Preoperative surgical planning system and method for performing range of motion analysis

Abstract

Improved surgical planning systems and methods are provided for planning orthopedic procedures, including creating, editing, executing, and / or reviewing surgical plans preoperatively, intraoperatively, and / or postoperatively. The surgical planning systems and methods may be utilized to plan and execute orthopedic procedures to restore joint function. In some embodiments, range of motion simulations may be performed on joints associated with multiple anatomical body size classifications, and range of motion data derived from the range of motion simulations may be stored within a storage system of the surgical planning system.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 18 / 353,168, filed July 17, 2023, which claims the benefit of U.S. Provisional Patent Application No. 63 / 399,190, filed August 18, 2022, U.S. Provisional Patent Application No. 63 / 406,562, filed September 14, 2022, and U.S. Provisional Patent Application No. 63 / 500,425, filed May 5, 2023, each of which is incorporated by reference in its entirety.

[0002] The present disclosure is directed to surgical planning, and more particularly to improved surgical planning systems and methods for planning orthopedic surgical procedures. [Background technology]

[0003] Joint arthroplasty is a type of orthopedic surgical procedure performed to repair or replace a diseased joint. To improve outcomes, surgeons may desire to establish a surgical plan for preparing the surgical site, selecting an implant, and placing the implant at the surgical site before performing the joint arthroplasty. The surgical plan may include capturing images of the surgical site and determining the position of the implant based on the images. Summary of the Invention [Means for solving the problem]

[0004] The present disclosure relates to improved surgical planning systems and methods.

[0005] The presently disclosed surgical planning systems and methods may be utilized in some embodiments for planning orthopedic surgical procedures, including creating, editing, executing, and / or reviewing surgical plans pre-operatively, intra-operatively, and / or post-operatively. The surgical planning systems and methods may be utilized for planning and executing orthopedic surgical procedures to restore joint function.

[0006] The surgical planning system may include, among other things, a processor configured to classify a representative patient population into a plurality of anatomical body size categories and to perform range of motion simulations for each of the plurality of anatomical body size categories. A memory device of the system may be operably coupled to the processor and configured to store range of motion data derived from the range of motion simulations for each of the plurality of anatomical body size categories.

[0007] A computer-implemented surgical planning method may include, inter alia, classifying a representative patient population into a plurality of anatomical body size categories via a processor of a surgical planning system, performing range of motion simulations for each of the plurality of anatomical body size categories, and storing range of motion data derived from the range of motion simulations for each of the plurality of anatomical body size categories in a memory device of the surgical planning system.

[0008] The surgical planning system may include, among other things, a processor configured to perform a range of motion simulation based on one or more parameters associated with the patient's posture, and a storage system operably connected to the processor and configured to store range of motion data derived from the range of motion simulation.

[0009] The surgical planning system may include, among other things, a processor configured to determine one or more posture parameters associated with a patient's posture, and the processor configured to adjust the implant plan based on the one or more posture parameters.

[0010] The computer-implemented surgical planning method may include, among other things, performing a range of motion simulation based on one or more parameters associated with the patient's posture, and storing range of motion data derived from the range of motion simulation in a storage system of the surgical planning system.

[0011] The surgical planning system may include, among other things, a processor configured to register at least one bone model from a local frame of reference to a global frame of reference, and to establish a surgical plan associated with the at least one bone model in the global frame of reference.

[0012] In accordance with an embodiment, a surgical planning system may include, among other things, a processor and a memory operatively coupled to the processor. The memory may be configured to store at least one bone model including one or more coordinate values. The processor may be configured to register the at least one bone model of the patient from a local frame of reference to a global frame of reference in response to adjusting the one or more coordinate values ​​based on the patient's posture. The processor may be configured to establish a surgical plan associated with the at least one bone model in the global frame of reference.

[0013] According to an embodiment, a computer-implemented surgical planning method can include, among other things, registering at least one bone model of a patient from a local frame of reference to a global frame of reference. The method can adjust one or more coordinate values ​​associated with the at least one bone model based on the patient's posture. The method can include establishing a surgical plan associated with the at least one bone model in the global frame of reference.

[0014] The embodiments, examples, and alternatives of the preceding paragraphs, claims, or the following description and drawings, including any of their various aspects or individual features, may be recited independently or in any combination. Features described in connection with one embodiment are applicable to all embodiments unless such features are incompatible.

[0015] The various features and advantages of the present disclosure will become apparent to those skilled in the art from the following detailed description. The drawings that accompany the detailed description can be briefly described as follows. [Brief explanation of the drawings]

[0016] [Figure 1] 1 illustrates a schematic diagram of an exemplary surgical planning system. [Figure 2] 2 illustrates a schematic diagram of an exemplary embodiment of the surgical planning system of FIG. 1. [Figure 3] 1 illustrates a schematic diagram of an exemplary cloud-based database that may be accessed by a surgical planning system. [Figure 4] 2A and 2B schematically illustrate additional exemplary aspects of the surgical planning system of FIG. 1. [Figure 5] 1A-1C schematically illustrate exemplary anatomical body size classifications that may be assigned by a surgical planning system. [Figure 6] 1 illustrates a schematic diagram of a method for establishing an anatomical body classification database for a surgical planning system. [Figure 7] 1 illustrates a schematic of a method for establishing a range of motion database for a surgical planning system. [Figure 8] 2A and 2B schematically illustrate additional exemplary aspects of the surgical planning system of FIG. 1. [Figure 9] 1 illustrates generally a method for planning an orthopedic surgical procedure for an individual patient using a surgical planning system. [Figure 10] 1 illustrates an exemplary user interface of a surgical planning system. [Figure 11]10A and 10B schematically illustrate another exemplary method for planning an orthopedic surgical procedure for a respective patient using a surgical planning system. [Figure 12] 1 illustrates another exemplary user interface of a surgical planning system. [Figure 13A] 10A and 10B schematically illustrate yet another exemplary method for planning an orthopedic surgical procedure for a respective patient using a surgical planning system. [Figure 13B] 10 illustrates yet another exemplary user interface of a surgical planning system. [Figure 14] 1 illustrates generally an exemplary method for post-operatively updating one or more databases associated with a surgical planning system. [Figure 15] 1 shows a set of posture types associated with anatomical structures. [Figure 16A] 1 illustrates an anatomical model associated with a set of posture types of an anatomical structure. [Figure 16B] 1 illustrates an anatomical model associated with a set of posture types of an anatomical structure. [Figure 16C] 1 illustrates an anatomical model associated with a set of posture types of an anatomical structure. [Figure 16D] An anatomical model is disclosed in a recumbent position. [Figure 17A] 16A-16C show the scapular angles associated with each posture type. [Figure 17B] 16A-16C show the scapular angles associated with each posture type. [Figure 17C] 16A-16C show the scapular angles associated with each posture type. [Figure 18A] 17A-17C show the scapular angles associated with each posture type, with the humerus and forearm models respectively in an elevated position. [Figure 18B] 17A-17C show the scapular angles associated with each posture type, with the humerus and forearm models respectively in an elevated position. [Figure 18C] 17A-17C show the scapular angles associated with each posture type, with the humerus and forearm models respectively in an elevated position. [Figure 19] A clinical example utilizing the techniques disclosed herein is disclosed. [Figure 20] A clinical example utilizing the techniques disclosed herein is disclosed. [Figure 21] A shoulder model is disclosed that includes a humeral implant mated with a glenoid implant associated with various postures and scapular angles. [Figure 22] A shoulder model is disclosed that includes a humeral implant mated with a glenoid implant associated with various postures and scapular angles. [Figure 23] A shoulder model is disclosed that includes a humeral implant mated with a glenoid implant associated with various postures and scapular angles. [Figure 24] Another shoulder model is disclosed that includes a humeral implant mated with a glenoid implant associated with posture and scapular angle. [Figure 25] Another shoulder model is disclosed that includes a humeral implant mated with a glenoid implant associated with posture and scapular angle. [Figure 26] Another shoulder model is disclosed that includes a humeral implant mated with a glenoid implant associated with posture and scapular angle. [Figure 27] A method for planning a surgical procedure for an individual patient using a surgical planning system is disclosed. [Figure 28] A patient shoulder model is disclosed. [Figure 29] A patient shoulder model is disclosed. [Figure 30] A patient shoulder model is disclosed. [Figure 31] A patient shoulder model is disclosed. [Figure 32] A patient shoulder model is disclosed. [Figure 33]A method for planning a surgical procedure for an individual patient using a surgical planning system is disclosed. [Figure 34] An anatomical model is disclosed. [Figure 35] 35 discloses a bone model associated with the anatomical model of FIG. 34 positioned relative to another bone model. [Figure 36] An anatomical model associated with a plane of motion of an anatomical structure is disclosed. [Figure 37] An anatomical model associated with a plane of motion of an anatomical structure is disclosed. [Figure 38] An anatomical model associated with a plane of motion of an anatomical structure is disclosed. [Figure 39] An anatomical model associated with a plane of motion of an anatomical structure is disclosed. [Figure 40] An anatomical model associated with a plane of motion of an anatomical structure is disclosed. [Figure 41] An anatomical model associated with a plane of motion of an anatomical structure is disclosed. [Figure 42] An anatomical model associated with a plane of motion of an anatomical structure is disclosed. [Figure 43] An anatomical model associated with a plane of motion of an anatomical structure is disclosed. [Figure 44] An anatomical model associated with a plane of motion of an anatomical structure is disclosed. [Figure 45] An anatomical model associated with a plane of motion of an anatomical structure is disclosed. [Figure 46] An anatomical model associated with a plane of motion of an anatomical structure is disclosed. [Figure 47] An anatomical model associated with a plane of motion of an anatomical structure is disclosed. [Figure 48] An anatomical model associated with a plane of motion of an anatomical structure is disclosed. [Figure 49] An anatomical model associated with a plane of motion of an anatomical structure is disclosed. [Figure 50]An anatomical model associated with a plane of motion of an anatomical structure is disclosed. [Figure 51] An anatomical model associated with a plane of motion of an anatomical structure is disclosed. DETAILED DESCRIPTION OF THE INVENTION

[0017] Like reference numbers and designations in the various drawings indicate like elements.

[0018] The present disclosure is directed to improved surgical planning systems and methods for planning orthopedic procedures, including creating, editing, executing, and / or reviewing surgical plans preoperatively, intraoperatively, and / or postoperatively. The surgical planning systems and methods may be utilized to plan and execute orthopedic procedures to restore joint function. These and other features of the present disclosure are discussed in more detail in the following sections of the detailed description.

[0019] According to an embodiment, a surgical planning system may include a processor. The processor may be configured to classify a representative patient population into a plurality of anatomical body size categories. The processor may be configured to perform a range of motion simulation for each of the plurality of anatomical body size categories. A storage system may be operatively connected to the processor and configured to store range of motion data derived from the range of motion simulation for each of the plurality of anatomical body size categories.

[0020] In any embodiment, the range of motion simulation can be configured to simulate motion-related characteristics associated with a virtual joint that can be derived from a representative patient population. The virtual joint can include one or more bones and can include virtual surgical implants positioned relative to the one or more bones.

[0021] In any embodiment, the motion-related characteristic may include abduction, adduction, extension, flexion, internal rotation, external rotation, or any combination thereof.

[0022] In any embodiment, the processor may be configured to identify a collision point that may indicate a maximum range of motion associated with the motion-related characteristic.

[0023] In any embodiment, the processor may be configured to identify an angular arc and a collision mode associated with the collision point.

[0024] In any embodiment, the processor may be configured to adjust the position of the virtual surgical implant relative to one or more bones in multiple offset directions.

[0025] In any embodiment, the processor may be configured to identify a second angular arc and a second collision mode associated with the second collision point based on the adjusted position of the virtual surgical implant.

[0026] In any embodiment, the processor may be configured to receive image data associated with a patient. The processor may be configured to generate a three-dimensional model of the patient's bones or joints based on the image data. The processor may be configured to assign one of a plurality of anatomical body size categories to the three-dimensional model of the bones or joints. The processor may be configured to display range of motion data for the assigned anatomical body size category.

[0027] In any embodiment, the processor may be configured to receive input of activities of daily living goals for the patient. The processor may be configured to adjust the position of the virtual surgical implant within the three-dimensional model to achieve the activities of daily living goals.

[0028] In any embodiment, the processor may be configured to query a surgical outcome database of the surgical planning system for post-operative surgical outcome data. The processor may be configured to assign one of a plurality of anatomical body size classifications to an anatomical structure associated with the post-operative surgical outcome data. The processor may be configured to update range of motion data associated with the assigned anatomical body size classification based on the post-operative surgical outcome data.

[0029] According to an embodiment, a computer-implemented surgical planning method may include classifying, via a processor of a surgical planning system, a representative patient population into a plurality of anatomical body size categories. The method may include performing a range of motion simulation for each of the plurality of anatomical body size categories. The method may include storing range of motion data derived from the range of motion simulation for each of the plurality of anatomical body size categories within a storage system of the surgical planning system.

[0030] In any embodiment, the range of motion simulation can be configured to simulate motion-related characteristics associated with a virtual joint that can be derived from a representative patient population. The virtual joint can include one or more bones and can include virtual surgical implants positioned relative to the one or more bones.

[0031] In any embodiment, performing a range of motion simulation may include identifying a collision point that may exhibit a maximum range of motion associated with a motion-related characteristic within the virtual joint.

[0032] In any embodiment, performing a range of motion simulation may include identifying an angular arc and impact mode associated with the impact point.

[0033] In any embodiment, performing the range of motion simulation may include adjusting the position of the virtual surgical implant relative to one or more bones in multiple offset directions.

[0034] In any embodiment, performing the range of motion simulation may include identifying a second angular arc and a second collision mode associated with a second collision point based on the adjusted position of the virtual surgical implant.

[0035] In any embodiment, the motion-related characteristic may include abduction, adduction, extension, flexion, internal rotation, external rotation, or any combination thereof.

[0036] In any embodiment, a method may include receiving image data associated with a patient. The method may include generating a three-dimensional model of a bone or joint of the patient based on the image data. The method may include assigning one of a plurality of anatomical body size categories to the three-dimensional model of the bone or joint. The method may include displaying range of motion data for the assigned anatomical body size category.

[0037] In any embodiment, the method may include receiving input of a patient's activity of daily living goals. The method may include adjusting a position within the three-dimensional model of a virtual surgical implant to achieve the activity of daily living goals.

[0038] In any embodiment, the method may include querying a surgical outcome database of the surgical planning system for post-operative surgical outcome data. The method may include assigning one of a plurality of anatomical body size classifications to an anatomical structure associated with the post-operative surgical outcome data. The method may include updating range of motion data associated with the assigned anatomical body size classification based on the post-operative surgical outcome data.

[0039] According to an embodiment, the surgical planning system can include a processor configured to perform a range of motion simulation based on one or more parameters associated with the patient's posture. A storage system can be operatively connected to the processor and configured to store range of motion data derived from the range of motion simulation.

[0040] In any embodiment, the one or more parameters may include a scapular angle associated with the patient's scapula.

[0041] According to an embodiment, a surgical planning system can include a processor configured to determine one or more posture parameters associated with a patient's posture, and the processor can be configured to adjust the implant plan based on the one or more posture parameters.

[0042] In any embodiment, the implant plan may include implant type, implant size, and implant location.

[0043] In any embodiment, the processor may be configured to perform a range of motion simulation based on one or more posture parameters.

[0044] According to an embodiment, a computer-implemented surgical planning method can include performing a range of motion simulation based on one or more parameters associated with a patient's posture, and storing range of motion data derived from the range of motion simulation in a storage system of the surgical planning system.

[0045] In any embodiment, the one or more parameters may include a scapular angle associated with the patient's scapula.

[0046] According to an embodiment, a surgical planning system can include a processor configured to register at least one bone model from a local frame of reference to a global frame of reference, and to establish a surgical plan associated with the at least one bone model in the global frame of reference.

[0047] In any embodiment, the processor can be configured to generate a statistical shape model associated with the at least one bone model registered to the global frame of reference, and the processor can be configured to establish a surgical plan based on the statistical shape model.

[0048] In any embodiment, the processor may be configured to determine one or more posture parameters associated with the patient's posture, and the processor may be configured to register the at least one bone model based on the one or more determined posture parameters.

[0049] In any embodiment, the processor may be configured to perform a range of motion simulation based on one or more posture parameters.

[0050] In any embodiment, the processor may be configured to generate a statistical shape model associated with at least one bone model registered to the global frame of reference.

[0051] In any embodiment, the processor may be configured to assign an anatomical body type classification to a statistical shape model.

[0052] In any embodiment, the processor may be configured to determine one or more posture parameters associated with the patient's posture, and the processor may be configured to register the at least one bone model based on the one or more determined posture parameters.

[0053] In any embodiment, the processor may be configured to establish an anatomical body size classification based on a plurality of modes, which may include at least one mode associated with one or more posture parameters.

[0054] In any embodiment, the processor may be configured to perform a range of motion simulation based on one or more posture parameters.

[0055] According to an embodiment, a surgical planning system may include a processor and a memory operatively coupled to the processor. The memory may be configured to store at least one bone model including one or more coordinate values. The processor may be configured to register the at least one bone model of a patient from a local frame of reference to a global frame of reference in response to adjusting the one or more coordinate values ​​based on a patient's posture. The processor may be configured to establish a surgical plan associated with the at least one bone model in the global frame of reference.

[0056] In any embodiment, the at least one bone model may be associated with the patient's scapula. The processor may be configured to determine a scapula axis that may extend through a reference point along an articular surface of the at least one bone model. The articular surface may be associated with a glenoid cavity of the scapula. The processor may be configured to determine a scapula plane through the at least one bone model such that the scapula plane may extend along the scapula axis. The processor may be configured to substantially align the scapula plane with a reference plane of the global frame of reference to register the at least one bone model to the global frame of reference. The reference plane may extend along a first axis and a second axis of the global frame of reference.

[0057] In any embodiment, the processor may be configured to establish a surgical plan in response to comparing at least one bone model of the patient with a bone model of another patient.

[0058] In any embodiment, the processor may be configured to register the at least one bone model based on one or more posture parameters associated with a posture of the patient, the one or more posture parameters may establish a transformation between the local frame of reference and the global frame of reference.

[0059] In any embodiment, the surgical plan may include an implant type, implant size, and / or implant location associated with the implant model.

[0060] In any embodiment, the processor may be configured to position the implant model based on movement of the at least one bone model relative to one or more planes of motion.

[0061] In any embodiment, the processor may be configured to position the implant model and the at least one bone model relative to one another in a global frame of reference based on the position of the implant specified in the surgical plan.

[0062] In any embodiment, the one or more posture parameters may include a scapular angle associated with the scapula.

[0063] In any embodiment, the one or more posture parameters may include a set of posture types, each of which may be associated with a discrete range of scapular angles and a respective transformation between the local and global frames of reference, and the processor may be configured to apply the transformation of a selected one of the posture types to the at least one bone model to register the at least one bone model to the global frame of reference.

[0064] In any embodiment, the processor may be configured to determine one or more attitude parameters. The processor may be configured to receive the one or more attitude parameters based on user input.

[0065] In any embodiment, the processor may be configured to perform a range of motion simulation based on one or more posture parameters.

[0066] In any embodiment, the processor may be configured to select a representative bone model from a set of representative bone models associated with the statistical shape model. The statistical shape model and the at least one bone model may be associated with a common bone of the anatomical structure. The processor may be configured to register the at least one bone model to a global frame of reference based on the selected representative bone model.

[0067] In any embodiment, each representative anatomical model of the set of representative bone models may be assigned a respective anatomical size classification based on the statistical shape model, and the processor may be configured to assign the anatomical size classification of the selected representative bone model to the at least one bone model.

[0068] In any embodiment, the processor may be configured to determine one or more posture parameters associated with the patient's posture, and the processor may be configured to register the at least one bone model to a global frame of reference based on the one or more determined posture parameters.

[0069] In any embodiment, the processor may be configured to establish an anatomical body size classification based on a plurality of modes, which may include at least one mode associated with one or more posture parameters.

[0070] In any embodiment, the processor may be configured to perform a range of motion simulation of the at least one bone model in a global frame of reference based on one or more posture parameters and / or the assigned anatomical body size classification.

[0071] In any embodiment, the processor may be configured to position the implant model based on movement of the at least one bone model relative to one or more planes of motion.

[0072] According to an embodiment, a computer-implemented surgical planning method can include registering at least one bone model of a patient from a local frame of reference to a global frame of reference. The method can adjust one or more coordinate values ​​associated with the at least one bone model based on the patient's posture. The method can include establishing a surgical plan associated with the at least one bone model in the global frame of reference.

[0073] In any embodiment, the surgical plan may include an implant type, an implant size, and / or an implant location associated with the implant model. The method may include positioning the implant model and the at least one bone model relative to one another in a global frame of reference based on the implant location specified in the surgical plan.

[0074] In any embodiment, the method may include determining one or more surgical measurements associated with the patient's posture. The method may include establishing a transformation between the local frame of reference and the global frame of reference based on the determined one or more surgical measurements. The registering step may include applying the transformation to the at least one bone model.

[0075] In any embodiment, the at least one bone model can be associated with the patient's scapula. The method can include fitting a scapular plane via the at least one bone model. Registering the at least one bone model can include adjusting an orientation of the at least one bone model with the mating scapular plane.

[0076] In any embodiment, establishing the surgical plan may include selecting a representative bone model from a set of representative bone models associated with a statistical shape model. The statistical shape model and the at least one bone model may be associated with a common bone of the anatomy. Establishing the surgical plan may include comparing the at least one bone model with the selected representative bone model.

[0077] In any embodiment, the method may include performing a range of motion simulation based on one or more parameters associated with the patient's posture. The method may include storing range of motion data derived from the range of motion simulation in a storage system of the surgical planning system.

[0078] In any embodiment, the at least one bone model may be associated with a scapula of the patient, and the one or more parameters may include a scapular angle associated with the scapula.

[0079] In any embodiment, the method may include positioning the implant model based on movement of the at least one bone model relative to one or more planes of motion.

[0080] 1 illustrates an exemplary surgical planning system 10 (hereinafter referred to as "system 10"). System 10 may be used to plan orthopedic procedures, including creating, editing, reviewing, refining, and / or executing surgical plans preoperatively, intraoperatively, and / or postoperatively. System 10 may be utilized for various orthopedic and other surgical procedures, such as, for example, arthroplasty to repair a joint.

[0081] Shoulder arthroplasty may be referenced periodically throughout this disclosure to illustrate or highlight particular features of system 10. However, the teachings of the present disclosure are not intended to be limited to any particular joint of the human musculoskeletal system and, therefore, should be understood as applicable to the shoulder, knee, hip, ankle, wrist, etc. Furthermore, the teachings of the present disclosure are not intended to be limited to arthroplasty procedures and, therefore, are applicable to the repair of fractures and / or other deformities within the scope of the present disclosure.

[0082] System 10 may include, among other things, at least one host computer 12, one or more client computers 14, one or more imaging devices 16, a cloud-based storage system 18, and a network 20. System 10 may include a greater or lesser number of subsystems within the scope of this disclosure.

[0083] Host computer 12 may be configured to execute one or more software programs. In some embodiments, host computer 12 may be two or more computers configured in cooperation to process software instructions serially or in parallel.

[0084] Host computer 12 may be in communication with network 20, which may itself include one or more computing devices. Network 20 may be, for example, a private local area network (LAN), a private wide area network (WAN), the Internet, or a mesh network.

[0085] The host computer 12 and each client computer 14 may include one or more of a computer processor, memory, storage means, network devices, and input and / or output devices and / or interfaces. Input devices may include a keyboard, mouse, etc. Output devices may include a monitor, speakers, printer, etc. Memory may include, for example, UVPROM, EEPROM, FLASH, RAM, ROM, DVD, CD, hard drive, or other computer-readable medium capable of storing data and / or other information related to the surgical planning and implementation techniques disclosed herein. The host computer 12 and each client computer 14 may be a desktop computer, laptop computer, smartphone, tablet, virtual machine, or any other computing device. Interfaces may facilitate communication with other systems and / or components of the network 20.

[0086] Each client computer 14 may be configured to communicate with the host computer 12 either directly, such as via a direct client interface 22, or through a network 20. In other embodiments, the client computers 14 are configured to communicate directly with each other via a peer-to-peer interface 24.

[0087] Each client computer 14 may be coupled to one or more imaging devices 16. Each imaging device 16 may be configured to capture or acquire one or more images 26 of a patient's anatomy present within a scan field (e.g., window) of the imaging device 16. The imaging devices 16 may be configured to capture or acquire two-dimensional (2D) and / or three-dimensional (3D) grayscale and / or color images 26. A variety of imaging devices 16 may be utilized, including, but not limited to, an X-ray machine, a computed tomography (CT) machine, or a magnetic resonance imaging (MRI) machine, for acquiring one or more images 26 of a patient.

[0088] The client computers 14 may also be configured to execute one or more software programs, such as those associated with various surgical planning tools. Each client computer 14 may be operable to access, locally and / or remotely execute, a planning environment 28 for creating, editing, executing, refining, and / or reviewing one or more surgical plans 36 during the pre-operative, intra-operative, and / or post-operative phases of a surgical procedure. The planning environment 28 may be a standalone software package or may be incorporated into another surgical tool. The planning environment 28 may be configured to communicate with the host computer 12 either through the network 20 or directly through a direct client interface 22.

[0089] The planning environment 28 may be further configured to interact with one or more of the imaging devices 16 to capture or obtain images 26 of the patient's anatomy. The planning environment 28 may provide for display or visualization of one or more images 26, bone models 30, implant models 32, transmission models 34, and / or surgical plans 36 via one or more graphical user interfaces (GUIs). Each image 26, bone model 30, implant model 32, transmission model 34, surgical plan 36, and other data and / or information may be associated with a specified data structure and stored in one or more files or records.

[0090] The planning environment 28 may include various modules for performing desired planning functions. For example, as discussed further below, the planning environment 28 may include a data module for accessing, retrieving, and / or storing data related to the surgical plan 36, a display module for displaying the data (e.g., in 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 a selected bone model and a selected implant model. 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.

[0091] Storage system 18 may be operable to store or otherwise provide data from / to other computing devices, such as host computer 12 and / or one or more client computers 14 of system 10. Storage system 18 may be, for example, a storage area network device (SAN) configured to communicate with host computer 12 and / or client computers 14 over network 20. While storage system 18 is shown as a separate device in system 10, in some embodiments it may be incorporated within or directly coupled to host computer 12 and / or client computer 14. Storage system 18 may be configured to store one or more of computer software instructions, data, database files, configuration information, etc.

[0092] In some embodiments, system 10 may be a client-server architecture configured to execute computer software on host computer 12, which may be accessible by client computer 14 using either a thin client application or a web browser that may be executed on client computer 14. Host computer 12 may load computer software instructions into memory from local storage or from storage system 18 and may execute the computer software using one or more computer processors.

[0093] The system 10 may further include one or more databases 38. The databases 38 may be stored in a central location, such as on the storage system 18. In another embodiment, the one or more databases 38 may be stored on the host computer 12 and / or may be distributed databases provided by one or more of the client computers 14. Each database 38 may be a relational database configured to associate one or more images 26, bone models 30, implant models 32, and / or transfer models 34 with each other and / or with a respective surgical plan 36. Each surgical plan 36 may be associated with a respective patient anatomy. Each image 26, bone model 30, implant model 32, transfer model 34, and surgical plan 36 may be assigned a unique identifier or database entry for storage on the storage system 18. Each database 38 may be configured to store data and other information corresponding to the images 26, bone models 30, implant models 32, transfer models 34, and surgical plans 36 in 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 image 26, bone model 30, implant model 32, transfer model 34, and surgical plan 36. The various data stored in the databases 38 may correspond to the respective patient's anatomy from previous surgical cases and may be arranged into one or more predetermined categories, such as gender, age, race, defect classification, procedure type, anatomical size classification, surgeon, facility, or organization.

[0094] Each image 26 and bone model 30 may include data and other information obtained from one or more medical devices or tools, such as imaging device 16. Bone model 30 may include one or more digital images and / or coordinate information related to the patient's anatomy obtained or derived from images 26 captured or otherwise obtained by imaging device 16.

[0095] Each implant model 32 and transfer model 34 may include coordinate information associated with a given design or design established or modified by the planning environment 28. A given design may correspond to one or more components. The planning environment 28 incorporates and / or interfaces with one or more modeling packages, such as a computer-aided design (CAD) package, to render the models 30, 32, 34 as two-dimensional (2D) and / or three-dimensional (3D) volumes or constructs, which may overlay one or more of the images 26 within the display screen of the GUI.

[0096] The implant models 32 may correspond to implants and components of various shapes and sizes. Each implant may include one or more components that can be placed at a surgical site, including screws, anchors, grafts, etc. Each implant model 32 may correspond to a single component or may include two or more components that can be configured to establish an assembly. Each implant and associated components may be formed from a variety of materials, including metallic and / or non-metallic materials. Each bone model 30, implant model 32, and transfer model 34 may correspond to 2D and / or 3D geometric shapes and may be utilized to generate wireframe, mesh, and / or solid constructs within the GUI.

[0097] Each surgical plan 36 may be associated with one or more of the images 26, bone models 30, implant models 32, and / or transfer models 34. The surgical plan 36 may include various parameters associated with the images 26, bone models 30, implant models 32, and / or transfer models 34. For example, the surgical plan 36 may include parameters related to bone density and bone quality associated with the patient's anatomical structures captured in the images 26. The surgical plan 36 may include parameters including spatial information related to the relative positioning and coordinate information of the selected bone models 30, implant models 32, and / or transfer models 34.

[0098] The surgical plan 36 may define one or more corrections to the bone model 30 and information related to the position of the implant model 32 and / or transfer model 34 relative to the original and / or corrected bone model 30. The surgical plan 36 may include coordinate information related to the corrected bone model 30 and the relative positions of the implant model 32 and / or transfer model 34 in one or more predetermined data structures. The planning environment 28 may be configured to perform one or more corrections to the various models either automatically or in response to user interaction with a user interface. Corrections to each bone model 30, implant model 32, transfer model 34, and / or surgical plan 36 may be stored in one or more of the databases 38 either automatically and / or in response to user interaction with the system 10.

[0099] One or more surgeons and / or other staff users may be presented with the planning environment 28 via the client computers 14 and may simultaneously access the images 26, bone models 30, implant models 32, transfer models 34, and surgical plans 36 stored in the database 38. Each user may interact with the planning environment 28 to create, view, refine, and / or modify various aspects of the surgical plan 36. Each client computer 14 may be configured to store local instances of the images 26, bone models 30, implant models 32, transfer models 34, and / or surgical plans 36, which may be synchronized in real time or periodically with the database 38. The planning environment 28 may be a standalone software package executing on the client computer 14 or may be provided as one or more web-based services executing on the host computer 12, for example.

[0100] The above-described system 10 may be configured to pre-plan a surgical procedure. The pre-operative planning provided by the system 10 may include features such as, but not limited to, building a virtual model of the patient's anatomy, classifying the virtual model, identifying landmarks within the virtual model, and selecting and orienting virtual implants within the virtual model.

[0101] 2, with continued reference to FIG. 1, the system 10 may include a computing device 40 including at least one processor 42 operably coupled to a memory 44 capable of storing computer-executable instructions. The computing device 40 may be considered representative of any of the computing devices disclosed herein, including, but not limited to, the host computer 12 and / or the client computer 14. The processor 42 may be configured to execute one or more of the planning environments 28 for creating, editing, executing, refining, and / or reviewing one or more surgical plans 36 and any associated bone models 30, implant models 32, and transfer models 34 during pre-operative, intra-operative, and / or post-operative phases of a surgical procedure.

[0102] The processor 42 may be a custom or commercially available processor, a central processing unit (CPU), or generally any device for executing software instructions. The memory 44 may include any one or combination of volatile and / or non-volatile memory elements. The processor 42 may be operatively coupled to the memory 44 and configured to execute one or more programs stored in the memory 44 based on various inputs received from other devices or data sources.

[0103] Planning environment 28 may include at least a data module 46, a display module 48, a spatial module 50, and a comparison module 52. Although four modules are shown, it should be understood that a greater or lesser number of modules may be utilized and / or further, one or more of the modules may be combined to provide the disclosed functionality.

[0104] The data module 46 may be configured to access, retrieve, and / or store data and other information corresponding to one or more images 26 of the patient's anatomy, bone model 30, implant model 32, transfer model 34, and / or surgical plan 36 in a database 38. The data and other information may be stored in the one or more databases 38 as one or more records or entries 54. In some embodiments, the data and other information may be stored in one or more files accessible by referencing one or more objects or memory locations referenced by the entries 54.

[0105] The memory 44 may be configured to access, load, edit, and / or store instances of one or more images 26, bone models 30, implant models 32, transmission models 34, and / or surgical plans 36 in response to one or more commands from the data module 46. The data module 46 may be configured to cause the memory 44 to store local instances of the images 26, bone models 30, implant models 32, transmission models 34, and / or surgical plans 36, which may be synchronized with entries 54 stored in the database 38.

[0106] The data module 46 may be configured to receive data and other information corresponding to at least one or more images 26 of the patient's anatomy from various sources, such as the imaging device 16. The data module 46 may be further configured to instruct and command the imaging device 16 to capture or acquire the images 26 automatically or in response to user interaction.

[0107] The display module 48 may be configured to display data and other information related to the one or more surgical plans 36 in at least one graphical user interface (GUI) 56, including one or more of the images 26, bone model 30, implant model 32, and / or transfer model 34. The computing device 40 may incorporate or be coupled to the display device 58. The display module 48 may be configured to enable the display device 58 to display information in the user interface 56. A surgeon or other user may interact with the user interface 56 within the planning environment 28 to view one or more images 26 of the patient's anatomy and / or any associated bone model 30, implant model 32, and transfer model 34. A surgeon or other user may interact with the user interface 56 via the planning environment 28 to create, edit, execute, refine, and / or review one or more surgical plans 36.

[0108] User interface 56 may include one or more display windows 60 and one or more objects 62 that may be presented within display windows 60. Display windows 60 may include any number of windows, and objects 62 may include any number of objects within the scope of this disclosure.

[0109] The surgeon or user may interact with the user interface 56, including objects 62 and / or display windows 60, to retrieve, view, edit, and store various aspects of the respective surgical plan 36, which may include information from the selected image 26, bone model 30, implant model 32, and / or transfer model 34. The objects 62 may include graphics such as menus, tabs, buttons, drop-down lists, directional indicators, etc. The objects 62 may be organized into one or more menu items associated with the respective display windows 60. Geometric objects containing the selected image 26, bone model 30, implant model 32, transfer model 34, and / or other information regarding the surgical plan 36 may be displayed in one or more of the display windows 60. Each transfer model 34 may include one or more surgical instruments used to implant the selected implant as part of the surgical plan 36.

[0110] The surgeon may interact with the objects 62 to specify various aspects of the surgical plan 36. For example, the surgeon may select one of the tabs to view or identify an aspect of the surgical plan 36 for one portion of the joint, such as the glenoid, and may select another of the tabs to view or identify an aspect of the surgical plan 36 for another portion of the joint, such as the humerus. The surgeon further takes various measurements of the joint (e.g., linear, angular, tissue density, etc.) as part of specifying aspects of the surgical plan 36.

[0111] The surgeon may interact with menu items to select and specify various aspects of the bone model 30, implant model 32, and / or transfer model 34 from the database 38. For example, the display module 48 may be configured to display one or more bone models 30 along with respective images 26 of the patient's anatomy and implant model 32 selected in response to the user's interaction with the user interface 56. The user may interact with drop-down lists of objects 62 in the display window 60 to specify the implant type, resection angle, and implant size. The resection angle menu item may be further associated with a resection plane.

[0112] The user may also interact with various buttons to change (e.g., increase or decrease) the resection angle. The user may interact with buttons adjacent to the selected implant model 32 to change (e.g., increase or decrease) the size of components of the selected implant model 32. The buttons may be overlaid on or located adjacent to the display window 60.

[0113] The user may further interact with the direction indicator to move a portion of the selected implant model 32 in different directions (e.g., up, down, left, right) within one of the display windows 60. The surgeon may, for example, utilize a mouse or other input device to drag or otherwise move the selected implant model 32 to a desired position within the display window 60. The surgeon may interact with one of the drop-down lists to specify the type and / or size of a component of the selected implant model 32.

[0114] The display module 48 may be configured to superimpose one or more of the bone model 30, the implant model 32, and the transfer model 34 over one or more of the images 26 in one or more of the display windows 60. The implant model 32 may include one or more components that establish an assembly. At least a portion of the implant model 32 may be configured to be at least partially received in a selected one of the volumes of the bone model 30. In some embodiments, the implant model 32 may have an articular surface sized to mate with an articular surface of an opposing bone or implant.

[0115] The display windows 60 may be configured to display the image 26, bone model 30, implant model 32, and / or transfer model 34 in various orientations. The display module 48 may be configured to display a two-dimensional (2D) representation of a selected bone model 30, implant model 32, and / or transfer model 34 in some display windows 60, and may be configured to display a 3D representation of the selected bone model 30, implant model 32, and / or transfer model 34 in other display windows 60, for example. The surgeon may interact with the user interface 56 to move (e.g., up, down, left, right, rotate, etc.) the selected bone model 30, selected implant model 32, and / or selected transfer model 34 in 2D and / or 3D space. Other embodiments for displaying 2D and / or 3D representations in the various display windows 60 are further contemplated within the scope of the present disclosure.

[0116] The display module 48 may be further configured such that a selected image 26, bone model 30, implant model 32, and / or transfer model 34 may be selectively displayed and hidden (e.g., toggled) within one or more of the display windows 60 in response to user interaction with the user interface 56, which may provide the surgeon with improved flexibility when reviewing aspects of the surgical plan 36. For example, the surgeon may interact with a drop-down list of objects 62 to selectively display and hide components of the selected implant model 32 within one of the display windows 60.

[0117] The selected bone model 30 may correspond to a bone associated with a joint, including any of the example joints disclosed herein. The display module 48 may be configured to display a cross-sectional view of the selected bone model 30 and the selected implant model 32, for example, in one or more of the display windows 60. The cross-sectional view of the bone model 30 may be presented or displayed along with the associated image 26 of the patient's anatomy.

[0118] The spatial module 50 can be configured to establish one or more resection planes along the selected bone model 30. A volume of the selected implant model 32 can be at least partially received in the volume of the selected bone model 30 along the resection planes. The resection planes can be defined by resection angles.

[0119] The spatial module 50 may further be configured to cause the display module 48 to display the resected portion of the selected bone model 30 in one of the display windows 60 in a manner different from the remaining portion of the bone model 30 on the opposite side of the resection plane. For example, the resected portion of the bone model 30 may be hidden from view in the display window 60 so that 26 respective portions of the patient's anatomy are shown. In other embodiments, the resected portion of the selected bone model 30 may be displayed in a relatively darker shade. The spatial module 50 may determine the resected portion, for example, by comparing the coordinates of the bone model 30 with the location of the resection plane. A user may interact with one or more buttons of the object 62 to toggle between the previous state and the modified (e.g., resected) state of a volume of the selected bone model 30.

[0120] Planning environment 28 may be further configured so that changes in one of the display windows 60 are synchronized with each of the other windows 60. The changes may be synchronized automatically and / or manually between the display windows 60 in response to user interaction.

[0121] The surgeon may utilize various instruments and devices to execute each surgical plan 36, which includes creating a surgical site and securing one or more implants to bone or other tissue to restore function to the respective joint. Each of the transfer models 34 may be associated with a respective surgical instrument or device (e.g., a transfer guide, etc.) or a respective implant model 32.

[0122] The surgical plan 36 may be associated with one or more positioning objects, such as guide pins (e.g., guide wires or Kirschner wires) sized to be anchored within tissue to position and orient various instruments, devices, and / or implants. The display module 48 may be configured to display virtual positions and virtual axes within one or more of the display windows 60. The virtual positions may be associated with specified positions of the positioning objects relative to the patient's anatomy (as represented by the image 26). The virtual axes may extend through the virtual positions and be associated with specified orientations of the positioning objects relative to the patient's anatomy. The spatial module 50 may be configured to set the virtual positions and / or virtual axes in response to placement of each implant model 32 relative to the bone model 30 and the associated patient's anatomy. The virtual positions and / or virtual axes may be automatically set and / or adjusted based on the position and orientation of the selected implant model 32 relative to the selected bone model 30 and / or in response to user interaction with the user interface 56.

[0123] The spatial module 50 may be further configured to determine one or more collision or contact points associated with the patient's anatomy. The contact points may be associated with one or more landmarks or other surface features along the bone model 30 and / or other portions of the patient's anatomy. Each contact point may be established along an articular or non-articular surface of a joint. The spatial module 50 may be configured to set the contact points based on a virtual position, a virtual axis, and / or the position and orientation of each implant model 32 relative to the patient's anatomy. The spatial module 50 may be configured to cause the display module 48 to display the contact points in one or more display windows 60. In some embodiments, the contact points may be automatically set and / or adjusted based on the position of the implant model 32 and / or in response to user interaction with the user interface 56. The virtual positions, virtual axes, and / or contact points may be stored in one or more entries 54 in the database 38 and associated with each surgical plan 36.

[0124] The comparison module 52 may be configured to generate or set one or more parameters associated with the implementation of the surgical plan 36. The parameters may include one or more settings or dimensions associated with each transfer model 34. The parameters may be based on a virtual position, a virtual axis, and / or a contact point CP. The comparison module 52 may be configured to determine one or more settings or dimensions associated with each transfer model 34 relative to the patient's anatomy, the bone model 30, the implant model 32, the virtual position, the virtual axis, and / or the contact point CP. The dimensions and settings may be used to form a physical instance of each respective transfer model 34. The settings may be used to specify the position and orientation of each respective transfer model 34 relative to the implant model 32 and / or the bone model 30. The settings may be used to configure one or more transfer members (e.g., objects) and associated instruments or devices associated with the transfer model 34. The comparison module 52 may be configured to generate settings and / or dimensions such that the transfer model 34, when coupled to the respective implant model 32, will contact one or more predetermined locations on or along the bone model 30 or the patient's anatomy at the installation location. The predetermined locations may include one or more of the contact points. The settings and dimensions may be communicated using various techniques, including one or more images in the user interface 56 or an output file. The settings and / or dimensions may be stored in one or more entries 54 in the database 38 associated with the transfer model 34.

[0125] A user may interact with a list of objects 62 associated with one of the display windows 60 to select a desired transmission model 34 from the database 38. The display module 48 may be configured to display the selected transmission model 34 in the display window 60 at various positions and orientations. The spatial module 50 may be configured to set an initial position of the selected transmission model 34 relative to a virtual position, a virtual axis, and / or a contact point.

[0126] The user may interact with the user interface 56 to set or adjust the position and / or orientation of the selected transfer model 34. The user may interact with the directional indicators of the object 62 to move the selected transfer model 34 and / or virtual position in different directions (e.g., up, down, left, right) in the display window 60. The surgeon may, for example, utilize a mouse or other input device to drag or otherwise move the selected transfer model 34 and / or virtual position to a desired location in the display window 60. The user may interact with the rotation indicators of the object to adjust the position and / or orientation of the transfer model 34 about a virtual axis relative to the selected bone model 30 and / or implant model 32. The user may interact with the tilt indicators of the object 62 to adjust the orientation of the selected transfer model 34 and associated virtual axis in its virtual position relative to the selected bone model 30 and / or implant model 32. The user may interact with other buttons and / or directional indicators to articulate or otherwise move the transfer model 34. The transfer models 34 may be articulated or otherwise moved independently or synchronously, which may occur manually in response to user interaction and / or automatically in response to positioning the transfer models 34 relative to the bone model 30 and / or implant model 32. Movement of the transfer models 34 may automatically adjust the respective contact points.

[0127] Various transmission members may be utilized in the planning environment 28 to execute the surgical plan 36. Each transmission member may be associated with a respective transmission model 34. The transmission members may be incorporated into transmission guides, implants, and / or assemblies to set the position and orientation of each implant prior to securing or otherwise fixing the implant to the surgical site.

[0128] 2 and with continued reference to FIG. 3, a computing device 40 including a processor 42 may be operatively connected to a storage system, such as storage system 18. Computing device 40 may interface with storage system 18 over network 20 to access various databases 38 stored thereon in order to establish and execute a surgical plan 36.

[0129] The databases 38 of storage system 18 may include a patient profile database 64, a surgeon profile database 65, a surgical outcomes database 66, a range of motion database 68, and an anatomical body size classification database 70. Additional databases may be stored on and accessed from storage system 18 within the scope of the present disclosure. Furthermore, one or more of the databases, although shown as separate databases, may be combined or linked together. For example, the anatomical body size classification database 70 may be combined or linked with the surgical outcomes database 66, the range of motion database 68, or both.

[0130] The patient profile database 64 may include information that is part of the indexed and stored records or entries related to one or more current patients associated with the system 10. The information stored on the patient profile database 64 may include, for each patient, gender, age, race, height, weight, defect classification, procedure type, surgeon, facility or organization, major joints, ADL / lifestyle goal profile (e.g., desired post-operative range of motion for abduction, adduction, external rotation, internal rotation, extension, flexion, external rotation combined with 60° abduction, internal rotation combined with 60° abduction, etc.), current surgical plan information, etc. The patient profile database 64 may further store or link to images 26 for a given patient.

[0131] Surgeon profile database 65 may contain information that is part of the indexed and stored records or entries related to one or more surgeon users associated with system 10. Information stored on surgeon profile database 65 may include the surgeon's name, facility or organization, historical data regarding the types of previous surgeries planned by the surgeon using system 10, data regarding the types of implants included in the surgeon's pre-operative surgical plan, data regarding the actual implants utilized in the surgeon's previous surgeries, etc. In some embodiments, surgeon profile database 65 may interface with patient profile database 64 to link each surgeon from surgeon profile database 65 to that surgeon's patients listed in patient profile database 64.

[0132] The surgical outcomes database 66 may include information that is part of the indexed and stored records or entries related to one or more prior patients associated with the system 10. The surgical outcomes database 66 may be created based on information logged by surgeons and / or other staff users after performing each surgical procedure and at each follow-up visit to show the progress of prior patients. Information stored on the surgical outcomes database 66 may include, for each prior patient, gender, age, race, height, weight, defect classification, procedure type, specific implants used, surgeon, facility or organization, major joint, visual analog pain score, ASES score, achieved activities of daily living / lifestyle profile (e.g., desired achieved postoperative range of motion for abduction, adduction, external rotation, internal rotation, extension, flexion, external rotation combined with 60° abduction, internal rotation combined with 60° abduction, etc.), surgical planning information, etc. The surgical outcomes database 66 may additionally store or link to pre- and post-operative images 26 for each prior patient.

[0133] Range of motion database 68 may include information that is part of indexed and stored records or entries related to one or more current and previous patients associated with system 10. Range of motion database 68 may store range of motion data derived from range of motion simulations performed by computing device 40 for each surgical plan 36. The range of motion data may include information related to simulated joint movements (e.g., abduction / adduction, flexion / extension, internal rotation / external rotation, etc.), identified contact or collision points for various implant locations, angular arcs and collision modes (e.g., implant-to-implant, implant-to-bone, bone-to-bone, etc.) for various implant locations, adjusted centers of rotation of implants at multiple incremental and offset orientations for various implant locations, etc.

[0134] The anatomical size classification database 70 may store a plurality of anatomical size classifications that characterize the anatomical variations and anatomical variances within a representative patient population for one or more intended surgical procedures (e.g., total shoulder arthroplasty, reverse shoulder arthroplasty, etc.). In some embodiments, the representative patient population may be derived by analyzing image data, such as images from previous patients stored in the surgical outcomes database 66 and / or any other imaging source, associated with a plurality of previous patients who have already undergone the intended surgical procedure. Each of the plurality of anatomical size classifications is a numerical classification of the anatomical configuration of the bones or joints of a representative patient population.

[0135] 1-3, and with reference to FIG. 4, computing device 40 may interface with a statistical shape modeler 72 for creating anatomical body type classification database 70. Statistical shape modeler 72 may be a software package that may be stored in memory 44 or storage system 18 of computing device 40 and executed by processor 42.

[0136] The statistical shape modeler 72 may receive multiple sets of image data 74 associated with a target bone or joint. In some embodiments, the sets of image data 74 consist of tens of thousands of sets of image data. Each set of image data 74 may include 2D and / or 3D anatomical images specific to a previous patient of a representative patient population for the target bone or joint and associated with a given type of surgical procedure. The statistical shape modeler 72 may analyze the multiple sets of image data 74 to construct a statistical shape model 75.

[0137] Statistical shape modeler 72 may receive as input a number of predefined modes 76 used to analyze a number of sets of image data 74. Each of modes 76 is a descriptor configured to characterize anatomical variations within a bone or joint associated with statistical shape model 75. Exemplary modes 76 that may be provided to the statistical shape modeler 72 may include, but are not limited to, glenoid size, scapular size, amount of tilt, amount of torsion, predicted amount of glenoid and sagittal neck length, glenoid angle relative to scapular neck, critical shoulder angle, acromion and / or coracoid prediction, humeral head size, humeral head varus / valgus, femoral and / or tibial varus / valgus, femoral and / or tibial internal / external rotation, subscapularis, deltoid, and / or supraspinatus integrity, ML and AP widths, intercondylar notch depth, tibial slope, knee Q angle, ACL / PCL stability, MCL / LCL stability, amount of flexion, amount of extension, quality and quantity of soft tissue surrounding the joint, patellar tracking angle, bone density, bony subluxation rate, anatomical landmarks, joint space, preoperative range of motion, any combination of the foregoing, and the like.

[0138] In some embodiments, at least seven different modes may be utilized by statistical shape modeler 72 to characterize statistical shape model 75. However, a greater or lesser number of modes may be provided within the scope of the present disclosure.

[0139] In some embodiments, the modes 76 may not be pre-defined. Rather, the statistical shape modeler 72 may be programmed to utilize artificial intelligence (e.g., neural networks) or machine learning to estimate the modes that best relate to the bones or joints modeled in the statistical shape model 75.

[0140] The statistical shape modeler 72 may receive as another input a number of predetermined standard deviations 78 used to analyze the multiple sets of image data 74. Each standard deviation 78 may represent the anatomical variance contained within each of the multiple predefined modes 76 (e.g., distance between features, orientation of features, relative features, etc.). The standard deviations 78 may be used to validate percentile ranges of a representative patient population represented within the statistical shape model 75. In some embodiments, at least seven different standard deviations (e.g., −3, −2, −1, 0, 1, 2, and 3) may be utilized by the statistical shape modeler 72 to further characterize all anatomical variance contained within the anatomical structures described within the statistical shape model 75. However, a greater or lesser number of standard deviations may be utilized within the scope of the present disclosure.

[0141] Statistical shape modeler 72, in response to commands from processor 42, may combine multiple standard deviations 78 with multiple predefined modes 76 to assign multiple anatomical body size classifications 80N, where N is an arbitrary number for bones or joints associated with statistical shape model 75, to classify the anatomical configurations of the entire patient population represented in statistical shape model 75. Each anatomical body size classification 80N may then be stored in anatomical body size classification database 70 of storage system 18.

[0142] 5 shows an exemplary anatomical body size classification 80 assigned to a particular bone model 30 derived from statistical shape model 75. In one embodiment, bone model 30 is a 3D model of the scapula of the shoulder joint. However, other bones and joints can be classified in a similar manner.

[0143] 4 may analyze bone model 30 with respect to each of a plurality of modes 761-767 to characterize any anatomical differences in bone model 30 compared to other similar bones / joints associated with statistical shape model 75. Of course, a greater or lesser number of modes are possible.

[0144] The statistical shape modeler 72 may further characterize any anatomical variance contained within each of the plurality of predefined modes 761-767 by analyzing each of the modes against a plurality of standard deviations 781-787. Of course, greater or lesser numbers of standard deviations are possible.

[0145] 5 , bone model 30 is assigned the numeric value 0213120 as its anatomical size classification 80. This numeric value represents a standard deviation of 0 within the first mode 761, a standard deviation of 2 within the second mode 762, a standard deviation of 1 within the third mode 763, a standard deviation of 3 within the fourth mode 764, a standard deviation of 1 within the fifth mode 765, a standard deviation of 2 within the sixth mode 766, and a standard deviation of 0 within the seventh mode 767. Anatomical size classification 80 is a unique numerical identifier for describing the anatomical structure associated with bone model 30.

[0146] 6, with continued reference to FIGS. 1-5, schematically illustrates a method 84 for creating the above-described anatomical body classification database 70. Method 84 may be implemented as part of a surgical planning procedure. Fewer or additional steps than those listed below may be implemented within the scope of the present disclosure, and the order of the listed steps is not intended to limit the present disclosure. System 10 may be configured to perform each of the steps of method 84 via any of its associated computing devices and modules. In an exemplary embodiment, computing device 40 of host computer 12 may be programmed to perform method 84. However, other embodiments are also contemplated within the scope of the present disclosure.

[0147] A statistical shape model 75 representing a patient population having pathological anatomy associated with the intended surgery may be constructed at step 86. A plurality of modes 76 may be identified within the statistical shape model 75 at step 88. The modes 76 may characterize anatomical variations within the statistical shape model 75.

[0148] Next, at step 90, multiple standard deviations 78 of the anatomical variance contained within each of the modes 76 may be established. The standard deviations 78 may be used to validate percentile ranges of a representative patient population associated with the statistical shape model 75.

[0149] The standard deviation 78 may be combined with the mode 76 to create a plurality of unique anatomical body size classifications 80 in step 92. In step 94, the anatomical body size classifications 80 may be aggregated to form the anatomical body size classification database 70. Thus, the anatomical body size classification database 70 may represent a large variance within a representative patient population that may affect implant function.

[0150] As a further part of the method 84, an appropriately sized implant model 32 may be selected and positioned in a default starting position and orientation relative to the bone or joint associated with each of the plurality of anatomical body types 80 in step 96. Accordingly, the default starting position and orientation of the implant model 32 may also be linked to the anatomical body types 80 and stored as part of the anatomical body type database 70 in step 97.

[0151] Once established, anatomical body classification database 70 may enable additional features, processes, and / or capabilities to be implemented within or performed by system 10 to enhance surgical planning. Exemplary implementations of such features are detailed below.

[0152] 7 illustrates a method 98 for augmenting range of motion database 68 with information contained within anatomical body classification database 70, for example. Method 98 may be implemented as part of a surgical planning procedure. Fewer or additional steps than those listed below may be implemented within the scope of the present disclosure, and the order of the listed steps is not intended to limit the present disclosure. System 10 may be configured to perform each of the steps of method 98 via any of its associated computing devices and modules. In an exemplary embodiment, computing device 40 of host computer 12 may be programmed to perform method 98. However, other embodiments are also contemplated within the scope of the present disclosure.

[0153] First, at step 100, one or more motion simulations may be performed for each anatomical body size classification 80 stored on the anatomical body size classification database 70. The motion simulations may be performed within a range of motion modeler 101, which may be a software package stored in memory 44 or storage system 18 of computing device 40 and executed by processor 42 (see, e.g., FIG. 8 ). Range of motion modeler 101 may receive each of the anatomical body size classifications 80 (and each associated bone model 30 and implant model 32, including default implant starting positions and orientations) as input from the anatomical body size classification database 70 when performing the motion simulations.

[0154] The range of motion simulation actually performed in step 100 depends, among other criteria, on the type of bone or joint being analyzed. Examples of types of movements that may be simulated as part of step 100 of method 98 include, but are not limited to, abduction / adduction, flexion / extension, internal / external rotation, etc.

[0155] Contact or collision points may be identified in step 102 to identify range of motion endpoints for each range of motion simulation performed on each anatomical body type 80. The angular arc and collision mode (e.g., implant-to-implant, implant-to-bone, bone-to-bone, etc.) for each contact point may be recorded in step 104.

[0156] The centers of rotation of the implant models 32 positioned within the bone models 30 for each anatomical body type 80 may be adjusted in step 106. In some embodiments, this step may include adjusting each implant model 32 in at least three offset directions (e.g., medial, medial, and posterior) relative to the respective bone models 30 to simulate different positions of the implant models 32.

[0157] At step 108, the center of rotation of the implant model 32 for each anatomical size classification 80 may be adjusted in multiple increments relative to the respective bone model 30 to record the angular arc and impact mode associated with the adjusted position. All range of motion data derived from the simulations performed at steps 100-108 may then be stored in the range of motion database 68 at step 110.

[0158] FIG. 9 schematically illustrates a method 112 for planning an orthopedic surgical procedure for a respective patient using system 10. Method 112 may be implemented as part of a surgical planning procedure to prepare a surgical plan for the patient. Fewer or additional steps than those listed below may be implemented within the scope of the present disclosure, and the order of the listed steps is not intended to limit the present disclosure. System 10 may be configured to perform each of the steps of method 112 via any of its associated computing devices and modules. In an exemplary embodiment, one or more computing devices 40 of client computer 14 may be programmed to perform method 112. However, other embodiments are also contemplated within the scope of the present disclosure.

[0159] Image data of a target bone or joint of a patient may be received at step 114. The image data may be received directly from the imaging device 16 or may be obtained by accessing a record or entry associated with the patient from the patient profile database 64.

[0160] A 3D model 30 (FIG. 2) of the target bone or joint may be generated in step 116. The planning environment 28 of the computing device 40 may incorporate and / or interface with one or more modeling packages, such as computer-aided design (CAD) packages, to render the 3D model of the target bone or joint.

[0161] Next, at step 118, computing device 40 may query anatomical body size classification database 70 to find bone models stored therein that have similar anatomical body size classifications. The anatomical body size classification 80 ( FIG. 4 ) that is closest to the anatomical structure encompassed by 3D model 30 ( FIG. 2 ) may then be assigned to 3D model 30 at step 120 and displayed on the range of motion user interface of computing device 40 at step 122. As part of displaying the anatomical body size classification 80, a confidence level indicator may be displayed within the range of motion user interface to visually indicate the similarity between the assigned anatomical body size classification 80 and the anatomical structure being analyzed. The confidence level indicator may be displayed as a percentage or any other visual indicator.

[0162] The range of motion database 68 may be queried at step 124 to obtain range of motion data associated with the assigned anatomical size classification 80. The range of motion data associated with the assigned anatomical size classification 80, including information such as angle arc and impact mode, may be displayed on a range of motion user interface at step 126.

[0163] In step 128, the surgeon or other staff user of system 10 may be queried to select the patient's desired activity of daily living goals. The positioning of the implant model 32 may be automatically adjusted relative to the bone model based on the activity of daily living selected in step 130. System 10 may then output a recommended implant size / type and position and orientation to meet the activity of daily living selected in step 132.

[0164] The surgeon may be prompted to modify the recommended implant type, positioning, and / or orientation according to their clinical judgment at step 134. Method 112 may end at step 136 in 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 ROM database 68 and the range of motion achieved by the surgeon's planned position and orientation may be presented to the user within the graphical user interface. This step may further include informing the surgeon within the graphical user interface of any potential impact the proposed changes may be based on past surgical outcome data associated with previous patients with similar anatomical body classifications.

[0165] 10 illustrates an exemplary range of motion user interface 105 that may be provided during the method 112 discussed above. The range of motion user interface 105 may be presented within the planning environment 28, for example.

[0166] The range of motion user interface 105 may include a range of motion dashboard 107, a display window 109, and a control panel 111. The range of motion dashboard 107 may present various range of motion data to the user. The range of motion dashboard 107 may include multiple selectable buttons 113 related to basic joint motion expectations for the patient. The basic joint motion expectations that may be represented by the buttons 113 may include, but are not limited to, desired post-operative range of motion for abduction, adduction, external rotation, internal rotation, extension, flexion, external rotation combined with 60 degrees of abduction, and internal rotation combined with 60 degrees of abduction.

[0167] The range of motion dashboard 107 may further include a bar graph 115 to show range of motion data for each of the underlying joint motion expectations. For example, the bar graph 115 may provide a visual indication of the range of motion achieved for a selected underlying joint motion expectation for one or more AMCs 80 (FIG. 4) that most closely resemble the patient's anatomy for which the surgical plan is being created.

[0168] The display window 109 may include a 3D window 117 and multiple 2D windows 119. A virtual bone model 121 of the patient's anatomy may be displayed within the 3D window 117 and the 2D window 119. The positioning of both virtual guide pins 123 and virtual implants 125 required to achieve the desired joint motion expectations may be displayed relative to the virtual bone model 121, providing the user with information on how best to approach the planned surgical procedure.

[0169] The display window 109 may be manipulated using a control panel 111. For example, the control panel 111 may include a number of toggles, buttons, sliders, etc. that allow a user to modify various settings, such as the positioning of the virtual guide pins 123 and / or virtual implants 125 relative to the virtual bone model 121. In an embodiment, a backside sheet volume 127 and a color-coded backside sheet map 129 may be provided on the display window 109 and may automatically update as adjustments are made to the virtual positions of the virtual guide pins 123 and virtual implants 125 relative to the virtual bone model 121. The information presented in the display window 109 may also automatically update as a user page through each of the buttons 113.

[0170] FIG. 11 schematically illustrates another method 138 for planning an orthopedic surgical procedure for a respective patient using system 10. Method 138 may be implemented as part of a surgical planning procedure to prepare a surgical plan for the patient. Fewer or additional steps than those listed below may be implemented within the scope of the present disclosure, and the order of the listed steps is not intended to limit the present disclosure. System 10 may be configured to perform each of the steps of method 138 via any of its associated computing devices and modules. In an exemplary embodiment, one or more computing devices 40 of client computer 14 may be programmed to perform method 138. However, other embodiments are also contemplated within the scope of the present disclosure.

[0171] Image data of a target bone or joint of a patient may be received at step 140. The image data may be received directly from the imaging device 16 or may be obtained by accessing a record or entry associated with the patient from the patient profile database 64.

[0172] A 3D model of the target bone or joint may be generated in step 142. Planning environment 28 of computing device 40 may incorporate and / or interface with one or more modeling packages, such as computer-aided design (CAD) packages, to render the 3D model of the target bone or joint.

[0173] Next, at step 144, the computing device 40 may query the anatomical body size classification database 70 to find bone models stored therein having an anatomical body size classification 80 similar to the anatomical body size classification 80 of the patient's bone or joint. The anatomical body size classification 80 that is closest to the anatomical structure encompassed by the 3D model may then be assigned to the 3D model at step 146 and displayed on the surgical outcomes user interface of the computing device 40 at step 148. As part of displaying the anatomical body size classification 80, a confidence level indicator may be displayed within the graphical user interface to visually indicate the similarity between the assigned anatomical body size classification and the anatomical structure being analyzed. The confidence level indicator may be displayed as a percentage or any other visual indicator.

[0174] The surgical outcome database 66 may be queried at step 150 to obtain the surgical outcome data most relevant to the assigned anatomical body size classification. The surgical outcome data associated with the assigned anatomical body size classification 80 may be displayed on the surgical outcome user interface at step 152. The surgical outcome data displayed to the user may be automatically updated in response to a user prompt, such as when the user changes the planned procedure type.

[0175] In one embodiment, the surgical outcomes database 66 can be queried to find previous surgeries involving patients with average bone densities comparable to the estimated average bone density of the bone associated with the patient's anatomy. This comparison can be used, for example, to recommend a particular surgical implant that is incompatible with the average bone density of the bone under study.

[0176] Next, at step 154, data from the surgical outcomes database 66 for equivalent anatomical body size classifications 80 and a plurality of variables associated with the surgical plan for operating on the patient may be utilized to determine one or more survival prediction indices. The variables may include factors such as surgical implant type, surgical implant size, surgical implant orientation, surgical procedure type, surgical implant backing sheet configuration, fastener orientation, or any combination thereof. The variables are inputs to the system 10 that may be selected by the surgeon or staff user within the surgical outcomes user interface.

[0177] The determined survival prediction indexes may be displayed on the surgical outcome user interface in step 156. Each survival prediction index may represent a percentile confidence level that the surgical plan will result in a successful surgical outcome for at least a predetermined time. For example, based on comparable anatomical body class 80 data and relevant variables selected / set by the surgeon, system 10 may determine and display a three-year post-operative survival prediction index of 40% for a comparable patient undergoing a standard total shoulder arthroplasty and a three-year post-operative survival prediction index of 85% for a comparable patient undergoing a reverse shoulder arthroplasty, thus indicating to the surgeon when a more successful patient outcome is likely to be obtained by performing a reverse shoulder arthroplasty rather than a standard total shoulder arthroplasty.

[0178] After displaying the displayed survival prediction index in step 156, system 10 may prompt the surgeon to make any corrections to the variables associated with the current surgical plan in step 158. If corrections are received as input to system 10, an updated survival prediction index may be displayed in step 160.

[0179] System 10 may output a recommended procedure type, implant size / type, and implant position / orientation to best match the equivalent anatomical body size classification at step 162. The surgeon may be prompted to modify the recommended implant type, positioning, and / or orientation according to their clinical judgment at step 164. Method 138 may end after receiving the surgeon's approval of the surgical plan at step 166.

[0180] 12 shows an exemplary surgical outcome user interface 141 that may be provided during the above-discussed method 138. The surgical outcome user interface 141 may be presented within the planning environment 28, for example.

[0181] The surgical outcome user interface 141 may include a graphical list 143, a display window 145, and a control panel 147 for displaying the anatomical body size classification 80 that is most similar to the anatomical body size classification of the patient's bone or joint.

[0182] The graphical list 143 may include a graph 149 of ASES score versus time for each of the listed equivalent anatomical body size categories 80. Although two anatomical body size categories 80 are shown listed in FIG. 12, the graphical list 143 may provide a greater or lesser number of anatomical body size categories 80 within the scope of the present disclosure.

[0183] The graphical list 143 may further include a confidence level indicator 151 that may be displayed adjacent to each equivalent anatomical body size classification 80. The confidence level indicator 151 may be a percentage or any other visual indicator to visually indicate the similarity between the assigned anatomical body size classification and the anatomical structure being analyzed. The user may select the desired equivalent anatomical body size classification 80 using, for example, an input selector 153.

[0184] Display window 145 may include a 3D window 155 and multiple 2D windows 157. A virtual bone model 159 of the patient's anatomy may be displayed within 3D window 155 and 2D window 157. Virtual guide pins 161 and virtual implants 163 associated with a selected equivalent anatomical body classification 80 may be displayed relative to virtual bone model 159, providing the user with information about how previous surgical procedures have been performed on patients with the equivalent anatomical body classification 80.

[0185] The display window 145 may be manipulated using a control panel 147. For example, the control panel 147 may include multiple toggles, buttons, sliders, etc. that allow a user to modify various settings, such as the positioning of the virtual guide pins 161 and / or virtual implants 163 relative to the virtual bone model 159. In an embodiment, the back sheet volume 165 and a color-coded back sheet map 167 may be displayed on the display window 145 and may automatically update as adjustments are made to the virtual positions of the virtual guide pins 161 and virtual implants 163 relative to the virtual bone model 159.

[0186] The surgical outcome user interface 141 may further include a schedule consultation button 199. A user may press or otherwise activate the schedule consultation button 199 to arrange a consultation with a surgeon who performed a previous procedure for a comparable anatomical size classification 80. Once the schedule consultation button 199 is activated, the user and the associated surgeon may be presented with a series of prompts for coordinating and conducting 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 consulting surgeon may be kept confidential during the consultation.

[0187] 13A schematically illustrates another method 168 for planning an orthopedic surgical procedure for a respective patient using system 10. Method 168 may be implemented as part of a surgical planning procedure to prepare a surgical plan for the patient. Fewer or additional steps than those listed below may be implemented within the scope of the present disclosure, and the order of the listed steps is not intended to limit the present disclosure. System 10 may be configured to perform each of the steps of method 168 via any of its associated computing devices and modules. In an exemplary embodiment, computing device 40 of host computer 12 may be programmed to perform method 168. However, other embodiments are further contemplated within the scope of the present disclosure.

[0188] Method 168 may begin at step 170 in response to receiving a pre-operative surgical plan approved by a respective surgeon. Surgeon profile database 65 may then be queried at step 172 for data regarding the surgeon's previous surgeries planned using system 10 for the procedure indicated by the approved pre-operative surgical plan. The data analyzed from surgeon profile database 65 may include the types and quantities of implants actually used in the surgeon's previous surgeries, as well as the types and quantities of implants included as part of the pre-operative surgical plan for each of the surgeon's relevant previous surgeries.

[0189] In step 174, system 10 may determine, for example, whether the surgeon has deviated from their past preoperative surgical plan by less than a predetermined percentage of their previous surgical procedures based on a comparison of the preoperative and postoperative data analyzed in step 172. In some embodiments, the predetermined percentage may be defined as 5% of their previous surgical procedures. However, other thresholds may be established within the scope of the present disclosure. In certain embodiments, a "deviation" is considered to have occurred if the surgeon changed the type of pre-planned procedure, changed the type of pre-planned implant, or used a deviation of two or more sizes during a previous surgical procedure.

[0190] If a YES flag is returned at step 174, a first surgical kit containing only the implants and instruments necessary to perform the approved pre-operative surgical procedure may be recommended at step 176. Alternatively, if a NO flag is returned at step 174, a second surgical kit containing a greater number of implants and instruments than the first surgical kit may be recommended at step 178. Instructions for assembling the associated surgical kit may then be issued at step 180.

[0191] 13B illustrates an exemplary deviation user interface 169 that may be provided during the method 168 discussed above. The deviation user interface 169 may be presented within the planning environment 28, for example.

[0192] Deviation user interface 169 may be configured to present various surgery-related information for a selected surgeon regarding the frequency with which the surgeon deviated from their previous preoperative surgical plans. Deviation user interface 169 may provide a case list 171 of the surgeon's previous surgeries and various bar graphs 173A-173F designed to communicate deviation-related information to the user. For example, bar graph 173A may indicate the percentage of previous surgeries performed as planned, bar graph 173B may indicate the percentage of implants planned and placed during previous surgeries, bar graph 173C may indicate planned implants versus implanted implants, bar graph 173D may indicate the type of deviation, bar graph 173E may indicate different implant families used in previous surgeries, and bar graph 173F may indicate different sizes of implants used during previous surgeries. Other deviation-related information may alternatively or additionally be communicated to the user via deviation user interface 169.

[0193] FIG. 14 schematically illustrates a method 182 for post-operatively updating one or more databases 38 associated with system 10. Method 182 may be performed after using system 10 to create a surgical plan for a patient and after executing the surgical plan during the actual surgical procedure. Fewer or additional steps than those listed below may be performed within the scope of the present disclosure, and the order of the listed steps is not intended to limit the present disclosure. System 10 may be configured to perform each of the steps of method 182 via any of its associated computing devices and modules. In an exemplary embodiment, computing device 40 of host computer 12 may be programmed to perform method 182. However, other embodiments are further contemplated within the scope of the present disclosure.

[0194] System 10 may receive post-operative patient outcome data from a user at step 184. In some embodiments, the post-operative patient outcome data may be manually entered by a surgeon or other staff member after a surgical procedure has been performed intraoperatively on a patient in accordance with a pre-operative surgical plan previously created within system 10. In other embodiments, the post-operative patient outcome data may be automatically communicated to system 10 after a surgical procedure has been performed as part of a closed feedback loop that may be implemented, for example, via a neural network. The post-operative outcome data may include information such as the size and type of implant used during the currently completed surgical procedure, the location and orientation of used implants, implant failure data, data related to the success or non-success of pre-operative activities of daily living, etc.

[0195] An anatomical body size classification 80 may be assigned to each anatomical structure associated with the post-operative patient outcome data in step 186. This may be accomplished, for example, by querying the anatomical body size classification database 70 to find bone models stored therein that have an anatomical body size classification similar to the anatomical body size classification of the anatomical structure represented in the post-operative patient outcome data.

[0196] At step 188, the surgical outcome database 66 may be updated with information contained within the post-operative patient outcome data. For example, the surgical outcome database 66 may be updated with the size and type of implant used during the currently completed surgical procedure, the location and orientation of the implants used, etc.

[0197] The size, type, location, and orientation of the implant indicated in the post-operative patient outcome data may be entered into the range of motion database 68 in step 190. Next, in step 192, one or more motion simulations may be performed for the anatomical structures and implants associated with the post-operative patient outcome data. Contact or collision points may be identified in step 194 to identify the range of motion end points for each range of motion simulation performed. The angular arc and collision mode (e.g., implant-to-implant, implant-to-bone, bone-to-bone, etc.) for each contact point may be recorded in step 196.

[0198] The implant's center of rotation associated with the postoperative patient outcome data may be adjusted in step 198. In step 200, the implant's center of rotation may be adjusted in multiple increments for each bone model to record the angular arc and impact mode associated with the adjusted position. All range of motion data derived from the simulations performed in steps 190-200 may then be stored in range of motion database 68 in step 202.

[0199] Referring to FIG. 15, the patient's anatomical structure can be associated with each posture, as disclosed in Moroder, P. et al. (2020). The influence of posture and scapulothoracic orientation on the choice of humeral component retrotorsion in reverse total shoulder arthroplasty. J Shoulder Elbow Surg (2020) 29, 1992–2001. A range of postures can be assigned to a set of posture types for the anatomical structure (e.g., A, B, C). FIG. 15 discloses a set of posture types (e.g., A, B, C). Posture type A may represent a perfect posture. Posture types B and C may deviate from posture type A.

[0200] Using the techniques disclosed herein, one or more characteristics associated with a patient's posture can be determined. While three posture types are disclosed, it should be understood that two or fewer or four or more posture types can be utilized in accordance with the teachings disclosed herein. A patient's posture can affect the relative position between two or more bones and / or joints, including non-adjacent and / or adjacent bones. A patient's posture can affect the relative position between opposing articular surfaces of adjacent bones. Using the techniques disclosed herein, the position and orientation of one or more implants for treating a patient can be established based on the determined posture characteristics.

[0201] 16A-16C disclose anatomical models 229 (shown as models 229-1, 229-2, and 229-3). Anatomical models 229-1 through 229-3 may be associated with each patient. Anatomical model 229 may include one or more bone models 230, which may be associated with any of the bones of the anatomy. Bone models 230 may represent bones associated with the shoulder joint, such as the scapula and / or humerus, and one or more bones of the associated limb, such as the ulna and / or radius of the forearm. The scapula may be associated with scapula model 230S. The humerus may be associated with humerus model 230H. The ulna and radius may be associated with ulna model 230U and radius model 230R. Anatomical models 229 and / or associated bone models 230 may be established and aligned using any of the techniques disclosed herein.

[0202] Continuing with reference to FIGS. 15 and 16A-16C, and with reference to FIGS. 17A-17C, anatomical models 229-1-229-3 may be associated with respective patient postures. Various techniques may be utilized to characterize patient posture. Planning system 10 (FIGS. 1-2) may be configured to determine one or more characteristics related to patient posture based on the orientation of one or more of bone models 230 of anatomical model 229. Bone models 230 of humerus 230H, ulna 230U, and / or radius 230R may be positioned at a resting (e.g., starting) angle relative to scapula model 230S, including during image acquisition.

[0203] The anatomical models 229-1 through 229-3 may establish one or more angles α that may be associated with the posture of the patient's anatomy. Various techniques may be utilized to define the angle α. A first bone model 230 associated with a first bone of the patient may extend along a first reference plane REF1. A second bone model 230 associated with a second bone of the patient may extend along a second reference plane REF2. The first and second reference planes REF1, REF2 may intersect to establish the angle α. In an embodiment, the angle α may be established relative to the first reference plane REF1 and axis X of the patient. The angle α may be associated with the posture of the patient.

[0204] A scapular angle associated with the patient's scapula may be established. The scapular angle may include one or more components relative to the patient's anatomy (e.g., a set of angles). In embodiments, the scapular angle may be defined based on scapular internal rotation, scapular upward rotation, and / or scapular internal tilt. The scapular angle may be determined when the patient is positioned in a standing or resting position (e.g., horizontal). In embodiments, the first bone model 230 may be a scapula model 230S associated with the patient's scapula. The second bone model 230 may be a humerus model 230H associated with the patient's humerus. Angle α may be defined as the angle between the spine of the scapula and the axis of the humerus relative to the patient's medial plane. The spine of the scapula model 230S may extend along a first reference plane REF1. The shaft of the humerus model 230H may extend along a second reference plane REF2. The spatial module 50 and / or another portion of the planning system 10 may be configured to determine the first and / or second reference planes REF1, REF2 and the associated angle α. In an embodiment, a surgeon or clinical user may interact with the user interface 56 to specify the first and / or second reference planes REF1, REF2.

[0205] The anatomical model 229 may include one or more bone models 230 aligned with an axis X. The axis X may be a vertical axis associated with the patient in an upright (e.g., standing) position and may be normalized to a coordinate system. The anatomical model 229 may include two or more bone models 230 aligned with one another to establish the scapular angle. The axis X may extend along one or more of the bone models 230. The axis X may be established along an intersection between the patient's planes of motion (e.g., sagittal and coronal). A first reference plane REF1 may extend along another one of the bone models 230, such as along the spine of the scapula model 230S. The first reference plane REF1 may intersect with the patient's axis X to establish the scapular angle. The orientation of the first reference plane REF1 may be established based on the internal rotation, upward rotation, and / or anterior tilt of the scapula. In embodiments, the scapular angle may be a set of values ​​defined for scapular internal rotation, scapular upward rotation, and / or scapular anteversion. For purposes of this disclosure, the terms "substantially," "approximately," and "about" mean ±10 percent of the stated value or relationship, unless otherwise indicated. The humerus model 230H, ulna model 230U, and / or radius model 230R may be substantially perpendicular or transverse to the patient's axis X. In the embodiment of FIGS. 17A-17C, the ulna model 230U and radius model 230R may be substantially parallel to axis X.

[0206] The scapular angles α of the anatomical models 229-1 through 229-3 may be the same or different from one another. The posture of each anatomical model 229-1 through 229-3 may be characterized by a set of posture types (e.g., A, B, C). Each posture type may be assigned a range of values ​​for one or more posture parameters (e.g., characteristics), such as scapular angle. In an embodiment, posture type A may be associated with approximately 32±6 degrees of scapular internal rotation, approximately −3±6 degrees of scapular upward rotation, and approximately 23±11 degrees of scapular internal (e.g., anterior) tilt. Posture type B may be associated with approximately 42±3 degrees of scapular internal rotation, approximately −12±7 degrees of scapular external rotation, and approximately 24±8 degrees of scapular internal tilt. Posture Type C can be associated with approximately 53±5 degrees of scapular internal rotation, approximately −15±13 degrees of scapular external rotation, and approximately 33±7 degrees of scapular internal tilt.

[0207] The scapular angle α in FIGS. 17A-17C may be associated with the posture types in FIGS. 15 and / or 16A-16C. Anatomical model 229-1 in FIG. 17A may be associated with posture type A in FIGS. 15 and 16A. Anatomical model 229-2 in FIG. 17B may be associated with posture type B in FIGS. 15 and 16B. Anatomical model 229-3 in FIG. 17C may be associated with posture type C in FIGS. 15 and 16C. In embodiments, anatomical model 229-1 may be associated with posture type A and / or a scapular angle having any of the values ​​within the disclosed ranges associated with posture type A. Anatomical model 229-2 may be associated with posture type B and / or a scapular angle having any of the values ​​within the disclosed ranges associated with posture type B. Anatomical model 229-3 may be associated with posture type C and / or a scapular angle having any of the values ​​within the disclosed ranges associated with posture type C.

[0208] Continuing with reference to FIGS. 17A-17C, and with reference to FIGS. 18A-18C, a patient's posture may limit the range of motion of a limb, such as the humerus and associated forearm. Anatomical models 229-1-229-3 may be associated with instances of humerus model 230H', ulna model 230U', and elevated radius model 230R'. The range of motion may be characterized by a reference (e.g., scapular) plane REF1 and / or associated scapular angle. Upward movement of the humerus may generally be limited approximately at reference plane REF1.

[0209] Image data associated with the anatomical model 229 and bone model 230 may be captured at acquisition orientations associated with one or more imaging devices 16 (FIGS. 1-2). Each imaging device 16 may be associated with an acquisition frame of reference. The acquisition frames of reference for two or more imaging devices 16 may be the same or different from one another. The patient may be positioned relative to a reference point in the acquisition frame of reference, which may vary between patients based on anatomical size, posture, morbidity, etc. The bone model 230 may be in a resting (e.g., starting) position of the patient during acquisition. The resting position may be associated with the patient's upright (e.g., vertical) or recumbent (e.g., horizontal) position during acquisition of the associated image data. FIG. 16D discloses an anatomical model 229-4. The anatomical model 229 may include one or more bone models 230, which may be associated with any of the bones of the anatomy. Anatomical model 229-4 may be associated with a recumbent (e.g., horizontal or supine) position of the patient (e.g., on the floor of the imaging device) during acquisition of associated image data. Anatomical model 229-4 may be associated with the same patient as one of anatomical models 229-1 through 229-3, such as anatomical model 229-2. The orientation of one or more bones of the patient in an upright position, such as the scapula and humerus, may be determined based on a transformation associated with the patient's recumbent position. In embodiments, the orientation of scapula 230S and / or humerus 230H of anatomical model 229-2 (FIG. 16B) may be established based on a transformation applied to the orientation of scapula 230S and / or humerus 230H of anatomical model 229-4 (FIG. 16D). The orientation of the scapula may be non-perpendicular to the axis of the acquisition frame of reference.

[0210] The orientation of the scapula in the acquisition frame of reference may be characterized by the patient's posture. The transformation may account for effects on the patient's anatomical structure in the recumbent position, such as relaxation of muscle structures. In embodiments, the transformation may include one or more predetermined transformation angles. The predetermined transformation angles may include three rotation angles relative to the axes of the frame of reference. The predetermined transformation angles may be established for one or more acquisition positions, such as the recumbent position and / or the upright position. A set of predetermined transformation angles may be established for each respective bone of the anatomical structure. The spatial module 50 may be configured to apply a transformation to each bone model 330 to transform the bone model 330 from the recumbent position to the upright position or vice versa.

[0211] Information related to a patient's posture can be incorporated into the systems and methods disclosed herein, such as system 10 (FIGS. 1-2), to establish a surgical (e.g., pre-operative) plan and / or determine and / or verify aspects of a patient's associated range of motion (ROM) using any of the techniques disclosed herein. System 10 can establish a pre-operative plan 36 based on one or more determined postural characteristics (e.g., parameters) associated with the patient's posture. The position and / or orientation of one or more implants specified in pre-operative plan 36 can be determined based on the determined postural characteristics. By incorporating postural information into the systems and methods disclosed herein, a surgeon or clinical user can plan the placement of one or more implants taking into account the resting (e.g., starting) angle of the scapula. The implants can be assigned a default starting position and / or orientation relative to the adjacent bones. System 10 can determine an offset to adjust the default starting position and / or orientation of the implant based on the determined postural characteristics. Postural information can be utilized to determine range of motion, including for activities of daily living.

[0212] The system 10 can be configured to determine one or more posture parameters associated with the patient's posture. The system 10 can be configured to adjust the implant plan based on the one or more posture parameters. The implant plan can include any of the parameters disclosed herein, such as implant type, implant size, and implant location.

[0213] Referring to Figures 19-20, patient posture can affect retroversion, as disclosed in Morode, P. et al. (2022). Patient Posture Affects Simulated ROM in Reverse Total Shoulder Arthroplasty: A Modeling Study Using Preoperative Planning Software. Clin Ortop Relat Res (2022) 480:619-631. Figures 19-20 show a clinical example of shoulder arthroplasty for a patient. The orientation of the implant relative to the humerus can be adjusted to change retroversion from 0 degrees to a value equal to internal rotation of the scapula (IRO). By setting the implant orientation to internal rotation of the scapula (IRO), a greater range of motion can be achieved and / or the likelihood of implant impingement can be reduced.

[0214] In embodiments, a posture transformation may be established. The posture transformation may be based on a posture classification and / or one or more measured posture parameters, including any of the posture parameters disclosed herein. The posture parameters may include one or more landmarks of the scapula, the distance or relative position between two or more landmarks, the scapular angle, and / or one or more bony dimensions of an anatomical structure (e.g., humerus length). In embodiments, the posture transformation may be utilized to adjust or otherwise set the position and / or orientation of planned implants for treating the patient, which may improve range of motion and activities of daily living.

[0215] One or more range of motion parameters may be utilized to establish the postural transformation. In embodiments, the parameters may be associated with one or more activities of daily living and / or lifestyle goals (e.g., desired post-operative range of motion for abduction, adduction, external rotation, internal rotation, upward rotation, extension, flexion, external rotation combined with 60° abduction, internal rotation combined with 60° abduction, etc.). Default values ​​for the one or more activities of daily living and / or lifestyle goals may be utilized as criteria for establishing the postural transformation.

[0216] System 10 may be configured to perform a range of motion simulation based on one or more parameters associated with the patient's posture. Storage system 18 may be configured to store range of motion data derived from the range of motion simulation. The parameters may include a scapular angle associated with the patient's scapula.

[0217] The method may include performing a range of motion simulation based on one or more parameters associated with the patient's posture. The method may include storing range of motion data derived from the range of motion simulation in storage system 18 of surgical planning system 10. The parameters may include a scapular angle associated with the patient's scapula.

[0218] 21-25 , with continued reference to FIG. 2 , planning system 10 may be configured to display a selected anatomical model 329 in one or more display windows 360 of graphical user interface 356. Anatomical model 329 may include one or more bone models 330, which may be associated with respective joints. Display module 48 may be configured to display anatomical model 329 in display window 360. Spatial module 50 may be configured to adjust the position of one or more bone models 330 relative to one another, to other portions of anatomical model 329, and / or to a reference system.

[0219] 21-26 disclose an anatomical model 329 associated with one or more patients. The anatomical model 329 may include a first anatomical model 329-1 (FIGS. 21-23) and / or a second anatomical model 329-2. The anatomical model 329 may include a shoulder model 329SM and one or more implant models 332 associated with various anatomical postures and scapular angles. The shoulder model 329SM may include a scapula model 330S and a humerus model 330H.

[0220] The spatial module 50 may be configured to arrange one or more implant models 332 relative to each other and / or the anatomical model 329. The implant models 332 may include a first (e.g., glenoid) implant model 332G and a second (e.g., humerus) implant model 332H. The implant models 332G, 332H may be mated to each other. The scapula model 330S, the anatomical model 329, the glenoid implant model 332G, and / or the humerus implant model 332H may be associated with various postures and scapular angles. Various parameters may be associated with scapular angles, such as abduction, adduction, flexion, extension, external rotation, internal rotation, upward rotation, abduction and internal rotation, and abduction and external rotation. A value may be assigned to each of the parameters and displayed to the user. The sum of the values ​​may be displayed to the surgeon or clinical user at the user interface 356 (see, e.g., FIGS. 22 and 25 ). A pose transformation may be applied to adjust the default starting position and / or orientation of the implant 332 based on the determined parameters.

[0221] The user interface 356 may include a first display window 360-1 and a second display window 360-2. The display module 48 may be configured to cause the user interface 356 to display different anatomical views in the display windows 360-1, 360-2. In an embodiment, the display module 48 may be configured to cause the first display window 360-1 to display an anterior (or posterior) view of the anatomical model 329-1. The display module 48 may be configured to cause the second display window 360-2 to display a lateral view of the anatomical model 329-1. The spatial module 50 may be configured to position the bone models 330 relative to each other and / or to a reference frame based on a determined posture of the patient. The surgeon or clinical user may interact with the display windows 360 and / or other portions of the user interface 356 to select one or more of the bone models 330. The display module 48 may be configured to establish a visual contrast between the selected bone model 330 and any remaining bone models 330 and / or other portions of the anatomical model 329 .

[0222] With continued reference to FIGS. 2 and 21 , and with reference to FIG. 22 , the spatial module 50 may be configured to adjust the positions of selected bone models 330 relative to one another and / or other portions of the anatomical model 329-1. The user interface 356 may include one or more (e.g., interactive) objects 362. The objects 362 may be disposed within the control panel 311. The objects 362 may include a button 362B, a radial button 362R, and / or a text box 362T. The text box 362T may be configured to display one or more values ​​associated with the anatomical model 329-1. A surgeon or clinical user may adjust one or more of the values ​​displayed in the text box 362T in response to selecting a respective text box 362T, button 362B, and / or radial button 362R. The buttons 362B, 362R may be associated with various properties (e.g., angular relationships) of the selected bone model 330, including any of the properties disclosed herein. In embodiments, the properties may include abduction, adduction, flexion, extension, external rotation, internal rotation, upward rotation, abduction and internal rotation, abduction and external rotation, and / or all movements. The text boxes 362T associated with all movements may be configured to display the sum of the values ​​in the text boxes 362T in their respective columns. A surgeon or clinical user may specify values ​​in one or more of the text boxes 362T to adjust the position and / or orientation of one or more of the selected bone models 330. A surgeon or clinical user may interact with the display window 360 to adjust the position and / or orientation of one or more selected bone models 330 and any associated values ​​in the control panel 311. The display window 360 and the control panel 311 may be dynamically linked such that changes to one may cause respective changes to the other, including values ​​specified in the text boxes 362T.

[0223] In the embodiment of FIGS. 21-23, anatomical model 329-1 may be associated with a scapular angle of 0 degrees (e.g., internal tilt). Spatial module 50 may be configured to assign default values ​​for each of the properties associated with object 362 of control panel 311 based on the determined and / or selected scapular angle. Spatial module 50 may be configured to arrange selected bone models 330 relative to one another based on the assigned values. The pose associated with scapular angle and anatomical model 329-1 of FIG. 21 may be assigned a pose type (e.g., Type A).

[0224] 22 and 23, a surgeon or clinical user may interact with one or more of the objects 362 to adjust the position of a selected bone model 330, such as humerus model 330H. The surgeon or clinical user may interact with one or more of the objects 362 to adjust the adduction of humerus model 330H from a first position (e.g., FIG. 22) to a second position (e.g., FIG. 23). The spatial module 50 may be configured so that unselected bone models 330 remain in fixed positions while the selected bone models 330 are adjusted, which may provide flexibility to determine one or more parameters of the pre-operative plan, such as the position and / or orientation of implants associated with each implant model 332. The surgeon or clinical user may interact with the user interface 356 to observe the effect of various characteristics on range of motion and one or more activities of daily living and / or lifestyle goals, including any of those disclosed herein.

[0225] 24-26 disclose an embodiment of a second anatomical model 329-2 within a display window 360 of a graphical user interface 356. The pose associated with the second anatomical model 329-2 may differ from the pose associated with the first anatomical model 329-1. The anatomical model 329-2 may be associated with a scapular angle of approximately 30 degrees (e.g., internal tilt). The pose associated with the scapular angle and anatomical model 329-2 of FIG. 24 may be assigned a pose type (e.g., Type C).

[0226] The planning system 10 may be configured to establish a surgical plan 36 based on the determined posture and / or scapular angle of each patient. The planning system 10 may be configured to determine the posture and / or scapular angle based on the patient's acquired position (e.g., upright or recumbent). The planning system 10 may be configured to apply a transformation to the patient's acquired position to predict or otherwise determine the patient's posture and / or scapular angle in the upright (e.g., standing) position. A surgeon or clinical user may interact with the planning system 10 to establish a surgical plan 36 based on the determined posture and / or scapular angle to assess range of motion for planned implant positioning, which may achieve one or more activities of daily living and / or lifestyle goals and / or improve patient mobility.

[0227] FIG. 27 discloses a method for a surgical procedure in flowchart 382. Method 382 may be utilized to pre-operatively plan, perform, evaluate, and / or verify aspects of various surgical procedures, such as arthroplasty procedures to restore function to shoulders, ankles, knees, hips, and other joints. Method 382 may be utilized with any of the planning systems and methods, virtual anatomical models, and bone models disclosed herein, such as planning system 10. Method 382 may be utilized to determine patient posture. Method 382 may be utilized to establish the position and / or orientation of one or more implants based on the orientation of an anatomical structure, such as the orientation of the scapula. The orientation of the anatomical structure may be correlated with the patient's posture. Method 382 may be utilized to determine the patient's posture. Fewer or additional steps than those listed below may be implemented within the scope of the present disclosure, and the order of the listed steps is not intended to limit the present disclosure. System 10 and any of the associated modules may be configured to implement features of any of the methods disclosed herein, including method 382. Reference is made to system 10.

[0228] 2 and 27, in step 382A, digital images of a patient's anatomy may be captured or otherwise obtained by an imaging device 16 (FIGS. 1-2), including any of the imaging devices disclosed herein, such as a computed tomography (CT) or magnetic resonance imaging (MRI) machine. The digital images may include image data that may be captured or otherwise obtained, such as by an imaging device 16, to establish one or more images 26 of the anatomy. The data module 46 may receive the image data directly from the imaging device 16 or may obtain the image data by accessing a record or entry associated with the patient from database 38 (FIG. 2) and / or patient profile database 64 (FIG. 3). The digital images may include any of the anatomy disclosed herein, such as the anatomy represented by bone model 330 and / or anatomical model 329 of FIGS. 21-23. The imaging device 16 may be associated with an acquisition frame of reference. The acquisition frame of reference may be associated with an axis and a set of coordinate values. The images 26 may be associated with the acquisition frame of reference of each imaging device 16.

[0229] 2 and 27 , and with reference to FIG. 28 , the image 26 may be associated with an anatomical model 329 and / or a bone model 330. The spatial module 50 may be configured to associate the anatomical model 329 with an acquisition frame of reference. While FIG. 28 discloses the anatomical model 329 relative to a set of implant models 332, it should be understood that the implant models 332 may be positioned relative to the anatomical model 329 after establishing a modified instance of the anatomical model 329 associated with the surgical plan 36. The data module 46 may be configured to store instances of one or more anatomical and bone models and associated coordinate values, such as the anatomical model 329 and / or the bone model 330, in the memory 44.

[0230] Digital images may be captured for various acquisition positions of the patient relative to the imaging device 16. The patient acquisition position may be generally horizontal. In embodiments, the patient acquisition may be substantially vertical. The patient image may be captured while the patient is in an upright position. The patient's posture in the upright position may deviate from a perfect posture. The image may be captured with an upright imaging device.

[0231] In step 382B, the digital image 26 may be segmented using a variety of techniques, such as by applying automatic, semi-automatic, or manual segmentation to the image 26. The system 10 may be configured to segment the image 26.

[0232] In step 382C, one or more anatomical and / or bone models may be generated. System 10 may be configured to generate one or more anatomical models 29, such as anatomical model 329. Anatomical model 329 may include one or more bone models 330. Anatomical model 329 may include information specifying the arrangement of bone models 330 relative to one another.

[0233] Anatomical model 329 may include shoulder model 329SM. Shoulder model 329SM may be associated with first anatomical model 329-1 of Figures 21-23. Bone model 330 may include scapula model 330S associated with the patient's scapula and humerus model 330H associated with the patient's humerus.

[0234] In an embodiment, a 3D mesh of the scapula and humerus may be reconstructed to establish a scapula model 330S and a humerus model 330H. The scapula model 330S may be established with respect to a local (e.g., scapula) frame of reference. The local frame of reference may be associated with a set of coordinate values. The spatial module 50 may be configured to associate the scapula frame of reference with a scanned (e.g., acquired) position of the scapula relative to the imaging device 16.

[0235] Various techniques for orienting anatomical structures, including the scapula, may be utilized. Anatomical structures, including the scapula, may remain in a local (e.g., acquisition) orientation for planning. The acquisition orientation may be related to an acquisition frame of reference of the imaging device 16. In embodiments, the Z-axis of the acquisition frame of reference may be horizontal with respect to the imaging device 16 and other acquisition systems that may acquire image data of the patient in a horizontal (e.g., recumbent) position. The Z-axis of the acquisition frame of reference may be perpendicular with respect to acquisition systems that may acquire image data of the patient in an upright (e.g., vertical or standing) position. Patient postural characteristics, such as scapular angle, may differ between the horizontal and upright positions.

[0236] In step 382D, the anatomical and / or bone model may be reoriented (e.g., registered) from a first frame of reference to a second, different frame of reference. In embodiments, the anatomical and / or bone model may be reoriented based on the patient's posture and associated postural characteristics. Reorienting the patient's anatomical and / or bone model based on posture may improve implant planning to achieve range of motion and activities of daily living and / or lifestyle goals. The acquisition position of the patient's anatomical structures, including the scapula, may be determined directly from the digital image. The disclosed systems and methods may normalize and / or realign the scapula to the scapular plane within a three-dimensional (3D) computer-aided design (CAD) model. One or more measurements and / or other information related to the patient may be captured preoperatively to manually and / or optically determine the patient's preoperative posture.

[0237] The spatial module 50 or another portion of the planning system 10 may be configured to reorient (e.g., register) at least one or more of the anatomical model and / or bone models from a first frame of reference to a second frame of reference. The first frame of reference may be a local or acquired frame of reference. The second frame of reference may be any of the frames of reference disclosed herein, such as a global frame of reference. The spatial module 50 may be configured to reorient the bone models 330 in the global frame of reference based on selected representative bone models 30, which may be associated with different patients. The spatial module 50 may be configured to register one or more of the patient's bone models 330 from the first frame of reference to the second frame of reference in response to adjusting one or more coordinate values ​​associated with each bone model 330 based on the patient's posture, including any of the posture parameters disclosed herein. The comparison module 52 may be configured to determine posture parameters associated with the patient's posture. The spatial module 50 may be configured to register the patient's bone models 330 to the global frame of reference based on the determined posture parameters.

[0238] The planning system 10 may be configured to normalize one or more datasets within a global frame of reference, including any of the anatomical models, bone models, implant models, and / or databases disclosed herein. Step 382D may include reorienting the scapula model 330S from its acquisition orientation in the acquisition frame of reference to the global frame of reference. The scapula model 330S may be reoriented using any of the techniques disclosed herein. The orientation of the scapula model 330S in the global frame of reference may be related to the anatomical position of the scapula when the patient is possibly standing, which may be affected by the patient's posture.

[0239] Various techniques may be utilized to reorient the anatomical model and / or bone model. The spatial module 50 and / or another portion of the system 10 may be configured to register the bone model from a first (e.g., local or acquired) frame of reference to a second (e.g., global) frame of reference based on one or more posture parameters associated with the patient's posture. The one or more posture parameters may be utilized to establish a transformation between the first and second frames of reference. The one or more posture parameters may include a scapular angle associated with the scapula (see, e.g., FIGS. 17A-17C). Various techniques may be utilized to establish the transformation, such as one or more parametric equations and / or matrices.

[0240] At step 382D-1, a global reference frame may be defined (see, e.g., FIG. 30). The planning system 10 may define the global reference frame using any of the techniques disclosed herein. The global reference frame may be associated with a set of coordinate values. The global reference frame may represent an anatomical position of the patient, which may differ from an acquisition position associated with the image data acquired by the imaging device 16. The anatomical position may correspond to the patient's posture in an upright (e.g., standing) position. The global reference frame may be established with respect to Z (0,0,1), Y (0,1,0), and X (1,0,0) axes. The Z axis of the global reference frame may correspond to the vertical direction. The X and Y axes of the global reference frame may extend along respective horizontal planes. The global reference frame may be associated with the patient's upright position. In embodiments, the global reference frame may be established with respect to one or more planes of motion of the patient, including any of the planes of motion disclosed herein. The X, Y, and Z axes may be established along respective planes of motion of the patient. Utilizing the techniques disclosed herein, activities of daily living and / or lifestyle goals can be established and / or assessed based on the patient's posture and / or plane of motion. Planning system 10 can be configured to establish and / or assess the patient's implant position and orientation, range of motion, and / or activities of daily living / lifestyle goals relative to a global frame of reference. In embodiments, range of motion modeler 101 (FIG. 8) can determine range of motion relative to the global frame of reference. Various databases disclosed herein can be normalized to the global frame of reference, including surgical outcome database 66, range of motion database 68, and / or anatomical body size classification database 70 (FIG. 3).

[0241] In step 382D-2, the bone model 330, such as the scapula model 330S, may be reoriented and normalized based on an anatomical (e.g., scapular) plane REF-A ( FIG. 31 ). Step 382D-2 may include fitting the scapular plane REF-A through the scapula model 330S. The scapular plane REF-A may be determined by landmarks or may be a best-fit scapular plane. The spatial module 50 may be configured to register the scapular frame of reference associated with the scapula module 330S to a global frame of reference, which may include translating and / or rotating the scapula model 330S. The scapular frame of reference may be established relative to a set of landmarks, such as three or more landmarks, associated with the scapula model 330S.

[0242] With continued reference to FIGS. 2 and 27-28, and with reference to FIG. 29, a scapular axis SA may be established. The scapular axis SA may extend through a reference point along the articular surface of the scapula model 330S. The articular surface may be associated with the glenoid cavity of the scapula. The scapular axis SA may extend between a first point P1 (e.g., the center of the glenoid cavity) and a second point P2 (e.g., the scapular triangle) of the scapula model 330S.

[0243] The scapular plane REF-A ( FIG. 31 ) may be established along the scapular axis SA and may extend between a first point P1 at the center of the glenoid fossa and a second point P2 at the scapular triangle. The scapular plane REF-A may extend through a third point P3. The third point P3 may be established at the inferior angle of the scapula. The spatial module 50 may be configured to determine the scapular axis SA and / or one or more anatomical landmarks along the scapular model 330S, including the first, second, and / or third points P1, P2, P3. The spatial module 50 may be configured to determine the scapular plane REF-A such that the scapular plane REF-A may extend along the scapular axis SA.

[0244] With continued reference to FIGS. 2 and 27-29, and with reference to FIG. 30, the scapula model 330S may be associated with a first (e.g., local, scapular, or acquired) frame of reference. The scapula frame of reference may have a base point PL. The spatial module 50 may be configured to apply a predetermined transformation to the scapula model 330S to reorient the scapula model 330S from the first frame of reference to a second, different frame of reference. The first frame of reference may be a local frame of reference. The second frame of reference may be the global frame of reference established in step 382D-1. The system 10 may establish a surgical plan 36 associated with the bone model 330 relative to the global frame of reference. The surgical plan 36 may include an implant plan associated with an implant. The implant plan may include the type of implant, the dimensions of the implant, and / or the position and / or orientation of the implant associated with the implant model.

[0245] With continued reference to FIGS. 2 and 27-30, and with reference to FIG. 31, registering the scapula model 330S in step 382D may include adjusting the orientation of the scapula model 330S with the fitted scapula plane REF-A. In an embodiment, the spatial module 50 may apply a predetermined transformation such that the scapula model 330S may be translated and / or rotated, thereby aligning (e.g., registering) the scapula reference frame of the scapula model 330S with the global reference frame. The origin PL of the scapula reference frame may be established at a first point P1 of the center of the glenoid cavity of the scapula model 330S. In the embodiment of FIG. 31, the alignment may occur such that the first point P1 of the center of the glenoid cavity may be positioned at the origin P0 of the global reference frame. The scapula plane REF-A may extend along a first axis and a second axis of the global reference frame. The spatial module 50 may be configured to substantially align the scapula plane REF-A with a reference plane of the global reference frame to register the scapula model 330S to the global reference frame. The alignment may occur such that the scapula plane REF-A may be aligned with the ZX plane of the global reference frame. In an embodiment, the alignment may occur such that the scapula axis SA may be parallel to the X axis of the global reference frame.

[0246] System 10 may be configured to perform a predetermined transformation of humerus model 330H from a local (e.g., humerus) frame of reference to a global frame of reference utilizing any of the techniques disclosed herein with respect to scapula model 330. In an embodiment, spatial module 50 may be configured to apply the same predetermined transformation associated with glenoid bone model 330G to humerus model 330H such that the relative position between glenoid bone model 330G and humerus model 330H remains the same between the frames of reference. The orientation of scapula model 330S and humerus model 330H with respect to the global frame of reference may represent the patient's posture in that anatomical position.

[0247] The system 10, according to any of the techniques disclosed herein, may be configured to register one or more implant models 32 to a global reference frame. In the embodiment of FIG. 30, the system 10 may be configured to register the position of one or more implant models 332 in the global reference frame. The implant models 332 may be disposed along the glenoid cavity and / or humeral head of the associated bone models 330S, 330H. The implant models 332 may be registered simultaneously with the registration of the scapula model 330S and / or humerus model 330H. In other embodiments, the implant models 332 may be positioned relative to the glenoid cavity and humerus models 330S, 330H subsequent to the registration of the scapula models 330S, 330H in the global reference frame.

[0248] Other techniques may be utilized to reorient the bone model 330 between different frames of reference. In embodiments, step 382D may include reorienting the scapula model 330S based on one or more preoperative surgical measurements in step 382D-3. The spatial module 50 may be configured to transform the scapula frame of reference to a global frame of reference based on surgical measurements, including one or more determined angles established by two or more anatomical landmarks. The preoperatively determined surgical measurements may be associated with the patient's posture. The surgical measurements may include a scapular angle associated with the patient's scapula (see, e.g., FIGS. 17A-17C). The surgical measurements and any associated landmarks may be determined automatically by the planning system 10 and / or manually by the surgeon or clinical user. The measurements may include relative positions and / or angles between two or more anatomical landmarks, axes, planes, etc.

[0249] With continued reference to FIGS. 27-28 and with reference to FIGS. 31-32, step 382D-3 may include reorienting (X, Y, Z) the scapular plane REF-A based on preoperative surgical angle measurements / analysis (e.g., degree and relationship to A, B, C posture types) and / or preoperative surgical classification (e.g., A, B, C posture types). Various techniques may be utilized to determine the surgical angle measurements. In embodiments, the angle measurements and associated postures may be determined automatically by the planning system 10. The system 10 may be configured to determine one or more posture parameters, such as the scapular angle. The system 10 may be adapted to determine the scapular angle in an acquisition orientation of the scapula (see, e.g., FIGS. 17A-17C). The system 10 may assign a posture type based on the determined scapular angle. In other embodiments, the system 10 may be configured to receive one or more posture parameters based on user input. The angle measurements and / or associated posture types may be determined manually by a surgeon or clinical user. The surgeon or clinical user may assign a posture type in response to assessing the patient. The surgeon or clinical user may assign a posture type based on visual observation of the patient in an upright position and / or based on determined angle measurements. A global frame of reference may be established to reorient the scapula model 330S using any of the techniques disclosed herein. The patient's posture type may be determined using any of the techniques disclosed herein.

[0250] Step 382D-3 may include establishing a transformation between the first (e.g., local) frame of reference and the second (e.g., global) frame of reference based on the determined surgical measurements. The transformation may be established utilizing any of the techniques disclosed herein. The spatial module 50 may be configured to perform the transformation to register the selected bone model 330 and / or the anatomical model 329 between the relevant frames of reference.

[0251] The posture parameters may include a set of posture types (e.g., A, B, and C). Each posture type may be associated with a discrete range of scapular angle α and a respective transformation between the local and global reference frames. One or more predetermined correction angles may be established for each posture type (e.g., A, B, or C). The predetermined correction angles may include three rotation angles relative to the axes of the reference frame. The predetermined correction angles may be established for one or more acquisition positions, such as a supine and / or standing position. The correction angles may approximate the posture of the patient's anatomy. The spatial module 50 may be configured to apply a transformation of a selected one of the posture types to each bone model 330 to register the bone model 330 to the global reference frame. The system 10 may be configured to perform the predetermined transformation so that the scapula model 330S and / or the humerus model 330H may be aligned with the global reference frame (see, e.g., FIG. 32 ).

[0252] The system 10 may be configured to reorient the scapula model 330S and / or the humerus model 330H within the global frame of reference based on the determined posture type (e.g., A, B, or C). The scapula model 330S may be oriented at one or more scapula angles within the scapula frame of reference, either alone or together with the humerus model 330H. In embodiments, the spatial module 50 may be configured to apply a predetermined transformation to align the scapula frame of reference with the global frame of reference based on the predetermined correction angle and / or the assigned posture type. In the embodiment of FIG. 32, the scapula model 330S may be oriented relative to the determined posture type (e.g., A, B, or C) in the global frame of reference.

[0253] Still other techniques may be utilized to reorient the anatomical and / or bone models from one reference system to another. In step 382D-4, the anatomical and / or bone models may be reoriented from a first reference system to a second reference system based on one or more predetermined correlations with anatomical landmarks and / or anatomical structures of one or more other patients. The planning system 10 may be configured to establish a surgical plan in response to comparing the anatomical and / or bone models of the patient with anatomical and / or bone models of one or more other patients and / or patient populations. The patient population may exclude the patient.

[0254] Step 382D-4 may include reorienting (X, Y, Z) the scapular plane REF-A (see, e.g., FIG. 31 ) of scapular model 330S based on one or more predetermined correlations. The predetermined correlations may be established with respect to anatomical landmarks and / or SSM / numerical configuration classifications. The SSM / numerical configuration classifications may be established using any of the techniques disclosed herein, such as statistical shape modeler 72. Planning system 10 may be configured to establish a transformation and associated parameters of the transformation for each anatomical build classification 80 based on the predetermined correlations, which may be used to register the associated bone model and / or anatomical model from one frame of reference to another.

[0255] In embodiments, a global (e.g., common) frame of reference may be established in step 382D-1 using any of the techniques disclosed herein. The scapula model 330S may be registered to the global frame of reference using one or more defined landmarks, including any of the anatomical landmarks disclosed herein. The system 10 may be configured to determine the position of one or more landmarks along the scapula and / or other parts of the anatomy. The landmarks may be used to define a transformation from the scapula frame of reference to a global coordinate system (e.g., see FIG. 30). The orientation of the scapula model 330S and humerus model 330H relative to the global frame of reference may represent the patient's anatomical position. Landmarks along the scapula may include the center of the glenoid cavity (e.g., point P1 in FIG. 29), the inferior angle of the scapula (e.g., point P3 in FIGS. 29 and 31), and / or the triangular prism (e.g., point P2 in FIG. 29).

[0256] Various techniques may be utilized to determine the landmarks, including any of the techniques disclosed herein. The surgeon or clinical user may interact with the display window 360 and / or other portions of the user interface 356 (e.g., FIGS. 21-23 ) to designate landmarks for each bone model 330, including the scapula model 330S. In an embodiment, the spatial module 50 may be configured to determine landmarks along the scapula model 330S and / or other bone models 330 of the anatomical model 329.

[0257] 2 and 4, with continued reference to FIGS. 27-28, scapula model 330S may be registered to a global frame of reference based on statistical shape models (SSMs) 75 and assigned numerical configuration classifications 80. One or more respective SSMs 75 may be established for the scapula, humerus, and / or other bones of the anatomy. Statistical shape modeler 72 may be configured to analyze multiple sets of image data 74 to construct each SSM 75. Statistical shape modeler 72 may be configured to determine the location of each landmark within SSM 75, which may be utilized to transform bone model 30 from a local frame of reference to a global frame of reference. In an embodiment, statistical shape modeler 72 may assign an anatomical build classification 80 to one or more of bone models 330, including scapula model 330S (e.g., FIGS. 27-28).

[0258] The statistical shape modeler 72 may query the anatomical body type classification database 70 to find bone models 30 stored therein that have similar anatomical body type classifications 80. Coordinate information of the bone models 30 associated with the anatomical body type classification database 70 may be normalized to a global frame of reference. In embodiments, normalizing the coordinate information may include applying a transformation to the associated bone models 30 from the acquisition frame of reference to the global frame of reference using any of the techniques disclosed herein.

[0259] The comparison module 52 and / or the statistical shape modeler 72 may be configured to select a representative bone model 30 from a set of representative bone models 30 associated with the statistical shape model 75. The patient's statistical shape model 75 and bone model 330 may be associated with a common bone of an anatomical structure, such as the scapula or humerus. The comparison module 52 and / or the statistical shape modeler 72 may be configured to assign an anatomical size classification 80 of the selected representative bone model 30 to the patient's bone model 330. Each representative bone model 30 in the set of representative bone models 30 may be assigned a respective anatomical size classification 80 based on the statistical shape model 75. The comparison module 52 and / or the statistical shape modeler 72 may be configured to assign the anatomical size classification 80 of the selected representative bone model 30 to the bone model 330.

[0260] The statistical shape modeler 72 may be configured to assign to the bone model 330 an anatomical body size classification 80 associated with another patient that most closely resembles the anatomical structure encompassed by the bone model 330. The anatomical body size classification database 70 may include stored information specifying one or more landmarks of the bone model 30 associated with the assigned anatomical body size classification 80. The bone model 30 associated with the assigned anatomical body size classification 80 may be registered to a global frame of reference.

[0261] In embodiments, establishing a surgical plan 36 for a patient may include selecting a representative bone model 30 from a set of representative bone models 30 associated with respective statistical shape models 75. The statistical shape models 75 and the representative bone models 30 may be associated with common bones of the anatomy. Establishing the surgical plan 36 may include comparing the patient's bone model 330 with the selected representative bone model 30 associated with the SSM 75. The surgical plan 36 may be established based on the bone models 330 in the global frame of reference.

[0262] The landmarks on the bone model 330 may be paired with associated landmarks on the bone model 30 of the assigned anatomical body size classification 80. The patient's bone model 330 may be reoriented so that the landmark pairs on the representative bone model 30 and the patient's bone model 330 may be substantially aligned in a global frame of reference. The patient's posture may be determined based on the landmark locations on the representative bone model 30.

[0263] In embodiments, instances of bone models 30 of the assigned anatomical body type classification 80 in the global frame of reference may be substantially aligned with the patient's bone model 330 in the local frame of reference to determine values ​​of one or more correction angles. The correction angles may include three rotation angles relative to the axes of the frame of reference. A transformation may be established based on the determined values ​​of the correction angles. The spatial module 50 may be configured to apply the transformation to each bone model 330 of the patient to register the bone models 330 to the global frame of reference. In other embodiments, the patient bone model 330 may be registered to the global frame of reference by substantially aligning the patient bone model 330 with a selected bone model 30 of another patient in the global frame of reference.

[0264] The statistical shape modeler 72 may be configured to utilize the SSM 75 to assign an anatomical body classification (AMC) 80 to the anatomical and / or bone model based on one or more bones of the anatomy, such as the scapula. The statistical shape modeler 72 may be configured to determine the position of the bone relative to the skeletal anatomy based on one or more properties of the bone and associated landmarks.

[0265] Patient positioning is performed using multiple AMC80 NThe patient's posture may be defined with respect to one or more parameters, including any of the parameters disclosed herein, such as scapular angle (e.g., FIGS. 17A-17C). The determined posture may be associated with a posture type (e.g., A, B, or C). The statistical shape modeler 72 may be configured to establish an anatomical build classification 80 based on one or more predefined modes (e.g., variation modes) 76. The parameters associated with the posture may establish one or more of the predefined modes 76, including any of the posture parameters disclosed herein, such as scapular angle. The statistical shape modeler 72 may be configured to receive the predefined modes 76 associated with the posture as input. The statistical shape modeler 72 may be configured to assign AMCs 80 to respective anatomical structures and associated bone models 30 based on the predefined modes 76 associated with the posture.

[0266] An AMC 80 may be selected based on (e.g., best) fit between the bone model 30 associated with the AMC 80 and the patient's bone model 330. Landmarks on the bone model 30 associated with the selected AMC 80 may be utilized to determine the patient's posture. In embodiments, the landmarks associated with the selected AMC 80 may be utilized to determine various posture characteristics, such as scapular angle relative to a global frame of reference and / or posture type. The patient's bone model 330 may be reoriented from the acquisition orientation to the global frame of reference by applying a transformation based on the determined posture.

[0267] The disclosed systems and methods may be utilized to orient a model of the scapula to substantially match the patient's preoperative posture, which may be utilized to determine and / or verify range of motion. Various embodiments may be utilized in accordance with the teachings disclosed herein, including determining range of motion based on posture information.

[0268] The system 10 may be configured to overlay a representative bone model 30 corresponding to the assigned anatomical body size classification 80 onto each bone model 330 of the patient (see, for example, bone models 330S-1, 330S-2 in FIG. 35 ). The surgeon or clinical user may interact with the user interface 356 to toggle on (and off) the visibility of the overlaid bone models 30 associated with the SSMs 75. The overlaid bone models 30 associated with the SSMs 75 may provide a pre-morbid representation of the patient's anatomy that the surgeon may evaluate to establish, edit, and / or approve a surgical plan.

[0269] In embodiments, step 382D may include replacing the patient's bone model 330 with a bone model 30 corresponding to the anatomical body size classification 80 assigned to the patient's bone model 330. The anatomical body size classification database 70 may include alignment information associated with the position of the substitute bone model 30 within the global frame of reference. The substitute bone model 30 may serve as a pre-morbid representation of the patient's anatomy. The pre-morbid representation may omit osteophytes and / or other surface irregularities that may otherwise impede the range of motion of the associated bone. The surgeon may remove the osteophytes and / or otherwise treat the surface irregularities during the surgical procedure. Analyzing the range of motion utilizing the substitute bone model 30, including within the global frame of reference, may provide a relatively more accurate prediction of the post-operative range of motion with the surface irregularities removed or otherwise treated.

[0270] 32, with continued reference to FIG. 27, in step 382E, the position and / or orientation of one or more implants may be determined based on the orientation of an associated bone model, such as scapula model 330S. System 10 may be configured to determine the position of one or more implants and associated implant models 332 based on the orientation of anatomical model 329 and / or bone model 330, including scapula model 330S, in a respective frame of reference, including any of the frames of reference disclosed herein. Implant models 332 may include glenoid implant model 332G and / or humeral implant model 332H.

[0271] The spatial module 50 may be configured to position the implant model 332 and the bone model 330 relative to one another in the global frame of reference based on the implant positions specified in the surgical plan 36. The system 10 may be configured to determine optimal implant positions based on the patient's predicted posture, including predicted posture type. In embodiments, the posterior rotation of the humeral implant model 332H may be adjusted to improve range of motion. The position and orientation of each implant model 332 relative to its respective bone model 330 may be established in the global frame of reference according to the assigned anatomical body size classification 80. The surgeon or clinical user may adjust the assigned position and / or orientation of the implant model 332 before approving the surgical plan 36.

[0272] At step 382F, a range of motion associated with each implant model 332 may be determined. Step 382F may include performing a range of motion simulation based on one or more parameters associated with the patient's posture. The bone model 330 may be associated with the patient's scapula. The parameters may include a scapular angle associated with the scapula. The system 10 may be configured to perform the range of motion simulation based on the determined posture parameters, such as the humerus model 330H. The system 10 may be configured to determine the range of motion based on an anatomical body size classification 80 assigned to the bone models 330, including the scapula model 330S of the scapula, using any of the techniques disclosed herein. The range of motion modeler 101 may be configured to perform a range of motion simulation of the bone models 330 in a global frame of reference based on the posture parameters and / or the assigned anatomical body size classification 80.

[0273] Step 382F may include storing the range of motion data derived from the range of motion simulation in storage system 18 of system 10. Data module 46 may be configured to store the range of motion data in storage system 18.

[0274] FIG. 33 discloses a method within a flowchart 482 for a surgical procedure. Method 482 may be utilized to pre-operatively plan, perform, evaluate, and / or verify aspects of various surgical procedures, such as arthroplasty procedures to restore function to the shoulder, ankle, knee, hip, and other joints. Method 482 may be utilized with any of the planning systems and methods, virtual anatomical models, and bone models disclosed herein, such as planning system 10. Method 482 may be utilized to determine the position and / or orientation of one or more implants based on the orientation of a patient's anatomical structures, such as the scapula and humerus. The orientation of the anatomical structures may be correlated with the patient's posture. Method 482 may be utilized to determine the patient's posture. Fewer or additional steps than those listed below may be implemented within the scope of this disclosure, and the order of the listed steps is not intended to limit this disclosure. Method 482 may incorporate any of the steps of method 382 disclosed herein, and vice versa.

[0046] Reference is made to system 10.

[0275] 2 with continued reference to FIG. 33, in step 482A, a digital image of a patient's anatomy may be captured by imaging device 16. Imaging device 16 may include any of the imaging devices disclosed herein. Computing device 40 may be configured to receive image data associated with the patient. In an embodiment, a shoulder CT scan or MRI may be acquired, such as by imaging device 16, to establish one or more images 26 of the anatomy. The images 26 may be associated with an anatomical model 29. Computing device 40 may be configured to generate, based on the image data, an anatomical model 29 and / or a bone model 30 of the patient and / or one or more other patients, including patients associated with a representative patient population. In step 482B, digital image 26 may be segmented using various techniques, such as by applying automatic, semi-automatic, or manual segmentation.

[0276] At step 482C, the planning system 10 may be configured to generate one or more anatomical models 29. The anatomical models 29 may include one or more bone models 30. The bone models 30 may represent respective bones, including any of the bones disclosed herein, such as the scapula and humerus. The anatomical models 29 may include information specifying the arrangement of the bone models 30 relative to one another. A three-dimensional (3D) mesh of the relevant bones (e.g., the scapula and humerus) may be reconstructed.

[0277] In step 482D, the orientation of one or more (e.g., a first) bone, such as a scapula, may be determined. The bone may be associated with an anatomical model, such as anatomical model 329 of FIG. 34. The anatomical model 329 of FIG. 34 may be associated with anatomical model 329 of FIG. 28. The bone may be associated with a respective bone model, such as scapula model 330S. Various techniques for determining the orientation of the scapula may be utilized, including any of the techniques disclosed herein.

[0278] Step 482D may include defining a global frame of reference in step 482D- 1. The global frame of reference may be defined using any of the techniques disclosed herein.

[0279] The orientation of bones, such as the scapula, may be measured or otherwise determined using a variety of techniques, including any of the techniques disclosed herein. Planning system 10 may be configured to perform any of the techniques disclosed in the steps of method 382 to measure or otherwise determine the orientation of bones.

[0280] With continued reference to FIGS. 2 and 33 , and with reference to FIG. 34 , the scapular orientation of the scapula model 330S in 3D space can be measured using various techniques. In embodiments, step 482D may include determining the location of landmarks associated with one or more of the bone models 330 in step 482D-2 (see, e.g., FIG. 29 ), including any of the landmarks disclosed herein. The landmarks may be associated with the scapula model 330S and / or the humerus model 330H. The spatial module 50 may be configured to define a transformation based on the relative distance between the landmarks and a reference point (e.g., an origin) of a reference system. The landmarks may be determined using any of the techniques disclosed herein. The scapular orientation of the scapula model 330S in 3D space can be measured based on one or more defined landmark points on the scapula. The landmark points may be manually specified by a surgeon or clinical user or automatically calculated by the system 10 using any of the techniques disclosed herein. Landmarks may be identified in a local (eg, scapular) frame of reference.

[0281] In embodiments, step 482D may include determining an anatomical plane REF-A associated with the anatomical structure in step 482D-3 (see, for example, FIG. 31 ). The anatomical plane REF-A may be a scapular plane associated with the scapula model 330S. The spatial module 50 may be configured to determine the anatomical plane REF-A, which may be a best-fit plane passing through the scapula model 330S. The scapular orientation of the scapula model 330S in 3D space may be measured based on the best-fit plane relative to the scapula. Various techniques may be utilized to measure the scapular orientation. The spatial module 50 may be configured to rotate the anatomical plane REF-A relative to the X-axis, Y-axis, and / or Z-axis of the reference system. The comparison module 52 may be configured to determine the orientation of the scapula model 330S based on an amount of rotation sufficient to align the anatomical plane REF-A relative to the X-axis, Y-axis, and / or Z-axis.

[0282] Other techniques for determining the orientation of the bones associated with the anatomical model in step 482D may be utilized. With continued reference to FIGS. 2, 4, and 33, and with reference to FIGS. 34-35, step 482D may include, in step 482D-4, determining the orientation of the bone model 330 (e.g., of the scapula) based on one or more predetermined correlations with anatomical landmarks and / or anatomical structures of one or more other patients and / or representative patient populations. The representative patient population may exclude the patient. The predetermined correlations may be established with respect to anatomical landmarks and / or SSM / numerical construct classifications. The SSM / numerical construct classifications may be established using any of the techniques disclosed herein. In an embodiment, a global frame of reference may be established in step 482D-1 using any of the techniques disclosed herein.

[0283] The storage system 18 may be configured to store two-dimensional and / or three-dimensional bone models 30 associated with one or more bones and / or one or more joints of a representative patient population. The bone models 30 may include a first set of bone models 30 and a second set of bone models 30. The first set of bone models 30 may be associated with a first bone of the anatomy. The second set of bone models 30 may be associated with a second bone of the anatomy. The bone models 30 in the first and second sets may be associated with a common anatomical model 29 of the patient.

[0284] The bone model 30 and associated bones of the representative patient population may be associated with one or more statistical shape models (SSMs) 75. Step 482D-4 may include analyzing the representative patient population within the SSMs 75. The planning environment 28 may be configured to analyze the representative patient population within the associated SSMs 75. The SSMs 75 may be established based on a statistically significant number of prior cases to characterize the associated bone variations of the anatomical structures. In embodiments, the SSMs 75 may be established based on at least 100-1,000 prior cases, or more narrowly, at least 10,000-20,000 prior cases. The statistical shape modeler 72 may be configured to create a plurality of anatomical body size classifications 80 based on a plurality of predefined modes (e.g., variation modes) 76 within the statistical shape model 75. The statistical shape modeler 72 may be configured to receive the one or more predefined modes 76 as input. The predefined modes 76 may characterize anatomical variations within a representative patient population and a standard deviation 78 of the anatomical variance contained within each of the predefined modes 76. The statistical shape modeler 72 may be configured to assign an anatomical body size classification 80 to the bone model 30. The storage system 18 may be configured to store the anatomical body size classification 80. Step 482D-4 may include identifying the predefined modes 76 within the SSM 75 of the representative patient population.

[0285] The predefined modes 76 that may be provided to the statistical shape modeler 72 may include any of the predefined modes disclosed herein, including, but not limited to, sizes of bones and / or portions of bones (e.g., scapula, glenoid, humerus, humeral head, shaft, etc.), amount of tilt, amount of torsion, amount of retroversion (e.g., humerus), predicted amounts of glenoid and sagittal neck length, glenoid to scapular neck angle, critical shoulder angles, acromion and / or coracoid prominence, humeral head varus / valgus, anatomical landmarks, joint cavity, preoperative range of motion, any combination of the foregoing, etc. In embodiments, the predefined modes 76 associated with the scapula and humerus may be the same or different. The number of predefined modes 76 may be selected based on the amount of variation associated with individual modes and / or combinations of modes. The amount of variation of the modes may vary based on the selected anatomy. The predefined modes 76 may include a posture mode associated with a patient's posture.

[0286] 35 with continuing reference to FIGS. 2, 4, and 33-34, a method 482 may include accessing a first patient three-dimensional model 330S-1 of the patient from memory. The first patient model 330S-1 may be associated with a first bone of the patient. The statistical shape modeler 72 may be configured to select a first representative (e.g., scapula) three-dimensional bone model 330S-2 in response to varying one or more of the predefined modes 76 within the SSM 75.

[0287] The statistical shape modeler 72 may be configured to assign an anatomical body size classification 80 associated with the first representative model 330S-2 to the first patient bone model 330S-1. The range of motion modeler 101 may be configured to perform a range of motion simulation for each bone's assigned anatomical body size classification 80. The statistical shape modeler 72 may be configured to assign an anatomical body size classification 80 to the bone model 330S-1 based on a posture model. The statistical shape modeler 72 and / or the comparison module 52 may be configured to determine one or more posture parameters associated with the patient's posture based on the anatomical body size classification 80 associated with the representative model 330S-2 of the scapula associated with another patient in the representative patient population. The orientation of the patient's selected bone model 300 may be measured based on the SSM 75. In an embodiment, the scapular orientation of the scapula model 330S in 3D space may be measured based on the SSM 75 associated with the scapula.

[0288] The anatomical body size classification database 70 may include coordinate information associated with the position of each bone model 30 within the global frame of reference and / or each acquired frame of reference. The scapular SSM 75 may be utilized to select a bone model 30 associated with the anatomical body size classification database 70 that most closely resembles the anatomical structure encompassed by the bone model 330 of each bone. The selected bone model 30 may be associated with a respective AMC 80. One or more posture parameters associated with the selected bone model 30 may be predetermined, such as scapular angle.

[0289] The comparison module 52 may be configured to select the first representative bone model 330S-2 from the first set of bone models 30 in response to comparing the first representative bone model 330S-2 with a first patient bone model 330S-1 associated with a first bone of the patient, such as a scapula.

[0290] The comparison module 52 may be configured to determine at least one patient characteristic associated with the first bone and / or the second bone of the patient in response to comparing the first and second spatial relationships. The patient characteristic may be associated with a posture of the patient. The comparison module 52 may be configured to establish an implant plan based on the patient characteristic.

[0291] The comparison module 52 may be configured to compare the first representative bone model 330S-2 with the patient bone model 330S-1 in response to the spatial module 50 at least partially or substantially matching the volume of the first representative bone model 330S-2 and the volume of the patient bone model 330S-1 to each other.

[0292] The transformation may be applied to the selected bone model 30 / 330S-2. The spatial module 50 may be configured to apply the transformation. The transformation may be established by reorienting (e.g., adjusting) the selected bone model 30 / 330S-2 to substantially align it with the patient's scapula model 330S-1. Once completed, the orientation of the associated scapula model 330S-1 of the patient's scapula may be calculated based on the transformation applied to the assigned bone model 30 / 330S-2. In an embodiment, the spatial module 50 may be configured to adjust the position of the patient bone model 330S / 330S-1 and / or the position of the patient bone model 330H based on the determined patient characteristics.

[0293] The spatial module 50 may be configured to register the first patient bone model 330S / 330S-1 and / or the second patient bone model 330H from the local frame of reference to the global frame of reference based on the determined patient characteristics. The planning environment 28 may be configured to establish a surgical plan associated with the patient bone model 330S / 330S-1 of the scapula and / or the patient bone model 330H of the humerus in the global frame of reference.

[0294] 2 and 33 , and with reference to FIG. 34 , at step 482E, a patient posture associated with the anatomical model 329 may be determined. The posture may be determined based on an orientation of a scapular model 330S associated with the anatomical model 329. The planning system 10 may be configured to predict or determine a posture type (e.g., A, B, or C) based on the orientation of the scapula. Step 482E may include determining one or more characteristics associated with the patient posture based on the selected anatomical model 339.

[0295] In step 482F, an initial anatomical position of another (e.g., second) bone of the anatomical structure associated with anatomical model 329 may be determined, such as the humerus associated with humerus model 330H. The initial anatomical position of the other bone may be determined based on the orientation determined in step 482E. Various techniques may be utilized to determine the initial anatomical humerus position, including any of the techniques disclosed herein, such as the technique disclosed in step 482D. It should be understood that while the technique of step 482F primarily refers to the humerus relative to the scapula, the technique may be utilized for any two adjacent and / or non-adjacent bones of the anatomical structure. In an embodiment, step 482D may be utilized to determine the orientation of the humerus, and step 482E may be utilized to determine the orientation of the scapula.

[0296] The system 10 can be configured to automatically generate a pre-operative surgical plan 36 (FIG. 2) based on the anatomical scapular posture and / or anatomical humerus position. The pre-operative plan 36 can specify various parameters (e.g., implant type, size, and orientation). The surgical plan 36 can include an implant plan associated with one or more implants to treat the patient.

[0297] In step 482G, the positions and / or orientations of one or more implant models 332 may be determined. The implant models 332 may include a first (e.g., glenoid) implant model 332G and / or a second (e.g., humerus) implant model 332H (see, e.g., FIG. 32 ). The implant models 332G, 332H may be configured to mate with one another. The system 10 may be configured to determine optimal implant positions based on the predicted posture and / or posture type, which may be determined in step 482E. The system 10 may be configured to establish an implant plan based on one or more posture parameters, which may be determined using any of the techniques disclosed herein. Step 482G may include establishing an implant plan associated with the patient's first bone and / or second bone in response to determining characteristics associated with the patient's posture. Step 482G may include applying a correction factor to the default implant positions and / or orientations based on the determined posture characteristics. The correction factor may be established based on a particular posture value (e.g., scapular angle) and / or posture type.

[0298] At step 482H, a range of motion associated with one or more bones of the anatomy may be determined. The range of motion may be based on the position and / or orientation of the implant model 332 determined at step 482F. In embodiments, the retroversion of the humeral implant associated with the humeral implant model 332H (e.g., FIG. 32) may be adjusted to improve clinical range of motion. The range of motion modeler 101 and / or another portion of the planning environment 28 may be configured to perform a range of motion simulation based on one or more patient characteristics, which may be determined using any of the techniques disclosed herein. Based on the anatomical scapular posture, the anatomical initial humeral position, and / or the selected implant (e.g., type, size, and orientation), the system 10 may be configured to predict or calculate a range of motion outcome for the current patient associated with the patient's anatomical model 329.

[0299] The planning environment 28 and / or other portions of the planning system 10 may be configured to determine the position and / or orientation of an implant based on kinematics associated with the patient's anatomy. FIGS. 36-37 disclose an anatomical model 529 including one or more bone models 530. The bone models 530 may include a first (e.g., scapula) bone model 530S and a second (e.g., humerus) bone model 530H. The scapula model 530S and the humerus model 530H may be associated with a shoulder model 529SM. The anatomical model 529 and each bone model 530 may be associated with one or more implant models 532, such as a glenoid implant model 532G and a humerus implant model 532H. The planning environment 28 and / or other portions of the planning system 10 may be configured to determine the position and / or orientation of the implant models 532 using any of the techniques disclosed herein.

[0300] The scapular model 530S may be associated with an anatomical (e.g., scapular) plane REF-A (see also FIG. 31 ). The scapular plane REF-A may be established utilizing any of the techniques disclosed herein. In embodiments, the scapular plane REF-A may be substantially vertical. The position and / or orientation of the glenoid implant model 532G and / or the humeral implant model 532H may be established relative to the scapular plane REF-A.

[0301] Continuing with reference to FIGS. 8 and 36-37, and with reference to FIGS. 38-39, the range of motion modeler 101 can be configured to determine the range of motion of the humerus model 530H relative to the scapular plane REF-A. The humerus model 530H can be moved in adduction (e.g., FIG. 38) and / or abduction (e.g., FIG. 39) to determine the range of motion relative to the scapular plane REF-A. In embodiments, determining the position and / or orientation of the implant model 532 can omit the anatomical position of the scapula, the patient's posture, and / or movement of the humerus model 530H relative to one or more planes of motion of the patient. The planning system 10 can determine the position and / or orientation of the implant model 532 that can achieve a desired (e.g., maximum) range of motion of the humerus model 530H relative to the scapular plane REF-A.

[0302] 40-41 disclose an anatomical model 629 including one or more bone models 630. The bone models 630 may include a first (e.g., scapula) bone model 630S and a second (e.g., humerus) bone model 630H. A patient posture associated with the anatomical model 629, including one or more posture characteristics, may be determined using any of the techniques disclosed herein. The scapula model 630S and / or the humerus model 630H may be oriented relative to the patient's posture. A scapular plane REF-A may be established based on the determined posture characteristics. The position and / or orientation of the glenoid implant model 632G and / or the humerus implant model 632H may be established with respect to the determined posture characteristics and / or the scapular plane REF-A.

[0303] 42-43, with continued reference to FIGS. 8 and 40-41, the range of motion modeler 101 can be configured to determine the range of motion of the humerus model 630H relative to the scapular plane REF-A. The planning system 10 can be configured to substantially align the elbow joint associated with the anatomical model 629 with the patient's sagittal plane. The humerus model 630H can be moved in adduction (e.g., FIG. 42) and / or abduction (e.g., FIG. 43) to determine the range of motion relative to the scapular plane REF-A. The movement of the humerus model 630H can be anatomical. In embodiments, determining the position and / or orientation of the implant model 632 can be based on one or more determined postural characteristics, but can omit movement of the humerus model 630H relative to one or more planes of motion of the patient. The planning system 10 may be configured to determine a position and / or orientation of the implant model 632 that may achieve a desired (e.g., maximum) range of motion of the humerus model 630H relative to the scapular plane REF-A based on the determined posture of the patient.

[0304] 44-45 disclose an anatomical model 729 including one or more bone models 730. The bone models 730 may include a first (e.g., scapula) bone model 730S and a second (e.g., humerus) bone model 730H. A patient posture associated with the anatomical model 729, including one or more posture characteristics, may be determined using any of the techniques disclosed herein. The scapula model 730S and / or the humerus model 730H may be oriented relative to the patient's posture. A scapular plane REF-A may be established based on the determined posture characteristics. The position and / or orientation of the glenoid implant model 732G and / or the humerus implant model 732H may be established with respect to the determined posture characteristics, the scapular plane REF-A, and / or the movement of the humerus model 730H relative to one or more planes of motion of the patient.

[0305] 8 and 44-5, and with reference to FIGS. 46-47, range of motion modeler 101 can be configured to determine the range of motion of humerus model 730H relative to one or more planes of motion REF-K associated with the patient. A global frame of reference can be established relative to one or more planes of motion, including any of the planes of motion disclosed herein. Registering bone model 730 to the global frame of reference can improve determining the range of motion of the patient's associated bones.

[0306] The range of motion modeler 101 may be configured to perform a range of motion simulation along or otherwise relative to the plane of motion REF-K. The range of motion modeler 101 may be configured to align the humerus model 730H with respect to the plane of motion REF-K. The humerus model 730H may be moved in adduction (e.g., FIG. 46) and / or abduction (e.g., FIG. 47) to determine the range of motion relative to the plane of motion REF-K. The plane of motion REF-K may include a first plane of motion REF-K1, a second plane of motion REF-K2 (e.g., FIGS. 48-49), and / or a third plane of motion REF-K3 (e.g., FIGS. 50-51). The first plane of motion REF-K1 may be associated with a coronal (e.g., frontal) plane of the patient. The coronal plane may be associated with deflection and / or extension of the associated bone. The second plane of motion REF-K2 may be associated with an axial (e.g., horizontal or transverse) plane of the patient. The axial plane may be associated with internal and / or external rotation of the associated bone. The third plane of motion REF-K3 may be associated with the patient's sagittal plane (e.g., longitudinal axis). The sagittal plane may be associated with abduction and / or adduction of the associated bone. The planning system 10 may be configured to rotate the humerus model 730H about the longitudinal axis LA of the diaphysis, which may be substantially perpendicular to the second plane of motion REF-K2. The scapular plane REF-A may be transverse to the patient's plane of motion REF-K.

[0307] The planning system 10 may be configured to determine a position and / or orientation of the implant model 732 that can achieve a desired (e.g., maximum) range of motion of the humerus model 730H relative to one or more or each of the patient's planes of motion REF-K. In embodiments, the planning system 10 may be configured to set the position and / or orientation of the implant model 732 based on the patient's posture. The planning system 10 may be configured to adjust or otherwise set the position and / or orientation of the implant model 732 based on the determined range of motion of the associated bone model 732 in one or more of the planes of motion REF-K. In embodiments, the planning system 10 may be configured to rotate the implant model 732 about one or more axes based on the determined range of motion in the plane of motion REF-K, which may occur simultaneously with or subsequent to positioning and / or orienting the implant model 732 based on the patient's determined posture.

[0308] The desired range of motion in the plane of motion REF-K may be associated with one or more activities of daily living and / or lifestyle goals. Determining the position of the implant in step 382E of method 382 (FIG. 27) and / or step 482G of method 482 (FIG. 33) may incorporate any of the techniques disclosed herein, including adjusting or otherwise configuring the position and / or orientation of the implant model based on the determined range of motion of the associated bone model in one or more of the planes of motion. Utilizing the techniques disclosed herein, the patient's range of motion and mobility based on the determined posture may be improved relative to the patient's plane of motion.

[0309] It should be understood that while the techniques disclosed herein regarding posture refer to the patient's scapula, the teachings herein may be utilized to determine range of motion and / or establish or adjust preoperative planning for other bones and joints.

[0310] The proposed surgical planning systems and methods of the present disclosure may be utilized to create and execute surgical plans tailored to individual patients, which may improve healing. The disclosed systems and methods may reduce complexity in executing surgical plans, including reduced packaging and instrumentation. In certain embodiments, the systems and methods may utilize a feedback loop to continuously improve the recommendations provided when developing a surgical plan. Thus, the proposed systems and methods offer improved capabilities compared to prior planning systems.

[0311] Although different non-limiting embodiments are illustrated as having particular components or steps, embodiments of the present disclosure are not limited to those particular combinations, and some of the components or features from any of the non-limiting embodiments may be used in combination with features or components from any of the other non-limiting embodiments.

[0312] It should be understood that like reference numerals identify corresponding or similar elements throughout the several views. It should be further understood that while particular component arrangements are disclosed and illustrated in these exemplary embodiments, other arrangements may also benefit from the teachings of the present disclosure.

[0313] The foregoing description should be interpreted as illustrative and not in any limiting sense. Those skilled in the art will recognize that certain modifications may fall within the scope of the present disclosure. For these reasons, the following claims should be studied to determine the true scope and content of the present disclosure. [Explanation of symbols]

[0314] 10 Surgical Planning System 12 Host Computer 14 client computers 16 Imaging devices 18 Storage Systems 20 Network 22 Client Interface 24 Peer-to-Peer Interface 26 images 28 Planning Environment 29 Anatomical Models 30 bone models 32 Implant Model 34 Transmission Model 36 Surgical Planning 38 databases 40 Computing Devices 42 processors 44 memory 46 Data Module 48 Display Module 50 Spatial Module 52 Comparison Module 54 entries 56 Graphical User Interface (GUI) 58 Display Devices 60 Display Window 62 objects 64 Patient Profile Database 65 Surgeon Profile Database 66 Surgical Outcomes Database 68 Range of Motion (ROM) Database 70 Anatomical Body Classification (AMC) Database 72 Statistical Shape Modeler 74 Image data 75 Statistical Shape Models 76 Mode 78 standard deviations 80N Anatomical Body Classification (AMC) 101 Range of Motion (ROM) Modeler

Claims

1. 1. A computer-implemented surgical planning method comprising: one or more processors registering at least one bone model of the patient from a local frame of reference to a global frame of reference, the one or more processors registering including adjusting one or more coordinate values ​​associated with the at least one bone model based on a posture of the patient; establishing, by the one or more processors, a surgical plan associated with the at least one bone model in the global frame of reference; performing, by the one or more processors, a range of motion simulation based on one or more parameters associated with the posture of the patient; storing range of motion data derived from the range of motion simulation in a memory device within a storage system of the surgical planning system; the at least one bone model is associated with a scapula of the patient; The one or more parameters include a scapular angle associated with the scapula.

2. the surgical plan includes an implant type, an implant size, and / or an implant location associated with an implant model; 10. The computer-implemented surgical planning method of claim 1, further comprising the one or more processors positioning the implant model and the at least one bone model relative to one another within the global frame of reference based on a position of the implant specified in the surgical plan.

3. determining, by the one or more processors, one or more surgical measurements associated with the posture of the patient; and the one or more processors establishing a transformation between the local frame of reference and the global frame of reference based on the determined one or more surgical measurements; The computer-implemented surgical planning method of claim 1 , wherein the registering step comprises the one or more processors applying the transformation to the at least one bone model.

4. the at least one bone model is associated with a scapula of the patient; the one or more processors fitting a scapular plane through the at least one bone model; 2. The computer-implemented surgical planning method of claim 1, wherein registering the at least one bone model comprises adjusting, by the one or more processors, an orientation of the at least one bone model with the fitted scapular plane.

5. The step of establishing the surgical plan comprises: selecting, by the one or more processors, a representative bone model from a set of representative bone models associated with a statistical shape model, wherein the statistical shape model and the at least one bone model are associated with common bones of an anatomical structure; and comparing, by the one or more processors, the at least one bone model with the selected representative bone model.

6. 10. The computer-implemented surgical planning method of claim 1, further comprising the one or more processors positioning an implant model based on movement of the at least one bone model relative to one or more planes of motion.

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