Patent Application
20230310805
This disclosure relates to the field of navigation of and maintaining position of medical devices, such as biopsy or ablation tools, relative to targets.
There are several commonly applied medical methods, such as endoscopic procedures or minimally invasive procedures, for treating various maladies affecting organs including the liver, brain, heart, lungs, gall bladder, kidneys, and bones. Often, one or more imaging modalities, such as magnetic resonance imaging (MRI), ultrasound imaging, computed tomography (CT), or fluoroscopy are employed by clinicians to identify and navigate to areas of interest within a patient and ultimately a target for biopsy or treatment. In some procedures, pre-operative scans may be utilized for target identification and intraoperative guidance. However, real-time imaging may be required to obtain a more accurate and current image of the target area. Furthermore, real-time image data displaying the current location of a medical device with respect to the target and its surroundings may be needed to navigate the medical device to the target in a safe and accurate manner (e.g., without causing damage to other organs or tissue).
For example, an endoscopic approach has proven useful in navigating to areas of interest within a patient, and particularly so for areas within luminal networks of the body such as the lungs, blood vessels, colorectal cavities, and the renal ducts. To enable the endoscopic approach, navigation systems have been developed that use previously acquired MM data or CT image data to generate a three-dimensional (3D) rendering, model, or volume of the particular body part.
The resulting volume generated from the MRI scan or CT scan may be utilized to create a navigation plan to facilitate the advancement of a navigation catheter (or other suitable medical device) through the luminal network to an area of interest. A locating or tracking system, such as an electromagnetic (EM) tracking system or shape sensing tracking system, may be utilized in conjunction with, for example, CT data, to facilitate guidance of the navigation catheter to the area of interest.
However, once a catheter is navigated to a desired location the position of the catheter within the patient is constantly in flux. Change in position of the catheter may be caused by the movement of tools through the catheter, movement of the lungs themselves during respiration, and movement caused by the proximity of the lungs to the heart which is in constant motion as part of the cardiac process. Accordingly, improvements to current systems are desired.
One aspect of the disclosure is directed to a method of maintaining orientation of a catheter relative to a target including: navigating a catheter in a luminal network, collecting data relating to movement of a distal tip of the catheter caused by physiological forces. The method of maintaining orientation also includes receiving images depicting the distal tip of the catheter and the target. The method of maintaining orientation also includes identifying the distal tip of the catheter and the target in the images. The method of maintaining orientation also includes determining an orientation of the distal tip of the catheter relative to the target. The method of maintaining orientation also includes confirming that the distal tip is oriented at the target. The method of maintaining orientation also includes articulating the distal tip of the catheter to maintain the orientation at the target based on the collected data. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods and systems described herein.
Implementations of this aspect of the disclosure may include one or more of the following features. The method where the collected data is received from an inertial measurement unit. The method further including determining a three-dimensional angle between a current orientation of the distal tip of the catheter and an orientation where a vector extending from the distal tip of the catheter intersect the target. The method further including articulating the distal tip of the catheter to achieve the orientation where the vector extending from the distal tip of the catheter intersect the target. The method where the images are fluoroscopic images. The method where the images are ultrasound images. The method where the physiological forces are caused by respiration and cardiac functions. The method where the data is collected during navigation of the catheter towards the target. The method further including presenting on a user interface a virtual catheter tip and a virtual target. The method further including presenting an indicator on the user interface when the physiological forces are in approximately the same phase of their cycle as when the distal tip was confirmed oriented at the target. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium, including software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions. One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions.
Another aspect of the disclosure is directed to a method of correcting alignment of catheter relative to a target including: receiving signals from an inertial measurement unit located at a distal end of a catheter, determining movement of the distal end of the catheter caused by physiological forces. The method of correcting alignment of catheter also includes receiving images depicting the distal end of the catheter and the target. The method of correcting alignment of catheter also includes identifying the distal end of the catheter and the target in the images. The method of correcting alignment of catheter also includes determining an orientation of the distal end of the catheter relative to the target. The method of correcting alignment of catheter also includes articulating the distal tip of the catheter to achieve and maintain an orientation towards the target such that a tool extended from an opening at the distal end of the catheter would intersect the target. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods and systems described herein.
Implementations of this aspect of the disclosure may include one or more of the following features. The method further including determining a three-dimensional angle between a current orientation of the distal end of the catheter and an orientation where a vector extending from the distal end of the catheter intersect the target. The method where the images are fluoroscopic images. The method where the images are ultrasound images. The method where the physiological forces are caused by respiration and cardiac functions. The method where the data is collected during navigation of the catheter towards the target. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium, including software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions. One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions.
A further aspect of the disclosure is directed to a system for maintaining orientation of a catheter towards a target including: a catheter including an inertial measurement unit (IMU), the IMU configured to generate signals relating to movement of the distal portion of the catheter, and a drive mechanism configured to articulate the distal portion of the catheter; and a computing device, the computing device including a processor and memory, the memory storing thereon instructions that when executed by the processor, receive signals from the IMU; determine motion of the IMU caused by physiological forces; receive images depicting the distal portion of the catheter and a target; determine the orientation of the distal portion of the catheter relative to the target based on the images; and send signals to the drive mechanism to articulating the distal portion of the catheter to achieve and maintain an orientation towards the target such that a tool extended from an opening at the distal portion of the catheter would intersect the target. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods and systems described herein.
Implementations of this aspect of the disclosure may include one or more of the following features. The system where the memory stores thereon instructions that when executed by the processor, determine a three-dimensional angle between a current orientation of the distal portion of the catheter and an orientation where a vector extending from the distal portion of the catheter intersect the target. The system where the movement of the distal portion of the catheter is a result of physiological forces including respiration and cardiac function. The system where the received images are fluoroscopic images. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium, including software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions. One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions.
Various aspects and embodiments of the disclosure are described hereinbelow with references to the drawings, wherein:
Catheters and catheter like devices, such as endoscopes, are used in a myriad of medical procedures. These flexible devices are typically used to navigate through luminal networks of the body including the vasculature, airways, and digestive systems. In accordance with the disclosure, to aide in navigating to a specific location, the distal tip of the catheter can be articulated, deflected, or rotated by a user through controls on the catheter proximal end outside the body. These manipulations allow the tip to point towards and enter branching structures. Upon arrival at the desired anatomic location a medical procedure may be performed such as lesion observation, heart valve replacement, stent or pacemaker deployment, radio frequency or microwave ablation, placement of chemotherapy drugs, and a variety of others.
In accordance with the disclosure, a 3D model of a patient's lungs or another suitable portion of the anatomy, may be generated from previously acquired scans, such as CT or MRI scans. The 3D model and related scan data are used to identify targets, e.g., potential lesions for biopsy or treatment, and to generate a pathway plan through the anatomy to reach the targets.
Once the pathway plan is generated and accepted by a clinician, that pathway plan may be utilized by a navigation system to drive a catheter or catheter like device along the pathway plan through the anatomy to reach the desired target. The driving of the catheter along the pathway plan may be manual or it may be robotic, or a combination of both. Manual systems include the ILLUMISITE navigation system sold by Medtronic PLC, robotic systems include the ION system sold by Intuitive Surgical Inc. and the MONARCH system sold by Auris Health, Inc. In a single procedure planning, registration of the pathway plan to the patient, and navigation are performed to enable a medical device, e.g., a catheter to be navigated along the planned path to reach a target, e.g., a lesion, so that a biopsy or treatment of the target can be completed.
One aspect of the system 100 is a software component for reviewing of computed tomography (CT) image scan data that has been acquired separately from system 100. The review of the CT image data allows a user to identify one or more targets, plan a pathway to an identified target (planning phase), navigate a catheter 102 to the target (navigation phase) using a user interface on computing device 122, and confirming placement of a sensor 104 relative to the target. The target may be tissue of interest identified by review of the CT image data during the planning phase. Following navigation, a medical device, such as a biopsy tool or other tool, may be inserted into catheter 102 to obtain a tissue sample from the tissue located at, or proximate to, the target.
As shown in
System 100 generally includes an operating table 112 configured to support a patient P, a bronchoscope 108 configured for insertion through patient P's mouth into patient P's airways; monitoring equipment 114 coupled to bronchoscope 108 or catheter 102 (e.g., a video display, for displaying the video images received from the video imaging system of bronchoscope 108 or the catheter 102); a locating or tracking system 114 including a locating module 116, a plurality of reference sensors 18 and a transmitter mat 120 including a plurality of incorporated markers; and a computing device 122 including software and/or hardware used to facilitate identification of a target, pathway planning to the target, navigation of a medical device to the target, and/or confirmation and/or determination of placement of catheter 102, or a suitable device therethrough, relative to the target.
In accordance with aspects of the disclosure, the visualization of intra-body navigation of a medical device, e.g., a biopsy tool, towards a target, e.g., a lesion, may be a portion of a larger workflow of a navigation system. A fluoroscopic imaging device 124 capable of acquiring fluoroscopic or x-ray images or video of the patient P is also included in this particular aspect of system 100. The images, sequence of images, or video captured by fluoroscopic imaging device 124 may be stored within fluoroscopic imaging device 124 or transmitted to computing device 122 for storage, processing, and display. Additionally, fluoroscopic imaging device 124 may move relative to the patient P so that images may be acquired from different angles or perspectives relative to patient P to create a sequence of fluoroscopic images, such as a fluoroscopic video. The pose of fluoroscopic imaging device 124 relative to patient P while capturing the images may be estimated via markers incorporated with the transmitter mat 120. The markers are positioned under patient P, between patient P and operating table 112 and between patient P and a radiation source or a sensing unit of fluoroscopic imaging device 124. The markers incorporated with the transmitter mat 120 may be two separate elements which may be coupled in a fixed manner or alternatively may be manufactured as a single unit. Fluoroscopic imaging device 124 may include a single imaging device or more than one imaging device.
Computing device 122 may be any suitable computing device including a processor and storage medium, wherein the processor is capable of executing instructions stored on the storage medium. Computing device 122 may further include a database configured to store patient data, CT data sets including CT images, fluoroscopic data sets including fluoroscopic images and video, fluoroscopic 3D reconstruction, navigation plans, and any other such data. Although not explicitly illustrated, computing device 122 may include inputs, or may otherwise be configured to receive, CT data sets, fluoroscopic images/video and other data described herein. Additionally, computing device 122 includes a display configured to display graphical user interfaces. Computing device 122 may be connected to one or more networks through which one or more databases may be accessed.
With respect to a planning phase, computing device 122 utilizes previously acquired CT or MM image data for generating and viewing a three-dimensional model or rendering of patient P's airways, enables the identification of a target on the three-dimensional model (automatically, semi-automatically, or manually), and allows for determining a pathway through patient P's airways to tissue located at and around the target. More specifically, CT images acquired from previous CT or MM scans are processed and assembled into a three-dimensional volume, which is then utilized to generate a three-dimensional model of patient P's airways. The three-dimensional model may be displayed on a display associated with computing device 122, or in any other suitable fashion. Using computing device 122, various views of the three-dimensional model or enhanced two-dimensional images generated from the three-dimensional model are presented. The enhanced two-dimensional images may possess some three-dimensional capabilities because they are generated from three-dimensional data. The three-dimensional model may be manipulated to facilitate identification of target on the three-dimensional model or two-dimensional images, and selection of a suitable pathway through patient P's airways to access tissue located at the target can be made. Once selected, the pathway plan, three-dimensional model, and images derived therefrom, can be saved and exported to a navigation system for use during the navigation phase(s).
With respect to the navigation phase, a six degrees-of-freedom electromagnetic locating or tracking system 114, or other suitable system for determining position and orientation of a distal portion of the catheter 102, is utilized for performing registration of the images and the pathway for navigation. Tracking system 114 includes the tracking module 116, a plurality of reference sensors 118, and the transmitter mat 120 (including the markers). Tracking system 114 is configured for use with a locatable guide 110 and particularly sensor 104. As described above, locatable guide 110 and sensor 104 are configured for insertion through catheter 102 into patient P's airways (either with or without bronchoscope 108) and are selectively lockable relative to one another via a locking mechanism.
Transmitter mat 120 is positioned beneath patient P. Transmitter mat 120 generates an electromagnetic field around at least a portion of the patient P within which the position of a plurality of reference sensors 118 and the sensor 104 can be determined with use of a tracking module 116. 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 degree-of-freedom sensor or a six degree-of-freedom sensor. One or more of reference sensors 118 are attached to the chest of the patient P. Registration is generally performed to coordinate locations of the three-dimensional model and two-dimensional images from the planning phase, with the patient P's airways as observed through the bronchoscope 108, and allow for the navigation phase to be undertaken with knowledge of the location of the sensor 104.
Registration of the patient P's location on the transmitter mat 120 may be performed by moving sensor 104 through the airways of the patient P. More specifically, data pertaining to locations of sensor 104, while locatable guide 110 is moving through the airways, is recorded using transmitter mat 120, reference sensors 118, and tracking system 114. A shape resulting from this location data is compared to an interior geometry of passages of the three-dimensional model generated in the planning phase, and a location correlation between the shape and the three-dimensional model based on the comparison is determined, e.g., utilizing the software on computing device 122. In addition, the software identifies non-tissue space (e.g., air filled cavities) in the three-dimensional model. The software aligns, or registers, an image representing a location of sensor 104 with the three-dimensional model and/or two-dimensional images generated from the three-dimension model, which are based on the recorded location data and an assumption that locatable guide 110 remains located in non-tissue space in patient P's airways. Alternatively, a manual registration technique may be employed by navigating the bronchoscope 108 with the sensor 104 to pre-specified locations in the lungs of the patient P, and manually correlating the images from the bronchoscope to the model data of the three-dimensional model.
Though described herein with respect to EMN systems using EM sensors, the instant disclosure is not so limited and may be used in conjunction with flexible sensor, ultrasonic sensors, or without sensors. Additionally, the methods described herein may be used in conjunction with robotic systems such that robotic actuators drive the catheter 102 or bronchoscope 108 proximate the target.
In accordance with the disclosure, the catheter 102 and its articulation and orientation relative to a target is achieved using a catheter drive mechanism 300. One example of such a drive mechanism can be seen in
As noted above,
An electric motor 314R, may include an encoder for converting mechanical motion into electrical signals and providing feedback to the computing device 122. Further, the electric motor 314R (R indicates this motor if for inducing rotation of the catheter 102) may include an optional gear box for increasing or reducing the rotational speed of an attached spur gear 315 mounted on a shaft driven by the electric motor 314R. Electric motors 314LR (LR referring to left-right movement of an articulating portion 317 of the catheter 102) and 314UD (referring to up-down movement of the articulating portion 317), each motor optionally includes an encoder and a gearbox. Respective spur gears 316 and 318 drive up-down and left-right steering cables, as will be described in greater detail below. All three electric motors 314 R, LR, and UD are securely attached to the stationary frame 302, to prevent their rotation and enable the spur gears 315, 316, and 318 to be driven by the electric motors.
To accomplish up-down articulation of the articulating portion 317 of the catheter 102, steering cables 319a-b may be employed. The distal ends of the steering cables 319a-b are attached to, or at, or near the distal end of the catheter 102. The proximal ends of the steering cables 319a-b are attached to the distal tips of the posts 320a, and 320b. As shown in
The opposing posts 320a and 320b have internal left-handed and right-handed threads, respectively, at least at their proximal ends. As shown in
To articulate the catheter in the upwards direction, a clinician may activate via an activation switch (not shown) for the electric motor 314UD causing it to rotate the spur gear 318, which in turn drives the planetary gear 326. The planetary gear 326 is connected through the internal gears 324a and 324b to the shafts 322a and 322b. The planetary gear 326 will cause the gears 324a and 324b to rotate in the same direction. The shafts 322a and 322b are threaded, and their rotation is transferred by mating threads formed on the inside of posts 320a and 320b into linear motion of the posts 320a and 320b. However, because the internal threads of post 320a are opposite that of post 320b, one post will travel distally and one will travel proximally (i.e., in opposite directions) upon rotation of the planetary gear 326. Thus, the upper cable 319a is pulled proximally to lift the catheter 102, while the lower cable 319b must be relaxed. As stated above, this same system can be used to control left-right movement of the end effector, using the electric motor 314LR, its spur gear 316, a second planetary gear (not shown), and a second set of threaded shafts 322 and posts 320 and two more steering cables 319. Moreover, by acting in unison, a system employing four steering cables can approximate the movements of the human wrist by having the three electric motors 314 and their associated gearing and steering cables 319 computer controlled by the computing device 122.
Though generally described above with respect to receiving manual inputs from a clinician as might be the case where the drive mechanism is part of a hand-held catheter system, the disclosure is not so limited. In a further embodiment, the drive mechanism 300 is part of a robotic system for navigating the catheter 102 to a desired location within the body. In accordance with this disclosure, in instances where the drive mechanism is part of a robotic catheter drive system, the position of the distal portion of the catheter 102 may be robotically controlled.
The drive mechanism may receive inputs from computing device 122 or another mechanism through which the surgeon specifies the desired action of the catheter 102. Where the clinician controls the movement of the catheter 102, this control may be enabled by a directional button, a joystick such as a thumb operated joystick, a toggle, a pressure sensor, a switch, a trackball, a dial, an optical sensor, and any combination thereof. The computing device responds to the user commands by sending control signals to the motors 314. The encoders of the motors 314 provide feedback to the control unit 24 about the current status of the motors 314.
In accordance with the disclosure, and as outlined in greater detail below, the drive mechanism 300 receives signals derived by the computing device 122 to drive the catheter 102 (e.g., extend and retract pull-wires) to maintain the orientation of the distal tip of the catheter 102 despite extension of a tool such as a biopsy needle or ablation catheter or movements caused by respiration and cardiac cycles.
As described in connection with
Following planning, registration, and then navigation of a catheter 102 proximate the target, a user interface (UI) 200 on computing device 122 may depict an image as seen in
Accordingly, a local registration process operating on computing device 122 may be employed. In accordance with the local registration process, once catheter 102 has been successfully navigated proximate, as shown in
Next at step 410 the target needs to be identified in the fluoroscopic 3D reconstruction. In one example, the clinician will be asked to mark the target in two different perspectives of the 3D reconstruction. At step 412, the entire fluoroscopic 3D reconstruction may be viewed to ensure that the target remains within an identified location, such as a circle placed on the target throughout the fluoroscopic 3D reconstruction. At step 414 the local registration can be accepted. At step 416 the relative position of the virtual catheter 202 in the 3D model relative to the virtual target 204 is updated to display the actual current relative position of the end of the catheter 102 and the target calculated by the local registration process 400. By the local registration process the offset between the location of the target and the tip of the catheter 102 is determined as they are observed in the fluoroscopic 3D reconstruction. The offset is utilized, via computing device 122, to correct any errors in the original registration process and minimize any CT-to-body divergence. As a result, the location and or orientation of the navigation catheter on the GUI with respect to the target is updated. At this point the clinician has a high degree of confidence in the position of the catheter 102 relative to the target as displayed in the UI 200.
By the process described above the relative positions of the catheter 102 and the target are marked in the 3D fluoroscopic reconstruction and the offset determined. In addition, the position of the catheter 102 is always being sensed either in the EM field to provide EM coordinates of its position, or in robotic coordinates if a robot is employed. The offset can then be used to update the position of the virtual distal tip 202 in UI 200 relative to the virtual target 204. Thus improving the registration and providing a clearer indication of the relative positions of the virtual distal tip 202 and virtual target 204, that more closely depicts the actual relative positions of the distal tip of the catheter 102 and the target in the patient.
While far improved, the local registration process 400 does not account for movement of the catheter 102 or the target caused by respiration or heartbeat. Further, after the local registration process, the clinician or robot will typically remove the LG 110 with sensor 104 from the catheter 102 and insert a medical device in the catheter 102 and advance the medical device towards the target. As will be appreciated, in addition to the effects of respiration and heartbeat the relative positions of the catheter 102 and the target can be affected by the removal of the LG and the insertion of other tools. Thus, while the local registration is an improvement and overcomes the CT to body divergence, it is necessarily a static update to the relative positions of the catheter 102 and the target.
As noted above, maintaining distal tip location and orientation to the target is difficult as the patient's body is moving due to pulmonary and cardiac activity along with muscle motion and disturbances cause by external forces such as the surgical staff moving the patient. Additional motion can be caused by motion of equipment around the patient such as surgical bed or anesthesia tube motion. These motions cause external forces that can alter the amount of distal tip articulation of the catheter 102, cause the catheter 102 to move forward or backward, or impart rotational forces on the catheter 102. If the catheter 102 is used as a tool to interact with the target location such as a lesion or is used to deploy a tool through a lumen in the catheter, the target anatomy can distort or move due to pressure from the tool deployment. As an example, deployment of a needle to perform biopsy on a lesion adjacent to a bronchial tube can result in movement of the catheter 102. The action of the needle perforating the stiffer, cartilage-like airway can distort the softer lung tissue behind causing both the lesion and the catheter 102 to move and the needle miss. Thus, the 3D model and the sensed position of the catheter 102, as depicted in
A further aspect of the disclosure is directed to the use of an inertial measurement unit (IMU) within catheter 102. For some of these applications the IMU 328 may be configured as a small microchip measuring as little as 2 mm×2 mm in size and less than 1 mm in thickness. As will be appreciated, such a small size makes IMUS very useful in medical navigation applications in accordance with the disclosure. However, other size devices may be employed without departing from the scope of the disclosure.
An IMU 328 is a sensor typically including one or more accelerometers, and one or more gyroscopes. Additionally, an IMU 328 may include one or more of a magnetometer, a pressure sensor, and other types of sensors. An IMU 328 provides individual velocity and acceleration measurements in the X, Y, and Z directions as well as roll about the X, Y, and Z axes. Using trigonometric operations, these measurements can be converted into a directional vector showing which way the IMU 238 is moving. Combining two vectors allows for calculation of distance traveled. While the effects of gravity need to be compensated for at all times, the gravity vector can be used to identify the orientation of the sensor. Identification of the orientation of the IMU 328 provides an indication of the orientation of the catheter 102. Thus, this in addition to using the local registration process 400 to determine the location of the distal portion of the catheter 102 relative to the target, the IMU 328 can be utilized to determine an orientation of the distal tip of the catheter 102.
A further aspect of the use of an IMU 328 is that its movement can be tracked throughout its navigation through the luminal network. As such, the effects of physiological forces from respiration and cardiac function can be detected and isolated from the overall movement of the catheter 102. In a sense, the IMU 328 can act as both a respiration rate monitor and a heart rate monitor. In some instances, this may require a pause to the navigation process to allow for collection of movement data while the catheter 102 is not otherwise being moved.
With collection of the physiological data such as heart rate and respiration rate, the movement of the distal portion of the catheter 102 caused by these physiological functions can be determined and tracked by the application running on computing device 122. Tracking can occur throughout the navigation process and the estimates of the movement caused by each force applied to the catheter 102 (e.g. motor force, hand manipulation, tissue responsive forces, and physiological forces) can be calculated and updated throughout navigation. And once proximate a target, as depicted in
As will be understood by those of skill in the art, even with motorized control as depicted in
A further aspect of the disclosure is directed to a method of addressing the above-identified shortcoming of prior catheter navigation systems. As described above, the method 600 may optionally start at step 602 with navigating a catheter 102 into a luminal network of a patient. This navigation may be manual or robotically driven and may follow a pre-planned pathway through a 3D model derived from pre-procedure images such as CT images. Further, prior to the onset of navigation the 3D model may be registered to the patient as described above. Those of skill in the art will recognize that method 600 may also begin after navigation and commence with step 604 wherein IMU 328 associated with the catheter 102 collects data related to movement of the catheter. This data regarding movement of the catheter 102, and particularly the IMU 328 enables determination of both respiration and heart rate data and the movements caused by the physiological forces. As an optional step 606, a UI on a display of computing device 122 may prompt the user to “Stop movement” of the catheter 102, allowing the IMU to collect just the physiological movement data (e.g., that caused by heartrate, breathing, and other internal muscular contractions of the patient).
After reaching a desired proximity to a target 508 at step 608, for example between 2 and 5 CM from the target for example based on detection of the position of the catheter via the EM sensor 104, a fluoroscopic sweep is acquired of the end of the catheter 102 and the target 508 at step 610. Following the process described above, the end of the catheter 102 and the target 508 are marked in images derived from the fluoroscopic sweep at step 612. At step 614 the orientation of the distal tip of the catheter 102 is determined based on the data received from the IMU 328. At step 616 the application determines whether the orientation of the distal tip of the catheter 102 is such that a vector perpendicular to a plane 502 defined by the opening 504 in the distal tip is pointed at the target 508. If the answer is no, at step 618 the application running on computing device 122 can signal the motors 314 to adjust the articulation of the catheter 102 to achieve the correct orientation based a 3D angle between the vector 506 that does not intersect the target 508 and a vector 510 that would intersect the target 508. As an alternative the computing device 122 may provide an output in a UI on a display of the computing device of the movement necessary to achieve an orientation of the opening 504 such that the vector traverses the target. If the answer is yes, the method proceeds to step 620, where the movement data collected by the IMU relating the heart rate and respiration (as well as other muscle movements) is utilized by the application to provide drive signals to the motors 314 of the catheter 102 to maintain the orientation of the opening 504 relative to the target.
At step 622, if other operations are undertaken such as removal of the LG or insertion of a biopsy needle, the position and orientation of the catheter 102 is maintained by the application running on computing device 122. The IMU 328 outputs signals relating to its orientation which is associated with the orientation of the plane 502 at the of opening 504 of the catheter 102. When movement of the IMU 328 is detected, based on these user activities the application running on the computing device 122 generates signals to the motors 314 to adjust the shape of the distal portion of the catheter 102 to correct any change in orientation relative to the target.
Further, as part of step 622 the movements of the catheter 102 and particularly the IMU 328 caused by respiration and heartbeat can be detected. Because these are highly cyclical and repeated movements the application running on the computing device and generate signals which are sent to the motors 314 to adjustment the position of the distal portion of the catheter 102 such that opening 504 remains oriented at the target 500 throughout the cardiac and respiratory cycles.
The maintaining of the orientation of the distal end of the catheter 102 may be occur automatically, with drive signals being generated by computing device 122 and delivered to the motors 314 to counteract the movements of the distal tip of the catheter 102. Alternatively, the movement of the distal portion of the catheter 102 can be manually controlled either via switches, levers, or a wheel associated with the motors 314 to achieve the desired orientation of the opening 504 towards the catheter. The need for, the magnitude and the direction of these movements may be presented on a UI 200.
Whether manually initiated or controlled or partially controlled via computing device 122 the amount and speed of the movements the catheter 102 caused by the motors 314 can be gated based on the proximity to the target. Thus, when navigating the central airways or larger lumens larger movements of the end of the catheter 102 are possible. As the catheter 102 approaches a target 500, particularly a target located closer to the periphery of the lung or other bodily organ, the range of available movements of the distal portion of the catheter 102 may be reduced. This reduction can increase the safety of the movements particularly in the periphery of organs like the lungs. The determination of proximity of these locations may be based on the tracking system 114 employing the EM sensor 104 or a shape sensor, as described above.
Similarly, the amount of drift or error in orientation of the opening 504 in the catheter 104 towards the target 500 can be adjusted as desired by the user or to the limits of the processing power and speed of the computing device 122. Where a user desires continual movement of the catheter 102 to confirm orientation the amount of acceptable drift can be reduced. Alternatively, if fewer movements are desired, for example due to the tissue being navigated, the acceptable drift can be increased, and the signals will be sent from the computing deice 122 to the motors 314 less frequently.
Still further, because of the cyclical nature of these physiological forces, the application running on the computing device can anticipated the application of forces on the catheter 102 and begin application of compensating signals at a timing to ensure proper orientation at all times.
In one embodiment, the representations of the virtual catheter tip 202 and target 204 can be seen to move in the images displayed in the UI 200 in concert with the physiological signals. The images may be live fluoroscopic images, 3D model images from the pre-procedure imaging and pathway plan, or other imaging modalities. In an embodiment where the UI 200 displays 3D model images the viewer is afforded a virtual image of the reality of the movements occurring within the patient. In the UI 200 in this embodiment the distal portion of the virtual catheter tip 202 may be seen to flex to maintain the orientation towards the virtual target 204.
In a further embodiment, the UI 200 may include an indicator. For example, a portion of the UI 200 may have a portion which either changes brightness or changes color (e.g., from red to yellow to green). Alternatively, movements caused by respiration and cardiac function can be graphed over time, and portions of the graph may include a color indicator or include a color band. The indicator can be timed relative to the cardiac and respiratory forces applied to the catheter 102. Despite the articulation of the catheter 102 to maintain the orientation of the opening 504 towards the target 500, in some circumstances either the user may find it desirable to or the application running on computing device 122 can be configured to limit the timing of the use of tools to only those portions of the cyclical movement caused by the physiological forces that correspond to the approximate timing in the respiratory and cardiac cycle of when the fluoroscopic images were acquired. By performing this gating, a further confirmation that despite the movement of the target and the catheter 102, and even though the IMU 328 has been utilized to articulate the catheter 102, the catheter 102 and the target at these portions of the cardiac and respiratory cycle are now substantially at the same locations (e.g., in the same phase of the cardiac and respiratory cycle) as when the original orientation confirmation was acquired.
In a further aspect of the disclosure, the imaging system for identification of the catheter 102 and the target could be an ultrasound system, computed tomography (CT) system, cone beam CT system, MRI system or another capable system of imaging both the catheter 102 and the target simultaneously. Further, though described herein as occurring just once, the external imaging (e.g., fluoroscopy, ultrasound,) may be repeated at intervals during the procedure to ensure continued orientation of the catheter tip and the target. Still further, thought described herein as being identified by a user viewing the fluoroscopic or ultrasound images to determine the location and orientation of the catheter 102 relative to the target and the location of the target, these systems and methods described herein may additionally or alternatively employ automatic identification methods. Such automatic methods may use image processing software to automatically identify the distal tip and its orientation from the imaging system output.
Still further, in embodiments of the disclosure the maintaining of orientation of the distal tip of the catheter 102 and the target is a feature that can be turned on and off by the user or automatically whenever the catheter is greater than a preset distance from the target. Still further, the UI 200 may include an indicator to alert the user if the orientation lock between the catheter 102 and the target is ever lost. Such a feature may also indicate that the external imaging needed to be renewed so that the method 600 can be started a new. As will be appreciated, this orientation lock may be turned may be selectively turned on or off as desired by the user or by the application running on computing device 120.
Reference is now made to
Application 718 may further include a user interface 716. Image data 714 may include the CT scans, the generated fluoroscopic 3D reconstructions of the target area and/or any other fluoroscopic image data and/or the generated one or more slices of the 3D reconstruction. Processor 704 may be coupled with memory 702, display 706, input device 710, output module 712, network interface 708 and imaging device 715. Workstation 701 may be a stationary computing device, such as a personal computer, or a portable computing device such as a tablet computer. Workstation 701 may embed a plurality of computer devices.
Memory 702 may include any non-transitory computer-readable storage media for storing data and/or software including instructions that are executable by processor 704 and which control the operation of workstation 701 and, in some embodiments, may also control the operation of imaging device 715. Imaging device 715 may be used to capture a sequence of fluoroscopic images based on which the fluoroscopic 3D reconstruction is generated and to capture a live 2D fluoroscopic view according to this disclosure. In an embodiment, memory 702 may include one or more storage devices such as solid-state storage devices, e.g., flash memory chips. Alternatively, or in addition to the one or more solid-state storage devices, memory 702 may include one or more mass storage devices connected to the processor 704 through a mass storage controller (not shown) and a communications bus (not shown).
Although the description of computer-readable media contained herein refers to solid-state storage, it should be appreciated by those skilled in the art that computer-readable storage media can be any available media that can be accessed by the processor 704. That is, computer readable storage media may include non-transitory, volatile and non-volatile, removable and non-removable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules or other data. For example, computer-readable storage media may include RAM, ROM, EPROM, EEPROM, flash memory or other solid-state memory technology, CD-ROM, DVD, Blu-Ray or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which may be used to store the desired information, and which may be accessed by workstation 1001.
Application 718 may, when executed by processor 704, cause display 706 to present user interface 716. User interface 716 may be configured to present to the user a single screen including a three-dimensional (3D) view of a 3D model of a target from the perspective of a tip of a medical device, a live two-dimensional (2D) fluoroscopic view showing the medical device, and a target mark, which corresponds to the 3D model of the target, overlaid on the live 2D fluoroscopic view. An example of the user interface 716 is shown, for example, in
Network interface 708 may be configured to connect to a network such as a local area network (LAN) consisting of a wired network and/or a wireless network, a wide area network (WAN), a wireless mobile network, a Bluetooth network, and/or the Internet. Network interface 708 may be used to connect between workstation 701 and imaging device 715. Network interface 708 may be also used to receive image data 714. Input device 710 may be any device by which a user may interact with workstation 701, such as, for example, a mouse, keyboard, foot pedal, touch screen, and/or voice interface. Output module 712 may include any connectivity port or bus, such as, for example, parallel ports, serial ports, universal serial busses (USB), or any other similar connectivity port known to those skilled in the art. From the foregoing and with reference to the various figures, those skilled in the art will appreciate that certain modifications can be made to the disclosure without departing from the scope of the disclosure.
While detailed embodiments are disclosed herein, the disclosed embodiments are merely examples of the disclosure, which may be embodied in various forms and aspects. For example, embodiments of an electromagnetic navigation system, which incorporates the target overlay systems and methods, are disclosed herein; however, the target overlay systems and methods may be applied to other navigation or tracking systems or methods known to those skilled in the art. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the disclosure in virtually any appropriately detailed structure.
This application is a continuation of U.S. patent application Ser. No. 17/307,790, filed on May 4, 2021, which claims the benefit of and priority to U.S. Provisional Patent Application No. 63/034,501, filed on Jun. 4, 2020, the entire disclosure of each of which is incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 63034501 | Jun 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17307790 | May 2021 | US |
| Child | 18206913 | US |
