(19)
(11)EP 2 996 611 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
26.06.2019 Bulletin 2019/26

(21)Application number: 14722833.2

(22)Date of filing:  12.03.2014
(51)International Patent Classification (IPC): 
A61B 34/20(2016.01)
A61B 17/56(2006.01)
A61B 17/02(2006.01)
(86)International application number:
PCT/US2014/024269
(87)International publication number:
WO 2014/165060 (09.10.2014 Gazette  2014/41)

(54)

SYSTEMS AND SOFTWARE FOR ESTABLISHING VIRTUAL CONSTRAINT BOUNDARIES

SYSTEME UND SOFTWARE ZUR ERSTELLUNG VON VIRTUELLEN EINSCHRÄNKUNGSGRENZEN

SYSTÈMES ET LOGICIELS DESTINÉS À ÉTABLIR DES FRONTIÈRES DE CONTRAINTES VIRTUELLES


(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: 13.03.2013 US 201361780148 P

(43)Date of publication of application:
23.03.2016 Bulletin 2016/12

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

(72)Inventors:
  • BOWLING, David, Gene
    Los Ranchos de Albuquerque, NM 87107 (US)
  • MALACKOWSKI, Donald, W.
    Schoolcraft, MI 49087 (US)
  • MOCTEZUMA DE LA BARRERA, José, Luis
    79104 Freiburg (DE)
  • ROESSLER, Patrick
    79249 Merzhausen (DE)
  • CULP, Jerry, A.
    Kalamazoo, MI 49009 (US)
  • STUART, John, Michael
    Rio Rancho, NM 87144 (US)
  • BEER, Joel, N.
    Albuquerque, NM 87108-1167 (US)

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


(56)References cited: : 
WO-A1-2006/091494
US-A1- 2008 214 898
WO-A2-2006/106419
US-A1- 2013 060 278
  
      
    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 invention relates generally to systems and computer program products for establishing and tracking virtual boundaries.

    BACKGROUND



    [0002] In robotic surgery virtual boundaries are created using computer aided design software to delineate areas in which an end effector of a robotic system can maneuver from areas in which the end effector is restricted. For instance, in orthopedic surgery a virtual cutting boundary may be created to delineate sections of bone to be removed by the end effector during the surgery from sections of bone that are to remain after the surgery.

    [0003] A navigation system tracks movement of the end effector with respect to the virtual cutting boundary to determine a position and/or orientation of the end effector relative to the virtual cutting boundary. The robotic system cooperates with the navigation system to guide movement of the end effector so that the end effector does not move beyond the virtual cutting boundary.

    [0004] Typically, virtual cutting boundaries are created prior to surgery. Virtual cutting boundaries are often created in a model of a patient's bone and fixed with respect to the bone so that when the model is loaded into the navigation system, the navigation system can track movement of the virtual cutting boundary by tracking movement of the bone.

    [0005] Virtual boundaries may define other anatomical features to be avoided by the end effector during surgery. Such features include nerves or other types of tissue to be protected from contact with the end effector. Virtual boundaries are also used to provide virtual pathways that direct the end effector toward the anatomy being treated. These examples of virtual boundaries are often fixed in relationship to the anatomy being treated so that all of the boundaries are tracked together as the anatomy moves. However, some anatomical features or other objects in the operating room may move relative to the anatomy being treated. For instance, retractors used to provide an opening in tissue for the end effector may move relative to the anatomy being treated. If not accurately tracked using an appropriate dynamic virtual constraint boundary, the end effector may inadvertently strike the retractors. As a result, the end effector may be damaged or become inoperative and the retractor may become dislodged from its position.

    [0006] Other typically untracked objects may also be in proximity to the end effector that should be avoided by the end effector, yet move relative to the anatomy being treated. Therefore, there is a need in the art for systems and methods for creating dynamic virtual boundaries for such objects.

    [0007] Document WO 2006/091494 A1 discloses a surgical apparatus including a surgical device, configured to be manipulated by a user to perform a procedure on a patient, and a computer system. The computer system is programmed to implement control parameters for controlling the surgical device to provide at least one of haptic guidance to the user and a limit on user manipulation of the surgical device, based on a relationship between an anatomy of the patient and at least one of a position, an orientation, a velocity, and an acceleration of a portion of the surgical device, and to adjust the control parameters in response to movement of the anatomy during the procedure.

    [0008] Further, document WO 2006/106419 A2 relates to a system for guiding resurfacing operations on at least a portion of a joint of at least one bone. The system uses a guide with actuators controlled by a computer to position a cutting tool relative to a bone.

    [0009] Moreover, document US 2008/214898 A1 discloses a surgical retractor system, in which first and second retractor blades are maintained in spaced relationship by a third retractor blade engaged with the first and second retractor blades. A guidance array adapts the retractor system for use with a surgical navigation system such that the surgical navigation system can determine the position and orientation of blades of the retractor by detecting the position and orientation of the guidance array.

    SUMMARY



    [0010] In one embodiment a system is provided that uses a plurality of virtual boundaries to guide movement of an instrument. The system includes an instrument tracking device to track movement of the instrument. The system also includes a first boundary tracking device to track movement of a first of the plurality of virtual boundaries wherein the first virtual boundary is associated with the anatomy to be treated. The system further includes a second boundary tracking device to track movements of a second of the plurality of virtual boundaries wherein the second virtual boundary is associated with a periphery of an opening in a patient to be avoided by the instrument. A controller is configured to receive information associated with the tracking devices including positions of the instrument relative to the first and second virtual boundaries. The controller is configured to guide movement of the instrument relative to each of the first and second virtual boundaries as the first and second virtual boundaries move relative to one another.

    [0011] In another embodiment a computer program product comprising software is provided for using a plurality of virtual boundaries to guide movement of an instrument. The software being configured to carry out the step of tracking movement of the instrument and a first virtual boundary associated with the anatomy to be treated. The software further being configured to carry out the step of tracking movement of a second virtual boundary relative to the first virtual boundary wherein the second virtual boundary is associated with a periphery of an opening in a patient to be avoided by the instrument. Movement of the instrument is guided relative to each of the first and second virtual boundaries as the first and second virtual boundaries move relative to one another.

    [0012] One advantage of these embodiments is the ability to dynamically track objects (such as other tools or anatomy) that may move relative to the anatomy of interest, in addition to tracking the instrument. The second virtual boundary can be a virtual constraint boundary or other type of virtual boundary that is tracked for movement relative to the first virtual boundary associated with the anatomy.

    BRIEF DESCRIPTION OF THE DRAWINGS



    [0013] Advantages of the present invention 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 wherein:

    Figure 1 is a perspective view of a navigation system of the present invention being used in conjunction with a robotic system;

    Figure 2 is a schematic view of the navigation system;

    Figure 3 is schematic view of the coordinate systems used in the navigation system;

    Figure 4 is a perspective view of a tissue opening for accessing a knee joint by an end effector of the robotic system;

    Figure 5 is an elevational view of a leg holder and retractor assembly being used to maintain the tissue opening;

    Figure 6 is a top perspective view of a retractor;

    Figure 7 is a top perspective view of an alternative retractor;

    Figure 8 is a top perspective view of the tissue opening showing an end effector in the tissue opening and a flexible shape sensing device for tracking movement of the tissue opening; and

    Figure 9 is a top perspective view of the tissue opening showing an end effector in the tissue opening and a machine vision system for tracking movement of the tissue opening.


    DETAILED DESCRIPTION



    [0014] Referring to Figure 1 a surgical navigation system 20 is illustrated. The system 20 is shown in a surgical setting such as an operating room of a medical facility. The navigation system 20 is set up to track movement of various objects in the operating room. Such objects include, for example, a surgical instrument 22, a femur F of a patient, and a tibia T of the patient. The navigation system 20 tracks these objects for purposes of displaying their relative positions and orientations to the surgeon and, in some cases, for purposes of controlling or constraining movement of the surgical instrument 22 relative to virtual cutting boundaries associated with the femur F and tibia T.

    [0015] The surgical navigation system 20 includes a computer cart assembly 24 that houses a navigation computer 26. A navigation interface is in operative communication with the navigation computer 26. The navigation interface includes a first display 28 adapted to be situated outside of the sterile field and a second display 29 adapted to be situated inside the sterile field. The displays 28, 29 are adjustably mounted to the computer cart assembly 24. First and second input devices 30, 32 such as a keyboard and mouse can be used to input information into the navigation computer 26 or otherwise select/control certain aspects of the navigation computer 26. Other input devices are contemplated including a touch screen (not shown) or voice-activation.

    [0016] A localizer 34 communicates with the navigation computer 26. In the embodiment shown, the localizer 34 is an optical localizer and includes a camera unit 36 (one example of a sensing device). The camera unit 36 has an outer casing 38 that houses one or more optical position sensors 40. In some embodiments at least two optical sensors 40 are employed, preferably three. The optical sensors 40 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 camera units, each with a separate CCD, or two or more CCDs, could also be arranged around the operating room. The CCDs detect infrared (IR) signals.

    [0017] Camera unit 36 is mounted on an adjustable arm to position the optical sensors 40 with a field of view of the below discussed trackers that, ideally, is free from obstructions. In some embodiments the camera unit 36 is adjustable in at least one degree of freedom by rotating about a rotational joint. In other embodiments, the camera unit 36 is adjustable about two or more degrees of freedom.

    [0018] The camera unit 36 includes a camera controller 42 in communication with the optical sensors 40 to receive signals from the optical sensors 40. The camera controller 42 communicates with the navigation computer 26 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 connection could also use a company specific protocol. In other embodiments, the optical sensors 40 communicate directly with the navigation computer 26.

    [0019] Position and orientation signals and/or data are transmitted to the navigation computer 26 for purposes of tracking objects. The computer cart assembly 24, display 28, and camera unit 36 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".

    [0020] The navigation computer 26 can be a personal computer or laptop computer. Navigation computer 26 has the display 28, central processing unit (CPU) and/or other processors, memory (not shown), and storage (not shown). The navigation computer 26 is loaded with software as described below. The software converts the signals received from the camera unit 36 into data representative of the position and orientation of the objects being tracked.

    [0021] Navigation system 20 includes a plurality of tracking devices 44, 46, 48, also referred to herein as trackers. In the illustrated embodiment, one tracker 44 is firmly affixed to the femur F of the patient and another tracker 46 is firmly affixed to the tibia T of the patient. Trackers 44, 46 are firmly affixed to sections of bone. Trackers 44, 46 may be attached to the femur F and tibia T in the manner shown in U.S. Patent No. 7,725, 162. Trackers 44, 46 could also be mounted like those shown in U.S. Provisional Patent Application No. 61/753,219, filed on January 16, 2013, entitled, "Tracking Devices and Navigation Systems and Methods for Use Thereof". In additional embodiments, a tracker (not shown) is attached to the patella to track a position and orientation of the patella. In yet further embodiments, the trackers 44, 46 could be mounted to other tissue types or parts of the anatomy.

    [0022] An instrument tracker 48 is firmly attached to the surgical instrument 22. The instrument tracker 48 may be integrated into the surgical instrument 22 during manufacture or may be separately mounted to the surgical instrument 22 in preparation for the surgical procedures. The working end of the surgical instrument 22, which is being tracked by virtue of the instrument tracker 48, may be a rotating bur, electrical ablation device, or the like.

    [0023] The trackers 44, 46, 48 can be battery powered with an internal battery or may have leads to receive power through the navigation computer 26, which, like the camera unit 36, preferably receives external power.

    [0024] In the embodiment shown, the surgical instrument 22 is attached to a surgical manipulator. Such an arrangement is shown in U.S. Patent Application No. 13/958,070, entitled, "Surgical Manipulator Capable of Controlling a Surgical Instrument in Multiple Modes".

    [0025] In other embodiments, the surgical instrument 22 may be manually positioned by only the hand of the user, without the aid of any cutting guide, jig, or other constraining mechanism such as a manipulator or robot. Such a surgical instrument is described in U.S. Patent Application No. 13/600,888, filed August 31, 2012, entitled, "Surgical Instrument Including Housing, a Cutting Accessory that Extends from the Housing and Actuators that Establish the Position of the Cutting Accessory Relative to the Housing".

    [0026] The optical sensors 40 of the localizer 34 receive light signals from the trackers 44, 46, 48. In the illustrated embodiment, the trackers 44, 46, 48 are active trackers. In this embodiment, each tracker 44, 46, 48 has at least three active tracking elements or markers for transmitting light signals to the optical sensors 40. The active markers can be, for example, light emitting diodes or LEDs 50 transmitting light, such as infrared light. The optical sensors 40 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 40 have sampling rates of 8000 Hz. The sampling rate is the rate at which the optical sensors 40 receive light signals from sequentially fired LEDs 50. In some embodiments, the light signals from the LEDs 50 are fired at different rates for each tracker 44, 46, 48.

    [0027] Referring to Figure 2, each of the LEDs 50 are connected to a tracker controller 62 located in a housing (not shown) of the associated tracker 44, 46, 48 that transmits/receives data to/from the navigation computer 26. In one embodiment, the tracker controllers 62 transmit data on the order of several Megabytes/second through wired connections with the navigation computer 26. In other embodiments, a wireless connection may be used. In these embodiments, the navigation computer 26 has a transceiver (not shown) to receive the data from the tracker controller 62.

    [0028] In other embodiments, the trackers 44, 46, 48 may have passive markers (not shown), such as reflectors that reflect light emitted from the camera unit 36. The reflected light is then received by the optical sensors 40. Active and passive arrangements are well known in the art.

    [0029] In some embodiments, the trackers 44, 46, 48 also include a gyroscope sensor 60 and accelerometer 70, such as the trackers shown in U.S. Provisional Patent Application No. 61/753,219, filed on January 16, 2013, entitled, "Tracking Devices and Navigation Systems and Methods for Use Thereof".

    [0030] The navigation computer 26 includes a navigation processor 52. It should be understood that the navigation processor 52 could include one or more processors to control operation of the navigation computer 26. The processors can be any type of microprocessor or multi-processor system. The term processor is not intended to limit the scope of the invention to a single processor.

    [0031] The camera unit 36 receives optical signals from the LEDs 50 of the trackers 44, 46, 48 and outputs to the processor 52 signals relating to the position of the LEDs 50 of the trackers 44, 46, 48 relative to the localizer 34. Based on the received optical (and non-optical signals in some embodiments), navigation processor 52 generates data indicating the relative positions and orientations of the trackers 44, 46, 48 relative to the localizer 34.

    [0032] Prior to the start of the surgical procedure, additional data are loaded into the navigation processor 52. Based on the position and orientation of the trackers 44, 46, 48 and the previously loaded data, navigation processor 52 determines the position of the working end of the surgical instrument 22 and the orientation of the surgical instrument 22 relative to the tissue against which the working end is to be applied. In some embodiments, navigation processor 52 forwards these data to a manipulator controller 54. The manipulator controller 54 can then use the data to control a robotic manipulator 56 as described in U.S. Provisional Patent Application No. 61/679,258, entitled, "Surgical Manipulator Capable of Controlling a Surgical Instrument in either a Semi-Autonomous Mode or a Manual, Boundary Constrained Mode," the disclosure of which is hereby incorporated by reference.

    [0033] The navigation processor 52 also generates image signals that indicate the relative position of the surgical instrument working end to the tissue. These image signals are applied to the displays 28, 29. Displays 28, 29, based on these signals, generate images that allow the surgeon and staff to view the relative position of the surgical instrument working end to the surgical site. The displays, 28, 29, as discussed above, may include a touch screen or other input/output device that allows entry of commands.

    [0034] Referring to Figure 3, tracking of objects is generally conducted with reference to a localizer coordinate system LCLZ. The localizer coordinate system 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 camera unit 36 may be used to track sudden or unexpected movement of the localizer coordinate system LCLZ, as may occur when the camera unit 36 is inadvertently bumped by surgical personnel.

    [0035] Each tracker 44, 46, 48 and object being tracked also has its own coordinate system separate from localizer coordinate system LCLZ. Components of the navigation system 20 that have their own coordinate systems are the bone trackers 44, 46 and the instrument tracker 48. These coordinate systems are represented as, respectively, bone tracker coordinate systems BTRK1, BTRK2, and instrument tracker coordinate system TLTR.

    [0036] Navigation system 20 monitors the positions of the femur F and tibia T of the patient by monitoring the position of bone trackers 44, 46 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 44, 46 are firmly attached.

    [0037] Prior to the start of the procedure, pre-operative images of the femur F and tibia T are generated (or of other tissues 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 mapped to the femur coordinate system FBONE and tibia coordinate system TBONE using well known methods in the art. These images 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 (OR) from kinematic studies, bone tracing, and other methods.

    [0038] During an initial phase of the procedure, the bone trackers 44, 46 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 Figures 1 and 2), such as disclosed in U.S.

    [0039] Patent No. 7,725,162 to Malackowski, et al., hereby incorporated by reference, having its own tracker PT (see Figure 2), 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 bone trackers 44, 46, 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 camera unit 36 is able to track the femur F and tibia T by tracking the bone trackers 44, 46. This pose-describing data are stored in memory integral with both manipulator controller 54 and navigation processor 52.

    [0040] The working end of the surgical instrument 22 (also referred to as energy applicator distal end) 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 both manipulator controller 54 and navigation processor 52.

    [0041] Referring to Figure 2, a localization engine 100 is a software module that can be considered part of the navigation system 20. Components of the localization engine 100 run on navigation processor 52. In some versions of the invention, the localization engine 100 may run on the manipulator controller 54.

    [0042] Localization engine 100 receives as inputs the optically-based signals from the camera controller 42 and, in some embodiments, the non-optically based signals from the tracker controller 62. 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 48, the localization engine 100 determines the pose of the instrument tracker coordinate system TLTR in the localizer coordinate system LCLZ.

    [0043] The localization engine 100 forwards the signals representative of the poses of trackers 44, 46, 48 to a coordinate transformer 102. Coordinate transformer 102 is a navigation system software module that runs on navigation processor 52. Coordinate transformer 102 references the data that defines the relationship between the pre-operative images of the patient and the bone trackers 44, 46. Coordinate transformer 102 also stores the data indicating the pose of the working end of the surgical instrument relative to the instrument tracker 48.

    [0044] During the procedure, the coordinate transformer 102 receives the data indicating the relative poses of the trackers 44, 46, 48 to the localizer 34. 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 and TBONE to the localizer coordinate system LCLZ.

    [0045] As a result, coordinate transformer 102 generates data indicating the position and orientation of the working end of the surgical instrument 22 relative to the tissue (e.g., bone) against which the instrument working end is applied. Image signals representative of these data are forwarded to displays 28, 29 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 54 to guide the manipulator 56 and corresponding movement of the surgical instrument 22.

    [0046] Before using the surgical instrument 22 to treat the patient, certain preparations are necessary such as draping the patient and preparing the surgical site for treatment. For instance, in knee arthroplasty, surgical personnel may secure the leg of interest in a leg holder, and drape the patient and equipment. One such leg holder is shown in U.S. Patent Application No. 13/554,010, entitled, "Multi-position Limb Holder", published as U.S. Patent Application Publication No. 2013/0019883.

    [0047] Other preparations include placing objects needed for surgery in the operating room. Some of these objects are used in proximity to areas in which the surgical instrument 22 will maneuver. These objects can include leg holders, retractors, suction/irrigation tools, surgical personnel, and the like. During the surgery, these objects are to be avoided by the surgical instrument 22. To facilitate the avoidance of these objects during the surgery position information for one or more of these objects is determined either directly or indirectly. In some embodiments, one or more of the objects are dynamically tracked by the navigation system 20 during the surgery.

    [0048] Referring to Figure 4, in one embodiment, position information can be obtained indirectly from an object using the pointer instrument P, an example of which is disclosed in U.S. Patent No. 7,725,162 to Malackowski, et al. The pointer P has its own tracker PT with LEDs 50 that transmit signals to the camera unit 36 in the same manner as trackers 44, 46, 48. Position of a tip of the pointer P is known relative to the LEDs 50 on the pointer P and stored in the pointer P in electronic format for later transmitting to the camera unit 36 via transceivers. Alternatively, the position information for the tip is stored in the navigation computer 26 or calibrated to a known location in the field. In either case, since the tip position is known, the pointer P can be used to determine the positions of objects to be avoided by the surgical instrument 22.

    [0049] Once the tip touches certain surfaces of the object, a trigger or switch (not shown) on the pointer P is actuated by the user or alternatively the tip may include a sensor that automatically senses when it is in contact with a surface. A corresponding signal is sent to the transceiver on the camera unit 36 to read the signals from the LEDs 50 on the pointer tracker PT so that the position of the tip can be calculated, which correlates to a point on the surface of the object. As more points on the surface are touched by the tip and their positions calculated by the navigation system 20, models of the object can be created to define a position and orientation of the object in the localizer coordinate system LCLZ. Such models can be created using conventional surface mapping tools and the like.

    [0050] The created models are used as virtual constraint boundaries to guide movement of the surgical instrument 22. The models may be displayed on displays 28, 29 to show the locations of the objects and/or information relating to the models can be forwarded to the manipulator controller 54 to guide the manipulator 56 and corresponding movement of the surgical instrument 22 relative to these virtual constraint boundaries to prevent the object from being contacted by the surgical instrument 22.

    [0051] When the object is stationary during the surgery the above method of determining position and/or orientation is suitable to provide a virtual constraint boundary, or if the object to be tracked is not stationary, but in a fixed location relative to another tracked object. However, if the object typically moves during the surgery, additional measures are needed to enable continuous tracking of the object. In some embodiments, mountable trackers 110 may be mounted to the objects. These trackers 110 may be generic with respect to the objects and thus, not be calibrated to the objects. In this case, the trackers 110 are first attached to the objects.

    [0052] One such object may be a retractor, such as the retractor assemblies 104 shown in Figure 4. The trackers 110 may be attached to the retractor assemblies 104 by a tracker connector located on the retractor assemblies 104, such as those shown in U.S Patent No. 7,725,162 to Malackowski, et al., or the trackers 110 may be mounted with conventional fasteners or clamps to fix the trackers 110 to the retractor assemblies 104. Examples of retractor assemblies that may be used are shown in U.S. Patent Application No. 13/554,010, entitled, "Multi-position Limb Holder", published as U.S. Patent Application Publication No. 2013/0019883. Once the tracker 110 is fixed to the retractor assembly 104, the pointer P can be used to register the surfaces or other points on the retractor assembly 104. Each tracker 110 includes three or more LEDs (not shown) that transmit signals to the camera unit 36 in the same manner as trackers 44, 46, 48. The camera unit 36 and/or navigation computer 26 are then able to determine a position of each of the LEDs in the localizer coordinate system LCLZ. While the camera unit 36 is receiving signals from the LEDs on tracker 110, the pointer P is used to touch on several points on the retractor assembly 104 and transmit corresponding signals to the camera unit 36 to determine position information from the pointer P using the pointer tracker PT. This enables the navigation computer 26 to associate points on the retractor assembly 104 with positions of the LEDs on the tracker 110. Then, through a boundary creation software module (not shown) run by the navigation processor 52, a virtual constraint boundary can be created that is associated with the retractor assembly 104 and dynamically trackable via the tracker 110.

    [0053] In some embodiments, the boundary can be created by connecting each of the captured points together. This creates a web or mesh that defines a surface boundary. If only two points are captured, the boundary may be a line between the points. If three points are captured, the boundary may be a triangle formed by lines connecting adjacent points. The displays 28, 29 can be used to provide visual feedback of the shape of the boundary created. The input devices, e.g., mouse, touch screen, etc. could be used to modify the boundary such as by shifting the boundary, enlarging or shrinking the boundary, changing the shape of the boundary, etc. Once created, the boundary may be defined in the boundary creation software module as a virtual constraint boundary across which the surgical instrument 22 is prevented from moving in accordance with the robotic control functionality described in U.S. Provisional Patent Application No. 61/679,258, entitled, "Surgical Manipulator Capable of Controlling a Surgical Instrument in either a Semi-Autonomous Mode or a Manual, Boundary Constrained Mode,". The manipulator controller 54 may also continuously track movement of the virtual constraint boundary and continuously adjust a path and/or orientation of the surgical instrument 22 as the virtual constraint boundary moves, to avoid the virtual constraint boundary.

    [0054] The virtual constraint boundary can also be tracked simultaneously with tracking of a virtual cutting boundary associated with the femur F or tibia T described in U.S. Provisional Patent Application No. 61/679,258, entitled, "Surgical Manipulator Capable of Controlling a Surgical Instrument in either a Semi-Autonomous Mode or a Manual, Boundary Constrained Mode," The virtual constraint boundary may move relative to the virtual cutting boundary during the surgery. Tracking of the boundaries would also enable tracking of the relative movement between such boundaries.

    [0055] Models of the objects being tracked may be displayed on displays 28, 29 to show the location of the objects. Representations of the virtual boundaries and the anatomy being treated may also be shown on displays 28, 29. Additionally, information relating to the virtual constraint boundaries and virtual cutting boundary can be forwarded to the manipulator controller 54 to guide the manipulator 56 and corresponding movement of the surgical instrument 22 relative to these virtual boundaries so that the surgical instrument 22 does not intrude on the virtual boundaries.

    [0056] In some embodiments, a virtual boundary is associated with the surgical instrument 22. The surgical instrument virtual boundary is tracked via the instrument tracker 48. The surgical instrument virtual boundary may be defined merely by a model of the surgical instrument 22. The manipulator controller 54 then monitors movement of the surgical instrument virtual boundary relative to the other virtual constraint boundaries, including the virtual cutting boundaries and other virtual constraint boundaries associated with other objects. The manipulator controller 54 is then programmed to continuously track movement of the boundaries and update guidance of the surgical instrument 22 as the boundaries move relative to the surgical instrument 22.

    [0057] Objects to be avoided by the surgical instrument 22 in the operating room may be tracked indirectly by associating the object with one or more trackers that are not directly fixed to the object. For instance, in Figure 4, the opening 106 in the tissue, although not directly attached to a tracker, is formed by the retractor assemblies 104 with trackers 110 fixed thereto. Since the retractor assemblies 104 form the opening 106, there is a general correlation between the size and shape of the opening 106 and the position and orientation of the retractor assemblies 104, which can be tracked by the navigation system 20 using the trackers 110, as described above. Therefore, the opening 106 can also be dynamically tracked.

    [0058] The opening 106 can be defined in the boundary creation software module using the points associated with the retractor assemblies 104 since the opening 106 lies along an edge of the retractor assemblies 104. Alternatively, the opening 106 can be traced using the pointer P. In the latter case, the pointer P is used to capture points defining a periphery of the opening 106 such that the points can be connected in the boundary creation software module to form a ring representing the opening 106. The ring may be defined in the boundary creation software module as a virtual constraint boundary to constrain movement of the surgical instrument 22 to within the ring in accordance with the robotic control functionality associated with such openings described in U.S. Provisional Patent Application No. 61/679,258, entitled, "Surgical Manipulator Capable of Controlling a Surgical Instrument in either a Semi-Autonomous Mode or a Manual, Boundary Constrained Mode,". The opening 106 could additionally be registered to the trackers 110 so that movement of the opening 106 is trackable using the trackers 110. Other tissues to be avoided by the surgical instrument 22 such as nerve tissue, ligaments, and the like can similarly be outlined by the pointer P and associated with the trackers 110 to track their movement.

    [0059] Referring to Figure 5, a leg holder 200 for supporting a leg of a patient is shown. The leg holder 200 is described in more detail in U.S. Patent Application No. 13/554,010, entitled, "Multi-position Limb Holder", published as U.S. Patent Application Publication No. 2013/0019883. An alternative retractor assembly 105 for attaching to the leg holder 200 is shown in Figure 5. The alternative retractor assembly 105 is described in more detail in U.S. Patent Application No. 13/554,010.

    [0060] Retractor heads 107, 109 in Figures 6 and 7 can be used to retract soft tissue to access bone in a surgical procedure. Use of these types of heads 107, 109 for retracting tissue is described in more detail in U.S. Patent Application No. 13/554,010. In Figures 6 and 7, tracking elements are fixed to the heads 107, 109 so that the heads 107, 109 can be tracked by the navigation system 20. In the embodiment shown, the tracking elements are three or more LEDs 50 that are integrated into the structure of each of the heads 107, 109 and fixed in relationship to one another. The geometric model of each head 107, 109 in relation to the LEDs 50 is also stored on the retractor head 107, 109 in memory (not shown) and can be transmitted to the camera unit 36 via transceivers (including transceiver, not shown, integrated into the retractor head 107, 109). Alternatively, the model of each head is pre-stored in the navigation computer 26 and accessed during navigation setup by identifying a type or serial no. of the retractor head 107, 109 using the boundary creation software module. The shape of each retractor head 107, 109 can also be identified by correlating a unique LED pattern on the retractor head 107, 109 to a database of retractor head shapes.

    [0061] By creating virtual constraint boundaries associated with the shapes of the retractor assemblies 104 and tracking movement of the virtual constraint boundaries using trackers 110 or integrated tracking elements, the manipulator controller 54 can guide movement of the surgical instrument 22 with respect to the retractor virtual constraint boundaries and the virtual cutting boundaries so that the surgical instrument 22 is not moved beyond these boundaries thereby avoiding inadvertent contact with the retractor assemblies 104 or with bone or other tissue to remain after the surgery. These virtual boundaries may be used in both a manual mode and semi-autonomous mode of the surgical manipulator as described in U.S. Provisional Patent Application No. 61/679,258, entitled, "Surgical Manipulator Capable of Controlling a Surgical Instrument in either a Semi-Autonomous Mode or a Manual, Boundary Constrained Mode,".

    [0062] Referring to Figure 8, a flexible shape sensing device 300 may also be used to determine a position of an object, such as opening 106. The flexible shape sensing device 300 includes a housing 302 having its own shape sensing coordinate system SS. The housing 302 forms part of a reflectometer, such as a Luna Distributed Sensing System commercially available from Luna Innovations Incorporated of Roanoke, Virginia. Another example of a commercially available reflectometer is the Optical Backscatter Reflectometer from Luna Innovations Incorporated.

    [0063] A fiber optic cable 304 extends from the housing 302 and is laid on the patient's skin about the opening 106 in close proximity to the opening 106. In some embodiments, the cable 304 is adhered to the skin in a perimeter with an offset from the opening 106. In some embodiments, the offset is less than five millimeters from the opening 106 at all locations along the perimeter of the opening 106. In other embodiments, different offsets may be used or the offsets may be measured after placing the fiber optic cable 304 so that the location of the fiber optic cable 304 relative to the opening 106 is known. The cable 304 is flexible so that as the shape of the opening 106 changes, the shape of the cable 304 also changes. Position of the cable 304 is able to be dynamically tracked. The flexible shape sensing device 300 including the reflectometer, cable, and other features, and their method of use for determining position are described in U.S. Patent No. 7,772,541 to Froggatt et al.

    [0064] Tracking elements, such as LEDs 50 may be integrated into the flexible shape sensing device 300. Alternatively, a tracker (not shown) can be mounted to the housing 302. The LEDs 50 integrated into the flexible shape sensing device 300 transmit signals to the camera unit 36 in the same manner as the LEDs 50 of the trackers 44, 46, 48. Accordingly, the position and orientation of the housing 302 and the shape sensing coordinate system SS can be determining by the navigation system 20 in the localizer coordinate system LCLZ. Movement of the cable 304 results in changes in position in shape sensing coordinate system SS, which is fixed with respect to housing 302. Coordinate system SS is registered to the localizer coordinate system LCLZ using the LEDs 50 on the housing 302. Once registered, changes in position of the cable 304 can also be determined in the localizer coordinate system LCLZ.

    [0065] The opening 106 may be defined in the boundary creation software module as a virtual constraint boundary to constrain movement of the surgical instrument 22 to within the opening 106 in accordance with the robotic control functionality associated with such openings described in U.S. Provisional Patent Application No. 61/679,258, entitled, "Surgical Manipulator Capable of Controlling a Surgical Instrument in either a Semi-Autonomous Mode or a Manual, Boundary Constrained Mode,". Other tissues to be avoided by the surgical instrument 22 such as nerve tissue, ligaments, and the like can similarly be tracked using flexible shape sensing devices 300. Likewise, flexible shape sensing devices 300 could be used to establish other boundaries, such as being integrated into gloves worn by the surgical staff so that boundaries associated with surgical personnel can be created.

    [0066] Machine vision can identify objects in the operating room and create virtual constraint boundaries associated with the objects. Figure 9 shows a machine vision system 400. Machine vision system 400 includes a 3-dimensional machine vision camera 402. The vision camera 402 is arranged so that a field-of-view of the vision camera 402 encompasses the surgical site and objects in proximity to the surgical site. As shown in Figure 9, such objects may include the surgical instrument 22 (shown as a cutting bur), retractor assemblies 104, femur F, and tibia T. The machine vision system 400 has a control unit (not shown) in communication with the vision camera 402. The control unit includes a processor, memory, and storage and is in communication with the navigation computer 26.

    [0067] Initially, the objects to be tracked are identified. The objects may be identified by selecting objects stored in memory on the control unit using machine vision software. For instance, groups of pixels associated with different sizes and shapes of retractor assemblies 104 may be stored in the control unit. By selecting one of the retractor assemblies 104 to be tracked the machine vision software identifies the corresponding group of pixels and the machine vision software then operates to detect like groups of pixels using conventional pattern recognition technology.

    [0068] Alternatively, the objects can be identified using an interface in which a user outlines or selects the objects to be tracked on the displays 28, 29. For instance, images taken by the vision camera 402 from overhead the surgical site - similar to the image shown in Figure 9 - are displayed on the displays 28, 29. The user then, using a mouse, digital pen, or the like, traces objects to be tracked on the display 28, 29. The machine vision software stores the pixels associated with the object that was traced into its memory. The user identifies each object by a unique identifier such as naming the object "MEDIAL RETRACTOR", etc. in the machine vision software so that the saved group of pixels is now associated with the unique identifier. Multiple objects could be stored in this manner. The machine vision system 400 utilizes conventional pattern recognition and associated software to later detect these objects.

    [0069] The machine vision system 400 is able to detect movement of these objects by continuously taking images, reviewing the images, and detecting movement of the groups of pixels associated with the objects. In some cases, position information from the control unit of the machine vision system 400 for the objects can be transmitted to the navigation computer 26. Likewise, position information from the navigation computer 26 can be transmitted from the navigation computer 26 to the control unit of the machine vision system 400.

    [0070] Control unit of the machine vision system 400 may provide position information for the objects in a machine vision coordinate system MV. The vision camera 402 also includes LEDs 50 so that the camera unit 36 can track and thus register the position and orientation of the machine vision coordinate system MV relative to the localizer coordinate system LCLZ. Thus, position information from the vision camera 402 can be determined in the localizer coordinate system LCLZ. Virtual boundaries can thus be associated with the objects in the machine vision system 400 and information relating to these virtual boundaries can be communicated to the navigation computer 26. Additionally, information relating to the virtual constraint boundaries can be forwarded to the manipulator controller 54 to guide the manipulator 56 and corresponding movement of the surgical instrument 22 relative to these virtual boundaries.

    [0071] The objects can also be initially registered to the localizer coordinate system LCLZ using the pointer P. For instance, when the retractor assemblies 104 are not equipped with trackers 110 or integrated tracking elements, the pointer P may be used to initially establish virtual constraint boundaries associated with the retractor assemblies 104 when the retractor assemblies 104 are at rest, i.e., not moving. These virtual constraint boundaries would then be stored in the navigation computer 26 and/or manipulator controller 54 for use in guiding the robotic manipulator 56. The machine vision system 400 would also be configured to detect movement of the retractor assemblies 104 as previously described, i.e., by tracking movement of the groups of pixels associated with the retractor assemblies 104.

    [0072] Machine vision detection of movement of a retractor assembly 104 could then be used to shift the virtual constraint boundary stored in the navigation computer for the retractor assembly 104 by defining a change in pose of the retractor assembly 104 (e.g., translation along 3 axes/rotation about 3 axes). The machine vision system 400 would operate to establish a first pose of the retractor assembly 140 at time t1 and a second pose at time t2. The difference in pose between t1 and t2 would be provided to the navigation computer 26 and/or manipulator controller 54 to move the associated virtual constraint boundary by a proportional amount in the localizer coordinate system LCLZ. In some embodiments, only 2-dimensional movement is detected by the vision camera 402 and shared with the navigation computer 26 and/or manipulator controller 54 to update a position of the retractor assembly 104.

    [0073] In some embodiments, the robotic system is a robotic surgical cutting system for cutting away material from a patient's anatomy, such as bone or soft tissue. Once the cutting system is determined to be in the proper position by the navigation system 20, the cutting system cuts away material to be replaced by surgical implants such as hip and knee implants, including unicompartmental, bicompartmental, or total knee implants. Some of these types of implants are shown in U.S. Patent Application No. 13/530,927, entitled, "Prosthetic Implant and Method of Implantation". The navigation system 20 instructs the surgeon on proper procedures for locating these implants on bone and securing the implants in position, including the use of trial implants.

    [0074] In other systems, the instrument 22 has a cutting tool that is movable in three degrees of freedom relative to a handheld housing and is manually positioned by the hand of the surgeon, without the aid of cutting jigs, guide arms or other constraining mechanism. Such systems are shown in U.S. Patent Application No. 13/600,888, entitled, "Surgical Instrument Including Housing, a Cutting Accessory that Extends from the Housing and Actuators that Establish the Position of the Cutting Accessory Relative to the Housing".

    [0075] In these embodiments, the system includes a hand held surgical cutting instrument having a cutting tool. A control system controls movement of the cutting tool in at least three degrees of freedom using internal actuators/motors, as shown in U.S. Patent Application No. 13/600,888, entitled, "Surgical Instrument Including Housing, a Cutting Accessory that Extends from the Housing and Actuators that Establish the Position of the Cutting Accessory Relative to the Housing". The navigation system 20 communicates with the control system. One tracker (such as tracker 48) is mounted to the instrument. Other trackers (such as trackers 44, 46) are mounted to a patient's anatomy. The navigation system 20 communicates with the control system of the hand held surgical cutting instrument. The navigation system 20 communicates position and/or orientation data to the control system. The position and/or orientation data is indicative of a position and/or orientation of the instrument 22 relative to the anatomy. This communication provides closed loop control to control cutting of the anatomy such that the cutting occurs within a predefined boundary (the term predefined boundary is understood to include predefined trajectory, volume, line, other shapes or geometric forms, and the like).

    [0076] In some embodiments, a 3-D video camera (not shown) is attached to the camera unit 36. The video camera is oriented such that a field of view of the camera unit 36 can be associated with the field of view of the video camera. In other words, the two fields of view may be matched or otherwise correlated such that if an object can be seen in video images streamed from the video camera, the objects are also within the field of view of the camera unit 36. A coordinate system of the video camera can also be transformed into the localizer coordinate system LCLZ or vice versa so that positions and/or orientations of objects shown in the video images streamed from the video camera are known in the localizer coordinate system LCLZ. Video images from the video camera can be streamed to the displays 28, 29 and the user can then identify on the displays 28, 29, using an input device, such as a mouse or touch screen, virtual constraint boundaries to delineate zones to be avoided by the instrument 22. The video images could be provided in 2-D or in 3-D to facilitate the creation of these virtual constraint boundaries. Information relating to the positions and/or orientation of these virtual constraint boundaries would be provided into the localizer coordinate system LCLZ and tracked by the navigation computer 26 or manipulator controller 54, for example, to prevent the instrument 22 from intruding on the boundaries created.

    [0077] In some embodiments, when the manipulator controller 54 or navigation computer 26 detect that the instrument 22 is approaching one of the virtual constraint boundaries, an alarm may be generated. The alarm may include visual, tactile, or audible feedback to the user that indicates to the user that the object associated with the virtual constraint boundary is about to be struck and/or may include visual, tactile, or audible indications of distance from the object or associated virtual constraint boundaries.

    [0078] 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 system (20) comprising:

    an instrument (22);

    an instrument tracking device (48) configured to track movement of said instrument (22);

    a navigation computer (26) configured to create a first virtual boundary associated with an anatomy to be treated by said instrument (22) and being configured to create a second virtual boundary associated with a periphery of a tissue opening (106) for accessing the anatomy to be treated in a patient to be avoided by said instrument (22);

    a first boundary tracking device (44, 46) configured to be mounted to the anatomy to be treated by said instrument (22);

    said surgical system (20) being configured to map a pose of a coordinate system of the anatomy to be treated to a coordinate system of the first boundary tracking device (44, 46);

    a second boundary tracking device (110, 300, 400, P) for tracking the periphery of the tissue opening (106);

    said navigation computer (26) configured to receive information from said tracking devices (44, 46, 110, 300, 400, P) and to track movement of the first and second virtual boundaries; and

    a controller (54) configured to receive information associated with said tracking devices (44, 46, 48, 110, 300, 400, P) including positions of said instrument (22) relative to the first and second virtual boundaries, said controller (54) configured to guide movement of said instrument (22) relative to each of the first and second virtual boundaries as the first and second virtual boundaries move relative to one another.


     
    2. A system (20) as set forth in claim 1 including a surgical manipulator (56) having a plurality of arms and a plurality of actuators for controlling a position of said instrument (22).
     
    3. A system (20) as set forth in claim 2 including a retractor (104, 105) for retracting tissue, said second boundary tracking device (110) being attached to said retractor (104, 105).
     
    4. A system (20) as set forth in claim 3 wherein said second boundary tracking device (110, 300, 400, P) includes one of a tracker mountable to said retractor (104, 105) or at least one tracking element (50) integrated into said retractor (104, 105).
     
    5. A system (20) as set forth in claim 3 wherein said navigation computer (26) is further configured to create a third virtual boundary associated with a second object to be avoided by said instrument (22), and further including a third boundary tracking device (110, 300, 400, P) provided for the second object to be avoided, said navigation computer (26) being configured to receive information from said third tracking device (110, 300, 400, P) and to track movement of the third virtual boundary, said controller (54) being configured to guide movement of said instrument (22) relative to each of the first, second, and third virtual boundaries.
     
    6. A system (20) as set forth in claim 5 wherein said controller (54) is configured to define the opening (106) in the patient for receipt of said instrument (22) based on positions of the second and third virtual boundaries and said controller (54) is configured to monitor a position of the periphery of the opening (106) using said second and third boundary tracking devices (110, 300, 400, P).
     
    7. A system (20) as set forth in claim 2 wherein said surgical manipulator (56) is a robotic manipulator (56) operable in manual and semi-autonomous modes.
     
    8. A system (20) as set forth in claim 1 wherein said second boundary tracking device (300) includes a flexible shape sensing system comprising a fiber optic cable (304) positionable adjacent the periphery of the opening (106).
     
    9. A system (20) as set forth in claim 1 wherein said second boundary tracking device (P) includes a pointer configured to capture points associated with the periphery of the opening (106) so that information relating to the points is used to create the second virtual boundary.
     
    10. A system (20) as set forth in claim 1 wherein said second boundary tracking device (400) includes a machine vision system, said machine vision system including a vision camera (402) and a control unit in communication with said controller (54), wherein said machine vision system (402) is configured to detect movement of the periphery of the opening (106).
     
    11. A system (20) as set forth in claim 1 wherein each of said tracking devices (44, 46, 48, 110, 300, 400, P) includes one or more tracking elements (50).
     
    12. A system (20) as set forth in claim 11 wherein said one or more tracking elements (50) include light emitting diodes.
     
    13. A system (20) as set forth in claim 11 wherein said tracking elements (50) include optical tracking elements and said system (20) further includes a plurality of sensing devices (36) to receive optical signals from said optical tracking elements (50).
     
    14. A system (20) as set forth in claim 1 wherein said second boundary tracking device (P) includes a pointer configured to capture points associated with the periphery of the opening (106)so that information relating to the points is used to create the second virtual boundary and said system (20) includes a machine vision camera (402) for detecting movement of the periphery of the opening (106), said controller (54) receiving position information derived from images taken by said machine vision camera (402) to adjust a position of the second virtual boundary after the second virtual boundary moves.
     
    15. A computer program product comprising software for operating a navigation computer (26) and controller (54) of a surgical system (20), the surgical system (20) comprising an instrument (22), an instrument tracking device (48) configured to track movement of the instrument (22), a first boundary tracking device (44, 46) configured to be mounted to an anatomy to be treated by the instrument (22), a second boundary tracking device (110, 300, 400, P), and an actuator configured to guide movement of the instrument (22), the software being configured to carry out the steps of:

    creating a first virtual boundary associated with an anatomy to be treated by said instrument (22);

    creating a second virtual boundary associated with a periphery of a tissue opening (106) for accessing the anatomy to be treated in a patient to be avoided by said instrument (22);

    mapping a pose of a coordinate system of the anatomy to be treated to a coordinate system of the first boundary tracking device (44, 46);receiving information from the tracking devices (44, 46, 110, 300, 400, P);

    tracking movement of the instrument (22);

    tracking movement of the first virtual boundary; and

    tracking movement of the second virtual boundary relative to the first virtual boundary;

    controlling the actuator to guide movement of the instrument (22) relative to each of the first and second virtual boundaries.


     
    16. A computer program product comprising the software as set forth in claim 15 wherein guiding movement of the instrument (22) relative to the first and second virtual boundaries is further defined as guiding cutting of the anatomy relative to the first virtual boundary and guiding movement of the instrument (22) so that the instrument (22) avoids contact with the periphery of the opening (106) associated with the second virtual boundary.
     
    17. A computer program product comprising software as set forth in claim 15, wherein the surgical system (20) further comprises a third boundary tracking device (110, 300, 400, P) for a second object to be avoided, said software being configured to further carry out the steps of:

    creating a third virtual boundary associated with the second object to be avoided by said instrument (22);

    receiving information from the third boundary tracking device (110, 300, 400, P);

    tracking movement of the third virtual boundary; and

    controlling the actuator to guide movement of the instrument (22) relative to each of the first, second, and third virtual boundaries.


     


    Ansprüche

    1. Chirurgiesystem (20), umfassend:

    ein Instrument (22);

    eine Instrumentenverfolgungsvorrichtung (48), die ausgelegt ist, eine Bewegung des Instruments (22) nachzuverfolgen;

    einen Navigationscomputer (26), der ausgelegt ist, eine erste virtuelle Grenze zu erstellen, die zu einer durch das Instrument (22) zu behandelnden Anatomie gehört, und der ausgelegt ist, eine zweite virtuelle Grenze zu erstellen, die zu einer von dem Instrument (22) zu vermeidende Peripherie einer Gewebeöffnung (106) in einem Patienten zum Zugriff auf die zu behandelnde Anatomie gehört;

    eine erste Grenzverfolgungsvorrichtung (44, 46), die ausgelegt ist, an der von dem Instrument (22) zu behandelnden Anatomie befestigt zu werden;

    wobei das Chirurgiesystem (20) ausgelegt ist, eine Stellung eines Koordinatensystems der zu behandelnden Anatomie auf ein Koordinatensystem der ersten Grenzverfolgungsvorrichtung (44, 46) abzubilden;

    eine zweite Grenzverfolgungsvorrichtung (110, 300, 400, P) zum Nachverfolgen der Peripherie der Gewebeöffnung (106);

    wobei der Navigationscomputer (26) ausgelegt ist, eine Information von den Verfolgungsvorrichtungen (44, 46, 110, 300, 400, P) zu empfangen und eine Bewegung der ersten und der zweiten virtuellen Grenzen nachzuverfolgen; und

    eine Steuerung (54), die ausgelegt ist, eine zu den Verfolgungsvorrichtungen (44, 46, 48, 110, 300, 400, P) gehörende Information zu empfangen, die Positionen des Instruments (22) relativ zur ersten und zweiten virtuellen Grenze enthält, wobei die Steuerung (54) ausgelegt ist, eine Bewegung des Instruments (22) relativ zu jeder der ersten und der zweiten virtuellen Grenze zu führen, während sich die erste und die zweite virtuelle Grenze relativ zueinander bewegen.


     
    2. System (20) nach Anspruch 1, das einen chirurgischen Manipulator (56) mit einer Mehrzahl von Armen und einer Mehrzahl von Stellgliedern zum Steuern einer Position des Instruments (22) enthält.
     
    3. System (20) nach Anspruch 2, das einen Retraktor (104, 105) zum Spreizen von Gewebe enthält, wobei die zweite Grenzverfolgungsvorrichtung (110) am Retraktor (104, 105) befestigt ist.
     
    4. System (20) nach Anspruch 3, wobei die zweite Grenzverfolgungsvorrichtung (110, 300, 400, P) entweder eine am Retraktor (104, 105) montierbare Nachführeinrichtung oder mindestens ein in den Retraktor (104, 105) integriertes Nachverfolgungselement (50) enthält.
     
    5. System (20) nach Anspruch 3, wobei der Navigationscomputer (26) ferner ausgelegt ist, eine dritte virtuelle Grenze zu erstellen, die zu einem von dem Instrument (22) zu vermeidenden zweiten Objekt gehört, und ferner eine dritte Grenzverfolgungsvorrichtung (110, 300, 400, P) enthält, die vorgesehen ist, damit das zweite Objekt vermieden wird, wobei der Navigationscomputer (26) ausgelegt ist, eine Information von der dritten Grenzverfolgungsvorrichtung (110, 300, 400, P) zu empfangen und eine Bewegung der dritten virtuellen Grenze nachzuverfolgen, wobei die Steuerung (54) ausgelegt ist, jeweils relativ zu jeder der ersten, zweiten und dritten Grenze eine Bewegung des Instruments (22) zu führen.
     
    6. System (20) nach Anspruch 5, wobei die Steuerung (54) ausgelegt ist, die Öffnung (106) im Patienten zur Aufnahme des Instruments (22) auf Grundlage von Positionen der zweiten und der dritten virtuellen Grenze zu definieren, und die Steuerung (54) ausgelegt ist, eine Position der Peripherie der Öffnung (106) unter Verwendung der zweiten und der dritten Grenzverfolgungsvorrichtungen (110, 300, 400, P) zu überwachen.
     
    7. System (20) nach Anspruch 2, wobei der chirurgische Manipulator (56) ein Robotermanipulator (56) ist, der in manuellen und semi-autonomen Modi betreibbar ist.
     
    8. System (20) nach Anspruch 1, wobei die zweite Grenzverfolgungsvorrichtung (300) ein flexibles Formerfassungssystem enthält, das ein Lichtleiterkabel (304) umfasst, das neben der Peripherie der Öffnung (106) positionierbar ist.
     
    9. System (20) nach Anspruch 1, wobei die zweite Grenzverfolgungsvorrichtung (P) einen Zeiger enthält, der ausgelegt ist, mit der Peripherie der Öffnung (106) verbundene Punkte zu erfassen, sodass eine zu den Punkten gehörende Information verwendet wird, um die zweite virtuelle Grenze zu erzeugen.
     
    10. System (20) nach Anspruch 1, wobei die zweite Grenzverfolgungsvorrichtung (400) ein Bildverarbeitungssystem enthält, wobei das Bildverarbeitungssystem eine Bildkamera (402) und eine Steuereinheit in Kommunikation mit der Steuerung (54) enthält, wobei das Bildverarbeitungssystem (402) ausgelegt ist, eine Bewegung der Peripherie der Öffnung (106) zu erfassen.
     
    11. System (20) nach Anspruch 1, wobei jede der Verfolgungsvorrichtungen (44, 46, 48, 110, 300, 400, P) ein oder mehrere Nachverfolgungselemente (50) enthält.
     
    12. System (20) nach Anspruch 11, wobei das eine oder die mehreren Nachverfolgungselemente (50) lichtemittierende Dioden enthalten.
     
    13. System (20) nach Anspruch 11, wobei die Nachverfolgungselemente (50) optische Nachverfolgungselemente enthalten und das System (20) ferner eine Mehrzahl von Sensorvorrichtungen (36) enthält, um optische Signale von den optischen Nachverfolgungselementen (50) zu empfangen.
     
    14. System (20) nach Anspruch 1, wobei die zweite Grenzverfolgungsvorrichtung (P) einen Zeiger enthält, der ausgelegt ist, zu der Peripherie der Öffnung (106) gehörende Punkte zu erfassen, sodass eine zu den Punkten gehörende Information verwendet wird, um die zweite virtuelle Grenze zu erzeugen, und das System (20) eine Bildverarbeitungskamera (402) zum Erkennen einer Bewegung der Peripherie der Öffnung (106) enthält, wobei die Steuerung (54) eine aus von der Bildverarbeitungskamera (402) gemachten Bildern abgeleitete Positionsinformation empfängt, um eine Position der zweiten virtuellen Grenze anzupassen, nachdem sich die zweite virtuelle Grenze bewegt.
     
    15. Computerprogrammprodukt, das Software zum Betreiben eines Navigationscomputers (26) und einer Steuerung (54) eines Chirurgiesystems (20) umfasst, wobei das Chirurgiesystem (20) ein Instrument (22), eine Instrumentenverfolgungsvorrichtung (48), die ausgelegt ist, eine Bewegung des Instruments (22) nachzuverfolgen, eine erste Grenzverfolgungsvorrichtung (44, 46), die ausgelegt ist, an einer von dem Instrument (22) zu behandelnden Anatomie befestigt zu werden, eine zweite Grenzverfolgungsvorrichtung (110, 300, 400, P) und ein Stellglied, das ausgelegt ist, eine Bewegung des Instruments (22) zu führen, wobei die Software ausgelegt ist, die Schritte auszuführen zum:

    Erstellen einer ersten virtuellen Grenze, die zu einer von dem Instrument (22) zu behandelnden Anatomie gehört;

    Erstellen einer zweiten virtuellen Grenze, die zu einer von dem Instrument (22) zu vermeidende Peripherie einer Gewebeöffnung (106) in einem Patienten zum Zugriff auf die zu behandelnde Anatomie gehört;

    Abbilden einer Stellung eines Koordinatensystems der zu behandelnden Anatomie auf ein Koordinatensystem der ersten Grenzverfolgungsvorrichtung (44, 46); Empfangen einer Information von den Verfolgungseinrichtungen (44, 46, 110, 300, 400, P);

    Nachverfolgen des Instruments (22);

    Nachverfolgen der ersten virtuellen Grenze; und

    Nachverfolgen der zweiten virtuellen Grenze relativ zur ersten virtuellen Grenze;

    Steuern des Stellglieds, um eine Bewegung des Instruments (22) jeweils relativ zu jeder der ersten und der zweiten virtuellen Grenze zu führen.


     
    16. Computerprogrammprodukt, das die Software nach Anspruch 15 umfasst, wobei das Führen einer Bewegung des Instruments (22) relativ zur ersten und zur zweiten virtuellen Grenze ferner als ein Führen eines Schneidens der Anatomie relativ zur ersten virtuellen Grenze und ein Führen einer Bewegung des Instruments (22) definiert ist, sodass das Instrument (22) einen Kontakt mit der Peripherie der Öffnung (106) vermeidet, die zu der zweiten virtuellen Grenze gehört.
     
    17. Computerprogrammprodukt, das die Software nach Anspruch 15 umfasst, wobei das Chirurgiesystem (20) ferner eine dritte Grenzverfolgungsvorrichtung (110, 300, 400, P) für ein zweites, zu vermeidendes Objekt umfasst, wobei die Software ausgelegt ist, ferner die Schritte auszuführen zum:

    Erstellen einer dritten virtuellen Grenze, die zu dem von dem Instrument (22) zu vermeidenden zweiten Objekt gehört;

    Empfangen einer Information von der dritten Grenzverfolgungseinrichtung (110, 300, 400, P);

    Nachverfolgen der dritten virtuellen Grenze; und

    Steuern des Stellglieds, um eine Bewegung des Instruments (22) jeweils relativ zu jeder der ersten, der zweiten und der dritten virtuellen Grenze zu führen.


     


    Revendications

    1. Système chirurgical (20) comprenant :

    un instrument (22) ;

    un dispositif de suivi d'instrument (48) conçu pour suivre le mouvement dudit instrument (22) ;

    un ordinateur de navigation (26) conçu pour créer une première limite virtuelle associée à une partie d'anatomie à traiter par ledit instrument (22) et qui est conçu pour créer une deuxième limite virtuelle associée à une périphérie d'une ouverture de tissus (106) pour accéder à la partie d'anatomie à traiter dans un patient à éviter par ledit instrument (22) ;

    un premier dispositif de suivi de limite (44, 46) conçu pour être monté sur la partie d'anatomie à traiter par ledit instrument (22) ;

    ledit système chirurgical (20) étant conçu pour mettre en correspondance une pose d'un système de coordonnées de la partie d'anatomie à traiter sur un système de coordonnées du premier dispositif de suivi de limite (44, 46) ;

    un deuxième dispositif de suivi de limite (110, 300, 400, P) pour suivre la périphérie de l'ouverture de tissus (106) ;

    ledit ordinateur de navigation (26) est conçu pour recevoir des informations à partir desdits dispositifs de suivi (44, 46, 110, 300, 400, P) et pour suivre le mouvement des première et deuxième limites virtuelles ; et

    un dispositif de commande (54) conçu pour recevoir des informations associées auxdits dispositifs de suivi (44, 46, 110, 300, 400, P) comprenant des positions dudit instrument (22) par rapport aux première et deuxième limites virtuelles, ledit dispositif de commande (54) est conçu pour guider le mouvement dudit instrument (22) par rapport à chacune des première et deuxième limites virtuelles lorsque les première et deuxième limites virtuelles se déplacent l'une par rapport à l'autre.


     
    2. Système (20) selon la revendication 1, comprenant un manipulateur chirurgical (56) ayant une pluralité de bras et une pluralité d'actionneurs pour commander une position dudit instrument (22).
     
    3. Système (20) selon la revendication 2, comprenant un rétracteur (104, 105) pour rétracter des tissus, ledit deuxième dispositif de suivi de limite (110) étant fixé audit rétracteur (104, 105).
     
    4. Système (20) selon la revendication 3, dans lequel ledit deuxième dispositif de suivi de limite (110, 300, 400, P) comprend un élément parmi un dispositif de suivi pouvant être monté sur ledit rétracteur (104, 105) ou au moins un élément de suivi (50) intégré dans ledit rétracteur (104, 105).
     
    5. Système (20) selon la revendication 3, dans lequel ledit ordinateur de navigation (26) est conçu en outre pour créer une troisième limite virtuelle associée à un second objet à éviter par ledit instrument (22), et comprenant en outre un troisième dispositif de suivi de limite (110, 300, 400, P) fourni pour le second objet à éviter, ledit ordinateur de navigation (26) étant conçu pour recevoir des informations à partir dudit troisième dispositif de suivi (110, 300, 400, P) et pour suivre le mouvement de la troisième limite virtuelle, ledit dispositif de commande (54) étant conçu pour guider le mouvement dudit instrument (22) par rapport à chacune des première, deuxième et troisième limites virtuelles.
     
    6. Système (20) selon la revendication 5, dans lequel ledit dispositif de commande (54) est conçu pour définir l'ouverture (106) dans le patient pour recevoir ledit instrument (22) sur la base des positions des deuxième et troisième limites virtuelles et ledit dispositif de commande (54) est conçu pour surveiller une position de la périphérie de l'ouverture (106) en utilisant lesdits deuxième et troisième dispositifs de suivi de limite (110, 300, 400, P).
     
    7. Système (20) selon la revendication 2, dans lequel ledit manipulateur chirurgical (56) est un manipulateur robotique (56) fonctionnant dans des modes manuel et semi-autonome.
     
    8. Système (20) selon la revendication 1, dans lequel ledit second dispositif de suivi de limite (300) comprend un système de détection de forme flexible comprenant un câble de fibre optique (304) positionnable adjacent à la périphérie de l'ouverture (106).
     
    9. Système (20) selon la revendication 1, dans lequel ledit deuxième dispositif de suivi de limite (P) comprend un pointeur conçu pour capturer des points associés à la périphérie de l'ouverture (106) de sorte que les informations concernant les points sont utilisées pour créer la deuxième limite virtuelle.
     
    10. Système (20) selon la revendication 1, dans lequel ledit deuxième dispositif de suivi de limite (400) comprend un système de vision artificielle, ledit système de vision artificielle comprenant une caméra de vision (402) et une unité de commande en communication avec ledit dispositif de commande (54), dans lequel ledit système de vision artificielle (402) est conçu pour détecter un mouvement de la périphérie de l'ouverture (106).
     
    11. Système (20) selon la revendication 1, dans lequel chacun desdits dispositifs de suivi (44, 46, 48, 110, 300, 400, P) comprend un ou plusieurs éléments de suivi (50).
     
    12. Système (20) selon la revendication 11, dans lequel lesdits un ou plusieurs éléments de suivi (50) comprennent des diodes électroluminescentes.
     
    13. Système (20) selon la revendication 11, dans lequel lesdits éléments de suivi (50) comprennent des éléments de suivi optique et ledit système (20) comprend en outre une pluralité de dispositifs de détection (36) pour recevoir des signaux optiques à partir desdits éléments de suivi optique (50).
     
    14. Système (20) selon la revendication 1, dans lequel ledit deuxième dispositif de suivi de limite (P) comprend un pointeur conçu pour capturer des points associés à la périphérie de l'ouverture (106) de sorte que des informations concernant les points sont utilisées pour créer la deuxième limite virtuelle et ledit système (20) comprend une caméra de vision artificielle (402) permettant de détecter le mouvement de la périphérie de l'ouverture (106), ledit dispositif de commande (54) recevant des informations de position provenant d'images prises par ladite caméra de vision artificielle (402) pour régler une position de la deuxième limite virtuelle après le déplacement de la deuxième limite virtuelle.
     
    15. Produit de programme informatique comprenant un logiciel permettant d'utiliser un ordinateur de navigation (26) et un dispositif de commande (54) d'un système chirurgical (20), le système chirurgical (20) comprenant un instrument (22), un dispositif de suivi d'instrument (48) conçu pour suivre le mouvement de l'instrument (22), un premier dispositif de suivi de limite (44, 46) conçu pour être monté sur une partie d'anatomie à traiter par l'instrument (22), un deuxième dispositif de suivi de limite (110, 300, 400, P) et un actionneur conçu pour guider le mouvement de l'instrument (22), le logiciel étant conçu pour mettre en oeuvre les étapes de :

    création d'une première limite virtuelle associée à une partie d'anatomie à traiter par ledit instrument (22) ;

    création d'une deuxième limite virtuelle associée à une périphérie d'une ouverture de tissus (106) pour accéder à la partie d'anatomie à traiter dans un patient à éviter par ledit instrument (22) ;

    mise en correspondance d'une pose d'un système de coordonnées de la partie d'anatomie à traiter sur un système de coordonnées d'un premier dispositif de suivi de limite (44, 46) ; réception des informations à partir des dispositifs de suivi (44, 46, 110, 300, 400, P) ;

    suivi du mouvement de l'instrument (22) ;

    suivi du mouvement de la première limite virtuelle ; et

    suivi du mouvement de la deuxième limite virtuelle par rapport à la première limite virtuelle ;

    commande de l'actionneur pour guider le mouvement de l'instrument (22) par rapport à chacune des première et deuxième limites virtuelles.


     
    16. Produit de programme informatique comprenant le logiciel selon la revendication 15, dans lequel le mouvement de guidage de l'instrument (22) par rapport aux première et deuxième limites virtuelles est défini en outre en tant que coupe de guidage de la partie d'anatomie par rapport à la première limite virtuelle et mouvement de guidage de l'instrument (22) de sorte que l'instrument (22) évite le contact avec la périphérie de l'ouverture (106) associée à la deuxième limite virtuelle.
     
    17. Produit de programme informatique comprenant un logiciel selon la revendication 15, dans lequel le système chirurgical (20) comprend en outre un troisième dispositif de suivi de limite (110, 300, 400, P) pour un second objet à éviter, ledit logiciel étant conçu pour mettre en oeuvre les étapes de :

    création d'une troisième limite virtuelle associée au second objet à éviter par ledit instrument (22) ;

    réception d'informations à partir du troisième dispositif de suivi de limite (110, 300, 400, P) ;

    suivi de mouvement de la troisième limite virtuelle ; et

    commande de l'actionneur pour guider le mouvement de l'instrument (22) par rapport à chacune des première, deuxième et troisième limites virtuelles.


     




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    Cited references

    REFERENCES CITED IN THE DESCRIPTION



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    Patent documents cited in the description