Improved pulmonary navigation path planning and alignment

Abstract

A system for performing surgical procedures includes: a catheter capable of navigating within a patient's luminal network; and a workstation operatively coupled to the catheter and including a memory and a processor, the memory storing instructions that, when executed by the processor, cause the processor to perform the following operations: generate a 3D model of the luminal network of the patient's lungs; identify target tissue in the generated 3D model; receive catheter information; generate multiple proposed pathways through the luminal network to the identified target tissue; determine weighting factors based on the generated multiple potential airways; modify the determined weighting factors based on the received catheter information; apply the modified weighting factors to the generated multiple proposed pathways; sort the generated proposed pathways after applying the modified weighting factors to the generated multiple proposed pathways; and display the sorted proposed pathways to the target tissue.

Description

[0001] background Technical Field

[0002] This disclosure relates to the field of navigating medical devices within a patient's body, and more particularly to planning pathways through the patient's lumen network and navigating medical devices to their target.

[0003] Related technical specifications

[0004] Several commonly used medical methods, such as endoscopic or minimally invasive surgery, are employed to treat a variety of diseases affecting organs including the liver, brain, heart, lungs, gallbladder, kidneys, and bones. Clinicians typically use one or more imaging modalities, such as magnetic resonance imaging (MRI), ultrasound, computed tomography (CT), cone-beam computed tomography (CBCT), or fluoroscopy (including 3D fluoroscopy), to identify and navigate to areas of interest within the patient and ultimately to the biopsy or treatment target. In some procedures, preoperative scans can be used for target identification and intraoperative guidance. However, real-time imaging may be necessary to obtain more accurate and up-to-date images of the target area. Furthermore, real-time image data showing the current position of the medical device relative to the target and its surroundings may be required to navigate the device to the target safely and accurately, e.g., without causing damage to other organs or tissues.

[0005] For example, endoscopic methods have proven to be very useful in navigating to areas of interest within a patient's body. To enable endoscopic methods, endoscopic navigation systems have been developed that use previously acquired MRI or CT image data to generate three-dimensional (3D) renderings, models, or volumes of specific body parts, such as the lungs.

[0006] In some applications, the acquired MRI or CT image data can be obtained during surgery (perioperative period). The resulting volume generated from the MRI or CT scan is then used to create a navigation plan to advance the endoscope (or other suitable medical device) to the area of ​​interest within the patient's anatomy. In some cases, the generated volume can be used to update a previously created navigation plan. Positioning or tracking systems, such as electromagnetic (EM) tracking systems or fiber optic shape sensing systems, can be combined with, for example, CT data to guide the endoscope to the area of ​​interest.

[0007] However, if the area of ​​interest is located near a small or narrow airway, larger interventional devices may have difficulty navigating to that area. Understandably, the difficulty in navigating larger interventional devices (such as those with cameras) within a narrow airway can lead to prolonged procedure time in navigating to the correct location relative to the area of ​​interest, potentially resulting in inaccurate navigation or the need for fluoroscopy, leading to additional setup time and radiation exposure. Summary of the Invention

[0008] A system for performing surgical procedures includes: a catheter capable of navigating within a network of lumens in a patient's lungs; and a workstation operatively coupled to the catheter, the workstation including a memory and a processor, the memory storing instructions that, when executed by the processor, cause the processor to perform the following operations: generate a 3D model of the network of lumens in the patient's lungs; identify target tissue in the generated 3D model; receive catheter information; generate multiple proposed pathways through the network of lumens to the identified target tissue; determine weighting factors based on the generated multiple potential pathways; modify the determined weighting factors based on the received catheter information; apply the modified weighting factors to the generated multiple proposed pathways; sort the generated proposed pathways after applying the modified weighting factors to the generated multiple proposed pathways; and display the sorted proposed pathways to the target tissue.

[0009] In various respects, additional instructions can be stored in the memory, which, when executed by the processor, cause the processor to receive patient information and modify the determined weighting factors based on the received medical device information and the received patient information.

[0010] In other respects, additional instructions may be stored in the memory that, when executed by a processor, cause the processor to receive weighting factors, including at least one of the following: the distance from the distal portion of the catheter to a selected portion of the target tissue; or the alignment of a candidate airway of the lumen network with the selected portion of the target tissue; or the distance to the bifurcation of the lumen network closest to the distal portion of the catheter; or the pleural or segmental boundary across the patient's lung; or the volume overlap of the expected trajectory of a surgical instrument received within the catheter; or an airway within the lumen network having an internal size smaller than a predetermined threshold.

[0011] In some respects, additional instructions may be stored in the memory that, when executed by a processor, cause the processor to determine the distance from the distal portion of the duct to a selected portion of the target tissue at the end of a plurality of generated proposed pathways.

[0012] In other respects, additional instructions may be stored in the memory that, when executed by the processor, cause the processor to determine the alignment of the candidate airway with the selected portion of the target tissue by determining the angle between the alignment vector of the working channel of the catheter and the vector from the position of the distal portion of the catheter to the selected portion of the target tissue.

[0013] In various respects, additional instructions may be stored in the memory that, when executed by the processor, cause the processor to determine a predetermined internal size threshold based on a percentage of the external size of the conduit.

[0014] In some respects, additional instructions may be stored in memory that, when executed by a processor, cause the processor to determine a predetermined internal size threshold based on the percentage increase in the external size of the conduit.

[0015] In various respects, additional instructions may be stored in the memory that, when executed by a processor, enable the processor to identify the pleural or segmental boundary between the distal portion of the catheter and the target tissue, which may result in pneumothorax if the pleural or segmental boundary is crossed.

[0016] In other respects, additional instructions may be stored in the memory that, when executed by the processor, cause the processor to determine the volume overlap between the proposed surgical tool path in one of the multiple generated proposed pathways and the volume coverage of the target tissue.

[0017] In some respects, additional instructions may be stored in the memory that, when executed by the processor, cause the processor to perform the following operations: receive catheter information about the type of catheter used for navigation to the target tissue; receive catheter information about the type of surgical instrument used to treat the target tissue; and receive catheter information about the external dimensions of the catheter.

[0018] According to another aspect of this disclosure, a method for performing a surgical procedure includes: generating a 3D model of a lumen network of a patient's lungs; identifying target tissue in the generated 3D model; receiving catheter information; generating multiple proposed pathways through the lumen network to the identified target tissue; determining weighting factors based on the generated multiple potential pathways; modifying the determined weighting factors based on the received catheter information; applying the modified weighting factors to the generated multiple proposed pathways; ranking the generated proposed pathways after applying the modified weighting factors to the generated multiple proposed pathways; and displaying the ranked proposed pathways to the target tissue.

[0019] In all respects, the weighting factors identified may include at least one of the following: the distance from the distal portion of the catheter to the center of volume of the target tissue, or the distance from the distal portion of the catheter to the center of malignancy of the target tissue; or the alignment of the candidate airway of the lumen network with the center of volume of the target tissue, or the alignment of the candidate airway of the lumen network with the center of malignancy of the target tissue; or the distance to the bifurcation of the lumen network closest to the distal portion of the catheter, or the pleural or segmental boundary across the patient's lung, or the volume overlap of the expected trajectory of the surgical instrument received within the catheter, or the airway within the lumen network having an internal size smaller than a predetermined threshold.

[0020] In other respects, the predetermined internal size threshold can be based on a percentage of the external size of the conduit.

[0021] In some respects, the predetermined internal size threshold can be based on the percentage increase in the external size of the conduit.

[0022] In various aspects, the alignment of the candidate airway with the center of volume of the target tissue can be determined by using the angle between the alignment vector of the working channel of the catheter and the vector from the position of the distal portion of the catheter to the center of volume of the target tissue.

[0023] According to another aspect of this disclosure, a system for performing surgical procedures includes: a catheter capable of navigating within a luminal network of a patient's lungs; and a workstation operatively coupled to the catheter, the workstation including a memory and a processor, the memory storing instructions that, when executed by the processor, cause the processor to perform the following operations: generate a 3D model of the luminal network of the patient's lungs; identify target tissue in the generated 3D model; generate multiple proposed pathways through the luminal network to reach the identified target tissue; and determine weighting factors based on the generated multiple potential pathways. Includes at least one of the following: the distance from the distal portion of the catheter to a selected portion of the target tissue, the alignment of the candidate airway of the lumen network with the selected portion of the target tissue, the distance to the bifurcation of the lumen network closest to the distal portion of the catheter, the pleural or segmental boundary across the patient's lung, the volume overlap of the expected trajectory of the surgical instrument received within the catheter, and the airway within the lumen network having an internal size less than a predetermined threshold; applying weighting factors to the generated multiple proposed pathways; ranking the generated proposed pathways; and displaying the ranked proposed pathways to the target tissue.

[0024] In various respects, additional instructions may be stored in the memory that, when executed by the processor, cause the processor to determine a predetermined internal size threshold based on a percentage of the external size of the conduit.

[0025] In other respects, additional instructions may be stored in the memory that, when executed by the processor, cause the processor to determine a predetermined internal size threshold based on the percentage increase in the external size of the conduit.

[0026] In some respects, additional instructions may be stored in the memory that, when executed by a processor, enable the processor to identify the pleural or segmental boundary between the distal portion of the catheter and the target tissue, which may result in pneumothorax if the pleural or segmental boundary is crossed.

[0027] In various respects, additional instructions can be stored in the memory that, when executed by the processor, cause the processor to determine the volume overlap between the proposed surgical tool path in a plurality of generated proposed pathways and the volume coverage of the target tissue. Attached Figure Description

[0028] Various aspects and embodiments of this disclosure are described below with reference to the accompanying drawings, in which:

[0029] Figure 1 This is a schematic diagram of the surgical system provided in accordance with this disclosure;

[0030] Figure 2 yes Figure 1 A three-dimensional view of the distal portion of the catheter in the surgical system;

[0031] Figure 3 yes Figure 1 A schematic diagram of the workstation of the surgical system;

[0032] Figure 4 yes Figure 1 The description of the graphical user interface of the surgical system shows a 3D representation of the patient's airway and the generation pathway leading to the area of ​​interest within the patient's lungs.

[0033] Figure 5 yes Figure 4 A magnified view of the detailed area indicated in the middle;

[0034] Figure 6 yes Figure 1 A diagram illustrating the surgical system's placement of medical equipment within the patient's lung airway, showing that the distal end of the medical equipment is not aligned with the center of the area of ​​concern;

[0035] Figure 7 yes Figure 1 The diagram shows the medical device, which aligns the distal end of the device with the center of the area of ​​interest.

[0036] Figure 8 yes Figure 1 A diagram of medical equipment, which shows... Figure 1The surgical instruments of the surgical system are advanced through the medical equipment and treated in the area of ​​concern;

[0037] Figure 9 yes Figure 8 A magnified view of the detailed area indicated in the middle;

[0038] Figure 10 yes Figure 1 A schematic diagram of a medical device, showing the bending radius of the medical device;

[0039] Figure 11 yes Figure 1 A schematic diagram of a medical device, illustrating the difference between the desired and actual posture of the medical device;

[0040] Figure 12 yes Figure 1 A diagram of the medical equipment, showing the length of the medical equipment reinforced within the patient's airway;

[0041] Figure 13 It is a graphical representation of a malignant tumor within the volume boundary of a lesion in a patient's lung;

[0042] Figure 14A This is a flowchart of a method for navigating medical devices to areas of interest within a patient's lumen network;

[0043] Figure 14B yes Figure 14A A continuation of the flowchart;

[0044] Figure 15 yes Figure 1 A 3D view of a robotic surgical system.

[0045] Figure 16 yes Figure 1 An exploded view of the drive mechanism for the extended working channel of the surgical system; and

[0046] Figure 17 This is a flowchart of a method for navigating medical devices to areas of interest within a patient's lumen network. Detailed Implementation

[0047] This disclosure relates to a surgical system configured to enable the navigation of medical devices through a patient's network of luminal pathways (e.g., pulmonary airways). The system generates a three-dimensional (3D) representation of the patient's airways using preoperative images (e.g., CT, CBCT, or MRI images) and identifies anatomical landmarks or target tissues (e.g., bifurcations or lesions) within the 3D representation. The system generates multiple pathways through the network of luminal pathways in the patient's lungs to reach the target tissue. A weighting factor is applied to each of the multiple pathways leading to the target tissue to prioritize or de-prioritize the pathways for consideration. The weighting factor may include distances to selected portions of the target tissue (e.g., distances to the surface of the target tissue and distances to the volume center, centroid, and / or malignant tumor center of the target tissue), alignment of the candidate airway with selected portions of the target tissue (e.g., the surface, volume center, centroid, and / or malignant tumor center of the target tissue), distances to bifurcations of the distal portion closest to the duct, crossing pleural or segmental boundaries, volume overlap of the expected tool passage trajectory, and combinations thereof. It is conceivable that selected portions of the target tissue can be selected automatically, semi-automatically, or manually. Although generally described as catheter-related, it is conceivable that the weighting factor can be associated with any suitable medical device without departing from the scope of this disclosure.

[0048] The distance between the distal portion of the catheter and the desired portion of the target tissue (e.g., surface, center of volume, center of mass, and / or center of malignancy) is determined at the end of the analyzed pathway. This distance is linear and its determination is unaffected by any structures or tissues between the distal portion of the catheter and the selected portion of the target tissue. Alignment of the candidate airway with the selected portion of the target tissue is determined using the angle between the alignment vector of the working channel of the catheter and the vector from the location of the distal portion of the catheter to the selected portion of the target tissue. It is conceivable that the system could store predetermined maximum angles (e.g., conical boundary lines) relative to the alignment vector of the working channel in 3D space, within which the target tissue must lie to be considered a proposed pathway. The distance to the bifurcation closest to the distal portion of the catheter is determined by identifying the location of the nearest bifurcation proximal to the distal portion of the catheter. As can be understood, if the distal portion of the catheter is close to the bifurcation, it is not adequately supported, and during alignment of surgical instruments advanced within the catheter, sampling of target tissue, or delivery of treatment to target tissue, the distal portion of the catheter is more likely to move relative to the target tissue as the catheter is pushed away. In an embodiment, the distance from the distal portion of the catheter to the nearest bifurcation can be compared to a predetermined threshold (e.g., 2 mm) within which minor disturbances are more likely to cause the distal portion of the catheter to lose its navigation position as the catheter is pushed away or otherwise forced away from the area of ​​interest or target tissue. The system identifies pleural or segmental boundaries between the distal portion of the catheter and the target tissue. As can be understood, puncture subsegmental boundaries or the pleura may cause pneumothorax. Therefore, potential pathways that may lead to a higher probability of pneumothorax are downgraded or scored lower. In an embodiment, the system may identify volumetric overlap of the expected tool passage trajectory, and the system prioritizes proposed pathways to the target tissue that can increase the volumetric overlap of the possible tool path's coverage of the target tissue volume.

[0049] As can be understood, weighting factors can vary based on a variety of factors, such as the type of surgery being performed, the type of medical device used for navigation to the target tissue, the type of surgical instrument used for treating or sampling the target tissue, the size of the medical device used for navigation to the target tissue, the range of motion of the catheter (e.g., minimum bending radius), the accuracy of the catheter's attitude control, the stiffness of the catheter, the volume of the target tissue, and the patient's medical history. Some weighting factors can be modified by assigning greater or less weight based on one or more of the factors described above. For example, the system can identify the medical device being used and thus identify the external dimensions of the medical device, the range of motion of the medical device, the accuracy of the attitude control of the medical device, the stiffness of the medical device, and combinations thereof. The system can assign predetermined thresholds to the internal dimensions of airways, such as the maximum internal dimension within which the medical device can navigate. The threshold for the internal dimensions of the airway can be equal to or greater than the external dimensions of the medical device, or can be calculated as a percentage of the external dimensions of the medical device; in embodiments, this threshold can be a percentage increase in the external dimensions of the medical device. If potential pathways include airways equal to or greater than the internal dimension threshold, these potential pathways are degraded.

[0050] Turns and bends along pathways leading to target tissue are constrained by the range of motion of the medical device (e.g., minimum bending radius). In this way, the system can assign a predetermined threshold to the radius of bends or curves along pathways leading to target tissue, such as the minimum bending radius achievable by the medical device. The threshold for the radius of the bend or curve can be equal to or greater than the minimum bending radius of the medical device, and in embodiments, this threshold can be a percentage increase in the bending radius of the medical device to accommodate tolerances and variations in the calculated pathway to target tissue. Potential pathways that include bends or curves equal to or less than the bending or curve radius threshold of the medical device are degraded.

[0051] As can be understood, the attitude control of a medical device may be more accurate in one region of a patient's airway than in others. In this way, the medical device may achieve a less accurate attitude in one direction than in others, which could hinder navigation or treatment of the area of ​​interest. The accuracy of the medical device's attitude control can be determined automatically or manually using both past and current data. In an embodiment, the system can update the weighted average of attitude accuracy in real time during surgery based on the medical device's attitude control performance in other parts of the patient's airway (e.g., where the medical device fails to achieve an accurate attitude). Potential pathways that involve manipulating the medical device into attitudes below a predetermined threshold for attitude accuracy are degraded.

[0052] During navigation to and treatment of the target tissue, one or more sections along the length of the medical device may require reinforcement to accomplish the desired diagnostic or therapeutic task. As can be understood, reinforcement of one or more sections along the length of the medical device requires space within the patient's airway to accommodate the reinforcement. For example, the system may require reinforcement of a portion of a distal section of the medical device adjacent to the patient's airway wall, which may abut against or otherwise contact the patient's airway wall. The system can determine a minimum threshold length of the medical device that needs reinforcement, taking into account the external dimensions of the medical device, the internal dimensions of the patient's airway, and any bends or bifurcations within the patient's airway. Potential pathways that include a portion of the patient's airway equal to or less than a predetermined length threshold are degraded.

[0053] A modified weighting factor is applied to each of the proposed pathways, and the weighted proposed pathways are ranked. The system displays one or more weighted proposed pathways for consideration and selects a proposed pathway automatically, semi-automatically, or manually. As will be understood, these and other aspects of this disclosure enable the selection of a lung navigation pathway that takes into account metrics beyond proximity. Incorporating these additional metrics into the pathway planning system and process allows for optimization of user experience, patient safety, and operative time efficiency compared to relying solely on proximity. These and other aspects of this disclosure will be described in further detail below. Although described generally with reference to the lungs, it is conceivable that the systems and methods described herein can be used for any structure within a patient's body (e.g., liver, kidney, prostate, gynecological organs, etc.).

[0054] Now turn to the attached image. Figure 1 A system 10 according to this disclosure is shown, which facilitates the navigation of medical devices through a network of lumens and to areas of interest. As will be described in further detail below, the surgical system 10 is typically configured to identify target tissue, automatically register real-time images captured by surgical instruments to a generated three-dimensional (3D) model, and navigate the surgical instruments to the target tissue.

[0055] System 10 includes a catheter guidance assembly 12 that includes an extended working channel (EWC) 14, which may be a smart extended working channel (sEWC) including an electromagnetic (EM) sensor. In one embodiment, sEWC 14 is inserted into a bronchoscope 16 to access the luminal network of patient P. In this way, sEWC 14 can be inserted into the working channel of bronchoscope 16 to navigate through the luminal network (e.g., the lungs) of patient P. It is contemplated that sEWC 14 itself may include imaging capabilities via an integrated camera or optics (not shown), and therefore does not strictly require a separate bronchoscope 16. In an embodiment, sEWC 14 can be selectively locked to bronchoscope 16 using a bronchoscope adapter 16a. In this way, the bronchoscope adapter 16a is configured to allow movement of the sEWC 14 relative to the bronchoscope 16 (this can be referred to as the unlocked state of the bronchoscope adapter 16a) or to inhibit movement of the sEWC 14 relative to the bronchoscope 16 (this can be referred to as the locked state of the bronchoscope adapter 16a). The bronchoscope adapter 16a is currently manufactured by Medtronic PLC under the trade name EDGE. ® Bronchoscope adapter or ILLUMISITE ® Bronchoscope adapters are marketed and are believed to be usable in conjunction with this disclosure.

[0056] Compared to the EWC, the sEWC 14 may include one or more EM sensors 14a, which are disposed within or on the sEWC 14 at a predetermined distance from the distal end 14b of the sEWC 14. It is conceivable that the EM sensors 14a may be five-DOF or six-DOF sensors. As can be understood, the position and orientation of the EM sensors 14a of the sEWC relative to a reference coordinate system can be determined, thereby determining the position and orientation of the distal portion of the sEWC 14 within the electromagnetic field. The conduit guidance assembly 12 is currently manufactured by Medtronic under the trade name SUPERDIMENSION. ® Surgical kit, ILLUMISITE TM Endobronchial surgical kit, ILLUMISITE TM Navigation catheter or EDGE ® The surgical kit is marketed and is believed to be usable in conjunction with this disclosure.

[0057] refer to Figure 2The catheter 70 (including one or more EM sensors 72) is inserted into the sEWC and selectively locked in place relative to the sEWC 14, such that the sensor 72 extends beyond the distal tip of the sEWC 14 by a predetermined distance. As can be understood, the EM sensor 72 disposed on the catheter 70 is separate from the EM sensor 14a disposed on the sEWC. The EM sensor 72 is disposed on or within the catheter 70 at a predetermined distance from the distal portion 76 of the catheter 70. In this way, the system 10 is able to determine the position of the distal portion of the catheter 70 within the lumen network of the patient P. It is contemplated that the catheter 70 can be selectively locked relative to the sEWC 14 at any time, regardless of the position of the distal portion 76 of the catheter 70 relative to the sEWC 14. It is conceivable that the catheter 70 can be selectively locked to the handle 12a of the catheter guiding assembly 12 using any suitable means (e.g., snap-fit, press-fit, friction fit, cam, one or more pawls, threaded engagement, or chuck clamp). It is foreseeable that the EM sensor 72 can be a five-degree-of-freedom sensor or a six-degree-of-freedom sensor. As will be described in further detail below, the position and orientation of the EM sensor 72 of the conduit 70 relative to the reference coordinate system can be obtained, thereby determining the position and orientation of the distal portion of the conduit 70 in the electromagnetic field.

[0058] At least one camera 74 is disposed on or near the distal surface 76a of the catheter 70 and is configured to capture, for example, still images, live images, or live video. Although generally described as disposed on the distal surface 76a of the catheter 70, it is contemplated that the camera 74 may be disposed at any suitable location on the camera 70 (e.g., a sidewall). In embodiments, the catheter 70 may include one or more light sources 80 disposed on or near the distal surface 76a of the catheter 70, or at any other suitable location (e.g., a side surface or a protrusion). The light source 80 may be, or may include, for example, a light-emitting diode (LED), an optical fiber connected to a light source located outside the patient P, or a combination thereof, and may emit one or more of white light, IR light, or near-infrared (NIR) light. In this way, the camera 74 may be, for example, a white light camera, an IR camera, or a NIR camera, a camera capable of capturing both white light and NIR light, or a combination thereof. In one non-limiting embodiment, camera 74 is a white-light miniature complementary metal-oxide-semiconductor (CMOS) camera; however, it is also contemplated that camera 74 can be any suitable camera, such as a charge-coupled device (CCD), complementary metal-oxide-semiconductor (CMOS), or N-type metal-oxide-semiconductor (NMOS), and in embodiments, depending on the design requirements of system 10, the camera can be an infrared (IR) camera. As will be understood, camera 74 captures images of the anatomical structures of patient P from a viewpoint looking outward from the distal portion 76 of catheter 70. In embodiments, camera 74 can be a dual-lens camera or an RGB-D camera, configured to identify the distance between camera 74 and anatomical features within the anatomical structures of patient P without departing from the scope of this disclosure. As described above, it is contemplated that camera 74 can be mounted on catheter 70, sEWC 14, or bronchoscope 16.

[0059] continue Figure 2In an embodiment, catheter 70 may include a working channel 82 defined through a proximal portion (not shown) and a distal surface 76a. However, in an embodiment, it is contemplated that the working channel 82 may extend through the sidewalls of catheter 70, depending on the design requirements of catheter 70. As understood, the working channel 82 is configured to receive a positionable guide (not shown) or surgical tool 90 (e.g., a biopsy tool). Catheter 70 includes an inertial measurement unit (IMU) 84 disposed within or adjacent to the distal portion 76. As understood, IMU 84 detects the orientation of the distal portion 76 of catheter 70 relative to a reference coordinate system and detects the movement and velocity of the distal portion 76 of catheter 70 as catheter 70 navigates within the lumen network of patient P. Using data received from IMU 84, system 10 is able to determine the alignment and trajectory information of the distal portion 76 of catheter 70. In an embodiment, system 10 may utilize data received from IMU 84 to determine a gravity vector, which can be used to determine the orientation of the distal portion 76 of catheter 70 within the airway of patient P. While generally described as using IMU 84 to detect the orientation and / or movement of the distal portion 76 of catheter 70, this disclosure is not limited thereto and may be used in conjunction with flexible sensors (e.g., fiber Bragg grating sensors, ultrasonic sensors), or without sensors, or in a combination thereof. As will be described in further detail below, it is contemplated that the devices and systems described herein may be used in conjunction with robotic systems, such that robotic actuators drive sEWC 14 or bronchoscope 16 toward a target.

[0060] Refer again Figure 1 System 10 typically includes an operating table 52 configured to support patient P and a monitoring device 24 (e.g., a video display for displaying video images received from a video imaging system of the bronchoscope 12 or a camera 74 of the catheter 70) coupled to the sEWC 14, bronchoscope 16, or catheter 70, a positioning or tracking system 46 including a tracking module 48, multiple reference sensors 50 and a transmitter pad 54 including multiple combined markers, and a workstation 20 having a computing device 22 including software and / or hardware for facilitating the following operations: target identification, pathway planning to the target, navigation of medical devices to the target, and / or confirmation and / or determination of the placement of, for example, the sEWC 14, bronchoscope 16, catheter 70, or surgical instruments (e.g., surgical instrument 90) relative to the target.

[0061] Tracking system 46 is, for example, a six-degree-of-freedom electromagnetic positioning or tracking system, or other suitable system for determining the position and orientation of the distal portion of, for example, sEWC 14, bronchoscope 16, catheter 70, or surgical instruments, for registering the detected positions of one or more of EM sensors 14a or 72 with a three-dimensional (3D) model generated from CT, CBCT, or MRI image scans. Tracking system 46 is configured for use with sEWC 14 and catheter 70, and particularly with EM sensors 14a and 72.

[0062] continue Figure 1 The transmitter pad 54 is positioned below the patient P. The transmitter pad 54 generates an electromagnetic field around at least a portion of the patient P, within which the tracking module 48 can be used to determine the positions of multiple reference sensors 50 and EM sensors 14a and 74. In a non-limiting embodiment, the transmitter pad 54 generates three or more electromagnetic fields. One or more of the reference sensors 50 are attached to the chest of the patient P. In an embodiment, the coordinates of the reference sensors 50 within the electromagnetic field generated by the transmitter pad 54 are sent to a computing device 22, where these coordinates are used to calculate a reference coordinate system (e.g., a reference coordinate system) for the patient P. As will be described in further detail below, registration is typically performed using coordinate positions from 3D models and 2D images from the planning phase, as well as the airway of the patient P as observed through the bronchoscope 12 or catheter 70, and allows for a navigation phase with the positions of the EM sensors 14a and 72 known. It is conceivable that either of the EM sensors 14a and 72 could be a single-coil sensor, enabling the system 10 to identify the position of the sEWC 14 or the conduit 70 within the EM field generated by the transmitter pad 54. However, it is also conceivable that the EM sensors 14a and 72 could be any suitable sensor, and could be sensors that enable the system 10 to identify the position, orientation, and / or attitude of the sEWC 14 or the conduit 70 within the EM field.

[0063] While the EMN system using EM sensors has been described in general, this disclosure is not limited thereto and can be used in conjunction with flexible sensors (e.g., fiber Bragg grating sensors), inertial measurement units (IMUs), ultrasonic sensors, optical sensors, attitude sensors (e.g., ultra-wideband, GPS, fiber Bragg, transmissive markers) or combinations thereof, or without sensors at all. It is conceivable that the devices and systems described herein can be used in conjunction with robotic systems to enable robotic actuators to drive the sEWC 14 or bronchoscope 16 toward a target.

[0064] According to various aspects of this disclosure, visualization of in vivo navigation of a medical device (e.g., a biopsy tool or treatment tool) toward a target (e.g., a lesion) can be part of a larger workflow of the navigation system. Imaging devices 56 capable of acquiring 2D and 3D images or videos of patient P (e.g., CT imaging devices, such as cone-beam computed tomography (CBCT) devices, including but not limited to Medtronic's O-arm™ system) are also included in specific aspects of system 10. Images, image sequences, or videos captured by imaging device 56 can be stored within imaging device 56 or transmitted to computing device 22 for storage, processing, and display. In embodiments, imaging device 56 can be moved relative to patient P, allowing images to be acquired from different angles or perspectives relative to patient P to create image sequences (e.g., fluorescence fluoroscopy videos). The orientation of imaging device 56 relative to patient P during image capture can be estimated via markers coupled to emitter pad 54. The markers are positioned below patient P, between patient P and operating table 52, and between patient P and the radiation source or sensing unit of imaging device 56. The marker associated with the transmitter pad 54 can be two separate elements, which can be fixedly connected, or alternatively, can be manufactured as a single unit. It is conceivable that the imaging device 56 may include a single imaging device or more than one imaging device.

[0065] continue Figure 1 And refer to other sources Figure 3 Workstation 20 includes a computer 22 and a monitor 24 configured to display one or more user interfaces 26 and / or 28. Workstation 20 may be a desktop or tower configuration with monitor 24, or it may be a laptop computer or other computing device. Workstation 20 includes a processor 30 that executes software stored in memory 32. Memory 32 may store video or other imaging data captured by bronchoscope 16 or catheter 70, or preoperative images from, for example, computed tomography (CT) scans, positron emission tomography (PET) scans, magnetic resonance imaging (MRI), cone-beam CT, etc. Additionally, memory 32 may store one or more software applications 34 to be executed on processor 30. Although not explicitly stated, monitor 24 may be integrated into a head-mounted display, such as that of an augmented reality (AR) head-mounted device, such as the HoloLens provided by Microsoft Corporation.

[0066] Network interface 36 enables workstation 20 to communicate with various other devices and systems via the Internet. Network interface 36 can connect workstation 20 to the Internet via a wired or wireless connection. Alternatively, communication can be made via ad-hoc Bluetooth® or a wireless network, enabling communication with a wide area network (WAN) and / or local area network (LAN). Network interface 36 can connect to the Internet via one or more gateways, routers, and Network Address Translation (NAT) devices. Network interface 36 can communicate with cloud storage system 38, where further image data and video can be stored. Cloud storage system 38 can be located remotely from the hospital or within the hospital premises, such as in a control room or hospital IT room. Input module 40 receives input from input devices such as a keyboard, mouse, voice commands, etc. Output module 42 connects processor 30 and memory 32 to various output devices, such as display 24. In an embodiment, workstation 20 may include its own display 44, which may be a touchscreen display.

[0067] During the planning or preoperative phase, the software application uses preoperative CT image data stored in memory 32 or obtained via network interface 36 to generate and view a 3D model of the patient P's anatomy. This enables the identification of the target tissue TT on the 3D model (automatically, semi-automatically, or manually), and in embodiments, allows selection of pathways PW through the patient P's anatomy to the target tissue, as will be described in further detail below. An example of such an application is ILOGIC, currently marketed by Medtronic. ® Planning and navigation kits and ILLUMISITE ® Planning and navigation suite. The 3D model can be displayed on monitor 24 or another suitable monitor (e.g., monitor 44) associated with workstation 20, or in any other suitable manner. Using workstation 20, various views of the 3D model can be provided, and / or the 3D model can be manipulated to facilitate the identification of target tissues (TT) and / or the selection of appropriate pathways (PW) leading to the target tissues.

[0068] It is conceivable that the 3D model can be generated by segmenting and reconstructing the lung airways of patient P to generate a 3D airway tree 100. The reconstructed 3D airway tree 100 includes various branches and bifurcations, which, in embodiments, can be labeled using, for example, widely accepted nomenclature (e.g., RB1 (right branch 1), LB1 (left branch 1), or B1 (bifurcation 1)). In embodiments, the segmentation and labeling of the lung airways of patient P is performed to a resolution including terminal bronchioles with a diameter of approximately less than 1 mm. As can be understood, segmenting the lung airways of patient P down to the terminal bronchioles improves the accuracy of the registration between the location of sEWC 14 and catheter 70 and the 3D model, improves the accuracy of the pathway to the target, and improves the ability of the software application to identify the location of sEWC 14 and catheter 70 within the airways and to navigate sEWC 14 and catheter 70 to the target tissue. Those skilled in the art will recognize that various algorithms can be used to segment CT image datasets, including, for example, connected component analysis, region growing, thresholding, clustering, watershed segmentation, or edge detection. It is conceivable that the entire reconstructed 3D airway tree can be labeled, or only branches or branch points within the reconstructed 3D airway tree located near pathways leading to target tissue can be labeled.

[0069] In an embodiment, software stored in memory 32 can identify and segment target critical structures (e.g., blood vessels, lymphatic vessels, lesions, and / or other intrathoracic structures) within a 3D model. It is contemplated that the segmentation process can be performed automatically, manually, or a combination of both. The segmentation process separates the target critical structure from surrounding tissue in the 3D model and identifies its location within the 3D model. In an embodiment, the software application segments CT images down to terminal bronchioles with a diameter less than 1 mm, enabling the identification and marking of branches and / or bifurcations deep within the luminal network of patient P. It is contemplated that this location can be updated based on a view selected on display 24, such that the view of the segmented target critical structure can approximate the view captured by camera 74 of catheter 70.

[0070] refer to Figures 4 to 8 Using a 3D model tree 100, or, in this embodiment, a 3D model or a combination thereof, software stored in memory 32 generates multiple proposed pathways PWs that traverse the luminal network of patient P to reach target tissue TT. In this way, the software stored in memory 32 identifies the location of target tissue TT within the lungs of patient P and identifies proposed pathway PWs starting from the smallest airway closest to target tissue TT. The software stored in memory 32 causes the pathway PWs to travel sequentially through subsequently larger airways until the proposed pathway PW reaches the trachea of ​​patient P. This process is repeated until a predetermined number of pathway PWs have been generated or all possible pathway PWs have been identified.

[0071] The software stored in memory 32 uses weighting factors to assign a ranking to each of the proposed pathways PW, and can manually, semi-automatically, or automatically select the preferred pathway PW leading to the target tissue TT from these proposed pathways via user interface 26. As will be understood, without departing from the scope of this disclosure, any number or type of weighting factors can be used to assign a ranking to each of the proposed pathways PW, and any or all weighting factors can be applied to the proposed pathways PW without departing from the scope of this disclosure. In a non-limiting embodiment, the weighting factors include the distance from the distal portion 76 of catheter 70 to a selected portion of the target tissue TT (e.g., surface, center of volume, center of centrifugation, and / or center of malignancy), the alignment of the candidate airway with the selected portion of the target tissue TT (e.g., surface, center of volume, center of centrifugation, and / or center of malignancy), the distance to the bifurcation closest to the distal portion 76 of catheter 70, crossing pleural or segmental boundaries, volume overlap of the expected tool passage trajectory, and combinations thereof. It is conceivable that selected portions of the target tissue TT can be selected automatically, semi-automatically, or manually. Although generally described as being related to catheter 70, it is conceivable that the weighting factor can be associated with any suitable medical device without departing from the scope of this disclosure.

[0072] The distance d between the distal portion 76 of catheter 70 and the selected portion of the target tissue TT is determined by software stored in memory 32 at the end of the pathway PW. Figure 8 and Figure 9The distance d is a linear distance, the determination of which is unaffected by any structure or tissue between the distal portion 76 and the selected portion of the target tissue TT; however, it is contemplated that any suitable method or pathway PW may be used to determine the distance d without departing from the scope of this disclosure. Software stored in memory 32 can identify the malignant tumor center of the target tissue TT and determine the distance d from the distal portion 76 of the catheter 70 to the identified malignant tumor center. In this manner, the software stored in memory 32 analyzes the 3D model and identifies the volumetric parameters (e.g., boundaries) of the target tissue TT. Based on the identified volumetric boundaries of the target tissue TT, a voxel map is generated by assigning attenuation values ​​(e.g., Huntsfield units) to each voxel of the target tissue TT. It is contemplated that the software stored in memory 32 can identify maximum attenuation values, minimum attenuation values, local maximum attenuation values, local minimum attenuation values, average or mean attenuation values ​​within and / or outside the target tissue, and / or combinations thereof. The software stored in memory 32 applies calculus to the 3D space of the voxel map to generate a volume vector diagram of the partial differential equation from the voxel with the highest Huntsfield unit to the edge or target tissue TT boundary, and forms the volume of the target tissue TT. In this way, the gradient or gradient curve 110 can be calculated from the voxel with the maximum decay value (or local maximum) to the voxel with the minimum decay value (or local minimum). Figure 13 As can be understood, a large or strong gradient 112 indicates malignant tissue, while a low or weak gradient 114 indicates benign tissue. Software stored in memory 32 analyzes the volumetric vector diagram and identifies the location (e.g., center of a malignant tumor) within the volumetric boundaries of the target tissue TT.

[0073] As can be understood, the center of malignancy in the target tissue TT may be located at the same or different locations from the center of volume or centroid of the target tissue. Therefore, the optimal pathway PW through the luminal network of the patient P, which is optimal for treating the center of volume or centroid of the target tissue TT, may not be optimal for treating the center of malignancy in the target tissue TT. It is foreseeable that the distance between the center of malignancy in the target tissue TT and the distal portion 76 of the catheter 70 can be determined by registering the position of the distal portion 76 of the catheter 70 to a 3D model in a reference coordinate system, as described further in detail herein. In this way, the center of malignancy in the target tissue TT can be identified in the reference coordinate system, and similarly, the position of the distal portion 76 of the catheter 70 can be determined.

[0074] The alignment of the candidate airway with a selected portion of the target tissue TT (e.g., surface, center of volume, center of mass, and / or center of malignancy) is determined by software stored in memory 32 using the angle β between the alignment vector AV of the working channel 82 of the catheter 70 and the vector TV from the position of the distal portion 76 of the catheter 70 to the selected portion of the target tissue TT. Figure 8 and Figure 9 In an embodiment, the software stored in memory 32 may store or otherwise define a predetermined maximum angle (e.g., a tapered boundary line) relative to the alignment vector in 3D space of the working channel 82, in which the target tissue TT must lie in order to be considered as the intended pathway PW.

[0075] The distance to the bifurcation of the distal portion 76 closest to the catheter 70 is determined by software stored in memory 32 by identifying the location of the nearest bifurcation proximal to the distal portion 76 of the catheter 70. It is understood that if the distal portion 76 of the catheter 70 is close to the bifurcation, then the distal portion 76 of the catheter 70 is not adequately supported. In this way, during alignment of the surgical instrument 90, sampling of the target tissue TT, or delivery of treatment to the target tissue TT, the distal portion 76 of the catheter 70 is more likely to move relative to the target tissue TT as the catheter 70 is pushed away from the target tissue TT. It is conceivable that a predetermined distance or threshold (e.g., 2 mm) can be defined within which the distal portion 76 of the catheter 70 is more likely to move relative to the target tissue TT as the catheter 70 is pushed away from the area of ​​interest or the target tissue TT. In an embodiment, system 10 may issue an alarm or warning (e.g., light, message, and / or haptic feedback) to the user that the distal portion 76 of catheter 70 is approaching or within a predetermined threshold distance from the nearest bifurcation. As will be understood, system 10 may use any suitable means (e.g., a robotic surgical system) to automatically inhibit the distal portion 76 of catheter 70 from moving toward or within the predetermined threshold distance.

[0076] The software stored in memory 32 identifies the pleural or segmental boundary SB between the distal portion 76 of the catheter and the target tissue TT. Figure 8 and Figure 9 As is understandable, puncture of the subsegment boundaries or pleura may result in pneumothorax. Therefore, the proposed pathway PW, which may lead to a higher likelihood of pneumothorax, is downgraded or scored lower.

[0077] In addition to the weighting factors mentioned above, the software stored in memory 32 also identifies volume overlap of the expected tool path. The software stored in memory 32 prioritizes proposed pathways PW leading to the target tissue TT, which can increase the volume overlap of possible tool paths (e.g., the path of surgical tool 90) with the volume of the target tissue TT.

[0078] As will be understood, weighting factors can vary based on a variety of factors, such as the type of surgery being performed, the type of medical device used for navigation to the target tissue TT, the type of surgical instrument used for treating or sampling the target tissue TT, the size of the medical device used for navigation to the target tissue TT, the range of motion of the catheter (e.g., minimum bending radius), the accuracy of catheter attitude control, the stiffness of the catheter, the volume of the target tissue TT, and the patient P's medical history. In this way, some weighting factors may be assigned greater or less weight depending on one or more of the factors described above. In a non-limiting embodiment, for medical devices with relatively large external dimensions or diameters (e.g., greater than or equal to 3.5 mm), the proximity and orientation of the distal portion of the medical device relative to the target tissue TT is more important than its location within the same airway as the target tissue TT. Figure 8 and Figure 9As can be understood, a small or narrow airway within the lungs of patient P cannot accommodate a large interventional device or medical device, such as those with an external size or diameter greater than 3.5 mm. Although generally described as having a diameter of 3.5 mm, those skilled in the art will recognize that interventional devices or other medical devices of any diameter cannot navigate within a smaller airway close to the external size of the medical device. In this way, the internal size of the unnavigable airway varies depending on the size of the medical device used. In a non-limiting embodiment, the external size of the medical device may be between about 3.5 mm and 4.2 mm. It is conceivable that software stored in memory 32 can automatically identify the medical device being used and therefore can be manually entered as the external size of the medical device, or the type and size of the medical device. The software stored in memory 32 can assign a predetermined threshold to the internal size of the airway, such as the maximum internal size within which the medical device can navigate. The predetermined threshold may be an internal size that is approximately equal to or less than the external size of the medical device. In one embodiment, the software stored in memory 32 can apply an offset to the identified maximum internal dimension, for example, the internal dimension being a percentage of the maximum internal dimension, which could be an increase of that percentage. In this way, the software stored in memory 32 can increase the maximum internal dimension of the airway by a predetermined amount to ensure that airways adjacent to the navigable airway are segmented and rendered. In a non-limiting embodiment, the software stored in memory 32 can reduce the internal dimension of the airway from approximately 3.5 mm of the external dimensions of the medical device to approximately 2 mm of internal dimension.

[0079] It is foreseeable that the system stored in memory 32 can automatically or manually identify the range of motion or minimum bending radius R of the medical device. Figure 9 As can be understood, the range of motion or minimum bending radius R of the medical device limits or otherwise hinders the passage of the medical device through the patient P's airway to a pathway requiring a tighter or otherwise smaller bend or curve than the minimum bending radius R. Software stored in memory 32 can assign predetermined thresholds to bends or curves within the patient P's airway, such as the minimum bending radius R achievable by the medical device. In an embodiment, the software stored in memory 32 can apply an offset to the predetermined threshold of the bending radius R, for example, the bending radius R being a percentage of the minimum bending radius R, which could be a percentage increase of the minimum bending radius R. In this way, the software stored in memory 32 can increase the minimum bending radius R by a predetermined amount to ensure that the medical device can be navigated through the patient P's airway to the target tissue TT.

[0080] In an embodiment, the system stored in memory 32 can determine the accuracy of the orientation of the medical device within one or more portions of the patient P's airway. As can be understood, navigation of the medical device through the patient P's airway, as well as diagnostic and / or therapeutic tasks, require the medical device to be positioned in a specific orientation relative to the patient P's airway or target tissue TT. The software stored in memory 32 can automatically or manually identify whether the medical device has achieved the desired orientation at one or more locations within the patient P's airway and determine the directional movement and / or orientation when the medical device can be positioned accurately or inaccurately. As can be understood, movements or orientations that are unlikely to be achieved by the medical device may hinder the medical device's navigation through the patient P's airway and accurate treatment of the target tissue TT. In an embodiment, the software stored in memory 32 can analyze orientation information obtained from previous surgeries or acquired in real time and determine the difference Δ between the desired and achieved orientations. Figure 10 The software stored in memory can assign a predetermined threshold to the accuracy of the actual attitude compared to the desired attitude. In a non-limiting embodiment, the predetermined threshold can be a percentage of the maximum deviation of the desired attitude from one or more axes (e.g., roll, pitch, yaw, and combinations thereof). If potential pathways include attitudes that manipulate the medical device to an accuracy less than or equal to the predetermined accuracy threshold of the attitude, these potential pathways are degraded. It is contemplated that the software stored in memory 32 can update the weighted accuracy of the medical device's attitude in real time as the medical device navigates within the patient P's airway.

[0081] As can be understood, during the navigation of a medical device through the patient P's airway to and treatment of the target tissue TT, one or more sections along the length of the medical device may require reinforcement to accomplish the desired diagnostic or therapeutic task. Reinforcement of one or more sections along the length of the medical device requires space within the patient P's airway to accommodate the reinforcement (e.g., reinforcement along a linear length). In this way, the software stored in memory 32 may require reinforcement of a portion of the distal portion of the medical device adjacent to the patient's airway wall, which may abut against or otherwise contact the patient's airway wall. It is conceivable that the software stored in memory 32 can determine the length L of the medical device that requires reinforcement. s Minimum threshold ( Figure 11 This can take into account the external dimensions of the medical device, the internal dimensions of the patient's airway, and any bends or bifurcations within the patient's airway. Potential pathways are downgraded if they include a portion of the patient P's airway that is equal to or less than a predetermined length threshold.

[0082] Registration of the patient P's position on the transmitter pad 54 can be performed by moving the EM sensors 14a and / or 72 through the patient P's airway. In this manner, as the sEWC 14 of the catheter 70 moves through the airway, software stored in memory 32 periodically determines the position of the EM sensors 14a or 72 in a coordinate system using the transmitter pad 54, reference sensor 50, and tracking system 46. The position data can be represented on the user interface 26 as markers or other suitable visual indicators, multiple of which form a point cloud whose shape can approximate the internal geometry of the 3D model. The shape generated from this position data is compared to the internal geometry of the passage in the 3D model, and a positional correlation between the compared shape and the 3D model is determined. Additionally, the software identifies non-organic spaces (e.g., air-filled cavities) in the 3D model. The software aligns or registers the image representing the location of EM sensors 14a or 72 to the 3D model and / or a 2D image generated based on the 3D model, based on the recorded location data and the assumption that the sEWC 14 or catheter 70 is still positioned in the non-tissue space of the patient P's airway. In embodiments, manual registration techniques may be employed by navigating the sEWC 14 or catheter 70 with EM sensors 14a and 72 to a pre-specified location in the patient P's lungs and manually associating images from the bronchoscope 16 or catheter 70 with model data from the 3D model. Although generally described herein as utilizing point clouds (e.g., multiple location data points), it is contemplated that registration can be performed using any number of location data points, and in a non-limiting embodiment, a single location data point may be used.

[0083] refer to Figure 14A and Figure 14BThis paper describes a method for generating a pathway to a target tissue within a luminal network of a patient P, and the method is generally identified by reference numeral 200. Initially, at step 202, the patient P is imaged, and the captured image is stored in memory 32. In step 204, software stored in memory 32 generates a 3D representation of the patient P's airway. In step 206, the target tissue TT is identified in the generated 3D representation of the patient P's airway. Optionally, in step 208, information about the patient P (e.g., the type of surgery being performed, the patient P's medical history, and the volume of the target tissue) is received. Optionally, in parallel, in step 210, information about the medical device (e.g., the type of medical device used for navigation to the target tissue TT, the type of surgical instrument used for treating or sampling the target tissue TT, and the size of the medical device used for navigation to the target tissue TT) is received. In step 212, the software stored in memory 32 generates a proposed pathway through the luminal network of the patient P to reach the target tissue TT. In step 214, the software stored in memory 32 analyzes the generated proposed pathway PW to calculate weighting factors, such as the distance from the distal end of the medical device to a selected portion of the target tissue TT (e.g., surface, center of volume, center of mass, and / or center of malignancy), the alignment of the candidate airway with the selected portion of the target tissue TT (e.g., surface, center of volume, center of mass, and / or center of malignancy), the distance to the bifurcation closest to the distal end of the medical device, the crossing of the pleura or segmental boundary, the volume overlap of the expected tool passage trajectory, and combinations thereof. Optionally, in step 216, the software stored in memory modifies the calculated weighting factors based on the medical device information received in step 210. Optionally, in step 218, in addition to or alternatively using the medical device information, the software stored in memory 32 may modify the calculated weighting factors based on patient P information received in step 208. In step 220, at least one of the weighting factors is applied to the generated proposed pathways PW to the target tissue TT, and in step 222, software stored in memory 32 sorts the generated proposed pathways PW to the target tissue TT based on the results of applying the modified weighting factors. In step 224, the sorted proposed pathways PW to the target tissue TT are displayed on user interface 26, wherein the desired pathway PW can be selected automatically or manually, and the method ends in step 224. As can be understood, depending on the user's needs or the surgery being performed, the above method can be repeated as needed.

[0084] Go to Figure 15 and Figure 16It is conceivable that system 10 may include a robotic surgical system 600 having a drive mechanism 602 including a robotic arm 604 operably coupled to a base or cart 606, which in an embodiment may be a workstation 20. The robotic arm 604 includes a bracket 608 configured to receive a portion of sEWC 14. sEWC 14 is coupled to bracket 608 using any suitable means (e.g., straps, mechanical fasteners, and / or couplings). It is conceivable that the robotic surgical system 600 may communicate with sEWC 14 via an electrical connection (e.g., contacts and / or plugs) or wirelessly with sEWC 14 to control or otherwise implement one or more motors disposed within sEWC 14. Figure 16 The movement of the sEWC 14 is possible, and in embodiments, images captured by a camera (not shown) associated with the sEWC 14 can be received. In this way, it is conceivable that the robotic surgical system 600 may include a wireless communication system 610 operably coupled thereto, allowing the sEWC 14 to communicate via, for example, Wi-Fi, Bluetooth, etc. ® Wireless communication with the robotic surgical system 600 and / or workstation 20. As will be understood, the robotic surgical system 600 may completely omit electrical contacts and may wirelessly communicate with the sEWC 14, or may utilize both electrical contacts and wireless communication. The wireless communication system 610 is substantially similar to the network interface 36 described above. Figure 3 Therefore, for the sake of brevity, the wireless communication system will not be described in detail herein. As indicated above, the robotic surgical system 600 and workstation 20 may be the same entity, or in embodiments, they may be widely distributed in multiple locations within the operating room. It is conceivable that workstation 20 may be located in a separate location, and display 44 ( Figure 1 and Figure 3 It could be an overhead monitor installed in the operating room.

[0085] As indicated above, it is contemplated that the sEWC 14 can be manually actuated via a cable or push wire, or electronically operated, for example, via one or more buttons, levers, toggle switches, actuators (not shown) operably coupled to a drive mechanism 614 disposed within an internal portion of the sEWC 14, although it is contemplated that the drive mechanism 614 can be operably coupled to any part of the sEWC 14. The drive mechanism 614 enables manipulation or hinge of the distal end of the sEWC 14 in four degrees of freedom or two articulated planes (e.g., left, right, up, or down), controlled by two push-pull wires. However, it is contemplated that, without departing from the scope of this disclosure, the drive mechanism 614 may include any suitable number of wires to enable movement or hinge of the distal end of the sEWC 14 in larger or smaller degrees of freedom. It is conceivable that the distal end of sEWC 14 can be manipulated in more than two hinge planes (e.g., in polar coordinates), or that the azimuth angle of the distal end of sEWC 14 can be changed while maintaining the angle of the distal end relative to the longitudinal axis of sEWC 14, or vice versa. In a non-limiting embodiment, system 10 may define the vector or trajectory of the distal end of sEWC 14 relative to the two hinge planes.

[0086] It is conceivable that the drive mechanism 614 may be actuated by a cable using a bundle of artificial steel bars or a draw wire 616 (e.g., metallic, non-metallic, and / or composite material), or it may be a nitinol wire mechanism. In embodiments, the drive mechanism 614 may include a motor 618 or other suitable device capable of moving the draw wire 616. In this way, the motor 618 is disposed within the sEWC 14 such that rotation of the output shaft of the motor 618 achieves a corresponding hinge at the distal end of the sEWC 14.

[0087] Although generally described as having a motor 618 disposed within the sEWC 14, it is contemplated that the sEWC 14 may not include the motor 618 disposed therein. More precisely, the drive mechanism 614 disposed within the sEWC 14 may interface with a motor 622 disposed within the support 608 of the robotic surgical system 600. In embodiments, the sEWC 14 may include one or more motors 618 for controlling the hinge of the distal end 14b of the sEWC 14 in a plane (e.g., left / empty or right / empty), and the drive mechanism 624 of the robotic surgical system 600 may include at least one motor 622 to achieve a second axis of rotation and for axial movement. In this way, the motors 618 of the sEWC 14 and the motors 622 of the robotic surgical system 600 cooperate to achieve four-way hinge of the distal end of the sEWC 14 and to achieve rotation of the sEWC 14. As can be understood, by removing the motor 618 from the sEWC 14, the manufacture of the sEWC 14 becomes increasingly cheaper, and it can be a disposable unit. In embodiments, the sEWC 14 can be integrated into the robotic surgical system 600 (e.g., as a single piece), and it does not have to be a separate component.

[0088] Based on the foregoing and with reference to the accompanying drawings, those skilled in the art will understand that certain modifications may be made to this disclosure without departing from its scope.

[0089] Although the description of computer-readable media contained herein refers to solid-state storage devices, those skilled in the art will understand that computer-readable storage media can be any available medium accessible to the processor 30. That is, computer-readable storage media can include non-transitory, volatile and non-volatile, removable and non-removable media implemented using any method or technique for storing information such as computer-readable instructions, data structures, program modules, or other data. For example, computer-readable storage media can include RAM, ROM, EPROM, EEPROM, flash memory or other solid-state memory technologies, CD-ROM, DVD, Blu-ray or other optical storage devices, magnetic cassettes, magnetic tapes, disk storage devices or other magnetic storage devices, or any other medium that can be used to store desired information and is accessible by the workstation 20.

[0090] Another aspect of this disclosure relates to a method for assisting clinicians during luminal network navigation. As described above and similar to method 200, at step 302, an image of a captured luminal network (e.g., lung airways) is received and stored in memory. At step 304, the image is reviewed (manually or automatically) to identify one or more targets (e.g., tumors) within the image. As will be understood, artificial intelligence and neural networks may be employed as part of the automated target identification step. At step 306, if a target is identified, the nearest lumen (e.g., airway) to the target is identified. Again, this nearest lumen may be identified manually or automatically. At step 308, an initial pathway to the target is generated. According to one aspect of this disclosure, the initial pathway is a pathway to the nearest point of access to the target or a pathway to the point in the luminal network closest to the target. However, as described above and for various reasons, the nearest point of access is not necessarily the optimal pathway for navigating the catheter 70 to the target to perform surgery (e.g., biopsy or treatment). At step 310, input may optionally be received by application 34 (e.g., via user interface 26) indicating the type of catheter 70 or the type of medical device to be navigated to the identified target.

[0091] At step 312, application 34 analyzes the initial pathway to determine whether a better pathway can be identified to navigate the selected catheter 70 or medical device to the identified target. The application may analyze various factors, including mechanical limitations and characteristics of the catheter 70 and medical device (e.g., bending radius, bending stiffness, column stiffness, etc.), the eccentricity of the target relative to the initially planned pathway (e.g., whether it is a tumor within or outside the lumen network), the nearest point of access to alternative pathways, proximity and angle of key structures (e.g., blood vessels, pleural boundaries, segmental boundaries), the size of the lumen for navigation within the lumen network (e.g., larger airways versus smaller airways), the ability to intubate along alternative pathways (e.g., stability), the alignment capability of catheter 70 with the target, the distance from the target to which catheter 70 can be navigated, the expected tissue characteristics, the lobe of the lung where the target is located when navigating within the lung, the reasonable limitations of catheter 70 and medical device, the number of curves or turns required to reach the target, and other factors not departing from the scope of this disclosure. Another aspect that may be considered is the possibility of motion decoupling. As those skilled in the art will understand, when the organ being navigated is elastic and flexible (e.g., the lungs), applying force to the catheter 70 will cause target movement. This is especially true when the airway size is close to or even smaller than the diameter of the catheter 70. When the initial pathway follows a lumen with a diameter close to or smaller than the catheter diameter, following that pathway may cause the target's position to shift, making the procedure more difficult to perform successfully. Therefore, navigating a pathway with a larger diameter lumen can reduce the coupled movement of the target as the catheter 70 is navigated toward it.

[0092] At step 314, the proposed alternative pathway is presented in user interface 26 associated with application 34. Presenting the alternative pathway on user interface 26 may include additional data, such as the probability of success of following the pathway, the benefits of the alternative pathway (e.g., improved intubation, improved alignment), airway size, safety improvements, avoidance of critical structures, risks on the pathway, motion decoupling, and any factors in conjunction with those described in step 312, as well as other factors not departing from the scope of this disclosure. As described above, these factors may be weighted by an algorithm incorporated into application 34 (or incorporated into a cost calculation function) and may optionally be presented in a ranking order based on the probability of success or another criterion chosen by the clinician. Step 314 enables the clinician to assess whether the identified alternative pathway, although its closest approach to the target is greater than the initial pathway, still provides a clinical or mechanical advantage in navigating catheter 70 to a location for initiating medical devices (e.g., biopsy or therapeutic devices) to perform surgery.

[0093] At step 316, a navigation pathway (initial or alternative pathway) can be selected via user interface 26, and navigation of catheter 70 and the medical device begins at step 318. If multiple targets exist, each target may undergo the above process to define a navigation pathway to each target. During navigation, application 34 is configured to receive positioning data of catheter 70 indicating the position and orientation of at least the distal portion of catheter 70 within the luminal network, and to present an indication of the catheter's position in a 3D model. Despite a previously selected navigation pathway, challenges (e.g., bleeding or obstruction) may still occur during navigation. In the case of pulmonary navigation, challenges may arise because imaging and modeling are performed while the lungs are in full inspiration, while navigation is performed while the lungs are substantially in expiration. Challenges may include inability to intubate at a location, lack of navigation progress, excessive tool passes, and other criteria not departing from the scope of this disclosure. If application 34 detects difficulties (at step 320), application 34 may present rerouting data (e.g., alternative pathways) from the current location of catheter 70 to the target on user interface 26 at step 322. Alternative pathways can be analyzed and identified using the same or similar factors as those identified and presented in steps 312 and 314 (above). If an alternative pathway is accepted at step 324, it is presented on the 3D model of user interface 26 at step 326, and the method returns to step 318 to navigate along that alternative pathway. If an alternative pathway is not accepted, the method also returns to step 318 for further navigation, but along the initially selected pathway. At step 328, it is determined whether catheter 70 or the medical device has reached the target. If not at step 328, the method returns to step 318 to continue navigation; if yes at step 328, a procedure (e.g., biopsy or treatment) can be performed. After the procedure is performed, at step 330 it is determined whether there is an additional target to navigate to. If yes at step 330, the user interface 26 is updated to display the navigation path to the next target, and the method returns to step 318. If no at step 330, the method terminates. As will be understood, one or more of these method steps may be omitted or performed in an alternative order without departing from the scope of this disclosure.

[0094] As described above, method 300 provides, in at least one aspect, the ability to reroute intraoperatively to the target when navigation of catheter 70 or medical device along the initial navigation pathway encounters challenges. This real-time updating of the potential pathway provides clinicians with updated intraoperative guidance for navigation within the luminal network. Therefore, application 34 and method 300 enable guidance to achieve successful navigation, even when challenges arise along the originally planned pathway to the target.

[0095] Although reference Figure 17 Method 300 is described as an application that begins with initial pathway planning (e.g., steps 302 to 316), but this disclosure is not limited thereto. In fact, the methods and applications described herein include various subroutines executed during the navigation of the conduit toward the target. These subroutines may be used as part of method 300 or as a separate application 34. For example, steps 318 to 326 may be embodied in an application separate from method 300.

[0096] Therefore, at any point after initiating catheter navigation toward the target (e.g., step 318), the surgeon may encounter difficulties or challenges. These challenges or difficulties can be detected automatically or by the surgeon, as noted in method 300. In the case of automatic detection, user interface 26 may present an indicator indicating that a challenge or difficulty has been detected and provide one or more alternative routes for navigating catheter 70 from its current location to the target (e.g., step 322). Alternatively, user interface 26 may include buttons or other features where, during catheter 70 navigation toward the target, the surgeon can request an alternative route for catheter 70 from its current location to the target. After presenting alternative routes from the current location of catheter 70 to the target, the surgeon is able to select one of these routes (e.g., step 324) and update user interface 26 to display the new route from the current location of catheter 70 to the target (e.g., step 3276), and the method returns to step 318 to continue navigating catheter 70 to the target following the intraoperatively updated route. As will be understood, new pathways can present alternative nearest points to the target and direct them to locations where different parts of the target can be sampled by biopsy tools, or to locations where therapeutic tools will be placed.

[0097] As an alternative to step 320, which detects difficulty or challenge, application 34 can simply detect that the surgeon has deviated from the planned route (e.g., as defined at step 316) and navigate catheter 70 into an unplanned airway. Upon detecting that the catheter has deviated into an unplanned airway, application 34 can directly jump to, for example, step 322 and present rerouting data from the newly entered airway to the target. The surgeon can then confirm this rerouting data and accept the alternative route (e.g., step 324), which was initiated by the surgeon through their navigation decision to enter an unplanned route. Similarly, upon confirmation, user interface 26 displays the updated route (e.g., step 326), and the surgeon can continue navigating catheter 70 to the target (e.g., step 318).

[0098] Another aspect of this disclosure relates to intraoperative lumen selection. According to this aspect, at any time during navigation of catheter 70, the surgeon can (e.g., in user interface 26) select an airway in the 3D model other than the airway that is part of the currently navigating pathway. Once selected (e.g., via a touchscreen, mouse, or other input device), application 34 generates an alternative pathway through the selected airway to reach the target (e.g., step 322). The surgeon can adopt the alternative pathway (e.g., step 324) and display it in the user interface (e.g., step 326) to continue navigation (e.g., step 318). Alternatively, the alternative pathway can be stored in memory and accessed by application 34 at different points during the procedure.

[0099] Additional features of application 34 may include both manual and automatic target identification and pathway generation. In some cases, such as when the images acquired at step 302 are cone-beam computed tomography (CBCT) images, these images may be acquired during the initial navigation of catheter 70. Therefore, steps 302 through 316 may be performed after a degree of initial navigation (e.g., step 318) in which catheter 70 enters the patient's airway. This reordering of the steps of method 300 can advantageously simplify the procedure. As with other applications 34, targets may be identified manually or automatically in the captured CBCT images (e.g., step 304). In cases where the target is within the airway, the application may automatically generate an initial pathway (e.g., step 308) without eliminating or skipping the identification of the nearest lumen (e.g., step 306). Alternatively, in cases where the target is outside the airway, the surgeon or another clinician using application 34 identifies the airway closest to the target (e.g., step 306), and application 34 automatically generates an initial pathway (e.g., step 308). Steps 310 to 316 can be performed, or the method can proceed directly to the navigation of the conduit toward the target (e.g., step 318).

[0100] Using the steps outlined in Method 300, whether as described above or in an alternative order and with or without omitting one or more of these steps, various routines and subroutines can be developed to generate initial and alternative pathways for navigating catheter 70 to the target. Routines and subroutines utilizing a portion of the steps of Method 300 can be stored as part of one or more applications 34. The alternative pathways generated by the routines and subroutines provide greater capability to navigate catheter 70 to the target and initiate one or more biopsy or therapeutic tools to successfully sample and treat the target tissue.

[0101] The invention can be further described with reference to the following numbered paragraphs:

[0102] 1. A surgical system comprising:

[0103] catheter;

[0104] A workstation operatively connected to the conduit, the workstation including a processing unit configured to:

[0105] Generate a 3D model of the lumen network in the patient's lungs;

[0106] Identify the target tissue in the generated 3D model;

[0107] Receive catheter information;

[0108] Multiple proposed pathways are generated to reach the identified target tissue through the lumen network;

[0109] Weighting factors are determined based on multiple potential pathways generated;

[0110] The determined weighting factor is modified based on the received catheter information;

[0111] The modified weighting factors are applied to the generated proposed pathways;

[0112] After applying the modified weighting factor to the generated plurality of proposed pathways, the generated proposed pathways are ranked; and

[0113] This displays the sorted proposed pathways to the target organization.

[0114] 2. The system according to paragraph 1, wherein the processing device is configured to receive patient information and modify the determined weighting factor based on the received medical device information and the received patient information.

[0115] 3. The system according to paragraph 1, wherein the processing device is configured to receive the weighting factor, the weighting factor comprising at least one of the following:

[0116] The distance from the distal portion of the catheter to a selected portion of the target tissue; or

[0117] Alignment of the candidate airways of the lumen network with selected portions of the target tissue; or

[0118] The distance to the bifurcation of the lumen network closest to the distal portion of the catheter; or

[0119] Crossing the pleural or segmental boundaries of the patient's lung; or

[0120] The volume overlap of the intended trajectory of the surgical instrument received within the catheter; or

[0121] The lumen network has airways with internal dimensions smaller than a predetermined threshold.

[0122] 4. The system according to paragraph 3, wherein the processing device is configured to determine the distance from the distal portion of the catheter to a selected portion of the target tissue at the end of the plurality of generated proposed pathways.

[0123] 5. The system according to paragraph 3, wherein the processing device is configured to determine the alignment of the candidate airway with the selected portion of the target tissue by determining the angle between the alignment vector of the working channel of the catheter and the vector from the position of the distal portion of the catheter to the selected portion of the target tissue.

[0124] 6. The system according to paragraph 3, wherein the processing device is configured as follows:

[0125] The predetermined internal size threshold is determined based on a percentage of the external size of the catheter; or

[0126] The predetermined internal size threshold is determined based on the percentage increase in the external size of the catheter.

[0127] 7. The system according to paragraph 3, wherein the processing device is configured as follows:

[0128] Identify the pleural or segmental boundary between the distal portion of the catheter and the target tissue, where crossing the pleural or segmental boundary may lead to pneumothorax; or

[0129] Determine the volume overlap between the proposed surgical tool path in the plurality of generated proposed pathways and the volume coverage of the target tissue.

[0130] 8. The system according to paragraph 1, wherein the processing device is configured to:

[0131] Receive catheter information regarding the type of catheter used for navigation to the target tissue;

[0132] Receive catheter information regarding the type of surgical tool used to treat the target tissue; and

[0133] Receive catheter information including the external dimensions of the catheter.

[0134] 9. A method of operating a surgical system, the method comprising:

[0135] Generate a 3D model of the lumen network in the patient's lungs;

[0136] Identify the target tissue in the generated 3D model;

[0137] Receive catheter information;

[0138] Multiple proposed pathways are generated to reach the identified target tissue through the lumen network;

[0139] Weighting factors are determined based on multiple potential pathways generated;

[0140] The determined weighting factor is modified based on the received catheter information;

[0141] The modified weighting factors are applied to the generated proposed pathways;

[0142] After applying the modified weighting factor to the generated plurality of proposed pathways, the generated proposed pathways are ranked; and

[0143] This displays the sorted proposed pathways to the target organization.

[0144] 10. The method according to paragraph 9, wherein the determined weighting factor includes at least one of the following:

[0145] The distance from the distal portion of the catheter to the center of volume of the target tissue; or

[0146] The distance from the distal portion of the catheter to the center of the malignant tumor in the target tissue; or

[0147] The alignment of the candidate airways of the lumen network with the volume center of the target tissue; or

[0148] The candidate airways of the luminal network are aligned with the center of the malignant tumor in the target tissue; or

[0149] The distance to the bifurcation of the lumen network closest to the distal portion of the catheter; or

[0150] Crossing the pleural or segmental boundaries of the patient's lung; or

[0151] The volume overlap of the intended trajectory of the surgical instrument received within the catheter; or

[0152] The lumen network has airways with internal dimensions smaller than a predetermined threshold.

[0153] 11. The method described in paragraph 10, further comprising:

[0154] The predetermined internal size threshold is determined based on a percentage of the external size of the catheter; or

[0155] The predetermined internal size threshold is determined based on the percentage increase in the external size of the catheter.

[0156] 12. The method according to paragraph 10 further includes using the angle between the alignment vector of the working channel of the catheter and the vector from the position of the distal portion of the catheter to the volume center of the target tissue to determine the alignment of the candidate airway with the volume center of the target tissue.

[0157] 13. A system comprising:

[0158] catheter; and

[0159] A workstation operatively connected to the conduit, the workstation including a processing unit configured to:

[0160] Generate a 3D model of the lumen network in the patient's lungs;

[0161] Identify the target tissue in the generated 3D model;

[0162] Multiple proposed pathways are generated to reach the identified target tissue through the lumen network;

[0163] Weighting factors are determined based on multiple potential pathways generated, and the weighting factors include at least one of the following:

[0164] The distance from the distal portion of the catheter to a selected portion of the target tissue; and

[0165] Alignment of the candidate airways of the lumen network with selected portions of the target tissue; and

[0166] The distance to the bifurcation of the lumen network closest to the distal portion of the catheter; and

[0167] The pleura or segmental boundary of the patient's lung; and

[0168] The volume overlap of the intended trajectory of the surgical instrument received within the catheter; and

[0169] The lumen network has airways with internal dimensions smaller than a predetermined threshold.

[0170] The weighting factor is applied to the generated multiple proposed pathways;

[0171] The generated proposed pathways are sorted; and

[0172] This displays the sorted proposed pathways to the target organization.

[0173] 14. The method according to paragraph 13, wherein the processing apparatus is configured to:

[0174] The predetermined internal size threshold is determined based on a percentage of the external size of the catheter; or

[0175] The predetermined internal size threshold is determined based on the percentage increase in the external size of the catheter.

[0176] 15. The method according to paragraph 13, wherein the processing apparatus is configured to:

[0177] Identify the pleural or segmental boundary between the distal portion of the catheter and the target tissue, where crossing the pleural or segmental boundary may lead to pneumothorax; or

[0178] Determine the volume overlap between the proposed surgical tool path in the plurality of generated proposed pathways and the volume coverage of the target tissue.

Claims

1. A system for performing surgical procedures, the system comprising: A catheter that is capable of navigating within the luminal network of a patient's lungs; as well as A workstation operatively connected to the conduit, the workstation including a memory and a processor, the memory storing instructions that, when executed by the processor, cause the processor to perform the following operations: Generate a 3D model of the lumen network of the patient's lungs; Identify the target tissue in the generated 3D model; Receive catheter information; Multiple proposed pathways are generated to reach the identified target tissue through the lumen network; Weighting factors are determined based on multiple potential pathways generated; The determined weighting factor is modified based on the received catheter information; The modified weighting factors are applied to the generated proposed pathways; After applying the modified weighting factor to the generated plurality of proposed pathways, the generated proposed pathways are sorted. as well as This displays the sorted proposed pathways to the target organization.

2. The system according to claim 1, wherein, The memory stores additional instructions that, when executed by the processor, cause the processor to receive patient information and modify the determined weighting factor based on the received medical device information and the received patient information.

3. The system according to claim 1, wherein, The memory stores additional instructions that, when executed by the processor, cause the processor to receive the weighting factor, the weighting factor including at least one of the following: The distance from the distal portion of the catheter to a selected portion of the target tissue; or Alignment of the candidate airways of the lumen network with selected portions of the target tissue; or The distance to the bifurcation of the lumen network closest to the distal portion of the catheter; or Crossing the pleura or segmental boundary of the patient's lung; or The volume overlap of the intended trajectory of the surgical instrument received within the catheter; or The lumen network has airways with internal dimensions smaller than a predetermined threshold.

4. The system according to claim 3, wherein, The memory stores additional instructions that, when executed by the processor, cause the processor to determine the distance from the distal portion of the duct to a selected portion of the target tissue at the end of the plurality of generated proposed pathways.

5. The system according to claim 3, wherein, The memory stores additional instructions that, when executed by the processor, cause the processor to determine the alignment of the candidate airway with the selected portion of the target tissue by determining the angle between the alignment vector of the working channel of the catheter and the vector from the position of the distal portion of the catheter to the selected portion of the target tissue.

6. The system according to claim 3, wherein, The memory stores additional instructions that, when executed by the processor, cause the processor to determine the predetermined internal size threshold based on a percentage of the external size of the conduit.

7. The system according to claim 6, wherein, The memory stores additional instructions that, when executed by the processor, cause the processor to determine the predetermined internal size threshold based on the percentage increase in the external size of the conduit.

8. The system according to claim 3, wherein, The memory stores additional instructions that, when executed by the processor, cause the processor to identify the pleural or segmental boundary between the distal portion of the catheter and the target tissue, which, if crossed, may result in pneumothorax.

9. The system according to claim 3, wherein, The memory stores additional instructions that, when executed by the processor, cause the processor to determine the volume overlap between the proposed surgical tool path in the plurality of generated proposed pathways and the volume coverage of the target tissue.

10. The system according to claim 1, wherein, The memory stores additional instructions that, when executed by the processor, cause the processor to perform the following operations: Receive catheter information regarding the type of catheter used for navigation to the target tissue; Receive catheter information regarding the type of surgical tool used to treat the target tissue; as well as Receive catheter information regarding the external dimensions of the catheter.

11. A method for performing a surgical procedure, the method comprising: Generate a 3D model of the lumen network in the patient's lungs; Identify the target tissue in the generated 3D model; Receive catheter information; Multiple proposed pathways are generated to reach the identified target tissue through the lumen network; Weighting factors are determined based on multiple potential pathways generated; The determined weighting factor is modified based on the received catheter information; The modified weighting factors are applied to the generated proposed pathways; After applying the modified weighting factor to the generated plurality of proposed pathways, the generated proposed pathways are sorted. as well as This displays the sorted proposed pathways to the target organization.

12. The method according to claim 11, wherein, Determining the weighting factor includes determining at least one of the following: The distance from the distal portion of the catheter to the center of volume of the target tissue; or The distance from the distal portion of the catheter to the center of the malignant tumor in the target tissue; or Alignment of the candidate airways of the lumen network with the volume center of the target tissue; or The candidate airways of the luminal network are aligned with the center of the malignant tumor in the target tissue; or The distance to the bifurcation of the lumen network closest to the distal portion of the catheter; or Crossing the pleura or segmental boundary of the patient's lung; or The volume overlap of the intended trajectory of the surgical instrument received within the catheter; or The lumen network has airways with internal dimensions smaller than a predetermined threshold.

13. The method of claim 12, further comprising determining the predetermined internal size threshold based on a percentage of the outer diameter of the catheter.

14. The method of claim 13, further comprising determining the predetermined internal size threshold based on a percentage increase in the external size of the catheter.

15. The method of claim 12, further comprising determining the alignment of the candidate airway with the center of volume of the target tissue using an angle between the alignment vector of the working channel of the catheter and a vector from the position of the distal portion of the catheter to the center of volume of the target tissue.

16. A system for performing surgical procedures, the system comprising: Catheter, which is capable of navigating within the patient's network of lumens; as well as A workstation operatively connected to the conduit, the workstation including a memory and a processor, the memory storing instructions that, when executed by the processor, cause the processor to perform the following operations: Generate a 3D model of the lumen network in the patient's lungs; Identify the target tissue in the generated 3D model; Multiple proposed pathways are generated to reach the identified target tissue through the lumen network; Weighting factors are determined based on multiple potential pathways generated, and the weighting factors include at least two of the following: The distance from the distal portion of the catheter to a selected portion of the target tissue; or Alignment of the candidate airways of the lumen network with selected portions of the target tissue; or The distance to the bifurcation of the lumen network closest to the distal portion of the catheter; or Crossing the pleura or segmental boundary of the patient's lung; or The volume overlap of the intended trajectory of the surgical instrument received within the catheter; or The lumen network has airways with internal dimensions smaller than a predetermined threshold. The weighting factor is applied to the generated multiple proposed pathways; The proposed pathways are then sorted. as well as This displays the sorted proposed pathways to the target organization.

17. The system according to claim 16, wherein, The memory stores additional instructions that, when executed by the processor, cause the processor to determine the predetermined internal size threshold based on a percentage of the external size of the conduit.

18. The system according to claim 16, wherein, The memory stores additional instructions that, when executed by the processor, cause the processor to determine the predetermined internal size threshold based on the percentage increase in the external size of the conduit.

19. The system according to claim 16, wherein, The memory stores additional instructions that, when executed by the processor, cause the processor to identify the pleural or segmental boundary between the distal portion of the catheter and the target tissue, which, if crossed, may result in pneumothorax.

20. The system according to claim 16, wherein, The memory stores additional instructions that, when executed by the processor, cause the processor to determine the volume overlap between the proposed surgical tool path in the plurality of generated proposed pathways and the volume coverage of the target tissue.

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