Patent Description:
Various medical procedures require the accurate localization of a three-dimensional position of a surgical instrument within the body in order to effect optimized treatment. For example, some surgical procedures to fuse vertebrae require that a surgeon drill multiple holes into the bone structure at specific locations. To achieve high levels of mechanical integrity in the fusing system, and to balance the forces created in the bone structure, it is necessary that the holes are drilled at the correct location. Vertebrae, like most bone structures, have complex shapes including non-planar curved surfaces making accurate and perpendicular drilling difficult.

Conventionally, using currently-available systems and methods, a surgeon manually holds and positions a drill guide tube by using a guidance system to overlay the drill tube's position onto a three dimensional image of the anatomical structures of a patient, for example, bone structures of the patient. This manual process is both tedious, time consuming, and error-prone. Further, whether the surgery can be considered successful largely depends upon the dexterity of the surgeon who performs it. Thus, there is a need for the use of robot assisted surgery to more accurately position surgical instruments and more accurately depict the position of those instruments in relation to the anatomical structures of the patient.

Currently, limited robotic assistance for surgical procedures is available. For example, certain systems allow a user to control a robotic actuator. These systems convert a surgeon's gross movements into micro-movements of the robotic actuator to more accurately position and steady the surgical instruments when undergoing surgery. Although these systems may aid in eliminating hand tremor and provide the surgeon with improved ability to work through a small opening, like many of the robots commercially available today, these systems are expensive, obtrusive, and require a cumbersome setup for the robot in relation to the patient and the user (e.g., a surgeon). Further, for certain procedures, such as thoracolumbar pedicle screw insertion, these conventional methods are known to be error-prone and tedious.

The current systems have many drawbacks including but not limited to the fact that autonomous movement and precise placement of a surgical instrument can be hindered by a lack of mechanical feedback and/or a loss of visual placement once the instrument is submerged within a portion of a patient. These drawbacks make the existing surgical applications error prone resulting in safety hazards to the patient as well as the surgeon during surgical procedures.

In addition, current robot assisted systems suffer from other disadvantages. The path and angle in which a surgical instrument is inserted into a patient (a trajectory of the instrument) may be limited due to the configuration of the robot arm and the manner in which it can move. For example, some current systems may not have enough range of motion or movement to place the surgical instrument at a trajectory ideal for placement into the patient and/or at a position that allows the surgeon an optimal view for performing the surgery.

The present disclosure overcomes the disadvantages of current robot assisted surgical applications. For example, the present disclosure allows for precisely locating anatomical structures in open, percutaneous, or minimally invasive surgery (MIS) procedures and positioning surgical instruments or implants during surgery. In addition, the present disclosure may improve stereotactic surgical procedures by allowing for identification and reference to a rigid anatomical structure relative to a pre-op computerized tomography (CT) scan, intra-op CT scan or fluoroscopy/x-ray based image of the anatomy. Further, the present disclosure may integrate a surgical robotic arm, a local positioning system, a dynamic reference base, and planning software to assist a surgeon in performing medical procedures in a more accurate and safe manner thereby reducing the error prone characteristics of current robot assisted systems and methods.

Exemplary aspects of the present disclosure may provide a surgical robot system comprising a robot base having a display, a robot arm coupled to the robot base, wherein movement of the robot arm is electronically controlled by the robot base, and an end-effector, coupled to the robot arm, containing one or more end-effector tracking markers. The robot base may be in electronic communication with the one or more end-effector tracking markers and the display is configured to indicate a location of the end-effector in relation to at least one of the robot base and the robot arm.

Exemplary aspects of the present disclosure may also provide a surgical robot system comprising a robot base having a display, a robot arm coupled to the robot base, wherein movement of the robot arm is electronically controlled by the robot base, and an end-effector, coupled to the robot arm, containing an instrument detecting sensor. The guide tube, disposed in the end-effector, may be configured to receive an instrument assembly housing an instrument, and the instrument detecting sensor may be configured to determine the presence of the instrument when the instrument assembly enters the guide tube.

Exemplary aspects of the present disclosure may provide a surgical robot system comprising a surgical robot base, a surgical robot arm electronically coupled to the surgical robot base, and an end-effector, coupled to the surgical robot arm, having a guide tube configured to receive an instrument assembly, the instrument assembly containing one or more grooves disposed along a length of the instrument assembly. The guide tube may be configured to engage at least one of the grooves to restrict rotational movement of the instrument assembly within the guide tube.

Exemplary aspects of the present disclosure may provide a surgical robot system comprising a robot base, a robot arm electronically coupled to the robot base, wherein the robot arm contains at least one depression and a magnet disposed proximate to each of the at least one depression, a clamp containing one or more balls, each of the one or more balls configured to magnetically engage one of the at least one depression, and an end-effector, electronically coupled to the robot base, configured to be coupled to the clamp.

Exemplary aspects of the present disclosure may provide a surgical robot system comprising a robot base, a robot arm electronically coupled to the robot base, and an end-effector electronically coupled to the robot base. The robot arm may contain a primary coil and the end-effector may contain a secondary coil wherein power is transmitted from the primary coil to the secondary coil to wirelessly power the end-effector.

Exemplary aspects of the present disclosure may provide a surgical robot system comprising a dynamic reference base (DRB) attached to patient fixture instrument, wherein the dynamic reference base has one or more DRB markers indicating a position of the patient fixture instrument in a navigational space, and a registration fixture, having one or more registration markers, indicating a location of a target anatomical structure in the navigational space and one or more registration fiducials indicating a location of the target anatomical structure in an image space. The surgical robot system may be configured to associate the location of the target anatomical structure with the patient fixture instrument in the navigational space and the image space taking into account a relationship between the one or more registration markers and the one or more fiducials and the relationship between the registration makers and the DRB markers. The patient fixture instrument is located in a position different from the target anatomical structure.

The invention is defined in appended independent claim <NUM>. Further embodiments are defined in appended dependent claims. It is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the description herein or illustrated in the drawings. The teachings of the present disclosure may be used and practiced in other embodiments and practiced or carried out in various ways.

The following discussion is presented to enable a person skilled in the art to make and use embodiments of the present disclosure. Various modifications to the illustrated embodiments will be readily apparent to those skilled in the art, and the principles herein can be applied to other embodiments and applications without departing from the scope of appended claims. Thus, the embodiments are not intended to be limited to embodiments shown, but are to be accorded the widest scope consistent with the principles and features disclosed herein. The following detailed description is to be read with reference to the figures, in which like elements in different figures have like reference numerals. The figures, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the embodiments. Skilled artisans will recognize the examples provided herein have many useful alternatives and fall within the scope of the embodiments.

<FIG>,<FIG>, and <FIG> illustrate a surgical robot system <NUM> in accordance with an exemplary embodiment. Surgical robot system <NUM> may include a surgical robot <NUM>, a robot arm <NUM>, a base <NUM>, a housing <NUM>, a display <NUM>, an end-effector or end-effectuator <NUM>, a guide tube <NUM>, a tracking array <NUM>, and tracking markers <NUM>.

<FIG> illustrates a portion of a surgical robot system <NUM> with control of the translation and orientation of end-effector <NUM> in accordance with an exemplary embodiment.

As shown in <FIG> and <FIG>, surgical robot <NUM> can comprise a display <NUM> and a housing <NUM>. Display <NUM> can be attached to the surgical robot <NUM> and in other exemplary embodiments, display <NUM> can be detached from surgical robot <NUM>, either within a surgical room with the surgical robot <NUM>, or in a remote location. In some embodiments, housing <NUM> can comprise robot arm <NUM> and an end-effector <NUM>. End-effector <NUM> may be coupled to the robot arm <NUM> and controlled by at least one motor. In exemplary embodiments, end-effector <NUM> can comprise a surgical instrument used to perform surgery on a patient <NUM>. In exemplary embodiments, end-effector <NUM> can be coupled to the surgical instrument. As used herein, the term "end-effector" is used interchangeably with the term "effectuator element. " In some embodiments, end-effector <NUM> can comprise any known structure for effecting the movement of the surgical instrument in a desired manner.

<FIG> illustrates a portion of a surgical robot <NUM> with control of the translation and orientation of end-effector <NUM> in accordance with an exemplary embodiment. As shown, some embodiments include a surgical robot system <NUM> capable of using robot <NUM> with an ability to move end-effector <NUM> along x-, y-, and z-axes (see <NUM>, <NUM>, <NUM> in <FIG>). In this embodiment, x-axis <NUM> can be orthogonal to y-axis <NUM> and z-axis <NUM>, y-axis <NUM> can be orthogonal to x-axis <NUM> and z-axis <NUM>, and z-axis <NUM> can be orthogonal to x-axis <NUM> and y-axis <NUM>. In an exemplary embodiment, robot <NUM> can be configured to effect movement of end-effector <NUM> along one axis independently of the other axes. For example, in some exemplary embodiments, robot <NUM> can cause the end-effector <NUM> to move a given distance of <NUM> or more along x-axis <NUM> without causing any substantial movement of end-effector <NUM> along y-axis <NUM> or z-axis <NUM>. As used in this context "substantial" may mean a deviation of more than two degrees or <NUM> from an intended path or some other predetermined deviation that may be appropriate for the surgical application.

In some further exemplary embodiments, end-effector <NUM> can be configured for selective rotation about one or more of x-axis <NUM>, y-axis <NUM>, and a Z Frame axis <NUM> (such that one or more of the Euler Angles (e.g., roll, pitch, and/or yaw) associated with end-effector <NUM> can be selectively controlled). For example, roll <NUM> is selective rotation about y-axis <NUM> without substantial deviation about or along x-axis <NUM> or Z Frame axis <NUM>; pitch <NUM> is selective rotation about x-axis <NUM> without substantial deviation about or along y-axis <NUM> or Z Frame axis <NUM>. In some exemplary embodiments, during operation, end-effector <NUM> and/or the surgical instrument may be aligned with a selected orientation axis (labeled "Z Tube" <NUM> in <FIG>) that can be selectively varied and monitored by robot system <NUM>. End-effector <NUM> may contain a linear actuator that causes guide tube <NUM> to move in Z Tube axis <NUM> direction.

In some exemplary embodiments, selective control of the translation and orientation of end-effector <NUM> can permit performance of medical procedures with significantly improved accuracy compared to conventional robots that utilize, for example, a six degree of freedom robot arm comprising only rotational axes. For example, in some exemplary embodiments, as shown in <FIG>, surgical robot system <NUM> may be used to operate on patient <NUM>, and robot arm <NUM> that can be positioned above the body of patient <NUM>, with end-effector <NUM> selectively angled relative to the z-axis toward the body of patient <NUM>.

In some exemplary embodiments, the position of the surgical instrument can be dynamically updated so that surgical robot <NUM> can be aware of the location of the surgical instrument at all times during the procedure. Consequently, in some exemplary embodiments, surgical robot <NUM> can move the surgical instrument to the desired position quickly, with minimal damage to patient <NUM>, and without any further assistance from a physician (unless the physician so desires). In some further embodiments, surgical robot <NUM> can be configured to correct the path of the surgical instrument if the surgical instrument strays from the selected, preplanned trajectory. In some exemplary embodiments, surgical robot <NUM> can be configured to permit stoppage, modification, and/or manual control of the movement of end-effector <NUM> and/or the surgical instrument. Thus, in use, in exemplary embodiments, a physician or other user can operate the system <NUM>, and has the option to stop, modify, or manually control the autonomous movement of end-effector <NUM> and/or the surgical instrument. Further details of surgical robot system <NUM> including the control and movement of a surgical instrument by surgical robot <NUM> can be found in co-pending U. patent application <CIT> from which this application claims priority under <NUM> U.

As shown in <FIG> and <FIG>, in exemplary embodiments, robotic surgical system <NUM> can comprise a plurality of tracking markers <NUM> configured to track the movement of robot arm <NUM>, end-effector <NUM>, and/or the surgical instrument in three dimensions. It should be appreciated that three dimensional positional information from tracking markers <NUM> can be used in conjunction with the one dimensional linear or rotational positional information from absolute or relative conventional linear or rotational encoders on each axis of robot <NUM> to maintain a high degree of accuracy. In exemplary embodiments, the plurality of tracking markers <NUM> can be mounted (or otherwise secured) thereon an outer surface of the robot <NUM>, such as, for example and without limitation, on base <NUM> of robot <NUM>, or robot arm <NUM> (see for example <FIG>). Further, in exemplary embodiments, the plurality of tracking markers <NUM> can be positioned on base <NUM> of robot <NUM> spaced from surgical field <NUM> to reduce the likelihood of being obscured by the surgeon, surgical tools, or other parts of robot <NUM>. In exemplary embodiments, at least one tracking marker <NUM> of the plurality of tracking markers <NUM> can be mounted or otherwise secured to end-effector <NUM> (see for example <FIG>).

In exemplary embodiments, system <NUM> can use tracking information collected relative to the robot base <NUM> to calculate the orientation and coordinates of the surgical instrument held in the tube <NUM> based on encoder counts along x-axis <NUM>, y-axis <NUM>, z-axis <NUM>, Z-tube axis <NUM>, and the roll <NUM> and pitch <NUM> axes.

In exemplary embodiments, one or more of markers <NUM> may be optical markers and at least one optical marker may be positioned on the robot <NUM> between the base <NUM> of the robot <NUM> and end-effector <NUM> instead of, or in addition to, other markers <NUM> on base <NUM>. In some embodiments, the positioning of one or more tracking markers <NUM> on end-effector <NUM> can maximize the accuracy of the positional measurements by serving to check or verify the position of end-effector <NUM> (calculated from the positional information of markers <NUM> on base <NUM> and encoder counts of z-axis <NUM>, x-axis <NUM>, y-axis <NUM>, roll axis <NUM>, pitch axis120, and Z-tube axis <NUM>).

In exemplary embodiments, the at least one tracking marker <NUM> can be mounted to a portion of the robot <NUM> that effects movement of end-effector <NUM> and/or the surgical instrument along the x-axis to enable the at least one tracking marker <NUM> to move along x-axis <NUM> as end-effector <NUM> and the surgical instrument move along the x-axis <NUM> (see <FIG>). In exemplary embodiments, placement of tracking markers <NUM> as described can reduce the likelihood of a surgeon blocking one or more tracking markers <NUM> from the cameras or detection device, or one or more tracking markers <NUM> becoming an obstruction to surgery.

In exemplary embodiments, because of the high accuracy in calculating the orientation and position of end-effector <NUM> based on an output of one or more of tracking markers <NUM> and/or encoder counts from each axis, it can be possible to very accurately determine the position of end-effector <NUM>. For example, in exemplary embodiments, without requiring knowledge of the counts of axis encoders for the z-axis <NUM> (which is between the x-axis <NUM> and the base <NUM>), knowing only the position of markers <NUM> on the x-axis <NUM> and the counts of encoders on the y-axis <NUM>, roll axis <NUM>, pitch axis <NUM>, and Z-tube axis <NUM> can enable computation of the position of end-effector <NUM>. In some embodiments, the placement of markers <NUM> on any intermediate axis of robot <NUM> can permit the exact position of end-effector <NUM> to be calculated based on location of such markers <NUM> and counts of encoders on axes (<NUM>, <NUM>, <NUM>, and <NUM>) between markers <NUM> and end-effector <NUM>. Further details of surgical robot system <NUM> including the control, movement and tracking of surgical robot <NUM> and of a surgical instrument can be found in co-pending U. patent application <CIT> from which this application claims priority under <NUM> U.

Exemplary embodiments include one or more markers coupled to the surgical instrument as described in greater detail below. In exemplary embodiments, these markers as well as markers <NUM> can comprise conventional infrared lightemitting diodes or an Optotrak® diode capable of being tracked using a commercially available infrared optical tracking system such as Optotrak®. Optotrak® is a registered trademark of Northern Digital Inc. , Waterloo, Ontario, Canada. In other embodiments, markers <NUM> can comprise conventional reflective spheres capable of being tracked using a commercially available optical tracking system such as Polaris Spectra. Polaris Spectra is also a registered trademark of Northern Digital, Inc.

Referring to <FIG>, surgical robot system <NUM> is shown and further includes cameras <NUM>, a camera arm <NUM>, camera arm joints <NUM> and <NUM>. <FIG> further depicts surgical field <NUM> and patient <NUM>.

In exemplary embodiments, light emitted from and/or reflected by markers <NUM> and markers on the surgical instrument can be read by camera <NUM> and can be used to monitor the location and movement of robot <NUM> (see for example camera <NUM> mounted on the camera arm <NUM> and capable of movement through camera arm joint <NUM> and camera arm joint <NUM> shown in <FIG>). In exemplary embodiments, markers <NUM> and the markers on the surgical instrument can comprise a radio-frequency and/or electromagnetic reflector or transceiver and the camera <NUM> can include or be replaced by a radio-frequency and/or electromagnetic transceiver.

<FIG> illustrates a surgical robot system <NUM> and camera stand <NUM> consistent with an exemplary embodiment of the present disclosure. Surgical robot system <NUM> may comprise display <NUM>, upper arm <NUM>, lower arm <NUM>, end-effector <NUM>, vertical column <NUM>, casters <NUM>, cabinet <NUM>, tablet drawer <NUM>, connector panel <NUM>, control panel <NUM>, and ring <NUM>. Camera stand <NUM> may comprise camera <NUM>. These components are described in greater with respect to <FIG>.

<FIG> illustrates a base <NUM> consistent with an exemplary embodiment of the present disclosure. Base <NUM> may be a portion of surgical robot system <NUM> and comprise cabinet <NUM>. Cabinet <NUM> may house certain components of surgical robot system <NUM> including but not limited to a battery <NUM>, a power distribution module <NUM>, a platform interface board module <NUM>, a computer <NUM>, a handle <NUM>, and a tablet drawer <NUM>. The connections and relationship between these components is described in greater detail with respect to <FIG>.

<FIG> illustrates a block diagram of certain components of an exemplary embodiment of surgical robot system <NUM>. Surgical robot system <NUM> may comprise platform subsystem <NUM>, computer subsystem <NUM>, motion control subsystem <NUM>, and tracking subsystem <NUM>. Platform subsystem <NUM> may further comprise battery <NUM>, power distribution module <NUM>, platform interface board module <NUM>, and tablet charging station <NUM>. Computer subsystem <NUM> may further comprise computer <NUM>, display <NUM>, and speaker <NUM>. Motion control subsystem <NUM> may further comprise driver circuit <NUM>, motors <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, stabilizers <NUM>, <NUM>, <NUM>, <NUM>, end-effector <NUM>, and controller <NUM>. Tracking subsystem <NUM> may further comprise position sensor <NUM> and camera converter <NUM>. System <NUM> may also comprise a foot pedal <NUM> and tablet <NUM>.

Input power is suppled to system <NUM> via a power source <NUM> which may be provided to power distribution module <NUM>. Power distribution module <NUM> receives input power and is configured to generate different power supply voltages that are provided to other modules, components, and subsystems of system <NUM>. Power distribution module <NUM> may be configured to provide different voltage supplies to platform interface module <NUM>, which may be provided to other components such as computer <NUM>, display <NUM>, speaker <NUM>, driver <NUM> to, for example, power motors <NUM>, <NUM>, <NUM>, <NUM> and end-effector <NUM>, motor <NUM>, ring <NUM>, camera converter <NUM>, and other components for system <NUM> for example, fans for cooling the electrical components within cabinet <NUM>.

Power distribution module <NUM> may also provide power to other components such as tablet charging station <NUM> that may be located within tablet drawer <NUM>. Tablet charging station <NUM> may be in wireless or wired communication with tablet <NUM> for charging table <NUM>. Tablet <NUM> may be used by a surgeon consistent with the present disclosure and described herein.

Power distribution module <NUM> may also be connected to battery <NUM>, which serves as temporary power source in the event that power distribution module <NUM> does not receive power from input power <NUM>. At other times, power distribution module <NUM> may serve to charge battery <NUM> if necessary.

Other components of platform subsystem <NUM> may also include connector panel <NUM>, control panel <NUM>, and ring <NUM>. Connector panel <NUM> may serve to connect different devices and components to system <NUM> and/or associated components and modules. Connector panel <NUM> may contain one or more ports that receive lines or connections from different components. For example, connector panel <NUM> may have a ground terminal port that may ground system <NUM> to other equipment, a port to connect foot pedal <NUM> to system <NUM>, a port to connect to tracking subsystem <NUM>, which may comprise position sensor <NUM>, camera converter <NUM>, and cameras <NUM> associated with camera stand <NUM>. Connector panel <NUM> may also include other ports to allow USB, Ethernet, HDMI communications to other components, such as computer <NUM>.

Control panel <NUM> may provide various buttons or indicators that control operation of system <NUM> and/or provide information regarding system <NUM>. For example, control panel <NUM> may include buttons to power on or off system <NUM>, lift or lower vertical column <NUM>, and lift or lower stabilizers <NUM>-<NUM> that may be designed to engage casters <NUM> to lock system <NUM> from physically moving. Other buttons may stop system <NUM> in the event of an emergency, which may remove all motor power and apply mechanical brakes to stop all motion from occurring. Control panel <NUM> may also have indicators notifying the user of certain system conditions such as a line power indicator or status of charge for battery <NUM>.

Ring <NUM> may be a visual indicator to notify the user of system <NUM> of different modes that system <NUM> is operating under and certain warnings to the user.

Computer subsystem <NUM> includes computer <NUM>, display <NUM>, and speaker <NUM>. Computer <NUM> includes an operating system and software to operate system <NUM>. Computer <NUM> may receive and process information from other components (for example, tracking subsystem <NUM>, platform subsystem <NUM>, and/or motion control subsystem <NUM>) in order to display information to the user. Further, computer subsystem <NUM> may also include speaker <NUM> to provide audio to the user.

Tracking subsystem <NUM> may include position sensor <NUM> and converter <NUM>. Tracking subsystem <NUM> may correspond to camera stand <NUM> including camera <NUM> as described with respect to <FIG>. Position sensor <NUM> may be camera <NUM>. Tracking subsystem may track the location of certain markers that are located on the different components of system <NUM> and/or instruments used by a user during a surgical procedure. This tracking may be conducted in a manner consistent with the present disclosure including the use of infrared technology that tracks the location of active or passive elements, such as LEDs or reflective markers, respectively. The location, orientation, and position of structures having these types of markers may be provided to computer <NUM> which may be shown to a user on display <NUM>. For example, a surgical instrument having these types of markers and tracked in this manner (which may be referred to as a navigational space) may be shown to a user in relation to a three dimensional image of a patient's anatomical structure.

Motion control subsystem <NUM> may be configured to physically move vertical column <NUM>, upper arm <NUM>, lower arm <NUM>, or rotate end-effector <NUM>. The physical movement may be conducted through the use of one or more motors <NUM>-<NUM>. For example, motor <NUM> may be configured to vertically lift or lower vertical column <NUM>. Motor <NUM> may be configured to laterally move upper arm <NUM> around a point of engagement with vertical column <NUM> as shown in <FIG>. Motor <NUM> may be configured to laterally move lower arm <NUM> around a point of engagement with upper arm <NUM> as shown in <FIG>. Motors <NUM> and <NUM> may be configured to move end-effector <NUM> in a manner such that one may control the roll and one may control the tilt, thereby providing multiple angles that end-effector <NUM> may be moved. These movements may be achieved by controller <NUM> which may control these movements through load cells disposed on end-effector <NUM> and activated by a user engaging these load cells to move system <NUM> in a desired manner.

Moreover, system <NUM> may provide for automatic movement of vertical column <NUM>, upper arm <NUM>, and lower arm <NUM> through a user indicating on display <NUM> (which may be a touchscreen input device) the location of a surgical instrument or component on three dimensional image of the patient's anatomy on display <NUM>. The user may initiate this automatic movement by stepping on foot pedal <NUM> or some other input means.

<FIG> illustrates a surgical robot system <NUM> consistent with an exemplary embodiment. Surgical robot system <NUM> may comprise end-effector <NUM>, robot arm <NUM>, guide tube <NUM>, instrument <NUM>, and robot base <NUM>. Instrument tool <NUM> may be attached to a tracking array <NUM> and have an associated trajectory <NUM>. Trajectory <NUM> may represent a path of movement that instrument tool <NUM> is configured to travel once it is secured in guide tube <NUM>, for example, a path of insertion of instrument tool <NUM> into a patient. In an exemplary operation, robot base <NUM> may be configured to be in electronic communication with robot arm <NUM> and end-effector <NUM> so that surgical robot system <NUM> may assist a user (for example, a surgeon) in operating on a patient. Surgical robot system <NUM> may be consistent with previously described surgical robot system <NUM> and <NUM>.

A tracking array <NUM> may be mounted on instrument <NUM> to monitor the location and orientation of instrument tool <NUM>. As described in greater detail below with respect to <FIG>, tracking array <NUM> may be attached to an instrument assembly <NUM> and may comprise markers <NUM>. Instrument assembly <NUM> may house instrument <NUM> as described in further detail below with respect to <FIG>. Markers <NUM> may be, for example, light emitting diodes and/or other types of markers as described consistent with the present disclosure. The tracking devices may be one or more line of sight devices associated with the surgical robot system. As an example, the tracking devices may be cameras associated with the surgical robot system and may also track tracking array <NUM> for a defined domain or relative orientations of the instrument in relation to the robot arm, the robot base, and/or a patient. The tracking devices may be consistent with those structures described in connection with camera stand <NUM> and tracking subsystem <NUM>.

<FIG> illustrate a top view, front view, and side view, respectively, of end-effector <NUM> consistent with an exemplary embodiment. End-effector <NUM> may additionally comprise one or more markers <NUM>. Markers <NUM> may be light emitting diodes or other types of markers that have been previously described.

Markers <NUM> may be disposed on end-effector <NUM> in a manner such that the markers are visible by one or more tracking devices associated with the surgical robot system. The tracking devices may track end-effector <NUM> as it moves to different positions and viewing angles by following the movement of tracking markers <NUM>. The location of markers <NUM> and/or end-effector <NUM> may be shown on a display associated with the surgical robot system, for example, display <NUM> as shown in <FIG> and/or display <NUM> shown in <FIG>. This display may allow a user to ensure that end-effector <NUM> is in a desirable position in relation to robot arm <NUM>, robot base <NUM>, the patient, and/or the user.

For example, as shown in <FIG>, markers <NUM> may be placed around the surface of end-effector <NUM> so that a tracking device placed away from the surgical field and facing toward the robot and surgical field is able to view at least <NUM> of the markers <NUM> through a range of common orientations of the end effector relative to the tracking device. For example, distribution of markers in this way allows end-effector <NUM> to be monitored by the tracking devices when end-effector <NUM> is rotated by +/- <NUM> degrees about the z-axis of the surgical robot system.

In addition, in exemplary embodiments, end-effector <NUM> may be equipped with infrared (IR) receivers that can detect when an external camera is getting ready to read markers <NUM>. Upon this detection, end-effector <NUM> may then illuminate markers <NUM>. The detection by the IR receivers that the external camera is ready to read markers <NUM> may signal the need to synchronize a duty cycle of markers <NUM>, which may be light emitting diodes, to an external camera. This may also allow for lower power consumption by the robotic system as a whole, whereby markers <NUM> would only be illuminated at the appropriate time instead of being illuminated continuously. Further, in exemplary embodiments, markers <NUM> may be powered off to prevent interference with other navigation tools, such as different types of surgical instruments.

<FIG> depicts instrument <NUM> and instrument assembly <NUM>. Instrument assembly <NUM> may further comprise tracking array <NUM>, markers <NUM>, an outer sleeve <NUM>, one or more grooves <NUM>, a tip <NUM>, and an opening <NUM>. Instrument <NUM> may include tip <NUM>. Ultimately, as explained in greater detail with respect to <FIG>, instrument assembly <NUM>, which may house instrument <NUM>, may be inserted into guide tube <NUM>.

Markers <NUM> may be of any type described herein including but not limited to light emitting diodes or reflective spheres. Markers <NUM> are monitored by tracking devices associated with the surgical robot system and may be one or more line of sight cameras. The cameras may track the location of instrument assembly <NUM> based on the position and orientation of tracking array <NUM> and markers <NUM>. A user, such as a surgeon, may orient instrument assembly <NUM> in a manner so that tracking array <NUM> and markers <NUM> are sufficiently recognized by the tracking devices to display instrument assembly <NUM> and markers <NUM> on, for example, display <NUM> of the exemplary surgical robot system. The manner in which a surgeon may place instrument assembly <NUM> into guide tube <NUM> and adjust instrument assembly <NUM> is explained in greater detail below.

Instrument assembly <NUM> may also include outer sleeve <NUM>. Outer sleeve <NUM> may contain one or more grooves <NUM> and tip <NUM>. As explained in greater detail below, tip <NUM> may contain lead-in features that assist in lining up one of grooves <NUM> with certain features of guide tube <NUM> to orient instrument assembly <NUM>. The manner in which a user inserts instrument assembly <NUM> into guide tube <NUM> is explained in further detail with respect to <FIG>.

<FIG> also depicts instrument <NUM>. Instrument <NUM> may be a surgical tool or implement associated with the surgical robot system. Instrument <NUM> may be inserted into instrument assembly <NUM> by inserting tip <NUM> into opening <NUM>. Once inside instrument assembly <NUM>, instrument <NUM> is free to rotate about its shaft axis and move in an axial direction as determined by the user. <FIG> depicts instrument <NUM> inserted into instrument assembly <NUM>. <FIG> depicts a bottom view of instrument <NUM> inserted into instrument assembly <NUM>.

<FIG> illustrate end-effector <NUM> consistent with an exemplary embodiment. End-effector <NUM> may comprise sensor <NUM> and sensor cover <NUM>. The surgical robot system may contain circuitry that is configured to restrict or prevent robot arm <NUM> from moving when an instrument (for example, instrument <NUM>) is in guide tube <NUM>. Restricting or preventing movement of robot arm <NUM> while instrument <NUM> or another surgical instrument is in guide tube <NUM> may prevent a potentially hazardous situation to the patient and/or the user of the system while a sharp instrument is engaged in guide tube <NUM>.

Sensor <NUM> may be configured such that it detects the presence of an instrument in guide tube <NUM>. As shown in <FIG>, sensor <NUM> may be embedded in an upper portion of guide tube <NUM>. Sensor <NUM> may be a hall effect sensor using magnetic properties of the instrument to detect the instrument's presence in guide tube <NUM>. Sensor <NUM> may be covered by sensor cover <NUM> as shown in <FIG>.

Sensor <NUM> may detect the instrument's presence in guide tube <NUM>. By way of example and in no way intended to limit the manner in which the sensor may be implemented, sensor <NUM> may be a capacitive or resistive sensor which uses changes in the electrical properties of guide tube <NUM>, such as its impedance, when an instrument is present in guide tube <NUM>. Further, sensor <NUM> may be a mechanical switch, such as an actuated or strain gauge. Further still, sensor <NUM> may be an optical sensor to determine the presence of an instrument in guide tube <NUM>. In addition, sensor <NUM> may be an inductive sensor that uses magnetic field changes to determine the presence of an instrument in guide tube <NUM>.

Sensor <NUM> may be configured to send a signal (sensor signal) to circuitry associated with the surgical robot system. Once the surgical robot system receives such a sensor signal, surgical robot system may restrict or prevent movement of robot arm <NUM> while an instrument is inside guide tube <NUM>.

In a further embodiment, the surgical robot system may also disable tracking markers <NUM> in response to the sensor signal. This disabling response would prevent the undesirable situation of optical interference and partial occlusion from tracking markers <NUM>, particularly if tracking markers are light emitting diodes.

<FIG> illustrate a top view of end-effector <NUM> while instrument assembly <NUM> is inside guide tube <NUM> consistent with an exemplary embodiment. End-effector <NUM> may further comprise spring <NUM> and ball detent <NUM>, both of which may be disposed in or near guide tube <NUM>. <FIG> also depict outer sleeve <NUM> and grooves <NUM>.

Instrument <NUM> may be disposed within instrument assembly <NUM> as described with respect to <FIG>. While instrument <NUM> is disposed in instrument assembly <NUM>, instrument assembly <NUM> may be inserted in guide tube <NUM>. Guide tube <NUM> may restrict the movement of instrument assembly <NUM> in a manner such that tracking array <NUM> remains in essentially the same orientation relative to robot arm <NUM> and robot base <NUM> so that tracking devices can display the location of instrument assembly <NUM> on, for example, display <NUM>. Instrument <NUM> may be free to rotate about its shaft without affecting rotation of the array and may move in a direction consistent with trajectory <NUM>.

Specifically, instrument assembly <NUM> (after instrument <NUM> is inserted therein), may be inserted into guide tube <NUM>. Structures on tip <NUM> of outer sleeve <NUM> may cause one of grooves <NUM> to line up and engage with ball detent <NUM>. Ball detent <NUM> may be in communication with spring <NUM> such that when a force is applied to ball detent <NUM>, it is able to move backward against spring <NUM> and when the force is removed spring <NUM> moves ball detent <NUM> in a forward direction. When ball detent <NUM> engages a groove <NUM> it may move forward into that groove <NUM> and spring <NUM> may apply sufficient force on ball detent <NUM> so that ball detent is biased towards that groove <NUM>. With ball detent <NUM> lined up and engaged with one of grooves <NUM>, instrument assembly <NUM> is inserted further into guide tube <NUM>. <FIG> depicts a groove <NUM> engaged with ball detent <NUM>.

Instrument <NUM> may freely rotate about its shaft and move along the path of trajectory <NUM> within instrument assembly <NUM>. Instrument assembly <NUM> may be restricted from rotating within guide tube <NUM> while a groove <NUM> is engaged with ball detent <NUM>. The rotational position of instrument assembly <NUM> within guide tube <NUM> may be chosen such that tracking array <NUM> is adequately visible to the tracking devices in order to properly display the position of instrument <NUM> on, for example, display <NUM> of the surgical robot system.

While rotational movement of instrument assembly <NUM> inside guide tube <NUM> may be restricted, the rotational position of instrument assembly <NUM> may be adjusted. For example, instrument assembly <NUM> may be adjusted so that tracking array <NUM> is in a better position to be visible by the tracking devices. In an exemplary embodiment, sufficient rotational force may be applied to instrument assembly <NUM> to disengage ball detent <NUM> from a groove <NUM>. Ball detent <NUM> may move backwards upon disengaging with a groove <NUM>. This disengagement is depicted in <FIG>. Once disengaged, the rotational position of instrument assembly <NUM> may be adjusted so that ball detent <NUM> moves forward and engages a different groove <NUM>.

Ball detent <NUM> and the one or more grooves <NUM> may be configured such that movement along the path of trajectory <NUM> is not restricted. This configuration may allow instrument assembly <NUM> to move along a path of trajectory <NUM>, while guide tube <NUM> restricts rotational movement of instrument assembly <NUM> to maintain a fixed orientation of tracking array <NUM> in relation to the tracking devices.

Ball detent <NUM> has been described in relation to spring <NUM> and being a spring plunger type of structure. However, it is understood that other structures may be used to restrict rotational movement of instrument assembly <NUM> in guide tube <NUM> in order to maintain an orientation of tracking array <NUM>. For example, such structures may include and are not limited to a coil spring, wave spring, flexture, torsional spring mounted to a lever, or a compressible material. Further, ball detent <NUM> and spring <NUM> have been described as being part of guide tube <NUM>, however, ball detent <NUM> and spring <NUM> may be disposed on instrument assembly <NUM> and engage with complimentary mechanisms associated with end-effector <NUM> or guide tube <NUM> to similarly restrict the rotation movement of instrument assembly <NUM>.

<FIG> illustrates end-effector <NUM>, instrument <NUM>, instrument assembly <NUM>, tracking array <NUM>, and guide tube <NUM> consistent with an exemplary embodiment. Instrument assembly <NUM> may further comprise groove <NUM>. Guide tube <NUM> may further comprise channel <NUM>.

As described previously, rotational movement of instrument assembly <NUM> may be restricted when it is received by guide tube <NUM>. In an exemplary embodiment to restrict movement of an instrument assembly while inside a guide tube, instrument assembly <NUM> may have groove <NUM> configured to engage channel <NUM> of guide tube <NUM> to similarly restrict rotational movement of instrument assembly <NUM> when received by guide tube <NUM>. Once groove <NUM> is engaged with channel <NUM>, instrument assembly <NUM> is restricted from rotating about its shaft axis while instrument assembly <NUM> is inside guide tube <NUM>.

Other methods and components may be used to restrict the rotational movement of an instrument assembly while inside a guide tube. For example, one or more cylindrical rollers may be used that is configured with roller axis perpendicular to the instrument shaft to roll and allow for axial movement of an instrument assembly along the path of trajectory <NUM> but is configured to remain stationary when attempts are made to rotationally move instrument assembly within guide tube <NUM>. This configuration would have the effect of fixing the orientation of tracking array <NUM>. The roller may be made of a flexible material and held rigidly protruding into guide tube <NUM> to engage with an outer sleeve of the instrument assembly. The roller may also be made of a rigid material and spring loaded, pushing into guide tube <NUM> to engage with the instrument assembly. Moreover, the roller may be disposed on an instrument assembly and engage guide tube <NUM> when the instrument assembly is inserted into guide tube <NUM>.

As another exemplary embodiment, rotation of an outer sleeve of instrument assembly may be restricted from rotating but allowing for axial movement through the use of anisotropic surface textures for the outer sleeve and guide tube <NUM>. This texture pattern may allow for different friction forces associated with rotation of the outer sleeve and axial movement so that a user may need to apply a relatively higher force to rotationally move the instrument assembly compared to moving the instrument assembly in an axial direction consistent with trajectory <NUM>.

<FIG> illustrate end-effector <NUM> and a portion of robot arm <NUM> consistent with an exemplary embodiment. End-effector <NUM> may further comprise body <NUM> and clamp <NUM>. Clamp <NUM> may comprise handle <NUM>, balls <NUM>, spring <NUM>, and lip <NUM>. Robot arm <NUM> may further comprise depressions <NUM>, mounting plate <NUM>, lip <NUM>, and magnets <NUM>.

End-effector <NUM> may mechanically interface and/or engage with the surgical robot system and robot arm <NUM> through one or more couplings. For example, end-effector <NUM> may engage with robot arm <NUM> through a locating coupling and/or a reinforcing coupling. Through these couplings, end-effector <NUM> may fasten with robot arm <NUM> outside a flexible and sterile barrier. In an exemplary embodiment, the locating coupling may be a magnetically kinematic mount and the reinforcing coupling may be a five bar over center clamping linkage.

With respect to the locating coupling, robot arm <NUM> may comprise mounting plate <NUM>, which may be non-magnetic material, one or more depressions <NUM>, lip <NUM>, and magnets <NUM>. Magnet <NUM> is mounted below each of depressions <NUM>. Portions of clamp <NUM> may comprise magnetic material and be attracted by one or more magnets <NUM>. Through the magnetic attraction of clamp <NUM> and robot arm <NUM>, balls <NUM> become seated into respective depressions <NUM>. For example, balls <NUM> as shown in <FIG> would be seated in depressions <NUM> as shown in <FIG>. This seating may be considered a magnetically-assisted kinematic coupling. Magnets <NUM> may be configured to be strong enough to support the entire weight of end-effector <NUM> regardless of the orientation of end-effector <NUM>. The locating coupling may be any style of kinematic mount that uniquely restrains six degrees of freedom.

With respect to the reinforcing coupling, portions of clamp <NUM> may be configured to be a fixed ground link and as such clamp <NUM> may serve as a five bar linkage. Closing clamp handle <NUM> may fasten end-effector <NUM> to robot arm <NUM> as lip <NUM> and lip <NUM> engage clamp <NUM> in a manner to secure end-effector <NUM> and robot arm <NUM>. When clamp handle <NUM> is closed, spring <NUM> may be stretched or stressed while clamp <NUM> is in a locked position. The locked position may be a position that provides for linkage past center. Because of a closed position that is past center, the linkage will not open absent a force applied to clamp handle <NUM> to release clamp <NUM>. Thus, in a locked position end-effector <NUM> may be robustly secured to robot arm <NUM>.

Spring <NUM> may be a curved beam in tension. Spring <NUM> may be comprised of a material that exhibits high stiffness and high yield strain such as Virgin PEEK (poly-ether-ether-ketone). The linkage between end-effector <NUM> and robot arm <NUM> may provide for a sterile barrier between end-effector <NUM> and robot arm <NUM> without impeding fastening of the two couplings.

The reinforcing coupling may be a linkage with multiple spring members. The reinforcing coupling may latch with a cam or friction based mechanism. The reinforcing coupling may also be a sufficiently powerful electromagnet that will support fastening end-effector <NUM> to robot arm <NUM>. The reinforcing coupling may be a multipiece collar completely separate from either end-effector <NUM> and/or robot arm <NUM> that slips over an interface between end-effector <NUM> and robot arm <NUM> and tightens with a screw mechanism, an over center linkage, or a cam mechanism.

<FIG> is a circuit diagram that illustrates power transfer between end-effector <NUM> and robot arm <NUM> consistent with an exemplary embodiment. End-effector <NUM> may comprise a coil <NUM>, resistor <NUM>, and diode <NUM>. Robot arm <NUM> may comprise coil <NUM> and voltage supply <NUM>.

End-effector <NUM> and robot arm <NUM> may be configured in a manner to allow for wireless power transfer in order to power end-effector <NUM> and components associated with end-effector <NUM>. In an exemplary embodiment, end-effector <NUM> may comprise coil <NUM> that receives an electromagnetic field generated by robot arm <NUM>. Robot arm <NUM> may contain coil <NUM>, which may serve as a primary coil in an inductive power transfer system between robot arm <NUM> and end-effector <NUM> over an air gap. In an exemplary embodiment, the air gap may be in the range of <NUM>-<NUM>. Coil <NUM> may be coupled to voltage supply <NUM> in order to generate the electromagnetic field. The electromagnetic field may be received by coil <NUM> of end-effector <NUM> to generate an electrical current.

The inductive power relationship between may power components of end-effector <NUM> such as tracking markers <NUM>, sensor <NUM>, and other electrical components associated with end-effector <NUM>. By providing wireless powering, end-effector <NUM> may be physically and/or electrically isolated from robot arm <NUM> while powering electronics and other components contained in end-effector <NUM>.

The resistance of resistor <NUM> may be varied among a number of distinct states, causing differential power draw. The power draw may be measured from the side of the surgical robot as a means of wirelessly passing a signal from end-effector <NUM> to the surgical robot base <NUM>. Alternatively, a battery could be used to power the electronics, and a standard wireless communications protocol such as Bluetooth may be used to exchange signals between end- effectuator <NUM> and robot base <NUM>. Data transferred to robot base <NUM> may include state information. This information may include a determination of whether end-effector <NUM> is detached from robot arm <NUM>, and if instrument <NUM> is present in guide tube <NUM>.

The power transmission between robot arm <NUM> and end-effector <NUM> may be based on electromagnetism, optics, or ultrasound. For each of these transmission types, the corresponding resistance on end-effector <NUM> can be varied to communicate the state of end-effector <NUM>. End-effector <NUM> may propagate power or receive one or more signals by any of the aforementioned principles to other items in the sterile field, such as drills, screw drivers, implant holders, or lights. In addition, power and/or signal may be passed to other sterile items via a contact connection.

Referring to <FIG> and <FIG>, prior to or during a surgical procedure, certain registration procedures may be conducted in order to track objects and a target anatomical structure of the patient both in a navigation space and an image space. In order to conduct such registration, a registration system <NUM> may be used as illustrated in <FIG>.

A patient fixation instrument <NUM> may be secured to a rigid anatomical structure of the patient and a dynamic reference base (DRB) <NUM> may be attached to patient fixation instrument <NUM>. For example, patient fixation instrument <NUM> may be inserted into opening <NUM> of dynamic reference base <NUM>. Dynamic reference base <NUM> may contain markers <NUM> that are visible to tracking devices, such as tracking subsystem <NUM>. These markers may be optical markers or reflective spheres as previously discussed herein.

Patient fixation instrument <NUM> is attached to a rigid anatomy of the patient and may remain attached throughout the surgical procedure. In an exemplary embodiment, patient fixation instrument <NUM> is attached to a rigid area of the patient, for example a bone, that is located away from the targeted anatomical structure subject to the surgical procedure. In order to track the targeted anatomical structure, dynamic reference base <NUM> is associated with the targeted anatomical structure through the use of a registration fixture that is temporarily placed on or near the targeted anatomical structure in order to register the dynamic reference base with the location of the targeted anatomical structure.

A registration fixture <NUM> is attached to patient fixation instrument <NUM> through the use of a pivot arm <NUM>. Pivot arm <NUM> is attached to patient fixation instrument <NUM> by inserting patient fixation instrument <NUM> through an opening <NUM> of registration fixture <NUM>. Pivot arm <NUM> is attached to registration fixture <NUM> by, for example, inserting a knob <NUM> through an opening <NUM> of pivot arm <NUM>.

Using pivot arm <NUM>, registration fixture <NUM> may be placed over the targeted anatomical structure and its location may be determined in an image space and navigation space using tracking markers or fiducials on registration fixture <NUM>. Registration fixture <NUM> may contain a collection of markers <NUM> that are visible in a navigational space (for example, markers <NUM> may be detectable by tracking subsystem <NUM>). Markers <NUM> may be optical markers visible in infrared light as previously described herein. Registration fixture <NUM> may also contain a collection of fiducials <NUM>, for example bearing balls, that are visible in an imaging space (for example, a three dimension CT image). As described in greater detail with respect to <FIG>, using registration fixture <NUM>, the targeted anatomical structure may be associated with dynamic reference base <NUM> thereby allowing depictions of objects in the navigational space to be overlaid on images of the anatomical structure. Dynamic reference base <NUM>, located at a position away from the targeted anatomical structure, may become a reference point thereby allowing removal of registration fixture <NUM> and/or pivot arm <NUM> from the surgical area.

<FIG> provides an exemplary method <NUM> for registration consistent with the present disclosure. Method <NUM> begins at step <NUM> wherein a graphical representation (or image(s)) of the targeted anatomical structure may be imported into system <NUM>, for example computer <NUM>. The graphical representation may be three dimensional CT or a fluoroscope scan of the targeted anatomical structure of the patient which includes registration fixture <NUM> and a detectable imaging pattern of fiducials <NUM>.

At step <NUM>, an imaging pattern of fiducials <NUM> is detected and registered in the imaging space and stored in computer <NUM>. Optionally, at this time at step <NUM>, a graphical representation of the registration fixture may be overlaid on the images of the targeted anatomical structure.

At step <NUM>, a navigational pattern of registration fixture <NUM> is detected and registered by recognizing markers <NUM>. Markers <NUM> may be optical markers that are recognized in the navigation space through infrared light by tracking subsystem <NUM> via position sensor <NUM>. Thus, the location, orientation, and other information of the targeted anatomical structure is registered in the navigation space. Therefore, registration fixture <NUM> may be recognized in both the image space through the use of fiducials <NUM> and the navigation space through the use of markers <NUM>. At step <NUM>, the registration of registration fixture in the image space is transferred to the navigation space. This transferal is done, for example, by using the relative position of the imaging pattern of fiducials <NUM> compared to the position of the navigation pattern of markers <NUM>.

At step <NUM>, registration of the navigation space of registration fixture (having been registered with the image space) is further transferred to the navigation space of dynamic registration array <NUM> attached to patient fixture instrument <NUM>. Thus, registration fixture <NUM> may be removed and dynamic reference base <NUM> may be used to track the targeted anatomical structure in both the navigation and image space because the navigation space is associated with the image space.

At steps <NUM> and <NUM>, the navigation space may be overlaid on the image space and objects with markers visible in the navigation space (for example, surgical instruments with optical markers). The objects may be tracked through graphical representations of the surgical instrument on the images of the targeted anatomical structure.

Although several embodiments of the invention have been disclosed in the foregoing specification, it is understood that many modifications and other embodiments of the invention will come to mind to which the invention pertains, having the benefit of the teaching presented in the foregoing description and associated drawings. It is thus understood that the invention is not limited to the specific embodiments disclosed hereinabove, and that many modifications and other embodiments are intended to be included within the scope of the appended claims. Moreover, although specific terms are employed herein, as well as in the claims which follow, they are used only in a generic and descriptive sense, and not for the purposes of limiting the described invention, nor the claims which follow.

Claim 1:
A surgical robot system comprising:
a surgical robot base (<NUM>)
a surgical robot arm (<NUM>) electronically coupled to the surgical robot base (<NUM>) and
an end-effector (<NUM>), coupled to the surgical robot arm (<NUM>), having a guide tube (<NUM>) wherein
the end-effector (<NUM>) is configured to receive an instrument assembly (<NUM>) having a tracking array (<NUM>) having a plurality of markers (<NUM>) to track the location of the instrument assembly (<NUM>),
characterized in that
the instrument assembly (<NUM>) has an outer sleeve (<NUM>) containing longitudinal grooves (<NUM>) disposed along a length of the instrument assembly (<NUM>),
further characterized in that the guide tube (<NUM>) is configured to engage at least one of the grooves (<NUM>) to restrict rotational movement of the instrument assembly (<NUM>) within the guide tube (<NUM>) and to restrict movement of the tracking array (<NUM>).