Patent Grant
RE49930
Not applicable.
The disclosure generally relates to the field of computer-aided surgery, and in particular, but not by way of limitation, the disclosed embodiments refer to computer aided-navigation in camera guided procedures of surgery and diagnosis in anatomical regions with rigid tissues such as bone, which includes arthroscopy of knee, hip, or shoulder, and open surgery in orthopedics and dentistry in which case a camera must be used to observe the operating field. One or more embodiments can also be employed in any other application domain, such as industrial inspection, that uses a camera system to visualize a work space that comprises rigid, non-deformable parts.
Minimally Invasive Surgical (MIS) procedures aim to minimize damage to healthy tissue by accessing targeted organs and anatomical cavities through relatively small size incisions. Since the workspace is not fully exposed, the surgeon typically carries the medical procedure using as guidance video acquired by a camera system that is inserted into the cavity. MIS procedures are being increasingly adopted in different medical specialties, such as orthopedics, abdominal surgery, urology, neurosurgery, and ENT, just to name a few.
Arthroscopy is a MIS procedure for treatment of damaged joints in which instruments and endoscopic camera (the arthroscope) are inserted into the articular cavity through small incisions (the surgical ports). Arthroscopy, as opposed to conventional open surgery, largely preserves the integrity of the articulation, which is beneficial for the patient in terms of reduction of trauma, risk of infection and recovery time. Unfortunately, arthroscopic procedures are relatively difficult to execute because of indirect visualization and limited maneuverability inside the joint, with novices having to undergo a long training period and experts often making mistakes of clinical consequences. This is a scenario where computer-assistive technologies for safely guiding the surgeon throughout the procedure can make a difference, both in terms of improving clinical outcome and in terms of decreasing the surgeon learning curve.
Depending on the particular clinical application, a system for Computer-Aided Surgery (CAS) comprises two distinct stages: (i) an offline step in which the procedure is planned leading to some sort of computational model that can either be a three-dimensional (3D) pre-operative image of the patient's organ (e.g. CT-Scan), a statistical bone model, or a set of guidelines for inferring meaningful locations with respect to anatomical landmarks; and (ii) an intra-operative navigation step in which the computer guides the surgeon throughout the procedure for the execution to be done as defined.
The intra-operative navigation usually passes by overlying the pre-operative computational model with the actual bone, and by localizing in real-time the tools and instruments with respect to each other, and with respect to the targeted organ. Typically, the technology to accomplish this task is Optical-Tracking (OT) that consists in using a stationary stereo head, henceforth called base station, for tracking a set of markers that are rigidly attached to instruments and/or bone. The stereo head comprises two infrared (IR) cameras that track a set of point markers that are rigidly attached to the object of interest. The position of each marker is estimated by simple triangulation and, since their relative arrangement is known ‘a priori’, the 3D pose of the object of interest is computed in the reference frame of the base station. Recently, a technological variant of OT was introduced in which the two IR cameras are replaced by two conventional video cameras operating in the visible spectrum, and the arrangements of IR markers are replaced by planar markers with printed known patterns.
The surgical navigation solutions that are currently available for Orthopedics, Neurosurgery, and ENT invariably rely in OT. In generic terms, the typical workflow passes by the surgeon to rigidly attach a tool marker to patient and/or targeted organ, which is followed by pin pointing anatomical landmarks with a calibrated tracked probe. The 3D position of these landmarks is determined in the coordinate system of the base station and the pre-operative computational model is registered with the patient. From this point on, it is possible to determine in real-time the pose of instruments with respect to patient and plan, which enables the system to safely guide the surgeon throughout the procedure. There are some variants to this scheme that mainly address the difficulties in performing the 3D registration of patient's anatomy with a pre-operative model with a tracked probe that tends to be an error prone, time consuming process. For example, the O-arm from Medtronic® combines OT with a CT-scanner that enables the acquiring of the 3D pre-operative model of patient's anatomy in the Operating Room (OR) before starting the procedure, which avoids the surgeon performing explicit registration. The system that is being developed by 7D Surgical® goes in the same direction with the 3D model being obtained using multi-view reconstruction and structured light to avoid the ionizing radiation of CT-scanning. Nevertheless, these systems still rely in conventional OT to know the relative position between instruments and anatomy after registration has been accomplished.
OT has proved to be an effective way of obtaining real-time 3D information in the OR, which largely explains the fact of being transversally used across different systems and solutions. However, the technology has several drawbacks that preclude a broader dissemination of surgical navigation: (i) it requires a significant investment in capital equipment, namely in acquiring the base station; (ii) it disrupts normal surgical workflow by changing the OR layout to accommodate additional equipment, by forcing the surgeon to work with instruments with bulky tool markers attached, and by constraining the team movements due to the need of preserving lines of sight between base station and tool markers; and (iii) it is not well suited to be used in MIS procedures because organs and tissues are occluded which avoids placing marker tools that can be observed from the outside by the base station. For example, OT based navigation in arthroscopic procedures always requires opening additional incisions such that the marker tool attached to the bone protrudes through patient skin.
In recent years some alternative technologies have emerged in an attempt of obviating the above-mentioned drawbacks. Electromagnetic Tracking (ET) is currently used in some surgical navigation systems with the advantage of not requiring preservation of a line of sight. However, it has the problem of being vulnerable to electromagnetic interference caused by nearby metals and devices, being in practice less reliable and accurate than OT. Moreover, it still requires additional capital equipment, namely a base station, and the need of attaching coil markers with hanging wires to organs makes it non amenable to MIS procedures.
The embodiments in the disclosure provide a new concept for computer-assisted procedures of surgery and diagnosis that target rigid, non-deformable anatomical parts such as bone, tissue, or teeth. The disclosure describes attaching small visual markers to instruments and anatomy of interest (e.g. bone surface), with each marker having a printed known pattern for detection and unique identification in images acquired by a free-moving camera, and a geometry that enables estimating its rotation and translation with respect to the camera using solely image processing techniques.
The concept, henceforth referred as Visual-Tracking Inside the Anatomical Cavity (VTIAC), introduces three main differences from other embodiments of OT/ET in the context of computer-aided surgery: First, the global world reference frame, instead of being the coordinate frame of the external base station, it is the system of coordinates of a marker that is rigidly attached to the anatomy of interest (e.g. bone surface). This marker, referred to herein as World Marker or WM, serves as absolute reference such that all measurements are expressed in its coordinates (world coordinates); Second, the free-moving camera acts as the single sensing modality with all measurements and real-time 3D inferences being carried by processing the acquired video. This feature avoids significant investments in additional capital equipment when compared with OT/ET; and Third, since measurements are performed in high resolution images acquired at close range, the metric accuracy of VTIAC is significantly better than the one accomplished with OT/ET.
The disclosure discloses the apparatus for VTIAC and the required initial calibration procedures, it describes how to use VTIAC to perform very accurate 3D measurements inside the anatomical cavity, and it shows how to use augmented reality, virtual reality, or robotics to provide real-time guidance to the surgeon after registering a pre-operative 3D plan.
In terms of clinical applications VTIAC is specially well suited for arthroscopy where the already existing monocular arthroscope acts as the free-moving camera that provides the video input. VTIAC can be successfully employed in any clinical procedure that targets anatomical regions with rigid parts, such as open orthopaedic surgery or dentistry, in which case the operating field must be observed by a camera that can either be attached to a tool or handheld. The disclosure describes illustrative implementations in knee arthroscopy and spine surgery that by no means limit the range of possible clinical applications.
For a more complete understanding of the present disclosure, reference is made to the following detailed description of exemplary embodiments considered in conjunction with the accompanying drawings.
1. Introduction
It should be understood that, although an illustrative implementation of one or more embodiments are provided below, the various specific embodiments may be implemented using any number of techniques known by persons of ordinary skill in the art. The disclosure should in no way be limited to the illustrative embodiments, drawings, and/or techniques illustrated below, including the exemplary designs and implementations illustrated and described herein.
One or more embodiments disclosed herein applies to camera-guided orthopedic MIS procedures, namely arthroscopy, that is used as illustrative example throughout most of the description. However, the application of the presently disclosed embodiments can include other surgical procedures and clinical specialties where the operating field comprises rigid, non-deformable parts and surfaces. The application of the disclosed embodiments requires a camera system for visualizing the anatomical scene that might already exist (e.g. arthroscopy) or be added (e.g. open orthopedic surgery).
One or more embodiments in the disclosure provide a surgical navigation scheme for arthroscopy and other procedures using a conventional camera and with scenes that comprise rigid surfaces. The surgical navigation scheme will be referred to as Visual-Tracking Inside the Anatomical Cavity (VTIAC). The disclosure relates to attaching small, recognizable visual markers to instruments and rigid anatomy (e.g. bones) and use the free-moving camera, that is the arthroscope in case of arthroscopic procedures, to estimate their relative rotation and translation (the relative 3D pose). For the case of the markers being planar with a printed known pattern, the relative 3D pose is determined by estimating the plane-to-image homography that is factorized to obtain the rotation and translation between plane and camera reference frames. The marker attached to the bone surface, referred to herein as World Marker (WM), serves as absolute reference with all measurements being expressed in its coordinate system (world coordinates). VTIAC can be used to obtain 3D information about the bone surface, register a pre-operative computational model, and ultimately solve the navigation issues by providing guidance using augmented reality, virtual reality, or robotic actuation.
VTIAC introduces many differences relatively to other embodiments of OT/ET in the context of computer-aided surgery in general and arthroscopy in particular. For example, the global world reference frame, instead of being the external stereo head (the base station), is substituted by the system of coordinates of the WM that is inside the articular cavity. This avoids issues related to preserving lines of sight in the OR, as well as the need of having marker tools protruding through patient skin. Second, for example, the approach relies on processing the video acquired by a free-moving camera, which means that in the case of arthroscopy there is no need of investing in additional capital equipment that provides alternative sensing modalities. Third, for example, measurements are performed in the images acquired at close range inside the anatomical cavity, which dramatically increases spatial and/or metric accuracy with respect to OT or ET.
1.1 Prior Art
In embodiments where the visual marker is a planar marker, the plane-to-image homography may be a factor in the VTIAC approach for surgical navigation. The projection of a plane into a perspective image may be described by a 3×3 matrix transformation (the homography) that encodes the plane rotation and translation (the plane 3D pose) in camera coordinates. The homography has been broadly used in the field of Computer Vision for several different purposes, ranging from camera calibration to visual tracking, and passing by 3D motion estimation.
The use of plane homographies in clinical setups has been relatively scarce. For example, an OT system, the MicronTracker® developed by Claronav®, may use planes with recognizable patterns as tool markers. These markers are tracked by a stereo camera system and the pose of the tool is determined through homography factorization. The approach herein described differs from MicronTracker® in that the tracking is performed by a moving monocular camera as opposed to a stationary stereo setup. Moreover, while in MicronTracker® the base station is the external stereo setup, which raises the issues about line of sight inherent to conventional OT, in VTIAC, measurements are carried out with respect to the WM that is rigidly attached to the surface inside the articular joint or anatomical cavity.
Other embodiments may be used to determine the relative pose between a laparoscope and an intra-operative ultrasound (US) probe or laser projector. In particular, the embodiments attach a printed planar pattern to the probe and/or projector that is viewed by the laparoscope. This enables estimation of the plane-to-image homography and determination of the relative pose of the probe and/or projector in camera coordinates. VTIAC provides a much broader range of functionalities that arise from using a World Marker (WM) attached to the bone surface. Thus, VTIAC not only provides the relative pose of tools and devices that are inserted into the anatomical cavity, but it also enables the reconstruction of points and contours on the surface of the organ of interest that are pin-pointed by the surgeon. This information can be used for a multitude of purposes such as metric measurements, registration of pre-operative models, or guidance using augmented reality, that are seamlessly supported by the framework. Moreover, measurements are typically represented in camera coordinates, which means that it is not possible to relate or integrate information across frames because the laparoscope is in constant motion. In VTIAC, all measurements are stored in the coordinate system of the WM that works as an absolute reference across time and space. Thus, the visual tracking process can even be discontinued, and the 3D information obtained till that moment becomes readily available as soon as the WM is redetected in the images acquired by the moving camera.
1.2 Structure and Notation
Section 2 provides an overview of the concepts behind the VTIAC, Section 3 provides details on the apparatus and calibration of the necessary tools to be used with the system, Section 4 provides a description of the visual markers' accurate detection under high radial distortion, Section 5 details the estimation of 3D pose from the detection of markers in the image and practical capabilities of the system, Section 6 provides an overview of the operation flow of the VTIAC system for operation during surgery and Section 7 provides extensions and variations on the tools and methods presented before.
In order to better illustrate the usefulness of VTIAC, two embodiments that can be applied to design a navigation system for the arthroscopic reconstruction of the Anterior Cruciate Ligament (ACL) and for Placing Pedicle Screws (PPS) in spine surgery are presented (sections 8 and 9). These procedures are mere examples that do not limit in any way the potential applications of VTIAC. As stated in the following sections, the VTIAC can be applied to a multitude of arthroscopic procedures, as well as open procedures and including dentistry surgery.
Notation: If not stated otherwise, points are represented by their vectors of coordinates and vectors are denoted by a bold letter (e.g., P, x). The rigid displacement between coordinate frames is represented by a 4×4 matrix in the Special Euclidean Group (SE(3)) where the left upper 3×3 submatrix is a rotation matrix and 3×1 right upper submatrix is a translation vector. Matrices are typically denoted by plain capital letters (e.g., C, T).
2. Overview of Visual-Tracking Inside the Anatomical Cavity (VTIAC)
The free-moving camera is assumed to be calibrated such that image points u in pixel coordinates can be mapped into image points x in metric coordinates as if the image had been acquired by a perfect pin-hole. For the sake of simplicity, and without lack of generality, it is considered that the free-moving camera is an arthroscopic camera and that the anatomical part of interest is a bone. It is also assumed that visual markers are planar with a known pattern.
After accessing the anatomical cavity, the surgeon starts by rigidly attaching a marker to the bone surface that is referred as the World Marker (WM). If the marker is planar, then its projection is described by an homography HC, that maps plane points into image points, and encodes the relative rotation RC and translation tC between marker and camera reference frames. Thus, and since HC can be estimated from image information, it is possible to use this homography relation to determine at every frame time instant the 4×4 matrix C that transforms world coordinates into camera coordinates (
Consider now an instrument or tool with a similar visual marker attached that is referred as Tool Marker (TM). Repeating the process of the previous paragraph the homography HT can be estimated from image information in order to determine the rigid transformation that maps TM coordinates into camera coordinates. If both WM and TM are simultaneously visible in the image, then it is possible to estimate the 3D poses of world and tool markers in the camera frame and find in a straightforward manner the location T of the tool or instrument in the world coordinate system (
T=C−1{circumflex over (T)} (equation 2)
Let's now assume that the tool or instrument is a calibrated touch-probe such that PT is the vector of 3D coordinates of its tip in the TM reference frame. The surgeon can reconstruct a point of interest in the bone surface by touching it with the probe and acquiring a frame where both WM and TM are visible. This enables computation of the pose T of the probe and the obtaining of the point of interest P expressed in world coordinates (
The process above can be applied to successive frames in order to reconstruct a curve in the bone surface. In this embodiment the surgeon outlines the contour of interest while keeping both WM and TM in the Field-of-View (FOV) of the free-moving camera. This enables the obtaining of successive P estimates that define the desired 3D curve. Since 3D reconstruction results are stored in World Marker coordinates, the action of outlining can be stopped and resumed at any time. If the process is interrupted for any reason, it suffices for the camera to see again the WM for all the 3D information to be restored without having to repeat the tedious touching process (
The 3D reconstruction results, that can either be points, contours, or sparse surface meshes, can be used for the purpose of measuring, estimating shape, or overlying a pre-operative plan in the actual patient anatomy (3D registration). This pre-operative plan can be a set of rules using anatomical landmarks, a statistical 3D model of the anatomy of interest, or an actual 3D image of the organ (e.g. CT Scan) augmented with guidance information inserted by the surgeon (surgical plan). Let's assume the latter for illustrative purposes (
The clinical execution might require, in one embodiment, multiple different instruments—such as guides, drills, shavers, saws, burrs, etc.—that can either be used in sequence or simultaneously. Each one of these instruments is assumed to have a Tool Marker (TM) attached that defines a local system of coordinates where the instrument's relevant parts—such as tip, symmetry axis, or even complete CAD model—are represented. The system processes each frame with the objective of detecting, identifying, and estimating the 3D pose of every TM that is in the FOV of the camera. If the WM is also visible in image, then it is possible to determine the pose of the camera C, locate the instruments in the world coordinate system, relate their poses T with the 3D information stored in the WM reference frame, and ultimately provide real-time assistance to the surgeon (
Thus, the last stage of VTIAC consists of assisting the surgeon by performing continuous processing of the video for estimating in real-time the 3D pose of instruments with respect to patient anatomy and/or surgical plan represented in WM coordinates. The assistance can take multiple forms depending on a specific task and a preferred user interface. Possibilities include overlaying guidance information in video using Augmented Reality (AR), using computer graphics to animate the motion of instruments in a Virtual Reality (VR) environment showing the patient's anatomy and/or surgical plan, or controlling the action of actuators in the case of procedures assisted by robotic systems such as the Mako® or the Navio® robots.
3. Overview of Methods, Apparatus and Initial Calibration Requirements
This section overviews the methods and apparatus that are required to perform computer-aided surgery using VTIAC. The apparatus includes:
Since the VTIAC uses images for measurements and 3D inference, the free-moving camera must be calibrated at all times during the procedure such that 2D image points u, represented in pixel coordinates, can be mapped into 2D points x (or back-projection directions) represented in the metric system of coordinates of the camera. The calibration includes determining the vector of parameters k and ξ of the back-projection function f−1 (the inverse of the projection function f) where k comprises the so-called intrinsic parameters—focal length, principal point, aspect ratio, and skew—and ξ stands for the radial distortion parameters.
x=f−1(u; k, ξ) (equation 4)
The camera can either be pre-calibrated from factory, using any standard method in literature, or calibrated in the Operating Room (OR) just before starting the procedure. The latter is especially recommendable for the case of arthroscopic cameras, or any other camera with exchangeable optics. The calibration in the OR can be quickly accomplished by acquiring one image of a known calibration pattern from an arbitrary viewpoint, as described in U.S. Patent Publication No. 2014/0285676, which is incorporated by reference in its entirety. If the camera parameters change during operation because the surgeon rotates the lens scope and/or varies the optical zoom, then the initial calibration may be updated at every frame time using the techniques described in U.S. Patent Publication No. 2014/0285676 and Patent Publication WO2014054958, both of which are incorporated by reference in their entireties. The camera calibration must also take into account the medium of operation that, in the case of arthroscopy, is a wet medium. In this situation the initial single image calibration can either be carried in wet medium, or performed in air followed by compensating for the difference in the refractive index of air and water-based medium.
3.2 World Marker (WM) and Tool Markers (TMs).
The surgeon starts by fixing the World Marker (WM) to the bone surface. The WM can be any object comprising at least one planar facet with a known pattern that can be secured (e.g., glued), printed or engraved, and that can be recognized in images; that is small enough to be inserted into the anatomical cavity (e.g., up to 5 mm diameter in the case of arthroscopy); and that can be mechanically attached to the surface such that bone and marker do not move with respect to each other.
A non-exhaustive list of objects that can be used as WM includes: a screw-like object with a flat head or facet (
The touch-probe in (iii) and the surgical tools in (iv) are instrumented with a visual marker (the Tool Marker or TM), which can either be originally built-in at manufacturing time, or rigidly attached by the user (
3.3 Tool Calibration in the Operating-Room (OR)
If the tool calibration includes finding the coordinates PT of a particular tool point in the TM reference frame (e.g. the tip of the touch probe (iii)), then the operation can be quickly carried simultaneously with the initial calibration of the camera without requiring the acquisition of additional calibration frames. As described, e.g., in U.S. Patent Publication No. 2014/0285676, the camera calibration can be accomplished by acquiring a single image of a known grid or checkerboard pattern. This enables recovering the intrinsic parameters k, the radial distortion parameters ξ, and the rigid transformation Ĝ that maps coordinates in the grid reference frame into coordinates in the camera reference frame. Thus, if the tool tip is placed in a pre-defined point PG that is known in grid coordinates, and the calibration image is such that TM is visible, then it is possible to estimate the 3D pose {circumflex over (T)} of the tool marker from image information and obtain the TM coordinates of the tool tip by applying the formula below (
The tool calibration of the surgical instruments (iv) can either consist in determining the location of a point, a line or axis, or a CAD model in the coordinate system of the TM attached to the particular instrument. This can be accomplished with the help of the calibrated camera and touch-probe using a method similar to the one used for 3D reconstruction on the bone surface, but where the role of the WM is replaced by the TM of the instrument (
3.4 Alternatives and Extensions in the Physical Configuration of Visual Markers
The visual marker used in the WM of (ii) and in the TMs of (iii) and (iv) can comprise a single plane facet with a known pattern as assumed so far, or multiple plane facets with each facet having its own pattern that can be secured (e.g., glued), printed, or engraved, and where the location of each planar pattern is known in a common local coordinate system of the visual marker. The advantage of having multiple planar patterns facing different directions is to extend the range of viewing positions and orientations from which the marker can be observed by the camera for estimating the relative 3D pose (
Alternatively, the visual marker can be non-planar, in which case it should comprise n≥3 points with known coordinates in the local reference frame of the marker, with these points being such that they can be detected and identified in image in order to allow estimation of the relative pose by applying a Perspective-n-Point (PnP) method.
4. Estimation of Rotation and Translation (the 3D Pose) of a Known Planar Pattern from Image Information.
The small visual markers that are attached to instruments, tools, and anatomy of interest play a fundamental role in VTIAC being key-enablers for using the camera as a measuring device for determining 3D pose. As discussed, the visual marker can have different topological configurations but, for the sake of simplicity and without compromising generality, it will be assumed that the visual marker is a planar surface with a known pattern.
This planar pattern should be such that it has a local system of coordinates, it is amenable to be detected and uniquely identified from its image projection, and it has fiducial points that can be accurately detected in image for estimating the plane-to-image homography H from point correspondences. A point correspondence is the association between a point in the pattern p expressed in local coordinates and its projection x represented in camera coordinates. The homography H is a projective transformation that maps the former into the latter, and that can be linearly estimated from N≥4 point correspondences. The homography encodes the rotation and translation between pattern and camera coordinate systems, which means that the factorization of H provides the 3D pose of the pattern in the camera reference frame.
There are several pattern designs that meet the above mentioned conditions. It will be assumed, without compromising generality, that the planar patterns are similar to the CalTag checkerboard patterns, where the quadrilateral shape and high contrast enable fast detection, the sharp corners provide accurate point correspondences, and a bitmap binary code allows visual identification (
One possibility for improving accuracy and robustness of 3D pose estimation is to correct radial distortion via software, before running the processing pipeline for detection, identification, and homography/pose estimation. However, this has several drawbacks, such as the computational effort in warping the entire frame, and the fact that interpolation also introduces artifacts that degrade the accuracy of geometric estimation.
Since radial distortion has a relatively small impact in pattern detection, this disclosure provides an alternative approach based in photo-geometry. The approach includes using standard methods for detection, identification, and initial estimation of pattern rotation r0 and translation t0, followed by refining the 3D pose estimate by minimizing the photo-geometric error in aligning the current pattern image with its template using a warping function that takes into account the non-linear distortion.
Let C0 be the initial 3D pose estimate of the planar pattern in camera coordinates. The objective is to determine the pose update Δ, that encodes the increments in rotation δR and in translation δt, such that the photo-geometric error ε1 is minimized (
where T(u) is the pattern template, I(u) is the current frame, Ni is the image region comprising the pattern, and w is the image warping function (
w(u; r, t)=f(x: k, ξ)o h(x; r, t)o f−1 (u; k′, ξ′) (equation 7)
with h being the homography map that depends on the relative 3D pose r and t, and f denoting the projection function of the camera that encodes the effect of radial distortion, as described, e.g., in Patent Publication WO/2014054958. Since the template can be understood as a synthetic, fronto-parallel image of the planar pattern (
C=ΔC0 (equation 8)
The iterative minimization of the photo-geometric error εi can be carried using different optimization schemes available in literature such as forward composition, inverse composition, or efficient second order minimization, which requires some changes in formulation and parametrization in SE(3). The formulation can also be extended to be resilient to changes in illumination.
5. 3D Measurement and Reconstruction using VTIAC.
Section 4 describes a method for estimating the 3D pose of a planar visual marker in camera coordinates. Let's consider two of these markers such that one is attached to the anatomy of interest (WM), and the other is attached to a calibrated touch probe (TM).
For reconstructing an arbitrary point P in world coordinates the surgeon places the tip of the probe in the point, positions the camera such that both WM and TM are in the FOV, and commands the system to acquire an image that is processed as follows (
The approach can be extended to obtain a 3D contour or a sparse 3D reconstruction of a surface region, in which case the surgeon uses the touch probe to respectively outline the contour or randomly grasp the surface, while the camera acquires continuous video and steps above are executed for each frame (
The 3D reconstruction results are stored in memory in world coordinates, which means that they can be overlaid in images whenever the WM is in the camera FOV by performing the following steps at each frame time instant (
The ability of VTIAC to reconstruct and store in memory points, curves, and regions in the anatomy of interest (e.g. bone) has a multitude of purposes and/or possible clinical applications. A non-exhaustive list includes:
As stated, the reconstruction results can also be used as input in standard 3D registration methods for aligning or overlying a computational model with the current patient's anatomy. Such methods estimate the rigid transformation M that maps points PM in the model into corresponding points P in the intra-operative reconstruction obtained with VTIAC (
6. Assisted Execution of the Clinical Procedure using VTIAC.
So far we have shown how to obtain relevant 3D data in the common coordinate system of the WM that may consist in reconstruction results, measurements and other types of 3D inferences, or the registration of surgical plan against patient's anatomy. The term ‘surgical plan’ is employed in a broad sense and can mean, among other things, a set of rules based on anatomical landmarks, e.g. placing the femoral tunnel of the ACL at ⅓ the length of the notch ceiling measured from its posterior end; the fitting of a statistical model of an anatomy or pathology, e.g. the shape model of CAM femuro-acetabular impingement; or a pre-operative image of the targeted anatomy that can, or cannot, be augmented with guidance information, e.g. a CT scan annotated by the surgeon using a 3D planning software. This section describes how VTIAC can combine this 3D data with real-time 3D pose estimation of surgical instruments to provide intra-operative navigation features.
Let the surgical instrument—that can be a needle, guide, drill, shaver, saw, burr, or any other object required for proper clinical execution—have a TM attached. The marker defines a local reference frame where the position of a point, axis, or CAD model of the tool is known (calibrated tool). Navigation is accomplished by executing the following processing steps at every frame time instant:
VTIAC navigation also works for the case of multiple instruments being used in simultaneous, in which case each instrument has its own TM enabling parallel detection, identification, and estimation of 3D pose T.
The aiding features can take multiple forms depending on the particular task and/or surgical procedure. A non-exhaustive list of these features includes:
The disclosure has considered that camera and tool or instrument are two entities with independent motions. There are situations for which it might be advantageous to assemble the camera in the tool or instrument such that the two entities become a single rigid body. The assembly, that is henceforth referred as a Camera Tool or CamT, must be calibrated such that the position of the tool tip, axis of interest, or CAD model of the tool or instrument, is known in the reference frame of the camera. Depending on the particular clinical application the camera can be mounted in a multitude of possible tools ranging from a touch-probe to an impactor for cup placement during hip arthroplasty, passing by burrs and drills. In this setup where camera and tools are physically attached, their relative 3D pose is known, and as long as the camera sees the WM, it is possible to determine the 3D pose of the tool in the global system of coordinates of WM.
7.2 Single-image Calibration of CamT:
The CamT described above can either be pre-calibrated from factory, or calibrated in the OR from a single image of a known grid or checkerboard pattern. In this case the surgeon acquires the calibration frame by positioning the camera such that the pattern is visible in image and the tool tip touches a particular point PG whose coordinates are known in the coordinate system of the grid (
7.3 Contactless Probe using a Laser Pointer:
Section 5 discloses a method for 3D reconstruction where the surgeon uses a calibrated touch-probe to pinpoint points of interest while the camera observes both the WM and the TM of the tool. There might be situations for which touching a particular location in the anatomy is difficult or even unfeasible. Examples include situations of limited access or poor maneuverability where the touch-probe cannot reach a particular location without occluding the WM. It is now disclosed an alternative probe that can replace the conventional touch-probe in the task of performing 3D reconstruction using VTIAC, and that has the advantage of avoiding the need of physical contact.
This alternative probe, henceforth referred as contactless probe, consists in a laser pointer that emits a collimated beam of visible light. The pointer has a visual marker attached—the Tool Marker or TM—and it is assumed to be calibrated such that the position of the line LT defined by the beam is known in TM coordinates.
For reconstruction the surgeon directs the laser pointer such that the beam becomes incident on the point of interest, and uses the camera to acquire an image where WM, TM, and point of light incidence are visible. The point is reconstructed in 3D by intersecting the line LT of the beam with the back-projection line Bx of the image point x where the point of light incidence is projected (
Contactless 3D reconstruction can also be accomplished using an Active Contactless Probe consisting in a Laser Rangefinder (LRF), or other equivalent device or technology relying on Time-of-Flight (ToF) principles, that is able to measure distances λ along the direction of the beam line LT. The LRF has a visual marker attached and it is assumed to be calibrated such that the origin and unit direction of measurement, that are respectively ST and dT, are known in the local reference frame of TM. For 3D reconstruction the surgeon orients the LRF such that the beam becomes incident with the point of interest in the anatomy, and acquires in a synchronous manner the distance measurement λ and an image where both WM and TM are visible. The point of interest can be outside the camera FOV (
PT=ST+λdT
7.5 Using Multiple WMs to Extend the Range of Operation:
The World Marker or WM works as a global reference, which means that it must be viewed by the camera whenever the surgeon wants to use VTIAC for reconstruction or guidance purposes. There might be situations for which keeping the WM in the camera FOV can be difficult to accomplish in practice, either because the camera has a limited FOV, or because the region to cover is simply too broad or wide. This problem is solved by using multiple markers as shown in
W′=C−1C′
Since W′ enables to map information from WM into WM′ and vice-versa, it suffices for the camera to see one of the markers for the reconstruction and guidance functionalities of VTIAC to be readily available. The region of operation can be further extended by placing additional markers and repeating the step above to register them in world coordinates.
7.6 Using VTIAC with a Surgical Robot
Section 6 discloses a method for using VTIAC to assist the execution of a clinical procedure where the guidance information is provided by either overlying info in the images or video (AR), or by animating a VR model of anatomy and tools. In addition, VTIAC can also be used to guide or control the action of a surgical robot (
A surgical system like the Navio® robot relies on conventional OT for determining in real-time the 3D pose between the robotized tool and patient's anatomy and/or surgical plan. VTIAC can be used as an alternative to conventional OT for providing the kinematic feedback required to control the robot in closed loop (
8. Example of Application of VTIAC for Arthroscopic Reconstruction of Anterior Cruciate Ligament (ACL) in the Knee
This section discloses an embodiment of VTIAC based-navigation for Reconstruction of Anterior Cruciate Ligament (ACL) in the Knee, which can also be generalized for other arthroscopic procedures such as in the shoulder or hip.
ACL tear is a common pathology for which arthroscopy is the standard treatment (e.g., >300000 cases per year worldwide). The procedure includes replacing the torn ACL by a substitution graft that is pulled into the joint through a tunnel opened with a drill. Placing this tunnel in the correct anatomical position is crucial for the knee to fully recover its functionality. One technique is the transtibial (TT) approach that opens the tunnel in a single step by drilling from the bottom of the tibia plate till entering into the femur notch. Recent studies show that in about 39% of the cases TT fails in positioning the tunnel at the femoral end, and that much better results can be accomplished using the anteromedial (AM) approach. Unfortunately, AM is used in about 15% of the cases because it is more difficult to execute and increases the risk of critically short tunnel or blowout of the posterior femur wall. Intra-operative navigation can help in disseminating the AM approach by dramatically decreasing the execution risk and complexity. VTIAC may be applied to accomplish this intra-operative navigation by indicating the location in the femur notch where to open the tunnel (the ligament footprint) and by guiding the angular orientation of drilling.
In a possible design of the navigated procedure the surgeon starts by calibrating the arthroscopic camera and by attaching the WM in the medial side of the inter-condyle region (
The orientation for opening the tunnel may be determined by registering a statistical model of the femur bone. For this purpose, the surgeon uses the touch probe to reconstruct the boundary contours of the inter-condyle region (
9. Example of Application of VTIAC for Guiding the Placement of Pedicle Screws (PPS) During Open Surgery of Spine.
This section discloses an embodiment of VTIAC based-navigation for Placing Pedicle Screws (PPS) during spine surgery, which can also be generalized to other open procedures where a rigid surface is exposed, such as total hip replacement, total knee replacement, open shoulder surgery and implant placement in dentistry.
Although VTIAC always requires a video input, its use is not limited to arthroscopy. The framework can also be applied to open orthopedic procedures, such as knee/hip arthroplasty or spine surgery, as far as a camera is employed to observe incision and relevant anatomy. The camera can either be a generic handheld camera (
There are several traumas and pathologies of the spine whose treatment passes by a surgery for vertebra fusion. The procedure includes placing screws in two consecutive vertebras for keeping in position a metallic rod that prevents intervertebral motion. Each screw must be carefully inserted along the vertebra pedicle otherwise it can irremediably damage the spinal medulla or a vital blood vessel. The dominant technique for Placing Pedicle Screws (PPS) is the so-called “free-hand” approach, in which the surgeon relies in his experience and knowledge to insert the screw while occasionally using fluoroscopy to confirm the correct positioning. Since this process is risky and error prone, several manufacturers developed navigation systems for PPS where a pre-operative 3D plan is overlaid with the patient anatomy in the OR using opto-tracking. In this case the surgeon uses a pre-operative model of the vertebra (e.g. CT-Scan or MRI) to specify the 3D line along which the screw must be inserted, as well as the depth of insertion. The model and the surgeon specifications are henceforth referred as the pre-operative 3D plan. This section describes how VTIAC can be applied to accomplish intra-operative navigation after planning.
In the OR, and after opening an incision for partial or total exposition of the vertebra, the surgeon starts by rigidly attaching a visual marker (WM) to the bone surface. This marker plays the role of World Marker (WM) and is placed in an arbitrary position decided by the surgeon. The next step is to overlay the pre-operative plan with patient's anatomy in the OR, which passes by reconstructing points and/or curves on the vertebra surface to be used as input in a suitable 3D registration algorithm.
One possibility is to perform the 3D registration using a set of fiducial points or landmarks in the anatomy. In this case the system indicates a succession of landmark points to be reconstructed that are pin-pointed in by the surgeon using the touch-probe (
After registration, the VTIAC is able to overlay the 3D pre-operative plan in the intra-operative video, as well as the tip, axis, or CAD model of the tool, whenever WM and TM are respectively in the FOV of the camera (
The VTIAC can then project the guidance information into the AR view, such as the angle of the tool relatively to the planned direction (
10. Application of VTIAC for Intra-operative Guidance in Other Clinical Procedures
VTIAC can be applied for intra-operative navigation in several other clinical procedures. A non-exhaustive list of possibilities include:
Arthroscopic reconstruction of Posterior Cruciate Ligament (PCL): The PCL is a ligament in the knee joint that connects the posterior intercondylar area of the tibia to the medial condyle of the femur. In a similar manner to the ACL, the PCL reconstruction consists in replacing the torn ligament by a substitution graft that is pulled inside the joint through a tunnel opened with a drill. VTIAC can be applied to guide the placement of these tunnels both in tibial and femoral sides.
Arthroscopic Resection of Femuro-Acetabular Impingement (FAI): FAI occurs when the ball shaped femoral head rubs abnormally in the acetabular socket, which in about 91% of the cases is caused by an excess of bone tissue in the femur head-neck that creates a bump known as CAM impingement. The treatment is surgical and consists in removing the CAM to restore the ball shape to the femur-head. To accomplish this objective the surgeon uses a CT-scan of the femur to study the CAM position and plan the extension of resection. This plan is then mentally transposed for the execution in the OR, which is a very error prone process. VTIAC can be applied to enforce the pre-planning by overlying the annotated 3D model with the patient's femur in order to safely guide the surgeon. After model registration the CAM footprint can be overlaid in the arthroscopic video using AR techniques and the system can inform the surgeon about the quantity of the bone tissue to remove at every instant.
Arthroscopic assessment and diagnosis of confocal defects in cartilage: Confocal defects are damages in the articular cartilage that can be repaired by filling the holes or craters with a bio-compatible material. This operation often requires placing in the hole or crater an rigid support structure called scaffolder. VTIAC can be used for measuring and determining the shape of confocal defects, as well as to guide the placement of these scaffolds.
Total hip replacement (THR): THR is an open surgical procedure for replacing the hip joint by an implant. The implant consists in a cup, that replaces acetabulum in the pelvic bone, and in a stem with a sphere that replaces the femural head. VTIAC can be applied to guide the placement of the cup such that it is inserted with optimal angular orientation, as well as to define the cut plane in the femural neck to remove the head and insert the stem with sphere.
Total Knee Replacement and Unicompartmental Knee Replacement: Knee arthroplasty is an open surgical procedure for replacing total or part of the knee joint by an implant (total or unicompartmental knee replacement). VTIAC can be applied to guide the surgeon in cutting the femural condyle and placing the implant.
Shoulder Joint Replacement: This is another open surgical procedure for replacing in total or in part the shoulder joint by an implant. VTIAC can be applied in assisting the surgeon in several steps of the execution such as indicating the plane of cut to remove humeral head, or guiding the reaming of humeral shaft and/or glenoid.
Placement of dental implants in Prosthodontics: VTIAC can be applied in dental surgery for placing an implant in the maxilar bone as planned in a pre-operative Cone Beam CT (CBCT) of the patient. In this case the WM is rigidly attached to a tooth, the CBCT is overlaid with patient's anatomy by using VTIAC features for 3D reconstruction, and the system provides intra-operative guidance for inserting the implant through any of the AR and VR features that have been described in the ACL and PPS examples.
11. Additional Notes and Remarks
As shown in
Programming and/or loading executable instructions onto memory 508 and processor 502 in order to transform the image processing system 500 into a non-generic particular machine or apparatus that applies VTIAC to surgical procedures is well-known in the art. Implementing instructions, real-time monitoring, and other functions by loading executable software into a computer and/or processor can be converted to a hardware implementation by well-known design rules and/or transform a general-purpose processor to a processor programmed for a specific application. For example, decisions between implementing a concept in software versus hardware may depend on a number of design choices that include stability of the design and numbers of units to be produced and issues involved in translating from the software domain to the hardware domain. Often a design may be developed and tested in a software form and subsequently transformed, by well-known design rules, to an equivalent hardware implementation in an ASIC or application specific hardware that hardwires the instructions of the software. In the same manner as a machine controlled by a new ASIC is a particular machine or apparatus, likewise a computer that has been programmed and/or loaded with executable instructions may be viewed as a non-generic particular machine or apparatus.
In addition,
As shown in
Memory 904 interfaces with computer bus 902 so as to provide information stored in memory 904 to CPU 912 during execution of software programs such as an operating system, application programs, device drivers, and software modules that comprise program code, and/or computer executable process steps, incorporating functionality described herein, e.g., one or more of process flows described herein. CPU 912 first loads computer executable process steps from storage, e.g., memory 904, computer readable storage medium/media 906, removable media drive, and/or other storage device. CPU 912 can then execute the stored process steps in order to execute the loaded computer-executable process steps. Stored data, e.g., data stored by a storage device, can be accessed by CPU 912 during the execution of computer-executable process steps.
Persistent storage, e.g., medium/media 906, can be used to store an operating system and one or more application programs. Persistent storage can also be used to store device drivers, such as one or more of a digital camera driver, monitor driver, printer driver, scanner driver, or other device drivers, web pages, content files, playlists and other files. Persistent storage can further include program modules and data files used to implement one or more embodiments of the present disclosure.
A network link typically provides information communication using transmission media through one or more networks to other devices that use or process the information. For example, the network link may provide a connection through a local network to a host computer or to equipment operated by a Network or Internet Service Provider (ISP). ISP equipment in turn provides data communication services through the public, worldwide packet-switching communication network of networks now commonly referred to as the Internet.
A computer called a server host connected to the Internet hosts a process that provides a service in response to information received over the Internet. For example, server host hosts a process that provides information representing video data for presentation at display 910. It is contemplated that the components of system 900 can be deployed in various configurations within other computer systems, e.g., host and server.
At least some embodiments of the present disclosure are related to the use of computer system 900 for implementing some or all of the techniques described herein. According to one embodiment, those techniques are performed by computer system 900 in response to processing unit 912 executing one or more sequences of one or more processor instructions contained in memory 904. Such instructions, also called computer instructions, software and program code, may be read into memory 904 from another computer-readable medium 906 such as storage device or network link. Execution of the sequences of instructions contained in memory 904 causes processing unit 912 to perform one or more of the method steps described herein. In alternative embodiments, hardware, such as ASIC, may be used in place of or in combination with software. Thus, embodiments of the present disclosure are not limited to any specific combination of hardware and software, unless otherwise explicitly stated herein.
The signals transmitted over network link and other networks through communications interface, carry information to and from computer system 900. Computer system 900 can send and receive information, including program code, through the networks, among others, through network link and communications interface. In an example using the Internet, a server host transmits program code for a particular application, requested by a message sent from computer, through Internet, ISP equipment, local network and communications interface. The received code may be executed by processor 902 as it is received, or may be stored in memory 904 or in storage device or other non-volatile storage for later execution, or both.
For the purposes of this disclosure a module is a software, hardware, or firmware (or combinations thereof) system, process or functionality, or component thereof, that performs or facilitates the processes, features, and/or functions described herein (with or without human interaction or augmentation). A module can include sub-modules. A module, or software components of a module, may be stored on a computer readable medium for execution by a processor. Modules may be integral to one or more servers, or be loaded and executed by one or more servers. One or more modules may be grouped into an engine or an application.
At least one embodiment is disclosed and variations, combinations, and/or modifications of the embodiment(s) and/or features of the embodiment(s) made by a person having ordinary skill in the art are within the scope of the disclosure. Alternative embodiments that result from combining, integrating, and/or omitting features of the embodiment(s) are also within the scope of the disclosure. Where numerical ranges or limitations are expressly stated, such express ranges or limitations may be understood to include iterative ranges or limitations of like magnitude falling within the expressly stated ranges or limitations (e.g., from about 1 to about 10 includes, 2, 3, 4, etc.; greater than 0.10 includes 0.11, 0.12, 0.13, etc.). The use of the term “about” means ±10% of the subsequent number, unless otherwise stated.
Use of the term “optionally” with respect to any element of a claim means that the element is required, or alternatively, the element is not required, both alternatives being within the scope of the claim. Use of broader terms such as comprises, includes, and having may be understood to provide support for narrower terms such as consisting of, consisting essentially of, and comprised substantially of Accordingly, the scope of protection is not limited by the description set out above but is defined by the claims that follow, that scope including all equivalents of the subject matter of the claims. Each and every claim is incorporated as further disclosure into the specification and the claims are embodiment(s) of the present disclosure.
While several embodiments have been provided in the present disclosure, it may be understood that the disclosed embodiments might be embodied in many other specific forms without departing from the spirit or scope of the present disclosure. The present examples are to be considered as illustrative and not restrictive, and the intention is not to be limited to the details given herein. For example, the various elements or components may be combined or integrated in another system or certain features may be omitted, or not implemented.
In addition, the various embodiments described and illustrated in the various embodiments as discrete or separate may be combined or integrated with other systems, modules, techniques, or methods without departing from the scope of the present disclosure. Other items shown or discussed as coupled or directly coupled or communicating with each other may be indirectly coupled or communicating through some interface, device, or intermediate component whether electrically, mechanically, or otherwise. Other examples of changes, substitutions, and alterations are ascertainable by one skilled in the art and may be made without departing from the spirit and scope disclosed herein.
In closing, it should be noted that the discussion of any reference is not an admission that it is prior art to the presently disclosed embodiments, especially any reference that may have a publication date after the priority date of this application. At the same time, each and every claim below is hereby incorporated into this detailed description or specification as additional embodiments of the presently disclosed embodiments.
This patent application is a Reissue Patent Application of U.S. Pat. No. 10,499,996, filed on Sep. 26, 2017 as U.S. patent application Ser. No. 15/561,666, which is a U.S. national phase application of PCT International Patent Application No. PCT/US2016/024262, filed on Mar. 25, 2016, which claims the benefit of U.S. Provisional Patent Application Ser. No. 62/138,529, filed on Mar. 26, 2015 and titled “Methods and Systems for Computer-Aided Navigation in Surgical Procedures”, and U.S. Provisional Patent Application Ser. No. 62/255,513, filed on Nov. 15, 2015 and titled “Methods and Systems for Computer-Aided Navigation in Surgical Procedures”, all of which are hereby incorporated by reference in their entireties.
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| Number | Date | Country | |
|---|---|---|---|
| 62255513 | Nov 2015 | US | |
| 62138529 | Mar 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15561666 | Mar 2016 | US |
| Child | 17548202 | US |
