EP4601579A1 - Systems and methods for confirming position or orientation of medical device relative to target - Google Patents
Systems and methods for confirming position or orientation of medical device relative to targetInfo
- Publication number
- EP4601579A1 EP4601579A1 EP23789783.0A EP23789783A EP4601579A1 EP 4601579 A1 EP4601579 A1 EP 4601579A1 EP 23789783 A EP23789783 A EP 23789783A EP 4601579 A1 EP4601579 A1 EP 4601579A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- target
- medical device
- tip
- processor
- images
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/25—User interfaces for surgical systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00809—Lung operations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
- A61B2034/107—Visualisation of planned trajectories or target regions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2046—Tracking techniques
- A61B2034/2048—Tracking techniques using an accelerometer or inertia sensor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2046—Tracking techniques
- A61B2034/2051—Electromagnetic tracking systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2072—Reference field transducer attached to an instrument or patient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/25—User interfaces for surgical systems
- A61B2034/252—User interfaces for surgical systems indicating steps of a surgical procedure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/25—User interfaces for surgical systems
- A61B2034/254—User interfaces for surgical systems being adapted depending on the stage of the surgical procedure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/36—Image-producing devices or illumination devices not otherwise provided for
- A61B2090/364—Correlation of different images or relation of image positions in respect to the body
- A61B2090/367—Correlation of different images or relation of image positions in respect to the body creating a 3D dataset from 2D images using position information
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/36—Image-producing devices or illumination devices not otherwise provided for
- A61B90/37—Surgical systems with images on a monitor during operation
- A61B2090/376—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/36—Image-producing devices or illumination devices not otherwise provided for
- A61B90/37—Surgical systems with images on a monitor during operation
- A61B2090/376—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy
- A61B2090/3762—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy using computed tomography systems [CT]
- A61B2090/3764—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy using computed tomography systems [CT] with a rotating C-arm having a cone beam emitting source
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
- A61B2090/3966—Radiopaque markers visible in an X-ray image
Definitions
- Imaging modalities such as magnetic resonance imaging, ultrasound imaging, computed tomography (CT), as well as others are employed by clinicians to identify areas of interest within a patient and ultimately targets for treatment.
- CT computed tomography
- 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.
- endobronchial navigation systems have been developed that use previously acquired MRI data or CT image data to generate a three dimensional rendering or volume of the particular body part such as the lungs.
- previously acquired images acquired from an MRI scan or CT scan of the patient, are utilized to generate a three dimensional or volumetric rendering of the particular body part of the patient.
- the resulting volume generated from the MRI scan or CT scan is then utilized to create a navigation plan to facilitate the advancement of a navigation catheter (or other suitable device) through a bronchoscope and a branch of the bronchus of a patient to an area of interest.
- Electromagnetic tracking may be utilized in conjunction with the CT data to facilitate guidance of the navigation catheter through the branch of the bronchus to the area of interest.
- the navigation catheter may be positioned within one of the airways of the branched luminal networks adjacent to, or within, the area of interest to provide access for one or more medical instruments.
- a fluoroscopic imaging device is commonly located in the operating room during navigation procedures.
- a clinician may use the standard fluoroscopic imaging device to visualize and confirm the placement of a tool after it has been navigated to a desired location.
- standard fluoroscopic images display highly dense objects such as metal tools and bones as well as large soft-tissue objects such as the heart, the fluoroscopic images have difficulty resolving small soft-tissue objects of interest such as lesions.
- the fluoroscope image is only a two dimensional projection. In order to be able to see small soft-tissue objects in three dimensional space, an X-ray volumetric reconstruction is needed.
- both the tool and the target should be visible in some sort of a three dimensional guidance system.
- a CT machine can be used with iterative scans during procedure to provide guidance through the body until the tools reach the target. This is a tedious procedure as it requires several full CT scans, a dedicated CT room and blind navigation between scans. In addition, each scan requires the staff to leave the room.
- a Cone-beam CT machine which is available in some operation rooms and is somewhat easier to operate, but is expensive and like the CT only provides blind navigation between scans, requires multiple iterations for navigation, and requires the staff to leave the room.
- the techniques of this disclosure generally relate to systems and methods for confirming whether a medical device is inside and/or aligned with a target using intraoperative imaging while the medical device is at or near a target.
- the disclosure provides a system including a computer system having a processor and a display that displays a graphical user interface.
- the computer system also has a computer readable storage medium storing thereon instructions that when executed by the processor cause the processor to receive a sequence of intraoperative X-ray images.
- Each intraoperative X-ray image includes at least a portion of a medical device and a target.
- the instructions when executed by the processor, also cause the processor to receive a marking of a tip of the medical device in at least two of the sequence of intraoperative X-ray images and construct a three-dimensional (3D) reconstruction based on the sequence of intraoperative X-ray images and the markings of the tip of the medical device, the 3D reconstruction including the medical device and the target.
- the instructions, when executed by the processor also cause the processor to display a slice of the 3D reconstruction passing through the tip of the medical device, determine a position of the target in the 3D reconstruction; and present feedback on the position of the tip of the medical device relative to the target.
- Implementations of the system may also include one or more of the following features.
- the instructions, when executed by the processor may cause the processor to augment the marking of the target or the marking of the medical device to show that the medical device is inside or outside the target.
- the instructions, when executed by the processor may cause the processor to present a message indicating that the medical device is inside or outside the target.
- the instructions, when executed by the processor may cause the processor to determine that the tip of the medical device is outside of the target, in response to determining that the tip of the medical device is outside of the target, determine whether the tip of the medical device is aligned with the target, and present a message indicating whether the tip of the medical device is aligned with the target.
- the instructions when executed by the processor, may cause the processor to determine that the tip of the medical device is outside of the target, in response to determining that the tip of the medical device is outside of the target, determine a distance of the tip of the medical device from the target or the position of the tip of the medical device relative to the target, and present a message indicating the distance of the tip of the medical device from the target or the position of the tip of the medical device relative to the target.
- the instructions when executed by the processor, may cause the processor to receive preoperative computed tomography (CT) images of the target, construct a 3D model of the target based on the preoperative CT images, and overlay the 3D model of the target on the 3D reconstruction.
- CT computed tomography
- the instructions when executed by the processor, may cause the processor to register the preoperative CT images with the 3D reconstruction, determine a position of the target in the 3D reconstruction based on the registering yielding a determined position of the target, and overlay the 3D model of the target on the 3D reconstruction based on the determined position of the target.
- the instructions when executed by the processor, may cause the processor to construct a 3D model of the medical device based on the sequence of intraoperative X-ray images, and overlay the 3D model of the medical device on the 3D reconstruction.
- the instructions when executed by the processor, may cause the processor to receive preoperative computed tomography (CT) images of the target; segment the target from the preoperative CT images, yielding a segmented target, and overlay the segmented target on the 3D reconstruction.
- CT computed tomography
- the instructions when executed by the processor, may cause the processor to receive preoperative computed tomography (CT) images of a lung, receive at least one marking of the target on the preoperative CT images, and overlay the at least one marking of the target on the 3D reconstruction.
- CT computed tomography
- the at least one marking of the target may represent a size or a shape of the target.
- the sequence of intraoperative X-ray images may be fluoroscopic images or cone beam CT images.
- the medical device may not include a position sensor.
- the medical device may be a biopsy tool.
- the disclosure provides a method.
- the method includes receiving a sequence of intraoperative X-ray images, receiving a marking of a tip of a medical device in at least two of the sequence of intraoperative X-ray images, and generating a three-dimensional (3D) reconstruction based on the sequence of intraoperative X-ray images and the markings of the tip of the medical device.
- the 3D reconstruction includes the at least a portion of the medical device and a target.
- the method also includes displaying a slice of the 3D reconstruction passing through the tip of the medical device, determining a position of the target in the 3D reconstruction, and presenting feedback on the position of the tip of the medical device relative to the target.
- Implementations of the method may also include one or more of the following features.
- the method may include augmenting the marking of the target or the marking of the medical device to show that the medical device is inside or outside the target.
- the method may include presenting a message indicating that the medical device is inside or outside the target.
- the method may include determining that the tip of the medical device is outside of the target, determining that the tip of the medical device is aligned with the target in response to determining that the tip of the medical device is outside of the target, determining a distance of the tip of the medical device from the target in response to determining that the tip of the medical device is aligned with the target, and presenting a message indicating that the tip of the medical device is aligned with the target and the distance of the tip of the medical device from the target.
- the method may include determining that the tip of the medical device is outside of the target, determining that the tip of the medical device is not aligned with the target in response to determining that the tip of the medical device is outside of the target, determining the position of the tip of the medical device relative to the target in response to determining that the tip of the medical device is not aligned with the target, and presenting a message indicating that the tip of the medical device is not aligned with the target and the position of the tip of the medical device relative to the target.
- the disclosure provides another system including a computer system having a processor and a display that display a graphical user interface.
- the computer system also has a computer readable storage medium storing thereon instructions that when executed by the processor cause the processor to receive a sequence of intraoperative X-ray images from an X-ray imaging device.
- Each intraoperative X-ray image includes at least a portion of a medical device and a target.
- the instructions when executed by the processor, also cause the processor to estimate a pose of the X-ray imaging device based on the sequence of intraoperative X-ray images yielding an estimated pose and generate a three-dimensional (3D) volume based on the sequence of intraoperative X-ray images and the estimated pose.
- the 3D volume includes the at least a portion of the medical device and the target.
- the instructions when executed by the processor, also cause the processor to display a slice of the 3D volume, from which a user starts a search for a tip of the medical device and the target in the slices of the 3D volume, receive position information of a scroll control object, and display other slices of the 3D volume corresponding to the position information.
- FIG. 1 is a perspective view of one illustrative example of an electromagnetic navigation (EMN) system incorporating a fluoroscopic imaging device in accordance with the disclosure
- FIG. 2A is a diagram that illustrates a user interface showing a slice of a fluoroscopic 3D reconstruction centered at the target;
- FIG. 2B is a diagram that illustrates a user interface showing a slice of the fluoroscopic 3D reconstruction centered at the tip of the medical device;
- FIGS. 3 and 4 are flowcharts that illustrate methods of visualizing the relationship between a medical device’s tip and a target;
- FIG. 5 is a diagram that illustrates a user interface for marking a medical device’s tip in fluoroscopic images of a portion of a lung;
- FIG. 6 is a diagram that illustrates a user interface for displaying a reconstructed volume and marking the target
- FIG. 7 is a diagram that illustrates a user interface for displaying an example of an augmentation to the marking of the medical device’s tip;
- FIG. 8 is a flowchart that illustrates another method of visualizing the relationship between a medical device’s tip and a target;
- FIG. 9 is a diagram that illustrates a user interface for providing textual feedback to a user while displaying a reconstructed volume in accordance with the method of FIG. 8;
- FIGS. 10A-10H are diagrams that illustrate other examples of user interfaces that implement aspects of the methods described herein.
- FIG. 11 is a diagram that illustrates a system configured for use with the methods of the disclosure. DETAILED DESCRIPTION
- a fluoroscopic three dimensional reconstruction or volume may be generated from two dimensional fluoroscopic images using limited angle tomosynthesis and displayed to help the clinician align the medical device with the target or confirm that the tip of the medical device is within the target.
- AP Anterior-Posterior
- the scattering makes it challenging to determine visually if the tip of the medical device (e.g., a biopsy tool) is inside the target (e.g., a lesion), above the target, or below the target.
- the 3D visualization of the target may significantly deteriorate in a case of a biopsy procedure that leads to local bleeding and atelectasis.
- FIGS. 2A and 2B illustrate the challenge of understanding whether a medical device is above or below a target by scrolling through slices of a fluoroscopic 3D reconstruction.
- FIG. 2A shows a slice of the fluoroscopic 3D reconstruction centered at the target and
- FIG. 2B shows a slice of the fluoroscopic 3D reconstruction centered at the tip of the medical device.
- the target is still visible at the slice centered at the tool’s tip.
- the tool is slightly below the target.
- This disclosure is directed to a system and method that supports the clinician in deciding whether a medical procedure (e.g., a biopsy) is performed at the correct location, by providing visual confirmation to the clinician that an end portion of a medical device (e.g., a biopsy tool) is inside or pointing towards the target.
- the confirmation may be provided via intra-operative imaging while the end portion of the medical device is in the vicinity of the target.
- the systems and methods of the disclosure are performed after navigating a medical device near a target and employ a 3D reconstruction generated based on intraoperative fluoroscopic images using limited angle tomosynthesis.
- the systems and methods of the disclosure also eliminate dependency on a locatable guide (LG) so that the medical device (e.g., biopsy tool) can be placed at a location for performing a medical procedure (e.g., a biopsy).
- LG locatable guide
- the systems and methods include performing a sweep with a fluoroscope, which yields a sequence of fluoroscopic images, reconstructing a volume based on the sequence of fluoroscopic images, displaying an initial slice from which the clinician starts a search, and identifying the target and medical device’s tip in the reconstructed volume by enabling the clinician to scroll through slices of the reconstructed volume.
- the relationship between the medical device and the target may be displayed such that the clinician can understand the relationship between the medical device and the target, e.g., that the tip of the medical device is inside or aligned with the target.
- additional visualization features are provided as feedback to the clinician.
- the markings of the target and/or medical device’s tip are augmented and/or a message or notification is provided to the clinician indicating whether the tip of the medical device is inside or outside of the target.
- the systems and methods of the disclosure estimate the orientation of the medical device’s tip, forecast where the medical device’s tip would travel if the clinician advanced the medical device along a trajectory from the current position of the medical device’s tip and aligned with the orientation of the medical device’s tip, then display the trajectory, which may also help the clinician understand if the end portion of the medical device is aligned with the target.
- FIG. 1 depicts an Electromagnetic Navigation (EMN) system 100 configured for reviewing CT image data to identify one or more targets, planning a pathway to an identified target (planning phase), navigating an extended working channel (EWC) 12 of a catheter assembly to a target (navigation phase) via a user interface, and confirming placement of the EWC 12 and a medical instrument (e.g., a biopsy tool) relative to the target.
- EWC Electromagnetic Navigation
- the target may be tissue of interest identified by review of the CT image data during the planning phase.
- a medical device such as a biopsy tool or other tool, may be inserted into the EWC 12 to obtain a tissue sample from tissue located at, or proximate to, the target.
- the EWC 12 is part of a catheter guide assembly 40.
- the EWC 12 is inserted into bronchoscope 30 for access to a luminal network of the patient P.
- the EWC 12 of catheter guide assembly 40 may be inserted into a working channel of bronchoscope 30 for navigation through a patient’s luminal network.
- a locatable guide (LG) 32, including a sensor 44 is inserted into the EWC 12 and locked into position such that the sensor 44 extends a desired distance beyond the distal tip of the EWC 12. The position and orientation of the sensor 44 relative to the reference coordinate system, and thus the distal portion of the EWC 12, within an electromagnetic field can be derived.
- Catheter guide assemblies 40 are currently marketed and sold by Medtronic PLC under the brand names superDimensionTM Procedure Kits, or EDGETM Procedure Kits, and are contemplated as useable with the disclosure.
- catheter guide assemblies 40 For a more detailed description of the catheter guide assemblies 40, reference is made to commonly-owned U.S. Patent Publication No. 2014/0046315, filed on March 15, 2013, by Ladtkow et al, U.S. Patent No. 7,233,820, and U.S. Patent No. 9,044,254, the entire contents of each of which are hereby incorporated by reference.
- the EMN system 100 generally includes an operating table 20 configured to support a patient P, a bronchoscope 30 configured for insertion through the patient’s P’s mouth into the patient’s P’s airways; monitoring equipment 120 coupled to the bronchoscope 30 (e.g., a video display, for displaying the video images received from the video imaging system of the bronchoscope 30); a tracking system 50 including a tracking module 52, a plurality of reference sensors 54 and a transmitter mat 56; and a workstation or computer system 125 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, confirmation of placement of an EWC 12, and confirmation of placement of a medical device, which extends through and out of the EWC 12, relative to the target.
- monitoring equipment 120 coupled to the bronchoscope 30
- a tracking system 50 including a tracking module 52, a plurality of reference sensors 54 and a transmitter mat 56
- a workstation or computer system 125 including software and/or hardware used
- a fluoroscopic imaging device 110 capable of acquiring fluoroscopic or x-ray images or video of the patient P is also included in this particular aspect of the system 100.
- the images, series of images, or video captured by the fluoroscopic imaging device 110 may be stored within the fluoroscopic imaging device 110 or transmitted to the computer system 125 for storage, processing, and display. Additionally, the fluoroscopic imaging device 110 may move relative to the patient P so that images may be acquired from different angles or perspectives relative to the patient P to create a fluoroscopic video.
- the fluoroscopic imaging device 110 includes an angle measurement device 111 which is configured to measure the angle of the fluoroscopic imaging device 110 relative to the patient P.
- the angle measurement device 111 may be an accelerometer.
- the fluoroscopic imaging device 110 may include a single imaging device or more than one imaging device. In the case where the fluoroscopic imaging device 110 includes multiple imaging devices, each imaging device may be a different type of imaging device or the same type. Further details regarding the fluoroscopic imaging device 110 are described in U.S. Patent No. 8,565,858, which is incorporated by reference in its entirety herein.
- the computer system 125 may be any suitable computer system including a processor and storage medium, wherein the processor is capable of executing instructions stored on the storage medium.
- the computer system 125 may further include a database configured to store patient data, CT data sets including CT images, fluoroscopic data sets including fluoroscopic images and video, navigation plans, and any other such data.
- a six degrees-of-freedom electromagnetic tracking system 50 e.g., similar to those disclosed in U.S. Patent Nos. 8,467,589, 6,188,355, and published PCT Application Nos. WO 00/10456 and WO 01/67035, the entire contents of each of which are incorporated herein by reference, or other suitable positioning measuring system, is utilized for performing registration of the images and the pathway for navigation, although other configurations are also contemplated.
- the tracking system 50 includes a tracking module 52, a plurality of reference sensors 54, and a transmitter mat 56.
- the tracking system 50 is configured for use with a locatable guide 32 and particularly the sensor 44.
- the locatable guide 32 and the sensor 44 are configured for insertion through an EWC 12 into a patient’s P’s airways (either with or without the bronchoscope 30) and are selectively lockable relative to one another via a locking mechanism.
- the transmitter mat 56 is positioned beneath patient P.
- the transmitter mat 56 generates an electromagnetic field around at least a portion of the patient P within which the position of the reference sensors 54 and the sensor 44 can be determined with use of a tracking module 52.
- One or more of the reference sensors 54 are attached to the chest of the patient P.
- the six degrees of freedom coordinates of the reference sensors 54 are sent to the computer system 125 (which includes the appropriate software) where they are used to calculate a patient coordinate frame of reference.
- the software aligns, or registers, an image representing a location of sensor 44 with a three dimensional model and two dimensional images generated from the three dimension model, which are based on the recorded location data and an assumption that locatable guide 32 remains located in non-tissue space in the patient’s P’s airways.
- a manual registration technique may be employed by navigating the bronchoscope 30 with the sensor 44 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.
- a user interface is displayed in the navigation software which shows the pathway that the clinician is to follow to reach the vicinity of the target with the tip of the EWC 12.
- One such navigation software is the superDimensionTM navigation system currently sold by Medtronic PLC.
- the locatable guide 32 may be unlocked from the EWC 12 and removed, leaving the EWC 12 in place as a guide channel for guiding medical devices including without limitation, optical systems, ultrasound probes, marker placement tools, biopsy tools, ablation tools (i.e., microwave ablation devices), laser probes, cryogenic probes, sensor probes, and aspirating needles to the target.
- medical devices including without limitation, optical systems, ultrasound probes, marker placement tools, biopsy tools, ablation tools (i.e., microwave ablation devices), laser probes, cryogenic probes, sensor probes, and aspirating needles to the target.
- the intraoperative fluoroscopic imaging may be replaced with another suitable modality of intraoperative X-ray imaging, such as intraoperative cone beam computed tomography (CBCT), which may also be referred to as C-arm CT, cone beam volume CT, flat panel CT, or Digital Volume Tomography (DVT).
- CBCT imaging involves X-ray computed tomography where the X-rays are divergent, forming a cone.
- first 2D CBCT images are acquired as a CBCT imaging device (not shown) is rotated about the patient P.
- Each first fluoroscopic image acquired by the fluoroscopic imaging device 110 may show radiopaque markers from a pattern of radiopaque markers disposed, for example, on the transmitter mat 56 under the patient P.
- a pose of the fluoroscopic imaging device 110 (e.g., a C-arm fluoroscope) is estimated for each of the first fluoroscopic images.
- the pose estimation may include generating a probability map.
- the probability map indicates the probability that each pixel of each of the first fluoroscopic images belongs to the projection of a radiopaque marker of the transmitter mat 56, which may include multiple radiopaque markers.
- the radiopaque markers may be in the form of a two-dimensional (2D) structure of markers.
- the 2D structure of markers may include multiple sphere-shaped markers arranged in a two-dimensional grid pattern.
- the probability map may be generated, for example, by feeding an image into a simple marker detector, such as a Harris corner detector, which outputs a new image of smooth densities, corresponding to the probability of each pixel belonging to a marker.
- the probability map includes pixels or densities, which correspond to markers.
- the probability map may be downscaled (i.e., reduced in size) in order to simplify the computations.
- Different candidates may be generated for the projection of the structure of markers on the image.
- the different candidates may be generated by virtually positioning the imaging device in a range of different possible poses. Possible poses of the fluoroscopic imaging device include 3D positions and orientations of the fluoroscopic imaging device. In some aspects, such a range may be limited according to the geometrical structure and/or degrees of freedom of the imaging device. For each possible pose, a virtual projection of at least a portion of the markers is generated, as if the fluoroscopic imaging device actually captured an image of the structure of markers while positioned at that pose.
- the candidate having the highest probability of being the projection of the structure of markers on the image is identified based on the image probability map.
- Each candidate i.e., a virtual projection of the structure of markers, may be overlaid or associated to the probability map.
- a probability score may be then determined or associated with each marker projection of the candidate. In some aspects, the probability score may be positive or negative, i.e., there may be a cost in case virtual markers projections falls within pixels of low probability.
- the probability scores of all of the markers’ projections of a candidate may be then summed and a total probability score may be determined for each candidate. For example, if the structure of markers were a two-dimensional grid, then the projection would have a grid form.
- Each point of the projection grid would he on at least one pixel of the probability map.
- a 2D grid candidate receives the highest probability score if its points lie on the highest density pixels, that is, if its points he on projections of the centres of the markers on the image.
- the candidate having the highest probability score may be determined as the candidate which has the highest probability of being the projection of the structure of markers on the image.
- the pose of the imaging device while capturing the image may be then estimated based on the virtual pose of the imaging device used to generate the identified candidate.
- a sequence of second fluoroscopic images or other suitable second intraoperative X-ray images is obtained from a second sweep of at least a portion of a medical device by a fluoroscopic imaging device or other suitable intraoperative X-ray imaging device (e.g., a CBCT imaging device).
- a fluoroscopic imaging device or other suitable intraoperative X-ray imaging device e.g., a CBCT imaging device
- poses of the fluoroscopic imaging device or other suitable intraoperative imaging device are estimated based on the sequence of second fluoroscopic images or other suitable second intraoperative X-ray images.
- a 3D reconstruction is generated based on the sequence of second fluoroscopic images or other suitable second intraoperative X-ray images and the estimated poses.
- the computer system 125 may execute an application that automatically segments the target to determine the position of the target.
- the segmentation may be performed using a suitable method such as a convolutional neural network (CNN).
- CNN convolutional neural network
- the feedback may include augmenting the marking of the target or the marking of the medical device to show that the medical device is inside or outside the target.
- a crosshairs symbol 704 indicating the center of the target and an ellipse, e.g., a circle 706, indicating the largest size of the target may be overlaid on the 3D reconstruction 701.
- a trajectory 708 of the tip 702 of medical device may be overlaid on the 3D reconstruction 701. The trajectory 708 may be determined based on the orientation of the medical device.
- the orientation of the medical device may be determined according to a suitable method known to a person skilled in the art. For example, the user may draw a line starting from the tip 702 of the medical device and going backward along the medical device. Then, the user’s line is used to compute the 3D orientation of the medical device.
- the orientation of the medical device may be estimated in multiple fluoroscopic 2D images. For example, the orientation of the medical device may be estimated in multiple fluoroscopic 2D images based on gradients analysis in the vicinity of the tip 702 of the medical device. Then, the 2D orientations of the medical device can be combined into a 3D orientation of the tip 702 of the medical device.
- determining the position of the tip 702 of the medical device may include estimating the position of the tip 702.
- the feedback may include presenting a message indicating that the medical device is inside or outside the target.
- FIG. 8 is a flowchart that illustrates an example of a method 800 of providing visual feedback to a user via a display.
- the method 800 determines that the tip of the medical device is outside of the target.
- the method 800 may determine that the tip of the medical device is outside of the target based on preoperative target information, which is registered to the fluoroscopic 3D reconstruction including the tip of the medical device.
- the preoperative target information may be obtained from the planning stage during which the center coordinates of the target are manually or automatically collected.
- the target information from the planning stage may be a simple ellipsoid that encapsulates the target in a preoperative CT image and that is marked by the user.
- the method 800 may include segmenting the target in the preoperative CT image to obtain a more accurate 3D representation of the target.
- the method 800 may include receiving preoperative computed tomography (CT) images of the target, constructing a 3D model of the target based on the preoperative CT images, and overlaying the 3D model of the target on the 3D reconstruction.
- the method may include registering the preoperative CT images with the 3D reconstruction, determining a position of the target in the 3D reconstruction based on the registering, yielding a determined position of the target, and overlaying the 3D model of the target on the 3D reconstruction based on the determined position of the target.
- the method 800 may include constructing a 3D model of the medical device based on the sequence of fluoroscopic images, and overlaying the 3D model of the medical device on the 3D reconstruction.
- the method 800 may include receiving preoperative computed tomography (CT) images of the target, segmenting the target from the preoperative CT images, yielding a segmented target, and overlaying the segmented target on the 3D reconstruction.
- CT computed tomography
- the method 800 may include receiving preoperative computed tomography (CT) images of a lung, receiving at least one marking of the target on the preoperative CT images, and overlaying the at least one marking of the target on the 3D reconstruction.
- the at least one marking of the target may include a shape of the target or may represent a size of the target.
- the medical device does not include a position sensor.
- FIGS. 10F shows an example of a user interface that allows a clinician to scroll through slices of the 3D reconstruction to visually identify a tool’s tip and a target.
- FIGS. 10G and 10H show another example of a user interface that augments the 3D reconstruction with representations of a target (e.g., a target sphere from planning), a tool, and a tool trajectory.
- the user interface may include user controls for rotating the augmented 3D reconstruction to visualize the tool and the tool trajectory relative to the target.
- FIG. 11 is a diagram of a system 1100 configured for use with the methods of the disclosure.
- the system 1100 may include a workstation 1101, which may be optionally connected to a fluoroscopic imaging device 110 (FIG. 1).
- the workstation 1101 may be coupled with the fluoroscope 1115, directly or indirectly, e.g., by wireless communication.
- the workstation 1101 may include a memory 1102, a processor 1104, a display 1106 and an input device 1110.
- Processor 1104 may include one or more hardware processors.
- the workstation 1101 may optionally include an output module 1112 and a network interface 1108.
- the memory 1102 may store an application 1118 and image data 1114.
- the application 1118 may include instructions executable by the processor 1104 for executing the methods of the disclosure including the methods of FIGS. 3, 4, and 8.
- the application 1118 may further include a user interface 1116.
- Image data 1114 may include the CT scans, the sequence of fluoroscopic images, the fluoroscopic 3D reconstructions and/or any other imaging information.
- the processor 1104 may be coupled with the memory 1102, display 1106, the input device 1110, the output module 1112, the network interface 1108 and the fluoroscope 1115.
- the workstation 1101 may be a stationary computer system, such as a personal computer, or a portable computer system such as a tablet computer.
- the workstation 1101 may embed multiple computer devices.
- 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 the workstation 1101.
- the application 1118 may, when executed by the processor 1104, cause the display 1106 to present the user interface 1116.
- the user interface 1116 may be configured to present to the user a single screen including a three-dimensional (3D) rendering of the tool, the lesion, and/or the catheter of this disclosure.
- the user interface 1116 may be further configured to display the lesion in different colors depending on whether the tool tip is aligned with the lesion in three dimensions.
- the network interface 1108 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 1108 may be used to connect between the workstation 1101 and the fluoroscope 1115.
- the network interface 1108 may be also used to receive the image data 1114.
- the input device 1110 may be any device by which a user may interact with the workstation 1101, such as, for example, a mouse, keyboard, foot pedal, touch screen, and/or voice interface.
- the output module 1112 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.
- a medical instrument such as a biopsy tool or an energy device, such as a microwave ablation catheter, that is positionable through one or more branched luminal networks of a patient to treat tissue may prove useful in the surgical arena and the disclosure is directed to systems and methods that are usable with such instruments, tools, and devices.
- Access to luminal networks may be percutaneous or through natural orifice using navigation techniques. Additionally, navigation through a luminal network may be accomplished using image-guidance. These image-guidance systems may be separate or integrated with the biopsy tool or energy device or a separate access tool and may include MRI, CT, fluoroscopy, ultrasound, electrical impedance tomography, optical, and/or device tracking systems. Methodologies for locating the access tool include EM, IR, echolocation, optical, and others. Tracking systems may be integrated to an imaging device, where tracking is done in virtual space or fused with preoperative or live images.
- the treatment target may be directly accessed from within the lumen, such as for the treatment of the endobronchial wall for COPD, Asthma, lung cancer, etc.
- the biopsy tool, the energy device and/or the additional access tool may be required to pierce the lumen and extend into other tissues to reach the target, such as for the treatment of disease within the parenchyma.
- Final localization and confirmation of energy device or tool placement may be performed with imaging and/or navigational guidance using a standard fluoroscopic imaging device incorporated with methods and systems described above.
- the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit.
- Computer-readable media may include non-transitory computer- readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).
- processors such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry.
- DSPs digital signal processors
- ASICs application specific integrated circuits
- FPGAs field programmable logic arrays
- processors may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.
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Abstract
Description
Claims
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| US202263416329P | 2022-10-14 | 2022-10-14 | |
| PCT/IB2023/060188 WO2024079639A1 (en) | 2022-10-14 | 2023-10-10 | Systems and methods for confirming position or orientation of medical device relative to target |
Publications (1)
| Publication Number | Publication Date |
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| EP4601579A1 true EP4601579A1 (en) | 2025-08-20 |
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| EP23789783.0A Pending EP4601579A1 (en) | 2022-10-14 | 2023-10-10 | Systems and methods for confirming position or orientation of medical device relative to target |
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| CN (1) | CN120018825A (en) |
| WO (1) | WO2024079639A1 (en) |
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| IL122578A (en) | 1997-12-12 | 2000-08-13 | Super Dimension Ltd | Wireless six-degree-of-freedom locator |
| US6593884B1 (en) | 1998-08-02 | 2003-07-15 | Super Dimension Ltd. | Intrabody navigation system for medical applications |
| WO2001054579A1 (en) | 2000-01-10 | 2001-08-02 | Super Dimension Ltd. | Methods and systems for performing medical procedures with reference to projective images and with respect to pre-stored images |
| AU2001241008A1 (en) | 2000-03-09 | 2001-09-17 | Super Dimension Ltd. | Object tracking using a single sensor or a pair of sensors |
| EP1499235B1 (en) | 2002-04-17 | 2016-08-17 | Covidien LP | Endoscope structures and techniques for navigating to a target in branched structure |
| US8218847B2 (en) | 2008-06-06 | 2012-07-10 | Superdimension, Ltd. | Hybrid registration method |
| US20110085720A1 (en) | 2009-05-14 | 2011-04-14 | Superdimension, Ltd. | Automatic Registration Technique |
| US9044254B2 (en) | 2012-08-07 | 2015-06-02 | Covidien Lp | Microwave ablation catheter and method of utilizing the same |
| US11564751B2 (en) * | 2019-02-01 | 2023-01-31 | Covidien Lp | Systems and methods for visualizing navigation of medical devices relative to targets |
| EP3895645A1 (en) * | 2020-04-14 | 2021-10-20 | Koninklijke Philips N.V. | Ablation planning system |
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- 2023-10-10 CN CN202380072343.6A patent/CN120018825A/en active Pending
- 2023-10-10 WO PCT/IB2023/060188 patent/WO2024079639A1/en not_active Ceased
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| WO2024079639A1 (en) | 2024-04-18 |
| CN120018825A (en) | 2025-05-16 |
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