MOBILE SURGICAL NAVIGATION SYSTEM

20210030479 · 2021-02-04

    Inventors

    Cpc classification

    International classification

    Abstract

    The optical tracking system for mobile surgical navigation generally includes An Optical Tracking System {10} which is able to sense Fiducials (21) located on Markers (20) via Optical Sensors (11). The Optical Tracking System has processing means to compute the pose (position+translation) of the Markers (2.0) and transfer them to a Tablet computer (40) via Communication Means (30). These metrological data are finally used by a surgical application.

    Claims

    1.-44. (canceled)

    45. An optical tracking system for medical applications, comprising: an optical tracking unit including a sensor and a tracking unit clock, a processing unit and energy providing device, the optical tracking unit, the sensor and the processing unit integrated in a single housing; a marker for attachment to an object or to a person; a display device receiving data from the tracking unit; and a wireless communication device connecting the tracking unit with the display device and allowing data to be transmitted between the tracking unit and the display device, wherein the sensor is configured to detect the marker so that the position and/or orientation of the marker relatively to the tracking unit is determined by data processing of sensor data, and wherein data processing is carried out by the processing unit such that the processed data transmitted by the wireless communication device between the tracking unit and the display device is optimized to the communication channel; or wherein the marker includes a marker sensor generating marker data and having a marker sensor clock, wherein the wireless communication device connecting the tracking unit with the marker and allowing data being transmitted between the tracking unit and the marker, and wherein the sensor detects the marker such that the position and/or orientation of the marker relatively to the tracking unit is determined by a data processing of sensor data and/or of marker data, and wherein during the data processing data timestamps are synchronized in real time to compensate a difference in time between different marker sensor clocks

    46. The optical tracking system as defined in claim 45, wherein the display device includes a tablet computer.

    47. The optical tracking system as defined in claim 45, wherein the energy providing device includes a battery pack, the battery pack being integrated in a same housing as the optical tracking unit or removably attached to the housing.

    48. The optical tracking system as defined in claim 45, wherein the optical tracking unit includes at least two sensors.

    49. The optical tracking system as defined in claim 45, wherein the marker includes a fiducial, a 3D position of the fiducial is computed using a triangulation technique.

    50. The optical tracking system as defined in claim 45, wherein the sensor includes a camera.

    51. The optical tracking system as defined in claim 45, wherein the marker includes a fiducial made of light generating elements.

    52. The optical tracking system as defined in claim 51, wherein the light generating elements are both used to transmit data and used as fiducials during the sensing phase.

    53. The optical tacking system as defined in claim 45, wherein the tracking unit includes an attachment mechanism to attach a surgical drape.

    54. The optical tracking system as defined in claim 45, wherein the wireless communication is performed via a physical layer based on a IEEE 802.11 standard, a IEEE 802.15 standard, or Li-Fi standard.

    55. The optical tracking system as defined in claim 45, wherein a time difference of clocks between the sensor data and a corresponding marker data is determined.

    56. The optical tracking system as defined in claim 45, wherein the marker sensor includes data from a three-axis accelerometer and a three-axis gyroscope that is part of the marker data.

    57. The optical tracking system as defined in claim 45, wherein a synchronization timestamp is estimated by correlation of common physical signals that can be retrieved independently from optical data and sensor data.

    58. The optical tracking system as defined in claim 57, wherein the common physical signals include acceleration, velocity and/or position.

    59. The optical tracking system as defined in claim 45, wherein sensor data or marker data is either interpolated or extrapolated to fit a common timestamp.

    60. The optical tracking system as defined in claim 45, wherein the wireless communication device includes a deterministic packet transmission technology.

    61. The optical tracking system as defined in claim 45, wherein the wireless communication device includes an optical or near-infrared communication.

    62. The optical tracking system as defined in claim 60, wherein the deterministic wireless packet transmission technology is using light generating elements that are also used as fiducials during a sensing phase.

    63. The optical tracking system as defined in claim 60, wherein the marker further includes a data bus, wherein the tracking unit clock is transferred to the marker via the deterministic packet transmission technology and tracking unit clock is further transferred on the data bus.

    64. The optical tracking system as defined in claim 45, wherein marker position and/or orientation provided by the optical tracking unit and marker sensor data are merged to provide an improved marker position and/or orientation.

    65. The optical tracking system as defined in claim 45, wherein a marker position and/or orientation provided by the optical tracking unit and marker sensor data are merged to provide an marker position and/or orientation at a higher update rate than the speed of the optical sensor.

    66. The optical tracking system as defined in claim 45, wherein the system is portable.

    67. A surgical device combined with an optical tracking system as defined in claim 45.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0080] Various other objects, features and attendant advantages of the present invention will become fully appreciated as the same becomes better understood when considered in conjunction with the accompanying drawings, in which like reference characters designate the same or similar parts throughout the several views, and wherein:

    [0081] FIG. 1 illustrates the main elements of the invention in a schematical perspective view;

    [0082] FIG. 2 presents a traditional Navigation Cart used in medical tracking applications;

    [0083] FIG. 3 illustrates an embodiment of the present invention;

    [0084] FIG. 4 illustrates an embodiment of the present invention;

    [0085] FIG. 5 illustrates a sequence diagram of an optical tracking system using active markers according to an embodiment of the present invention;

    [0086] FIG. 6 illustrates an embodiment of the invention;

    [0087] FIG. 7 illustrates a sequence diagram of an optical tracking system using active markers according to an embodiment of the present invention;

    [0088] FIG. 8 illustrates a sequence diagram of an optical tracking system using active Markers according to an embodiment of the present invention;

    [0089] FIG. 9 illustrates an embodiment that correspond to the sequence diagram of FIG. 8 (with only one marker);

    [0090] FIG. 10 illustrates an embodiment that correspond to the sequence diagram of FIG. 7 (with only one marker).

    [0091] FIG. 11 illustrates an embodiment of the invention without display means.

    DETAILED DESCRIPTION OF THE INVENTION

    [0092] FIG. 1 illustrates schematically main elements of an embodiment of the invention. The setup comprises an Optical Tracking System 10, in this example comprising two cameras 11, a battery pack 12 and a fixation mechanism 13. Markers 20 comprising fiducials 21 are fixed 22 to the patient and/or the surgical instruments. Fiducials 21 are identified by the camera, and triangulated to get their 3D position. Pose (orientation and/or position) of the markers 20 can be determined if at least three fiducials 21 are seen by the two cameras and triangulated. Poses (and other data) can be transferredin this example via a wireless link 30to a tablet 40. The tablet comprises for example a PC/processing unit 41, a touch-screen 42 and means to receive the data from the tracking system via the link 30. The Optical Tracking System 10, as well as the tablet 40 can be draped to be operated within the sterile field or otherwise protected.

    [0093] FIG. 2 illustrates a traditional Navigation Cart 50. The Optical Tracking System 10, the Markers 20 and their sub-components are similar to FIG. 1 except that the Optical Tracking System 10 is on a mechanical arm 51 (resp. pole) fixed on the cart. This arm contains necessary cables for the power supply and to connect the tracking system directly to the PC or computer 41. The tracking system may be oriented to aim the Markers 20 using a Handle 52. The cart is powered by a cable directly plugged into the wall outlet. The navigation application runs on the PC 41 and is displayed on a (touch) screen 42. The problems linked to a traditional Navigation Cart 50 are the following: Navigation Carts 50 are bulky and cumbersome and require consequence storage space; There are numerous risks of damage of the Optical Tracking System 10 when moving in/out of the storage space (e, g. Optical Tracking System got damaged when hit through a door, damages due to vibrations of the cart when rolled on a paved floor); There are line of sight (occlusions) problems as Markers 20 are located inside the sterile field, the Optical Tracking System 10 is placed outside and nurses surgeons are moving in-between.

    [0094] FIG. 3 illustrates another embodiment of the present invention. The Optical Tracking System 10 is clipped on a (non-sterile) Holder 61 of a Surgical Lamp 60. The Surgical Lamp 60 being fixed to the ceiling via a Mechanical Arm 62, Power for the Optical Tracking System 10 is either taken from the lamp or embedded in a battery pack (not represented here but presented in FIG. 1). The Optical Tracking System transfers data to the Tablet by means of a wireless communication 30. Wireless data transfer is optimized to fit transmission bandwidth while delivering the maximum update rate with the minimum latency to the (tablet) PC.

    [0095] FIG. 4 illustrates an alternative embodiment of the present invention. The Optical Tracking System 10 comprises a Mechanism 14 to precisely fix a Sterile Window 61 in front of the Optical Sensors 11. The Sterile Window 61 is preferably integrated in a Sterile Drape 60 that covers partly or entirely the Optical Tracking System 10. The Sterile Window 61 and/or the Sterile Drape 60 has a fixation mechanism (62e. g. hook, clip, magnet, or other equivalent etc.) to precisely attach the window on another part that is located on the Optical Tracking System 14. Ideally the window should fit parallel to the Optical Sensors 11. at a known distance. This precise fixation enables to adapt the optical model of the tracking system 10 to compensate for optical diffractions through the Sterile Window 61.

    [0096] FIG. 5 illustrates a typical sequence diagram of an Optical Tracking System using active Markers with a deterministic wireless packet transmission using infrared light. Data transfer between the Optical Tracking System 10 to the Tablet PC 40 can either be wired or wireless. The tracking system queries the Markers 20 to activate them (active markers). The Markers 20 switch their IR-LEDs 21 on (switch IR-LEDs on) as fiducials. The fiducials (IR-LEDs 21) are simultaneously detected by the Optical Tracking System (sense fiducials). Fiducials 21 are further identified (fids. identification) within data generated by the different Optical Sensors (e.g. images if the optical sensor is a camera) and triangulated (fids. triangulation). Pose (position and/or orientation) of the markers 20 is estimated in the tracking system (pose estimation) and further send to the Tablet (send pose data). A subsequent cycle starts with the same sequence (. . . ) for tracking purposes.

    [0097] FIG. 6 illustrates another embodiment of the invention. The Optical Tracking System 10 is used for both tracking and overlaying information on camera images 70 either in real-time and/or for archiving purposes after a medical, for example surgical, intervention. Different overlays are possible as 72 refers to the tooltip position of a surgical instrument in the image (given the instrument is tracked and the position of the tooltip is known with respect to the Marker coordinate system). Reference 71 presents an augmented-reality view (overlay of a preoperative 3D reconstruction of the patient in the optical sensor image). Reference 73 presents the 3D trajectory of the tool (and optionally the distance to the patient). Reference 74 presents the Marker registration error of the tool. Any other type of information could be overlaid in the camera images like an ultrasound probe image, cardiogram, heartbeat, etc.

    [0098] FIG. 7 illustrates a sequence diagram of an Optical Tracking System using active Markers 20, which have embedded sensors. The sequence is similar to FIG. 5 except that there is a wireless link with deterministic wireless packet transmission between the Markers 20 and the Optical Tracking System 10 to transfer the embedded sensors data linked to an optical acquisition to the Optical Tracking System (retrieve embedded sensors). The embedded sensor data can be used alone or together with the optical data to estimate the marker pose, e.g. position and/or orientation, (processingdata fusion). The advantage of having a deterministic wireless packet transmission is the possibility to have both the pose (position and/or orientation) data and the embedded sensors marker data with a common timestamp as all the timings within the system are deterministic. The resulting pose (position and/or orientation) and/or the embedded sensor data are finally send to the tablet (sendfusedpose data and/or embedded sensors). Note that several embedded sensors data packets can be send during an optical acquisition cycle, dependent on the speed/frequency acquisition of data from both sources (embedded sensors data and optical data). This method can be used to have a common timestamp to compute a sensor fusion between optical 3D/6D data and embedded marker pose (position and/or orientation) data. This method is useful for example to augment the precision of the measurements or to compensate data loss. A loss can typically occur when the optical detection is impaired, when a marker 20 cannot be detected by the sensors 11. This can happen if somebody stands in the way (for example the surgeon) or another obstacle is present and, during a certain time, the optical detection is not working properly. The missing optical data may thus be replaced by the embedded sensor data.

    [0099] FIG. 8 is an example of a sequence diagram of an Optical Tracking System 10 using active Markers 20. The active Markers having embedded sensors. This is an alternative sequence to FIG. 7. During the active markers message, the timestamp and/or any other information related to the current acquisition cycle of the tracking system is sent to the markers (active markers with timestampTS). The markers directly transmit embedded sensors information to the tablet including a timestamp information (retrieve embedded sensors with TS) with any wired or wireless transmission means. The Optical Tracking System 10 also send the pose (position and/or orientation) data including the timestamp information to the tablet (send pose data) with any wired or wireless transmission means. This method allows to resynchronize the timestamps of data coming both from the Markers and from the Optical Tracking System. Note that the transmission delays between the various components is ideally deterministic, which enables optimal sensor fusion directly on the tablet.

    [0100] FIG. 9 illustrates concrete embodiment that correspond to the sequence diagram of FIG. 8 (with only one marker). In this example, the Optical Tracking System 10 further comprises a real-time deterministic wireless packet transmission 15 that is used to transmit the timestamp of the Optical Tracking System, as well as to inform the markers when the optical measurement is taking place 16. If the Fiducials 2:1 are light elements, this piece of information corresponds to the moment when the lights of the Marker are switched on. Both the transferred timestamp of the optical tracking system and the deterministic transmission time enable to synchronize the internal clock of the marker with the clock of the optical tracking system. The Marker 20 further comprises Embedded Sensors that acquire data with the synchronized clock 23 and means to transfer the data 24 to the Tablet PC 40, Optical tracking data are transferred to the Tablet PC via another transmission means 30. As both tracking data and embedded sensor data are acquired on the same synchronized clock, it is possible to operate precise data fusion on the Tablet PC.

    [0101] FIG. 10 illustrates an embodiment that corresponds to sequence diagram of FIG. 7 (with only one marker). In this example, the Optical Tracking System 10 further comprises a real-time deterministic wireless packet receptor 15 that is used to retrieve the markers embedded sensor 23 data 25. As the system is deterministic, the Optical Tracking System knows the exact time when the marker sensors data has been acquired, which enable to fuse optical data with data from embedded marker sensors. Data can be fused within the tracking system and further transmitted 30 to the Tablet PC 40. Raw optical tracking data and/or embedded sensor data with a synchronized timestamp can alternatively be transmitted to the Tablet PC 40.

    [0102] FIG. 11 illustrates an embodiment of the invention without display means. The setup comprises an Optical Tracking System 10 that comprises a navigation Software for craniotomies as an application example. A marker 20 is fixed on the skull of a patient 80 via an attachment mechanism 22 (for example a screw or another equivalent means). The surgeon is holding a probe 27 that is a basically marker with a tooltip. The probe has an aiming interface 25 composed if a LCD screen 26b or a LED arrangement 26a. The Optical Tracking System can communicate data to the Markers via wireless communication means 16. Transferred data can comprise information on how to update the aiming interface. Prior to the craniotomy, the surgeon defines the ablation area based on imaging data. After a registration process, the aiming system 26 on the probe 27 helps the surgeon to move (and optionally orient) the tooltip to the correct location on the skull surface to match the planning. For example, the upper LED may blink to indicate that the probe should be moved upwards. Optional buttons 28 on the probe may be used to interact with the navigation Software (e.g. capture surface points during the registration process or move to the next ablation zone).

    [0103] Overview

    [0104] Turning now descriptively to the drawings, in which similar reference characters denote similar elements throughout the several views, the figures illustrate embodiments of an Optical Tracking System 10 which is able to sense Fiducials 2:1 located on Markers 20 via

    [0105] Optical Sensors 11. The Optical Tracking System has processing means in the same housing to compute the pose (position+translation) of the Markers 20 and transfer them to a Tablet computer 40 via Wireless Communication Means 30. These metrological data are finally used by a surgical application.

    [0106] In an embodiment, sensors may be integrated within the Markers 20. Marker sensor data generated by said integrated sensors may be transferred wirelessly to the Optical Tracking System 10 and/or to the PC 40, so that there is a known relation between the optical pose (position and/or orientation) data timestamp (linked to the optical detection with the sensors 11 and the markers 20) and the marker sensor data timestamp (linked to the data generated by the integrated sensors). This relation drastically simplifies data fusion of the marker data sensor with the optical tracking data.

    [0107] Optical Tracking System

    [0108] An Optical Tracking System 10 comprises one or several sensors further called Optical Sensors 11. Optical Sensors 11 retrieve angular information of the Fiducials 21 in view. Fiducials 21 are then identified by cross-checking them on the different Optical Sensors 11. Triangulation is used to compute the 3D positions of the Fiducials 21. If at least three Fiducials 21 are affixed together on one Marker 20, it is possible to compute its pose (that is its position and/or orientation).

    [0109] Fiducials 21 may either be active: they transmit light (e. g. LEDs) or passive: they define a specific pattern (e. g. OR Codes) or they reflect light (e. g. Reflective spheres, disks). Most of Optical Tracking Systems are operating in the visible spectrum or near infrared (IR). Tracking systems using reflective material usually have rings of IR-LEDs around the Optical Sensors 11. These IR-LEDs are flashed, light is reflected on the reflective material and finally captured by optical sensors(e. g. Cameras).

    [0110] The Optical Tracking System 10 can be powered via wire (e. g. USB charger) or alternatively by mean of a battery pack 12.. Battery pack may be recharged by a conventional external charger or by an internal charging electronics. Other charging mechanisms may be considered like solar cells, induction etc.

    [0111] Depending upon the position of the Fiducials 21 and the Optical Sensors 11, triangulation-based optical trackers can be divided into two categories: the inside-out and the outside-in systems. Inside-out systems place the Fiducials 21 at fixed places in the environment and the Optical Sensors 11 on a target object. On the other hand, outside-in systems place the Fiducials 21 on the target object and the Optical Sensors 11 at fixed places in the environment.

    [0112] A fixation mechanism 13 allows to fix the system on an inside-out configuration like on a traditional Navigation Cart SO. More innovative locations could be on a pole or an arm (fixed on the operating table, on the separation between the anaesthetist and the surgical field, or on the cluster of surgical lamps), clipped directly on a surgical lamp (see FIG. 3) or other equipment (e, g. C-Arm, CT, MRI, surgical microscope). One could imagine an add-on handler so a surgeon/nurse could hold the device when needed (e.g. Naviswiss Clip-on style). The tracking system could even be fixed directly on the surgeon (e. g. Integrated in the surgical helmet, placed on glasses, etc.), In an outside-in configuration, it can be fixed on a surgical drill, on an endoscope, on the patient (e. g. via an orthopaedic pinSteinmann nail). If the tracking system is operating in the sterile field, it should be (at least partly) wrapped with a sterile drape 60. Care should be taken to have the Optical Sensors 11 as less perturbed as possible with this drape as light will be reflected and will bias the triangulation. An optical-grade window 61 is typically inserted in the sterile drape to reduce these perturbations and improve the overall accuracy of the system. If the placement of the optical windows of the surgical drape is reproducible, it is possible to integrate the diffraction of the light within the optical model of the system. Taking into account this windows will reduce the triangulation error and provide a better overall accuracy of the system. A straight forward example would be to calibrate the optical tracking system with the reproducible drape in front of it. If it cannot be compensated, the drape should be designed to reduce as much as possible the optical degradations.

    [0113] Optical Sensors 11 are any types of cameras including conventional CMOS/CCD array sensor, light field camera, any optical system composed of a sensor and either a diaphragm and lens(es) (e.g. a conventional digital camera system) or simply a mask pattern in front of the camera sensor. 2D/3D SpaceCoders technology is an alternate possibility (spaceCoder: a Nanometric 3D Position Sensing Device, author E. Grenet & al, published in CSEM Scientific Technical Report 2011). A single camera can be used if the markers comprises at least four fiducials. The company Intellijoint has designed such a camera as an example.

    [0114] Near infrared filter can be used in combination with infrared LEDs. More generally, any filter can be used to increase the SNR.

    [0115] Communication Means 30 to the PC are preferably wireless communication means such as Wi-Fi, wireless personal area network (WPAN), ANT+, Li-Fi, NFC, etc. It can alternatively be any wired connection (Ethernet, USB, Firewire, etc).

    [0116] Communication with active Markers can be realized by IR uni- or bi-directional optical communication or any wireless Communication Means already presented. A real-time deterministic wireless transmission is preferred.

    [0117] FIGS. 7 and 8 present two configurations where such wireless communication enables to retrieve embedded sensors with a common timestamp. Such approaches allow precise sensor fusions techniques. For example, if the markers are equipped with 3D accelerometers and 3D gyroscopes, it is possible to fuse the optical pose (position and/or orientation) with the marker sensor data as presented in (An Inertial and Optical Sensor Fusion Approach for Six Degree-of-Freedom Pose Estimation, Changyu & al, published in Sensors 2015), In this last example, the key aspect is to use a deterministic wireless transmission so that it is possible to have a common timestamp between the data provided by the different sources. A difference of a few microseconds can drastically bias the sensor fusion. Note that wireless protocols like UDP or TCP-IP over Bluetooth or Wi-Fi cannot guarantee a deterministic transmission. As such, real-time inertial and optical sensor fusion cannot be achieved using such non-deterministic technologies (see RT-WiFi: Real-Time High-Speed Communication Protocol for Wireless Cyber-Physical Control Applications, Vi-Hung Wei & al, Real-Time Systems Symposium (RTSS), 2013 IEEE 34.sup.th).

    [0118] The device can be powered by a wire which can also serve to transfer data (e.g. PoE, USB, Firewire). A data cable can be only used to power the device, data being effectively transferred to the PC wirelessly with any suitable protocol (for example as mentioned above). Device can be powered by mean of a battery, electrolytic capacitor, supercapacitor and/or by induction or other equivalent.

    [0119] In order to design a nomad optical tracking system, the optical sensors, computation up the 3D position of fiducials (respectively pose or position and/or orientation of markers) and the power supply should ideally be integrated in the same housing. Preferably, it should be possible to replace the battery during the surgery (e.g. via a clipping, magnetic mechanism or other attachment means) and the wireless transmission should be designed for a low-energy transmission. It practically means that the quantity of data to transmit should be optimized for the used wireless packet transmission technology and ideally as small as possible. Thus, the transmission time will be as short as possible and also the energy use will be optimized.

    [0120] Fixation can be permanent (screws) or easily removable using a clipping mechanism (magnets, clips, etc.) so that the tracking system 10 may rapidly be attached/detached.

    [0121] The system 10 can be designed to offer a fixation mechanism (magnets, clips, notch, hole, etc.) to perfectly place the optical-window of the sterile drape. The attachment mechanism should be designed so that whatever drape is placed, the light going thought the optical window is behaving similarly. The optical model for triangulation is of course preferably designed to take this optical window into account.

    [0122] Near infrared optical tracking systems are widely used in surgery. They basically comprise a set of cameras with a known baseline (respective transformation between the cameras). The cameras operate in the near infrared so that flashes are not disturbing the users. The flashes are emitted by infrared lights that are preferably arranged on a ring around the camera lenses and/or by IR-LEDs (fiducials) located on the Markers.

    [0123] Most frequently used cameras are stereo-camera (comprising two cameras) fixed on a bar. The respective pose or position and/or orientation of the cameras is factory calibrated. Once a fiducial is identified by both cameras, it is possible to compute its 3D position by triangulation. System comprising more cameras are also possible. In this case, triangulation is carried out using the data coming from the different optical sensors.

    [0124] Example of commonly used passive optical stereo-tracking systems which are commercially available are Atracsys infiniTrack, fusionTrack and spryTrack, NDI Polaris or Axios CamBar.

    [0125] Mono-camera systems can alternatively be used. They use projective geometry and at least 4 points on a marker to compute the 3D position of the fiducials. An example of such camera is the one developed by the company named Intelijoint.

    [0126] Tag-based stereo cameras could alternatively also used both in the visible and the near infrared. These cameras detect specific patterns (tags) that could be for example QR-Codes and use elements of the pattern as fiducials. Examples of commonly used tag-based optical tracking systems are Naviswiss ClipOn, ClaroNav MicronTracker.

    [0127] Markers

    [0128] Markers 20also called rigid bodies in the literatureare comprise several Fiducials 21 rigidly fixed altogether. The position of the Fiducial with respect to the Attachment Mechanism 22 or the tooltip is called the geometry and should be well known. During the tracking process, these fiducials 21 are detected, identified and their 3D position computed. If at least three fiducials are detected, an algorithm is further used (e. g. Least-Squares Fitting of Two 3-D Point Sets, Arun 1987) to calculate the pose (position+orientation) of the Marker in the tracking system referential.

    [0129] In IR systems, Fiducials 21 may be IR-LEDs or spheres/disks composed of reflective materials. Markers could alternatively be tags of known patterns. In this case, Fiducials are specific points on these patterns. With such a technology, a Marker could be defined with a single pattern.

    [0130] The Attachment Mechanism 21 is used to fix/glue the Marker 20 both on the patient (e.g. through a pin) and the surgical instruments (e.g. digitizer used for registration, drill, ultrasound probe, or other tools).

    [0131] As Markers are operating in the surgical field, they need to be sterile.

    [0132] Reflective Markers have a typical base of carbon, stainless steel or titanium. Reflective disks or spheres are screwed on the base. Position of reflective fiducials is designed to provide a unique geometry to simplify their identification.

    [0133] Active Markers comprise IR-LEDs. In a non-synchronized configuration, IR-LEDs are always on and should provide similar characteristics as the reflective Makers. If the IR-LEDs are synchronized with the tracking system (e. g. by mean of optical communication), they can emit more energy. Overall power consumption is also reduced and the battery lasts longer. This synchronization of the markers can alternatively be done via a wireless deterministic communication means previously described.

    [0134] Having wireless Communication Means 30 between the Markers and the Optical Tracking System(s) allows to retrieve extra information from the Marker 20 (e. g. marker serial number, calibration, button status, battery status, or any other embedded sensor like inertial, gyroscopic, accelerometer) back to the Tracking System (see FIG. 7) or direct to the Tablet (see FIG. 8). In the other direction, overall application status could be displayed on the Marker 20 (e. g. status of the tracking on a visible LEDs, screen to display application info, targeting mechanism to keep the instrument on a trajectory or to reach an ablation area as illustrated in FIG. 11, error feedback, etc.). Depending on the application, the components may exchange data in another workflow. Markers could communicate between themselves independently to exchange data, retrieve warning/error status, etc. Even markers 20 not localized in the field of the optical tracker 10 could communicate and be identified by tracked markers 20. Their identification can be signalled to the tracker :10 permitting the end-user application on the tablet 40 to localize all activated markers 20, even ones not visible by the optical tracker 10.

    [0135] As discussed previously, a deterministic wireless packet transmission mechanism is required in order to retrieve the timestamp from the optical tracking system or to send the real-time marker sensor data to the optical tracking system.

    [0136] Tags markers are usually printed patterns placed on a flat surface and providing an attachment mechanism. ClaroNav and Naviswiss are providing system using such markers.

    [0137] Communication Means

    [0138] Communication Means 30 enable the Tracking System 10 to send metrological data to the PC/Processing Unit 41. In a traditional system, communication means are wired. As such, there are no real needs to optimize the bandwidth. Raw data (e. g. full images) may be transferred to the PC for further processing. Wired connections on nomad or smaller Tracking Systems might however be a major concern within a surgical field. Accessibility of all the working field is of main importance for the surgeon. Wired accessories (e.g. Markers) are less and less tolerated in the sterile field for security reasons and ergonomics. They now are more and more replaced by wireless accessories.

    [0139] The proposed system aims to reduce the data to a minimum to be able to send them via a wireless link like WPAN or Wi-Fi. As such, most of the tracking processing should be realized on the tracking system itself. In a minimal configuration only the timestamp (resp. counter), the pose (6 DoF) and the. ID of every visible Markers 20 need to be transferred. Another advantage of this compact data transfer is to allow higher update rates as well as smaller latencies. Energy consumption will also be reduced if the data bandwidth is low. Saving energy is typically necessary if the tracking system is operated with a battery.

    [0140] Tablet

    [0141] The Tablet 40 runs the Navigation Software. Even if this application is specific to a surgical gesture, Navigation Software share more or less the same basis. Marker poses or positions and/or orientations coming from the Optical Tracking System 10 through Communication Means 30 are retrieved/computed by the application running on the Tablet. Relative transformation of Markers 20 are further used to provide metrological information to the surgeon (e.g. real-time location of a biopsy needle in pre-operative imaging, cutting planes that should follow a navigated saw as defined in a pre-operative step, testing the range of motion of a joint, etc.).

    [0142] As the Tablet 40 is no longer fixed on a Navigation Cart 50 and thanks to its compact size, it may be placed closer to or even in the sterile field. It should preferably be wrapped in a sterile bag so that the surgeon can touch it with his/her glows without being contaminated.

    [0143] Tablets could be any Tablet available on the market like an iPad, an Android Tablet or a Microsoft Surfacer. It can also be a laptop with touch capabilities like a Lenovo Yoga. The tablet is preferably a medical-grade product.

    [0144] It is to be noted that in an embodiment of the invention, the Tablet could be avoided. In this case, the Navigation Software is running in the Optical Tracking System. The interface is no longer the tablet and can be directly integrated in the instruments. For example, buttons on the markers could be used as input devices, screens and/or LEDs on the Markers could display navigation information.

    Other Embodiments of the Invention

    [0145] In an embodiment of the invention, part of the processing is preferably done in the same housing as the tracking system in order to reduce the optical pose or position and/or orientation data bandwidth. For example, a processing unit located in the Optical Tracking System 10 can process the raw data coming from the Optical Sensors 11 up to the triangulation of the 3D position of the fiducials 21 and/or the pose or position and/or orientation of the Markers 20. A minimal wireless communication transfer packet would comprise, timestamp (respectively counter), poses (6 DoF) and IDs of the markers. This lightweight data transfer enables a higher update rate of the metrological data and by the way to reduce the overall latency of the system. This will furthermore reduce the energy consumption for the transmission. As an example, imagine a stereo tracking system composed of two VGA optical sensors (640480 pixels), Pixels are grayscale 8 bits. If the raw data are transferred non-compressed to the Tablet, a bandwidth of 2480640=614400 bytes=4.9 mbits is necessary. If data are transferred through Bluetooth v1.2 with a throughput of about 80 kbit/s, about 4900/80 s=1 minute is necessary to get the next measurement. In the other hand if only the poses or position and/or orientation of the markers are communicated and two markers are visible in the images, a total of 26 floating values have to be transmitted. In case of 32 bits floating values, two poses (position and/or orientation) are stored in 264=48 bytes=0.375 kbit meaning that more than 200 update can be realized every second. For tracking system with limited processing power, the computation and transmission of marker poses (6 DoF) within a tight time constraint could be a limitation. In that case, required minimal information such as fiducials centroids in the images are transmitted to the tablet to compute markers poses (positions and/or orientations). The minimum data to send is deduced using the tracking system processing limit, communication bandwidth, tablet processing limitation, required maximal latency, required frame acquisition rate, and/or end-user final application refreshment rate.

    [0146] In an embodiment of the invention, the Communication Means 30 are wireless (preferably WPAN), so that the tracking system 10 can be integrated in the infrastructure of the operating room requiring only a power source to operate. No data cables have to be installed in the room. Power for the Optical Tracking System 10 could be taken directly in the surgical lamp 60 and the device can directly be clamped on the Surgical Lamp 60 (see FIG. 3). An alternate solution would be to have a battery pack attached to the tracking system 10 in a way that it is easily exchanged or recharged. The fixation mechanism may be a clip, a hook, a magnet, etc. The battery pack may be connected to the tracking system 10 via a standard USB connector like a USB charger.

    [0147] In an embodiment of the invention, the Optical Tracking system 10 is preferably operating on batteries and is no longer fixed on the Navigation Cart but on another location, such as: [0148] Directly on a pole or an arm fixed on the operation table; [0149] Clamped on the separation between the anaesthetist and the surgical field; [0150] Placed on a mechanical arm that is part of a cluster of hanging surgical lamps; [0151] Fixed/clipped/integrated in other surgical equipment (C-Arm, surgical microscope, interventional MRI, CT scan, endoscope), fixed directly on the patient or on surgical instruments (e.g. on drills, saw, etc.).

    [0152] In an embodiment of the invention, the Marker 20 has wireless communication means 30 (preferably WPAN, and/or an unidirectional/bidirectional optical channel). Communication can take place between Markers 20 themselves and/or between Markers 20 and Optical Tracking System(s) 10 and/or between Markers 20 and the Tablet 40 and/or between Optical Tracking System(s) 10 and the Tablet 40.

    [0153] In an embodiment of the invention, wireless communication between the Optical Tracking System(s) 10 and active Markers 20 is preferably deterministic and enables to synchronize the overall system by either deciding the exact moment when the IR-LEDs 21 of the Markers 20 should be switched on and/or to synchronize the clocks of the different elements in order to define time slots. Using several Optical Tracking Systems 10 with such synchronization enable to timeslot their acquisition so that there is no cross-talk between them and the measurement accuracy is guaranteed. Having multiple Optical Tracking Systems 10 in parallel enable to increase the working volume by covering it with multiple cameras 11, reduce the line-of-sight problem as Markers 20 can be seen at different viewing angles, and/or increase the acquisition speed as the Optical Tracking Systems 10 are acquiring the ones after the others. For example, a system having an update rate of 25 Hz (40 ms) usually acquired the images of the fiducials within 1 ms. Theoretically forty well synchronized Optical Tracking Systems 10 could acquire data keeping their 25 Hz update rate. The tablet 40 will effectively receive 1000 measurement per seconds successively from the forty tracking systems 10.

    [0154] In an embodiment of the invention, several Optical Tracking Systems 10 are wirelessly connected to the Tablet 40, redundant tracking data can be retrieved and used on the fly to verify the accuracy of measures. They alternatively can be used for optical data fusion.

    [0155] In an embodiment of the invention, Optical Tracking Systems 10 may communicate between themselves independently to exchange data such as calibration, shocks issues. Connected Optical Tracking System(s) 10 may report issues of surrounding trackers to the tablet.

    [0156] In an embodiment of the invention, wireless communication 30 enables to send extra information to the Optical Tracking System 10 (respectively to the Tablet 40). Such information could be the calibration of the Marker 20 (position of the Fiducials 21), button status, battery status, and/or other integrated memory or embedded sensor data (gyroscope, inertial, acceleration, temperature, humidity, GPS, temperature, blood pressure, electrodes, ECG, stimulators, etc.). in case of wireless deterministic communication (e.g. optical or near-infrared communication), integrated sensor data (e. g. inertial, gyroscopes) may be combined with optical measurement (pose of the Marker 20) to provide pose (position and/or orientation) information event if the Marker 20 is not or partly viewed by the Optical Tracking System(s) 10. This redundancy can alternatively be used to improve the accuracy by performing sensor fusion and/or as a redundant pose (position and/or orientation) information. The drift of an inertial sensor can be also corrected when the Marker 20 is in view of the Optical Tracking System 10. FIGS. 7 and 8 presents two different configurations where the time can be synchronised between Markers 20 and Optical Tracking 10 system in order to perform optimal sensor fusion.

    [0157] In an embodiment of the invention, application data (respectively hi-level measurement data like estimation of registration error, reaching point information) may be sent back from the Tablet 40 (respectively Tracking System(s) 10) to the Markers 20. Actuators on the Markers 20 can be used to sense/display this information. For example, a digitizer can vibrate when an anatomical point is correctly registered, visible LEDs can display the status of the Marker 20 (e. g. colour range from green to red, blinking red, status can be the registration error, information if the marker is visible by a tracking system, etc.), a screen located on the Marker 20 can display application data, a visual targeting system on a tracked tool can help the surgeon to position it within a pre-determined trajectory, a sound can be emitted from a Marker 20, etc. The tablet (respectively Optical Tracking System(s)) could also refine, recalibrate, deactivate specific sensors on markers based on redundant information analysed on the fly.

    [0158] In an embodiment of the invention as presented in FIG. 11, the Marker 20 may comprise actuators(e.g. buttons 28, touchpads, and/or pressure sensors) and/or optionally displays (LEDs 26a, LCD 26band/or screen) in order for the surgeon to keep sterile when interacting with the surgical application that could run on the Tablet 40. In this case, the Tablet 40 has no need to be sterile. In extreme setup as the one of FIG. 11, there is no need of a tablet. The interface is directly on the probe hold by the surgeon.

    [0159] In an embodiment of the invention, an Intelligent Tool or robot sharing the same deterministic wireless communication may directly use pose (position and/or orientation) data and/or other data coming from the different connected elements to perform a specific task. For example, the tool can stop drilling if a specific region is reached, the region being defined (pre-operatively) on base of scanner/MRI/ultrasound images. Another example is a robot that could receive the transformation between the end-effector and the patient and use it to operate (e,g. to drill a hole, to perform a biopsy, to move an endoscope to follow in real-time the movements of the patient, etc.).

    [0160] In an embodiment of the invention, Optical Tracking Data may be broadcasted. Several devices may be connected for processing tracking data. They can independently process these data on different applications.

    [0161] In an embodiment of the invention, a battery may be used to get rid of a power wire. In this case, the Optical Tracking System may be totally wireless. The battery may be a rechargeable one (via a wire, induction, and/or solar cells). The battery may be a supercapacitor and/or an accumulator. The battery may be permanently inside the same housing as the tracking device or clipped, so that it may easily be exchanged.

    [0162] In an embodiment of the invention, the Optical Tracking System may be used for tracking purposes as well as to record image/videos during operation. Data can be 2D or 3D. For example, it is easy to compute disparity images/videos from a stereo camera 11. These recordings could be realized for archiving, reglementary and/or display purposes. Real-time disparity images/videos may be further used: [0163] To make any 3D computation on the reconstructed surface (e.g. rigid registration between pre-operative images and the reconstructed surface, gait analysis, measurement on the mesh, etc.); [0164] As an interface to the system in a similar way as the Microsoft Kinect is used for games. For example, the surgeon may trigger action by a specific hand/finger gestures in front of the tracking system. It may be used to start stop recording. It may alternatively be used directly by a patient to interact with an interface while tracking in a rehabilitation application. [0165] For post-surgery analysis. Images/videos combined with any other internal/external metadata may be overlaid for post-surgery analysis (see FIG. 6). Internal meta-data may be tracking parameters, errors in the system (triangulation, registration, etc.). External metadata may be vital parameters of the patient (e.g. heart rate, electrocardiogram, 3d reconstructions of the organs of the patient, etc.). Metadata may be augmented in the images like placing precisely the 3d reconstruction of an organ at the correct position in the image. Registration error or tool-tip of a marker may be overlaid at the correct location in an image. Note that most of these processing may alternatively be computed in real-time during the surgery.

    [0166] As the Optical Tracking System may be very compact and mobile, it may be placed within the surgical field. In this case, the system may be either sterile or placed in a sterile drape. If no care is taken when selecting the drape, overall tracking accuracy can be hardly affected. In an embodiment of the invention, the Optical Tracking System comprises a mechanism to precisely fix a sterile window in front of the Optical Sensors (see FIG. 4). The sterile window is integrated in the sterile drape that covers partly or entirely the Optical Tracking System. The sterile window and/or the sterile drape has a fixation mechanism (e. h. hooks, notches, holes, clips, magnets, etc.) to precisely fix the optical window on a complementary part located on the tracking system. Ideally the window should fit parallel to the optical sensors at a known distance. This window (especially the reflection within it) should be considered in the optical model for triangulation and during the calibration procedure in order to improve its overall metrological accuracy. This window is typically an optical-grade transparent thin plastic or glass. It can be composed of one part covering all the Optical Sensors or one window per Sensor. If a reproducible drape is not possible, it should be designed such that it affects as less as possible the optical measure.

    [0167] In an embodiment of the invention, the Optical Tracking System comprises a Real-Time Supervision Unit (RTSU) that is operating all the time (e. g. when the system is shipped, used, moved and/or stored). The RTSU is sleeping until a shock and/or vibrations and/or a temperature and/or a hygrometry threshold is reached. If such an event occurs, the RTSU records it, optionally tags it with a global time. Such events can be retrieved by the driver/firmware. The system can decide to enter an error mode if specific events occur (typically when a big shock is detected the system can be decalibrated). This error mode can be left if a specific verification procedure is realized. The RTSU may be powered on an extra battery/accumulator so that it is operational even if the system is switched oft The RTSU accumulator could recharge when the tracking system is in operation and powered with another source.

    [0168] In an embodiment of the invention, the system can be used in another field than surgery like interventional radiology, diagnostics, rehabilitation, reverse engineering, part checking and/or motion capture.

    [0169] In an embodiment of the invention, fiducials and/or markers are placed on the person/object to be tracked, the optical tracking system is placed on a (autonomous) mobile platform which is following the person/object. The mobile platform can be a robotic arm, a cart, a (flying) drone, etc. Information from the mobile platform and the optical system can be combined to provide an absolute measurement data of the person/object. Information on the optical tracking system can be used to control the mobile platform. The real-time deterministic wireless packet transmission means can be used to achieve such a task.

    Operation of a Preferred Embodiment

    [0170] The Optical Tracking System 10 acquires data from the Fiducials 21 through the Optical Sensors 11 during the navigated part of the surgery. At the start of each acquisition cycle, the tracking system is either sending a message to the active Markers 20 to switch their IR-LEDs 21 on, and/or flashing the IR-LEDs 21 around the optical sensors to reflect light in case of reflective Markers 20, and/or simply acquire a pair of images if the Markers 20 are Tags. For each Optical Sensor 11, angular position of the Fiducials 21 is further determined. Given epipolar and marker geometry constraints, the fiducials 21 are identified and triangulated. At the end, their 3D position and the Marker 20 they belong to is known. A rigid registration algorithm is further used to compute the poses (positions and/or orientations) of the Markers 20 with respect to the Optical Tracking System 10 referential. Timestamp, markers IDs and their respective poses i.e. positions and/or orientations (and other optional data) are sent to the Tablet 40 though a wireless link 30. The wireless data transfer protocol is designed to optimize the bandwidth in order to guarantee the best update rate and the minimum latency. The application running on the. Tablet 40 uses poses (position and/or orientation) information to assist the surgeon during the surgery as an illustrative application of the invention. Alternatively, application information can be pushed back (directly or via the tracking system) to the markers 20 in order to provide a visual or tactile feedback on the tracked instruments used by the surgeon.

    [0171] Markers 20 may integrate embedded sensors. A deterministic wireless packet transmission protocol is used to transmit embedded sensors data to the Optical Tracking System 10 while optical tracking is in operation. As the system is deterministic, it is possible to synchronize the timestamp of both marker sensor data with their respective pose (position and/or orientation) data. When the timestamps are expressed in the same clock referential, it is possible to adjust any of the data to fit an exact same timestamp using either interpolation or extrapolation techniques. Synchronized data can be further used for data fusion. The sensed data as well as raw data expressed in the same clock referential can further be transmitted to the Navigation PC or Tablet PC 40.

    [0172] What has been described and illustrated herein is a preferred embodiment of the invention along with some of its variations. The terms, descriptions and figures used herein are set forth by way of illustration only and are not meant as limitations. Those skilled in the art will recognize that many variations are possible within the spirit and scope of the invention in which all terms are meant in their broadest, reasonable sense unless otherwise indicated. Also, individual embodiments discussed in the present description are not exclusive and further embodiments of the present invention may be obtained by combination of different individual embodiments and features of said embodiments disclosed herein. Any headings utilized within the description are for convenience only and have no legal or limiting effect.