Patent ID: 12193751

DETAILED DESCRIPTION

This disclosure is directed to improved surgical planning systems and methods for planning orthopaedic procedures, including pre-operatively, intra-operatively, and/or post-operatively to create, edit, execute, and/or review surgical plans. The surgical planning systems and methods may be utilized for planning and implementing orthopaedic procedures to restore functionality to a joint. These and other features of this disclosure are discussed in greater detail in the following paragraphs of this detailed description.

FIG.1illustrates an exemplary surgical planning system10(hereinafter referred to as “the system10”). The system10may be used for planning orthopaedic procedures, including pre-operatively, intra-operatively, and/or post-operatively to create, edit, review, refine, and/or execute surgical plans. The system10may be utilized for various orthopaedic and other surgical procedures, such as an arthroplasty to repair a joint, for example.

Shoulder arthroplasty may be periodically referenced throughout this disclosure to illustrate or emphasize certain features of the system10. However, the teachings of this disclosure are not intended to be limited to any particular joint of the human musculoskeletal system and should therefore be understood as being applicable to the shoulder, knee, hip, ankle, wrist, etc. Moreover, the teachings of this disclosure are not intended to be limited to arthroplasty procedures and are therefore applicable to the repair of fractures and/or other deformities within the scope of this disclosure.

The system10may include, among other things, at least one host computer12, one or more client computers14, one or more imaging devices16, a cloud-based storage system18, and a network20. The system10may include a greater or fewer number of subsystems within the scope of this disclosure.

The host computer12may be configured to execute one or more software programs. In some implementations, the host computer12may be more than one computer jointly configured to process software instructions serially or in parallel.

The host computer12may be in communication with the network20, which itself may include one or more computing devices. The network20may be a private local area network (LAN), a private wide area network (WAN), the Internet, or a mesh network, for example.

The host computer12and each client computer14may include one or more of a computer processor, memory, storage means, network device and input and/or output devices and/or interfaces. The input devices may include a keyboard, mouse, etc. The output devices may include a monitor, speakers, printers, etc. The memory may, for example, include UVPROM, EEPROM, FLASH, RAM, ROM, DVD, CD, a hard drive, or other computer readable medium that may store data and/or other information relating to the surgical planning and implementation techniques disclosed herein. The host computer12and each client computer14may be a desktop computer, laptop computer, smart phone, tablet, virtual machine, or any other computing device. The interfaces may facilitate communication with the other systems and/or components of the network20.

Each client computer14may be configured to communicate with the host computer12either directly, such as via a direct client interface22, or over the network20. In other implementations, the client computers14are configured to communicate with each other directly via a peer-to-peer interface24.

Each client computer14may be coupled to one or more of the imaging devices16. Each imaging device16may be configured to capture or acquire one or more images26of patient anatomy residing within a scan field (e.g., window) of the imaging device16. The imaging device16may be configured to capture or acquire two dimensional (2D) and/or three dimensional (3D) greyscale and/or color images26. Various imaging devices16may be utilized, including but not limited to an X-ray machine, a computerized tomography (CT) machine, or a magnetic resonance imaging (MRI) machine, for obtaining one or more images26of a patient.

The client computers14may also be configured to execute one or more software programs, such as those associated with various surgical planning tools. Each client computer14may be operable to access and locally and/or remotely execute a planning environment28for creating, editing, executing, refining, and/or reviewing one or more surgical plans36during pre-operative, intra-operative and/or post-operative phases of a surgery. The planning environment28may be a standalone software package or may be incorporated into another surgical tool. The planning environment28may be configured to communicate with the host computer12either over the network20or directly through the direct client interface22.

The planning environment28may be further configured to interact with one or more of the imaging devices16to capture or acquire images26of patient anatomy. The planning environment28may provide a display or visualization of one or more images26, bone models30, implant models32, transfer models34, and/or surgical plans36via one or more graphical user interfaces (GUI). Each image26, bone model30, implant model32, transfer model34, surgical plan36, and other data and/or information may be stored in one or more files or records according to a specified data structure.

The planning environment28may include various modules for performing the desired planning functions. For example, as further discussed below, the planning environment28may include a data module for accessing, retrieving, and/or storing data concerning the surgical plans36, a display module for displaying the data (e.g., within one or more GUIs), a spatial module for modifying the data displayed by the display module, and a comparison module for determining one or more relationships between selected bone models and selected implant models. However, a greater or fewer number of modules may be utilized, and/or one or more of the modules may be combined to provide the disclosed functionality.

The storage system18may be operable to store or otherwise provide data from/to other computing devices, such as the host computer12and/or the one or more client computers14, of the system10. The storage system18may be a storage area network device (SAN) configured to communicate with the host computer12and/or the client computers14over the network20, for example. Although shown as a separate device of the system10, the storage system18may in some implementations be incorporated within or directly coupled to the host computer12and/or client computers14. The storage system18may be configured to store one or more of computer software instructions, data, database files, configuration information, etc.

In some implementations, the system10may be a client-server architecture configured to execute computer software on the host computer12, which may be accessible by the client computers14using either a thin client application or a web browser that can be executed on the client computers14. The host computer12may load the computer software instructions from local storage, or from the storage system18, into memory and may execute the computer software using the one or more computer processors.

The system10may further include one or more databases38. The databases38may be stored at a central location, such as on the storage system18. In another implementation, one or more databases38may be stored at the host computer12and/or may be a distributed database provided by one or more of the client computers14. Each database38may be a relational database configured to associate one or more images26, bone models30, implant models32, and/or transfer models34to each other and/or to a respective surgical plan36. Each surgical plan36may be associated with the anatomy of a respective patient. Each image26, bone model30, implant model32, transfer model34, and surgical plan36may be assigned a unique identifier or database entry for storage on the storage system18. Each database38may be configured to store data and other information corresponding to the images26, bone models30, implant models32, transfer models34, and surgical plans36in one or more database records or entries, and/or may be configured to link or otherwise associate one or more files corresponding to each respective image26, bone model30, implant model32, transfer model34, and surgical plan36. The various data stored in the database(s)38may correspond to respective patient anatomies from prior surgical cases, and may be arranged into one or more predefined categories such as sex, age, ethnicity, defect category, procedure type, anatomical makeup classification, surgeon, facility or organization, etc.

Each image26and bone model30may include data and other information obtained from one or more medical devices or tools, such as the imaging devices16. The bone models30may include one or more digital images and/or coordinate information relating to an anatomy of the patient obtained or derived from image(s)26captured or otherwise obtained by the imaging device(s)16.

Each implant model32and transfer model34may include coordinate information associated with a predefined design or a design established or modified by the planning environment28. The predefined design may correspond to one or more components. The planning environment28may incorporate and/or interface with one or more modeling packages, such as a computer aided design (CAD) package, to render the models30,32, and34as two-dimensional (2D) and/or three-dimensional (3D) volumes or constructs, which may overlay one or more of the images26in a display screen of a GUI.

The implant models32may correspond to implants and components of various shapes and sizes. Each implant may include one or more components that may be situated at a surgical site including screws, anchors, grafts, etc. Each implant model32may correspond to a single component or may include two or more components that may be configured to establish an assembly. Each implant and associated component(s) may be formed of various materials, including metallic and/or non-metallic materials. Each bone model30, implant model32, and transfer model34may correspond to 2D and/or 3D geometry, and may be utilized to generate a wireframe, mesh, and/or solid construct in a GUI.

Each surgical plan36may be associated with one or more of the images26, bone models30, implant models32, and/or transfer models34. The surgical plan36may include various parameters associated with the images26, bone models30, implant models32, and/or transfer models34. For example, the surgical plan36may include parameters relating to bone density and bone quality associated with patient anatomy captured in the image(s)26. The surgical plan36may include parameters including spatial information relating to relative positioning and coordinate information of the selected bone model(s)30, implant model(s)32, and/or transfer model(s)34.

The surgical plan36may define one or more revisions to a bone model30and information relating to a position of an implant model32and/or transfer model34relative to the original and/or revised bone model30. The surgical plan36may include coordinate information relating to the revised bone model30and a relative position of the implant model32and/or transfer model34in one or more predefined data structure(s). The planning environment28may be configured to implement one or more revisions to the various models, either automatically or in response to user interaction with the user interface(s). Revisions to each bone model30, implant model32, transfer model34, and/or surgical plan36may be stored in one or more of the databases38, either automatically and/or in response to user interaction with the system10.

One or more surgeons and/or other staff users may be presented with the planning environment28via the client computers14and may simultaneously access each image26, bone model30, implant model32, transfer model34, and surgical plan36stored in the database(s)38. Each user may interact with the planning environment28to create, view, refine, and/or modify various aspects of the surgical plan36. Each client computer14may be configured to store local instances of the images26, bone models30, implant models32, transfer models34, and/or surgical plans36, which may be synchronized in real-time or periodically with the database(s)38. The planning environment28may be a standalone software package executed on a client computer14or may be provided as one or more web-based services executed on the host computer12, for example.

The system10described above may be configured for preoperatively planning surgical procedures. The preoperative planning provided by the system10may include, but is not limited to, features such as constructing a virtual model of a patient's anatomy, classifying the virtual model, identifying landmarks within the virtual model, selecting and orienting virtual implants within the virtual model, etc.

Referring now toFIG.2, with continuing reference toFIG.1, the system10may include a computing device40including at least one processor42coupled to a memory44capable of storing computer executable instructions. The computing device40may be considered representative of any of the computing devices disclosed herein, including but not limited to the host computer12and/or the client computers14. The processor42may be configured to execute one or more of the planning environments28for creating, editing, executing, refining, and/or reviewing one or more surgical plans36and any associated bone models30, implant models32, and transfer models34during pre-operative, intra-operative, and/or post-operative phases of a surgery.

The processor42can be a custom made or commercially available processor, central processing unit (CPU), or generally any device for executing software instructions. The memory44can include any one or combination of volatile memory elements and/or nonvolatile memory elements. The processor42may be operably coupled to the memory44and may be configured to execute one or more programs stored in the memory44based on various inputs received from other devices or data sources.

The planning environment28may include at least a data module46, a display module48, a spatial module50, and a comparison module52. Although four modules are shown, it should be understood that a greater or fewer number of modules could be utilized, and/or further that one or more of the modules could be combined to provide the disclosed functionality.

The data module46may be configured to access, retrieve, and/or store data and other information in the database(s)38corresponding to one or more images26of patient anatomy, bone model(s)30, implant model(s)32, transfer model(s)34, and/or surgical plan(s)36. The data and other information may be stored in one or more databases38as one or more records or entries54. In some implementations, the data and other information may be stored in one or more files that are accessible by referencing one or more objects or memory locations referenced by the entries54.

The memory44may be configured to access, load, edit, and/or store instances of one or more images26, bone models30, implant models32, transfer models34, and/or surgical plans36in response to one or more commands from the data module46. The data module46may be configured to cause the memory44to store a local instance of the image(s)26, bone model(s)30, implant model(s)32, transfer model(s)34, and/or surgical plan(s)36, which may be synchronized with the entries54stored in the database(s)38.

The data module46may be configured to receive data and other information corresponding to at least one or more images26of patient anatomy from various sources, such as the imaging device(s)16, for example. The data module46may be further configured to command the imaging device16to capture or acquire the images26automatically or in response to user interaction.

The display module48may be configured to display data and other information relating to one or more surgical plans36in at least one graphical user interface (GUI)56, including one or more of the images26, bone models30, implant models32, and/or transfer models34. The computing device40may incorporate or be coupled to a display device58. The display module48may be configured to allow the display device58to display information in the user interface56. A surgeon or other user may interact with the user interface56within the planning environment28to view one or more images26of patient anatomy and/or any associated bone models30, implant models32, and transfer models34. The surgeon or other user may interact with the user interface56via the planning environment28to create, edit, execute, refine, and/or review one or more surgical plans36.

The user interface56may include one or more display windows60and one or more objects62that may be presented within the display windows60. The display windows60may include any number of windows, and the objects62may include any number of objects within the scope of this disclosure.

A surgeon or user may interact with the user interface56, including the objects62and/or display windows60, to retrieve, view, edit, store, etc., various aspects of a respective surgical plan36, which may include information from the selected image(s)26, bone model(s)30, implant model(s)32and/or transfer model(s)34. The objects62may include graphics such as menus, tabs, buttons, drop-down lists, directional indicators, etc. The objects62may be organized in one or more menu items associated with the respective display windows60. Geometric objects, including selected image(s)26, bone model(s)30, implant model(s)32, transfer model(s)34, and/or other information relating to the surgical plan36, may be displayed in one or more of the display windows60. Each transfer model34may include one or more surgical instruments used to implant a selected implant as part of the surgical plan36.

[moss] The surgeon may interact with the objects62to specify various aspects of the surgical plan36. For example, the surgeon may select one of the tabs to view or specify aspects of the surgical plan36for one portion of a joint, such as a glenoid, for example, and may select another one of the tabs to view or specify aspects of the surgical plan36for another portion of the joint, such as a humerus, for example. The surgeon make further take various measurements (e.g., linear, angular, tissue density, etc.) of the joint as part specifying aspects of the surgical plan36.

The surgeon may interact with the menu items to select and specify various aspects of the bone models30, implant models32, and/or transfer models34from the database38. For example, the display module48may be configured to display one or more bone models30together with the respective image(s)26of the patient anatomy and implant models32selected in response to user interaction with the user interface56. The user may interact with the drop-down lists of the objects62within the display windows60to specify implant type, resection angle, and implant size. The resection angle menu item may be further associated with a resection plane.

The user may also interact with various buttons to change (e.g., increase or decrease) a resection angle. The user may interact with buttons adjacent the selected implant model32to change (e.g., increase or decrease) a size of a component of the selected implant model32. The buttons may be overlaid onto or may be situated adjacent to the display windows60.

The user may further interact with directional indicators to move a portion of the selected implant model32in different directions (e.g., up, down, left, right) in one of the display windows60. The surgeon may drag or otherwise move the selected implant model32to a desired position in the display window60utilizing a mouse or other input device, for example. The surgeon may interact with one of the drop-down lists to specify a type and/or size of a component of the selected implant model32.

The display module48may be configured to superimpose one or more of the bone models30, the implant models32, and the transfer models34over one or more of the images26within one or more of the display windows60. The implant model32may include one or more components that establish an assembly. At least a portion of the implant model32may be configured to be at least partially received in a volume of a selected one of the bone models30. In some implementations, the implant model32may have an articulation surface dimensioned to mate with an articular surface of an opposed bone or implant.

The display windows60may be configured to display the images26, bone models30, implant models32, and/or transfer models34at various orientations. The display module48may be configured to display two dimensional (2D) representation(s) of the selected bone model(s)30, implant model(s)32, and/or transfer model(s)34in the some of the display windows60, and may be configured to display 3D representation(s) of the selected bone model30, implant model32, and/or transfer model(s)34in another of the display windows60, for example. The surgeon may interact with the user interface56to move (e.g., up, down, left, right, rotate, etc.) the selected bone model30, selected implant model32, and/or selected transfer model34in 2D space and/or 3D space. Other implementations for displaying 2D and/or 3D representations in the various display windows60are further contemplated within the scope of this disclosure.

The display module48may be further configured such that the selected image(s)26, bone model(s)30, implant model(s)32, and/or transfer model(s)34may be selectively displayed and hidden (e.g., toggled) in one or more of the display windows60in response to user interaction with the user interface56, which may provide the surgeon with enhanced flexibility in reviewing aspects of the surgical plan36. For example, the surgeon may interact with drop-down lists of the objects62to selectively display and hide components of the selected implant model32in one of the display windows60.

The selected bone model30may correspond to a bone associated with a joint, including any of the exemplary joints disclosed herein. The display module48may be configured to display a sectional view of the selected bone model30and selected implant model32in one or more of the display windows60, for example. The sectional view of the bone model(s)30may be presented or displayed together with the associated image(s)26of the patient anatomy.

The spatial module50may be configured to establish one or more resection planes along the selected bone model30. A volume of the selected implant model32may be at least partially received in a volume of the selected bone model30along the resection plane(s). The resection plane(s) may be defined by a resection angle.

The spatial module50may be further configured to cause the display module48to display an excised portion of the selected bone model30to be displayed in one of the display windows60in a different manner than a remainder of the bone model30on an opposed side of the resection plane. For example, the excised portion of the bone model30may be hidden from display in the display window60such that the respective portion of the26of the patient anatomy is shown. In other implementations, the excised portion of the selected bone model30may be displayed in a relatively darker shade. The spatial module50may determine the excised portion by comparing coordinates of the bone model30with respect to a position of the resection plane, for example. The user may interact with one or more buttons of the objects62to toggle between a volume of previous and revised (e.g., resected) states of the selected bone model30.

The planning environment28may be further configured such that changes in one of the display windows60are synchronized with each of the other windows60. The changes may be synchronized between the display windows60automatically and/or manually in response to user interaction.

The surgeon may utilize various instrumentation and devices to implement each surgical plan36, including preparing the surgical site and securing one or more implants to bone or other tissue to restore functionality to the respective joint. Each of the transfer models34may be associated with a respective surgical instrument or device (e.g., transfer guides, etc.) or a respective implant model32.

The surgical plan36may be associated with one or more positioning objects such as a guide pin (e.g., guide wire or Kirschner wire) dimensioned to be secured in tissue to position and orient the various instrumentation, devices and/or implants. The display module48may be configured to display a virtual position and virtual axis in one or more of the display windows60. The virtual position may be associated with a specified position of the positioning object relative to the patient anatomy (as represented by the image(s)26). The virtual axis may extend through the virtual position and may be associated with a specified orientation of the positioning object relative to the patient anatomy. The spatial module50may be configured to set the virtual position and/or virtual axis in response to placement of a respective implant model32relative to the bone model30and associated patient anatomy. The virtual position and/or virtual axis may be set and/or adjusted automatically based on a position and orientation of the selected implant model32relative to the selected bone model30and/or in response to user interaction with the user interface56.

The spatial module50may be further configured to determine one or more collision or contact points associated with the patient anatomy. The contact points may be associated with one or more landmarks or other surface features along the bone model30and/or other portions of the patient anatomy. Each contact point may be established along an articular surface or non-articular surface of a joint. The spatial module50may be configured to set the contact points based on the virtual position, virtual axis, and/or position and orientation of the respective implant model32relative to the patient anatomy. The spatial module50may be configured to cause the display module48to display the contact points in one or more of the display windows60. In some implementations, the contact points may be set and/or adjusted automatically based on a position of the implant model32and/or in response to user interaction with the user interface56. The virtual position, virtual axis, and/or contact points may be stored in one or more entries54in the database38and may be associated with the respective surgical plan36.

The comparison module52may be configured to generate or set one or more parameters associated with implementing the surgical plan36. The parameters may include one or more settings or dimensions associated with the respective transfer models34. The parameters may be based on the virtual position, virtual axis, and/or contact points. The comparison module52may be configured to determine one or more settings or dimensions associated with the respective transfer models34relative to the patient anatomy, bone model(s)30, implant model(s)32, virtual position, virtual axis, and/or contact points CP. The dimensions and settings may be utilized to form a physical instance of each respective transfer model34. The settings may be utilized to specify a position and orientation of each respective transfer model34relative to the implant model32and/or bone model30. The settings may be utilized to configure one or more transfer members (e.g., objects) and related instrumentation or devices associated with the transfer model34. The comparison module52may be configured to generate the settings and/or dimensions such that the transfer model34contacts one or more predetermined positions at or along the bone model30or patient anatomy in an installed position when coupled to the respective implant model32. The predetermined positions may include one or more of the contact points. The settings and dimensions may be communicated utilizing various techniques, including one or more graphics in the user interface56or output files. The settings and/or dimensions may be stored in one or more entries54in the database38associated with the transfer models34.

The user may interact with a list of the objects62associated with one of the display windows60to select a desired transfer model34from the database38. The display module48may be configured to display the selected transfer model34in the display windows60at various positions and orientations. The spatial module50may be configured to set an initial position of the selected transfer model34according to the virtual position, virtual axis, and/or contact points.

The user may interact with the user interface56to set or adjust a position and/or orientation of the selected transfer model34. The user may interact with directional indicators of the objects62to move the selected transfer model34and/or virtual position in different directions (e.g., up, down, left, right) in the display windows60. The surgeon may drag or otherwise move the selected transfer model34and/or virtual position to a desired position in the display windows60utilizing a mouse or other input device, for example. The user may interact with rotational indicators of the objects to adjust a position and/or orientation of the transfer model34about the virtual axis relative to the selected bone model30and/or implant model32. The user may interact with tilt indicators of the objects62to adjust an orientation of the selected transfer model34and associated virtual axis at the virtual position relative to the selected bone model30and/or implant model32. The user may interact with other buttons and/or directional indicators to cause the transfer model34to articulate or otherwise move. The transfer model34may be articulated or otherwise moved independently or synchronously, which may occur manually in response to user interaction and/or automatically in response to situating the transfer model34relative to the bone model30and/or implant model32. Movement of the transfer model34may cause an automatic adjustment to the respective contact points.

Various transfer members may be utilized with the planning environment28to implement the surgical plan(s)36. Each transfer member may be associated with a respective transfer model34. The transfer members may be incorporated into transfer guides, implants, and/or assemblies to set a position and orientation of the respective implant prior to fixing or otherwise securing the implant at a surgical site.

Referring now toFIG.3, with continued reference toFIG.2, the computing device40may interface with the storage system18over the network20for accessing various databases38stored thereon in order to establish and implement the surgical plans36.

The databases38of the storage system18may include a patient profile database64, a surgeon profile database65, a surgical outcomes database66, a range of motion database68, and an anatomical makeup classification database70. Additional databases could be stored on and accessed from the storage system18within the scope of this disclosure. Moreover, although shown as separate databases, one or more of the databases could be combined or linked together. For example, the anatomical makeup classification database70could be combined or linked with the surgical outcomes database66, the range of motion database68, or both.

The patient profile database64may include information that is part of an indexed and stored record or entry related to one or more current patients associated with the system10. The information stored on the patient profile database64may include the sex, age, ethnicity, height, weight, defect category, procedure type, surgeon, facility or organization, dominant joint, acts of daily living/lifestyle goals profile (e.g., desired post-surgery range of motion for abduction, adduction, external rotation, internal rotation, extension, flexion, external rotation combined with 60° abduction, internal rotation with 60° abduction, etc.), current surgical plan information, etc. for each patient. The patient profile database64may further store or link to the images26for a given patient.

The surgeon profile database65may include information that is part of indexed and stored records or entries related to one or more surgeon users associated with the system10. The information stored on the surgeon profile database65may include the surgeon's name, facility or organization, historical data concerning the types of prior surgeries planned by the surgeon using the system10, data concerning the types of implants included in the surgeon's preoperative surgical plans, data concerning the actual implants utilized in the surgeon's prior surgeries, etc. In some implementations, the surgeon profile database65may interface with the patient profile database64for linking each surgeon from the surgeon profile database65to his/her patients listed in the patient profile database64.

The surgical outcomes database66may include information that is part of indexed and stored records or entries related to one or more prior patients associated with the system10. The surgical outcomes database66may be created based on information logged by surgeons and/or other staff users after performing each surgery and at each follow-up visit for indicating the progress of the prior patient. The information stored on the surgical outcomes database66may include the sex, age, ethnicity, height, weight, defect category, procedure type, specific implants used, surgeon, facility or organization, dominant joint, visual analog pain scores, ASES scores, achieved acts of daily living/lifestyle profile (e.g., achieved post-surgery range of motion for abduction, adduction, external rotation, internal rotation, extension, flexion, external rotation combined with 60° abduction, internal rotation with 60° abduction, etc.), surgical plan information, etc. for each prior patient. The surgical outcomes database66may additionally store or link to preoperative and postoperative images26for each prior patient.

The range of motion database68may include information that is part of indexed and stored records or entries related to one or more current and prior patients associated with the system10. The range of motion database68may store range of motion data derived from range of motion simulations performed by the computing device40for each surgical plan36. The range of motion data may include information related to simulated joint motions (e.g., abduction/adduction, flexion/extension, internal/external rotation, etc.), identified contact or collision points for various implant positions, angular arc and mode of collision (e.g., implant-to-implant, implant-to-bone, bone-to-bone, etc.) for various implant positions, adjusted center of rotation of implants in multiple increments and offset directions for various implant positions, etc.

The anatomical makeup classification database70may store a plurality of anatomical makeup classifications that characterize anatomical differences and variances within the anatomical differences within a representative patient population for one or more intended surgeries (e.g., total shoulder, reverse shoulder, etc.). In some implementations, the representative patient population may be derived by analyzing image data, such as images from the prior patients stored on the surgical outcomes database66and/or any other imaging source, associated with a plurality of prior patients who have already received the intended surgery. Each of the plurality of anatomical makeup classifications is a numerical classification of an anatomical makeup of a bone or a joint of the representative patient population.

Referring now toFIG.4, with continued reference toFIGS.1-3, the computing device40may interface with a statistical shape modeler72for creating the anatomical makeup classification database70. The statistical shape modeler72may be a software package stored in the memory44of the computing device40or in the storage system18and which may be executed by the processor42.

The statistical shape modeler72may receive a plurality of sets of image data74associated with a bone or joint of interest. In some implementations, the sets of image data74is made up of tens of thousands of sets of image data. Each set of image data74may include 2D and/or 3D anatomical images specific to prior patients of a representative patient population for the bone or joint of interest and related to a given type of surgery. The statistical shape modeler72may analyze the plurality of sets of image data74for constructing a statistical shape model75.

As an input, the statistical shape modeler72may receive a plurality of predefined modes76to be used for analyzing the plurality of sets of image data74. Each of the modes76is a descriptor configured for characterizing anatomical differences in the bone or joint associated with the statistical shape model75. Exemplary modes76that may be provided to the statistical shape modeler72may include but are not limited to size of glenoid, size of scapula, amount of inclination, amount of version, projected amount of glenoid and sagittal neck length, angle of glenoid relative to scapular neck, critical shoulder angle, projection of acromion and/or coracoid, size of humeral head, varus/valgus of humeral head, varus/valgus of femur and/or tibia, internal/external rotation of femur and/or tibia, integrity of subscapularis, deltoid, and/or supraspinatus, ML and AP width, intercondylar notch depth, tibial slope, Q-angle of the knee, ACL/PCL stability, MCL/LCL stability, amount of flexion, amount of extension, quality and amount of soft tissue surrounding joint, patellar tracking angle, bone density, bone quality subluxation percentage, anatomical landmarks, joint space, pre-operative range of motion, any combinations of the foregoing, etc.

In some implementations, at least seven different modes may be utilized by the statistical shape modeler72to characterize the statistical shape model75. However, a greater or fewer number of modes may be provided within the scope of this disclosure.

In some implementations, the modes76may not be predefined. Rather, the statistical shape modeler72may be programmed to utilize artificial intelligence (e.g. a neural network) or machine learning to extrapolate the modes that best relate to the bone or joint being modeled within the statistical shape model75.

As another input, the statistical shape modeler72may receive a plurality of predefined standard deviations78to be used for analyzing the plurality of sets of image data74. Each standard deviation78may represent anatomical variances (e.g., distances between features, orientation of features, relative features, etc.) contained within each of the plurality of predefined modes76. The standard deviations78may be used to validate a percentile coverage of the representative patient population that is represented within the statistical shape model75. In some implementations, at least seven different standards of deviation (e.g., −3, −2, −1, 0, 1, 2, and 3) may be utilized by the statistical shape modeler72to further characterize all anatomical variances contained within the anatomies described within the statistical shape model75. However, a greater or fewer number of standard deviations could be utilized within the scope of this disclosure.

The statistical shape modeler72may, in response to commands from the processor42, combine the plurality of standard deviations78with the plurality of predefined modes76to assign a plurality of anatomical makeup classifications80N, wherein N is any number, to the bone or joint associated with the statistical shape model75in order to categorize the anatomical makeup of the entire patient population represented within the statistical shape model75. Each anatomical makeup classification80Nmay then be saved in the anatomical makeup classification database70of the storage system18.

FIG.5illustrates an exemplary anatomic makeup classification80as assigned to a specific bone model82derived from the statistical shape model75. In an embodiment, the bone model82is a 3D model of a scapula of a shoulder joint. However, other bones and joints could also be classified in a similar manner.

The statistical shape modeler72ofFIG.4may analyze the bone model82in respect to each of a plurality of modes761to767, in order to characterize any anatomical differences in the bone model82compared to the other similar bones/joints associated with the statistical shape model75. Of course, a greater or fewer number of modes are possible.

The statistical shape modeler72may further characterize any anatomical variances contained within each of the plurality of predefined modes761-767by analyzing each of the modes with respect to a plurality of standard deviations781-787. Of course, a greater or fewer number of standards of deviation are possible.

In the implementation shown inFIG.5, the bone model82is assigned the numerical value 0213120 as its anatomical makeup classification80. This numerical value represents a standard of deviation of 0 within the first mode761, a standard of deviation of 2 within the second mode762, a standard of deviation of 1 within the third mode763, a standard of deviation of 3 within the fourth mode764, a standard of deviation of 1 in the fifth mode765, a standard of deviation of 2 within the sixth mode766, and a standard of deviation of 0 in the seventh mode767. The anatomical makeup classification80is a unique numeric identifier for describing the anatomy associated with the bone model82.

FIG.6, with continued reference toFIGS.1-5, schematically illustrates a method84for creating the anatomical makeup classification database70described above. The method84may be performed as part of a surgical planning procedure. Fewer or additional steps than are recited below could be performed within the scope of this disclosure, and the recited order of steps is not intended to limit this disclosure. The system10, via any of its associated computing devices and modules, may be configured to execute each of the steps of the method84. In an exemplary implementation, the computing device40of the host computer12may be programmed to execute the method84. However, other implementations are further contemplated within the scope of this disclosure.

A statistical shape model75that is representative of a patient population having pathologic anatomies associated with an intended surgery may be constructed at step86. A plurality of modes76may be identified within the statistical shape model75at step88. The modes76may characterize anatomical differences within the statistical shape model75.

Next, at step90, a plurality of standard deviations78of anatomical variances contained within each of the modes76may be established. The standard deviations78may be used to validate a percentile coverage of the representative patient population associated with the statistical shape model75.

The standard deviations78may be combined with the modes76to create a plurality of unique anatomical makeup classifications80at step92. At step94, the anatomical makeup classifications80may be consolidated to form the anatomical makeup classification database70. The anatomical makeup classification database70may therefore represent major variances within the representative patient population which may influence implant function.

As further part of the method84, an appropriate sized implant model32may be selected and positioned to a default starting position and orientation relative to the bone or joint associated with each of the plurality of anatomical makeup classifications80at step96. The default starting positions and orientations of the implant models32may therefore also be linked to and stored, at step97, with the anatomical makeup classifications80as part of the anatomical makeup classification database70.

Once built, the anatomical makeup classification database70may enable additional features, processes, and/or capabilities to be implemented within or executed by the system10for enhancing surgical planning Example implementations of such features are detailed below.

FIG.7, for example, illustrates a method98for augmenting the range of motion database68with the information contained within the anatomical makeup classification database70. The method98may be performed as part of a surgical planning procedure. Fewer or additional steps than are recited below could be performed within the scope of this disclosure, and the recited order of steps is not intended to limit this disclosure. The system10, via any of its associated computing devices and modules, may be configured to execute each of the steps of the method98. In an exemplary implementation, the computing device40of the host computer12may be programmed to execute the method98. However, other implementations are further contemplated within the scope of this disclosure.

First, at step100, one or more motion simulations may be performed on each anatomical makeup classification80stored on the anatomical makeup classification database70. The motion simulations may be performed within a range of motion modeler101, which may be a software package stored in the memory44of the computing device40or in the storage system18and which may be executed by the processor42(see, e.g.,FIG.8). The range of motion modeler101may receive each of the anatomical makeup classifications80(and each associated bone model30and implant model32, including default implant starting positions and orientations) as inputs from the anatomical makeup classification database70when performing the motion simulations.

The range of motion simulations actually performed at step100will depend on the type of bone or joint being analyzed, among other criteria. Examples of the types of motions that can be simulated as part of step100of the method98include but are not limited to abduction/adduction, flexion/extension, internal/external rotation, etc.

Contact or collision points may be identified at step102for identifying the range of motion end points for each range of motion simulation performed on each anatomical makeup classification80. The angular arc and mode of collision (e.g., implant-to-implant, implant-to-bone, bone-to-bone, etc.) for each contact point may be recorded at step104.

The center of rotation of the implant models32positioned within the bone models30for each anatomical makeup classification80may be adjusted at step106. In some implementations, this step may include adjusting each implant model32in at least three offset directions (e.g., medial, interior, and posterior) relative to the respective bone model30to simulation different positions of the implant models32.

At step108, the center of rotation of the implant model32for each anatomical makeup classification80may be adjusted relative to the respective bone model30in multiple increments for recording the angular arcs and collision modes associated with the adjusted positions. All range of motion data derived from the simulations performed at steps100-108may then be saved within the range of motion database68at step110.

FIG.9schematically illustrates a method112for planning an orthopedic procedure for a respective patient using the system10. The method112may be performed as part of a surgical planning procedure for preparing a surgical plan for the patient. Fewer or additional steps than are recited below could be performed within the scope of this disclosure, and the recited order of steps is not intended to limit this disclosure. The system10, via any of its associated computing devices and modules, may be configured to execute each of the steps of the method112. In an exemplary implementation, the computing device40of one or more of the client computers14may be programmed to execute the method112. However, other implementations are further contemplated within the scope of this disclosure.

Image data of a bone or joint of interest of the patient may be received at step114. The image data may be received directly from the imaging device16or may be acquired by accessing the record or entry associated with the patient from the patient profile database64.

[moms] A 3D model of the bone or joint of interest may be generated at step116. The planning environment28of the computing device40may incorporate and/or interface with one or more modeling packages, such as a computer aided design (CAD) package, to render the 3D model of the bone or joint of interest.

Next, at step118, the computing device40may query the anatomical makeup classification database70to locate bone models stored therein that have similar anatomical makeup classifications. The anatomical makeup classification that is closest to the anatomy encompassed by the 3D model may then be assigned to the 3D model at step120and displayed on a range of motion user interface of the computing device40at step122. As part of displaying the anatomical makeup classification, a confidence level indicator may be displayed within the range of motion user interface for visually indicating the similarity between the assigned anatomical makeup classification and the anatomy being analyzed. The confidence level indicator may be displayed as a percentage or any other visual indicator.

The range of motion database68may be queried at step124to obtain range of motion data that is relevant to the assigned anatomical makeup classification. The range of motion data associated with the assigned anatomical makeup classification, including information such as the angular arc and the mode of impingement, may be displayed on the range of motion user interface at step126.

At step128, the surgeon or other staff user of the system10may be queried to select the desired acts of daily living goals of the patient. The positioning of the implant model may be automatically adjusted relative to the bone model based on the selected acts of daily living at step130. The system10may then output a recommended implant size/type and position and orientation for meeting the selected acts of daily living at step132.

The surgeon may be prompted to modify the recommended implant type, positioning, and/or orientation per his/her clinical judgement at step134. The method112may end at step136in response to receiving the surgeon's approval of the surgical plan. As part of this step, a comparison of the simulated range of motion results stored in the ROM database68to the range of motion achieved by the surgeon's planned positions and orientations may be presented to the user within a graphical user interface. This step may further include notifying the surgeon within the graphical user interface of any potential impact the proposed changes may have based on past surgical outcome data associated with prior patients having similar anatomical makeup classifications.

FIG.10illustrates an exemplary range of motion user interface105that may be provided during the method112discussed above. The range of motion user interface105may be presented within the planning environment28, for example.

The range of motion user interface105may include a range of motion dashboard107, a display window109, and a control panel111. The range of motion dashboard107may present various range of motion data to the user. The range of motion dashboard107may include a plurality of selectable buttons113related to foundational joint motion expectations for the patient. The foundational joint motion expectations that may be represented by the buttons113may include but is not limited to desired post-surgery range of motion for abduction, adduction, external rotation, internal rotation, extension, flexion, external rotation combined with 60° abduction, and internal rotation combined with 60° abduction.

The range of motion dashboard107may further include a bar graph115for illustrating range of motion data for each of the foundational joint motion expectations. For example, the bar graph115may provide a visual display of the range of motion achieved for a selected foundational joint motion expectation for one or more AMCs that are closest to the anatomy of the patient that the surgical plan is being created for.

The display window109may include a 3D window117and multiple 2D windows119. A virtual bone model121of the patient's anatomy may be displayed within the 3D window117and the 2D windows119. A positioning of both a virtual guide pin123and a virtual implant125that is necessary for achieving the desired joint motion expectations may be displayed relative to the virtual bone model121to provide the user with information on how to best approach the surgery being planned.

The display window109may be manipulated using the control panel111. For example, the control panel111may include a plurality of toggles, buttons, sliders, etc. that allow the user to modify various settings, such as the positioning of the virtual guide pin123and/or the virtual implant125relative to the virtual bone model121. In an embodiment, a backside seating amount127and a color-coded backside seating map129may be provided on the display window109and may automatically update as adjustments are made to the virtual positions of the virtual guide pin123and the virtual implant125relative to the virtual bone model121. The information presented in the display window109may also automatically update as the user pages through each of the buttons113.

FIG.11schematically illustrates another method138for planning an orthopedic procedure for a respective patient using the system10. The method138may be performed as part of a surgical planning procedure for preparing a surgical plan for the patient. Fewer or additional steps than are recited below could be performed within the scope of this disclosure, and the recited order of steps is not intended to limit this disclosure. The system10, via any of its associated computing devices and modules, may be configured to execute each of the steps of the method138. In an exemplary implementation, the computing device40of one or more of the client computers14may be programmed to execute the method138. However, other implementations are further contemplated within the scope of this disclosure.

Image data of a bone or joint of interest of the patient may be received at step140. The image data may be received directly from the imaging device16or may be acquired by accessing the record or entry associated with the patient from the patient profile database64.

A 3D model of the bone or joint of interest may be generated at step142. The planning environment28of the computing device40may incorporate and/or interface with one or more modeling packages, such as a computer aided design (CAD) package, to render the 3D model of the bone or joint of interest.

Next, at step144, the computing device40may query the anatomical makeup classification database70to locate bone models stored therein that have anatomical makeup classifications that are similar to the anatomical makeup classification of the bone or joint of the patient. The anatomical makeup classification that is closest to the anatomy encompassed by the 3D model may then be assigned to the 3D model at step146and displayed on a surgical outcomes user interface of the computing device40at step148. As part of displaying the anatomical makeup classification, a confidence level indicator may be displayed within the graphical user interface for visually indicating the similarity between the assigned anatomical makeup classification and the anatomy being analyzed. The confidence level indicator may be displayed as a percentage or any other visual indicator.

The surgical outcomes database66may be queried at step150to obtain surgical outcomes data that is most relevant to the assigned anatomical makeup classification. The surgical outcomes data associated with the assigned anatomical makeup classification may be displayed on the surgical outcomes user interface at step152. The surgical outcomes data that is displayed to the user may be automatically updated in response to a user prompt, such as when the user changes the planned procedure type, for example.

In an embodiment, the surgical outcomes database66may be queried to locate prior surgeries that involved patients having an average bone density that is comparable to an estimated average bone density of a bone associated with the anatomy of the patient. This comparison can be used to recommend a particular surgical implant that is not incompatible with the average bone density of the bone under study, for example.

Next, at step154, data from the surgical outcomes database66for the comparable anatomical makeup classifications and a plurality of variables associated with a surgical plan for operating on the patient may be leveraged in order to determine one or more survivorship predictive indexes. The variables may include factors such as surgical implant type, surgical implant size, surgical implant orientation, a surgical procedure type, a surgical implant backside seating configuration, a fastener orientation, or any combinations thereof. The variables are inputs to the system10that may be selected by the surgeon or staff user within the surgical outcomes user interface.

[mom] The determined survivorship predictive index may be displayed on the surgical outcomes user interface at step156. Each survivorship predictive index may be a percentile representation of a confidence level that the surgical plan will result in a successful surgical outcome for at least a predefined amount of time. For example, based on the data of the comparable anatomical makeup classifications and the relevant variables selected/set by the surgeon, the system10may determine and display a survivorship predictive index of 40% at three years post-surgery for comparable patients who underwent a standard total shoulder arthroplasty procedure and a survivorship predictive index of 85% at three years post-surgery for comparable patients who underwent a reverse shoulder arthroplasty procedure, thus indicating to the surgeon that a more successful outcome for the patient could likely be obtained by performing a reverse shoulder arthroplasty procedure rather than a standard total shoulder arthroplasty procedure.

After displaying the survivorship predictive index displayed at step156, the system10may prompt the surgeon for making any revisions to the variables associated with the current surgical plan at step158. If revisions are received as inputs into the system10, an updated survivorship predictive index may be displayed at step160.

The system10may output a recommended procedure type, implant size/type, and implant position/orientation for best matching the comparable anatomical makeup classifications at step162. The surgeon may be prompted to modify the recommended implant type, positioning, and/or orientation per his/her clinical judgement at step164. The method138may end after receiving, at step166, the surgeon's approval of the surgical plan.

FIG.12illustrates an exemplary surgical outcomes user interface141that may be provided during the method138discussed above. The surgical outcomes user interface141may be presented within the planning environment28, for example.

The surgical outcomes user interface141may include a graphical listing143for displaying the anatomical makeup classifications80most similar to the anatomical makeup classification of the bone or joint of the patient, a display window145, and a control panel147.

The graphical listing143may include a graph149of ASES score versus time for each of the comparable anatomical makeup classifications80that are listed. Although two anatomical makeup classifications80are shown being listed inFIG.12, the graphical listing143could provide a greater or fewer number of anatomical makeup classifications80within the scope of this disclosure.

The graphical listing143may further include a confidence level indicator151that may be displayed adjacent to each comparable anatomical makeup classification80. The confidence level indicator151may be a percentage or any other visual indicator for visually indicating the similarity between the assigned anatomical makeup classification and the anatomy being analyzed. The user may select the desired comparable anatomical makeup classification80using an input selector153, for example.

The display window145may include a 3D window155and multiple 2D windows157. A virtual bone model159of the patient's anatomy may be displayed within the 3D window155and the 2D windows157. A virtual guide pin161and a virtual implant163associated with the selected comparable anatomical makeup classification80may be displayed relative to the virtual bone model159to provide the user with information on how prior surgeries were conducted for patient's having the comparable anatomical makeup classification80.

The display window145may be manipulated using the control panel147. For example, the control panel147may include a plurality of toggles, buttons, sliders, etc. that allow the user to modify various settings, such as the positioning of the virtual guide pin161and/or the virtual implant163relative to the virtual bone model159. In an embodiment, a backside seating amount165and a color-coded backside seating map167may be displayed on the display window145and may automatically update as adjustments are made to the virtual positions of the virtual guide pin161and the virtual implant163relative to the virtual bone model159.

The surgical outcomes user interface141may further include a consult scheduling button199. The user may press or otherwise actuate the consult scheduling button199in order to arrange a consultation with a surgeon who performed the prior surgery for the comparable anatomical makeup classification80. Once the consult scheduling button199has been actuated, the user and the relevant surgeon may be presented with a series of prompts for coordinating and carrying out the consultation. The consultation may be conducted via chat room, telephone, video conference, etc. If desired, the identities of one or both of the requesting surgeon and the consulting surgeon may be kept confidential during the consultation.

FIG.13Aschematically illustrates yet another method168for planning an orthopedic procedure for a respective patient using the system10. The method168may be performed as part of a surgical planning procedure for preparing a surgical plan for the patient. Fewer or additional steps than are recited below could be performed within the scope of this disclosure, and the recited order of steps is not intended to limit this disclosure. The system10, via any of its associated computing devices and modules, may be configured to execute each of the steps of the method168. In an exemplary implementation, the computing device40of the host computer12may be programmed to execute the method168. However, other implementations are further contemplated within the scope of this disclosure.

The method168may begin at step170in response to receiving a preoperative surgical plan that has been approved by a respective surgeon. The surgeon profile database65may then be queried at step172for data concerning the surgeon's prior surgeries planned using the system10for the procedure indicated by the approved preoperative surgical plan. The data analyzed from the surgeon profile database65may include the type and amount of implants actually used in the surgeon's prior surgeries, and the type and amount of implants included as part of the preoperative surgical plan for each of the surgeon's relevant prior surgeries.

At step174, the system10may determine, based on a comparison of the pre-operative and post-operative data analyzed at step172, for example, whether the surgeon has deviated from his/her past preoperative surgical plans in less than a predefined percent of his/her prior surgical procedures. In some implementations, the predefined percent may be defined as 5% of the prior surgical procedures. However, other thresholds may be established within the scope of this disclosure. In an embodiment, a “deviation” is assumed to have taken place when the surgeon changed the pre-planned procedure type, changed the pre-planned implant type, or employed a size deviation of more than one size during the prior surgical procedures.

If a YES flag is returned at step174, a first surgical kit that includes only those implants and instrumentation necessary for executing the approved preoperative surgical may be recommended at step176. Alternatively, if a NO flag is returned at step174, a second surgical kit that includes a greater number of implants and instrumentation than the first surgical kit may be recommended at step178. An order for assembling the relevant surgical kit may then be issued at step180.

FIG.13Billustrates an exemplary deviation user interface169that may be provided during the method168discussed above. The deviation user interface169may be presented within the planning environment28, for example.

The deviation user interface169may be configured to present various surgery-related information pertaining to a selected surgeon related to how often the surgeon has deviated from his/her past preoperative surgical plans. The deviation user interface169may provide a case listing171of the surgeon's prior surgeries and various bar graphs173A-173F designed for conveying deviation related information to the user. For example, the bar graph173A may illustrate the percent of prior surgeries executed as planned, the bar graph173B may illustrate the percent of implants implanted as planned during prior surgeries, the bar graph173C may illustrate planned versus implanted implants, the bar graph173D may illustrate deviation type, the bar graph173E may illustrate different implant families used in the prior surgeries, and the bar graph173F may illustrate different sizes of implants used during prior surgeries. Other deviation related information could alternatively or additionally be conveyed to the user via the deviation user interface169.

FIG.14schematically illustrates a method182for postoperatively updating one or more databases38associated with the system10. The method182may be performed subsequent to using the system10to prepare a surgical plan for a patient and subsequent to implementing the surgical plan during an actual surgery. Fewer or additional steps than are recited below could be performed within the scope of this disclosure, and the recited order of steps is not intended to limit this disclosure. The system10, via any of its associated computing devices and modules, may be configured to execute each of the steps of the method182. In an exemplary implementation, the computing device40of the host computer12may be programmed to execute the method182. However, other implementations are further contemplated within the scope of this disclosure.

The system10may receive postoperative patient outcome data from a user at step184. In some implementations, the postoperative patient outcome data may be manually entered by a surgeon or other staff after intraoperatively performing a surgical procedure on the patient according to a preoperative surgical plan previously created within the system10. In other implementations, the postoperative patient outcome data may be automatically communicated to the system10after performing the surgical procedure as part of a closed feedback loop that can be implemented via a neural network, for example. The postoperative outcome data may include information such as the size and types of implants used during the now completed surgical procedure, the positions and orientations of the used implants, implant failure data, data related to the achievement or non-achievement of pre-operative acts of daily living goals, etc.

An anatomic makeup classification80may be assigned to each anatomy associated with the postoperative patient outcome data at step186. This may be achieved, for example, by querying the anatomical makeup classification database70to locate bone models stored therein that have anatomical makeup classifications that are similar to the anatomical makeup classification of the anatomy indicated within the postoperative patient outcome data.

At step188, the surgical outcomes database66may be updated with the information contained within the postoperative patient outcome data. For example, the surgical outcomes database66may be updated with the size and types of implants used during the now completed surgical procedure, the positions and orientations of the used implants, etc.

The size, type, position, and orientation of the implants indicated within the postoperative patient outcome data may be input into the range of motion database68at step190. Next, at step192, one or more motion simulations may be performed on the anatomy and implants associated with the postoperative patient outcome data. Contact or collision points may be identified at step194for identifying the range of motion end points for each range of motion simulation performed. The angular arc and mode of collision (e.g., implant-to-implant, implant-to-bone, bone-to-bone, etc.) for each contact point may be recorded at step196.

The center of rotation of the implants associated with the postoperative patient outcome data may be adjusted at step198. At step200, the center of rotation of the implants may be adjusted relative to the respective bone model in multiple increments for recording the angular arcs and collision modes associated with the adjusted positions. All range of motion data derived from the simulations performed at steps190-200may then be saved within the range of motion database68at step202.

The proposed surgical planning systems and methods of this disclosure may be utilized to create and implement surgical plans that are tailored to the individual patient, which may improve healing. The disclosed systems and methods may reduce complexity in implementing the surgical plans, including reduced packaging and instrumentation. In certain implementations, the system and methods may utilize feedback loops for continuously improving the recommendations provided when developing surgical plans. The proposed systems and methods therefore provide improved functionality compared to prior planning systems.

Although the different non-limiting embodiments are illustrated as having specific components or steps, the embodiments of this disclosure are not limited to those particular combinations. It is possible to use some of the components or features from any of the non-limiting embodiments in combination with features or components from any of the other non-limiting embodiments.

It should be understood that like reference numerals identify corresponding or similar elements throughout the several drawings. It should further be understood that although a particular component arrangement is disclosed and illustrated in these exemplary embodiments, other arrangements could also benefit from the teachings of this disclosure.

The foregoing description shall be interpreted as illustrative and not in any limiting sense. A worker of ordinary skill in the art would understand that certain modifications could come within the scope of this disclosure. For these reasons, the following claims should be studied to determine the true scope and content of this disclosure.