Patent Description:
The spinal column is a highly complex system of bones and connective tissues that provide support for the body and protect the delicate spinal cord and nerves. The spinal column includes a series of vertebral bodies stacked atop one another, each vertebral body including an inner or central portion of relatively weak cancellous bone and an outer portion of relatively strong cortical bone. Situated between each vertebral body is an intervertebral disc that cushions and dampens compressive forces exerted upon the spinal column. A vertebral canal containing the spinal cord is located behind the vertebral bodies. The spine has a natural curvature (i.e., lordosis in the lumbar and cervical regions and kyphosis in the thoracic region) such that the endplates of the upper and lower vertebrae are inclined towards one another.

There are many types of spinal column disorders including scoliosis (abnormal lateral curvature of the spine), excess kyphosis (abnormal forward curvature of the spine), excess lordosis (abnormal backward curvature of the spine), spondylolisthesis (forward displacement of one vertebra over another), and other disorders caused by abnormalities, disease, or trauma (such as ruptured or slipped discs, degenerative disc disease, fractured vertebrae, and the like). Patients that suffer from such conditions often experience extreme and debilitating pain, as well as diminished nerve function. Posterior fixation for spinal fusions, decompression, deformity, and other reconstructions are performed to treat these patients. The aim of posterior fixation in lumbar, thoracic, and cervical procedures is to stabilize the spinal segments, correct multi-axis alignment, and aid in optimizing the long-term health of the spinal cord and nerves.

Spinal deformity is the result of structural change to the normal alignment of the spine and is usually due to at least one unstable motion segment. The definition and scope of spinal deformity, as well as treatment options, continues to evolve. Surgical objectives for spinal deformity correction include curvature correction, prevention of further deformity, improvement or preservation of neurological function, and the restoration of sagittal and coronal balance. Sagittal plane alignment and parameters in cases of adult spinal deformity (ASD) are becoming increasingly recognized as correlative to health related quality of life score (HRQOL). In the literature, there are significant correlations between HRQOL scores and radiographic parameters such as Sagittal Vertical Axis (SVA), Pelvic Tilt (PT) and mismatch between pelvic incidence and lumbar lordosis.

The SRS-Schwab classification of ASD was developed to assist surgeons with a way to categorize ASD, and provide methods of radiographic analysis. This classification system helps provide a protocol for pre-operative treatment planning and post-op assessment. The current environment to utilize this classification system requires surgeons to examine pre-operative patient films and measure pelvic incidence, lumbar lordosis, pelvic tilt, and sagittal vertical axis either manually or through the use of pre-operative software. After the procedure, the surgeon examines the post-operative films and measures the same parameters and how they changed as a result of the surgery. A need exists for systems and methods for assessing these and other spinal parameters intraoperatively and assessing changes to these intraoperative spinal parameters as a surgical procedure progresses towards a pre-operative plan.

During spinal surgeries, screws, hooks, and rods are devices used to stabilize the spine. Such procedures often require the instrumentation of many bony elements. The devices, for example rods, can be extremely challenging to design and implant into the patient. Spinal rods are usually formed of stainless steel, titanium, cobalt chrome, or other similarly hard metal, and as such are difficult to bend without some sort of leverage-based bender. Moreover, a spinal rod needs to be oriented in six degrees of freedom to compensate for the anatomical structure of a patient's spine as well as the attachment points (screws, hooks, etc.) for securing the rod to the vertebrae. Additionally, the physiological problem being treated as well as the physician's preferences will determine the exact configuration necessary. Accordingly, the size, length, and particular bends of the spinal rod depends on the size, number, and position of each vertebrae to be constrained, the spatial relationship amongst vertebrae, as well as the screws and hooks used to hold the rods attached to the vertebrae.

The bending of a spinal rod can be accomplished by a number of methods. The most widely used method is a three-point bender called a French Bender. The French bender is a pliers-like device that is manually operated to place one or more bends in a rod. The French bender requires both handles to operate and provides leverage based on the length of the handle. The use of the French bender requires a high degree of physician skill because the determination of the location, angle, and rotation of bends is often subjective and can be difficult to correlate to a patient's anatomy. Other methods of bending a rod to fit a screw and/or hook construct include the use of an in-situ rod bender and a keyhole bender. However, all of these methods can be subjective, iterative, and are often referred to as an "art. " As such, rod bending and reduction activities can be a time consuming and potentially frustrating step in the finalization of a complex and/or long spinal construct. Increased time in the operating room to achieve optimum bending can be costly to the patient and increase the chance of the morbidity. When rod bending is performed poorly, the rod can preload the construct and increase the chance of failure of the fixation system. The bending and re-bending involved can also promote metal fatigue and the creation of stress risers in the rod.

Efforts directed to computer-aided design or shaping of spinal rods have been largely unsuccessful due to the lack of bending devices as well as lack of understanding of all of the issues involved in bending surgical devices. Recently, in <CIT>, there is described a rod bending system which includes a spatial measurement sub-system with a digitizer to obtain the three dimensional location of surgical implants (screws, hooks, etc.), software to convert the implant locations to a series of bend instructions, and a mechanical rod bender used to execute the bend instructions such that the rod will be bent precisely to custom fit within each of the screws. This is advantageous because it provides quantifiable rod bending steps that are customized to each patient's anatomy enabling surgeons to create custom-fit rods on the first pass, thereby increasing the speed and efficiency of rod bending, particularly in complex cases. This, in turn, reduces the morbidity and cost associated with such procedures. However, a need still exists for improved rod bending systems that allow for curvature and deformity correction in fixation procedures, provide the user with more rod bending options, and accommodate more of the user's clinical preferences.

<CIT> describes a surgical navigation system which tracks the position of an array of reflective spheres and components attached to the array.

The present invention provides a system for intra operative planning and assessment of spinal deformity correction during a surgical spinal procedure, the system comprising a spatial tracking IR-reflective tracking array attached to a digitizer pointer used to digitize the surgical implant location, as set out in claim <NUM>.

Described below, for the purposes of background and context useful for understanding the invention, are a system and methods for rod bending that enable a use (e.g., surgeon) to customize rod bend instructions to suit the desired correction of a patient's spinal condition.

Described below is a spatial tracking system for obtaining the three-dimensional position information of surgical implants, a processing system with software to convert the implant locations to a series of bend instructions based on a desired correction, and a mechanical rod bender for bending a surgical linking device to achieve the desired spinal correction.

The spatial tracking system includes includes an infrared (IR) position sensor and at least one IR-reflective tracking array attached to at digitizer pointer used to digitize the surgical implant location. The spatial tracking system is communicatively linked to the processing system such that the processing system may utilize the spatial position information to generate bend instructions.

The processing system is programmed to generate bend instructions based on one or more surgeon-prescribed clinical objectives. For example, the processing system may be programmed to create a custom bend, adjust one or more points to which the rod will be bent to, suggest a pre-bent rod option, provide spinal correction in the sagittal plane, provide spinal correction in the coronal plane, and provide correction to achieve global spinal balance, and as well as perform a plurality of predetermined functions. The processing system may be further programmed to receive preoperative spinal parameters, input planned or target spinal parameters, and/or track intraoperative measurement of those parameters. The processing system is further configured to preview and display the results of these clinical objectives and/or predetermined functions to the user in a meaningful way.

One or more surgical procedures may be performed using the system.

Also described is a system for intraoperative planning and assessment of spinal deformity correction during a surgical spinal procedure, the system comprising: a spatial tracking system comprising an IR sensor and an IR tracking array, said IR tracking array being arranged along a proximal end of a surgical pointer tool capable of digitizing the location of an implanted surgical device and relaying to the spatial tracking system via the IR sensor; a control unit in communication with the spatial tracking system, said control unit being configured to: (a) receive the digitized location data of a plurality of implanted screws; (b) receive the digitized location data of at least one anatomical reference point; (c) generate at least one virtual anatomic reference line based on the digitized location data of said at least one anatomical reference point; (d) accept one or more spine correction inputs; and (e) generating at least one rod solution output shaped to engage the screws at locations distinct from the digitized location.

The spine correction input is a spine correction in the coronal plane. According to some implementations, the spine correction input comprises aligning all of the digitized screw locations relative to the CSVL in the coronal plane. According to some implementations, the system generates a rod solution output that includes T a vertically straight rod along at least a portion of the length.

According to some implementations, the virtual anatomic reference line is the central sacral vertical line (CSVL). According to some implementations, the at least one anatomical reference point comprises at least two points that correlate to the CSVL. According to other implementations, the at least one anatomical reference point comprises two points that lie along the CSVL. According to some implementations, the at least two points are the left iliac crest, the right iliac crest, and the midpoint of the sacrum. According to some implementations, the at least one anatomical reference point comprises a superior point and an inferior point on the sacrum.

The control unit is configured to generate at least one measurement value based on at least two anatomically-based reference lines. According to some implementations, this measurement value may be an offset distance between the two reference lines. According to some implementations, the two reference lines are the central sacral vertical line (CSVL) and the C7 plumb line (C7PL). According to yet other implementations, the control unit is further configured to assess intraoperative spinal balance based on a relationship between said CSVL and C7PL and communicate that assessment to a user. In some implementations, the r relationship may be based on the coronal offset distance between the CSVL and C7PL. In yet other implementations, the communication may be a color.

For example, the communication may be such that a first color designates an offset distance indicating a balanced spine within the coronal plane and a second color designates an offset distance indicating an unbalanced spine within the coronal plane.

The control unit is configured to generate at least one measurement value based on at least one anatomically-based reference point. According to one or more implementations, the measurement value comprises an intraoperative lumbar lordosis angle and a planned pelvic incidence angle. According to some implementations, the control unit is further configured to assess intraoperative spinal balance based on a relationship between an intraoperative lumbar lordosis angle measurement and a planned pelvic incidence angle. In some instances, the lumbar lordosis angle and pelvic incidence angle may be measured at least once during the operation progress. According to some implementations, the relationship between lumbar lordosis and pelvic incidence may be based on the variance between the intraoperative lumbar lordosis angle and the planned pelvic incidence angle. According to some implementions, the communication may be a color. For example, a first color may designate variance indicating a balanced spine within the sagittal plane and a second color designates a variance distance indicating an unbalanced spine within the sagittal plane.

Many advantages of the present invention will be apparent to those skilled in the art with a reading of this specification in conjunction with the attached drawings, wherein like reference numerals are applied to like elements and wherein:.

Illustrative embodiments of the invention are described below. Various systems and methods are also described as background and context useful for understanding the invention. In the interest of clarity, not all features of an actual implementation are described in this specification. It will of course be appreciated that in development of any such actual embodiment, numerous implantation-specific decisions must be made to achieve the developers' specific goals such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure.

With reference now to <FIG>, there is shown, by way of example, a surgical planning, assessment, and correction system <NUM> including a spatial tracking system <NUM> to obtain the location of one or more surgical implants <NUM>, a control unit <NUM> containing software to convert the implant locations to a series of bend instructions, and a bending device <NUM> to execute the bend instructions.

Preferably, the spatial tracking system <NUM> includes an IR position sensor <NUM>, a digitizer pointer <NUM>, as well as other components including Host USB converter <NUM>. The spatial tracking system <NUM> is in communication with control unit <NUM>. The control unit <NUM> has spatial relation software and C-arm video import capabilities and is communicatively linked to the display <NUM> so that information relevant to the surgical procedure may be conveyed to the user in a meaningful manner. By way of example, the relevant information includes, but is not limited to, spatial positioning data (e.g., translational data in the x, y, and z axes and orientation/rotational data Rx, Ry, and Rz) acquired by the IR position sensor <NUM> and intraoperative fluoroscopic images generated by the C-arm fluoroscope.

The system <NUM> comprises a neuromonitoring system communicatively linked to the spatial tracking system <NUM> and/or the C-arm via the control unit <NUM>. By way of example only, the neuromonitoring system may be the neuromonitoring system shown and described in <CIT>.

<FIG> depict the various components of one or more digitizer pointers <NUM>. <FIG> detail an example IR-reflective tracking array <NUM> component of the digitizer pointer <NUM>, according to the invention.

Array <NUM> includes a housing <NUM>, bilateral shutters <NUM>, and a plurality of IR-reflective spheres <NUM> arranged in a calculated manner at various locations on the array <NUM> such that their position information is selectively detectable by the IR position sensor <NUM>. Housing <NUM> comprises a top housing <NUM>, bottom housing <NUM>, and a distal threaded aperture <NUM> configured to threadably receive the threaded end <NUM> of a stylus (e.g., stylus <NUM>, <NUM>, <NUM>, and/or <NUM>). Top housing portion <NUM> is further comprised of upper portion <NUM>, underside <NUM>, and sides <NUM>. A plurality of sphere apertures <NUM> extend between upper portion <NUM> and underside <NUM> and are sized and dimensioned to receive reflective spheres <NUM> within recessed pockets <NUM>. Each side <NUM> includes cutout <NUM> sized and dimensioned to receive tongue <NUM>. Bottom housing <NUM> is comprised of a first face <NUM> and a second face <NUM>. The first face <NUM> includes nesting platforms <NUM> and bullet posts <NUM>. Each shutter <NUM> includes handle portion <NUM>, cover portion <NUM>, tongue <NUM>, interdigitating gear teeth <NUM>, and channel <NUM> for receiving bullet posts <NUM>. A spring <NUM> extends between the two shutters <NUM> and is held in place via spring posts <NUM>.

In an assembled state, each IR-reflective sphere <NUM> is nested on a platform <NUM>. Top housing <NUM> is placed over bottom housing <NUM> in a snap fit configuration such that each IR-reflective sphere <NUM> fits within a recessed pocket <NUM> within its respective sphere aperture <NUM>. According to one implementation, bilateral shutters <NUM> are positioned over the housing <NUM> with tongues <NUM> sliding into cutouts <NUM> such that each shutter cover <NUM> obscures exactly one half of the IR-reflective sphere <NUM> (for example, the middle IR-reflective sphere <NUM>) as depicted in <FIG>.

As depicted in <FIG>, the IR-reflective tracking array <NUM> mates with one or more surgical objects (for example styluses <NUM>, <NUM>, <NUM>, <NUM>). Each stylus <NUM>, <NUM>, <NUM>, <NUM> includes a threaded proximal end <NUM> for mating with the threaded distal aperture <NUM> of the IR-reflective tracking array <NUM>, elongate shaft <NUM>, and shaped distal tip <NUM>. Shaped distal tip <NUM> may be any shape that is complimentary to, and fits securely within, the shape of a particular screw head. For example, <FIG> shows styluses <NUM>, <NUM>, <NUM>, and <NUM> each with a different shaped distal tip designed to mate with different open screw systems, minimally-invasive screw systems, and closed tulip, iliac, and offset connector systems. The distal tip <NUM> is preferably inserted into each screw while orienting the digitizer pointer coaxial to that screw (or other fixation device).

According to some implementations (for example, the implementations shown with respect to styluses <NUM>, <NUM>, and <NUM>), the length of the elongate shaft <NUM> is fixed relative to the array <NUM> such that all digitized points are a consistent length from the geometry of the IR-reflective markers <NUM> and position information may be obtained from this relationship. According to other implementations (for example, the implementation shown with respect to offset pointer <NUM>), the length of the elongate shaft <NUM> is adjustable relative to the array <NUM> such as that shown with stylus <NUM>, effectively elongating the distance from the digitized point and the IR-reflective markers. This longer distance translates to digitization of a point above the actual screw head based on the distance the user adjusted the elongate shaft <NUM>. As will be appreciated in conjunction with the discussion below, the resulting bend instructions would shape a rod that traverses that point above the screw allowing the user to reduce the screw to the rod.

As shown in <FIG>, offset pointer <NUM> includes an elongate tubular member <NUM> and an inner piston <NUM>. Elongate tubular member <NUM> is comprised of a milled helical slot <NUM> and a plurality of offset depth slots <NUM> located around the helix that correspond to a plurality of offset distances as will be described below. Inner piston <NUM> includes shaft <NUM>, T-shaped cap <NUM>, springs <NUM>, and bushing <NUM>. The T-shaped cap <NUM> is positioned over the proximal end of the shaft <NUM> and is preferably welded to the proximal end <NUM> of the elongate tubular member <NUM>. Springs <NUM> are slideably positioned along the length of the shaft <NUM> between the distal end <NUM> of the T-shaped cap <NUM> and bushing <NUM>. Bushing <NUM> is positioned over the distal end of the shaft <NUM>. Pin <NUM> is travels through, and protrudes laterally from, slots <NUM>, <NUM> on the inner shaft <NUM> and bushing <NUM>, thereby securing the bushing <NUM> to the inner shaft <NUM>. The pin <NUM> is sized and dimensioned such that it travels through the helical slot <NUM> and be positioned within each of the offset depth slots <NUM>.

The offset pointer <NUM> gives the user the ability to execute planned screw movement by a specific, pre-determined amount. The user inserts the offset pointer <NUM> into the screw head. Keeping the distal tip <NUM> engaged to the screw head, the user then selects an offset amount to be added to the screw and angles the offset pointer <NUM> in the direction he or she wishes to apply the offset to. To adjust between offset depth slots <NUM>, the shaft <NUM> is pulled away from the array <NUM> and twisted until the pin <NUM> falls into the desired offset slot <NUM>. As the shaft <NUM> is pulled, it telescopes in and out of the elongate tubular member <NUM> such that the distance between the shaped distal end <NUM> and the array <NUM> is increased. For purposes of illustration, <FIG> shows the offset pointer <NUM> with the pin <NUM> in the <NUM> offset slot <NUM> corresponding to a <NUM> offset between the pointer <NUM> length and the IR-reflective array <NUM>. Offset options for sagittal correction may be provided, by way of example only from <NUM> to <NUM> offsets in <NUM> increments. The system <NUM> will then acquire position information at that point in space as opposed to where the screw sits, allowing for sagittal correction of one or more vertebral levels.

The digitizer pointer <NUM> may be used to acquire positional information about some or all screw locations. The shaped distal tip <NUM> may be coaxially aligned into the screw head and the array <NUM> is triggered to register the screw point. Screw locations may be digitized in a superior-inferior or inferior-superior direction. According to some implementations, the first screw location digitized correlates to the rod insertion direction component of the bend instructions (described below). Squeezing handles <NUM> activates the spring mechanism and permits the shutters <NUM> to open equally via the interdigitating gear teeth <NUM> (<FIG>). Opening the shutter covers <NUM> exposes the middle IR-reflective sphere <NUM> and allows the IR tracking array <NUM> to be "seen" by the IR position sensor <NUM> and the position of the digitizer pointer <NUM> to be digitized. In this way, the IR position sensor <NUM> only recognizes the digitizer pointer <NUM> once the middle sphere <NUM> is exposed which allows for point-by-point tracking and obviates the sensing and digitization of one or more unnecessary data points which may occur with prior art systems that continually track surgical objects. Further, use of the gear mechanism allows the passive IR-reflective sphere <NUM> to be "seen" symmetrically by the IR position sensor <NUM>, thereby enabling a more accurate calculation of position information by the system <NUM>. According to some implementations, the control unit <NUM> emits an audible sound to notify the user that the middle sphere <NUM> is recognized by the IR position sensor <NUM> and the screw point is acquired. Once a point has been registered, the shutter handles <NUM> may be released, thereby closing the bilateral shutters <NUM>. This process is then repeated for all screw locations to be digitized.

In accordance with the present invention, there are provided a plurality of algorithms for achieving rod bends. The surgical bending algorithms may be divided into two smaller sub-systems: (<NUM>) the spatial location algorithms that acquire, collect, and digitize points in space and (<NUM>) the bending algorithms that analyze the points and calculate the bend instructions and rod length needed to bend a rod with the mechanical bending device <NUM>.

As set forth above, the spatial tracking system <NUM> measures the six degrees of freedom (<NUM> DOF) information for the tracked IR-reflective spheres <NUM>. These data provide the full pose (position and orientation) of each screw of interest which may then be made available to the algorithm library to calculate the bend instructions. <FIG> is a flow chart indicating the steps of the spatial location data acquisition process according to one example. The system <NUM> initializes the sensor objects from configuration to connect to, control, and read data from the IR position sensor <NUM> (step <NUM>). The system <NUM> then inspects all devices connected to it and finds the device with a device ID that corresponds to the IR position sensor <NUM> (step <NUM>). At step <NUM>, if an IR position sensor <NUM> is found at step <NUM>, the system <NUM> continues to establish a connection with the IR position sensor <NUM> (step <NUM>). However, if not the system <NUM> continues to search. After the system <NUM> connects to the IR sensor <NUM>, it then loads a tool file that defines the array <NUM> (step <NUM>). After initialization and tool file loading, the IR sensor <NUM> must prepare for taking data. At step <NUM>, the IR sensor <NUM> is enabled and ready to generate positional data but is left idle until tracking is enabled. By way of example and as described with reference to <FIG>, selecting the position of the IR sensor <NUM> with respect to the patient's body causes the control unit <NUM> to send the IR sensor <NUM> a command to begin tracking. With tracking enabled (step <NUM>), the IR sensor <NUM> may be polled to for data (step <NUM>). Preferably, new data is requested twenty times per second from the IR sensor <NUM>. At step <NUM>, the data generated from polling the IR sensor <NUM> is checked to ensure that it is reporting valid data. The data may be considered valid if all of the IR-reflective spheres <NUM> are visible to the IR sensor <NUM>, the digitizer pointer <NUM> is fully inside the IR sensor's <NUM> working volume, there is no interference between the IR sensor <NUM> and the digitizer pointer <NUM>, and both the location and rotation information reported are not null. At step <NUM>, if the data is not deemed valid, then the digitized point is not used by the system <NUM> and polling is resumed. If the fifth IR-reflective sphere <NUM> (i.e. the middle sphere) is visible on the digitizer pointer <NUM> (step <NUM>), the process of collecting positional data for the bend algorithm commences. If the middle sphere <NUM> is not visible, then the data is available to the system <NUM> only to show proximity of the IR sensor <NUM> and IR-reflective tracking array <NUM> (step <NUM>). Points used by the bend algorithm are preferably an average of several raw elements (step <NUM>). Normally, five points are collected at this step before the points are processed and made available to the bend algorithm. The position data is averaged using a mean calculation. The directions are averaged in the quaternion representation (raw form) then converted to a unit direction vector. The data is rotated from the spatial tracking system <NUM> coordinate from into the system <NUM> coordinate frame using a rotation matrix. At step <NUM>, after all processing, the data is available for the bend algorithm to collect and process further as will be described in greater detail below.

The surgical bending software takes the location and direction data of the screw locations as described above and uses one or more geometry-based algorithms to convert these relative screw locations into a series of bend instructions. <FIG> is a flow chart indicating the steps of the surgical bending process according to a first example. At the input validation step <NUM>, the system <NUM> may validate the system inputs to ensure the rod overhang is greater than zero, validate the sensor setup to ensure that the IR sensor <NUM> location has been set, and validate each of the acquired points. By way of the example, the validation of each of the acquired points ensures, for example, that there are at least two screw points digitized, no two screw locations are too far apart, no two screw locations are too close together, and the span between the superior-most and inferior-most screw locations is not longer than the longest available rod.

At the transformation step <NUM>, the data may be centered and aligned such that the first data point acquired is set at the system <NUM> coordinate's origin and all data is aligned to the x-axis of the system's coordinates thereby reducing any potential misalignment of the IR sensor <NUM> relative to the patient's spine.

At the rod calculations step <NUM>, the system <NUM> may perform rod calculations for a straight rod solution, a pre-bent rod solution, and a custom-bend solution. For a straight rod solution, the system <NUM> first determines the length of a straight rod that will span all of the screw locations. This length may be calculated to accommodate each of the screw heads, hex and nose lengths of the rods chosen, and the user's selected rod overhang length. The system <NUM> then fits the data to a straight line, if the screw data is within tolerance of the straight line, then the bend instructions will return a straight rod, otherwise it will return no rod solution and proceed to look for a pre-bent rod solution. By way of example only, the tolerance may be <NUM> in each of the sagittal and coronal planes.

For a pre-bent rod solution, the system <NUM> first determines the length of the shortest pre-bent rod from the available rod from the available rods (as will be described in greater detail below) that will span all of the screw locations. This length may be calculated to accommodate each of the screw heads, hex and nose lengths of the rods chosen, and the user's selected rod overhang length. Next, the system <NUM> fits the digitized screw data to a circular arc in <NUM>-dimensional space. If the screw data is within the tolerance of the arc, then the bend instructions will return a pre-bent rod solution, otherwise it will return no rod solution and proceed to look for a custom-bend rod solution. By way of example, this tolerance may be <NUM> in each of the sagittal and coronal planes.

<FIG> depicts a flow chart of a custom bend algorithm according to one example. At step <NUM>, screw location and direction data is generated by the spatial tracking system <NUM> as set forth above. The data is then projected into two planes: the x-y plane (coronal view) and the x-z plane (sagittal view). Each projection is then handled as a 2D data set. At step <NUM>, a fixed size loop is generated over small incremental offsets for the first bend location for the end of the rod which optimizes the ability of the bend reduction step <NUM> to make smooth solutions. At step <NUM>, the system <NUM> creates a spline node at each screw location and makes a piecewise continuous <NUM>th order polynomial curve (cubic spline) through the screw points. At step <NUM>, the smooth, continuous spline is sampled at a regular interval (e.g., every <NUM>) along the curve to generate an initial set of proposed bend locations. At step <NUM>, as many bends as possible are removed from the initial set of proposed bend locations from step <NUM> as possible to reduce the number of bends the user must execute on a rod in order to fit it into a screw at each digitized screw point. According to one example, no bend is removed if eliminating it would: (<NUM>) cause the path of the bent rod to deviate more than a predefined tolerance limit; (<NUM>) cause any of the bend angles to exceed the maximum desired bend angle; and (<NUM>) cause the rod-to-screw intersection angle to exceed the maximum angulation of the screw head. Once the number of bends has been reduced, the 2D data sets are combined and handled as a 3D data set. The 3D line segments are then evaluated based on distance between each line segment interaction (Location), the angle between two line segments (Bend Angle), and the rotation (Rotation) needed to orient the bend into the next bend plane using the following calculations:.

These calculated numbers are then tabulated to the physical design of the rod bender <NUM> and the selected rod material and diameter. Bend angles account for the mechanical rod bender's <NUM> tolerance and will account for the rod's material and diameter based on previous calibration testing performed with mechanical rod bender <NUM> and the specific kind of rod. Calibration testing quantifies the amount of spring-back that is expected when bending a certain rod material and diameter. By way of illustration, a <NUM> diameter titanium rod's spring-back can be characterized by a <NUM>st order linear equation: <MAT> where BAT is the theoretical bend angle needed that was calculated from the 3D line segment and BAA is the actual bend angle needed to bend the rod to so it can spring back to the theoretical bend angle. Thus, using this equation, when <NUM> degrees of bend is calculated from the 3D line segment above, the "spring-back" equation for that rod will formulate that a <NUM> degree bend needs to be executed in order for it to spring-back to <NUM> degrees. The length of the final rod is the total of all the calculated distances plus the selected rod overhang.

Once all of the rod solutions have been generated, the loop is completed (step <NUM>). At step <NUM>, from all of the rod solutions generated in the loop above, the system <NUM> may output the rod solution having the smallest maximum bend angle (i.e., the smoothest bent rod). It is to be appreciated that the system <NUM> may choose the rod solution displayed based on any number of other criteria. At step <NUM>, the system <NUM> then generates the three-dimensional locations of the bends in space.

Referring back to the flow chart of <FIG>, from the geometric bend locations and/or pre-bent rod output of the rod calculations step <NUM> above, the system <NUM> generates instructions for the user to choose a straight rod, a pre-bent rod, or to custom bend a rod (step <NUM>). All of the output instructions are human-readable strings or characters. In all cases, the length of the required rod is calculated as described above and is displayed to the user as either a cut rod or standard rod. For custom bend solutions, rods are loaded into the bender with the "inserter end" (e.g., one pre-determined end of the rod) into the bender collet <NUM>. If, due to geometric constraints, the rod cannot be bent from the inserter end, then the instructions are flipped, and the cut (or nose) end of the rod is instructed to be put into the bender collet <NUM>. The bend instructions are generated from the geometric bend locations and are given as "Location", "Rotation", and "Bend" values as will be described in greater detail below. These values correspond to marks on the mechanical bender <NUM>.

<FIG> depict a flow chart of a second example of a custom bend algorithm. In accordance with this second example, the custom bend algorithm includes a virtual bender used to render a virtual rod. The following calculations and the flowcharts of <FIG> highlight the steps of this example.

The 3D vector si= [six, siy, siz]T denotes the i,th screw digitized by the user such that the set of N acquired screws that defines a rod construct may be denoted as <MAT> It may be assumed that the screws have been collected in order (e.g. superior-most screw to inferior-most screw or inferior-most screw to superior-most screw) so the index i can also be thought of as the index through time.

A virtual rod (R) of length Lr given in mm is broken down into Nr uniformly distributed points, R = [r0,. , r Nr-<NUM>]. Each rod point ri is composed of two components, a spatial component and a directional component <MAT>, where <MAT>. The segments between rod points is constant and defined by <MAT>.

A virtual bender (B) consists of a mandrel (M) of radius Mr (mm). Preferably, though not necessary, the key assumption when bending the virtual rod around M is the conservation of arc length. For illustrative purposes only, if a <NUM>° bend is introduced to an example rod R of length <NUM> around a mandrel with radius <NUM> to produce a rod R̂, then <MAT> The virtual rod, R, is bent according to a list of instructions. Each instruction consists of a location (Il), rotation (Ir), and bend angle (Iθ). The location is the position of the rod in the bender and corresponds to the point directly under the mandrel M. The rotation is given in degrees (<NUM>°- <NUM>°) and corresponds to the amount the rod is rotated from <NUM> in the collet. The bend angle is given by a single letter that corresponds to a specific angle in degrees. There is a corresponding notch on the bender with the same letter for the user to select.

The rod is initialized (step <NUM>) such that the spatial component <MAT>, and the direction component <MAT> which effectively orients the virtual rod to be at zero rotation in the virtual bender. For each bend instruction (step <NUM>), the system <NUM> rotates the virtual rod around the x-axis by Ir (step <NUM>). The system <NUM> finds the point <MAT> that matches Il. The virtual rod is translated by -r̂i. Next, each rod point from i to i + Mr * Iθ is projected onto the mandrel M while preserving segment length (step <NUM>-<NUM>). The virtual rod is then rotated around the x-axis by angle -Ir. Next, the system <NUM> checks that <MAT> to verify that the virtual rod in the collet has the correct direction vector (step <NUM>). At this point, R has approximated the geometry of the rod as it would be bent in the physical mechanical bender <NUM>.

The next step is to align the bent virtual rod to the acquired screw positions (step <NUM>). According to one example, the alignment process has two stages-first, the system <NUM> finds the optimum rotation coarse scale (step <NUM>). Second, the system performs the iterative closest point iteration algorithm fine scale.

Preferably, the system first initializes the result close to a global minimum (step <NUM>). In the rod alignment algorithm, this initialization follows the approach described below:
Using the arc length of the custom rod and the arc length of the screws, putative matches from the screws to the rod are produced. This produces two 3D point sets of equal size. Given two 3D mean centered point sets <MAT>, then in the least squares sense, it is desireable to minimize <MAT> Where T denotes the rotation matrix. Let <MAT> denote the optimum 3D rotation matrix, then <MAT> It turns out that <MAT>, where <MAT> and <MAT> (step <NUM>).

Due to error potentially introduced by differences in arc length, the proposed solution may not be the global minimum. Thus, the following are repeated until convergence (step <NUM>):.

Next the virtual rod is rendered at step <NUM>. The curve may be simplified for rendering purposes by traversing each triad of rod points and calculating the angle between the two vectors. If the first triad is {r<NUM>, r<NUM>, r2}, the two vectors are formed as v = r<NUM> - r<NUM> and w = r<NUM> - r<NUM>. If |v × w| = <NUM>, then the middle point of the triad (in this case r<NUM>) is redundant, provides no new information to the geometry of the rod and may be removed.

It will be appreciated that, in accordance with this rod bending algorithm, the virtual bender may be capable of bending a rod at any location of any angle perfectly to observe arc length. Using a virtually bent 3D rod to determine problem screws (i.e. screw locations with a high screw-rod fit error) may give an accurate fit between the actual screws and actual rod before the actual rod is bent. This may be particularly advantageous in certain surgical applications where it is desirable to quantify the amount of offset between a rod solution and the digitized screw locations as well as input one or more surgical parameters into the rod bending calculation.

There is described a third example of an algorithm for generating a custom bend which may be utilized in conjunction with the second example. The approach is directed to one or more algorithms that sample from probability distributions and employ random sampling to obtain a numerical result. A Markov chain is a sequence of random variables, X<NUM>, X<NUM>. , such that the current state, the future and past states are independent.

Given an ordered set of screws that define a construct <MAT> where si = [six, siy, siz]T denotes the ith 3D screw digitized by the user, the system <NUM> finds the set of bend instructions that define a rod that fits the screws in an optimum way defined by an error function. It is to be appreciated that the search of the bender space is quite complex as there are several constraints that must be observed for the algorithm to produce valid bend instructions (e.g., the bend locations cannot be in close proximity to the screws, the bend locations must be in multiples of <NUM> apart, the bend angles must be in multiples of <NUM>°, no bend angle can be greater than <NUM>°, etc.).

In accordance with the second example, the likelihood or error function may be constructed based on how well the virtual rod fits the data. Here, the rod is fit to the data in the least squares sense. In this way, a likelihood function is defined that incorporates, for example, a prior to prefer fewer bend instructions: <MAT> such that the log-likelihood function may be defined as <MAT> Where Nb denotes the number of bends in the rod, Ns denotes the number of screw locations, si is the i'th screw, ri is the i'th rod point, and α is the control hyper-parameter for the number of bends (e.g. α = <NUM>).

As can be seen from equation (<NUM>), there has been introduced a prior to control the number of bends introduced into the rod. This probabilistic approach to bend instruction generation allows for tailoring of constraints, for instance, a prior on the severity of the bends could also be introduced. Further, a prior could be introduced on how to define how close to the screws the bends may be located. This prior may have a "preferred" value, but probabilistically, there may be an optimal solution away from this idealized value. By way of example, some hypothesized rules that may be applied to this algorithm include, but are not limited to: birth move: add a bend to the current solution; death move; remove a bend from the current solution; update move: translate rod points along the rod. Use of this example may provide more potential rod solutions to the user.

Details of the system <NUM> are now discussed in conjunction with a first example of a method for obtaining a custom-fit rod. The system <NUM> is typically utilized at the end of a posterior or lateral fixation surgical procedure after screws, hooks or other instrumentation have been placed, but prior to rod insertion. As shown in the flowchart of <FIG>, the system <NUM> obtains position information of the implanted screw positions and outputs bend instructions for a rod shaped to custom-fit within those implanted screws. At step <NUM>, pertinent information is inputted into the system via a setup screen. At step <NUM>, the user designates the side for which a rod will be created (patient's left or right side). At step <NUM>, the system <NUM> digitizes the screw locations. At step <NUM>, the system <NUM> outputs bend instructions. At step <NUM>, the user bends the rod according to the bend instructions. Steps <NUM>-<NUM> may then be repeated for a rod on the contralateral side of the patient if desired.

<FIG> illustrates, by way of example only, one example of a screen display <NUM> of the control unit <NUM> capable of receiving input from a user in addition to communicating feedback information to the user. In this example (though it is not a necessity), a graphical user interface (GUI) is utilized to enter data directly from the screen display <NUM>. As depicted in <FIG>, the screen display <NUM> may contain a header bar <NUM>, a navigation column <NUM>, device column <NUM>, and a message bar <NUM>.

Header bar <NUM> may allow the user to view the date and time, alter settings, adjust the system volume, and obtain help information via date and time display <NUM>, settings menu <NUM>, volume menu <NUM>, and help menu <NUM> respectively. Selecting the settings drop-down menu <NUM> allows the user to navigate to system, history, and shutdown buttons (not shown). For example, choosing the system button displays the rod bending software version and rod bender configuration file; choosing the shutdown option shuts down the rod bending software application as well as any other software application residing on the control unit <NUM> (e.g. a neuromonitoring software application); and choosing the history option allows the user to navigate to historical bend points/instruction data in previous system sessions as will be described in greater detail below. Selecting the help menu <NUM> navigates the user to the system user manual. As will be described in greater detail below, navigation column <NUM> contains various buttons (e.g., buttons <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) for navigation through various steps in the rod bending process. Pressing button <NUM> expands/minimizes the details of the navigation column. Devices column <NUM> contains various buttons indicating the status of one or more devices associated with the system <NUM>. By way of example, devices column <NUM> may include buttons <NUM> and <NUM> for the digitizer <NUM> and IR sensor <NUM> components of the system <NUM>, respectively. Pressing button <NUM> expands/minimizes the details of the devices column. Furthermore, pop-up message bar <NUM> communicates instructions, alerts, and system errors to the user.

<FIG> depict an example setup screen. Upon selecting setup button <NUM> on the display screen <NUM>, the system <NUM> automatically initiates the setup procedure. The system <NUM> is configured to detect the connection status of each of its required components. By way of example only, icons <NUM>, <NUM> indicate the connectivity and activity status of the digitizer <NUM> and IR sensor <NUM>, respectively. If one or more required components are not connected or are connected improperly, the display <NUM> may alert the user to address the issue before proceeding via textual, audio, and/or visual means (e.g., textual messages, audible tones, colored icons or screens, blinking icons or screens, etc.). The digitizer icon <NUM> is a status indicator for the active acquisition and/or recognition of the digitizer and the presence and background color of the icon <NUM> may change to indicate the digitizer tracking status. By way of example, the icon <NUM> may be absent when the system <NUM> is not acquiring screws and does not recognize the digitizer, gray when the system <NUM> is not acquiring screws and recognizes the digitizer, green when the system <NUM> is in screw acquisition mode and recognizes the digitizer, and red when the system <NUM> is in screw acquisition mode and does not recognize the digitizer. Pressing button <NUM> expands/minimizes the details of the device column <NUM>. Depending on the type of surgery, type of patient deformity, etc., it may be advantageous for the user to choose a digitizer from a selection of different digitizers. According to one example, pressing icon <NUM> expands a pull-out window for the different stylus options available with the system <NUM> (e.g., styluses <NUM>, <NUM>, <NUM>, <NUM> as described above). According to another example, the IR sensor graphic icon <NUM> is a status indicator for the IR sensor <NUM>. The presence and background color of the icon <NUM> may change to indicate the status of the IR sensor <NUM>. By way of example, the icon <NUM> may be absent when the system <NUM> does not recognize the IR sensor <NUM>, gray when the system <NUM> recognizes the IR sensor <NUM> is connected to the system <NUM>, and red when the system <NUM> senses a communication or bump error for the IR sensor <NUM>. Preferably, the IR sensor <NUM> should be recognized if it is connected after initialization of the bending application.

With all of the required components properly connected to the system <NUM>, the user may then input one or more pieces of case-specific information from one or more drop-down menus. By way of example, drop-down menus for rod system <NUM>, rod material/diameter <NUM>, rod overhang <NUM>, procedure type (not shown), and anatomical spinal levels of the surgical procedure) may be accessed from the setup selection panel <NUM> of the screen display <NUM>. The rod system drop-down menu <NUM> allows the user to choose the rod system he/she plans to use. This selection drives choices for the rod material/diameter <NUM> drop-down menus. By way of example, under the rod system drop-down menu <NUM>, the system <NUM> may be programmed with numerous fixation options from one or more manufacturers. Alternatively, it may be programmed with the fixation system selections for one manufacturer only (e.g. NuVasive® Precept®, Armada®, and SpherX® EXT). The user may also choose the combination of rod material (e.g. titanium, cobalt chrome, etc.) and rod diameter (e.g. <NUM> diameter, <NUM> diameter, <NUM> diameter, etc.). The drop-down menu <NUM> for material and diameter options may preferably be dependent upon the choice of rod system. Because the geometry and sizes can vary between manufacturers and/or rod systems, programming the system <NUM> with these specific inputs can aid in outputting even more accurate bend instructions. The user may also choose the amount of overhang from the rod overhang pull-down menu <NUM>. By way of example, the amount of overhang may be selectable in <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> lengths. According to one example, this function prescribes a symmetric overhang on both the superior and inferior ends of the rod. According to another example, this function also prescribes different overhang lengths on either end of the rod based on user preference and patient anatomical considerations. Although not shown, the system <NUM> also contains functionality for accommodating multiple rod diameters and transitional rods as used, for example in Occipital-Cervical-Thoracic (OCT) fusion procedures.

After the setup inputs have been inputted into the setup selection panel <NUM>, the system <NUM> aids the user in setting up the IR sensor <NUM> in an optimal position for positional data acquisition. It is to be appreciated that any visual (textual, graphic) indicator may be used to indicate the IR sensor placement instructions. According to some implementations, an active graphic directs the user to position the IR sensor <NUM> relative to the digitizer array <NUM> held static within the patient's body. As shown in <FIG>, the user first selects the side of the patient the IR sensor <NUM> is located on by selecting the left side sensor position button <NUM> or right side sensor position button <NUM> in the IR sensor setup panel <NUM>. Choosing the left or right side sensor position button <NUM>, <NUM> activates a the IR sensor positioning panel <NUM> such that sensor graphic <NUM> and a tracking volume box graphic <NUM> appear on the display screen <NUM>. Tracking volume box <NUM> that moves with the sensor graphic <NUM> as the IR sensor <NUM> is moved. Next, the user positions the digitizer array <NUM> into the body of the patient. Once recognized by the system <NUM>, a target volume box <NUM> (which may be displayed as white in color) is positioned over the patient graphic <NUM>. Next, the user moves the IR sensor <NUM> relative to the digitizer array <NUM> until the tracking volume box <NUM> matches up to the position of the target volume box <NUM>. According to some implementations, the sensor graphic <NUM> increases in size if it is moved superior to the target tracking volume and decreases in size if it is moved inferior to the target volume. According to some other implementations, the tracking volume box <NUM> may be color-coded to depict the relative distance to the target volume. By way of example, the tracking volume box <NUM> may be depicted in red if the distance to the target volume is outside of a certain distance in one or more axes (e.g., outside ± <NUM> in all <NUM> axes. ) and green if within or equal to ± <NUM> in all <NUM> axes. Once the optimal position of the IR sensor <NUM> has been ascertained, the setup process is complete.

Once the user has completed all of the required steps in the setup screen, a graphic (e.g., a check) may appear on setup button <NUM> to indicate such a completion and the system <NUM> proceeds to step <NUM> in the flowchart of <FIG>. Using the GUI, the user designates which side of the patient's spine to acquire digitized positional information from by selecting either the Left "L" toggle/status button <NUM> or Right "R" toggle/status button <NUM>. The user then selects the Acquire.

Screws button <NUM> which navigates the display screen <NUM> to an Acquire Screws (left or right) screen shown by way of example in <FIG>. In Acquire Screws mode, the display screen <NUM> includes a sagittal view panel <NUM> and a coronal view panel <NUM> with spine graphics <NUM>, <NUM> in each of the sagittal and coronal views, respectively. Spine graphic <NUM> may flip orientation depending on which side of the spine the user is digitizing (left or right). Additionally, spine graphic <NUM> may highlight the side of the patient the user is digitizing (left or right). The user may digitize the location of each implanted screw using, by way of example, the digitizer pointer <NUM> as described above. As each screw point <NUM> is digitized, its relative location with respect to the other acquired screw points <NUM> can be viewed in both sagittal and coronal views via the sagittal view panel <NUM> and the coronal view panel <NUM> as shown in <FIG>. Optionally, the last screw point digitized may have a different graphic <NUM> than the previously-acquired screw points <NUM> (by way of example, the last screw point acquired <NUM> may be a halo and the previously-acquired screw points <NUM> may be circles). The screws locations may be digitized from a superior-to-inferior or inferior-to-superior direction and according to some examples, the system <NUM> can detect which direction the digitization is occurring in after the acquisition of two consecutive screw point locations. If during the digitization process, the user wishes to delete a digitized screw point, he/she may do so by pressing the "Clear Point" button <NUM>. If the user wishes to delete all digitized screw points, he/she may do so by pressing the "Clear All Points" button <NUM>.

Once the digitized screw points <NUM> are deemed acceptable, the user may press the "Calculate Rod" button <NUM> which initiates the curve calculation preferably using one of the algorithms discussed above. Once a rod solution has been calculated, a rod graphic <NUM> populates through the screw points <NUM>, <NUM> and a confirmation graphic (e.g., a check) may appear on the "Acquire Screws" button <NUM> to indicate that the system <NUM> has generated a rod solution. Simultaneously, the "Calculate Rod" button <NUM> becomes the "Undo Rod" button <NUM>. If the user presses the "Undo Rod" button <NUM>, the rod solution <NUM> is cleared and the user may acquire more screw points or clear one or more screw points. After the "Undo Rod" button <NUM> is pressed, it then changes back to the "Calculate Rod" button <NUM>. Optionally, the system <NUM> may include a visual graphic for where along a rod the curve calculation is generating a severe bend (acute angle). The user may select "Undo Rod" button <NUM>, perform one or more surgical maneuvers (e.g. reduce the screw, backup the screw, adjust the screw head, etc.), redigitize the screw point, and generate a more feasible solution. If the rod solution is acceptable to the user, the Screw Acquisition step <NUM> is complete and the system <NUM> proceeds the Bend Instructions step <NUM> in the flowchart of <FIG>. Alternatively, although not shown the system <NUM> may display the offending point resulting in the severe bend angle in red and offer the next-best solution that includes a bend angle falling within a pre-determined range of angles for that bender. If the rod solution is acceptable to the user, the Screw Acquisition step <NUM> is complete and the system <NUM> proceeds the Bend Instructions step <NUM> in the flowchart of <FIG>.

The user then selects the "Bend Instructions" button <NUM> which navigates the display screen <NUM> to a Bend Instructions (left or right) screen shown by way of example in <FIG>. The bend instructions within the bend instructions panel <NUM> allows the user to view the bend instructions corresponding to the resulting rod solution in the Acquire Screws screen (<FIG>). By way of example, the bend instructions panel <NUM> contains three fields containing various aspects of the bending instruction: upper message field <NUM>, bender instructions field <NUM>, and lower message field <NUM>. By way of example, the upper message field <NUM> may communicate the rod cut length, rod type, and/or rod loading instructions to the user (e.g. "Cut Rod: <NUM> Load Inserter End Into Bender"). The bender instructions field <NUM> displays rows <NUM> of bend maneuvers in location <NUM>, rotation <NUM>, and bend angle <NUM> to perform on the mechanical bender <NUM> as will be described in greater detail below. In the example shown in <FIG>, there are five rows indicating five bend instructions. The lower message field <NUM> may communicate the direction of insertion or orientation of implanting the rod to the user. For example, the lower message field <NUM> shown in <FIG> provides the following sample instruction: "Insert Rod head to foot. " In some implementations, the rod insertion direction into the patient is dependent on the sequence of screw digitization (superior-to-inferior or inferior-to superior). Preferably, the bend instruction algorithm takes into account the orientation of the inferior, superior, anterior, and posterior aspects of the rod and ensures that these aspects are known to the user. As the instructions for use direct the user to load the rod into the bender, the system <NUM> manages which bends are imparted on the rod first based on the severity of the bend angles. The section of the bend instructions with greater bend angles may be performed first then the straighter bend sections of the bend instructions may be performed last. Further, the instructions may also direct the user to align a laser line or orientation line on the rod to an alignment arrow (not shown) on the mechanical rod bender <NUM>. This alignment controls the Anterior / Posterior orientation of the rod geometry and generates bend instructions accordingly. The user follows the bend instructions generated by the system <NUM> for location (location may be color-coded on the bender <NUM> and on the screen <NUM> as green triangle), rotation (rotation may be color-coded on the bender <NUM> and on the screen <NUM> as red circle), and bend angle (bend angle may be color-coded on the bender <NUM> and on the screen <NUM> as blue square), sequentially, starting at the first bend instruction and working sequentially until the final bend is completed. From here, the user may repeat steps <NUM>-<NUM> on the rod construct for the contralateral side of the patient's spine.

Within a surgical procedure, a user may wish to toggle between left and right screens to view left and right digitized screw points, rod previews, and bend instructions for reference or comparison. Selecting the Left "L" toggle/status button <NUM> and right "R" toggle/status button <NUM> allows the user to do so. According to one more implementations, the GUI may additionally include a History feature. Selecting the History button (not shown) will allow the user to refer back to any previous rod bending solution. The user navigates to the Bend Instructions screen <NUM> based on choice of the L/R toggle buttons <NUM>, <NUM> and pressing Bend Instruction button <NUM>. If navigating to previous bend instructions, the Bend Instructions screen will display previous bend instructions. Once the user has selected the desired rod solution, the user then executes the bends using the mechanical bender <NUM>.

The examples described with respect to <FIG> and <FIG> above contemplate digitizing the implanted screw positions and outputting bend instructions for a rod shaped to custom-fit within those implanted screws. In one or more additional examples, the system <NUM> obtains position information of the implanted screws (steps <NUM> and <NUM>), accepts correction inputs via one or more advanced options features (step <NUM>), and generates for viewing bend instructions for a rod shaped to fit at locations apart from those implanted screw positions (step <NUM>) as depicted in the flowchart of <FIG>. Installing a rod shaped in this manner could correct a curvature or deformity in the patient's spine according to a user's prescribed surgical plan. Details of the system <NUM> are discussed now discussed with examples for obtaining a rod bent according to one or more surgical plans.

As depicted in <FIG>, selecting the "Advanced Options" button <NUM> expands an Advanced Options menu <NUM> from which the user may perform one or more corrections to the digitized screw points and the system <NUM> generates bend instructions that will achieve those desired corrections on the patient's spine once the rod is implanted and the screws are brought to the rod.

In some surgical procedures, a user may wish that the rod bend solution will consider a point that is not a digitized screw point in determining the bend instructions. According to some implementations, this point is an adjusted distance from the digitized screw point location. Selecting the "Adjust Points" button <NUM> from the Advanced Options menu <NUM> navigates the user to an Adjust Points screen as depicted in <FIG>. Selecting a digitized screw location of interest (for example the screw point represented as dot <NUM> in <FIG>) highlights the screw point and brings up an adjust points control <NUM> in each of the sagittal and coronal views <NUM>, <NUM>. The user adjusts point <NUM> to its desired location in the sagittal and coronal planes using arrows <NUM>, <NUM>, <NUM>, and <NUM>. In some implementations, as the point moves, dot <NUM> changes color based on the distance from the originally digitized screw location as shown in <FIG>. Preferably, that color corresponds to color-coded offset distance indicator <NUM> which provides visual feedback to the user as to the distance the point has been adjusted. As depicted by way of example, dot <NUM> appears yellow in <FIG> indicating that the point has moved <NUM> in each of the sagittal and coronal planes. In some implementations, the system <NUM> may have a maximum distance from the digitized point past which it will not allow the manipulated point to exceed (by way of example only, this distance may be <NUM>). In other implementations, this distance may be depicted as a distance (for example, the numeral <NUM> in <FIG>, indicating that a screw point is <NUM> from its original location). The user may adjust as many points as desired in this fashion. The user may reset all adjusted points to their original configurations via "Reset" button <NUM> or may undo the last adjusted point via the "Undo Last" button <NUM>. Once satisfied with the adjusted points, the user may either proceed to one or more additional advanced options as set forth below or select "Calculate Rod" <NUM>. Once "Calculate Rod" <NUM> has been selected, the system <NUM> generates a rod in which the curve traverses the adjusted points, as in <FIG>, thereby creating a correction-specific rod and providing the user with the ability to correct the curvature or deformity in the spine according to his or her prescribed curve.

According to other implementations, a user may wish for a smoother rod bend. When the "Virtual Point" button <NUM> (shown by way of example in <FIG>) is selected, the system <NUM> allows the user to add an additional point anywhere in between the superior-most and inferior-most digitized screw locations. While there is no screw at this location, this point is taken into consideration during the curve calculation and may coerce the curve into a more natural shape yielding a smoother rod bend. Once satisfied with the virtual points, the user may either proceed to one or more additional advanced options as set forth below or select "Calculate Rod" <NUM> and as described above, the system <NUM> generates a correction-specific rod solution <NUM> that the user may use to correct the spine to the shape of the rod.

It may be advantageous for some patient anatomies for a user to use a pre-bent rod. Use of a pre-bent rod eliminates the need for making additional bends to a rod while assuring that a desirable rod curve is achieved. After all screw points have been digitized in the Acquire Screws step <NUM>, selecting the "View Pre-Bent Rod" button <NUM> from the Advanced Options menu <NUM> navigates the user to a "View Pre-Bent Rod" screen as depicted in <FIG>. Based on the digitized screw locations shown in <FIG>, the system <NUM> calculates and outputs the best pre-bent rod geometry based on the selected manufacturer's rod system that was chosen during the setup step <NUM> (e.g. NuVasive® Precept®) and displays the best fit virtual pre-bent rod solution <NUM> available on top of the digitized screw points for viewing in the sagittal and coronal views <NUM>, <NUM> (see <FIG>). Preferably, the system <NUM> only generates a pre-bent rod solution if the geometry of the pre-bent rod fits the digitized screw points within a predetermined curve fitting tolerance (e.g. <NUM>). As depicted in <FIG>, a color-coded offset distance indicator <NUM> may provide the user with an indication of the distance each screw position will be from the pre-bent rod construct. If the user is satisfied with the pre-bent rod suggestion, the system <NUM> proceeds to the Bend Instructions step <NUM> which displays the corresponding pre-bent rod specifications in the Bend Instructions Screen (<FIG>). The upper message field <NUM> instructs the user that, based on the digitized screw points, an <NUM> pre-bent rod is recommended. From here, the user may decide whether the patient's anatomical and surgical requirements would be better suited with a pre-bent option or a custom-bent option. Armed with the information from <FIG>, the user may then adjust the screw positions to fit the pre-bent rod if needed (e.g., adjust the screw head, adjust the screw depth, etc.).

In some instances, a user may want to align or correct the patient's spine in the sagittal plane (i.e., add or subtract lordosis or kyphosis). The system <NUM> includes a sagittal correction feature in which the user is able to measure the amount of lordosis in the spine and adjust angles in the sagittal plane. The system <NUM> then incorporates these inputs into the bend algorithm such that the rod solution includes the desired alignment or correction.

Selecting the "View Vectors" button <NUM> from the Advanced Options menu <NUM> initiates the sagittal correction feature. The user may select at least two points of interest and the system then determines the appropriate vector in the sagittal view. According to the example shown in <FIG> and <FIG>, the angles are measured and adjusted based on the screw trajectory screw axis position) using the digitized screw data acquired in the Acquire Screws step <NUM>. As shown in <FIG>, the user selects at least two screw points of interest (e.g., screw points <NUM> and <NUM>). The system <NUM> then measures the angle between the screw trajectories (shown here as <NUM> degrees). In some implementations, the system <NUM> may measure the total amount of lumbar lordosis by measuring the lumbar lordosis angle <NUM> in the superior lumbar spine (shown in <FIG> as <NUM> degrees) and the lumbar lordosis angle <NUM> in the inferior lumbar spine (show in <FIG> as <NUM> degrees). Using the angle adjustment buttons <NUM>, <NUM> on the Angle Adjustment Menu <NUM>, the user may increase or decrease the desired angle correction of the spine in the sagittal plane (i.e., add or subtract lordosis or kyphosis superiorly or inferiorly). As the angle is adjusted, the angular position <NUM> between the two screw points <NUM>, <NUM> is changed as well. <FIG> illustrates an example in which the angular position <NUM> between points <NUM> and <NUM> is increased to <NUM> degrees). The system <NUM> may include a color-coded offset distance indicator <NUM> to provide the user with an indication of the distance each digitized screw position will be adjusted in the sagittal plane as described above. Once the desired amount of angular correction is achieved, the user may select the "Set" button <NUM>, and then the "Calculate Rod" button <NUM>. The system <NUM> then displays a rod solution <NUM> incorporating the user's clinical objective for correction of the spine in the sagittal plane as depicted in <FIG>.

According to the example of the sagittal correction feature shown in <FIG>, the superior and inferior lumbar lordosis angles <NUM>, <NUM> are measured, displayed, and adjusted referencing anatomy from an imported lateral radiographic image. By way of example, lateral radiographic image <NUM> may be inputted into the system <NUM>. The user may touch the screen <NUM> and move lines <NUM> over at least two points of interest (e.g. the superior endplate of V1 and the inferior endplate of V3) and the system <NUM> then then measures the angle between the two lines <NUM>. The Using the angle adjustment buttons <NUM>, <NUM> on the Superior Angle Adjustment Menu <NUM> or Inferior Angle Adjustment Menu <NUM>, the user may increase or decrease the desired angle correction of the spine in the sagittal plane (i.e., add or subtract lordosis or kyphosis superiorly or inferiorly). As either the superior or inferior lumbar lordosis angle is adjusted, the amount of adjustment is dynamically altered in its respective angle measurement box (i.e., either superior lumbar lordosis angle box <NUM> or inferior lumbar lordosis angle box <NUM>). As depicted in <FIG>, the user adjusts angle lines <NUM> as part of the inferior lumbar lordosis angle. The system <NUM> measures this angle as <NUM> degrees as depicted in angle measurement field <NUM>. The user then uses button <NUM> in superior angle adjustment menu <NUM> to increase the angle. This change is depicted in inferior lumbar lordosis angle box <NUM>. Once the desired amount of correction is achieved, in this example, it is achieved at <NUM> degrees. The user may then press the capture angle button <NUM> and this parameter may be correlated to the digitized screw positions corresponding to the vertebral levels that those angles were measured off of. The system <NUM> may include a color-coded offset distance indicator <NUM> to provide the user with an indication of the distance each digitized screw position will be adjusted in the sagittal plane as described above. Once the desired amount of angular correction is achieved, the user may select the "Set" button <NUM>, and then the "Calculate Rod" button <NUM>. The system <NUM> then displays a rod solution <NUM> incorporating the user's clinical objective for correction of the spine in the sagittal plane as depicted in <FIG>.

It is to be appreciated that, because patient position (e.g., pelvic tilt) may have an effect on the lumbar lordosis measurements, the sagittal correction feature of the system will be able to account for any patient positioning-related deviations. It will also be appreciated that in addition to lordotic corrections, the sagittal angle assessment tool may be useful for other types of surgical maneuvers, including but not limited to pedicle subtraction osteotomy (PSO) procedures and anterior column reconstruction (ACR) procedures.

In some instances, a user may want to align or correct the patient's spine in the coronal plane (i.e., correct scoliosis). The system <NUM> includes one or more coronal correction features in which the user is able to view the patient's spine (and deformity) in the coronal plane via anterior-posterior x-rays; measure one or more anatomic reference angles; and/or persuade one or more screw locations towards a particular coronal alignment profile by manually or automatically biasing which direction the rod bend curve is adjusted. The system <NUM> may then incorporates these inputs into the bend algorithm such that the rod solution includes the desired alignment or correction.

Selecting the "Coronal Correction" button <NUM> from the Advanced Options menu <NUM> initiates the coronal correction feature. The user may wish to ascertain the degree of coronal deformity by referencing spinal anatomy, measuring the coronal Cobb angles between two anatomical references in the coronal plane, and adjusting those angles intraoperatively as part of the surgical plan to bring the spine into (or closer to) vertical alignment.

According to the example shown in <FIG>, the coronal Cobb angles may be ascertained using anterior-posterior radiographic images. Anterior-posterior radiographic image <NUM> may be inputted into the system <NUM>. According to one implementation, the coronal Cobb angle may be determined by drawing lines parallel with the endplates of the most tilted vertebrae above and below the apex of the curve and measuring the angle between them. The user may touch the screen <NUM> and move lines <NUM> over at least two points of interest (e.g. the superior endplate of T11 and the inferior endplate of L3) and the system <NUM> then measures the angle between the two lines <NUM>. Using the angle adjustment buttons <NUM>, <NUM> on the Superior Vertebra Angle adjustment menu <NUM> and/or the Inferior Vertebra Angle adjustment menu <NUM>, the' user may increase or decrease the desired angle correction of the spine in the coronal plane (i.e., add or subtract correction to make the endplates of the superior and inferior vertebrae selected more parallel with one another). As either the superior or inferior component of the coronal angle is adjusted, the coronal Cobb angle measurement may be dynamically altered in the coronal Cobb angle measurement box <NUM>. By way of example, in <FIG>, the starting coronal Cobb angle is <NUM> degrees. The user uses buttons <NUM>, <NUM> to reduce the angle lines <NUM> between T11 and L3. Once the desired amount of correction is achieved (shown, by way of example, in <FIG> as a coronal Cobb Angle of <NUM> degrees), the user may then press the capture angle button <NUM>. This parameter may be correlated to the digitized screw positions corresponding to the vertebral levels that those angles were measured off of. The system <NUM> may include a color-coded offset distance indicator <NUM> to provide the user with an indication of the distance each digitized screw position will be adjusted in the coronal plane as described above (not shown here). Once the desired amount of angular correction is achieved, the user may select the "Set" button <NUM>, and then the "Calculate Rod" button <NUM>. The system <NUM> then displays a rod solution <NUM> incorporating the user's clinical objective for correction of the spine in the coronal plane.

According to the example shown in <FIG>, the coronal Cobb angle may be displayed and adjusted referencing anatomy from digitized locations of screws placed in the left and right pedicles of the vertebrae of interest. The system links left and right digitized screw locations for each respective vertebrae (line <NUM>) and measures the angle between the two lines <NUM> (shown here in <FIG> as <NUM> degrees). According to one implementation, the coronal Cobb angle may be determined by selecting the screw location of the most tilted vertebrae above and below the apex of the curve. Using the angle adjustment buttons on the Angle Adjustment menu <NUM>, the user may increase or decrease the desired angle correction of the spine in the coronal plane (i.e. add or subtract correction to make the endplates of the superior and inferior vertebrae selected by the user more parallel with one another). As the coronal angle is adjusted, the Cobb angle measurement may be dynamically altered as set forth above. Here, however, instead of coronal Cobb angle measurement box <NUM>, the Cobb angle may displayed alongside the radiographic image (shown in <FIG> with a starting coronal Cobb angle of <NUM> degrees). The user uses the buttons in menu <NUM> to reduce the angle lines <NUM> between T11 and L3. Once the desired amount of correction is achieved (shown, by way of example, in <FIG> as <NUM> degrees, the user may then press the "Set" button <NUM> and this parameter may be correlated to the digitized screw positions corresponding to the vertebral levels that those angles were measured off of. The system <NUM> may include a color-coded offset distance indicator <NUM> to provide the user with an indication of the distance each digitized screw position will be adjusted in the coronal plane as described above (not shown here). Once the desired amount of angular correction is achieved, the user may select the "Calculate Rod" button <NUM>. The system <NUM> then displays a rod solution <NUM> incorporating the user's clinical objective for correction of the spine in the coronal plane.

According to one or more other implementations of the coronal correction feature, the user may select at least two points of interest and the system then generates a best fit reference line through all points including and lying between the at least two points of interest. In some instances, the ideal correction of the spine in the coronal plane is a straight vertical line extending between the superior-most and inferior-most screw locations of interest. However, depending on a patient's individual anatomy, achieving a straight vertical line may not be feasible. The user may wish to achieve a certain amount of correction relative to the ideal correction. From the display screen, the user may select a percentage of relative correction between the screw points as digitized (<NUM>% correction) and the best fit reference line (<NUM>%). Furthermore, the system then calculates a rod solution and shows an off-center indicator <NUM> to provide a user with an indication of the distance each screw is from the coronally-adjusted rod construct as set forth above.

According to the example shown in <FIG>, the user may straighten all points within the construct (global coronal correction). From the display screen <NUM>, the superior and inferior screw points <NUM>, <NUM> are selected and the system <NUM> generates a best fit global reference line <NUM> through all points <NUM>, <NUM>, <NUM>. Using the Coronal Correction Menu <NUM>, the user manipulates the + and - buttons <NUM>, <NUM> to adjust the percentage of correction desired. In the example shown in <FIG>, the amount of desired correction is shown as <NUM>% on the percentage correction indicator <NUM>, meaning the rod solution <NUM> will be a straight line in the coronal plane and all screw locations will be adjusted to fit the rod/line. As depicted in <FIG>, the system <NUM> may include a color-coded offset distance indicator <NUM> to provide the user with an indication of the distance each digitized screw position will be adjusted in the coronal plane as set forth above. If the user deems this an acceptable rod solution, the user selects the "Calculate Rod" button <NUM> to view the rod solution <NUM> (<FIG>) and receive bend instructions or proceeds to another advanced feature as will be described in greater detail below.

According to the example shown in <FIG>, the user may straighten a subset of the screw points within the construct (segmental coronal correction). Based on the sequence those points are inputted into the system, a best-fit segmental reference line is generated through the points in the direction of the last chosen point. If an inferior point <NUM> is selected first and then a superior point <NUM> is selected second, the system <NUM> will draw the best-fit segmental reference line <NUM> superiorly as shown in <FIG>. Conversely, if a superior point <NUM> is selected first and then an inferior point <NUM> is selected second, the system <NUM> will draw the best-fit segmental reference line <NUM> inferiorly. Using the Coronal Correction Menu <NUM>, the user manipulates the + and - buttons <NUM>, <NUM> to adjust the percentage of correction desired. In the example shown in <FIG>, the amount of desired correction is shown as <NUM>% on the percentage correction indicator <NUM>, meaning the rod solution <NUM> will be a straight line in the coronal plane and all selected screw locations will be adjusted to fit the rod/line. As shown in <FIG>, however, unselected screw locations <NUM> will not be adjusted to fit the rod/line and their relative locations will be inputted into the system <NUM> and taken into consideration when the rod calculation is made. As depicted in <FIG>, the system <NUM> may include a color-coded offset distance indicator <NUM> to provide the user with an indication of the distance each digitized screw position will be adjusted in the coronal plane as set forth above. If the user deems this an acceptable rod solution, the user selects the "Calculate Rod" button <NUM> to view the rod solution <NUM> (<FIG>) and receive bend instructions or proceeds to another advanced feature as will be described in greater detail below.

According to another example, segmental coronal correction may be achieved relative to the patient's central sacral vertical line (CSVL) instead of a best-fit segmental reference line running through two selected digitized screw locations. The CSVL is the vertical line passing through the center of the sacrum that may serves as the vertical reference line for the patient's coronal deformity as well as a guide for spinal correction in the coronal plane in accordance with the coronal assessment and correction features of the present disclosure.

<FIG> illustrate a method for using the CSVL line for assessing coronal deformity and achieving coronal correction according to one example. Preferably, this method commences after all screws are implanted into the patient and digitized in the manner set forth above. The user generates one or more radiographic images of the sacrum, localizes a superior and inferior point on the sacrum, and marks those points (e.g., implants Caspar pins, marks the patient's skin with a marker, etc.). Next, the user selects the "Alignment" button <NUM> (<FIG>). Upon such a selection, the user is prompted to digitize the marked skin points representing the superior and inferior sacral landmarks. As shown by way of example in <FIG>, box <NUM> may pop up to instruct the user of the various steps of the workflow. Here, the superior point on the sacrum has already been digitized (shown as digitized point <NUM>) and check mark <NUM>. Box <NUM> further instructs the user to "Acquire Point at Inferior End. " Selecting "Clear Coronal Alignment Line" <NUM> to re-digitize the sacral points and/or exit out of the CSVL coronal correction feature. Once the superior and inferior sacral points are digitized, a dashed line <NUM> representing the patient's true CSVL line appears on the screen (<FIG>) and the digitized screw locations <NUM> are reoriented in system <NUM> relative to the CSVL line <NUM>. The display <NUM> in the coronal view now represents the patient's current coronal curve relative to a vertical reference (CSVL). From here, the user may select two points (i.e., the screw segment) he/she would like to correct or straighten relative to the CSVL. As shown in <FIG>, by way of example, the user selects points <NUM> and <NUM>. According to one implementation, the first point chosen <NUM> is the point of rotation of the segment and the origin of the straightening line <NUM>. The second point <NUM> determines the direction of the straightening line <NUM>. The straightening line <NUM> may be drawn parallel to the CSVL line <NUM> as the objective of coronal correction is to make the spine as vertical as possible in the coronal plane. If the user deems this an acceptable rod solution, the user selects the "Calculate Rod" button <NUM> to view the rod solution <NUM> (<FIG>) and receive bend instructions. The user now has a rod solution he/she can pull the screws to, knowing that it is straight relative to the CSVL line and therefore providing the desired correction of the coronal deformity. The user will and receive bend instructions or proceeds to another advanced feature as will be described in greater detail below.

In some spinal procedures (e.g., anterior column deformity correction procedures), restoring a patient's spine to a balanced position may be a desired surgical outcome. The system <NUM> may include a Global Spinal Balance feature in which the control unit <NUM> is configured to receive and assess <NUM>) preoperative spinal parameter measurements; <NUM>) target spinal parameter inputs; <NUM>) intraoperative spinal parameter inputs; and <NUM>) postoperative spinal parameter inputs. One or more of these inputs may be tracked and/or compared against other inputs to assess how the surgical correction is progressing toward a surgical plan, assess how close the patient's spine is to achieving global spinal balance, and utilized to develop/refine an operative plan to achieve the desired surgical correction.

Spinal parameters may comprise the patient's Pelvic Incidence (PI), Pelvic Tilt (PT), Sacral Slope (SS), Lumbar Lordosis (LL), Superior Lumbar Lordosis (↑LL), Inferior Lumbar Lordosis (↓LL), C7 Plumb Line offset (C7PL), and Thoracic Kyphosis (TK), T1 tilt, and Sagittal Vertical Axis (SVA) measurements. The target spinal parameter measurements may be a clinical guideline (by way of example only, the SRS-Schwab classification, or a patient-specific goal based on that patient's anatomy). Depending on user preference, these spinal parameters may comprise Pelvic Incidence (PI), Pelvic Tilt (PT), Sacral Slope (SS), Lumbar Lordosis (LL), Superior Lumbar Lordosis (↑ LL), Inferior Lumbar Lordosis (↓LL), C7 Plumb Line offset (C7PL), and Thoracic Kyphosis (TK), T1 tilt, and Sagittal Vertical Axis (SVA) measurements.

<FIG> depicts a flowchart indicating the steps of the Global Spinal Balance feature according to one example. At step <NUM>, the system <NUM> inputs a patient's preoperative spinal parameter measurements. Next, the system generates theoretical target spinal parameter measurements (step <NUM>). One or more target spinal parameter measurements may be optionally adjusted the user in accordance with a surgical plan a step <NUM>. At step <NUM>, a target spinal rod may be scaled to match the patient's anatomy using the theoretical or adjusted target spinal parameter measurements from step <NUM> or <NUM>. This scaled target rod may then be displayed <NUM> to the user. Optionally, the system <NUM> may generate one or more measurements (step <NUM>) during the surgical procedure. At step <NUM>, the target spinal parameter data may then be adjusted based on the intraoperative measurements from step <NUM>. Finally, the system <NUM> may generate bend instructions for balanced spine correction.

The user may input a patient's preoperative measurements into the system <NUM> as depicted, by way of example in <FIG>. Selecting the Pre-Op measurement button <NUM> allows the user to input measurements into PI, LL, Superior LL, Inferior LL, C7PL, and TK input fields <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> respectively. Such pre-operative measurements may be obtained from manual measurement means imported from any number of commercially-available desktop and mobile software applications. These pre-operative anatomical measurements may be used to understand the imbalance in the patient's deformed spine as well as help determine an operative plan to implant devices that would adjust or form the spine to a more natural balance (e.g., rods, screws, a hyperlordotic intervertebral implant, etc.).

As depicted in <FIG>, the global spinal balance feature allows the user to adjust the patient's anatomical measurement values to the user's preferred target spinal parameters for a balanced and/or aligned spine. According to one implementation, selecting the target measurement button <NUM> populates measurements into input fields <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> that represent an ideal or properly balanced spine. If the user accepts these target spinal parameters, the system <NUM> would output a theoretical rod solution comprising rod shapes and curves representing an ideal or properly balanced spine scaled and overlaid onto the digitized screw points as shown in <FIG>. The system <NUM> may also include a color-coded offset distance indicator <NUM> to provide the user with an indication of the distance each digitized screw position is from the rod solution in the sagittal and coronal planes as set forth above. Alternatively, if the user seeks to achieve a different alignment, he or she may use buttons <NUM>, <NUM>, <NUM> to adjust these target spinal parameters. The user could then refer to the correction indicator <NUM> for an indication of how much correction (relative to the pre-operative and theoretical spinal parameters) would be achieved based on those adjusted input correction values. The user's input correction values would then drive the rod bending algorithm (based on the digitized screw locations) to a rod shape customized to the user's plan for that particular placement. The final rod could be positioned within the patient and the screws and spine would be adjusted to the rod at the desired alignment.

In accordance with the Global Spinal Balance feature, spinal parameter inputs may be assessed intraoperatively. For example, the user may wish to intraoperatively measure the amount of lumbar lordosis that has been achieved (for example, after placement of an intervertebral implant). As depicted in <FIG>, the system <NUM> may include be configured to obtain or import one or more lateral images, generate one or more lines between two or more landmarks on the patient's anatomy, determine a relationship between those landmarks, and adjust one or more spinal parameters to be used in generating the rod solution. As shown by way of example in <FIG>, the user first selects the intraoperative measurement button <NUM>. Next, lateral radiographic image <NUM> may be inputted into the system <NUM>. The user may touch the screen <NUM> and move lines <NUM> over at least two points of interest (e.g. the superior endplate of.

V1 and the superior endplate of V2) and the system <NUM> then measures the angle between the two lines <NUM>. As shown in <FIG>, the system <NUM> measures this angle as <NUM> degrees as indicated in the angle measurement field <NUM>. Optionally, the system may compare the intraoperative measurement to the preoperative and/or target spinal parameter value and provide an indication to the user of how much correction has been achieved relative to the pre-operative and theoretical spinal parameters. Using the angle measurement buttons <NUM>, <NUM>, the user may increase the desired angle of correction of the spine in the sagittal plane (i.e., add or subtract lordosis or kyphosis). As the angle is adjusted, the amount of adjustment may dynamically displayed within angle measurement field <NUM>. The system <NUM> may include a color-coded offset distance indicator (not shown) to provide the user with an indication of the distance each digitized screw position will be adjusted in the sagittal plane as described above. Once the desired amount of angular correction is updated, the user may press the "Set" button <NUM> and then the "Calculate Rod" button (not shown in this view). The system then displays a rod solution <NUM> incorporating the user's intraoperative objective for correction of the spine in the sagittal plane.

The user may also wish to intraoperatively measure the patient's pelvic incidence angle. As shown in <FIG>, selecting the intra-op measurement button <NUM> optionally brings up a PI assessment tool. The system <NUM> obtains a fluoroscopic image <NUM> of the patient's pelvis. The user first selects the femoral head button <NUM> and uses arrows <NUM> on the PI Adjustment Menu <NUM> to locate the center point of the femoral head <NUM>. Next, the user selects the posterior sacrum button <NUM> and uses arrows <NUM> to identify the posterior aspect of the sacral endplate <NUM>. Then, the user selects the anterior sacrum button <NUM> and uses arrows <NUM> to identify the anterior aspect of the sacral end plate <NUM>. With all PI inputs selected, the user may press the "Draw PI" button <NUM> after which the system <NUM> automatically draws and measures the pelvic incidence angle <NUM> for the user.

The illustrative example above included the use of target spinal parameter inputs to determine a target rod shape to restore or improve spinal balance. However, it is to be appreciated that not all examples require such a determination. <FIG> depicts a flowchart indicating the steps of an intraoperative Global Spinal Balance assessment feature according to one example. At step <NUM>, the system <NUM> inputs a patient's preoperative spinal parameter measurements. Next, the system generates theoretical target spinal parameter measurements (step <NUM>). One or more target spinal parameter measurements may be optionally adjusted the user in accordance with a surgical plan at step <NUM>. At step <NUM>, the system may measure one or more spinal parameter measurements intraoperatively and provide one or more indications to the user how the surgical procedure is progressing. At step <NUM>, the system may measure one or more spinal parameter measurements postoperatively to assess the final status of the deformity correction and balance achieved.

As depicted in <FIG>, the global spinal balance feature allows the user to adjust the patient's anatomical measurement values to the user's preferred target spinal parameters for a balanced and/or aligned spine. According to one implementation, selecting the target measurement button <NUM> populates measurements into input fields <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> that represent an ideal or properly balanced spine. Alternatively, if the user seeks to achieve a different alignment, he or she may use buttons <NUM>, <NUM>, <NUM> to adjust these target spinal parameters. In accordance with the Global Spinal Balance feature, spinal parameter inputs may be assessed intraoperatively. For example, the user may wish to intraoperatively measure the amount of lumbar lordosis that has been achieved (for example, after placement of an intervertebral implant). As depicted in <FIG>, the system <NUM> may include be configured to obtain or import one or more lateral images, generate one or more lines between two or more landmarks on the patient's anatomy, determine a relationship between those landmarks, and adjust one or more spinal parameters to be used in generating the rod solution. As shown by way of example in <FIG>, the user first selects the intraoperative measurement button <NUM>. Next, lateral radiographic image <NUM> may be inputted into the system <NUM>. The user may touch the screen <NUM> and move lines <NUM> over at least two points of interest (e.g. the superior endplate of V1 and the superior endplate of V2) and the system <NUM> then measures the angle between the two lines <NUM>. As shown in <FIG>, the system <NUM> measures this angle as <NUM> degrees as indicated in the angle measurement field <NUM>. Optionally, the system may compare the intraoperative measurement to the preoperative and/or target spinal parameter value and provide an indication to the user of how much correction has been achieved relative to the pre-operative and theoretical target spinal parameters. Using the angle measurement buttons <NUM>, <NUM>, the user may increase the desired angle of correction of the spine in the sagittal plane (i.e., add or subtract lordosis or kyphosis). As the angle is adjusted, the amount of adjustment may dynamically displayed within angle measurement field <NUM>.

According to one or more implementations, the user is provided with a visual indication as to how the surgical procedure is proceeding relative to the targeted plan. By way of example, as once the intraoperative lumbar lordosis measurement is within <NUM> degrees of the planned pelvic incidence value, then both buttons will be represented on the screen <NUM> as green. Once the intraoperative lumbar lordosis measurement is greater than <NUM> but less than <NUM> degrees of the planned pelvic incidence value, then both buttons will be represented on the screen <NUM> as yellow. Once the intraoperative lumbar lordosis measurement is equal or greater than <NUM> degrees, then both buttons will be represented on the screen <NUM> as red.

In some circumstances, the user may want to assess the amount/severity of coronal plane deformity and/or intraoperatively ascertain the amount of correction achieved with a given rod bend configuration. The system may include a Coronal Offset Assessment feature configured to obtain or import one or more Anterior-Posterior images, acquire digital position information regarding landmarks on the patient's anatomy, generate one or more lines between those landmarks, and determine a relationship between those landmarks.

According to some implementations, the system <NUM> first obtains a fluoroscopic image <NUM> of the iliac sacral region (<FIG>). The user digitizes two points <NUM> and selects the Iliac Line: Set button <NUM> to establish a horizontal iliac line <NUM>. Next, the user digitizes the midpoint <NUM> of the sacrum and selects the CSVL Line: Set button <NUM> and the system <NUM> automatically generates an orthogonal line (CSVL line <NUM>) from the sacral midpoint <NUM> to the iliac line <NUM>. The system <NUM> then obtains a fluoroscopic image <NUM> of the C7 vertebra as depicted in <FIG>. The user digitizes the midpoint <NUM> of the C7 vertebra and selects the "C7PL: Set" button <NUM> and the system <NUM> automatically generates an orthogonal line (C7PL line <NUM>) from the midpoint <NUM> of C7 to the iliac line <NUM>. Finally, the system <NUM> calculates the coronal offset distance (in box <NUM>) using the offset distance between the CSVL line <NUM> and the C7PL line <NUM> line. As such, the user is given an intraoperative assessment of the amount of coronal offset corrected or left to be corrected which affords the opportunity to decide if a surgical planning goal has been achieved or if one or more spinal parameter inputs need to be updated with respect to coronal alignment.

As set forth above, the system <NUM> provides the user with the functionality to select two points on the spine and generate a best-fit reference line between those two points to which to generate a rod solution and correct the spine to. In some instances, it may be desirable to intraoperatively represent the spine's true deformity in the coronal plane and to correct the spine relative to a pelvic anatomical reference. As such, there is provided a virtual orthogonal reference line through which the user may intraoperatively assess a deformed spine against and/or correct coronal a spinal deformity to.

For purposes of illustration, assume that a user has digitized the screw points <NUM> as shown in <FIG> and contemplates performing segmental coronal correction (as set forth above) with straightening line <NUM> as the best-fit reference line. The user may select the "Virtual T-Square" button <NUM> to activate the Virtual T-Square feature. <FIG> describe the Virtual T-Square feature in greater detail. First, the user localizes three points of reference on the patient's anatomy via c-arm fluoroscopy and marks the location of those anatomical references (e.g., implants Caspar pins, marks the patient's skin with a marker, etc.). By way of example, the anatomical points of reference may be the left iliac crest, right iliac crest, and sacral midpoint. The user may be prompted (via text box, audible alert, and the like) to digitize each of the previously-identified anatomical reference points in a manner previously described herein. As the system <NUM> registers the digitized location of the marks designating the left and right points on the iliac crest, points <NUM>, <NUM> appear on the screen <NUM>, respectively and a horizontal line <NUM> representing the iliac line is drawn between the left and right iliac crest points <NUM>, <NUM>. This is shown, by way of example only as a dashed line <NUM> in <FIG>. Next, the system <NUM> registers the digitized location of the sacral midpoint, point <NUM> appears on screen <NUM>, and dashed line <NUM> representing the CSVL is drawn superiorly and orthogonal to the iliac line <NUM>. The system <NUM> may use one or more algorithms to detect that, when the Virtual T-Square feature is activated, the next three acquired digitized points will correspond to the three anatomical reference points of interests. With the CSVL line <NUM> established the digitized screw locations <NUM> may be reoriented in system <NUM> relative to the CSVL line <NUM>, the user may select two points (i.e., the screw segment) he/she would like to correct or straighten relative to the CSVL as set forth above. The user may also generate a rod solution, receive bend instructions, and output a rod to pull the screws to, knowing that it is straight relative to the CSVL line as explained in detail above. Selecting "Reset" button <NUM> clears the lines <NUM>, <NUM> and all adjustments in the Coronal View and returns the adjusted spheres to their original digitized locations. If the user toggles off the Virtual T-square button <NUM>, the reference lines <NUM> are cleared and the orientation of the points converts back the best fit <NUM> within the Coronal View window.

In some instances, in addition to intraoperatively assessing and/or correcting the spine's true coronal deformity, it may be further desirable to intraoperatively assess coronal spinal balance. Coronal spinal balance is determined by measuring the offset between the CSVL and a C7. The Virtual T-square feature may be included with a C7 Plumb Line Measurement feature. After the user has acquired the CSVL line via the Virtual T-square feature <NUM>, the "C7 Plumb Line" button <NUM> is enabled. <FIG> describes the C7 Plumb Line feature in greater detail. First, the user localizes the center of the C7 vertebra via c-arm fluoroscopy and superficially marks the location of this anatomical reference on the patient's skin (e.g., with an "X"). The user may be prompted (via text box, audible alert, and the like) to digitize each of the C7 vertebra points in a manner previously described herein. As the system <NUM> registers the digitized location of the marks designating the C7 vertebra, point <NUM> appears on the screen <NUM> and a vertical line <NUM> representing the C7 Plumb Line is drawn parallel to the CSVL and orthogonal to the iliac line <NUM>. This is shown, by way of example only as a dashed line <NUM> in <FIG>. The system <NUM> may use one or more algorithms to detect that, when the C7 Plumb Line feature is activated, the next acquired digitized points will correspond to the C7 anatomical landmark. Finally, the system <NUM> calculates the coronal offset distance using the offset distance between the CSVL line <NUM> and the C7PL line <NUM>. By way of example, a double arrow line is drawn between the two vertical lines to represent the degree of coronal offset, and hence the spinal balance or imbalance in the coronal plane (shown in <FIG> as <NUM>). A color-coded coronal offset distance indicator may provide the user with an indication of the degree of coronal offset. By way of example, an offset of <NUM>-<NUM> could be indicated with a green double arrow line; an offset of <NUM>-<NUM> could be indicated with a yellow double arrow line; and an offset of greater than <NUM> could be indicated with a red double arrow line. As such, the user is given an intraoperative assessment of the amount of coronal offset corrected or left to be corrected which affords the opportunity to decide if a surgical planning goal has been achieved or if one or more spinal parameter inputs need to be updated with respect to coronal alignment.

From one or many of the features discussed above, once the user has selected the desired rod solution, the user then executes the bends using a mechanical rod bender <NUM>. It is contemplated that the mechanical rod bender <NUM> may be any bender that takes into account six degrees of freedom information as it effects bends onto a spinal rod. By way of example, according to one implementation, the mechanical rod bender <NUM> may be the bender described in commonly-owned <CIT>. According to a second implementation, the mechanical rod bender <NUM> may be the bender shown in <FIG>. First and second levers <NUM>, <NUM> are shown as is lever handle <NUM> designed for grabbing the lever <NUM> manually and a base <NUM> for holding lever <NUM> in a static position. Second lever <NUM> has a rod pass through <NUM> so that an infinitely long rod can be used as well as steady the rod during the bending process with the rod bending device <NUM>. The user grabs handle <NUM> and opens it to bend a particular rod by picking an angle on the angle gauge <NUM> and closing the handle <NUM> such that levers <NUM>, <NUM> are brought closer together. The mechanical rod bender <NUM> in other examples could be produced to bend the rod during the handle opening movement as well. The rod moves through mandrel <NUM> and in between moving die <NUM> and fixed die <NUM>. The rod is bent between the two dies <NUM>, <NUM>. Gauges on the bender <NUM> allow the user to manipulate the rod in order to determine bend position, bend angle, and bend rotation. The rod is held in place by collet <NUM>. By sliding slide block <NUM> along base <NUM>, the rod can be moved proximally and distally within the mechanical rod bender <NUM>. Position may be measured by click stops <NUM> at regular intervals along base <NUM>. Each click stop <NUM> is a measured distance along the base <NUM> and thus moving a specific number of click stops <NUM> gives one a precise location for the location of a rod bend.

The bend angle is measured by using angle gauge <NUM>. Angle gauge <NUM> has ratchet teeth <NUM> spaced at regular intervals. Each ratchet stop represents five degrees of bend angle with the particular bend angle gauge <NUM> as the handle <NUM> is opened and closed. It is to be appreciated that each ratchet step may represent any suitable degree increment (e.g., between. <NUM> degrees to <NUM> degrees). The bend rotation is controlled by collet knob <NUM>. By rotating collet knob <NUM> either clockwise or counterclockwise, the user can set a particular rotation angle. The collet knob <NUM> is marked with regular interval notches <NUM> but this particular example is continuously turnable and thus has infinite settings. Once a user turns knob <NUM>, the user can set the knob <NUM> at a particular marking or in between or the like to determine a particular angle rotation to a high degree of accuracy. Additionally, base <NUM> may have a ruler <NUM> along its length to aid the user in measuring a rod intraoperatively.

According to another implementation, the rod bender <NUM> may be a pneumatic or motor-driven device which automatically adjusts the location, rotation and bend angle of the rod. By way of example, three motors may be utilized for each movement. A linear translator motor would move the rod in and out of the mandrel <NUM> and moving die <NUM>. One rotational motor would rotate the rod and moving die <NUM>. The bend calculations could be converted into an interface program that would run to power and control the motors. The automated bender would lessen the possibility of user error in following the manual bend instructions. It would also increase the resolution or number of bends that can be imparted in the rod making for a smoother looking rod.

Claim 1:
A system for intraoperative planning and assessment of spinal deformity correction during a surgical spinal procedure, the system comprising:
a spatial tracking IR-reflective tracking array attached to a digitizer pointer used to digitize the surgical implant location, wherein the tracking array (<NUM>) includes:
a housing (<NUM>);
a plurality of IR-reflective spheres (<NUM>);
characterized in that the tracking array (<NUM>) further comprises first and second shutters (<NUM>);
wherein each shutter (<NUM>) includes a cover portion (<NUM>); and the shutters (<NUM>) are positioned over the housing (<NUM>) such that each shutter cover (<NUM>) obscures exactly one half of the IR-reflective sphere (<NUM>).