Catheter control using shape detection

Abstract

A system and method of adjusting a control parameter of a catheter includes receiving sensor data from a sensor on a distal portion of the catheter; detecting a location of the distal portion of the catheter within the luminal network of the patient; determining a shape of the catheter within the luminal network of the patient; control parameters of a drive motor operably coupled to the catheter are modified based on the detected position of the distal portion of the catheter and the determined shape of the catheter within the luminal network of the patient.

Description

Cross-reference to related applications

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 529,607, filed July 28, 2023, and U.S. Patent Application Serial No. 18 / 744,270, filed June 14, 2024, the entire contents of each of which are incorporated herein by reference. Technical Field

[0002] This disclosure pertains to the navigation and control of medical devices, such as catheters within luminal structures.

[0003] Several commonly used medical methods, such as endoscopic or minimally invasive surgery, exist for treating 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), or fluoroscopy, to identify areas of interest within the patient's body and targets for biopsy or treatment, ultimately navigating to those areas and targets. 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 safely and accurately navigate the device to the target, e.g., without harming other organs or tissues.

[0004] For example, endoscopic methods have proven useful in navigating to areas of interest within a patient's body, particularly within the body's network of cavities, such as the lungs, blood vessels, colorectal cavities, and renal ducts. To enable endoscopic methods, 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.

[0005] The resulting volumes generated from MRI or CT scans can be used to create navigation plans to facilitate the advancement of a navigation catheter (or other suitable medical device) through a network of lumens to the area of ​​interest. These MRI or CT scans are typically acquired at a point prior to any navigation of the patient.

[0006] During navigation, positioning or tracking systems, such as electromagnetic (EM) tracking systems or shape sensing tracking systems, can be combined with, for example, CT data to facilitate the guidance of the navigation catheter to the area of ​​interest. While these systems are effective, there is always a desire to improve them. Summary of the Invention

[0007] One aspect of this disclosure relates to a method comprising receiving electromagnetic (EM) sensor data from a sensor on a distal portion of a catheter. The method further comprises detecting the position of the distal portion of the catheter within a patient's lumen network. The method further comprises determining the shape of the catheter within the patient's lumen network. The method further comprises modifying control parameters of a drive motor operatively coupled to the catheter based on the detected position of the distal portion of the catheter and the determined shape of the catheter within the patient's lumen network. The method further comprises articulating the catheter. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each computer program being configured to perform the actions of the methods and systems described herein.

[0008] Implementations of this aspect of the disclosure may include one or more of the following features. The method further includes comparing a determined shape of the catheter with a path plan; and modifying the determined shape of the catheter based on the comparison. A drive motor is operatively connected to at least one draw cable, and modifications to control parameters adjust one or more of the following: the pulling distance of at least one draw cable, the speed at which the at least one draw cable is driven by the drive motor, or the force applied by the drive motor to at least one draw cable to articulate the catheter. The drive motor is located in a handle connected to the catheter, the handle including one or more input devices for controlling the drive motor. The drive motor is operatively connected to a robotic arm configured to advance the catheter within a patient's lumen network. Determining the shape of the catheter determines the position and angle of at least one bend in the catheter. The position of the distal portion of the catheter, the shape of the catheter, and the control parameters of the drive motor are repeatedly detected until the distal portion of the catheter approaches a target. Implementations of the described techniques may include hardware, methods, or processes, or computer software on a computer-accessible medium, including software, firmware, hardware, or combinations thereof installed on a system that causes the system to perform these actions in operation. One or more computer programs can be configured to perform specific operations or actions by including instructions that, when executed by a data processing device, cause the device to perform those actions.

[0009] A second aspect of this disclosure relates to a navigation system comprising: a catheter having sensors formed on its distal portion; and at least one pull wire integrated into the catheter and extending along its length. The system also includes a drive motor formed on the proximal portion of the catheter, the motor being operably connected to the pull wire via a threaded shaft. The system further includes a memory storing an application program that, when executed by a processor, performs the following steps: receiving sensor data from the sensors; detecting the position of the distal portion of the catheter within a patient's lumen network; determining the shape of the catheter within the patient's lumen network; modifying control parameters of the drive motor based on the detected position of the distal portion of the catheter and the determined shape of the catheter within the patient's lumen network; and driving the drive motor to articulate the distal portion of the catheter. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each computer program being configured to perform the actions of the methods and systems described herein.

[0010] Implementations of this aspect of the disclosure may include one or more of the following features. In the system, the determined shape of the catheter is based on sensor data received from sensors. When executed by a processor, the application compares the determined shape of the catheter with a path plan for the lumen network; and modifies the determined shape of the catheter based on this comparison. Modifying control parameters adjusts one or more of the following: the pulling distance of at least one drawstring, the speed at which at least one drawstring is driven by a drive motor, or the force applied by the drive motor to at least one drawstring to articulate the catheter. The drive motor is located in a handle connected to the catheter, the handle including one or more input devices for controlling the drive motor. The drive motor is operatively connected to a robotic arm configured to advance the catheter within the patient's lumen network. Determining the shape of the catheter determines the position and angle of at least one bend in the catheter. The position of the distal portion of the catheter is repeatedly detected, the shape of the catheter is determined, and the control parameters of the drive motor are modified until the distal portion of the catheter approaches a target. The sensor is one or more of a fiber optic, electromagnetic (EM) sensor, inertial measurement unit (IMU), or ultrasonic sensor. The system further includes a second pull wire integrated into and extending the length of the conduit, operably connected to a drive motor and configured to hinge the conduit in a direction opposite to that of the at least one pull wire. The second pull wire is integrated into and extends the length of the conduit, and actuation of the second motor hinges the conduit in a direction substantially orthogonal to the hinge direction caused by the at least one and second pull wires. The system further includes a third drive motor operably connected to the conduit and configured to rotate the conduit about its longitudinal axis. The sensor is an electromagnetic sensor configured to detect an electromagnetic field generated by the transmitter pad. Embodiments of the described technology may include hardware, methods, or processes, or computer software on a computer-accessible medium, including software, firmware, hardware, or combinations thereof installed on the system that causes the system to perform these actions in operation. One or more computer programs may be configured to perform specific operations or actions by including instructions that, when executed by a data processing device, cause the device to perform these actions. Attached Figure Description

[0011] Various aspects of this disclosure are described below with reference to the accompanying drawings, in which:

[0012] Figure 1 This is a schematic diagram of a cavity network navigation system based on the contents of this disclosure;

[0013] Figure 2 This is a flowchart of a method for controlling a conduit according to this disclosure;

[0014] Figure 3A and Figure 3BAspects of an articulation system for catheters according to this disclosure are described;

[0015] Figure 4 It is a 3D model generated as part of the path planning based on the content of this disclosure; and

[0016] Figure 5 This is a schematic diagram of an imaging and computing system based on this disclosure. Detailed Implementation

[0017] Catheters and catheter-like devices, such as endoscopes, are used in a variety of medical procedures. These flexible devices are typically used for navigation through the body's network of cavities, including the vascular system, airway, and digestive system. According to this disclosure, to aid navigation to a specific location, a user can articulate, deflect, or rotate the distal tip of the catheter either externally or via a robotic interface. These manipulations allow the tip to point and enter branching structures. Upon reaching the desired anatomical location, the medical procedure can be performed.

[0018] A common unmet need among all these tools is the significant effort physicians need to expend to improve their proficiency in manipulating them. The primary challenge stems from the fundamental limitations of the human brain in processing high-dimensional data. Specifically, physicians typically need to mentally register the position and orientation of a 3D object (i.e., a catheter) onto a 2D display (e.g., an endoscopic image, a fluorescein image, an ultrasound image, etc.) while simultaneously deciding how to turn the handle knob to orient the catheter in the desired direction. Furthermore, the lack of explicit feedback from clinicians makes effectively controlling motor-driven catheters challenging. On the one hand, this cognitive burden increases the risk of operator-related medical errors. On the other hand, the demanding eye-hand coordination limits the product to use only by highly trained, elite physicians, thus preventing its accessibility to other, less well-off clients.

[0019] This disclosure describes systems and methods that significantly enhance automated navigation and catheter control during navigation procedures. Aspects of this disclosure relate to the accurate and repeatable semi-autonomous and / or autonomous (e.g., robotic) navigation of a catheter to the most distal regions of the lung. These methods can be employed in a variety of products used in different minimally invasive procedures, including but not limited to bronchoscopy.

[0020] One aspect of this disclosure relates to the control exerted on the catheter during navigation of different portions of the airway in the lungs. During navigation in the central airway, there is a competing challenge: there is little resistance to catheter movement, but a greater degree of articulation may be required on the distal portion of the catheter to allow advancement into airways with openings at a larger angle relative to the airway in which the catheter is located. As navigation progresses towards the periphery, the airway narrows and begins to affect catheter navigation. The airway is not only subject to friction due to contact between the catheter and tissue, but the airway itself may also move due to the forces exerted by the catheter on the tissue. Furthermore, as the catheter moves further into the periphery, smaller and more controlled movements may be more suitable for achieving efficient navigation into smaller branch airways. Even further, as the shape of the catheter incorporates more and more bends, the shape of the catheter affects how the forces applied via the motor at the proximal end are transmitted through the catheter to achieve articulation at the distal end.

[0021] Figure 1 This is a three-dimensional diagram of an exemplary system for facilitating the navigation of a medical device (e.g., a catheter) to a soft tissue target via the airways of the lungs. Figure 1 As shown, catheter 102 is part of catheter guiding assembly 106. In one aspect, catheter 102 is inserted into bronchoscope 108 to access the lumen network of patient P. Specifically, catheter 102 of catheter guiding assembly 106 can be inserted into the working channel of bronchoscope 108 for navigation through the patient's lumen network. Catheter 102 itself may include imaging capabilities via an integrated camera or optics component 109, thus not strictly requiring a separate bronchoscope 108. A positionable guide (LG) 110 (second catheter) including sensor 104 can be inserted into catheter 102 and locked in place such that sensor 104 extends beyond the distal tip of catheter 102 to a desired distance. The position and orientation of sensor 104 relative to a reference coordinate system, and thus the position and orientation of the distal portion of catheter 102 in an electromagnetic field, can be determined. The catheter guidance kit 106 is currently marketed and sold by Medtronic under the trade names SUPERDIMENSION® Surgical Kit, ILLUMISITE™ Endobronchial Surgical Kit, ILLUMISITE™ Navigation Catheter, or EDGE™ Surgical Kit, and is believed to be usable in conjunction with this disclosure.

[0022] System 100 typically includes: an operating table 112 and monitoring equipment 114 configured to support a patient P, the monitoring equipment being coupled to a bronchoscope 108 or catheter 102 (e.g., a video display for displaying video images received from a video imaging system of the bronchoscope 108 or catheter 102); a positioning or tracking system 114 including a positioning module 116, multiple reference sensors 18, and a transmitter pad 120 including multiple coupled markers; and a computing device 122 including software and / or hardware for facilitating target identification, path planning to the target, navigation of medical devices to the target, and / or confirmation and / or determination of the placement of the catheter 102 or appropriate devices passing through it relative to the target. Figure 4 A 3D model depicting a portion of the preoperative pathway planning was created to guide the clinician as they navigate catheter 102 to the target (shown in green). The 3D model can be employed in the methods described below.

[0023] As is typical for navigation of the catheter guidance assembly 10, a six-degree-of-freedom electromagnetic positioning or tracking system 114, or other suitable systems (described below) for determining the position and orientation of the distal portion of the catheter 102, are used to perform registration of the detected position of the sensor 104 with a 3D model generated from CT or MRI image scans. The tracking system 114 includes a tracking module 116, multiple reference sensors 118, and a transmitter pad 120 (including markers). The tracking system 114 is configured for use with the positionable guide 110, and in particular the sensor 104. As described above, the positionable guide 110 and the sensor 104 are configured for insertion through the catheter 102 into the airway of the patient P (with or without a bronchoscope 108) and can be selectively locked relative to each other via a locking mechanism.

[0024] The transmitter pad 120 is positioned below the patient P. The transmitter pad 120 generates an electromagnetic field around at least a portion of the patient P, within which the tracking module 116 can be used to determine the positions of a plurality of reference sensors 118 and sensors 104. In some embodiments, a second electromagnetic sensor 126 may also be incorporated into the end of the catheter 102. The second electromagnetic sensor 126 may be a five-DOF or six-DOF sensor and may be employed as a complement to or alternative to sensor 104 in LG 110. One or more of the reference sensors 118 are attached to the chest of the patient P. Registration is typically performed to reconcile the positions from the three-dimensional model and two-dimensional images from the planning phase with the airway of the patient P as observed through the bronchoscope 108, and to allow for the navigation phase with the positions of the sensors 104 known.

[0025] Registration of the patient P's position on the transmitter pad 120 can be performed by moving sensor 104 or 126 across the patient P's airway. More specifically, as the catheter 102 and / or the positionable guide 110 moves across the airway, data relating to the position of sensor 104 or 126 is recorded using the transmitter pad 120, reference sensor 118, and tracking system 114. The shape generated from this position data is compared with a 3D model (e.g., Figure 4 The internal geometry of the passageway in the 3D model is compared, and software on computing device 122 is used, for example, to determine the positional correlation between the compared shape and the 3D model. Additionally, the software identifies non-organic spaces (e.g., air-filled cavities) in the 3D model. The software aligns or registers images representing the positions of sensors 104 or 126 with the 3D model and / or 2D images generated from the 3D model, based on recorded positional data and the assumption that the positionable guide 110 remains located within non-organic spaces in the patient P's airway. Alternatively, a manual registration technique can be employed by navigating the bronchoscope 108 with sensors 104 to a pre-specified location in the patient P's lungs and manually correlating the images from the bronchoscope with model data from the 3D model.

[0026] Although this document describes an EMN system using EM sensors, this disclosure is not limited thereto and can be used in conjunction with flexible sensors (such as fiber Bragg grating sensors), inertial measurement units (IMUs), ultrasonic sensors, or without sensors. Additionally, as outlined below, the methods described herein can be used in conjunction with robotic systems to enable robotic actuators to drive the duct 102 or bronchoscope 108 toward a target.

[0027] 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 124 capable of acquiring 2D and 3D images or videos of patient P (e.g., CT imaging devices, such as Medtronic's O-arm™ system or other cone-beam computed tomography (CBCT) devices) are also included in this particular aspect of system 100. Images, image sequences, or videos captured by imaging device 124 can be stored within imaging device 124 or transmitted to computing device 122 for storage, processing, and display. Additionally, imaging device 124 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 such as fluorescence fluoroscopy videos. The orientation of imaging device 124 relative to patient P during image acquisition can be estimated via markers attached to emitter pad 120. The markers are positioned below patient P, between patient P and operating table 112, and between patient P and the radiation source or sensing unit of imaging device 124. The marker associated with the transmitter pad 120 may be two separate elements that are fixedly connected, or the marker may alternatively be manufactured as a single unit. The imaging device 124 may include a single imaging device or more than one imaging device.

[0028] The computing device 122 can be any suitable computing device including a processor and a storage medium, wherein the processor is capable of executing instructions stored on the storage medium. The computing device 122 may further include a database configured to store patient data, CT datasets including CT images, fluoroscopy datasets including images and videos, 3D reconstructions, navigation planning, and any other such data. Although not explicitly shown, the computing device 122 may include input terminals or may be configured to receive CT datasets, fluoroscopy images / videos, and other data described herein. Additionally, the computing device 122 includes a display configured to display a graphical user interface. The computing device 122 may be connected to one or more networks through which one or more databases can be accessed.

[0029] The conduit guide assembly 106 can be manually operated to manipulate the distal portion of the conduit 102. Alternatively or additionally, according to this disclosure, a draw cable described below is capable of manipulating and shaping the distal portion of the conduit 102. The draw cable can be connected to a motor drive mechanism. The motor drive mechanism can be handheld and includes one or more buttons or joysticks to enable manipulation of the distal portion of the conduit 102. Alternatively, the conduit guide assembly 106 and any motor drive mechanism can be configured for integration into a robotic assembly, and the articulation and control of the draw cable can be performed via a computing device 122 and an associated input device (e.g., a handheld controller similar to a game controller).

[0030] Figure 2 A method 200 according to this disclosure is depicted. As described above, catheter 102 is configured for navigation within a patient's lungs. At step 202, navigation of catheter 102 begins. Sensors 104, 126 on the distal portion of catheter 102 detect an electromagnetic field generated by transmitter pad 120. As during the registration process described above, the positions of sensors 104, 126 are detected at step 204. The detection of the positions of sensors 104, 126 is performed continuously during navigation at set time intervals (e.g., 20 times per second). Data from the detected positions of sensors 104 are collected by an application running on computing device 122. At step 206, the application is assembled using the data from the sensor positions 104 collected during navigation to form an estimated shape of catheter 102 at any point during navigation. Catheter 102 is typically located within the airway of the patient's lungs during navigation, and the estimated shape of the catheter can be compared with the airway shape planned along the path from preoperative planning to the current position of sensor 104. This comparison can be used to further refine the estimated shape of catheter 102. At step 208, by estimating the shape of catheter 102, control parameters, such as those of a motor-driven device (described below), can be modified. For example, as mentioned above, during central navigation, faster and more extreme (larger angle) manipulation of the drawstring may be necessary to alter the shape of the distal portion of catheter 102 and allow access to the airway. Similarly, smaller and less rapid manipulation of the drawstring can be employed when catheter 102 approaches the periphery. As will be understood, the tissue at the periphery of the lung is highly flexible, and manipulation of catheter 102 via the drawstring can distort the shape of the lung. Violent or forceful movement of catheter 102 can cause lung tissue to move along with catheter 102, leading to more frequent CT body deviations. When tissue is distorted, it is further altered compared to its position during preoperative imaging (e.g., CT or MRI) capture. Therefore, by modifying control parameters 208, the force applied by the catheter can be appropriately adjusted based on the position of catheter 102 within the lung.

[0031] Alternatively, if the catheter 102 is not moved by motorization via a motor-driven device (e.g., a semi-autonomous or autonomous robot), but rather by manual manipulation, the estimated shape of the catheter at step 206 can be used to calculate manual adjustments to the catheter 102, and these manual adjustments can be output to the user at step 207. As an example, the calculated manual adjustments can be displayed on the user interface of the computing device 122, and can be accompanied by auditory and visual orientation for adjusting the position and orientation of the catheter 102 using one or more manipulators on the proximal portion of the catheter 102 (e.g., a handle).

[0032] Furthermore, as understood, the shape of catheter 102 alters how forces are applied proximally (e.g., at the handle or robot interface) and how they are transmitted via the drawstring to the distal portion. The shape of catheter 102, particularly the sharp bends (or high-angle bends) within catheter 102, necessitates altering the distance the drawstring is actuated or the force applied to the drawstring to achieve the desired shape change of the distal portion of catheter 102. For example, if navigation to one of the upper lobes of the lung is required, catheter 102 needs to form a near 180-degree bend within catheter 102 as it descends through the trachea, subsequently orienting the distal portion toward the bifurcation leading to the upper lobe by manipulation (e.g., via the drawstring). As will be understood, although the distal portion of catheter 102 may be the only portion articulated with the drawstring, after advancement through the bifurcation of the airway, the exemplary near 180-degree bend in catheter 102 remains within catheter 102 and is advanced proximally along catheter 102 as the distal portion is further advanced into the airway. At each bifurcation, an additional bend is formed in the conduit 102 until it is determined at step 210 that the distal portion of the conduit 102 has approached the target. If it has been reached, method 200 can stop; otherwise, the method returns to step 202 and continues execution. With each bend of the conduit 102, the pulling distance of the drawstring and the force required to achieve that pulling distance change. Therefore, in addition to adjusting the control parameters based on the positions detected by sensors 104, 126, the control parameters are also adjusted at step 208 based on the determined shape of the conduit 102, taking into account the changes required based on the bends of the conduit 102 (e.g., the shape of the conduit 102).

[0033] Furthermore, the shape of the catheter 102 affects not only the pulling distance of the pull cords, but also the number of pull cords used (in cases where more than one is used), the distance each pull cord travels, and the force applied to each pull cord. For example, when the catheter 102 is straight, bending the catheter to the left by 0.5 mm may require shortening the length of one pull cord by 1 mm. However, if the catheter 102 has a curved shape after navigating through multiple bifurcations of the airway, bending the catheter 102 to the left by approximately 0.5 mm may require shortening the first pull cord by 0.75 mm and the second pull cord by 0.5 mm. Similarly, to achieve a 0.5 mm leftward bend, the force applied by the pull cords can be proportionally distributed between the two pull cords. These and other factors can be included as part of the control parameters modified at step 208.

[0034] According to this disclosure, the catheter 102 and its articulation and orientation relative to the target are achieved using a catheter drive mechanism 300. An example of such a drive mechanism may be... Figure 3A As seen in the figure, the housing includes three drive motors for manipulating the conduit extending from it in five degrees of freedom (e.g., left, right, up, down, and rotation). Other types of drive mechanisms and other manipulation techniques involving fewer or more degrees of freedom may be employed without departing from the scope of this disclosure.

[0035] As mentioned above, Figure 3A A drive mechanism 300 is depicted housed within a body 301 and mounted on a support 302 integrally connected to the body 301. A catheter 102 is connected to and forms an integrated unit with inner housings 304a and 304b in one aspect of this disclosure, and is connected to a spur gear 306. This integrated unit is rotatable relative to the housing 301, such that the catheter 102, the inner housings 304a to 304b, and the spur gear 306 can rotate about an axis “z”. The catheter 102 and the integrated inner housings 304a to 304b are radially supported by bearings 308, 310, and 312. Although the drive mechanism 300 is described in detail herein, other drive mechanisms may be employed to enable a robot or clinician to drive the catheter to a desired position without departing from the scope of this disclosure.

[0036] Electric motor 314R may include an encoder for converting mechanical motion into electrical signals and providing feedback to computing device 122. Further, electric motor 314R (where R indicates the motor if it is used to cause rotation of conduit 102) may include an optional gearbox for increasing or decreasing the rotational speed of an attached spur gear 315 mounted on a shaft driven by electric motor 314R. Electric motors 314LR (LR refers to the left-right movement of the hinge portion 317 of conduit 102) and 314UD (referring to the up-down movement of the hinge portion 317) may optionally include an encoder and a gearbox. Corresponding spur gears 316 and 318 drive the up-down and left-right pull wires, as will be described in more detail below. All three electric motors 314R, 314LR, and 314UD are securely attached to a fixed frame 302 to prevent rotation and to enable spur gears 315, 316, and 318 to be driven by the electric motors.

[0037] Figure 3B Details of the mechanism for hinged portion 317 of conduit 102 are depicted. Specifically, the manner of vertical hinged connection envisioned in one aspect of this disclosure is described below. Such a system, coupled solely to an electric motor 314UD for driving the spur gear 316, would achieve the hinged connection as described above in a two-wire system. However, in the case of a contemplated four-wire system, a second system identical to the one described below could be used to drive the left and right cables. Therefore, for ease of understanding, only one system is described herein, and it is understood that those skilled in the art will readily understand how a second such system could be employed in a four-wire system. Those skilled in the art will recognize that other mechanisms can be employed to achieve hinged distal portions of the conduit, and other hinged conduits can be used, without departing from the scope of this disclosure.

[0038] To achieve the upper and lower hinge of the hinged portion 317 of catheter 102, drawstrings 319a and 319b can be used. The distal ends of drawstrings 319a and 319b are attached to the distal end of catheter 102, or attached at the distal end of the catheter, or attached near the distal end of the catheter. The proximal ends of drawstrings 319a and 319b are attached to the distal tips of posts 320a and 320b. Figure 3B As shown, columns 320a and 320b reciprocate longitudinally in opposite directions. The movement of column 320a lengthens a drawwire 319a, while simultaneously, the opposite longitudinal movement of column 320b effectively shortens drawwire 319b. The combined effect of the change in effective length between drawwires 319a and 319b is that the hinge portion 317 of the conduit 102 shaft is compressed on the side where drawwire 319b is shortened, and extended on the side where drawwire 319a is lengthened.

[0039] Opposite posts 320a and 320b have internal left-hand and right-hand threads, respectively, at least near their proximal ends. For example... Figure 3A As shown, housed within housing 304b are two threaded shafts 322a and 322b, one left-hand threaded and the other right-hand threaded, to correspond and engage with posts 320a and 320b. The distal ends of shafts 322a and 322b are screwed into the interior of posts 320a and 320b, with spur gears 324a and 324b at their proximal ends. Shafts 322a and 322b are free to rotate about their axes. Spur gears 324a and 324b engage with the internal teeth of planetary gear 326. Planetary gear 326 also has external teeth that engage with the teeth of spur gear 318 on the proximal end of electric motor 314UD.

[0040] To hinge the catheter in the upward direction, the clinician can activate the electric motor 314UD via an activation switch (not shown), causing it to rotate the spur gear 318, which in turn drives the planetary gear 326. The planetary gear 326 is connected to shafts 322a and 322b via internal gears 324a and 324b. The planetary gear 326 will cause gears 324a and 324b to rotate in the same direction. Shafts 322a and 322b are threaded, and their rotation is converted into linear motion of shafts 320a and 320b by mating threads formed on the inner sides of shafts 320a and 320b. However, because the internal threads of shafts 320a and 320b are opposite, as the planetary gear 326 rotates, one shaft will travel distally while the other will travel proximally (i.e., in opposite directions). Therefore, pulling the upper cable 319a proximally lifts the catheter 102, while the lower cable 319b must be released. As described above, the same system can be used to control the left and right movement of the end effector using an electric motor 314LR, its spur gear 316, a second planetary gear (not shown), a second set of threaded shafts 322 and column 320, and two additional pull cables 319. Furthermore, by acting in unison, a system employing four steering cables can approximate the movement of a human wrist by having three electric motors 314 and their associated drives and pull cables 319 controlled by a computer (e.g., via a handle or robot interface with finger controls). As will be understood, the first pair of pull cables 319 hinges the conduit 102 in a plane substantially orthogonal to the plane of the second pair of pull cables. The use of two pairs of pull cables allows for hinges from the longitudinal axis of the conduit 102 in virtually any direction.

[0041] According to one aspect of this disclosure, when catheter 102 is advanced into a patient’s cavity network (e.g., the airway of the lungs), an application on the computing device can receive input from sensors 104, 126 and, taking into account modifications to control parameters to take into account the position of sensors 104, 126 and the shape of catheter 102, guide electric motor 314 to articulate or rotate catheter 102 so that the catheter is advanced along a path to a target in the patient’s body (step 208).

[0042] The clinician can hold the catheter assembly 106, and as the clinician advances the catheter 102 into the patient, the application determines the articulation of the end of the catheter 102 required to allow the catheter 102 to reach the target location. Furthermore, the drive mechanism 300 can be integrated into one or more robotic arms or trolleys (not shown) so that the catheter 102 and the drive mechanism 300 can move in the z-direction (along the longitudinal axis of the catheter 102).

[0043] The drive mechanism 300 can receive input from the computing device 122 or another mechanism, through which the surgeon specifies the desired movement of the catheter 102. When the clinician controls the movement of the catheter 102, this control can be achieved via directional buttons, joysticks (such as thumb-operated joysticks), toggle switches, pressure sensors, switches, trackballs, dials, optical sensors, and any combination thereof. The computing device 122 responds to user commands by sending control signals to the motor 314. The encoder of the motor 314 provides feedback to the control unit regarding the current state of the motor 314.

[0044] As described in this disclosure and in more detail below, the drive mechanism 300 receives signals from the computing device 122 to drive the catheter 102 (e.g., extend and retract a drawstring) to maintain the orientation of the distal tip of the catheter 102 in the event of extension of a tool such as a biopsy needle or ablation catheter or movement caused by respiratory and cardiac cycles.

[0045] Such as combination Figure 3A and Figure 3B As described, the catheter 102 is operated via a set of control devices at its proximal end to achieve rotation and distal tip deflection. (This is in conjunction with...) Figure 3A and Figure 3BCompared to the described aspects, the manually advanced catheter 102 may not include a motor 314R, but instead relies on manual manipulation to rotate the catheter 102. Alternatively, the drive mechanism may consist of only a single drawwire 319 or a pair of drawwires 319a, 319b. Thus, articulation is achieved in opposite directions via a single drawwire or a pair of drawwires. One or more knobs, levers, or wheels on the proximal handle control or actuate the corresponding motor 314 to achieve distal tip articulation. The rotation and advancement / retraction of the catheter 102 are controlled by the user's hand directly pushing, pulling, and rotating the catheter 102 within the patient's body. Figure 3A and Figure 3B As described, any or all of these manual controls can be removed, and the user can indirectly control the conduit operation via an interface with the motor (such as a joystick), which can be located on a handle (not shown) connected to conduit 102 or to computing device 122. Navigation can also be performed fully automatically under user supervision.

[0046] Once catheter 102 is navigated to a location close to the target tissue (e.g., a tumor or lesion), medical procedures can begin. For example, the LG 110 with sensor 104 can be removed from catheter 102. Once removed, biopsy or therapeutic instruments (e.g., microwave, radiofrequency, cryosurgery, or chemical ablation catheters) can be inserted through the lumen of catheter 102 to interact with the tumor or lesion (e.g., to collect a biopsy or treat the tumor).

[0047] Now for reference Figure 5 This diagram is configured to be used with, including Figure 2 This is a schematic diagram of a system 700 used in conjunction with the method of this disclosure, method 200. System 700 may include a workstation 701 and optionally an imaging device 715 (e.g., a fluoroscope or ultrasound device). Workstation 701 may be directly or indirectly connected to imaging device 715, for example, via wireless communication. Workstation 701 may include a memory 702, a processor 704, a display 706, and an input device 710. The processor or hardware processor 704 may include one or more hardware processors. Workstation 701 may optionally include an output module 712 and a network interface 708. Memory 702 may store application program 718 and image data 714. Application program 718 may include functions executable by processor 704 for performing tasks including... Figure 2 The method disclosed herein is the instruction of the method.

[0048] Application 718 may further include user interface 716. Image data 714 may include CT scans, fluoroscopic 3D reconstructions of the generated target region, and / or any other fluoroscopic image data and / or one or more slices of the generated 3D reconstruction. Processor 704 may be connected to memory 702, display 706, input device 710, output module 712, network interface 708, and imaging device 715. Workstation 701 may be a fixed computing device such as a personal computer, or a portable computing device such as a tablet computer. Workstation 701 may embed multiple computing devices.

[0049] Memory 702 may include any non-transitory computer-readable storage medium for storing data and / or software, including instructions executable by processor 704, which control the operation of workstation 701 and also control the operation of imaging device 715. Imaging device 715 may be used to capture fluorescence fluoroscopic image sequences (on which fluorescence fluoroscopic 3D reconstructions are generated) and capture real-time 2D fluorescence fluoroscopic views according to this disclosure. Memory 702 may include one or more storage devices, such as solid-state storage devices (e.g., flash memory chips). As an alternative to or supplement to one or more solid-state storage devices, memory 702 may include one or more mass storage devices connected to processor 704 via a mass storage controller (not shown) and a communication bus (not shown).

[0050] Although the description of computer-readable media 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 704. 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 tape cassettes, magnetic tape, disk storage devices or other magnetic storage devices, or any other medium that can be used to store desired information and is accessible by workstation 701.

[0051] When executed by processor 704, application 718 can cause display 706 to present user interface 716. User interface 716 can be configured to present a single screen to the user, including a 3D view of a three-dimensional (3D) model of the target from the perspective of the tip of the medical device, a real-time two-dimensional (2D) fluorescence perspective view of the medical device, and target markers corresponding to the 3D model of the target overlaid on the real-time 2D fluorescence perspective view. User interface 716 can be further configured to display the target markers in different colors depending on whether the tip of the medical device is aligned with the target in three dimensions.

[0052] Network interface 708 can be configured to connect to a network, such as a local area network (LAN), wide area network (WAN), wireless mobile network, Bluetooth network, and / or the Internet, consisting of wired and / or wireless networks. Network interface 708 can be used to establish a connection between workstation 701 and imaging device 715. Network interface 708 can also be used to receive image data 714. Input device 710 can be any device that a user can use to interact with workstation 701, such as a mouse, keyboard, foot pedal, touchscreen, and / or voice interface. Output module 712 can include any connection port or bus, such as a parallel port, serial port, universal serial bus (USB), or any other similar connection port known to those skilled in the art. Based on the foregoing and with reference to the various accompanying drawings, those skilled in the art will understand that certain modifications can be made to this disclosure without departing from the scope of this disclosure.

[0053] This disclosure is further described in the examples numbered below.

[0054] Example 1 - A method comprising: receiving electromagnetic (EM) sensor data from a sensor on a distal portion of a catheter; detecting the position of the distal portion of the catheter within a patient's lumen network; determining the shape of the catheter within the patient's lumen network; modifying control parameters of a drive motor operatively coupled to the catheter based on the detected position of the distal portion of the catheter and the determined shape of the catheter within the patient's lumen network; and hinged the catheter.

[0055] Example 2 - The method described in Example 1 further includes comparing the determined shape of the catheter with the path plan; and modifying the determined shape of the catheter based on the comparison.

[0056] Example 3 - The method as described in Example 1, wherein a drive motor is operatively connected to at least one pull wire, and modifications to these control parameters will adjust one or more of the following: the pulling distance of at least one pull wire, the speed at which at least one pull wire is driven by the drive motor, or the force applied by the drive motor to at least one pull wire to articulate the conduit.

[0057] Example 4 - The method as described in Example 1, wherein a drive motor is located in a handle connected to the catheter, the handle including one or more input devices for controlling the drive motor; and / or the drive motor is operatively connected to a robotic arm configured to advance the catheter within a patient's lumen network.

[0058] Example 5 - The method as described in Example 1, wherein determining the shape of the catheter will determine the position and angle of at least one bend in the catheter; and / or repeatedly detecting the position of the distal portion of the catheter, determining the shape of the catheter, and modifying the control parameters of the drive motor until the distal portion of the catheter approaches the target.

[0059] Example 6 - A navigation system comprising: a catheter including sensors formed on its distal portion; at least one pull wire integrated into the catheter and extending along its length; a drive motor formed on the proximal portion of the catheter, the motor being operably connected to the pull wire via a threaded shaft; and a memory storing an application that, when executed by a processor, performs the following steps: receiving sensor data from the sensors; detecting the position of the distal portion of the catheter within a patient's lumen network; determining the shape of the catheter within the patient's lumen network; modifying control parameters of the drive motor based on the detected position of the distal portion of the catheter and the determined shape of the catheter within the patient's lumen network; and driving the drive motor to articulate the distal portion of the catheter.

[0060] Example 7 - A system as described in Example 6, wherein the determined shape of the catheter is based on sensor data received from a sensor; and / or the application, when executed by the processor, compares the determined shape of the catheter with the path planning of the lumen network; and modifies the determined shape of the catheter based on the comparison.

[0061] Example 8 - A system as described in Example 6, wherein modifying the control parameters will adjust one or more of the following: the pulling distance of at least one cable, the speed at which at least one cable is driven by a drive motor, or the force applied by the drive motor to at least one cable to articulate the conduit.

[0062] Example 9 - A system as described in Example 6, wherein a drive motor is located in a handle connected to the catheter, the handle including one or more input devices for controlling the drive motor, or the drive motor is operatively connected to a robotic arm configured to advance the catheter within a patient's lumen network.

[0063] Example 10 - A system as described in Example 6, wherein determining the shape of the catheter determines the position and angle of at least one bend in the catheter; and / or repeatedly detecting the position of the distal portion of the catheter, determining the shape of the catheter, and modifying the control parameters of the drive motor until the distal portion of the catheter approaches the target.

[0064] Example 11 - A system as described in Example 6, wherein the sensor is one or more of an optical fiber, an electromagnetic (EM) sensor, an inertial measurement unit (IMU), or an ultrasonic sensor.

[0065] Example 12 - The system as described in Example 6 further includes a second pull wire integrated into the catheter and extending the length of the catheter, the second pull wire being operatively connected to a drive motor and configured to hinge the catheter in a direction opposite to that of at least one pull wire.

[0066] Example 13 - The system as described in Example 12 further includes a second drive motor operably connected to a second pair of pull wires, wherein the second pair of pull wires are integrated into the conduit and extend the length of the conduit, and actuation of the second motor hinges the conduit in a direction substantially orthogonal to the hinge direction caused by at least one pull wire and the second pull wire.

[0067] Example 14 - The system as described in Example 13 further includes a third drive motor operatively connected to the catheter and configured to rotate the catheter about its longitudinal axis.

[0068] Example 15 - A system as described in Example 6, wherein the sensor is an electromagnetic sensor configured to detect an electromagnetic field generated by the transmitter pad.

[0069] While this document discloses detailed aspects, these aspects are merely examples of the aspects covered herein, which can be embodied in various forms and aspects. Therefore, the specific structural and functional details disclosed herein should not be construed as restrictive, but rather as the basis for the claims and as a representative basis for teaching those skilled in the art to employ this disclosure in various ways in virtually any suitably detailed structure.

Claims

1. A method comprising: Electromagnetic (EM) sensor data is received from a sensor on the distal portion of the catheter; Detect the position of the distal portion of the catheter within the patient's lumen network; Determine the shape of the catheter within the patient's lumen network; The control parameters of the drive motor operatively coupled to the catheter are modified based on the detected position of the distal portion of the catheter and the determined shape of the catheter within the patient's lumen network. as well as The conduit is hinged.

2. The method of claim 1, further comprising: The determined shape of the catheter is compared with the planned path; as well as The determined shape of the catheter is modified based on the comparison.

3. The method as described in claim 1, wherein, The drive motor is operatively connected to at least one pull wire, and modifications to these control parameters will adjust one or more of the following: the pulling distance of the at least one pull wire, the speed at which the at least one pull wire is driven by the drive motor, or the force applied by the drive motor to the at least one pull wire to hinge the conduit.

4. The method of claim 1, wherein, The drive motor is located in a handle connected to the conduit, the handle including one or more input devices for controlling the drive motor; and / or The drive motor is operably connected to a robotic arm configured to advance the catheter within the patient's network of lumens.

5. The method of claim 1, wherein, Determining the shape of the catheter will determine the position and angle of at least one bend in the catheter; and / or The position of the distal portion of the catheter is repeatedly detected, the shape of the catheter is determined, and the control parameters of the drive motor are modified until the distal portion of the catheter approaches the target.

6. A navigation system, comprising: The catheter includes a sensor formed on its distal portion; At least one pull wire, said at least one pull wire being integrated into the catheter and extending along the length of the catheter; A drive motor is formed on the proximal portion of the conduit and is operably connected to the pull wire via a threaded shaft; The memory, on which the application is stored, performs the following steps when executed by the processor: Receive sensor data from the sensor; Detect the position of the distal portion of the catheter within the patient's lumen network; Determine the shape of the catheter within the patient's lumen network; The control parameters of the drive motor are modified based on the detected position of the distal portion of the catheter and the determined shape of the catheter within the patient's lumen network. as well as The drive motor is driven to hinge the distal portion of the conduit.

7. The system of claim 6, wherein, The determined shape of the catheter is based on sensor data received from the sensor; and / or when the application is executed by the processor: The determined shape of the catheter is compared with the path planning of the lumen network; and The determined shape of the catheter is modified based on the comparison.

8. The system of claim 6, wherein, Modifying the control parameters will adjust one or more of the following: the pulling distance of the at least one pull wire, the speed at which the at least one pull wire is driven by the drive motor, or the force applied by the drive motor to the at least one pull wire to hinge the conduit.

9. The system of claim 6, wherein, The drive motor is located in a handle connected to the conduit, the handle including one or more input devices for controlling the drive motor, or The drive motor is operably connected to a robotic arm configured to advance the catheter within the patient's network of lumens.

10. The system of claim 6, wherein, Determining the shape of the catheter will determine the position and angle of at least one bend in the catheter; and / or The position of the distal portion of the catheter is repeatedly detected, the shape of the catheter is determined, and the control parameters of the drive motor are modified until the distal portion of the catheter approaches the target.

11. The system of claim 6, wherein, The sensor is one or more of an optical fiber, electromagnetic (EM) sensor, inertial measurement unit (IMU), or ultrasonic sensor.

12. The system of claim 6, further comprising a second pull wire integrated into the conduit and extending the length of the conduit, the second pull wire being operatively connected to the drive motor and configured to hinge the conduit in a direction opposite to the at least one pull wire.

13. The system of claim 12, further comprising a second drive motor operably connected to a second pull cable, wherein, The second pair of pull wires is integrated into the conduit and extends the length of the conduit, and the actuation of the second motor hinges the conduit in a direction substantially orthogonal to the hinge direction caused by the at least one pull wire and the second pull wire.

14. The system of claim 13, further comprising a third drive motor operably connected to the catheter and configured to rotate the catheter about its longitudinal axis.

15. The system of claim 6, wherein, The sensor is an electromagnetic sensor configured to detect the electromagnetic field generated by the transmitter pad.

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