Patent Description:
The present invention relates generally to a system for demonstrating planned autonomous manipulation of an anatomy.

Robotic surgical systems are increasingly utilized to perform surgical procedures on patients. The robotic surgical system typically includes a robotic device including a moveable arm having a free, distal end, which may be placed with a high degree of accuracy. A tool or end effector, which is applied to the surgical site, attaches to the free end of the arm. The operator is able to move the arm and thereby precisely position the tool at the surgical site to perform the procedure.

<CIT> discloses a surgical manipulator that can be controlled either in a manual mode or in a semi-automatic mode. Furthermore, from <CIT> a method for generating a tool path for cutting a bone is known, wherein a pre-operative planning software is used for overlaying an image of the bone and an image of a cutting pattern.

Operators often desire dynamic control of the tool in different manipulation modes during a surgical operation. For example, in some instances, the operator may desire a manual mode to control the tool manually for bulk manipulation of the anatomy. In other instances, the operator may desire to control the tool in an autonomous mode for automated and highly accurate manipulation of the anatomy.

In view of the efficiency and accuracy of autonomous manipulation, it is likely that autonomous manipulation will replace manual manipulation in the future. However, operators may be hesitant to commit to autonomous manipulation in the operating room. Many operators prefer manual manipulation because manual manipulation gives the operator the impression of having total control over the tool. Said differently, operators may hesitate to allow the robotic device to autonomously operate on the patient because of a perceived lack of control associated with autonomous manipulation.

One embodiment of a robotic surgical system for manipulating an anatomy and demonstrating planned autonomous manipulation of the anatomy is provided with the features of claim <NUM>. The robotic surgical system includes a tool configured to manipulate the anatomy. A controller is configured to generate manipulation parameters representing planned constraints on autonomous manipulation of a volume of the anatomy by the tool in a first mode. The controller generates demonstrative parameters relating to the manipulation parameters. The demonstrative parameters are defined in relation to a surface of the anatomy such that the demonstrative parameters are less invasive to the anatomy than the manipulation parameters. The controller is configured to instruct movement of the tool in accordance with the demonstrative parameters in a second mode thereby demonstrating planned constraints on autonomous manipulation of the anatomy in relation to the surface of the anatomy.

Another embodiment of a robotic surgical system for manipulating an anatomy and demonstrating planned autonomous manipulation of the anatomy is provided with the features of claim <NUM>. The robotic surgical system includes an end effector configured to manipulate the anatomy and a demonstrative tool configured to interact with the anatomy. A controller is configured to generate manipulation parameters representing planned constraints on autonomous manipulation of a volume of the anatomy by the end effector in a first mode. The controller generates demonstrative parameters relating to the manipulation parameters. The demonstrative parameters are defined in relation to a surface of the anatomy such that the demonstrative parameters are less invasive to the anatomy than the manipulation parameters. The controller is configured to instruct movement of the demonstrative tool in accordance with the demonstrative parameters in a second mode thereby demonstrating planned constraints on autonomous manipulation of the anatomy in relation to the surface of the anatomy.

One embodiment - not according to the invention - of a method of demonstrating planned autonomous manipulation of an anatomy by a tool of a robotic surgical system is also provided. The method comprises generating manipulation parameters representing planned constraints on autonomous manipulation of a volume of the anatomy by the tool in a first mode. Demonstrative parameters relating to the manipulation parameters are generated. The demonstrative parameters are defined in relation to a surface of the anatomy such that the demonstrative parameters are less invasive to the anatomy than the manipulation parameters. The tool is autonomously moved in accordance with the demonstrative parameters in a second mode thereby demonstrating planned constraints on autonomous manipulation of the anatomy in relation to the surface of the anatomy.

Another embodiment - not according to the invention - of a method of demonstrating planned autonomous manipulation of an anatomy by an end effector of a robotic surgical system is also provided. The method comprises generating manipulation parameters representing planned constraints on autonomous manipulation of a volume of the anatomy by the end effector in a first mode. Demonstrative parameters relating to the manipulation parameters are generated. The demonstrative parameters are defined in relation to a surface of the anatomy such that the demonstrative parameters are less invasive to the anatomy than the manipulation parameters. A demonstrative tool is autonomously moved in accordance with the demonstrative parameters in a second mode thereby demonstrating planned constraints on autonomous manipulation of the anatomy in relation to the surface of the anatomy.

The system and method advantageously demonstrate planned autonomous manipulation in the second mode. Unlike the invasiveness of manipulation in the first mode, demonstration in the second mode is minimally or non-invasive as it is performed in relation to the surface of the anatomy. By autonomously moving the end effector or demonstrative tool in the second mode, the operator can visualize a representation of planned autonomous movement before committing to autonomous manipulation in the first mode. Thus, the second mode provides operators with a greater sense of control and confidence thereby alleviating operator hesitancy in using autonomous manipulation in the first mode.

Referring to the Figures, wherein like numerals indicate like or corresponding parts throughout the several views, a system <NUM> and method for manipulating an anatomy of a patient <NUM> are shown throughout.

As shown in <FIG>, the system <NUM> is a robotic surgical cutting system for cutting away material from the anatomy of the patient <NUM>, such as bone or soft tissue. In <FIG>, the patient <NUM> is undergoing a surgical procedure. The anatomy in <FIG> includes a femur (F) and a tibia (T) of the patient <NUM>. The surgical procedure may involve tissue removal. In other examples, the surgical procedure involves partial or total knee or hip replacement surgery. The system <NUM> is designed to cut 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 <CIT>, entitled, "Prosthetic Implant and Method of Implantation". Those skilled in the art appreciate that the system and method disclosed herein may be used to perform other procedures, surgical or non-surgical, or may be used in industrial applications or other applications where robotic systems are utilized.

The system <NUM> includes a manipulator <NUM>. The manipulator <NUM> has a base <NUM> and a linkage <NUM>. The linkage <NUM> may comprise links forming a serial arm or parallel arm configuration. An end effector <NUM> couples to the manipulator <NUM> and is movable relative to the base <NUM> to interact with the surgical environment, and more specifically, the anatomy. The end effector <NUM> is grasped by the operator. One exemplary arrangement of the manipulator <NUM> and the end effector <NUM> is described in <CIT>, entitled, "Surgical Manipulator Capable of Controlling a Surgical Instrument in Multiple Modes". The manipulator <NUM> and the end effector <NUM> may be arranged in alternative configurations. The end effector <NUM> includes an energy applicator <NUM> designed to contact the tissue of the patient <NUM> at the surgical site. The end effector <NUM> may have various configurations depending on the application. The energy applicator <NUM> may be a drill, a saw blade, a bur, an ultrasonic vibrating tip, a probe, a stylus, or the like. The manipulator <NUM> also houses a manipulator computer <NUM>, or other type of control unit. The end effector <NUM> can be like that shown in <CIT>, entitled, "End Effector of a Surgical Robotic Manipulator".

Referring to <FIG>, the system <NUM> includes a controller <NUM>. The controller <NUM> includes software and/or hardware for controlling the manipulator <NUM>. The controller <NUM> directs the motion of the manipulator <NUM> and controls an orientation of the end effector <NUM> with respect to a coordinate system. In one embodiment, the coordinate system is a manipulator coordinate system MNPL (see <FIG>). The manipulator coordinate system MNPL has an origin, and the origin is located at a point on the manipulator <NUM>. One example of the manipulator coordinate system MNPL is described in <CIT>, entitled, "Surgical Manipulator Capable of Controlling a Surgical Instrument in Multiple Modes".

The system <NUM> further includes a navigation system <NUM>. One example of the navigation system <NUM> and components related thereto is described in <CIT>, entitled, "Navigation System Including Optical and Non-Optical Sensors". The navigation system <NUM> is set up to track movement of various objects. Such objects include, for example, the end effector <NUM>, and the anatomy, e.g., femur F and tibia T. The navigation system <NUM> tracks these objects to gather position information of each object in a localizer coordinate system LCLZ. Coordinates in the localizer coordinate system LCLZ may be transformed to the manipulator coordinate system MNPL using conventional transformation techniques. The navigation system <NUM> is also capable of displaying a virtual representation of their relative positions and orientations to the operator.

The navigation system <NUM> includes a computer cart assembly <NUM> that houses a navigation computer <NUM>, and/or other types of control units. A navigation interface is in operative communication with the navigation computer <NUM>. The navigation interface includes one or more displays <NUM>. First and second input devices <NUM>, <NUM> such as a keyboard and mouse may be used to input information into the navigation computer <NUM> or otherwise select/control certain characteristics of the navigation computer <NUM>. Other input devices <NUM>, <NUM> are contemplated including a touch screen (not shown) or voice-activation. The controller <NUM> may be implemented on any suitable device or devices in the system <NUM>, including, but not limited to, the manipulator computer <NUM>, the navigation computer <NUM>, and any combination thereof.

The navigation system <NUM> also includes a localizer <NUM> that communicates with the navigation computer <NUM>. In one embodiment, the localizer <NUM> is an optical localizer and includes a camera unit <NUM>. The camera unit <NUM> has an outer casing <NUM> that houses one or more optical position sensors <NUM>. The system <NUM> includes one or more trackers. The trackers may include a pointer tracker PT, a tool tracker <NUM>, a first patient tracker <NUM>, and a second patient tracker <NUM>. The trackers include active markers <NUM>. The active markers <NUM> may be light emitting diodes or LEDs. In other embodiments, the trackers <NUM>, <NUM>, <NUM> may have passive markers, such as reflectors, which reflect light emitted from the camera unit <NUM>. Those skilled in the art appreciate that the other suitable tracking systems and methods not specifically described herein may be utilized.

In the illustrated embodiment of <FIG>, the first patient tracker <NUM> is firmly affixed to the femur F of the patient <NUM> and the second patient tracker <NUM> is firmly affixed to the tibia T of the patient <NUM>. The patient trackers <NUM>, <NUM> are firmly affixed to sections of bone. The tool tracker <NUM> is firmly attached to the end effector <NUM>. It should be appreciated that the trackers <NUM>, <NUM>, <NUM> may be fixed to their respective components in any suitable manner.

The trackers <NUM>, <NUM>, <NUM> communicate with the camera unit <NUM> to provide position data to the camera unit <NUM>. The camera unit <NUM> provides the position data of the trackers <NUM>, <NUM>, <NUM> to the navigation computer <NUM>. In one embodiment, the navigation computer <NUM> determines and communicates position data of the femur F and tibia T and position data of the end effector <NUM> to the manipulator computer <NUM>. Position data for the femur F, tibia T, and end effector <NUM> may be determined by the tracker position data using conventional registration/navigation techniques. The position data includes position information corresponding to the position and/or orientation of the femur F, tibia T, end effector <NUM> and any other objects being tracked. The position data described herein may be position data, orientation data, or a combination of position data and orientation data.

The manipulator computer <NUM> transforms the position data from the localizer coordinate system LCLZ into the manipulator coordinate system MNPL by determining a transformation matrix using the navigation-based data for the end effector <NUM> and encoder-based position data for the end effector <NUM>. Encoders (not shown) located at joints of the manipulator <NUM> are used to determine the encoder-based position data. The manipulator computer <NUM> uses the encoders to calculate an encoder-based position and orientation of the end effector <NUM> in the manipulator coordinate system MNPL. Since the position and orientation of the end effector <NUM> are also known in the localizer coordinate system LCLZ, the transformation matrix may be generated.

As shown in <FIG>, the controller <NUM> further includes software modules. The software modules may be part of a computer program or programs that operate on the manipulator computer <NUM>, navigation computer <NUM>, or a combination thereof, to process data to assist with control of the system <NUM>. The software modules include sets of instructions stored in memory on the manipulator computer <NUM>, navigation computer <NUM>, or a combination thereof, to be executed by one or more processors of the computers <NUM>, <NUM>. Additionally, software modules for prompting and/or communicating with the operator may form part of the program or programs and may include instructions stored in memory on the manipulator computer <NUM>, navigation computer <NUM>, or a combination thereof. The operator interacts with the first and second input devices <NUM>, <NUM> and the one or more displays <NUM> to communicate with the software modules.

In one embodiment, the controller <NUM> includes a manipulator controller <NUM> for processing data to direct motion of the manipulator <NUM>. The manipulator controller <NUM> may receive and process data from a single source or multiple sources.

The controller <NUM> further includes a navigation controller <NUM> for communicating the position data relating to the femur F, tibia T, and end effector <NUM> to the manipulator controller <NUM>. The manipulator controller <NUM> receives and processes the position data provided by the navigation controller <NUM> to direct movement of the manipulator <NUM>. In one embodiment, as shown in <FIG>, the navigation controller <NUM> is implemented on the navigation computer <NUM>.

The manipulator controller <NUM> or navigation controller <NUM> may also communicate positions of the patient <NUM> and end effector <NUM> to the operator by displaying an image of the femur F and/or tibia T and the end effector <NUM> on the display <NUM>. The manipulator computer <NUM> or navigation computer <NUM> may also display instructions or request information on the display <NUM> such that the operator may interact with the manipulator computer <NUM> for directing the manipulator <NUM>.

The manipulator <NUM> autonomously interacts with the anatomy. Specifically, the system <NUM> may include a semi-autonomous mode, an example of which is described in <CIT>, entitled, "Surgical Manipulator Capable of Controlling a Surgical Instrument in Multiple Modes". In the semi-autonomous mode, the manipulator <NUM> directs autonomous movement of the end effector <NUM> and, in turn, the energy applicator <NUM> at the surgical site. The manipulator <NUM> is capable of moving the end effector <NUM> free of operator assistance. Free of operator assistance may mean that an operator does not physically contact the end effector <NUM> to apply force to move the end effector <NUM>. Instead, the operator may use some form of control to remotely manage starting and stopping of movement. For example, the operator may hold down a button of a remote control to start movement of the end effector <NUM> and release the button to stop movement of the end effector <NUM>. Alternatively, the operator may press a button to start movement of the end effector <NUM> and press a button to stop movement of the end effector <NUM>.

The controller <NUM> is configured to generate manipulation parameters <NUM> in relation to a volume <NUM> of the anatomy, as shown in <FIG>. The manipulation parameters <NUM> represent planned constraints on autonomous manipulation of the volume <NUM> by the energy applicator <NUM> of the end effector <NUM>. As described below, the manipulation parameters <NUM> may include virtual cutting boundaries, tool cutting paths, or any combination thereof. The manipulation parameters <NUM> are defined to promote manipulation, removal, and/or cutting of the volume <NUM> of the anatomy. The manipulation parameters <NUM> are executed in a first mode. In one embodiment, the first mode may be understood to be a "manipulation" or "cutting" mode. Therefore, for simplicity, the first mode is hereinafter referred to as the manipulation mode in the detailed description.

As shown in <FIG>, the controller <NUM> includes a boundary generator <NUM> for generating the manipulation parameters <NUM>. The boundary generator <NUM> is a software module that may be implemented on the manipulator controller <NUM>, as shown in <FIG>. Alternatively, the boundary generator <NUM> may be implemented on other components, such as the navigation controller <NUM>.

As shown in <FIG>, the boundary generator <NUM> generates a cutting boundary <NUM> for constraining the end effector <NUM> and/or energy applicator <NUM> in relation to the anatomy. The cutting boundary <NUM> is a virtual boundary in that the boundary is not physically present, but rather is implemented by controlling position and movement of the manipulator <NUM> and the end effector <NUM>. The cutting boundary <NUM> delineates sections of tissue to be removed by the end effector <NUM> during the surgery from sections of tissue that are to remain after the surgery. As shown in <FIG>, the cutting boundary <NUM> is associated with the anatomy, and more specifically a target surface <NUM> of the anatomy. The cutting boundary <NUM> is defined in relation to the target surface <NUM>. The target surface <NUM> is a contiguous defined surface area of the tissue that is to remain after cutting has completed. For implant procedures, the target surface <NUM> is the surface of the bone remaining after the removal procedure and is the surface to which the implant is to be mounted. The cutting boundary <NUM> may have a profile that substantially conforms to the target surface <NUM>.

During the procedure, the cutting boundary <NUM> may be slightly offset or spaced apart from the target surface <NUM>. In one embodiment, this is done to account for the size and manipulation characteristics of the energy applicator <NUM> of the end effector <NUM>. The manipulation characteristics of the end effector <NUM> may cause a breaching of the cutting boundary <NUM>. To account for this overreaching, the cutting boundary <NUM> may be translated from target surface <NUM> by a predetermined distance defined between the target surface <NUM> and the cutting boundary <NUM>. Those skilled in the art understand that the cutting boundary <NUM> may have other configurations not specifically described herein and may be configured or oriented in relation to anatomy not shown or described.

The cutting boundary <NUM> may be derived from various inputs to the manipulator <NUM>, and more specifically, the boundary generator <NUM>. One input into the boundary generator <NUM> includes preoperative images of the site on which the procedure is to be performed. If the manipulator <NUM> selectively removes tissue so the patient <NUM> may be fitted with an implant, a second input into the boundary generator <NUM> is a map of the shape of the implant. The initial version of this map may come from an implant database. The shape of the implant defines the boundaries of the tissue that should be removed to receive the implant. This relationship is especially true if the implant is an orthopedic implant intended to be fitted to the bone of the patient <NUM>. Preoperative images of the anatomy may be segmented to create a computer-generated model of the anatomy. The manipulation parameters <NUM> may be generated based on the computer-generated model of the anatomy. More specifically, the cutting boundary <NUM> may be generated in relation to the computer-generated model.

Another input into boundary generator <NUM> is the operator settings. These settings may indicate to which tissue the energy applicator <NUM> should be applied. If the energy applicator <NUM> removes tissues, the settings may identify the boundaries between the tissue to be removed and the tissue that remains after application of the energy applicator <NUM>. If the manipulator <NUM> assists in the fitting of an orthopedic implant, these settings may define where over the tissue the implant should be positioned. These settings may be entered preoperatively using a data processing unit. Alternatively, these settings may be entered through an input/output unit associated with one of the components of the system <NUM> such as with navigation interface <NUM>, <NUM>.

Based on the above input data and instructions, boundary generator <NUM> may generate the cutting boundary <NUM>. The cutting boundary <NUM> may be two-dimensional or three-dimensional. For example, the cutting boundary <NUM> may be generated as a virtual map or other three-dimensional model. The created maps or models guide movement of the end effector <NUM>. The models may be displayed on displays <NUM> to show the locations of the objects. Additionally, information relating to the models may be forwarded to the manipulator controller <NUM> to guide the manipulator <NUM> and corresponding movement of the end effector <NUM> relative to the cutting boundary <NUM>.

In practice, prior to the start of the procedure the operator at the surgical site may set an initial version of the cutting boundary <NUM>. At the start of the procedure, data that more precisely defines the implant that is to be actually fitted to the patient <NUM> may be loaded into the boundary generator <NUM>. Such data may come from a storage device associated with the implant such as a memory stick or an RFID tag. Such data may be a component of the implant database data supplied to the boundary generator <NUM>. These data are based on post manufacture measurements of the specific implant. These data provide a definition of the shape of the specific implant that, due to manufacturing variations, may be slightly different than the previously available stock definition of implant shape. Based on this implant-specific data, the boundary generator <NUM> may update the cutting boundary <NUM> to reflect the boundaries between the tissue to be removed and the tissue that should remain in place. Implants that could be implanted into the patient <NUM> include those shown in <CIT> and entitled, "Prosthetic Implant and Method of Implantation". The implants disclosed herein could be implanted in the patient <NUM> after the appropriate amount of material, such as bone, is removed. Other implants are also contemplated.

As shown in <FIG>, the controller <NUM> further includes a tool path generator <NUM> for generating manipulation parameters <NUM>. The tool path generator <NUM> is another software module run by the controller <NUM>, and more specifically, the manipulator controller <NUM>. The tool path generator <NUM> generates a cutting path <NUM> for the end effector <NUM> to follow, as shown in <FIG>. The cutting path <NUM> is represented by the back and forth line. In <FIG>, the cutting path <NUM> is configured to facilitate removal of the volume <NUM> of bone which is to be removed to receive the implant. The smoothness and quality of the finished surface depends in part of the relative positioning of the back and forth line. More specifically, the closer together each back and forth pass of the line, the more precise and smooth is the finished surface. In <FIG>, the dashed line represents the exterior surface <NUM> of the bone that is to be removed using manipulator <NUM>. One exemplary system and method for generating the cutting path <NUM> is explained in <CIT>, entitled, "Surgical Manipulator Capable of Controlling a Surgical Instrument in Multiple Modes".

As shown in <FIG>, the system <NUM> and method are configured to demonstrate planned autonomous manipulation of the anatomy. The system <NUM> includes a demonstrative tool <NUM> configured to interact with the anatomy to demonstrate characteristics of the planned manipulation. The controller <NUM> does so in a second mode. In one embodiment, the second mode may be understood to be a "demo" or "demonstration" mode. Therefore, for simplicity, the second mode is hereinafter referred to as the demo mode in the detailed description. The demonstrative tool <NUM> interacts with the anatomy to demonstrate the planned procedure in the demo mode. As such, characteristics of the manipulation parameters <NUM> are visually demonstrated to the operator in the demo mode.

In one embodiment, the demonstrative tool <NUM> is the end effector <NUM> itself, and in particular, the energy applicator <NUM>. That is, the end effector <NUM> is utilized to demonstrate the planned procedure and carry out the planned procedure. Thus, the terms "demonstrative tool" and "end effector" may be interchangeable depending upon if the end effector <NUM> is also utilized as the demonstrative tool <NUM>, as described in this section. Accordingly, in this section, it is to be understood that the end effector <NUM> is the demonstrative tool <NUM> and that the term "demonstrative tool" is recited to help distinguish demonstrative and manipulative characteristics of the system <NUM> and method.

As shown in <FIG>, the controller <NUM> generates demonstrative parameters <NUM> relating to the manipulation parameters <NUM>. The demonstrative parameters <NUM> represent characteristics of the planned constraints on autonomous manipulation of the volume <NUM> in the manipulation mode. Movement of the demonstrative tool <NUM> is dictated and restricted by the demonstrative parameters <NUM>.

The demonstrative parameters <NUM> are defined in relation to the exterior surface <NUM> of the anatomy such that the demonstrative parameters <NUM> are less invasive to the anatomy than the manipulation parameters <NUM>. Unlike the invasiveness of manipulation in the manipulation mode, demonstration in the demo mode is minimally or non-invasive as it is performed in relation to the exterior surface <NUM> of the anatomy. Those skilled in the art appreciate that demonstration is performed in relation to some characteristics of the manipulation parameters <NUM> and not based on the exact manipulation parameters <NUM> because doing so would cause manipulation of the anatomy, thereby defeating one major purpose of providing demonstration.

The controller <NUM> is configured to instruct movement of the demonstrative tool <NUM> in accordance with the demonstrative parameters <NUM>. In one embodiment, the controller <NUM> instructs autonomous movement of the demonstrative tool <NUM> in the demo mode. That is, movement of the demonstrative tool <NUM> in accordance with the demonstrative parameters <NUM> occurs autonomously in the demo mode. Autonomous movement of the demonstrative tool <NUM> occurs free of operator assistance such that the operator does not physically contact the demonstrative tool <NUM> to apply force to move the demonstrative tool <NUM>. By autonomously moving the demonstrative tool <NUM> in the demo mode, the operator may visualize characteristics of the manipulation parameters <NUM> free of distraction. Details described herein regarding autonomous movement of the end effector <NUM> in the manipulation mode are equally applicable to autonomous movement of the demonstrative tool <NUM> in the demo mode.

The demonstrative parameters <NUM> relate to the manipulation parameters <NUM>. The demonstrative parameters <NUM> may be generated from the same inputs to the manipulator <NUM> as the inputs utilized in generating the cutting boundary <NUM> and/or cutting path <NUM>. The boundary generator <NUM> and tool path generator <NUM> of the controller <NUM> may generate the demonstrative parameters <NUM>. The demonstrative parameters <NUM> may be generated based on the computer-generated model of the anatomy. However, unlike manipulation parameters <NUM>, which promote manipulation of the volume <NUM>, the demonstrative parameters <NUM> are defined in relation to the exterior surface <NUM> of the anatomy. The demonstrative parameters <NUM> significantly preserve the volume <NUM> because the demonstrative tool <NUM> is prevented from significantly penetrating the exterior surface <NUM>.

<FIG> illustrates one example of the demonstrative parameters <NUM> wherein the demonstrative parameters <NUM> are non-invasive. The demonstrative parameters <NUM> are defined such that the demonstrative tool <NUM> is spaced apart from the exterior surface <NUM> of the anatomy throughout movement in the demo mode. That is, the demonstrative tool <NUM> does not physically touch the exterior surface <NUM>.

As shown in <FIG>, the demonstrative parameters <NUM> may include a demonstrative boundary <NUM>, a demonstrative path <NUM>, or any combination thereof. Several examples of the relationship between the demonstrative parameters <NUM> and the cutting boundary <NUM> and/or cutting path <NUM> are described in detail below.

The demonstrative path <NUM> is derived from the cutting boundary <NUM> and/or cutting path <NUM>. The demonstrative path <NUM> demonstrates a representation of the cutting boundary <NUM> and/or cutting path <NUM>, but does so in relation to the exterior surface <NUM> of the anatomy. The demonstrative tool <NUM> moves along the demonstrative path <NUM> to demonstrate the cutting boundary <NUM> and/or cutting path <NUM> in the demo mode. The demonstrative path <NUM> is spaced apart from the cutting boundary <NUM> and cutting path <NUM>.

<FIG> illustrates a perspective view of the anatomy of <FIG>, which is a femur bone requiring a medial implant in a partial (unicompartmental) knee replacement procedure. <FIG> illustrates another perspective view of a femur bone, this time requiring a patellofemoral implant. In both <FIG>, the demonstrative path <NUM> is specifically tailored to the implant location. In <FIG>, the demonstrative path 106a represents the perimeter of the underlying cutting boundary <NUM>. In <FIG>, the demonstrative path 106b represents the underlying cutting path <NUM>. Again, the demonstrative path <NUM> may represent both the underlying cutting boundary <NUM> and cutting path <NUM>.

The demonstrative tool <NUM> traverses along the demonstrative path <NUM> in the demo mode. Generally, the demonstrative tool <NUM> traverses along the demonstrative path <NUM> at least once, and potentially, as many times as desired by the operator.

The demonstrative boundary <NUM> constrains movement of the demonstrative tool <NUM> such that the demonstrative tool <NUM> is prevented from moving beyond a virtual constraint defined by the demonstrative boundary <NUM>. The virtual constraint may align with the perimeter derived from the cutting boundary <NUM> and/or cutting path <NUM>. The demonstrative tool <NUM> moves in relation to the virtual constraint to demonstrate the perimeter in the demo mode. The demonstrative boundary <NUM> identifies to the operator the limits of the cutting boundary <NUM>, but in relation to the exterior surface <NUM> of the anatomy. The demonstrative boundary <NUM> encompasses the demonstrative path <NUM> or extends beyond the demonstrative path <NUM>. The demonstrative boundary <NUM> may also be tailored to the specific implant.

In some instances, the demonstrative boundary <NUM> supplements the demonstrative path <NUM>. For example, the demonstrative tool <NUM> may move along the demonstrative path <NUM> to demonstrate the perimeter. The demonstrative boundary <NUM> prevents the demonstrative tool <NUM> from inadvertently approaching or touching the exterior surface <NUM>. This may be particularly advantageous in instances when the patient (anatomy) moves or movement of the demonstrative tool <NUM> is otherwise interfered with during demonstration. This may also be advantageous when the operator wishes to manually confirm the limits the underlying cutting boundary <NUM> with the demonstrative tool <NUM>. For example, the operator may manually move the demonstrative tool <NUM> against the demonstrative boundary <NUM> to haptically sense the presence of the demonstrative boundary <NUM>. The operator may perform such technique before activating demonstration in the demo mode.

In other examples, the demonstrative path <NUM> can be actively controlled and/or manipulated by the operator. The demonstrative path <NUM> may be reactively employed in response to sensed movement of the tool <NUM> by the operator. For example, the tool <NUM> may initially be moved along the demonstrative boundary <NUM>. Thereafter, the operator may desire to move the tool <NUM> to the demonstrative path <NUM> by moving the tool <NUM> away from the boundary <NUM> and towards the primary cutting area of the surgical site. In such instances, the demonstrative path <NUM> reactively triggers such that the tool <NUM> becomes locked into the demonstrative path <NUM>.

In one embodiment, the demonstrative boundary <NUM> is spaced apart from the cutting boundary <NUM> such that the exterior surface <NUM> is located between the target surface <NUM> and the demonstrative boundary <NUM>. By controlling movement of the demonstrative tool <NUM> in relation to the exterior surface <NUM> of the anatomy, the demonstrative boundary <NUM> prevents the demonstrative tool <NUM> from reaching the target surface <NUM>, and in some instances, the exterior surface <NUM>. The demonstrative boundary <NUM> may be spaced apart from the cutting boundary <NUM> by any distance suitable to provide demonstration.

<FIG> provides one example illustrating the relationship between the manipulation parameters <NUM> and the demonstrative parameters <NUM>. In this example, the cutting boundary <NUM> and the target surface <NUM> correspond to the curved surface area of the volume. The cutting path <NUM> is defined in relation to several layers of the semi-spherical volume. For simplicity in illustration, the cutting path <NUM> is shown as a multi-layer spiral. The upper flat surface of the volume corresponds to the existing exterior surface <NUM> of the anatomy prior to cutting or manipulation in the manipulation mode. In this example, the demonstrative path <NUM> represents a two-dimensional version of the underlying semi-spherical cutting boundary <NUM> and/or cutting path <NUM>. Thus, the demonstrative path <NUM> is a two-dimensional spiral corresponding to the underlying three-dimensional cutting path <NUM>. Although flattened, the demonstrative path <NUM> in this example nevertheless represents significant portions of the intended cutting boundary <NUM> and/or cutting path <NUM> with respect to the volume. The demonstrative path <NUM> may include duplicative movement of the demonstrative tool <NUM> since the three-dimensional cutting path <NUM> is flattened into a two-dimensional demonstrative path <NUM>. The demonstrative boundary <NUM> supplements the demonstrative path <NUM> by preventing manual movement of the demonstrative tool <NUM> beyond the virtual constraint defined by the demonstrative boundary <NUM>. In this example, the demonstrative boundaries <NUM> include a circular disc 104a and a cylindrical wall 104b encompassing the demonstrative path <NUM>. As shown in <FIG>, the demonstrative boundaries <NUM> form an open cylindrical volume such that the demonstrative tool <NUM> is not constrained and free to move upward and away from the volume. However, the demonstrative boundaries <NUM> may be a closed area or volume such that the demonstrative tool <NUM> is constrained within the area or volume. The demonstrative boundaries <NUM> may fill in space within the demonstrative path <NUM> and may expand beyond the demonstrative path <NUM>.

<FIG> provides another example, this time relating to a rectangular volume of material to be removed. The cutting boundary <NUM> and the target surface <NUM> correspond to the interior sides of the rectangular volume. The cutting path <NUM> is defined in relation to several layers of the rectangular volume. For simplicity in illustration, the cutting path <NUM> is a multi-layered rectangular spiral. The top surface of the volume corresponds to the existing exterior surface <NUM> of the anatomy prior to cutting or manipulation in the manipulation mode. In this example, the demonstrative path <NUM> represents a two-dimensional version of the underlying rectangular cutting boundary <NUM> and/or cutting path <NUM>. Thus, the demonstrative path <NUM> is a flattened rectangular spiral. The demonstrative boundary <NUM> supplements the demonstrative path <NUM> to prevent manual movement of the demonstrative tool <NUM> beyond the virtual constraints defined by the demonstrative boundary <NUM>. In this example, the demonstrative boundaries <NUM> are the sidewalls 104b and the rectangular area 104a encompassing the demonstrative path <NUM>. The demonstrative boundaries <NUM> may be closed or open areas or volumes.

Similarly, the cutting boundary <NUM> in <FIG> defines a shape designed to receive an implant and the cutting path <NUM> in <FIG> is defined in relation to several layers of the volume <NUM> for manipulating the anatomy to receive the implant. The demonstrative path <NUM> is shaped to conform and/or align to the exterior surface <NUM> of the anatomy and the demonstrative path <NUM> demonstrates the limits of the underlying cutting boundary <NUM> and/or cutting path <NUM>. Although not penetrating the exterior surface <NUM>, the demonstrative path <NUM> in <FIG> nevertheless represents the perimeter of the cutting boundary <NUM>. The demonstrative boundary <NUM> supplements the demonstrative path <NUM> to prevent manual movement of the demonstrative tool <NUM> beyond the virtual constraints. In this example, the demonstrative boundaries <NUM> are the sidewalls 104a, 104b defining the bounds of the underlying cutting boundary <NUM> and/or cutting path <NUM>.

<FIG> illustrates a series of screen-shots of a display, such as the display <NUM> of the navigation interface, representing how the operator may utilize the demo mode in relation to the manipulation mode. At screen <NUM>, the display <NUM> prompts the user to select between the demo mode and the manipulation mode. The demo mode may be selected by pressing a demo mode button <NUM> and the manipulation mode may be selected by pressing a manipulation mode button <NUM>. The system <NUM> includes switches or buttons implemented in any suitable hardware or software for allowing the operator to switch between the manipulation mode and demo mode. Here, the operator selects the demo mode by pressing the demo mode button <NUM>.

At screen <NUM>, the display prompts a demo mode selection screen in response to the operator pressing the demo mode button <NUM>. Here, the operator may select a "non-invasive" demo wherein the demonstrative tool <NUM> does not physically touch the exterior surface <NUM> during demonstration or a "minimally invasive" demo wherein the demonstrative tool <NUM> grazes, skims or etches the exterior surface <NUM> during demonstration. This type of demo is described in detail below. The "non-invasive" demo mode may be selected by pressing a "non-invasive" demo mode button <NUM> and the "minimally invasive" demo mode may be selected by pressing a "minimally invasive" mode button <NUM>.

At screen <NUM>, the display shows the demonstrative tool <NUM> in relation to the anatomy, as shown and described in <FIG>, for example. The system <NUM> tracks the anatomy and the demonstrative tool <NUM> in real-time and displays the positions of the anatomy and the demonstrative tool <NUM> relative to one another. Here, the system <NUM> creates a demo initiation region <NUM> for ensuring that the demonstrative tool <NUM> is in a suitable position before the demo mode activates. The location of the demo initiation region <NUM> may be selected based on any suitable factor, such as manipulation parameters <NUM> or demonstrative parameters <NUM>. The system <NUM> displays the demo initiation region <NUM> on the screen with a request for the operator to move the demonstrative tool <NUM> within the demo initiation region <NUM>. In <FIG>, the request is textual message stating, "place tool here. " The demo initiation region <NUM> is a virtual region defined with respect to the anatomy. The manipulator <NUM> may be instructed to stop moving once the system <NUM> determines that the demonstrative tool <NUM> enters the demo initiation region <NUM>. Alternatively, the demo initiation region <NUM> may be a virtual constraint region such that once the demonstrative tool <NUM> enters the demo initiation region <NUM>, the demo initiation region <NUM> locks the demonstrative tool <NUM> in place. Once the demonstrative tool <NUM> enters the demo initiation region <NUM>, the system <NUM> is ready to initiate the non-invasive demo mode. In some embodiments, the system <NUM> may provide a haptic, visual, or audible indicator that the system <NUM> is ready to initiate the non-invasive demo mode. For example, the system <NUM> may illuminate a green colored indictor when the once the demonstrative tool <NUM> enters the demo initiation region <NUM>.

At screen <NUM>, the display shows the demonstrative tool <NUM> providing the non-invasive demo according to the example of <FIG>, for example. Movement of the demonstrative tool <NUM> in the demo mode may be tracked with the navigation system <NUM>. The navigation system <NUM> tracks the demonstrative tool <NUM> and displays the virtual representation of the demonstrative tool <NUM> relative to the position of the anatomy. The manipulator controller <NUM> or navigation controller <NUM> may display an image of the femur F and/or tibia T and the demonstrative tool <NUM> on the display <NUM>.

The system <NUM> moves the demonstrative tool <NUM> in accordance with the non-invasive demonstrative parameters <NUM>. The system <NUM> may present the demo on the display before, after, or simultaneously during actual performance of the demonstration in the demo mode. The operator visually confirms that the intended planned autonomous manipulation of the anatomy, as demonstrated, is satisfactory. The operator may do so by examining the actual, in-person, relationship between the demonstrative tool <NUM> and the anatomy. Additionally or alternatively, the operator may examine the display <NUM> presenting the virtual relationship between the demonstrative tool <NUM> and the anatomy.

Through this process, the demo mode provides operators with a greater sense of control and confidence, thereby alleviating operator hesitancy in using autonomous manipulation in the manipulation mode.

The demo mode may be performed for a predetermined duration or until the operator manually stops the demo mode. Once the demo mode is completed, the demonstrative tool <NUM> returns to any appropriate position, such as the demo initiation region <NUM> or a position that is far from the anatomy. At this point, the system <NUM> may once again prompt the user to select between the demo mode and the manipulation mode at screen <NUM>. Of course, the operator, if desired, may choose to re-experience the demo mode by selecting the demo mode button <NUM> again. However, if the demo is satisfactory, the operator chooses the manipulation mode button <NUM> to initiate the manipulation mode. The operator switches from the demo mode to the manipulation mode to activate autonomous manipulation of the anatomy in accordance with the manipulation parameters <NUM>, as described herein. Manipulation in the manipulation mode is displayed in real-time at screen <NUM>.

The surgical system <NUM> may implement various other embodiments of the demonstrative tool <NUM> and demonstrative parameters <NUM> other than those described above.

In some embodiments, the demonstrative parameters <NUM> may be mathematically transformed from the manipulation parameters <NUM>. For example, the demonstrative boundary <NUM> may be derived from the cutting boundary <NUM>. The demonstrative boundary <NUM> may be shifted apart from the cutting boundary <NUM> and modified to correspond to the exterior surface <NUM> of the anatomy. The demonstrative boundary <NUM> may be formed based on preoperative images of the exterior surface <NUM> and/or the implant. For example, the demonstrative boundary <NUM> may be generated as a virtual map or other three-dimensional model.

Similarly, the demonstrative path <NUM> may be derived from the cutting path <NUM>. The demonstrative path <NUM> may be spaced apart from the cutting path <NUM> and transformed to conform to the exterior surface <NUM> of the anatomy and/or implant. The demonstrative boundary <NUM> and demonstrative path <NUM> may be two-dimensional or three-dimensional.

With autonomous movement, there generally is a trade-off between accuracy in movement of the end effector <NUM> and velocity (feed-rate) of the end effector <NUM>. It may be desirable for operators to quickly execute demonstration in the demo mode such that there is not undue delay in the surgical procedure. To avoid such delay, the demonstrative parameters <NUM> may be deliberately less accurate than the manipulation parameters <NUM>. For example, the demonstrative boundary <NUM> may be roughly based on the exterior surface <NUM>. The demonstrative boundary <NUM> need not be exactly shaped to the exterior surface <NUM> of the anatomy. For example, the demonstrative boundary <NUM> may be planar and spaced in relation to a highest point on the exterior surface <NUM> of the anatomy. The demonstrative boundary <NUM> need not have the same level of accuracy as the cutting boundary <NUM> because demonstration may be intended to serve as a check on the manipulation parameters <NUM>. Accuracy may also be diminished because the demonstrative boundary <NUM> is less invasive than the cutting boundary <NUM>.

Similarly, the demonstrative path <NUM> may be roughly based on cutting path <NUM>. For example, spacing between the back and forth lines in the cutting path <NUM> may be increased for the demonstrative path <NUM> such that less time is required for the demonstrative tool <NUM> to traverse the path <NUM>.

In one embodiment, as shown in <FIG> for example, the demonstrative parameters <NUM> may be minimally-invasive, rather than non-invasive. Here, the demonstrative tool <NUM> may physically manipulate the anatomy in the demo mode during demonstration. The demonstrative parameters <NUM> are defined such that the demonstrative tool <NUM> penetrates the exterior surface <NUM> of the anatomy during movement in the demo mode. The demonstrative tool <NUM> may graze, scratch, or etch the exterior surface <NUM> to represent planned cutting boundaries and/or cutting paths. In one embodiment, the demonstrative tool <NUM> is instructed to graze, scratch, or etch <NUM> or less of the exterior surface <NUM>. In another embodiment, the demonstrative tool <NUM> is instructed to graze, scratch, or etch <NUM> or less of the exterior surface <NUM>. In yet another embodiment, the demonstrative tool <NUM> is instructed to graze, scratch, or etch <NUM> or less of the exterior surface <NUM>. Placement of the demonstrative boundary <NUM> beneath the exterior surface <NUM> in <FIG> is exaggerated for simplicity in illustration.

Demonstrative manipulation provides permanent visualization of characteristics of the planned manipulation parameters <NUM>. This way, the operator may physically see a static outline or path representing characteristics of the manipulation parameters <NUM> after movement ceases in the demo mode. As compared with the manipulation mode, allowing some manipulation in the demo mode is not intended to promote removal of the volume <NUM> for purposes of reaching the target surface <NUM> of the anatomy, as intended in the manipulation mode.

<FIG> illustrates one implementation of the embodiment wherein the demonstrative parameters <NUM> are minimally-invasive. The demonstrative parameters <NUM> are defined such that the demonstrative tool <NUM> scratches the exterior surface <NUM> of the anatomy during movement in the demo mode. The demonstrative tool <NUM> physically touches the exterior surface <NUM>. The demonstrative boundary <NUM> remains significantly spaced apart from the cutting boundary <NUM>. However, the demonstrative boundary <NUM> is defined just below the exterior surface <NUM> such that the demonstrative boundary <NUM> is located between the cutting boundary <NUM> and the exterior surface <NUM>. By being just below the exterior surface <NUM>, the demonstrative boundary <NUM> allows minimal penetration of the exterior surface <NUM>. The demonstrative boundary <NUM> prevents the demonstrative tool <NUM> from reaching the target surface <NUM> and significant portions of the volume <NUM>. The demonstrative boundary <NUM> may be disposed beneath the exterior surface <NUM> by any minimally-invasive distance suitable for demonstration.

In some embodiments, the end effector <NUM> and the demonstrative tool <NUM> are distinct and separate tools. That is, the demonstrative tool <NUM> is utilized only for demonstration in the demo mode, and not for manipulation in the manipulation mode. Similarly, the end effector <NUM> is utilized only for manipulation in the manipulation mode, and not for demonstration in the demo mode. One example of the demonstrative tool <NUM> may be a stylus or probe for pointing at the anatomy. The demonstrative tool <NUM> may be supported directly or indirectly by the manipulator <NUM>. Alternatively, the demonstrative tool <NUM> may be supported and controlled independent of the manipulator <NUM>. When the end effector <NUM> and the demonstrative tool <NUM> are distinct and separate tools, details described herein regarding the system <NUM> interactions and control of the end effector <NUM> are equally applicable to the demonstrative tool <NUM>.

In such instances, the end effector <NUM> may be swapped out with the demonstrative tool <NUM> before demonstration is to occur in the demo mode. Thereafter, the demonstrative tool <NUM> may be swapped with the end effector <NUM> before manipulation is to occur in the manipulation mode. In embodiments where the demonstrative tool <NUM> is independently supported, the demonstrative tool <NUM> may not need to be swapped with the end effector <NUM> when switching between the manipulation mode and demo mode.

When the end effector <NUM> serves as the demonstrative tool <NUM>, it may be desirable to ensure that the manipulative capabilities of the end effector <NUM> are disabled throughout a portion, or the entirety, of the demo mode. For example, disabling the manipulative capabilities of the end effector <NUM> may include preventing a burr from rotating, and the like. Doing so prevents inadvertent manipulation of the anatomy during demonstration in the demo mode. When the demo mode is switched to the manipulation mode, the manipulative capabilities of the end effector <NUM> may be enabled to allow the end effector <NUM> to effectively manipulate the anatomy in the manipulation mode, as intended.

Demonstrating the invasive depth of the planned manipulation in the manipulation mode using the demonstrative tool <NUM> may be difficult since movement of the demonstrative tool <NUM> is non-invasive or minimally-invasive. As such, the navigation system <NUM> may supplement autonomous demonstration in the demo mode. The navigation system <NUM> may provide a heat map with respect to the virtual representation of the exterior surface <NUM> of the anatomy provided on the display <NUM>. The heat map may be based on the manipulation parameters <NUM> and may present different colors to fully capture the invasive depth of the manipulation parameters <NUM>. For example, darker colors may indicate deeper planned cutting boundaries <NUM> or paths <NUM> while lighter colors indicate shallower cutting boundaries <NUM> or paths <NUM>. Movement of the demonstrative tool <NUM> may be layered over the heat map to give the operator a full demonstrative effect.

In some embodiments, the demonstrative parameters <NUM> may be illuminated directly onto the exterior surface <NUM> in the demo mode during movement of the demonstrative tool <NUM>. This may be done to supplement demonstration. For example, the demonstrative boundary <NUM> or demonstrative path <NUM> may be illuminated on the exterior surface <NUM> of the anatomy using an illuminated point source or line. The point source or line may be static or moving (animated). For example, when animated, the point source or line may create a comet tail traversing the demonstrative boundary <NUM> or demonstrative path <NUM>. The system <NUM> may employ any suitable illumination device, such as a laser or projector, for illuminating the demonstrative parameters <NUM> directly onto the exterior surface <NUM> in the demo mode.

The system <NUM> may provide options for modifying settings relating to demonstration in the demo mode. This option may be set in the operator settings. Such settings may dictate when, where, and how to provide the demonstration. For example, the operator may set whether switching between the manipulation mode and the demo mode is performed manually or autonomously. The operator may also set whether the demonstration is to be performed by the end effector <NUM> or some other demonstrative tool <NUM>, such as a probe, stylus, etc. The operator may set the speed and/or accuracy of the demonstration. For example, the operator may set the speed of the demo to be faster than manipulation if the demo is non-invasive or slower than manipulation if the demo is minimally invasive. The operator may set whether to enable or disable the certain characteristics of the demonstration, such as the demonstrative boundary <NUM> or demonstrative path <NUM>. Moreover, the operator may disable demonstration altogether. Those skilled in the art appreciate that various other settings are possible in relation to modifying the demonstration that are not specifically recited herein.

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.

Claim 1:
A robotic surgical system (<NUM>) for manipulating an anatomy and demonstrating planned autonomous manipulation of the anatomy, said system comprising:
a manipulator (<NUM>) having a base (<NUM>);
an end effector (<NUM>) being configured to manipulate the anatomy, wherein the end effector (<NUM>) is coupled to the manipulator (<NUM>) and movable relative to the base (<NUM>) to interact with the anatomy;
a demonstrative tool (<NUM>) being configured to interact with the anatomy; and
a controller (<NUM>) configured to generate manipulation parameters (<NUM>) representing planned constraints on autonomous manipulation of a volume (<NUM>) of the anatomy by said end effector (<NUM>) in a first mode and generate minimally-invasive or non-invasive demonstrative parameters (<NUM>) relating to said manipulation parameters (<NUM>) and defined in relation to an exterior surface (<NUM>) of the anatomy such that said minimally-invasive or non-invasive demonstrative parameters (<NUM>) are less invasive to the anatomy than said manipulation parameters (<NUM>) and wherein said controller (<NUM>) is configured to instruct movement of said demonstrative tool (<NUM>) in accordance with said minimally-invasive or non-invasive demonstrative parameters (<NUM>) in a second mode thereby demonstrating planned constraints on autonomous manipulation of the anatomy in relation to the exterior surface (<NUM>) of the anatomy;
characterized in that said demonstrative parameters are less invasive to the anatomy than said manipulation parameters with respect to an amount of anatomy volume to be removed, which is located at a predetermined distance to the existing external anatomy surface.