Patent Application
20220370144
The present invention relates generally to medical imaging and mapping, and specifically to registration of medical images with a position tracking system.
In image-guided surgery a medical practitioner uses instruments that are tracked in real time so that positions and/or orientations of the instruments may be presented on images of a patient's anatomy during a surgical procedure. In some cases both the tracking and the imaging of the patient's anatomy may be implemented by one modality, such as fluoroscopy. However, because fluoroscopy uses ionizing radiation, its use should be minimized. Consequently in many scenarios an image of the patient is prepared in one modality, such as magnetic resonance imaging (MRI) or computerized tomography (CT) fluoroscopy, and the instrument tracking uses a different modality, such as magnetic tracking.
For accurate utilization of imaging in conjunction with instrument tracking, the two modalities should be accurately registered with each other. For this purpose, for example, United States Patent Application Publication 2019/0046272, whose disclosure is incorporated herein by reference, describes a method, which includes receiving a CT image of voxels of a subject's head, and analyzing the image to identify respective locations of the subject's eyes in the image, so defining a first line segment joining the respective locations. The method includes identifying a voxel subset overlaying bony sections of the head, lying on a second line segment parallel to the first line segment and on a third line segment orthogonal to the first line segment. A magnetic tracking system configured to measure positions on the subject's head is activated, and a probe, operative in the system, is positioned in proximity to the bony sections to measure positions of a surface of the head overlaying the bony sections. A correspondence between the positions and the voxel subset is formed, and a registration between the CT image and the magnetic tracking system is generated in response to the correspondence.
As another example, U.S. Pat. No. 10,265,137 describes a template, which may be aligned to the patient and instruments passed though the guide elements and into various targets. The template may be aligned using one or more of, for example, a position sensing system or a live imaging modality to register the patient to the template.
United States Patent Application Publication 2019/0282301 describes image guidance software comprising an algorithm for registering a virtual device model to the image space automatically, approximating the most likely configuration of a device on the skin surface before the actual device is placed on the patient. The virtual model of the device and its reachable area are overlaid on the planning image data, in order to visualize and quantify the reachability of the target.
United States Patent Application Publication 2006/0116576 describes systems and method for navigating a medical probe (such as a catheter) relative to an anatomical body (such as a heart). A mark (such as a point or line), representing an anatomical region of interest (such as tissue targeted for treatment or tissue not targeted for treatment) is displayed on a representation of the anatomical body. The positions of the medical probe and the mark are determined within a three-dimensional coordinate system, and the proximity between the medical probe and the mark determined based on these positions. This proximity can then be indicated to a user, e.g., using graphics, text, or audible sounds.
U.S. Pat. No. 8,657,809 describes a surgical navigation system, which includes a camera that is fixedly attached to a patient. The camera space merges with the patient space and thereby eliminates the need for a separate patient tracker. The surgical navigation system calculates the position of a surgical tool with a tracking device in view of the camera and shows on a display device the position of the surgical tool with respect to the patient superimposed and in correlation with a scan image of the patient.
United States Patent Application Publication 2014/0343408 describes an apparatus and methods for use with an imaging device that acquires an external image of a multi-lumen structure within a subject's body. A tool with a location sensor coupled thereto is moved along branches of the structure. The multi-lumen structure is registered with the external image, such that the multi-lumen structure and the external image of the multi-lumen structure have a common frame of coordinates, by sensing the location coordinates of the tool while the tool moves along a plurality of branch lines within the multi-lumen structure, the branch lines defining a plurality of paths within the multi-lumen structure. The branch lines are identified within the image, and a correspondence between the sensed location coordinates of the tool and the plurality of branch lines within the image is determined.
Embodiments of the present invention that are described hereinbelow provide improved apparatus and methods for registration of images with a tracking system.
There is therefore provided, in accordance with an embodiment of the invention, medical apparatus including a probe, which includes a handle having a longitudinal axis, a distal tip disposed on the longitudinal axis, and a position sensor, which is disposed in the handle on the longitudinal axis at a predefined distance from the distal tip and is configured to output a signal indicative of a location of the probe. An alignment jig includes a connector configured to be fixed removably to the distal tip of the probe and three protrusions, which extend from the connector and are configured to contact a surface of a body of a patient at respective points, which are disposed in a plane perpendicular to the longitudinal axis when the connector is fixed to the distal tip of the probe.
In a disclosed embodiment, the connector includes a socket, which fits over the distal tip. Additionally or alternatively, the protrusions include rollers, which are configured to contact and roll over the surface of the body.
There is also provided, in accordance with an embodiment of the invention, medical apparatus, including a registration probe, which has a longitudinal axis and a distal tip disposed on the longitudinal axis, and which includes an alignment jig including three protrusions, which extend from the distal tip and are configured to contact a surface of a part of a body of a patient at respective points, which are disposed in a plane perpendicular to the longitudinal axis. A position sensor is disposed on the longitudinal axis at a predefined distance from the distal tip. a position-tracking system is configured to acquire position coordinates of the position sensor in a first frame of reference defined by the position-tracking system in a vicinity of the part of the body of the patient. A processing unit is configured to receive three-dimensional (3D) image data with respect to at least the part of the body of the patient in a second frame of reference, to receive the position coordinates acquired by the position-tracking system while the distal tip of the registration probe contacts the locations on the surface of the part of the body of the patient, and to register the first and second frames of reference by comparing the position coordinates to corresponding locations in the three-dimensional image data.
In a disclosed embodiment, the position-tracking system includes a magnetic position-tracking system. Additionally or alternatively, the three-dimensional image data includes data from a computerized tomography (CT) system or from a magnetic resonance imaging (MRI) system. In one embodiment, the part of the body of the patient includes a head of the patient, and the 2D image shows a face of the patient.
In some embodiments, registering the first and second frames of reference includes applying relative scaling, rotations and translations between the first and second frames of reference so as to maximize a correlation between the position coordinates and the corresponding locations in the three-dimensional image data.
Additionally or alternatively, the processing unit receives the landmark locations from a practitioner operating the registration probe to mark the locations on the 2D image.
There is additionally provided, in accordance with an embodiment of the invention, a method for registering medical images. The method includes providing a probe including a handle having a longitudinal axis, a distal tip disposed on the longitudinal axis, and a position sensor, which is disposed in the handle on the longitudinal axis at a predefined distance from the distal tip and is configured to output a signal indicative of a location of the probe. An alignment jig is fitted over the distal tip of the probe, wherein the alignment jig includes three protrusions, which extend from the connector and are configured to contact a surface of a body of a patient at respective points, which are disposed in a plane perpendicular to the longitudinal axis when the connector is fixed to the distal tip of the probe. The probe is applied in registering a position-tracking system, which is configured to acquire position coordinates of the position sensor, with a frame of reference of three-dimensional (3D) image data with respect to at least a part of the body of the patient.
In a disclosed embodiment, the alignment jig is fitted removably over the distal tip.
Additionally or alternatively, the part of the body of the patient includes a head of the patient, and applying the probe includes bringing the alignment jig into contact with a face of the patient.
The present invention will be more fully understood from the following detailed description of the embodiments thereof, taken together with the drawings in which:
Magnetic tracking systems are used for tracking instruments in invasive diagnostic and therapeutic procedures, such as image-guided surgery, using pre-acquired images, such as CT images, of the part of the body of the patient undergoing the procedure. In order for the tracking to be effective, frames of reference of the image and the tracking system have to be registered with each other. In a typical registration procedure between, for example, a CT image and a magnetic tracking system, the coordinates of a number of different anatomical points (referred to as landmarks) are marked in the CT image, and the coordinates of the same landmarks are acquired by the tracking system. Once pairs of such coordinate points have been acquired, a fitting process is applied in order to estimate the transformation, including scaling, rotation and translation, that best aligns, i.e., registers, the two sets of points. The fit may be computed, for example, using algorithms that are known in the art, such as cumulative distance metric or an iterative closest point (ICP) algorithm.
As an example, we will consider a procedure requiring tracking of an instrument used on a patient's head, such as an ear, nose, and throat (ENT) procedure. In such a procedure, the head of the patient is registered with the frame of reference of the tracking system. Example of such a registration procedure is described in U.S. patent application Ser. No. 16/704,042, filed Dec. 5, 2019, whose disclosure is incorporated herein by reference. In the described procedure, a processing unit of a magnetic tracking system receives 3D image data of a head of the patient, and generates a 2D image of the surface of the part of the head based on the 3D image data. The processing unit further renders the 2D image to a display screen, and superimposes, under guidance from a medical practitioner, such as a physician, onto the displayed 2D image icons indicating locations of respective landmarks on the surface of the head. The physician touches with the distal end of a registration probe comprising a magnetic position sensor, guided by these icons on the 2D image, the corresponding points on the patient's head and indicates to the processing unit which point he/she has touched. The processing unit receives the corresponding 3D position coordinates of the position sensor acquired by the position-tracking system from these points. Finally, the processing unit registers the frame of reference of the position-tracking system with the frame of reference of the 3D image data by relative translations and rotations of the two frames of reference, until the correlation between the 3D coordinates acquired by the position-tracking system and the coordinates of the 3D image data corresponding to the icons is maximized.
Errors may, however, be introduced into the recorded 3D coordinates of the patient's head and cause a concomitant error in the registration between the frames of reference of the image and the tracking system. One type of error is caused by the registration probe being held so that its longitudinal axis (the axis connecting the distal end and the position sensor) is not perpendicular to the patient's skin. Even when the position sensor measures the angular orientation of the probe, in addition to the 3D location coordinates of the sensor, significant errors can still arise in maintaining the desired perpendicular orientation of the probe relative to the surface of the patient's head (i.e., the skin). This error, in turn, leads to an inaccuracy in the estimated location of the distal end of the registration probe.
Another error may be caused by the distal end of the registration probe indenting the skin due to pressure exerted by the practitioner. This indentation can be particularly significant in soft areas of the head (for example, cheeks) and for patients whose skin is swollen, for example due to medication. Yet another error may be caused by the registration probe dragging the skin sideways, which can occur in elderly patients with loose skin.
The embodiments of the present invention that are described herein address this problem by providing an alignment jig at the distal end of the registration probe, to ensure that the probe is held perpendicular to the skin surface and indents the skin only minimally. To enhance sterility, the jig can advantageously be produced as a disposable plastic part, which fits over the distal tip of the registration probe; although alternatively, the jig may be a fixed, integral part of the probe. The jig comprises three protrusions, which extend distally from the probe and contact the surface of the patient's body at respective points, which lie in a plane perpendicular to the longitudinal axis of the probe. The protrusions divide the pressure exerted by the practitioner and thus assist the practitioner in holding the probe perpendicular to the body surface without indenting the skin too deeply. When the probe is to be used in registering a tracking system with an image of the patient's face, the jig is made sufficiently narrow to reliably contact all areas of the face, such as the nose. Additionally or alternatively, the protrusions comprise rollers, which aid in shifting the probe smoothly across the patient's skin.
In the disclosed embodiments, a medical apparatus includes a registration probe comprising a handle having a longitudinal axis, with a distal tip on the longitudinal axis. A position sensor is mounted in the handle of the registration probe on the longitudinal axis, at a certain predefined distance from the distal tip. The position sensor outputs a signal indicative of the location of the registration probe. An alignment jig comprises a connector, which is fixed removably to the tip of the registration probe. Three protrusions extend from the connector and contact the surface of a patient's body at respective points. As noted earlier, these points are disposed in a plane that is perpendicular to the longitudinal axis of the handle when the connector is fixed to the tip of the registration probe.
The three-point contact of the jig establishes the angular orientation of the registration probe with respect to the skin with greater accuracy and ease than can be accomplished with a single-point registration probe. Thus, the jig ensures accurate and repeatable perpendicular orientation of the probe with respect to the skin while reducing the possible indentation of the skin by the distal end of the probe. These features of the alignment jig improve the accuracy and repeatability of the recorded position of the distal tip of the registration probe on the skin of the patient, thus improving the registration between the frames of reference of the image and the tracking system.
Position-tracking system 12 is used to track positions and orientations of one or more instruments, such as catheters or guidewires, that are inserted into patient 14 during a medical procedure performed on the patient. As is described below, position-tracking system 12 is also able to track the position, and possibly also the orientation, of a registration probe 16 that is external to the patient. Probe 16 comprises a handle 18 that may be held by a medical practitioner 20, typically a physician, during use of system 10 for positioning the probe in a desired location and orientation. Probe 16 further comprises a distal tip with an alignment jig 100 and a position sensor 22, whose position and orientation are tracked by position tracking system 12.
For clarity and simplicity in the following description, the medical procedure referred to above is assumed to comprise an invasive procedure on a nasal sinus of patient 14, so that medical apparatus 10 and magnetic position-tracking system 12 are assumed to be configured to operate in and around the region of the nasal sinus. However, systems 10 and 12 may alternatively be configured to operate in and around other regions of a patient, such as the thorax, kidneys or abdomen, and those having ordinary skill in the art will be able to adapt the elements of the systems that are described herein for operation in such other regions. Furthermore, the principles of the present invention may be applied in conjunction with other types of tracking systems (not necessarily magnetic), as well as other sorts of 3D imaging modalities, such as MRI.
Tracking system 12 is operated by a system processor 24, comprising a processing unit 26 communicating with a probe tracking module 28. The function of module 28 is described below. System processor 24 may be mounted in a console 30, which comprises operating controls 32 that typically include a pointing device such as a mouse or trackball. Physician 20 uses operating controls 32 to transmit commands to system processor 24, which, as described below, is further used to present to the physician data and guiding imagery on a display screen 34.
System processor 24 typically comprises a programmable processor, which uses software stored in a memory of processing unit 26 to operate apparatus 10. The software may be downloaded to system processor 24 in electronic form, over a network, for example, or it may, alternatively or additionally, be provided and/or stored on non-transitory tangible media, such as magnetic, optical, or electronic memory. System processor 24 further stores digitized 3D CT image 48 of head 38 of patient 14, wherein the CT image has been acquired by a separate CT system (not shown), possibly at a different point in time. CT image 48 comprises the 3D coordinates of each point in the image, as well as the radiographic density of the image at each point, with the density given in Hounsfield units, for example.
In order to track the instruments referred to above within patient 14, as well as to track probe 16, processing unit 26 uses probe tracking module 28 to operate, via a cable 35, a plurality of magnetic field generators 36, such as coils. In one embodiment, typically applicable if patient 14 is anesthetized and has a recumbent immobile head 38 on a bed 40, generators 36, as illustrated in
Generators 36 radiate alternating magnetic fields into and around head 38 of patient 14, and these fields generate signals in magnetic detectors in the instruments and in position sensor 22 of probe 16. The signals are conveyed back to processing unit 26 and probe tracking module 28, via a cable 44 connecting probe 16 to console 30. The processing unit and the module together analyze the signals to derive location and orientation coordinates of the instruments and probe 16 with respect to generators 36. Magnetic field generators 36 thus define a coordinate frame of reference 46 of magnetic tracking system 12.
During the process of registration, as detailed in the above-referenced U.S. patent application Ser. No. 16/704,042, processing unit 26 accesses 3D CT image 48 and renders it into a 2D image 50 on display screen 34. Processing unit 26 further superimposes icons 54 onto selected points on 2D image 50, typically corresponding to anatomical landmarks on the patient's face. Physician 20 brings alignment jig 100 of registration probe 16 into contact with a surface 52 of patient 14 (i.e., with the skin of the patient) at each point corresponding to an icon 54 in turn, and processing unit 26 records the 3D coordinates of the probe at each of these points.
Using these recorded coordinates and the coordinates of the corresponding points in the frame of reference of CT image 48, processing unit 26 registers the frame of reference of position-tracking system 12 with the frame of reference of 3D CT image 48 by computing a transformation including relative scaling, rotations and translations of the two frames of reference. Typically, the transformation is found by a fitting process, which maximizes the correlation between the registered 3D coordinates of the probe and the 3D coordinates of CT image 48 corresponding to icons 54. For maximizing the correlation, processing unit 26 may use algorithms such as cumulative distance metric or an iterative closest point (ICP) algorithm. After the initial registration using icons 54, the accuracy of the registration may be increased by superimposing additional icons on image 50 to be contacted by physician 20 using registration probe 16 and to be recorded by processing unit 26.
A communication between physician 20 and processing unit 26 is established in order to indicate which point on surface 52 is touched. For example, processing unit 26 may cause an icon 54 to flash on display screen 34, thus indicating to physician 20 the point he/she is expected to touch. Once physician 20 has touched this point, he/she indicates through controls 32 (for example, by pressing a key in the keypad or clicking the mouse) that the point has been touched. Alternatively, each icon 54 may be numbered using a numerical sequence, and physician 20 indicates through controls 32 which of the icons he/she has touched.
Jig 100 touches surface 52 of patient 14 (i.e., the skin of the patient) at a location 102. A line 104 indicates schematically a plane P that is tangent to surface 52 at location 102. A longitudinal axis 106 of handle 18 forms an angle a with respect to line 104 (plane P). Position sensor 22 in handle 18 is offset from distal tip 23 by a distance D, for example 4 cm. In order to reduce errors of registration due to this offset, it is desirable to hold probe 16 perpendicular to surface 52, i.e., to maintain angle a at 90°. In the pictured embodiment, alignment jig 100 (shown in detail in
Alignment jig 100 is also useful in reducing registration error due to compressing or displacing the skin of patient 14 in a direction perpendicular to the skin (perpendicular to plane P), as well as due to lateral movement of probe 16 along the skin.
Reference is now made to
As shown in
Three protrusions 114 extend distally from a body 111 of alignment jig 100 and define a plane perpendicular to axis 116 of the alignment jig. The triangular arrangement of protrusions 114 is shown in
As shown in
In the pictured embodiment, alignment jig 100 is a separate entity from probe 16. It may be produced inexpensively, for example from molded plastic, and then disposed of after use, thus avoiding the need for cleaning and sterilization.
It will be appreciated that the embodiments described above are cited by way of example, and that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art.
