(19)
(11)EP 3 397 188 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
09.09.2020 Bulletin 2020/37

(21)Application number: 16829205.0

(22)Date of filing:  29.12.2016
(51)International Patent Classification (IPC): 
A61B 34/30(2016.01)
A61B 90/00(2016.01)
A61B 34/20(2016.01)
(86)International application number:
PCT/US2016/069152
(87)International publication number:
WO 2017/117369 (06.07.2017 Gazette  2017/27)

(54)

SYSTEM AND METHODS FOR PREPARING SURGERY ON A PATIENT AT A TARGET SITE DEFINED BY A VIRTUAL OBJECT

SYSTEM UND VERFAHREN ZUR VORBEREITUNG EINES CHIRURGISCHEN EINGRIFFS AN EINEM PATIENTEN AN EINER DURCH EIN VIRTUELLES OBJEKT DEFINIERTEN ZIELSTELLE

SYSTÈME ET PROCÉDÉS POUR PRÉPARER UNE INTERVENTION CHIRURGICALE SUR UN PATIENT AU NIVEAU D'UN SITE CIBLE DÉFINI PAR UN OBJET VIRTUEL


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 31.12.2015 US 201562273543 P

(43)Date of publication of application:
07.11.2018 Bulletin 2018/45

(73)Proprietor: Stryker Corporation
Kalamazoo, MI 49002 (US)

(72)Inventor:
  • MALACKOWSKI, Donald, W.
    Schoolcraft, MI 49087 (US)

(74)Representative: Röthinger, Rainer 
Wuesthoff & Wuesthoff Patentanwälte PartG mbB Schweigerstrasse 2
81541 München
81541 München (DE)


(56)References cited: : 
WO-A1-2011/134083
US-A1- 2014 276 943
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    TECHNICAL FIELD



    [0001] The present disclosure relates generally to a system and method for preparing the performance of surgery on a patient at a target site defined by a virtual object. As reflected by the appended claims, performing the actual operation on the patient does not form part of the invention.

    BACKGROUND



    [0002] Navigation systems assist users in precisely locating objects. For instance, navigation systems are used in industrial, aerospace, and medical applications. In the medical field, navigation systems assist surgeons in precisely placing surgical instruments relative to a target site in a patient. The target site usually requires some form of treatment, such as tissue removal. In some cases, the target site is defined in the navigation system using a virtual object, such as a 3-D model. A representation of the virtual object can be displayed to the user during surgery to assist the user in visualizing placement of a treatment end of the instrument relative to the target site. For instance, the target site may be associated with a bone of the patient and the virtual object may define a volume of the bone to be removed by the treatment end of the instrument.

    [0003] Conventional navigation systems employ a localizer that cooperates with trackers to provide position and/or orientation data associated with the instrument and the target site, e.g., the volume of the bone to be removed. The localizer is usually placed so that it has a field of view of the trackers. The trackers are fixed to the instrument and to the patient to move in concert with the instrument and the patient. The tracker attached to the patient is attached to the bone being treated thereby maintaining a rigid relationship with respect to the target site owing to the rigid nature of the bone. By using separate trackers on the instrument and the patient, the treatment end of the instrument can be precisely positioned to stay within the target site.

    [0004] Often, the target site is located adjacent to sensitive anatomical structures, such as soft tissue, that should be avoided during surgery. These sensitive anatomical structures are difficult to track using conventional trackers, as these sensitive anatomical structures can shift relative to the trackers due to their elastic and/or flexible nature. Just as often, retractors or other tools are located near the target site that should also be avoided during the surgery. The retractors or other tools could be tracked in the same manner as the instrument being used for treating the patient, but adding trackers to the retractors and other tools can substantially increase costs and complexity in the navigation system, particularly by increasing the number of objects to be tracked by the navigation system. As a result, in current surgical procedures, avoidance is sometimes the responsibility of the user, so extreme care must be taken by the user to avoid sensitive anatomical structures and untracked tools that may be near the target site.

    [0005] Thus, there is a need in the art for navigation systems and methods that address the identification of sensitive anatomical structures and/or other structures that are to be avoided during surgery.

    [0006] Document US 2014/276943 A1 is directed to systems and methods for establishing and tracking virtual boundaries. The virtual boundaries can delineate zones in which an instrument is not permitted during a surgical procedure. The virtual boundaries can also delineate zones in which the surgical instrument is permitted during the surgical procedure. The virtual boundaries can also identify objects or structures to be treated by the instrument or to be avoided by the instrument during the surgical procedure.

    [0007] Document WO 2011/134083 A1 describes systems and methods for surgical guidance and image registration, in which three-dimensional image data associated with an object or patient is registered to topological image data obtained using a surface topology imaging device. The surface topology imaging device may include fiducial markers, which may be tracked by an optical position measurement system that also tracks fiducial markers on a movable instrument. The instrument may be registered to the topological image data, such that the topological image data and the movable instrument are registered to the three-dimensional image data. The three-dimensional image data may be CT or MRI data associated with a patient. The system may also co-register images pertaining to a surgical plan with the three-dimensional image data. In another aspect, the surface topology imaging device may be configured to directly track fiducial markers on a movable instrument. The fiducial markers may be tracked according to surface texture.

    SUMMARY



    [0008] In one embodiment, a surgical navigation system for performing surgery at a target site defined by a virtual object is provided. The surgical navigation system includes a patient tracker to be attached to a patient. A localizer cooperates with the patient tracker and generates localizer data associated with the target site on an anatomy of the patient during the surgery. The target site is defined by a virtual object associated with a virtual model of the anatomy. The surgical navigation system also includes a vision device to generate 3-D image data associated with the target site and surfaces surrounding the target site. A navigation computer in communication with the localizer and the vision device is configured to combine said localizer data and said 3-D image data into a common coordinate system, evaluate said 3-D image data and said localizer data in said common coordinate system to determine a region to be avoided outside of the target site by merging said 3-D image data and said localizer data to form merged data, and select at least a portion of the merged data to define the region to be avoided, the portion representing surfaces surrounding the target site that are outside of the target site.

    [0009] In another embodiment, a method for operating a surgical system according to claim 6 is provided.

    [0010] These systems and methods provide several advantages. For instance, by capturing both localizer data using the localizer and image data using the vision device, the navigation computer is able to identify the region to be avoided that is located outside of the target site. As a result, these systems and methods, in some embodiments, provide for accurate placement of surgical instruments to avoid sensitive anatomical structures that are otherwise difficult to track and to avoid other tools near the target site that may not be outfitted with separate trackers.

    BRIEF DESCRIPTION OF THE DRAWINGS



    [0011] Advantages will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings.

    Figure 1 is a perspective view of a robotic surgical system comprising a localizer and a vision device.

    Figure 2 is a schematic view of a control system for controlling the robotic surgical system.

    Figure 3 is a perspective view of coordinate systems used in the robotic surgical system.

    Figure 4 is an illustration of image data from the vision device being combined with localizer data from the localizer to yield a virtual object defining a region to be avoided.

    Figure 5 is a flow chart of steps carried out by a method of treating the patient.


    DETAILED DESCRIPTION



    [0012] As shown in FIG. 1, a system 20 for treating a patient 22 is illustrated. The system 20 is shown in a surgical setting such as an operating room of a medical facility. In the embodiment shown, the system 20 comprises a machining station 24 and a guidance station 26. The guidance station 26 is set up to track movement of various objects in the operating room. Such objects include, for example, a surgical instrument 30, a femur F of a patient, and a tibia T of the patient. The guidance station 26 tracks these objects for purposes of displaying their relative positions and orientations to a user and, in some cases, for purposes of controlling or constraining movement of the surgical instrument 30 relative to target sites. The surgical instrument 30 is shown as part of the machining station 24. However, in other embodiments, the surgical instrument 30 is manually held and moved by the user.

    [0013] The target sites to be treated by the surgical instrument 30 are defined by virtual objects. In the embodiment shown, a femur target site TS is shown, which is associated with the femur F. Of course, several other target sites, such as a target site for the tibia T, are also possible, with each being defined by its own separate virtual object. The virtual objects representing the target sites are pre-operatively set by the user and/or automatically generated to define volumes of material to be treated, trajectories for the surgical instrument 30, planes to be cut by the surgical instrument 30, bores to be drilled, and the like. In the embodiment shown, a virtual object VB (see Figure 4) defines the volume of material to be removed from the femur F. In some cases, the virtual objects are set or re-set intraoperatively, i.e., during the surgical procedure. It should be appreciated that although the description set forth herein relates to orthopedic surgical procedures, the systems and methods described herein are likewise suitable for any type of surgical procedure.

    [0014] The guidance station 26 includes a navigation cart assembly 32 that houses a navigation computer 34. A navigation interface is in operative communication with the navigation computer 34. The navigation interface includes a first display 36 adapted to be situated outside of the sterile field and a second display 38 adapted to be situated inside the sterile field. The displays 36, 38 are adjustably mounted to the navigation cart assembly 32. First and second input devices 40, 42 such as a keyboard and mouse can be used to input information into the navigation computer 34 or otherwise select/control certain aspects of the navigation computer 34. Other input devices are contemplated including a touch screen (not shown) or voice-activation.

    [0015] A localizer 44 communicates with the navigation computer 34. In the embodiment shown, the localizer 44 is an optical localizer and includes a localizer camera unit 46. The localizer camera unit 46 has an outer casing 48 that houses one or more optical position sensors 50. In some embodiments at least two optical sensors 50 are employed, preferably three, four, or more. The optical sensors 50 may be three separate charge-coupled devices (CCD). In one embodiment three, one-dimensional CCDs are employed. It should be appreciated that in other embodiments, separate localizer camera units, each with a separate CCD, or two or more CCDs, could also be arranged around the operating room. The CCDs detect infrared signals. Additionally, the localizer 44 may employ different modalities and may be an electromagnetic localizer, RF localizer, ultrasound localizer, or any other conventional localizer capable of tracking objects.

    [0016] The localizer camera unit 46 is mounted to an adjustable arm to position the optical sensors 50 with a field of view of the below discussed trackers that, ideally, is free from obstructions. In some embodiments the localizer camera unit 46 is adjustable in at least one degree of freedom by rotating about a rotational joint. In other embodiments, the localizer camera unit 46 is adjustable about two or more degrees of freedom.

    [0017] The localizer camera unit 46 includes a localizer camera controller 52 in communication with the optical sensors 50 to receive signals from the optical sensors 50. The localizer camera controller 52 communicates with the navigation computer 34 through either a wired or wireless connection (not shown). One such connection may be an IEEE 1394 interface, which is a serial bus interface standard for high-speed communications and isochronous real-time data transfer. The connections could also use a company specific protocol. In other embodiments, the optical sensors 50 communicate directly with the navigation computer 34.

    [0018] Position and orientation signals and/or data are transmitted to the navigation computer 34 for purposes of tracking objects. The navigation cart assembly 32, displays 36, 38, and localizer camera unit 46 may be like those described in U.S. Patent No. 7,725,162 to Malackowski, et al. issued on May 25, 2010, entitled "Surgery System".

    [0019] Navigation computer 34 has the displays 36, 38, central processing unit (CPU) and/or other processors 62, memory (not shown), and storage (not shown) necessary for carrying out the functions described herein. The navigation computer 34 is loaded with software as described below. The software converts the signals received from the localizer camera unit 46 into localizer data representative of the position and orientation of the objects being tracked.

    [0020] Guidance station 26 is operable with a plurality of tracking devices 54, 56, 58, also referred to herein as trackers. In the illustrated embodiment, one tracker is 54 is firmly affixed to the femur F of the patient and another tracker 56 is firmly affixed to the tibia T of the patient. Trackers 54, 56 are firmly affixed to sections of bone. Trackers 54, 56 may be attached to the femur F and tibia T in the manner shown in U.S. Patent No. 7,725,1 62. Trackers 54, 56 could also be mounted like those shown in U.S. Patent Application Publication No. 2014/0200621, filed on January 16, 2014, entitled, "Navigation Systems and Methods for Indicating and Reducing Line-of-Sight Errors". In yet further embodiments, the trackers 54, 56 could be mounted to other tissues of the anatomy.

    [0021] An instrument tracker 58 is firmly attached to the surgical instrument 30. The instrument tracker 58 may be integrated into the surgical instrument 30 during manufacture or may be separately mounted to the surgical instrument 30 in preparation for surgical procedures. A treatment end of the surgical instrument 30, which is being tracked by virtue of the instrument tracker 58, may be a rotating bur, electrical ablation device, or the like.

    [0022] The trackers 54, 56, 58 can be battery powered with an internal battery or may have leads to receive power through the navigation computer 34, which, like the localizer camera unit 46, preferably receives external power.

    [0023] In the embodiment shown, the surgical instrument 30 is attached to a manipulator 66 of the machining station 24. The manipulator 66 may also be referred to as a robotic device or a robotic arm. Such an arrangement is shown in U.S. Patent No. 9,119,655, entitled, "Surgical Manipulator Capable of Controlling a Surgical Instrument in Multiple Modes". It should be appreciated that in other embodiments, the surgical instrument 30 is manually manipulated without any robotic constraint on its position and/or orientation. The surgical instrument 30 may be any surgical instrument (also referred to as a tool) that is useful in performing medical/surgical procedures. The surgical instrument 30 may be a burring instrument, an electrosurgical instrument, an ultrasonic instrument, a reamer, an impactor, a sagittal saw, or other instrument. In some embodiments, multiple surgical instruments are employed to treat the patient, with each being separately tracked by the localizer 44.

    [0024] The optical sensors 50 of the localizer 44 receive light signals from the trackers 54, 56, 58. In the illustrated embodiment, the trackers 54, 56, 58 are active trackers. In this embodiment, each tracker 54, 56, 58 has at least three active tracking elements or markers for transmitting light signals to the optical sensors 50. The active markers can be, for example, light emitting diodes or LEDs 60 transmitting light, such as infrared light. The optical sensors 50 preferably have sampling rates of 100 Hz or more, more preferably 300 Hz or more, and most preferably 500 Hz or more. In some embodiments, the optical sensors 50 have sampling rates of 8000 Hz. The sampling rate is the rate at which the optical sensors 50 receive light signals from sequentially fired LEDs 60. In some embodiments, the light signals from the LEDs 60 are fired at different rates for each tracker 54, 56, 58.

    [0025] Referring to Figure 2, each of the LEDs 60 are connected to a tracker controller 61 located in a housing of the associated tracker 54, 56, 58 that transmits/receives data to/from the navigation computer 34. In one embodiment, the tracker controllers 61 transmit data on the order of several Megabytes/second through wired connections with the navigation computer 34. In other embodiments, a wireless connection may be used. In these embodiments, the navigation computer 34 has a transceiver (not shown) to receive data from the tracker controller.

    [0026] In other embodiments, the trackers 54, 56, 58 may have passive markers (not shown), such as reflectors that reflect light emitted from the localizer camera unit 46. The reflected light is then received by the optical sensors 50. Active and passive arrangements are well known in the art.

    [0027] In some embodiments, the trackers 54, 56, 58 also include a gyroscope sensor and accelerometer, such as the trackers shown in U.S. Patent No. 9,008,757 to Wu, issued on April 14, 2015, entitled "Navigation System Including Optical and Non-Optical Sensors".

    [0028] The navigation computer 34 includes the navigation processor 62. It should be understood that the navigation processor 62 could include one or more processors to control operation of the navigation computer 34. The processors can be any type of microprocessor or multi-processor system. The term processor is not intended to limit the scope of any embodiment to a single processor.

    [0029] The localizer camera unit 46 receives optical signals from the LEDs 60 of the trackers 54, 56, 58 and outputs to the navigation processor 62 signals relating to the position of the LEDs 60 of the trackers 54, 56, 58 relative to the localizer 44. Based on the received optical (and non-optical signals in some embodiments), navigation processor 62 generates data indicating the relative positions and orientations of the trackers 54, 56, 58 relative to the localizer 44, such as through known triangulation methods. In some embodiments, the data is generated by the localizer camera controller 52 and then transmitted to the navigation computer 34.

    [0030] Prior to the start of the surgical procedure, additional data are loaded into the navigation processor 62. Based on the position and orientation of the trackers 54, 56, 58 and the previously loaded data, navigation processor 62 determines the position of the treatment end of the surgical instrument 30 (e.g., the centroid of a surgical bur) and the orientation of the surgical instrument 30 relative to the target sites against which the treatment end is to be applied, such as the femur target site TS. In some embodiments, navigation processor 62 forwards these data to a manipulator controller 64. The manipulator controller 64 can then use the data to control the manipulator 66 as described in U.S. Patent No. 9,119,655, entitled, "Surgical Manipulator Capable of Controlling a Surgical Instrument in Multiple Modes". In one embodiment, the manipulator 66 is controlled with respect to the virtual objects set by the surgeon. In the embodiment described herein, the virtual object VB defines the volume of material of the femur F to be removed by the surgical instrument 30. Thus, the virtual object VB provides a virtual boundary for the treatment end of the surgical instrument 30 to stay within (i.e., for a separate virtual object associated with the treatment end of the surgical instrument to stay within).

    [0031] The navigation processor 62 also generates image signals that indicate the relative position of the treatment end to the target sites. These image signals are applied to the displays 36, 38. Displays 36, 38, based on these signals, generate images that allow the surgeon and staff to virtually view the relative position of the treatment end to the target sites. In most cases, the images illustrate the treatment end with respect to one target site at a time. For instance, in a surgical procedure in which the femur F and the tibia T are both being treated, the femur target site TS and the relative position of the treatment end of the surgical instrument 30 to the femur target site TS may be visually represented while material is being removed from the femur F. Likewise, when the user is finished removing material from the femur F and is ready to remove material from the tibia T, the display 36, 38 may only illustrate placement of the treatment end of the surgical instrument 30 with respect to the target site associated with the tibia T.

    [0032] Referring to Figure 3, tracking of objects is generally conducted with reference to a localizer coordinate system LCLZ. The localizer coordinate system LCLZ has an origin and an orientation (a set of x, y, and z axes). During the procedure one goal is to keep the localizer coordinate system LCLZ in a known position. An accelerometer (not shown) mounted to the localizer camera unit 46 may be used to track sudden or unexpected movement of the localizer coordinate system LCLZ, as may occur when the localizer camera unit 46 is inadvertently bumped by surgical personnel.

    [0033] Each tracker 54, 56, 58, and object being tracked also has its own coordinate system separate from the localizer coordinate system LCLZ. For instance, the trackers 54, 56, 58 have bone tracker coordinate system BTRK1, bone tracker coordinate system BTRK2, and instrument tracker coordinate system TLTR.

    [0034] In the embodiment shown, the guidance station 26 monitors the positions of the femur F and tibia T of the patient by monitoring the position of bone trackers 54, 56 firmly attached to bone. Femur coordinate system is FBONE and tibia coordinate system is TBONE, which are the coordinate systems of the bones to which the bone trackers 54, 56 are firmly attached.

    [0035] Prior to the start of the procedure, pre-operative images of the anatomy of interest are generated, such as pre-operative images of the femur F and tibia T (or of other tissues or structures in other embodiments). These images may be based on MRI scans, radiological scans or computed tomography (CT) scans of the patient's anatomy. These images are used to develop virtual models of anatomy of interest, such as virtual models of the femur F and tibia T and/or other anatomy to be treated by the surgical instrument 30. Often the virtual models are 3-D models that comprise data representing the entire anatomy being treated or at least a portion of the anatomy to be treated and data representing the virtual obj ects that define the target sites. In the embodiment shown, a virtual model VM of the femur is a 3-D model comprising model data that represents a portion of the femur F and the virtual object VB (see Figure 4). The virtual object VB defines the target site TS and the volume of material to be removed from the femur F during the surgical procedure. The virtual objects may be defined within the virtual models and may be represented as mesh surfaces, constructive solid geometries (CSG), voxels, or using other virtual object representation techniques.

    [0036] The pre-operative images and/or the virtual models are mapped to the femur coordinate system FBONE and tibia coordinate system TBONE using well known methods in the art. These pre-operative images and/or virtual models are fixed in the femur coordinate system FBONE and tibia coordinate system TBONE. As an alternative to taking pre-operative images, plans for treatment can be developed in the operating room from kinematic studies, bone tracing, and other methods. These same methods could also be used to generate the 3-D virtual models previously described.

    [0037] During an initial phase of the procedure described herein, the bone trackers 54, 56 are firmly affixed to the bones of the patient. The pose (position and orientation) of coordinate systems FBONE and TBONE are mapped to coordinate systems BTRK1 and BTRK2, respectively. In one embodiment, a pointer instrument P (see Figure 1), such as disclosed in U.S. Patent No. 7,725,162 to Malackowski, et al., may be used to register the femur coordinate system FBONE and tibia coordinate system TBONE to the bone tracker coordinate systems BTRK1 and BTRK2, respectively. Given the fixed relationship between the bones and their trackers 54, 56, positions and orientations of the femur F and tibia T in the femur coordinate system FBONE and tibia coordinate system TBONE can be transformed to the bone tracker coordinate systems BTRK1 and BTRK2 so the localizer camera unit 46 is able to track the femur F and tibia T by tracking the trackers 54, 56. These pose-describing data are stored in memory integral with both the manipulator controller 64 and the navigation processor 62.

    [0038] The treatment end of the surgical instrument 30 (also referred to as a distal end of an energy applicator) has its own coordinate system EAPP. The origin of the coordinate system EAPP may represent a centroid of a surgical cutting bur, for example. The pose of coordinate system EAPP is fixed to the pose of instrument tracker coordinate system TLTR before the procedure begins. Accordingly, the poses of these coordinate systems EAPP, TLTR relative to each other are determined. The pose-describing data are stored in memory integral with manipulator controller 64 and navigation processor 62.

    [0039] Referring to Figure 2, a localization engine 100 is a software module that can be considered part of the navigation computer 34. Components of the localization engine 100 run on navigation processor 62. The localization engine 100 may run on the manipulator controller 64 and/or the navigation processor 62.

    [0040] Localization engine 100 receives as inputs the optically-based signals from the localizer camera controller 52 and, in some embodiments, the non-optically based signals from the tracker controller (not shown). Based on these signals, localization engine 100 determines the pose of the bone tracker coordinate systems BTRK1 and BTRK2 in the localizer coordinate system LCLZ. Based on the same signals received for the instrument tracker 58, the localization engine 100 determines the pose of the instrument tracker coordinate system TLTR in the localizer coordinate system LCLZ.

    [0041] The localization engine 100 forwards the signals representative of the poses of trackers 54, 56, 58 to a coordinate transformer 102. Coordinate transformer 102 is a software module that runs on navigation processor 62. Coordinate transformer 102 references the data that defines the relationship between the pre-operative images and/or the virtual models of the patient and the bone trackers 54, 56. Coordinate transformer 102 also stores the data indicating the pose of the treatment end of the surgical instrument 30 relative to the instrument tracker 58. Coordinate transformer 102 also references the data that defines the virtual objects, if separate from the virtual models.

    [0042] During the procedure, the coordinate transformer 102 receives the data indicating the relative poses of the trackers 54, 56, 58 to the localizer 44. Based on these data and the previously loaded data, the coordinate transformer 102 generates data indicating the relative position and orientation of both the coordinate system EAPP, and the bone coordinate systems, FBONE, TBONE to the localizer coordinate system LCLZ.

    [0043] As a result, coordinate transformer 102 generates data indicating the position and orientation of the treatment end of the surgical instrument 30 relative to the target sites against which the treatment end is applied. Image signals representative of these data are forwarded to displays 36, 38 enabling the surgeon and staff to view this information. In certain embodiments, other signals representative of these data can be forwarded to the manipulator controller 64 to guide the manipulator 66 and corresponding movement of the surgical instrument 30. Thus, this data also indicates a virtual location of the treatment end of the surgical instrument 30, which may also be modeled as a separate virtual object, with respect to the virtual models and the virtual obj ects.

    [0044] Referring back to Figure 1, the guidance station 26 further includes a vision device 72. In the embodiment shown, the vision device is mounted to the localizer camera unit 46. In other embodiments, the vision device 72 may be mounted on a separate adjustable arm to position the vision device 72 separately from the localizer camera unit 46. The vision device 72 is preferably placed with a field of view of the target sites free from obstructions. The vision device 72 has a vision controller 73 in operative communication with the navigation computer 34. The vision device 72 may also be referred to as an imaging device or a digital imaging device capable of capturing 3-D images in real-time. One example of a suitable vision device is the commercially available Kinect SDK or similar Kinect model, sold by Microsoft Corporation. In other embodiments, the vision device 72 may comprise a laser array or a stereo camera system.

    [0045] The vision device 72 has an outer housing 76 that supports one or more image sensors 78, 79. One of the image sensors may be a depth image sensor 78 used to identify a depth image, while the other image sensor may be a color image sensor 79 used to generate color images. Both image sensors 78, 79 may be in the form of CMOS sensors or other suitable sensors. Additionally, a light source 80 is supported in the housing 76 to generate and transmit light that is reflected back by surfaces in the field of view of the depth image sensor 78.

    [0046] The sensors 78, 79 and the light source 80 communicate with the vision controller 73 to determine the distances of the surfaces in the field of view with respect to a vision coordinate system VIS (see Figure 3). In one embodiment the light source 80 emits infrared light and the vision controller 73 determines the elapsed time required for the infrared light to reflect off the surfaces in the field of view and return to the depth image sensor 78. This process is repeated over a plurality of iterations to determine distances from the vision device 72 to surfaces in the field of view of the vision device 72 so that a point cloud 202 can be generated (see Figure 4).

    [0047] The navigation computer 34 communicates with the vision controller 73 to receive signals and/or data representative of the point cloud 202. Imaging software, comprising an image generator module, is loaded on the navigation computer 34 and run by the navigation processor 62 to create the point cloud 202 based on the field of view of the vision device 72. The point cloud 202 is created in the vision coordinate system VIS. The point cloud 202 is a set of image data points in the vision coordinate system VIS that correspond to the surfaces in the field of view of the vision device 72. These image data points are defined by x, y, z coordinates. The point cloud 202 can be saved or stored as an image data file.

    [0048] It should be appreciated that by integrating the vision device 72 into the localizer camera unit 46, the vision coordinate system VIS can be easily registered to the localizer coordinate system LCLZ since the location of the image sensors 78, 79 relative to the optical sensors 50, and vice versa, is known and fixed. During manufacturing the vision device 72 can be calibrated to the localizer 44 to generate data with respect to the same coordinate system so that the vision coordinate system VIS does not need to be transformed to the localizer coordinate system LCLZ via the coordinate transformer 102.

    [0049] In other embodiments, such as those in which the vision device 72 is separate from the localizer camera unit 46, the vision device 72 may have a tracker (not shown) rigidly mounted to the housing 76 to establish a relationship between the vision coordinate system VIS and the localizer coordinate system LCLZ. For instance, using preloaded data defining a relationship between the tracker's coordinate system and the vision coordinate system VIS, the coordinate transformer 102, based on the position of the tracker in the localizer coordinate system LCLZ, could transform the vision coordinate system VIS to the localizer coordinate system LCLZ.

    [0050] Referring to Figure 4, the vision device 72 collects images of the target sites and the surfaces surrounding the target sites that are in the field of view of the vision device 72. In the embodiment shown, the vision device 72 collects images of the target site TS and the surfaces surrounding the target site TS that are in the field of view of the vision device 72. The navigation computer 34 cooperates with the vision controller 73 to create the point cloud 202 of the target site TS and the surfaces surrounding the target site TS, which defines image data associated with the target site TS and the surfaces surrounding the target site TS.

    [0051] At the same time that the image data is being generated, the localizer data is also being generated. The navigation computer 34 cooperates with the localizer 44 to determine a position and orientation of the virtual models and the virtual objects defining the target sites in the localizer coordinate system LCLZ. In the embodiment shown, the navigation computer 34 cooperates with the localizer 44 to determine a position and orientation of the virtual model VM of the femur F and the position and orientation of the virtual object VB in the localizer coordinate system LCLZ. This localizer data comprises the model data defining the virtual model VM and the virtual object VB. In some cases, the model data includes data points in the form of a point cloud associated with the virtual model VM and a separate point cloud associated with the virtual object VB.

    [0052] Still referring to Figure 4, the navigation processor 62 runs a data merge module 101 (see Figure 1), which is a software module that merges the localizer data and the image data to yield merged data (once the localizer data and the image data is located in, or transformed to, a common coordinate system). The merged data represents a second virtual object VR that defines a region R to be avoided during the surgery that is outside of the target site TS. This merging of data is illustrated by arrows in Figure 4. In the embodiment shown, the merged data that represents the second virtual object VR may comprise: (1) data points 204 associated with bone that is to be avoided by the surgical instrument 30 that is outside of the target site TS; (2) data points 206 associated with exposed soft tissue that is to be avoided by the surgical instrument 30 that is outside of the target site TS; (3) data points 208 associated with retractors that are to be avoided by the surgical instrument 30; and (4) data points 210 associated with skin of the patient that is outside of the target site TS.

    [0053] In some embodiments, like that shown in Figure 4, the merged data comprises all data points in the point cloud 202 that have coordinates located outside of the virtual object VB after the localizer data and the image data are merged. In some cases, when a path for the treatment end of the surgical instrument 30 to reach the target site TS is not completely clear, such as when the target site TS is at least partially obstructed by soft tissue or other sensitive anatomical structures, defining all visible surfaces outside of the target site TS as part of the second virtual object VR can be particularly advantageous so that the surgical instrument 30 is able to avoid any sensitive anatomical structures, tools, etc., that are located outside of the target site TS.

    [0054] The merged data that represents the second virtual object VR, and which defines the region R to be avoided, can be processed by the navigation processor 62 so that a representation thereof can be displayed to the user on the displays 38, 39 and the user can visualize a position and orientation of the surgical instrument 30 relative to the region R. In some cases, the data points that virtually define the region R to be avoided can be converted into a mesh surface, a constructive solid geometry (CSG), voxels, or other virtual object types using various virtual object representation techniques. Additionally, the navigation processor 62 may automatically limit the size of the second virtual object VR, and thus the extent of the region R, to a predefined distance from the target site TS, or the user may be able to manually refine the second virtual object VR, including defining an outer perimeter of the second virtual object VR.

    [0055] It should be noted that the second virtual object VR may change in configuration (e.g., size, shape, position, etc.) during the surgical procedure owing to the elastic and/or flexible nature of some of the tissues in the region R defined by the second virtual object VR. Additionally, the region R may change as retractors are adjusted, or as additional tools or equipment are brought into and out of the field of view of the vision device 72. In other words, the nature of the region R to be avoided is dynamic and may continuously change, but with the navigation techniques described herein, the second virtual object VR can be continuously updated (e.g., at a predefined frequency) with each new set of image data and localizer data so that the user is able to avoid the region R to be avoided during the surgical procedure regardless of changes to the region R.

    [0056] The second virtual object VR that defines the region R to be avoided can also be transmitted to the manipulator controller 64 and treated as a "no-fly" zone in which the treatment end of the surgical instrument 30 is prevented from entering. As a result, when the manipulator 66 operates in an autonomous mode, the manipulator 66 is able to control positioning of the surgical instrument 30 to avoid the region R and thereby avoid sensitive anatomical structures, such as soft tissue and bone to be preserved, and tools, such as retractors, suction tubes, and the like, located near the target site TS.

    [0057] Referring to Figure 5, one embodiment of a method for determining the region R to be avoided is shown. In step 300, a surgeon or other medical professional creates a surgical plan for the patient. The surgical plan identifies the surgical procedure to be performed and the treatment to be undertaken. The surgical plan is often based on pre-operative images, such as images taken from MRI or CT scans, which are converted into a 3-D virtual model VM of the patient's anatomy. The virtual object VB defining the target site TS to be treated during the surgical procedure is also generated and associated with the 3-D virtual model VM as part of the surgical plan.

    [0058] In step 302, data relating to the virtual model VM and the virtual object VB, which defines the target volume of material to be treated at the target site TS, such as the target volume of bone to be removed, are transferred to the navigation computer 34 to be stored in the navigation computer 34.

    [0059] In step 304, localizer data is then generated. The localizer data comprises data associated with the positions and orientations of the virtual model VM and the virtual object VB in the localizer coordinate system LCLZ. Image data is simultaneously being generated in step 306 so that at each time step during navigation, there is corresponding localizer data and image data. The image data comprises the point cloud 202 which comprises the position and orientation of surfaces in the field of view of the vision device 72, including surfaces of the target site TS and surfaces outside of the target site TS.

    [0060] In step 308, the data merge module 101 of the navigation computer 34 evaluates the localizer data and the image data. In particular, the data merge module 101 merges data points from the image data (e.g., the point cloud 202) with data points from the localizer data (e.g., data points for the virtual object VB). In step 310, the data merge module 101 then identifies all of the data points from the image data that fall outside of the virtual object VB. This remaining data set yields the region R to be avoided, which is then saved in memory in the navigation computer 34 as the second virtual object VR to be avoided by the surgical instrument 30. In step 312, the user operates the surgical instrument 30, either manually, or robotically, to remove the target volume of tissue from the target site, while avoiding the region R. The steps 304-312 repeat for each processing time step during navigation until the surgical procedure is complete, e.g., until all the tissue has been removed from the target site TS. As a result, the method is able to compensate for changes to the region R during the surgical procedure.

    [0061] In other embodiments, it should be appreciated that the systems and methods described herein for merging localizer data and image data could similarly be performed to generate other types of virtual objects, other than virtual objects that define regions to be avoided, like the region R. For instance, the localizer data and the image data could be merged to yield virtual objects that define target sites, such as volumes of material to be removed, desired trajectories for the surgical instrument 30, and the like. Additionally, the image data and the localizer data could be merged for other purposes.

    [0062] As will be appreciated by one skilled in the art, aspects of the present embodiments may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied thereon. Computer software including instructions or code for performing the methodologies described herein, may be stored in one or more of the associated memory devices (for example, ROM, fixed or removable memory) and, when ready to be utilized, loaded in part or in whole (for example, into RAM) and implemented by a CPU. Such software could include, but is not limited to, firmware, resident software, microcode, and the like.

    [0063] Several embodiments have been discussed in the foregoing description. However, the embodiments discussed herein are not intended to be exhaustive or limit the invention to any particular form. The terminology which has been used is intended to be in the nature of words of description rather than of limitation. Many modifications and variations are possible in light of the above teachings and the invention may be practiced otherwise than as specifically described.


    Claims

    1. A surgical navigation system comprising:

    a tracker (54, 56) configured to be attached to a patient;

    a localizer (44) configured to cooperate with said tracker (54, 56) to generate localizer data associated with a target site on an anatomy of the patient with the target site defined by a virtual object (VB) associated with a virtual model (VM) of the anatomy;

    a vision device (72) configured to generate 3-D surface-image data associated with the target site and surfaces surrounding the target site;

    a navigation computer (34) coupled to said localizer (44) and said vision device (72),

    wherein said navigation computer (34) is configured to:

    combine said localizer data and said 3-D surface-image data into a common coordinate system; and

    evaluate said 3-D surface-image data and said localizer data in said common coordinate system to determine a region (R) to be avoided outside of the target site by merging said 3-D surface-image data and said localizer data to form merged data; and

    wherein the surgical navigation system is characterized in that said navigation computer (34) is further configured to:
    select at least a portion of the merged data to define the region (R) to be avoided, the portion representing surfaces surrounding the target site that are outside of the target site.


     
    2. The system as set forth in claim 1, wherein said navigation computer (34) is configured to generate a second virtual object (VR) defining said region (R).
     
    3. The system as set forth in any one of claims 1 and 2, wherein said 3-D surface-image data generated by said vision device (72) comprises a three dimensional map of at least a portion of the surfaces surrounding the target site that are outside of the target site.
     
    4. The system as set forth in claim 3, wherein said three dimensional map comprises one or more of a point cloud, a range map, a plane, a line, or a single point.
     
    5. The system as set forth in any one of claims 1-4, wherein said navigation computer (34) is coupled to a robotic device (66), wherein an end effector (30) is coupled to said robotic device (66), and wherein said robotic device (66) is operable to move said end effector (30) with respect to the target site while avoiding the region (R) to be avoided.
     
    6. A method for operating a surgical system comprising a tracker (54, 56) attached to a patient, a localizer (44), a vision device (72), and a navigation computer (34), said method comprising the steps of:

    generating, with the localizer (44), localizer data associated with a target site on an anatomy of the patient with the target site defined by a virtual object (VB) associated with a virtual model (VM) of the anatomy;

    generating, with the vision device (72), 3-D surface-image data associated with the target site and surfaces surrounding the target site;

    combining, by the navigation computer (34), the localizer data and the 3-D surface- image data into a common coordinate system;

    evaluating, by the navigation computer (34), the 3-D surface-image data and the localizer data in the common coordinate system to determine a region (R) to be avoided outside of the target site by merging the 3-D surface-image data and the localizer data to form merged data; and

    selecting, by the navigation computer (34), at least a portion of the merged data to define the region (R) to be avoided, the portion representing surfaces surrounding the target site that are outside of the target site.


     
    7. The method as set forth in claim 6 further comprising the navigation computer (34) generating a second virtual object (VR) defining the region (R).
     
    8. The method as set forth in any one of claims 6 and 7, wherein generating the 3-D surface-image data associated with the target site and surfaces surrounding the target site comprises generating a three dimensional map of at least a portion of the surfaces surrounding the target site that are outside of the target site.
     
    9. The method as set forth in claim 8, wherein generating the three dimensional map of the at least a portion of the surfaces surrounding the target site that are outside of the target site comprises generating one or more of a point cloud, a range map, a plane, a line, or a single point.
     
    10. The method as set forth in any one of claims 6 to 9, wherein the navigation computer (34) is coupled to a robotic device (66) and an end effector (30) is coupled to the robotic device (66).
     


    Ansprüche

    1. Chirurgisches Navigationssystem umfassend:

    einen Tracker (54, 56), der dazu ausgebildet ist, an einem Patienten angebracht zu werden;

    einen Lokalisierer (44), der dazu ausgebildet ist, mit dem Tracker (54, 56) zu kooperieren, um Lokalisiererdaten zu erzeugen, die einem Zielort auf einer Anatomie des Patienten zugeordnet sind, wobei der Zielort durch ein virtuelles Objekt (VB) definiert ist, das einem virtuellen Modell (VM) der Anatomie zugeordnet ist;

    ein Sichtgerät (72), das dazu ausgebildet ist, 3D-Oberflächenbilddaten zu erzeugen, die dem Zielort und den Zielort umgebenden Oberflächen zugeordnet sind;

    einen mit dem Lokalisierer (44) und dem Sichtgerät (72) gekoppelten Navigationscomputer (34),

    wobei der Navigationscomputer (34) dazu ausgebildet ist:

    die Lokalisiererdaten und die 3D-Oberflächenbilddaten in einem gemeinsamen Koordinatensystem zu kombinieren; und

    die 3D-Oberflächenbilddaten und die Lokalisiererdaten in dem gemeinsamen Koordinatensystem auszuwerten, um eine Region (R) zu bestimmen, die außerhalb des Zielortes vermieden werden soll, indem die 3D-Oberflächenbilddaten und die Lokalisiererdaten zusammengefügt werden, um zusammengefügte Daten zu bilden; und

    wobei das chirurgische Navigationssystem dadurch gekennzeichnet ist, dass der Navigationscomputer (34) ferner dazu ausgebildet ist:
    zumindest einen Teil der zusammengefügten Daten auszuwählen, um die zu vermeidende Region (R) zu definieren, wobei der Teil Oberflächen außerhalb des Zielortes repräsentiert, die den Zielort umgeben.


     
    2. System nach Anspruch 1, wobei der Navigationscomputer (34) dazu ausgebildet ist, ein zweites virtuelles Objekt (VR) zu erzeugen, das die Region (R) definiert.
     
    3. System nach einem der Ansprüche 1 und 2, wobei die von dem Sichtgerät (72) erzeugten 3D-Oberflächenbilddaten eine dreidimensionale Karte zumindest eines Teils der den Zielort umgebenden Oberflächen außerhalb des Zielortes umfassen.
     
    4. System nach Anspruch 3, wobei die dreidimensionale Karte eine Punktwolke und/oder eine Bereichskarte und/oder eine Ebene und/oder eine Linie und/oder einen einzelnen Punkt umfasst.
     
    5. System nach einem der Ansprüche 1 bis 4, wobei der Navigationscomputer (34) mit einer Robotervorrichtung (66) gekoppelt ist, wobei ein Endeffektor (30) mit der Robotervorrichtung (66) gekoppelt ist und wobei die Robotervorrichtung (66) betreibbar ist, um den Endeffektor (30) in Bezug auf den Zielort unter Vermeidung der zu vermeidenden Region (R) zu bewegen.
     
    6. Verfahren zum Betreiben eines chirurgischen Systems, das einen an einem Patienten angebrachten Tracker (54, 56), einen Lokalisierer (44), ein Sichtgerät (72) und einen Navigationscomputer (34) umfasst, wobei das Verfahren die Schritte umfasst:

    Erzeugen von einem Zielort auf einer Anatomie des Patienten zugeordneten Lokalisiererdaten mit dem Lokalisierer (44), wobei der Zielort durch ein virtuelles Objekt (VB) definiert ist, das einem virtuellen Modell (VM) der Anatomie zugeordnet ist;

    Erzeugen von dem Zielort und den Zielort umgebenden Oberflächen zugeordneten 3D-Oberflächenbilddaten mit dem Sichtgerät (72);

    Kombinieren der Lokalisiererdaten und der 3D-Oberflächenbilddaten in einem gemeinsamen Koordinatensystem mit dem Navigationscomputer (34);

    Auswerten der 3D-Oberflächenbilddaten und der Lokalisiererdaten in dem gemeinsamen Koordinatensystem mit dem Navigationscomputer (34), um eine außerhalb des Zielortes zu vermeidende Region (R) zu bestimmen, indem die 3D-Oberflächenbilddaten und die Lokalisiererdaten zusammengefügt werden, um zusammengefügte Daten zu bilden; und

    Auswählen mindestens eines Teils der zusammengefügten Daten mit dem Navigationscomputer (34), um die zu vermeidende Region (R) zu definieren, wobei der Teil den Zielort umgebende Oberflächen außerhalb des Zielortes repräsentiert.


     
    7. Verfahren nach Anspruch 6, ferner umfassend das Erzeugen eines zweiten virtuellen Objekts (VR), das die Region (R) definiert, mit dem Navigationscomputer (34).
     
    8. Verfahren nach einem der Ansprüche 6 und 7, wobei das Erzeugen der dem Zielort und den Zielort umgebenden Oberflächen zugeordneten 3D-Oberflächenbilddaten das Erzeugen einer dreidimensionalen Karte zumindest eines Teils der den Zielort umgebenden Oberflächen außerhalb des Zielortes umfasst.
     
    9. Verfahren nach Anspruch 8, wobei das Erzeugen der dreidimensionalen Karte des zumindest einen Teils der den Zielort umgebenden Oberflächen außerhalb des Zielortes das Erzeugen einer Punktwolke und/oder einer Bereichskarte und/oder einer Ebene und/oder einer Linie und/oder eines einzelnen Punktes umfasst.
     
    10. Verfahren nach einem der Ansprüche 6 bis 9, wobei der Navigationscomputer (34) mit einer Robotervorrichtung (66) gekoppelt ist und ein Endeffektor (30) mit der Robotervorrichtung (66) gekoppelt ist.
     


    Revendications

    1. Système de navigation chirurgicale comprenant :

    un dispositif de suivi (54, 56) configuré pour être fixé à un patient ;

    un localisateur (44) configuré pour coopérer avec ledit dispositif de suivi (54, 56) pour générer des données de localisateur associées avec un site cible sur une anatomie du patient avec le site cible défini par un objet virtuel (VB) associé avec un modèle virtuel (VM) de l'anatomie ;

    un dispositif de vision (72) configuré pour générer des données d'images de surface 3D associées avec le site cible et des surfaces entourant le site cible ;

    un ordinateur de navigation (34) couplé audit localisateur (44) et audit dispositif de vision (72),

    dans lequel ledit ordinateur de navigation (34) est configuré pour :

    combiner lesdites données de localisateur et lesdites données d'images de surface 3D en un système de coordonnées commun ; et

    évaluer lesdites données d'images de surface 3D et lesdites données de localisateur dans ledit système de coordonnées commun pour déterminer une région (R) devant être évitée à l'extérieur du site cible en fusionnant lesdites données d'images de surface 3D et lesdites données de localisateur pour former des données fusionnées ; et

    dans lequel le système de navigation chirurgicale est caractérisé en ce que ledit ordinateur de navigation (34) est en outre configuré pour :

    sélectionner au moins une partie des données fusionnées pour définir la région (R) devant être évitée, la partie représentant des surfaces entourant le site cible qui sont à l'extérieur du site cible.


     
    2. Système selon la revendication 1, dans lequel ledit ordinateur de navigation (34) est configuré pour générer un deuxième objet virtuel (VR) définissant ladite région (R).
     
    3. Système selon l'une quelconque des revendications 1 et 2, dans lequel lesdites données d'images de surface 3D générées par ledit dispositif de vision (72) comprennent une carte tridimensionnelle d'au moins une partie des surfaces entourant le site cible qui sont à l'extérieur du site cible.
     
    4. Système selon la revendication 3, dans lequel ladite carte tridimensionnelle comprend un(e) ou plus parmi un nuage de points, une carte de localisation, un plan, une ligne, ou un point unique.
     
    5. Système selon l'une quelconque des revendications 1 à 4, dans lequel ledit ordinateur de navigation (34) est couplé à un dispositif robotique (66), dans lequel un effecteur terminal (30) est couplé audit dispositif robotique (66), et dans lequel ledit dispositif robotique (66) est utilisable pour déplacer ledit effecteur terminal (30) par rapport au site cible tout en évitant la région (R) devant être évitée.
     
    6. Procédé de fonctionnement d'un système chirurgical comprenant un dispositif de suivi (54, 56) fixé à un patient, un localisateur (44), un dispositif de vision (72), et un ordinateur de navigation (34), ledit procédé comprenant les étapes de :

    génération, avec le localisateur (44), de données de localisateur associées avec un site cible sur une anatomie du patient avec le site cible défini par un objet virtuel (VB) associé avec un modèle virtuel (VM) de l'anatomie ;

    génération, avec le dispositif de vision (72), de données d'images de surface 3D associées avec le site cible et des surfaces entourant le site cible ;

    combinaison, par l'ordinateur de navigation (34), des données de localisateur et des données d'images de surface 3D en un système de coordonnées commun ;

    évaluation, par l'ordinateur de navigation (34), des données d'images de surface 3D et des données de localisateur dans le système de coordonnées commun pour déterminer une région (R) devant être évitée à l'extérieur du site cible en fusionnant les données d'images de surface 3D et les données de localisateur pour former des données fusionnées ; et

    sélection, par l'ordinateur de navigation (34), d'au moins une partie des données fusionnées pour définir la région (R) devant être évitée, la partie représentant des surfaces entourant le site cible qui sont à l'extérieur du site cible.


     
    7. Procédé selon la revendication 6, comprenant en outre l'ordinateur de navigation (34) générant un deuxième objet virtuel (VR) définissant la région (R).
     
    8. Procédé selon l'une quelconque des revendications 6 et 7, dans lequel la génération des données d'images de surface 3D associées avec le site cible et les surfaces entourant le site cible comprend la génération d'une carte tridimensionnelle d'au moins une partie des surfaces entourant le site cible qui sont à l'extérieur du site cible.
     
    9. Procédé selon la revendication 8, dans lequel la génération de la carte tridimensionnelle de l'au moins une partie des surfaces entourant le site cible qui sont à l'extérieur du site cible comprend la génération d'un(e) ou plus parmi un nuage de points, une carte de localisation, un plan, une ligne, ou un point unique.
     
    10. Procédé selon l'une quelconque des revendications 6 à 9, dans lequel l'ordinateur de navigation (34) est couplé à un dispositif robotique (66) et un effecteur terminal (30) est couplé au dispositif robotique (66).
     




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    Cited references

    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description