A flowchart illustrating a method 150 for generating a model of an anatomical region of a patient's anatomical structure. In some examples, the anatomical region may be a diseased lung. The method 150 and other methods described herein are illustrated as a set of operations or processes that may be performed in the same or different order than that shown in the figure. Depending on the configuration of the apparatus 100, one or more of the illustrated processes may be omitted in some examples of the method. Additionally, one or more processes not explicitly illustrated in the flowchart may be included before, after, between, or as part of the illustrated process. In some examples, one or more of the processes in the flowchart may be implemented at least in part by a control system executing code stored on a non-transitory, tangible, machine-readable medium that, when executed by one or more processors (e.g., a processor of the control system), causes the one or more processors to perform one or more of the processes.
[0034] Method 150 may include a process 152 of determining whether anatomical image data (e.g., X-ray and / or CT image data) of a region of the patient's anatomical structure is available. If anatomical image data is not available, then a passage through the anatomical region may be traversed using an instrument system (e.g., system 100) in process 154 to collect positioning data that provides survey information about the configuration of the region of the patient's anatomical structure (e.g., airway diameter, airway length, airway orientation, and relative positions of multiple airways). The survey of the region may be performed using the instrument system preoperatively or during a treatment procedure. Additional descriptions of the survey process are described in International Publication No. WO2021168061A1 filed on February 18, 2021 (disclosing "Systems and methods for delivering targeted therapy"), which is incorporated herein by reference in its entirety for all purposes. In process 156, while surveying the passage, obstructions in the passage, such as mucus plugs, may be visualized in images from an imaging system of the instrument system. At process 158, positioning data may be recorded by the instrument and / or instrument control system to capture the location of the obstacle. As obstacles are encountered during traversal of the anatomical region using the instrument, the process of identifying and recording the location of the obstacle may be repeated. At process 174, an anatomical model may be generated from the positioning data, and the location of the obstacle may be marked and / or otherwise displayed within the anatomical model.
[0035] If anatomical image data is available at process 152, the anatomical image data may be received at process 160 (e.g., by a control system of a robotic-assisted medical system). At process 162, a segmentation procedure may be performed on the image data to define pathways in an anatomical region. The segmentation procedure may identify graphical elements in the image data that represent or otherwise correspond to anatomical structures or features. During the segmentation process, pixels or voxels generated from the image data may be divided into segments or elements and / or labeled to indicate that they share certain characteristics or calculated properties, such as color, density, intensity, and texture. At process 174, the segments or elements associated with the anatomical features of the patient may be used to generate portions of the anatomical model.
[0036] In process 164, a gap in the segmentation may be identified. To determine the nature of the gap (e.g., whether it represents a mucus plug obstruction in the airway or whether the airway terminates), additional information from the anatomical image data may be considered. For example, in process 166, two close segments (e.g., pixels, voxels, or a continuous group thereof) separated by a gap may be identified. Based on properties of the segments, such as similar direction vectors defined by centerline points through the segments, a small (e.g., below a threshold) distance between the centerline endpoints of the two segments, and / or similar size (e.g., within a threshold variance) diameters of the segments, the segments may be considered to be close to each other. In process 168, information about the two separated segments, such as their orientation, diameter, and / or connection with other segments may be considered to determine that the gap represents an obstruction (e.g., mucus plug, sputum) within a continuous anatomical passage represented by the two segments. In some examples, a continuous anatomical passage may be characterized by segments having similar size diameters, segment centerline vectors having similar directions, and / or segment centerline endpoints that are within a threshold distance from each other. In some examples, if a cylinder can be extended along a trajectory that would include two segments based on its diameter and centerline, then the gap can be determined to be an obstacle. At process 174, an anatomical model can be generated based on the segmented data, and the segments separated by the gap can be connected in the anatomical model. The anatomical model can be labeled to identify the location of the obstacle in the anatomical model. For example, the location of a mucus plug can be identified in the anatomical model of the continuous lung airway.
[0037] Additionally or alternatively, an obstructed continuous passage (e.g., an airway) may be determined based on the vasculature extending along the passage. In process 170, segmentation of the vasculature in the anatomical region may be performed. In process 172, the vasculature segmentation may be used to determine that gaps represent obstructions (e.g., mucus plugs) within a continuous anatomical passage extending along adjacent vasculature. In process 174, an anatomical model may be generated based on the passage and vasculature segmentation data, and segmented segments separated by gaps may be connected in the anatomical model, wherein the model is labeled to indicate the location of the obstruction. Gaps between segments may be connected by bridging segments to bridge the gaps, and the anatomical model may include the bridging segments. Characteristics of the bridging segments may be determined by characteristics of adjacent segments and gaps (e.g., diameter size, length, orientation).
[0038] Optionally, if the anatomical model is used or generated during a treatment procedure, the anatomical model may be altered, improved, or otherwise updated during subsequent traversals of the patient's anatomy by the instrument based on the new information. For example, the location of treatment delivery (e.g., the location and size of ablation lesions) may be recorded and added to the displayed model. Optionally, if an obstruction (e.g., a mucus plug) is removed from the anatomy (e.g., by aspiration), the location of any obstruction (e.g., a mucus plug) recorded in the anatomical model may be removed from the model. In some examples, a record of the previous location of an obstruction may be maintained for future reference (e.g., to monitor redevelopment of an obstruction in the same location). Optionally, the model may be modified to include the current location of the instrument based on operator input or an instrument tracking system.
[0039] Figure 3 2 is a flow chart illustrating a method 200 for performing a treatment such as an ablation treatment. In process 202, an anatomical model of a region of a patient's anatomy may be generated or received. In some examples, the model may be constructed using a method such as Figure 2 The anatomical model is generated using method 150 depicted in the flowchart of . The treatment method 200 may further include process 204, in which anatomical constraints may be identified. The anatomical constraints may be identified from the anatomical model and may include constraints that may hinder navigation of the instrument. The anatomical constraints may include, for example, an anatomical lumen diameter (e.g., an outer diameter of the instrument) that is less than a predetermined threshold, an anatomical channel that is curved to the extent that it is difficult to navigate (e.g., a sharp turn that is not navigable based on the known flexibility or other constraints of the instrument), a mucus plug within the anatomical channel, or sensitive anatomical structures such as the pleura, organs, blood vessels, etc. that should be protected from ablative energy. Identifying the anatomical constraints may include visually indicating the location of the anatomical constraints using markings (e.g., colors, graphic symbols, alphanumeric text) on the displayed model.
[0040] In process 206, a treatment plan may be generated with reference to the anatomical model. For example, Figure 4Parameters from an anatomical model 300 are schematically illustrated, which may be inputs to a treatment plan 302. The anatomical model 300 parameters may include anatomical constraints, including the location 310 of obstacles (e.g., mucus plugs) in the model, the size (e.g., diameter, length, etc.) 312 of channels in the model, the location and / or shape of the smallest navigable channel 314 in the model, and the location and / or shape of channels 316 in the model that are difficult to navigate (e.g., tortuous, narrow, sharp angles). Other parameters based on the anatomical model, user input, sensor input, or other accessible information may also or alternatively be used as inputs to the treatment plan 302. For example, a treatment region parameter 318 may be a region of a patient's anatomy that is identified for receiving ablation therapy (e.g., a region identified on a model). The treatment region parameter may be determined, for example, by operator input, prior diagnosis, or image analysis, which identifies the region to be treated. In some examples, the default region may be an entire organ, such as a lung. In other examples, the default region may be a portion of an organ, such as a left lung or a right lung. Any of these parameters, alone or in combination with other parameters, may be used as inputs to the treatment plan 302. Branch generation parameters 320 may identify, for example, the generation of the most distal side of the channel to be treated (e.g., farthest from the anatomical entrance channel). Parameters 320 may be determined based on, for example, operator input, or may be based on known instrument constraints, such as the length of the elongated instrument, the diameter of the delivery or treatment instrument (e.g., the maximum diameter or the diameter at the distal portion), and / or the minimum allowable bending radius based on the flexibility of the delivery or treatment instrument. Pathology parameters 322 may include information about the patient condition being diagnosed. The information may be determined by operator input or an electronic medical record. The information may include a maximum allowable duration of the entire procedure time based on patient tolerance due to the patient condition. Instrument parameters 324 may include information about one or more delivery catheters, suction devices, treatment instruments, and / or ablation devices that may be used during treatment. For example, the information may include a diameter and a minimum bending radius. The information may include a recommended dosage chart for a particular treatment or ablation instrument. Previous treatment information parameters 326 may include information from previous treatments of the same patient. For example, the previous treatment information may include the location of a previous ablation treatment in an anatomical region.
[0041] The treatment plan 302 may be optimized based on the input parameters 310-326 and may include one or more optimization factors 330-348. Typically, a lung treatment plan may include delivering an ablation device to a distal portion of a target airway branch and delivering energy from the ablation device to tissue of the airway as the ablation device moves from the distal portion toward a defined proximal position (e.g., the position of a delivery device such as a delivery catheter 120). The treatment process may be repeated until all identified airway branches are treated. Typically, optimization of the treatment plan may prioritize treatment in areas that are easier and faster to reach with an ablation device and / or areas that provide the largest surface area or volume for ablation. The treatment plan may provide a predicted percentage of anatomical areas that can be treated based on the plan. The treatment plan may include a visual depiction of the entire treatment path that the treatment device will follow. The treatment path may include a starting distal point in a first branch having a proximal retraction point for a first trajectory and a second distal point in a second branch having a second proximal retraction point for a second trajectory. Other point treatments or trajectory start and end points may be provided by the treatment plan.
[0042] Factors 330-348 may be selected to optimize the treatment plan 302. Factor 330 may be the order or priority of the anatomical branches to be treated. Factor 332 may be the volume or cumulative surface area of all channels to be treated. Factor 334 may be a treatment mode, such as a point treatment mode, a limited trajectory treatment mode, or a hybrid point and trajectory treatment mode, as described in further detail below. The treatment mode may determine whether the ablation device is stationary or moving when delivering ablative energy. Factor 336 may be the duration of the treatment or the portion of the treatment. Factor 338 may be the drive mode of the treatment device, such as an automatic retraction mode, a semi-automatic retraction mode, an operator-controlled mode, a safety mode, and / or a lumen centering mode, as described in further detail below. Factor 340 may include a treatment dose. The dose factor may be calculated by the control system and may include power level, dwell time, and / or instrument speed (e.g., retraction speed along a trajectory). Determining the dose factor may include referencing a dose chart for the ablation device. The diameter of the channel may strongly affect the dose. For example, a channel with a large diameter may warrant a larger dose than a channel with a smaller diameter to achieve a comparable ablation result. Factor 342 may include defined keep-out zones where treatment should be avoided. For example, an area occluded by a mucus plug may be avoided or treated differently because the mucus may be difficult or time-consuming to remove, or may require suction or tool replacement. As another example, an area with a channel that is too small for an instrument to navigate may be in a keep-out zone. As another example, an area with a channel shape that includes a bend that exceeds the instrument's bend radius may be in a keep-out zone. As another example, an area with sensitive anatomical structures (e.g., near the pleura, organs, large blood vessels, etc.) may be a keep-out zone. Factor 344 may include pathway characteristics. For example, a plan may identify a channel that may be characterized as relatively long, smooth, and / or straight. This characteristic may provide an indication of the ease or speed with which an ablation device may be moved or dragged through the channel. In other examples, a channel may be characterized based on changes in lumen diameter. This characteristic may provide an indication of the ease or speed with which an ablation device may be passed through the channel. For example, a channel with greater diameter variability may require more adjustments to the ablation device diameter to ensure ablation contact. Such adjustments may be time consuming or require additional calculations by the operator or control system. Factor 346 may include the length of the area to be treated or the distance the treatment device may move through the channel. Factor 348 may include the spacing between treatment points or treatment trajectories.
[0043] Reference again Figure 2, the treatment method 200 may further include a process 208, in which navigation guidance may be provided during the procedure. The navigation guidance may be provided to a control system (e.g., control system 812) to activate a drive system of a robot-assisted manipulator (e.g., manipulator 802) to implement the navigation guidance. Additionally or alternatively, the navigation guidance may be provided to a user for the operator to control the navigation. The navigation guidance may include a graphical user interface that displays an anatomical model with a treatment path marked on the model. The treatment path may show where the instrument should be positioned (e.g., an orientation point of an ablation device or a predicted contact area on a channel wall) in order to perform a point treatment or start and end a trajectory treatment (e.g., where the ablation device is moved or dragged). The trajectory treatment may be performed using an ablation device that remains actuated or under manipulator control during the movement of the ablation device, such as to keep the ablation device in the center of the lumen. Some or all of the trajectory treatments may be performed using an ablation device that is not actuated and dragged along the trajectory. In some examples, the travel points may be displayed in a numbered order to indicate the order of branches along the treatment path. Alternatively, the display may only provide the path to the next target point.
[0044] Figure 5 A graphical user interface 400 is illustrated that is displayed on a display system 402 (e.g., display system 810). The graphical user interface 400 may provide navigation guidance. The graphical user interface 400 illustrates an anatomical channel (e.g., a channel in an anatomical model) 404 in which a delivery device 406 is parked. An ablation system 408 extends distally from the delivery device 406 and includes an ablation device 410, such as an expandable balloon, cage, or other energy delivery device. Markings 412, such as graphical symbols or highlighted channel lengths, may indicate a preferred location for parking the distal end of the delivery device 406. Markings 414, such as graphical symbols or highlighted channel lengths, may indicate the depth to which the ablation device should extend from the delivery device 406 to perform an ablation treatment. A previous distal treatment location may be designated with a marking 416 to indicate the location of a previous ablation. A subsequent proximal target location may be designated with a marking 418 to indicate the location of a proposed treatment location along a treatment trajectory 420. Marker 416 may have a different color, shade, or shape than marker 418, and the characteristics of marker 418 may change to the characteristics of marker 416 after treatment is performed. Alternatively, marker 418 may be removed after treatment occurs at the location of marker 418. As an example, a colored ring or marker may be displayed along the channel. The marker may change color based on the position of the device in the channel relative to the target position (e.g., green indicates an acceptable position and red indicates that the device needs to be moved closer to the target position). A different color may be displayed after ablative energy is delivered.
[0045] Figure 6A graphical user interface 500 is illustrated which is displayed on a display system 502. The graphical user interface 500 may provide navigation guidance. The graphical user interface 500 illustrates an anatomical model 504 having markings 511, 514, 518, and 520 indicating parking positions of an ordered delivery instrument (e.g., instrument 120). In some examples, the parking position of the delivery instrument may be at the carina or at the trachea. The ablation device may be extended from the parking position to a marked position distal to the parking position. For example, an ablation device (e.g., ablation device 124) may first be extended from parking position 511 to marking 510 for treatment. The ablation device may be operated under controlled motion (e.g., actuated movement of the ablation device), or may be dragged (e.g., passively moved) along a trajectory 525 toward the parking position 511. The movement may be, for example, manually actuated, robot-assisted in response to operator control, or robot-guided based on a programmed trajectory. The ablation device may then be extended from parking position 511 to position 512 for point (e.g., discrete location) ablation treatment. Next, the delivery device may be moved proximally to a parking position 514. The ablation device may be extended from position 514 to position 513 and may be moved back to the parking position 514 along a trajectory 526. The ablation device may then be extended from position 514 to perform a spot treatment at position 515. The ablation device may be operated or dragged from position 516 along a trajectory toward the parking position 514. Next, the delivery device may be moved proximally to a parking position 518. The ablation device may be extended from the parking position 518 to perform a spot treatment at position 517. Next, the delivery device may be moved distally to a parking position 520 and the ablation device may be extended to perform a spot treatment at positions 519 and 521. Then, the delivery device may be withdrawn proximally to position 518 and the ablation device may be extended to perform a spot treatment at positions 522 and 523. After treatment, the marker at the treatment position may change color, shade, or shape, or may be completely removed from the display. In some examples, only the marker for the next position of the ablation device may be displayed. In some examples, the ablation device may be energized and retracted along the length of the airway, such as from position 510 to just distal to position 511, or from position 515 to position 516, so that a length of the airway is treated in a single energy delivery event.
[0046] Reference again Figure 2, treatment method 200 may further include process 210, in which an anatomical model or treatment plan may be updated while a treatment procedure is being performed. The ablation device may be tracked to provide real-time positioning of the device, and the positioning information may be registered to the anatomical model and optionally displayed on the anatomical model. Efficacy indicators may be displayed with reference to the anatomical model. For example, efficacy may be determined based on measuring friction or tension, applied power, duration of energy delivery, and / or specifications of the ablation device. The treatment plan may be updated. For example, the treatment locations in a preoperative treatment plan (e.g., plan 302) may be compared to the actual treatment locations in the implemented plan. The treatment plan may be updated during the procedure based on the actual treatment locations so that treatment areas do not overlap. When a procedure is being performed, an indicator (e.g., auditory, tactile, visual) may be presented if an area that has been previously treated is about to undergo additional or overlapping treatment.
[0047] At process 212, a treatment report may be generated. In some examples, a treatment report may be generated after an ablation treatment has been completed. The treatment report may include an image of an anatomical model (either a complete anatomical model or a portion thereof) with the treated area marked, including the duration and power level of the treatment and / or an assessment of the efficacy of the ablation associated with a specific location within the model. The treatment report may provide measurements (e.g., percentages) of the channels treated in the anatomical region compared to the expected measurements of the channels to be treated. Measurements of the actual treatment area compared to the predicted treatment area may be used to evaluate the treatment performed.
[0048] Optionally, the updated model from the treatment report can be used to plan future treatment procedures for the same patient and / or to determine areas omitted from the original procedure that should be treated in a subsequent treatment procedure. Optionally, a new anatomical model for a future time point can be created and can be overlaid or otherwise compared with the updated model from the treatment report to develop a new treatment plan for a subsequent treatment procedure. During the subsequent procedure, an indicator (e.g., auditory, tactile, visual) can be presented to avoid treating in a previously treated area. Optionally, at process 214, the efficacy of the treatment can be evaluated. Figure 8 Examples of methods for assessing efficacy are provided, as will be described in detail below.
[0049] Figure 7 A flow chart illustrating a method 600 for determining an ablation therapy using first and second treatment modes is provided. Examples of treatment modes include a point treatment mode, a trajectory treatment mode, or a hybrid point and trajectory treatment mode. The determined treatment mode (described below) may be used to generate and / or optimize a treatment plan (e.g., via treatment mode factors 334) and provide navigation guidance as described above in processes 206 and 208. In process 602, a first ablation therapy according to a first treatment mode may be determined for an ablation device. The first ablation therapy may be performed at a first intracavitary treatment location (e.g., Figure 5414 in the figure). At process 604, anatomical information about a second intracavitary location may be received. The anatomical information may include the sensitivity of the anatomical structure, the diameter of the lumen, the tightness of the lumen curvature, or other information about the ease, difficulty, or risk of injury of moving through the channel. The anatomical information may be determined by inputs 310-316 or other inputs 318-326 of the anatomical model 300. The second intracavitary location may be a location for point ablation, or may be a location along a movement trajectory of the ablation device. At process 606, a second treatment according to a second treatment mode may be determined for the ablation device. Based on the anatomical information, a second intracavitary location (e.g., Figure 5 A second ablation treatment is performed at a location at a marker 418 in the ablation chamber. For example, if the anatomical information indicates that the anatomical structure includes a sensitive area, an irregular diameter, or a sharp turn that exceeds a tortuosity threshold, then a point treatment mode may be determined. Alternatively, if the anatomical information indicates that the anatomical structure between the first and second intracavitary locations includes a channel length that is relatively straight (e.g., below the tortuosity threshold) and / or has a uniform diameter, then a defined trajectory treatment mode may be used. During the ablation procedure, processes 604 and 606 may be repeated multiple times.
[0050] The treatment mode may include a point treatment mode, in which the ablation device is positioned at a first target and the ablation device engages the wall of the anatomical lumen (e.g., if it is a balloon, cage, or expandable electrode, the device expands). Ablative energy is delivered while the ablation device engages the wall. After the point treatment, the ablation device disengages from the wall of the anatomical lumen (e.g., if expandable, the device contracts). The ablation device retracts to the next target point and the process repeats. In some examples, for each treatment, the targets may be spaced a predetermined distance apart. In some examples, the targets may vary based on the parameters of the ablation device and the response of the ablation device to lumen properties at a certain location. Examples of such properties may include the diameter of the lumen, the humidity level, the flexibility or expandability of the lumen at that location, tissue properties, and / or tissue depth. The target may be user-defined, or may be determined based on the maximum allowed distance for the desired result.
[0051] The treatment mode may also include a limited trajectory treatment mode, in which the ablation device is positioned at a first distal target and the ablation device engages the wall of the anatomical lumen (e.g., if it is a balloon, cage, or expandable electrode, the device expands). Ablation energy can be delivered while the device is retracted until the device reaches the next target point. The movement of the ablation device can be controlled so that the manipulator assembly can adjust the orientation, size, or other properties of the active ablation device as the device is retracted. Adjustments can be selected to maintain the ablation device along the centerline of the lumen. Alternatively, the ablation device can be passively dragged along the anatomical lumen. In some examples, the deployment of the ablation device can be optimized by maintaining the axis in a consistent orientation relative to the anatomical lumen. The next target may be the nearest proximal carina, trachea, and / or parking position of the delivery device. In some examples, the next target may be a predetermined distance close to the previous target, where the system pauses before another treatment.
[0052] The treatment modes may also include hybrid treatment modes, where the treatment modes are switched based on the anatomy. For example, in the limited trajectory treatment mode, it may be difficult to drag the ablation device around a sharp turn, so the mode may be switched to spot mode. As another example, there may be sensitive anatomy, so spot ablation may be provided around the sensitive anatomy. As another example, spot ablation may be used in the small airways to avoid over-ablation that may occur using the limited trajectory treatment mode. In another example, in situations where the diameter size of the lumen changes dramatically, spot ablation may be used to avoid the need to continuously change the diameter size of the expandable element during trajectory treatment.
[0053] The dose (e.g., dose factor 340) may vary during the treatment mode depending on the anatomy. For example, device expansion, treatment duration and dwell time, power, and retraction speed may vary based on the size of the channel. In some examples, the diameter of the channel may be determined during the procedure by an imaging system such as endoscopic camera imaging, ultrasound imaging, intraoperative CT, or optical coherence tomography (OCT). In some examples, the airway size may be based on a registered map. For example, an anatomical model (e.g., a model generated in process 152) may be used as a map registered to the instrument. Based on the position of the instrument in the anatomical model, the diameter of the airway may be calculated. The airway size may also be based on sensors of a sensor system that detects contact with the airway wall (e.g., a pressure sensor, a force sensor, an impedance sensor, a contact sensor, and / or an optical fiber integrated into the outer layer of an expandable ablation device). In some examples, the ablation device may include a dose chart that provides a recommended dose.
[0054] The drive mode (e.g., drive mode factor 338) used to control the movement of the ablation device may also be changed during the planned ablation procedure. In the automatic retraction drive mode, the operator may position the ablation device at a first target and provide input to start treatment. The entire treatment, including all movement or adjustment of the ablation device, may be automatically performed by the control system. In the semi-automatic drive movement, the operator may position the device at a first target and provide input (e.g., button presses). The control system may perform treatment as long as the input is triggered, but the control system may stop once the input is released or the final target is reached. In the operator-controlled drive mode, the graphical user interface may provide indicators of when to treat, when to retract, and when to stop treatment. For example, the operator may engage a separate "treatment", "stop treatment", or "retract" button. Activating the "treatment" button may cause the ablation device to expand and cause the ablation device to deliver energy. Activating the "stop treatment" button may stop energy delivery and, in some examples, may cause the ablation device to retract. Alternatively, pressing the "treatment" button for the first time may start treatment, and pressing the activation a second time may end treatment. Activating the "retract" button may cause the ablation device to move from a distal point to a more proximal point. In some examples, the operation may be performed only while the button is pressed. In some embodiments, the system may include an insertion drive mode, and an "insert" button may be provided. Activating the "insert" button may result in insertion of the device such that treatment is provided from a proximal to a distal location in the anatomy.
[0055] In any drive mode, if an interference condition is met (e.g., FRL, incorrect orientation, force above a threshold, or visual cue), treatment may be stopped, retracted, and / or inserted. In any drive mode, retraction may include automatically centering the catheter / device in the middle of the airway. Centering may be based on an intracavitary camera view. Analysis of video images may be used to detect the hole structure and detect whether the catheter is pointing to the center of the hole structure. The operator can view the real-time view and adjust the articulation of the ablation device. In some examples, centering may be based on closing an orientation ring on the orientation within the registration model using, for example, one or more position sensors using the measured orientation of the catheter. In some examples, centering may be based on the detected orientation of the instrument relative to the airway wall (e.g., using a pressure sensor, a force sensor, an EM sensor, an impedance sensor, a contact sensor, and / or an optical fiber integrated into the outer layer of the expandable ablation device).
[0056] Figure 8A flow chart illustrating a method 700 for evaluating the efficacy of a treatment is provided. In process 702, a robotic-assisted manipulator (e.g., manipulator system 802) may be actuated to move an ablation device from a first intracavitary position in an anatomical passage to a second intracavitary position in the anatomical passage. In process 704, sensor data may be received from a sensor system coupled to an elongated instrument carrying the ablation device. In process 706, an ablation treatment may be delivered to the anatomical passage while the robotic-assisted manipulator is actuated. In process 708, contact between the ablation device and the anatomical passage may be evaluated based on the sensor data and an expected rate of movement of the ablation device. For example, process 708 may be used to evaluate the efficacy of process 164 of method 150.
[0057] The sensor data may include positioning sensor data that can be used to help evaluate the efficacy of ablation. The sensor data may include, for example, shape information of the elongated instrument, position / orientation information of the ablation device, speed information of the ablation device (which may include direction), actuator data, and / or force information of the ablation device. For example, a measurement of friction during dragging or other movement along a defined trajectory may be determined by measuring retraction actuator data and positioning data. If the actuator data indicates that the ablation device is moving through the channel in the retraction direction, but the shape sensor or orientation sensor indicates that no movement has occurred, then overtreatment may be occurring or may have occurred in that area of the channel. If the actuator data indicates that the ablation device is moving through the channel in the retraction direction and the distal tip of the catheter moves suddenly, then the length of the channel that the ablation device quickly passes through may be under-treated. Contact with the airway wall may be determined by measuring the actuator force during retraction, and then determining the tension by subtracting the contribution of catheter friction and catheter bending. A relatively high tension or a tension exceeding a tension threshold may indicate good or acceptable contact, which may be associated with good ablation. A relatively low pull force or a pull force below a pull force threshold may indicate poor contact, slight or unacceptable contact, which may be associated with poor ablation. In some examples, a measurement of position compared to time may be used instead of retract actuator data. Pull force may be identified using distal sensing on the ablation device.
[0058] In some examples, ablation therapy may be performed without an anatomical model or treatment plan, but ablation treatment locations may be tracked and located using a position sensor coupled to the treatment device (or instrument) that provides data in a positioning sensor reference frame. In one example, an alert (auditory, visual, and / or tactile) may be provided to the user indicating that an area has been previously treated to avoid duplicate or overlapping treatments. The record of ablation treatment locations may be used as input to subsequent anatomical models and / or treatment plans. In some embodiments, if the treatment device is registered to the patient anatomy during an initial procedure (e.g., registered to known anatomical landmarks in the patient anatomy, such as the carina and major bifurcation) and then realigned to the patient anatomy in a follow-up procedure, the record of ablation treatment locations may be used during the follow-up procedure. During the follow-up procedure, an alert (e.g., visual, audible, or tactile) may be provided indicating that a location was previously treated.
[0059] In some examples, the systems and methods disclosed herein may be used in medical procedures performed using a robotic-assisted medical system, as described in further detail below. Fig. 9 As shown, the robotic-assisted medical system 800 may include a manipulator assembly 802 for operating a medical device 804 (e.g., the medical device system 100, a delivery device, a treatment device, or any of the devices described herein) to perform various procedures on a patient P located on a table T in a surgical environment 801. The manipulator assembly 802 may be a teleoperated, non-teleoperated, or hybrid teleoperated and non-teleoperated assembly having selected degrees of freedom of motion that may be powered and / or teleoperated and selected degrees of freedom of motion that may be non-powered and / or non-teleoperated. A main assembly 806, which may be inside or outside the surgical environment 801, typically includes one or more control devices for controlling the manipulator assembly 802. The manipulator assembly 802 supports the medical device 804 and may optionally include a plurality of actuators or motors that drive inputs on the medical device 804 in response to commands from a control system 812. The actuator may optionally include a drive system that, when coupled to the medical device 804, can advance the medical device 804 into a natural or surgically created anatomical hole. Other drive systems can move the distal end of the medical device in multiple degrees of freedom, which can include three degrees of linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes). Manipulator assembly 802 can support various other systems for irrigation, treatment, or other purposes. Such systems can include fluid systems (including, for example, reservoirs, heating / cooling elements, pumps, and valves), generators, lasers, interrogators, and ablation components.
[0060] The robotic-assisted medical system 800 also includes a display system 810 for displaying images or representations of the surgical site and medical instrument 804 generated by a sensor system 808, which may include an endoscopic imaging system. The display system 810 and the main assembly 806 may be oriented so that the operator O can use the perception of telepresence to control the medical instrument 804 and the main assembly 806. Any of the graphical user interfaces previously described may be displayed on the display system 810 and / or the display system of the independent planning workstation.
[0061] The sensor system 808 may include a position / location sensor system (e.g., an actuator encoder or an electromagnetic (EM) sensor system) and / or a shape sensor system (e.g., a fiber optic shape sensor) for determining the position, orientation, speed, velocity, posture, and / or shape of the medical device 804. The sensor system 808 may also include temperature, pressure, force, or contact sensors, etc. Data from the sensor system 808 may be used to generate survey information about the configuration of a region of the patient's anatomy, including airway diameter, airway length, airway orientation, and the relative position of multiple airways.
[0062] The robotic-assisted medical system 800 may also include a control system 812. The control system 812 includes at least one memory 816 and at least one computer processor 814 for implementing control between the medical device 804, the main assembly 806, the sensor system 808, and the display system 810. The control system 812 also includes programming instructions (e.g., a non-transitory machine-readable medium storing instructions) to implement multiple operating modes of the robotic-assisted medical system, including a navigation planning mode, a navigation mode, and / or a program mode. The control system 812 also includes programming instructions (e.g., a non-transitory machine-readable medium storing instructions) to implement some or all of the processes described according to the aspects disclosed herein, including, for example, expanding the expandable device, adjusting the temperature of the heating system, adjusting the valve to control fluid delivery, controlling the flow rate of the fluid, controlling the insertion and retraction of the treatment device, controlling the actuation of the distal end of the treatment device, receiving sensor information, modifying the signal based on the sensor information, selecting a treatment position, and / or determining the size to which the expandable device can be expanded.
[0063] The control system 812 may optionally further include a virtual visualization system to provide navigation assistance to the operator O when controlling the medical device 804 during an image-guided surgical procedure. Virtual navigation using the virtual visualization system may be based on reference to a preoperative or intraoperative data set of acquired anatomical passages. The virtual visualization system processes images of the surgical site imaged using imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, etc. The control system 812 may use the preoperative images to locate the target tissue (using visual imaging techniques and / or by receiving user input) and create a preoperative plan, including an optimal first position for performing occlusion of bronchial passages and vasculature. The preoperative plan may include, for example, a planned size of the expandable device, a duration of treatment, a treatment temperature, and / or multiple deployment positions.
[0064] In the specification, the specific details of describing some examples have been set forth. Many specific details are set forth to provide a thorough understanding of the examples. However, it will be apparent to those skilled in the art that some examples may be practiced without some or all of these specific details. The specific examples disclosed herein are meant to be illustrative, but not restrictive. Those skilled in the art may implement other elements, although not specifically described herein, within the scope and spirit of the present disclosure.
[0065] As long as feasible, the elements described in detail with reference to an example, implementation or application may be optionally included in other examples, implementations or applications that are not specifically shown or described. For example, if the element is described in detail with reference to an example and is not described with reference to a second example, the element may still be referred to as being included in the second example. Therefore, in order to avoid unnecessary repetition in the following description, unless specifically described otherwise, one or more elements shown and described in association with an example, implementation or application may be incorporated into other examples, implementations or aspects, unless one or more elements make the example or implementation inoperative, or unless two or more of the elements provide conflicting functions. Not all of the processes described may be performed in all examples of the disclosed method. Additionally, one or more processes not explicitly described in may be included before, after, between or as part of the process described. In some examples, one or more of the processes may be performed by a control system, or may be implemented at least in part in the form of executable code stored on a non-temporary, tangible, machine-readable medium, which may enable one or more processors to perform one or more of the processes when the code is run by one or more processors.
[0066] Any changes and additional modifications to the described devices, apparatus, methods, and any additional applications of the principles of the present disclosure are fully contemplated, as would normally occur to a person skilled in the art to which the present disclosure relates. In addition, the dimensions provided herein are for specific examples, and it is contemplated that different sizes, dimensions, and / or ratios may be utilized to implement the concepts of the present disclosure. In order to avoid unnecessary descriptive repetitions, one or more components or actions described according to an illustrative example may be used or omitted from other illustrative examples where applicable. For the sake of brevity, the multiple reiterations of these combinations will not be described separately. For the sake of simplicity, in some cases, the same reference numerals are used throughout the accompanying drawings to refer to the same or similar parts.
[0067] The system and method described herein can be applied to any of various anatomical systems including lungs, colon, intestines, stomach, liver, kidney and calyces, brain, heart, circulatory system including vascular system, etc., via natural or surgically created connection channels for imaging. Although some examples about medical procedures are provided herein, any reference to medical or surgical instruments and medical or surgical methods is non-restrictive. For example, the apparatus, system and method described herein can be used for non-medical purposes, including industrial use, general robot use, and sensing or manipulating non-tissue artifacts. Other example applications relate to cosmetic improvement, imaging of human or animal anatomical structures, collecting data from human or animal anatomical structures, and training medical or non-medical personnel. Additional example applications include procedures for tissues removed from human or animal anatomical structures (without returning to human or animal anatomical structures) and performing procedures on human or animal corpses. In addition, these technologies can also be used for surgical and non-surgical medical or diagnostic procedures.
[0068] One or more elements in the examples of the present disclosure may be implemented in software to be executed on a processor of a computer system such as a control processing system. When implemented in software, the elements of the examples of the present disclosure may be code segments that perform various tasks. The program or code segment may be stored in a processor-readable storage medium or device, which may be downloaded via a computer data signal embodied in a carrier wave on a transmission medium or a communication link. The processor-readable storage device may include any medium that can store information, including optical media, semiconductor media, and / or magnetic media. Examples of processor-readable storage devices include electronic circuits; semiconductor devices, semiconductor memory devices, read-only memories (ROMs), flash memories, erasable programmable read-only memories (EPROMs); floppy disks, CD-ROMs, optical disks, hard disks, or other storage devices. The code segments may be downloaded via computer networks such as the Internet, intranets, etc. Any of a variety of centralized or distributed data processing architectures may be used. Programming instructions may be implemented as multiple separate programs or subroutines, or they may be integrated into multiple other aspects of the system described herein. In some examples, the control system may support wireless communication protocols such as Bluetooth, Infrared Data Association (IrDA), HomeRF, IEEE 802.11, Digital Enhanced Cordless Telecommunications (DECT), Ultra-Wideband (UWB), ZigBee, and wireless telemetry.
[0069] It should be noted that the processes and displays presented may not be inherently related to any particular computer or other device. Various general purpose systems may be used with programs according to the teachings herein, or it may prove convenient to construct more specialized devices to perform the described operations. The required structures for various of these systems will appear as elements in the claims. In addition, examples of the present invention are described without reference to any particular programming language. It should be understood that a variety of programming languages may be used to implement the teachings of the present invention as described herein.
[0070] The present disclosure describes the state of various instruments, instrument parts and anatomical structures in three-dimensional space. As used herein, the term position refers to the position of an object or a part of an object in three-dimensional space (e.g., three translational degrees of freedom along Cartesian x, y and z coordinates). As used herein, the term orientation refers to the rotational placement of an object or a part of an object (e.g., in one or more rotational degrees of freedom, such as roll, pitch and / or yaw). As used herein, the term posture refers to the position of an object or a part of an object in at least one translational degree of freedom and the orientation of an object or a part of an object in at least one rotational degree of freedom (e.g., up to six degrees of freedom in total). As used herein, the term shape refers to a set of postures, positions or orientations measured along an object.
[0071] Although certain illustrative examples of the present invention have been described and shown in the drawings, it is to be understood that such examples are intended to illustrate and not to limit the present invention, and that the examples of the present invention are not limited to the specific construction and arrangements shown and described, since various other modifications may be made by those skilled in the art.
[0072] Various aspects of the subject matter described herein are set forth in the following numbered examples.
[0073] Example 1. A system comprising a robot-assisted manipulator, an ablation device configured to be coupled to the robot-assisted manipulator, and a control system coupled to the robot-assisted manipulator. The control system is configured to determine a first ablation therapy according to a first treatment mode at a first intracavitary location, receive anatomical information about a second intracavitary location, and determine a second ablation therapy according to a second treatment mode at the second intracavitary location based on the anatomical information.
[0074] Example 2. A system according to Example 1, wherein the anatomical information includes an assessment of diameter uniformity between the first intracavitary location and the second intracavitary location.
[0075] Example 3. The system of Example 2, wherein if the diameter uniformity is irregular, then the second ablation therapy is determined to be a spot therapy mode.
[0076] Example 4. The system of Example 2, wherein if the diameter uniformity is consistent, then the second ablation therapy is determined to be a defined trajectory treatment mode.
[0077] Example 5. A system according to Example 1, wherein the anatomical information includes an assessment of the tortuosity of a passage between the first intracavitary location and the second intracavitary location.
[0078] Example 6. The system of Example 5, wherein the second ablation therapy is determined to be a point therapy mode if the channel curvature exceeds a curvature threshold.
[0079] Example 7. A system according to Example 5, wherein if the channel curvature is below a curvature threshold, then the second ablation therapy is determined to be a limited trajectory treatment mode.
[0080] Example 8. A system according to Example 1, wherein the first or second treatment mode is a point treatment mode, wherein the ablation device is stationary during application of energy.
[0081] Example 9. A system according to Example 1, wherein the first or second treatment mode is a defined trajectory treatment mode, wherein the ablation device moves along a defined trajectory during application of energy.
[0082] Example 10. A system comprising a robot-assisted manipulator, an elongated instrument configured for manipulation by the robot-assisted manipulator, an ablation device coupled to a distal portion of the elongated instrument, a sensor system coupled to the elongated instrument, and a control system coupled to the robot-assisted manipulator. The control system is configured to actuate the robot-assisted manipulator to move the ablation device from a first intracavitary position in an anatomical channel to a second intracavitary position in the anatomical channel, wherein an expected rate of movement of the ablation device is associated with the actuation of the robot-assisted manipulator. The control system is also configured to receive sensor data from the sensor system while actuating the robot-assisted manipulator, deliver ablation therapy to the anatomical channel while actuating the robot-assisted manipulator, and evaluate ablation device contact with the anatomical channel based on the received sensor data and the expected rate of movement of the ablation device.
[0083] Example 11. A system according to Example 10, wherein the sensor data includes shape information for the slender instrument.
[0084] Example 12. A system according to Example 10 or Example 11, wherein the sensor data includes position information for the ablation device.
[0085] Example 13. A system according to any of Examples 10-12, wherein the sensor data includes rate information for the ablation device.
[0086] Example 14. A system according to any of Examples 10-13, wherein the sensor data includes force information for the ablation device.
[0087] Example 15. A system according to Example 14, wherein the force information includes a measurement of tension, and wherein if the tension exceeds a tension threshold, then ablation device contact is assessed as acceptable.
[0088] Example 16. A system according to Example 14, wherein the force information includes a measurement of tension, and wherein if the tension is below a tension threshold, then ablation device contact is assessed as unacceptable.
[0089] Example 17. A system according to any of Examples 10-16, wherein the evaluating includes determining from the sensor data that actual ablation device movement is less than an expected rate of movement of the ablation device and that the ablation device contact is longer than expected.
[0090] Example 18. A system according to any of Examples 10-16, wherein the evaluating includes determining from the sensor data that actual ablation device movement is greater than an expected rate of the ablation device movement and that the ablation device contact is shorter than expected.
[0091] Example 19. A system according to Example 18, wherein the control system is further configured to deliver another ablation therapy to the anatomical channel when the evaluation determines that the ablation device contact is shorter than expected.
[0092] Example 20. A system according to any of Examples 10-19, further comprising: a delivery catheter coupled to the robotic-assisted manipulator, wherein the elongated instrument extends through the delivery catheter.
Claims
1. A system comprising: Processor; and a memory having stored thereon computer readable instructions that, when executed by the processor, cause the system to: receiving anatomical image data of an anatomical region; segmenting the anatomical image data to identify anatomical pathways in the anatomical region; identifying a gap between a first segment and a second segment of the segmented anatomical image data; generating a bridging segment to bridge the gap; and An anatomical model of a diseased lung is generated that includes the first segment, the second segment, and the bridging segment. 2 . The system of claim 1 , wherein the computer readable instructions, when executed by the processor, further cause the system to determine a characteristic of the bridging segment based on one or more of the first segment, the second segment, or the gap. 3 . The system of claim 2 , wherein the characteristic of the bridge segment comprises a bridge diameter determined by the first segment and the second segment.
4. The system of claim 2 or claim 3, wherein the characteristic of the bridging segment comprises a bridge length determined by the length of the gap.
5. A system according to any one of claims 1-4, wherein the computer-readable instructions, when executed by the processor, further cause the system to segment the vascular system in the anatomical region, and wherein identifying the gap between the first segment and the second segment includes determining that the segmented vascular system extends between the first segment and the second segment.
6. The system of any one of claims 1-5, wherein the gap is associated with a mucus plug in the anatomical region.
7. A system comprising: Processor; and a memory having stored thereon computer readable instructions that, when executed by the processor, cause the system to: identifying multiple channels in an anatomical region; identifying at least one anatomically constrained region in the plurality of channels; as well as An ablation treatment plan is determined based on the at least one anatomical constraint region, the ablation treatment plan comprising a treatment order for the channels and a plurality of sequential treatment locations.
8. The system of claim 7, wherein the plurality of sequential treatment positions comprises a start treatment position for delivering a first ablation treatment of the ablation treatment plan and a stop treatment position for delivering a final ablation treatment of the ablation treatment plan.
9. The system of claim 7 or claim 8, wherein the anatomical constraint region comprises an obstruction in one of the plurality of channels.
10. The system of any one of claims 7-9, wherein the anatomical constraint region comprises a channel diameter size of a channel of the plurality of channels that is smaller than a diameter of a device used in the ablation therapy plan.
11. The system of any one of claims 7-10, wherein the anatomical constraint region comprises a shape of a channel of the plurality of channels that exceeds a bend radius of an instrument used in the ablation therapy plan.
12. The system of any one of claims 7-11, wherein the ablation treatment plan comprises one or more treatment modes.
13. The system of any one of claims 7-12, wherein the ablation treatment plan includes a treatment duration.
14. The system of any one of claims 7-13, wherein the ablation therapy plan includes a drive mode for an instrument used in the ablation therapy plan.
15. The system of any one of claims 7-14, wherein the ablation treatment plan includes a treatment dose.
16. The system of any one of claims 7-15, wherein the ablation therapy plan includes a keep-out zone that is not traversed by a device used in the ablation therapy plan.
17. The system of any one of claims 7-16, wherein the ablation therapy plan includes a distance of instrument movement used in the ablation therapy plan.
18. The system of any one of claims 7-17, wherein the ablation treatment plan includes a spacing distance between the sequential treatment locations.
19. A system comprising: Processor; and a memory having stored thereon computer readable instructions that, when executed by the processor, cause the system to: Generate ablation treatment plans; providing navigation guidance to perform ablation therapy according to the ablation therapy plan; as well as A treatment report is generated after performing the ablation treatment according to the ablation treatment plan.
20. The system of claim 19, wherein the treatment report includes an image of an anatomical model with treatment markings indicating ablation locations generated during the ablation treatment.
21. The system of claim 20, wherein the treatment marker comprises a duration or a power level of the ablation treatment at the ablation location.
22. A system according to claim 20 or claim 21, wherein the computer readable instructions, when executed by the processor, cause the system to: A second ablation treatment plan is generated based on the image of the anatomical model with the treatment markings.
23. The system of any one of claims 19-22, wherein the treatment report includes a measurement of an actual treatment area of a performed ablation treatment compared to a predicted treatment area from the ablation treatment plan.
Citation Information
Patent Citations
Systems and methods for delivering targeted therapy
WO2021168061A1