Multiple bone prediction for orthopedic procedures
Patent Information
- Application Number
- JP2026078532
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-07-17
- Filing Date
- 2026-05-07
- Publication Date
- 2026-09-01
AI Technical Summary
【0018】 本開示の様々な特徴および利点は、以下の詳細な説明により、当業者には明瞭であろう。詳細な説明に添付された図面について、以下のように簡単に説明することができる。
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Figure 2026139663000001_ABST
Abstract
Description
Technical Field
[0001] Cross-Reference to Related Applications This application claims the priority benefit of U.S. Application No. 18 / 353,270 filed July 17, 2023, which claims the priority benefit of U.S. Provisional Application No. 63 / 399,190 filed August 18, 2022 and U.S. Provisional Application No. 63 / 406,562 filed September 14, 2022, and each of these documents is incorporated herein by reference in its entirety.
[0002] The present disclosure relates to surgical planning, and more specifically, to improved surgical planning systems and methods for planning orthopedic procedures. Background Art
[0003] Arthroplasty is a type of orthopedic procedure performed to repair or replace a diseased joint. To improve patient outcomes, prior to performing arthroplasty, a surgeon may desire to establish a surgical plan for preparing the surgical site, selecting an implant, and placing the implant at the surgical site. Surgical planning may include acquiring an image of the surgical site and determining the position of the implant based on the image. Summary of the Invention Means for Solving the Problems
[0004] The present disclosure relates to improved surgical planning systems and methods.
[0005] The surgical planning systems and methods of the present disclosure may be used in several embodiments for planning orthopedic procedures, including preoperatively, intraoperatively, and / or postoperatively, to create, edit, execute, and / or review a surgical plan. The surgical planning systems and methods may be used for planning and performing orthopedic procedures to restore joint function.
[0006] The surgical planning system may include, in particular, a processor configured to classify a representative patient population into several anatomical body size classifications and to perform range of motion simulations for each of the anatomical body size classifications. The system's memory device may be operablely coupled to the processor and may be configured to store range of motion data derived from the range of motion simulations for each of the anatomical body size classifications.
[0007] A surgical planning method performed by a computer may include, in particular, classifying a representative patient population into multiple anatomical body size classifications via the processor of the surgical planning system; performing range of motion simulations for each of the multiple anatomical body size classifications; and storing the range of motion data derived from the range of motion simulations for each of the multiple anatomical body size classifications in the memory device of the surgical planning system.
[0008] A surgical planning system according to one embodiment may include, among other things, a processor operably connected to a storage system. The storage system may be configured to store a plurality of three-dimensional bone models associated with one or more bones of a representative patient population. The plurality of bone models may include a first set associated with a first bone and a second set associated with a second bone. The processor may be configured to select a first representative bone model from the first set of bone models in response to comparing the first representative bone model with a first patient three-dimensional bone model associated with the patient's first bone. The first representative bone model may be associated with a second representative bone model of the second set of bone models. A first spatial relationship may be established between the first patient bone model and the second patient three-dimensional bone model. The second patient bone model may be associated with the patient's second bone. A second spatial relationship may be established between the first representative bone model and the second representative bone model. The processor may be configured to determine at least one patient characteristic associated with the patient's first and / or second bone in response to comparing the first spatial relationship with the second spatial relationship.
[0009] A computer-based surgical planning method according to one embodiment may, in particular, include accessing a first patient bone model of a patient from memory. The first patient model may be associated with the patient's first bone. The method may also include accessing a second patient bone model of a patient from memory. The second patient bone model may be associated with the patient's second bone. The method may include selecting an anatomical model from a plurality of anatomical models based on the first and second patient bone models. The plurality of anatomical models may be associated with one or more bones and / or one or more joints of a representative patient population, which may include at least the first and second bones. The method may include determining one or more characteristics related to the patient's posture based on the selected anatomical model.
[0010] A surgical planning system according to one embodiment may include, among other things, a processor and memory operably coupled to the processor. The processor may be configured to receive image data including first and second two-dimensional images of a patient's first and second bones. The processor may be configured to determine first profiles of the first and second bones along a first reference plane associated with the first image. The processor may be configured to determine second profiles of the first and second bones along a second reference plane associated with the second image. The processor may be configured to determine orientations of the first and second bones based on a representative anatomical model associated with another patient, which may include projecting a first silhouette of the representative anatomical model onto the first profile along the first reference plane, and projecting a second silhouette of the representative anatomical model onto the second profile along the second reference plane. The processor may be configured to determine one or more postural characteristics associated with the patient's posture based on the determined orientations. The processor may be configured to establish a surgical plan associated with the first and / or second bones based on one or more postural characteristics.
[0011] A surgical planning system according to one embodiment may include, among other things, a processor operably connected to memory. The processor may be configured to access a first three-dimensional bone model from memory. The first bone model may be associated with the first bone. The processor may be configured to access a partial three-dimensional bone model of the patient's first bone. The partial bone model may represent a smaller portion of the first bone compared to the first representative bone model. The processor may be configured to establish a registration location for the first bone model by registering the partial bone model of the first bone with respect to the first bone model at least partially.
[0012] A surgical planning system according to one embodiment may include, among other things, a processor operably connected to a storage system. The storage system may be configured to store multiple three-dimensional bone models associated with one or more bones and / or one or more joints of a representative patient population. The processor may be configured to select a first representative three-dimensional bone model from a first set of bone models associated with a first bone of a representative patient population. The processor may be configured to register a partial three-dimensional bone model of a patient's first bone at least partially with respect to the first representative bone model. The partial bone model may represent a smaller portion of the first bone compared to the first bone model.
[0013] A computer-based surgical planning method according to one embodiment may include, in particular, selecting a first representative three-dimensional bone model related to the first bone. The method may also include selecting a partial three-dimensional bone model of the patient's first bone. The partial bone model may represent a smaller portion of the first bone compared to the first representative bone model. The method may include establishing the registration location of the first representative bone model by at least partially registering the partial bone model of the first bone relative to the first representative bone model. The method may also include analyzing the first bone based on the registration location of the first representative bone model.
[0014] A surgical planning system according to one embodiment may include, among other things, a processor operably connected to memory. The processor may be configured to access a first three-dimensional bone model from memory. The first bone model may be associated with the first bone. The processor may be configured to access a fragmentary three-dimensional bone model of the patient's first bone. The fragmentary bone model may include one or more fragmentary bone portions associated with one or more corresponding bone fragments of the first bone. The processor may be configured to establish a registration state of the fragmentary bone model by registering one or more fragmentary bone portions of the fragmentary bone model at least partially with respect to the volume of the first bone model.
[0015] A surgical planning system according to one embodiment may include, in particular, a processor operably connected to a storage system. The storage system may be configured to store a plurality of three-dimensional bone models associated with one or more bones and / or one or more joints of a representative patient population. The processor may be configured to select a first three-dimensional bone model from a first set of bone models associated with a first bone of a representative patient population. The processor may be configured to establish the registration status of a fragmentary bone model by at least partially registering one or more fragments of a fragmentary three-dimensional bone model of the patient's first bone with respect to the first bone model. One or more fragments may be associated with one or more corresponding fragments of the first bone.
[0016] A computer-aided surgical planning method according to one embodiment may include, in particular, selecting a first three-dimensional bone model associated with the first bone. The method may also include selecting a fragmentary three-dimensional bone model of the patient's first bone. The fragmentary bone model may include one or more fragmentary portions associated with one or more corresponding bone fragments of the first bone. The method may include establishing the registration status of the fragmentary bone model by registering one or more fragmentary portions of the fragmentary bone model at least partially with respect to the volume of the first bone model. The method may also include analyzing the first bone based on the registration status of the fragmentary bone model.
[0017] The embodiments, examples, and alternatives described in the above paragraphs, claims, the following description, and the drawings may be considered independently or in any combination, including any various aspects thereof and any corresponding features. Each feature described in relation to a particular embodiment is applicable to all embodiments unless the features are incompatible with each other.
[0018] The various features and advantages of this disclosure will be apparent to those skilled in the art from the following detailed description. The drawings attached to the detailed description can be briefly described below. [Brief explanation of the drawing]
[0019] [Figure 1] This diagram schematically illustrates an exemplary surgical planning system. [Figure 2] Figure 1 schematically illustrates an exemplary configuration of a surgical planning system. [Figure 3] This diagram schematically illustrates an exemplary cloud-based database accessible by the surgical planning system. [Figure 4] Figure 1 schematically illustrates an additional exemplary embodiment of the surgical planning system. [Figure 5]Figuratively illustrates exemplary anatomical physique classifications that can be assigned by a surgical planning system. [Figure 6] Figuratively illustrates a method for establishing an anatomical physique classification database for a surgical planning system. [Figure 7] Figuratively illustrates a method for establishing a range of motion database for a surgical planning system. [Figure 8] Figuratively illustrates additional exemplary aspects of the surgical planning system in Fig. 1. [Figure 9] Figuratively illustrates a method for planning an orthopedic procedure for a corresponding patient using a surgical planning system. [Figure 10] Illustrates an exemplary user interface of a surgical planning system. [Figure 11] Figuratively illustrates another exemplary method for planning an orthopedic procedure for a corresponding patient using a surgical planning system. [Figure 12] Illustrates another exemplary user interface of a surgical planning system. [Figure 13A] Figuratively illustrates yet another exemplary method for planning an orthopedic procedure for a corresponding patient using a surgical planning system. [Figure 13B] Illustrates yet another exemplary user interface of a surgical planning system. [Figure 14] Figuratively illustrates an exemplary method for postoperatively updating one or more databases associated with a surgical planning system. [Figure 15] Illustrates a set of posture types associated with an anatomical structure. [Figure 16A] Illustrates an anatomical model associated with a set of posture types of an anatomical structure. [Figure 16B] Illustrates an anatomical model associated with a set of posture types of an anatomical structure. [Figure 16C]This diagram illustrates an anatomical model related to a set of postural types involving anatomical structures. [Figure 16D] An anatomical model in a supine position is disclosed. [Figure 17A] Figures 16A to 16C illustrate the angles of the scapula associated with each corresponding posture type. [Figure 17B] Figures 16A to 16C illustrate the angles of the scapula associated with each corresponding posture type. [Figure 17C] Figures 16A to 16C illustrate the angles of the scapula associated with each corresponding posture type. [Figure 18A] Figures 17A to 17C illustrate the angles of the scapula associated with the corresponding posture types for each model in which the humerus and forearm are in an elevated position. [Figure 18B] Figures 17A to 17C illustrate the angles of the scapula associated with the corresponding posture types for each model in which the humerus and forearm are in an elevated position. [Figure 18C] Figures 17A to 17C illustrate the angles of the scapula associated with the corresponding posture types for each model in which the humerus and forearm are in an elevated position. [Figure 19] This specification discloses a clinical case utilizing the technology disclosed herein. [Figure 20] This specification discloses a clinical case utilizing the technology disclosed herein. [Figure 21] This document discloses a shoulder joint model that includes a humeral implant engaged with a glenoid implant, in relation to various postures and scapular angles. [Figure 22] This document discloses a shoulder joint model that includes a humeral implant engaged with a glenoid implant, in relation to various postures and scapular angles. [Figure 23] This document discloses a shoulder joint model that includes a humeral implant engaged with a glenoid implant, in relation to various postures and scapular angles. [Figure 24]Another shoulder joint model is disclosed, which includes a humeral implant engaged with a glenoid implant, in relation to posture and scapular angle. [Figure 25] Another shoulder joint model is disclosed, which includes a humeral implant engaged with a glenoid implant, in relation to posture and scapular angle. [Figure 26] Another shoulder joint model is disclosed, which includes a humeral implant engaged with a glenoid implant, in relation to posture and scapular angle. [Figure 27] This document discloses a method for planning surgical procedures for each patient using a surgical planning system. [Figure 28] A model of the patient's shoulder joint is disclosed. [Figure 29] A model of the patient's shoulder joint is disclosed. [Figure 30] A model of the patient's shoulder joint is disclosed. [Figure 31] A model of the patient's shoulder joint is disclosed. [Figure 32] A model of the patient's shoulder joint is disclosed. [Figure 33] This document discloses a method for planning surgical procedures for each patient using a surgical planning system. [Figure 34] Anatomical models are disclosed. [Figure 35] Anatomical models are disclosed. [Figure 36] Anatomical models are disclosed. [Figure 37A] Anatomical models are disclosed. [Figure 37B] Anatomical models are disclosed. [Figure 38A] Anatomical models are disclosed. [Figure 38B] Anatomical models are disclosed. [Figure 39]Disclosed is another method for planning surgical procedures for each corresponding patient using a surgical planning system, in which a portion of the bone may be omitted from the image data. [Figure 40] A model of the patient's shoulder joint is disclosed. [Figure 41] A model of the patient's shoulder joint is disclosed. [Figure 42] A model of the patient's shoulder joint is disclosed. [Figure 43] A model of the patient's shoulder joint is disclosed. [Figure 44] A model of the patient's shoulder joint is disclosed. [Figure 45] A model of the patient's shoulder joint is disclosed. [Figure 46A] An anatomical model related to the patient's scapula is disclosed. [Figure 46B] An anatomical model related to the patient's scapula is disclosed. [Figure 47A] An anatomical model related to the patient's humerus is disclosed. [Figure 47B] An anatomical model related to the patient's humerus is disclosed. [Figure 48A] This document discloses an anatomical model related to the patient's knee joint. [Figure 48B] This document discloses an anatomical model related to the patient's knee joint. [Figure 48C] This document discloses an anatomical model related to the patient's knee joint. [Figure 49A] This document discloses another anatomical model related to the patient's knee joint. [Figure 49B] This document discloses another anatomical model related to the patient's knee joint. [Figure 50A] This discloses yet another anatomical model related to the patient's knee joint. [Figure 50B] This discloses yet another anatomical model related to the patient's knee joint. [Figure 51A] An anatomical model related to the patient's hip joint is disclosed. [Figure 51B] An anatomical model related to the patient's hip joint is disclosed. [Figure 52] This document discloses yet another method for planning surgical procedures for each corresponding patient using a surgical planning system. [Figure 53] This document discloses a shoulder joint model projected onto a profile related to the patient's anatomical structure. [Figure 54] This document discloses a shoulder joint model projected onto a profile related to the patient's anatomical structure. [Figure 55] This document discloses a method for planning surgical procedures for each corresponding patient using a surgical planning system, including the placement of bone fragments. [Figure 56A] Various arrangements of bone fragments are disclosed. [Figure 56B] Various arrangements of bone fragments are disclosed. [Figure 56C] Various arrangements of bone fragments are disclosed. [Figure 57A] Various arrangements of bone fragments are disclosed. [Figure 57B] Various arrangements of bone fragments are disclosed. [Figure 58A] Various arrangements of bone fragments are disclosed. [Figure 58B] Various arrangements of bone fragments are disclosed. [Figure 58C] Various arrangements of bone fragments are disclosed. [Figure 59A] Various arrangements of bone fragments are disclosed. [Figure 59B] Various arrangements of bone fragments are disclosed. [Figure 59C] Various arrangements of bone fragments are disclosed. [Figure 60] Various arrangements of bone fragments are disclosed. [Modes for carrying out the invention]
[0020] Similar reference numerals and notations in various drawings indicate the same type of component.
[0021] This disclosure relates to an improved surgical planning system and method for planning orthopedic procedures, including preoperative, intraoperative, and / or postoperative stages, for the purpose of creating, compiling, executing, and / or reviewing surgical plans. The surgical planning system and method may be used to plan and perform orthopedic procedures to restore joint function. These and other features of this disclosure are described in further detail in the following paragraphs of this detailed description.
[0022] A surgical planning system according to one embodiment may include a processor. The processor may be configured to classify a representative patient population into a plurality of anatomical body size classifications. The processor may be configured to perform range of motion simulations for each of the plurality of anatomical body size classifications. A storage system may be operably connected to the processor and may be configured to store range of motion data that can be derived from the range of motion simulations for each of the plurality of anatomical body size classifications.
[0023] In any embodiment, the range of motion simulation may be configured to simulate motion-related characteristics associated with a virtual joint that may be derived from a representative patient population. The virtual joint may include one or more bones and may also include a virtual surgical implant positioned relative to one or more bones.
[0024] In any embodiment, the motion-related characteristics may include abduction, adduction, extension, flexion, internal rotation, external rotation, or any combination thereof.
[0025] In any embodiment, the processor may be configured to identify a collision point that can mark the maximum range of motion related to motion-related characteristics.
[0026] In any embodiment, the processor may be configured to identify the angular arc and collision mode associated with the collision point.
[0027] In any embodiment, the processor may be configured to adjust the position of a virtual surgical implant relative to one or more bones in a plurality of offset directions.
[0028] In any embodiment, the processor may be configured to identify 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.
[0029] In any embodiment, the processor may be configured to receive patient-related image data. 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 several anatomical body classifications to the three-dimensional model of the bones or joints. The processor may be configured to display range of motion data related to the assigned anatomical body classification.
[0030] In any embodiment, the processor may be configured to receive input of the patient's activity of daily living (ADL) goals. The processor may also be configured to adjust the position of a virtual surgical implant in a three-dimensional model in order to achieve the ADL goals.
[0031] In any embodiment, the processor may be configured to query the surgical outcome database of the surgical planning system for postoperative surgical outcome data. The processor may be configured to assign one of several anatomical body size classifications to anatomical structures associated with postoperative 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 postoperative surgical outcome data.
[0032] A computer-based surgical planning method according to one embodiment may include the step of classifying a representative patient population into multiple anatomical body size classifications via the processor of the surgical planning system. The method may also include the step of performing range of motion simulations for each of the multiple anatomical body size classifications. The method may also include the step of storing the range of motion data derived from the range of motion simulations for each of the multiple anatomical body size classifications in the storage system of the surgical planning system.
[0033] In any embodiment, the range of motion simulation may be configured to simulate motion-related characteristics associated with a virtual joint that may be derived from a representative patient population. The virtual joint may include one or more bones and may also include a virtual surgical implant positioned relative to one or more bones.
[0034] In any embodiment, performing a range of motion simulation may include identifying collision points that can mark the maximum range of motion related to motion-related characteristics within a virtual joint.
[0035] In any embodiment, performing a range of motion simulation may include identifying angular arcs and collision modes associated with the collision point.
[0036] In any embodiment, performing a range of motion simulation may include adjusting the position of a virtual surgical implant relative to one or more bones in multiple offset directions.
[0037] In any embodiment, performing a 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 a virtual surgical implant.
[0038] In any embodiment, the motion-related characteristics may include abduction, adduction, extension, flexion, internal rotation, external rotation, or any combination thereof.
[0039] In any embodiment, the method may include receiving patient-related image data. The method may include generating a three-dimensional model of the patient's bones or joints based on the image data. The method may include assigning one of several anatomical body classifications to the three-dimensional model of the bones or joints. The method may also include displaying range of motion data related to the assigned anatomical body classification.
[0040] In any embodiment, the method may include receiving input of the patient's activity of daily living goals. The method may also include adjusting the position of a virtual surgical implant in a three-dimensional model to achieve the activity of daily living goals.
[0041] In any embodiment, the method may include querying a surgical outcome database of a surgical planning system with respect to postoperative surgical outcome data. The method may also include assigning one of several anatomical body size classifications to anatomical structures associated with postoperative surgical outcome data. The method may also include updating range of motion data associated with the assigned anatomical body size classification based on the postoperative surgical outcome data.
[0042] A surgical planning system according to one embodiment may include a processor operably connected to a storage system. The storage system may be configured to store a plurality of three-dimensional bone models associated with one or more bones of a representative patient population. The plurality of bone models may include a first set associated with a first bone and a second set associated with a second bone. The processor may be configured to select a first representative bone model from the first set of bone models in response to comparing the first representative bone model with a first patient three-dimensional bone model associated with the patient's first bone. The first representative bone model may be associated with a second representative bone model of the second set of bone models. A first spatial relationship may be established between the first patient bone model and the second patient three-dimensional bone model. The second patient bone model may be associated with the patient's second bone. A second spatial relationship may be established between the first representative bone model and the second representative bone model. The processor may be configured to determine at least one patient characteristic associated with the patient's first and / or second bone in response to comparing the first spatial relationship with the second spatial relationship.
[0043] In any embodiment, at least one patient characteristic may be associated with the patient's posture.
[0044] In any embodiment, the processor may be configured to establish an implant plan based on at least one patient characteristic.
[0045] In any embodiment, the first bone and the second bone may be adjacent bones.
[0046] In any embodiment, the first bone and the second bone may not be adjacent bones.
[0047] In any embodiment, the processor may be configured to perform range of motion simulations based on the characteristics of at least one patient.
[0048] In any embodiment, the processor may be configured to receive patient-related image data. The processor may also be configured to generate a first patient bone model and a second patient bone model based on the image data.
[0049] In any embodiment, the processor may be configured to determine a deviation between a first spatial relationship and a second spatial relationship based on one or more markers associated with a first bone and / or a second bone. The processor may be configured to determine at least one patient characteristic based on the deviation.
[0050] In any embodiment, the processor may be configured to compare the first representative bone model with the first patient bone model in response to at least partially matching the volume of the first representative bone model with the volume of the first patient bone model. The processor may be configured to compare the second representative bone model with the second patient bone model in response to at least partially matching the volume of the second representative bone model with the volume of the second patient bone model.
[0051] In any embodiment, the processor may be configured to adjust the position of a first patient bone model and / or a second patient bone model based on at least one patient characteristic.
[0052] In any embodiment, the processor may be configured to register a first patient bone model and / or a second patient bone model from a local reference system to a global reference system based on at least one patient characteristic. The processor may also be configured to establish a surgical plan related to the first patient bone model and / or the second patient bone model within the global reference system.
[0053] In any embodiment, the processor may be configured to analyze a representative patient population within a statistical shape model.
[0054] In any embodiment, the processor may be configured to create multiple anatomical body size classifications based on multiple predefined modes in a statistical shape model that characterize anatomical differences within a representative patient population, and further based on multiple standard deviations of anatomical variances contained within each of the multiple predefined modes. The processor may be configured to assign the anatomical body size classifications to a bone model. A storage system may be configured to store the anatomical body size classifications.
[0055] In any embodiment, the processor may be configured to select a first representative bone model in response to a change in one or more predefined modes.
[0056] In any embodiment, the processor may be configured to assign an anatomical body size classification associated with a first representative bone model to a first patient bone model. The processor may be configured to assign an anatomical body size classification associated with a second representative bone model to a second patient bone model. The processor may be configured to perform range of motion simulations with respect to the assigned anatomical body size classifications.
[0057] In any embodiment, the predefined modes may include posture modes related to posture. The processor may be configured to assign anatomical body type classifications to bone models based on the posture modes. The processor may be configured to determine one or more posture parameters related to a patient's posture based on anatomical body type classifications associated with a first representative bone model and / or a second representative bone model.
[0058] In any embodiment, the processor may be configured to establish an implant plan based on one or more posture parameters.
[0059] A computer-based surgical planning method according to one embodiment may include accessing a first patient bone model of a patient from memory. The first patient model may be associated with the patient's first bone. The method may also include accessing a second patient bone model of a patient from memory. The second patient bone model may be associated with the patient's second bone. The method may include selecting an anatomical model from a plurality of anatomical models based on the first and second patient bone models. The plurality of anatomical models may be associated with one or more bones and / or one or more joints of a representative patient population, which may include at least the first and second bones. The method may include determining one or more characteristics related to the patient's posture based on the selected anatomical model.
[0060] In any embodiment, the step of selecting an anatomical model may be performed in response to fitting the anatomical model at least partially to a first patient bone model and to a second patient bone model.
[0061] In any embodiment, the method may include establishing an implant plan related to the patient's primary and / or secondary bone in response to a step of determining one or more characteristics.
[0062] In any embodiment, the method may include analyzing a representative patient population within a statistical shape model.
[0063] In any embodiment, the method may include identifying several predefined modes within a statistical shape model of a representative patient population. These predefined modes may include posture-related postural modes. The method may also include establishing several standard deviations of anatomical variances contained within each of the predefined modes. The step of selecting an anatomical model may be performed in response to a change in one or more of the predefined modes within the statistical shape model.
[0064] A surgical planning system according to one embodiment may include a processor and memory operably coupled to the processor. The processor may be configured to receive image data including a first two-dimensional image and a second two-dimensional image of a patient's first and second bones. The processor may be configured to determine a first profile of the first and second bones along a first reference plane associated with the first image. The processor may be configured to determine a second profile of the first and second bones along a second reference plane associated with the second image. The processor may be configured to determine the orientation of the first and second bones based on a representative anatomical model associated with another patient, which may include projecting a first silhouette of the representative anatomical model onto the first profile along the first reference plane, and projecting a second silhouette of the representative anatomical model onto the second profile along the second reference plane. The processor may be configured to determine one or more postural characteristics associated with the patient's posture based on the determined orientation. The processor may be configured to establish a surgical plan associated with the first and / or second bones based on one or more postural characteristics.
[0065] In any embodiment, the processor may be configured to determine a first acquisition direction associated with a first image based on a comparison of the degree of fit between a first silhouette and a first profile. The processor may be configured to determine a second acquisition direction associated with a second image based on a comparison of the degree of fit between a second silhouette and a second profile. The processor may be configured to determine one or more pose characteristics based on the first and second acquisition directions.
[0066] In any embodiment, the processor may be configured to determine a first acquisition direction in response to iterative adjustments to the projection of a first silhouette onto a first profile along a first reference plane. The processor may also be configured to determine a second acquisition direction in response to iterative adjustments to the projection of a second silhouette onto a second profile along a second reference plane.
[0067] In any embodiment, the first reference plane and the second reference plane may be perpendicular to each other.
[0068] In any embodiment, the first bone may be associated with the patient's scapula. The second bone may be associated with the patient's humerus.
[0069] A surgical planning system according to one embodiment may include a processor operably connected to memory. The processor may be configured to access a first representative three-dimensional bone model from memory. The first bone model may be associated with the first bone. The processor may be configured to access a partial three-dimensional bone model of the patient's first bone. The partial bone model may represent a smaller portion of the first bone compared to the first representative bone model. The processor may be configured to establish a registration location for the first bone model by registering the partial bone model of the first bone with respect to the first bone model at least partially.
[0070] In any embodiment, the processor may be configured to establish an implant plan in response to the establishment of a registration position for the first bone model.
[0071] In any embodiment, the processor may be configured to determine one or more postural parameters related to the patient's posture based on the registration position of the first bone model. The processor may also be configured to establish an implant plan based on one or more postural parameters.
[0072] In any embodiment, the processor may be configured to receive patient-related image data in which a portion of the first bone is omitted. The processor may be configured to generate a partial bone model based on the image data.
[0073] In any embodiment, the first bone may be the humerus. The partial bone model may omit the distal portion of the humerus. The first bone model may include the distal portion of the humerus.
[0074] In any embodiment, the processor may be configured to determine an axis associated with the first bone based on the registration position of the first bone model.
[0075] A surgical planning system according to one embodiment may include a processor operably connected to a storage system. The storage system may be configured to store multiple three-dimensional bone models associated with one or more bones and / or one or more joints of a representative patient population. The processor may be configured to select a first representative three-dimensional bone model from a first set of bone models associated with a first bone of a representative patient population. The processor may be configured to register a partial three-dimensional bone model of a patient's first bone at least partially with respect to the first representative bone model. The partial bone model may represent a smaller portion of the first bone compared to the first bone model.
[0076] In any embodiment, the processor may be configured to receive patient-related image data in which a portion of the first bone may be omitted. The processor may be configured to generate a partial bone model based on the image data.
[0077] In any embodiment, a partial bone model may be associated with a long bone. The partial bone model may include a diaphysis portion associated with the diaphysis of the long bone and a head portion associated with the head of the long bone. The processor may be configured to at least partially register the diaphysis portion of the partial bone model with respect to the diaphysis portion of a first representative bone model. The processor may be configured to substantially align the center point of the head portion of the partial bone model with respect to the center point of the head portion of the first representative bone model. The processor may be configured to at least partially register the partial bone model with respect to the first representative bone model by rotating the head portions of the partial bone models around their respective center points.
[0078] In any embodiment, the processor may be configured to select a second representative three-dimensional bone model from a second set of bone models associated with the second bone. The processor may be configured to establish a registration location for the second representative bone model by at least partially registering the second representative bone model with respect to the second three-dimensional bone model of the patient's second bone. Based on the registration location of the second representative bone model, the processor may be configured to select a first representative bone model from a first set of bone models.
[0079] In any embodiment, the first bone and the second bone may be adjacent bones.
[0080] In any embodiment, the processor may be configured to analyze a representative patient population within a statistical shape model.
[0081] In any embodiment, the processor may be configured to create multiple anatomical body size classifications based on multiple predefined modes in a statistical shape model that characterize anatomical differences within a representative patient population, and further based on multiple standard deviations of anatomical variances contained within each of the multiple predefined modes. The processor may be configured to assign the anatomical body size classifications to a bone model. A storage system may be configured to store the anatomical body size classifications.
[0082] In any embodiment, the processor may be configured to select a first representative bone model and / or a second representative bone model in response to a change in one or more predefined modes.
[0083] In any embodiment, the processor may be configured to establish an implant plan in response to the registration of a partial bone model against a first representative bone model.
[0084] In any embodiment, a partial bone model and a second bone model may be associated with the patient's anatomical model. A first representative bone model and a second representative bone model may be associated with a representative anatomical model of another patient. The processor may be configured to select a representative anatomical model from a set of anatomical models associated with the first and second bones. The processor may be configured to register the representative anatomical model at least partially with the patient's anatomical model.
[0085] In any embodiment, the processor may be configured to select a representative anatomical model in response to determining the minimum volume deviation within a first set of volume deviations. The first set of volume deviations may be established between the patient's anatomical model and the corresponding representative anatomical model in the set of anatomical models in response to changing one or more predefined modes within the statistical shape model.
[0086] A computer-based surgical planning method according to one embodiment may include selecting a first representative three-dimensional bone model related to the first bone. The method may also include selecting a partial three-dimensional bone model of the patient's first bone. The partial bone model may represent a smaller portion of the first bone compared to the first representative bone model. The method may include establishing the registration location of the first representative bone model by at least partially registering the partial bone model of the first bone relative to the first representative bone model. The method may also include analyzing the first bone based on the registration location of the first representative bone model.
[0087] In any embodiment, the method may include establishing an implant plan based on the registration location of a first representative bone model.
[0088] In any embodiment, the method may include accessing multiple three-dimensional bone models associated with one or more bones and / or one or more joints of a representative patient population. The method may also include selecting a first representative bone model from a set of bone models associated with a first bone of a representative patient population.
[0089] In any embodiment, the method may include selecting a second representative three-dimensional bone model from a second set of bone models associated with a second bone of a representative patient population. The method may also include establishing the registration location of the second representative bone model by at least partially registering it with the three-dimensional bone model of the patient's second bone. In response to establishing the registration location of the second representative bone model, the method may also include selecting a first representative bone model from a first set of bone models.
[0090] In any embodiment, the method may include analyzing a representative patient population within a statistical shape model.
[0091] In embodiments, the method may include identifying a number of predefined modes within a statistical shape model of a representative patient population.
[0092] In any embodiment, the method may include establishing multiple standard deviations of anatomical variances contained within each of a plurality of predefined modes. The step of selecting a first representative bone model and / or a second representative bone model may be performed in response to a change in one or more of the predefined modes within the statistical shape model.
[0093] In any embodiment, the first bone may be the humerus. The second bone may be the scapula. The partial bone model may omit the distal portion of the humerus. The first representative bone model may include the distal portion of the humerus.
[0094] A surgical planning system according to one embodiment may include a processor operably connected to memory. The processor may be configured to access a first three-dimensional bone model from memory. The first bone model may be associated with the first bone. The processor may be configured to access a fragmentary three-dimensional bone model of the patient's first bone. The fragmentary bone model may include one or more fragmentary bone portions associated with one or more corresponding bone fragments of the first bone. The processor may be configured to establish the registration state of the fragmentary bone model by registering one or more fragmentary bone portions of the fragmentary bone model at least partially with respect to the volume of the first bone model.
[0095] In any embodiment, the processor may be configured to establish an implant plan based on the registration state of a fragmentary bone model. The implant plan may be associated with at least one implant configured to fix one or more bone fragments.
[0096] In any embodiment, the processor may be configured to receive patient-related image data. The processor may be configured to generate a fragmentary bone model based on the image data.
[0097] In any embodiment, the first bone may be a long bone. The fragmentary bone model may include a diaphysis portion related to the diaphysis of the long bone. The processor may be configured to establish the registration state of the fragmentary bone model by at least partially registering the diaphysis portion of the fragmentary bone model with respect to the diaphysis portion of the first bone model.
[0098] A surgical planning system according to one embodiment may include a processor operably connected to a storage system. The storage system may be configured to store multiple three-dimensional bone models associated with one or more bones and / or one or more joints of a representative patient population. The processor may be configured to select a first three-dimensional bone model from a first set of bone models associated with a first bone of a representative patient population. The processor may be configured to establish the registration status of a fragmentary bone model by at least partially registering one or more fragments of a fragmentary three-dimensional bone model of the patient's first bone with respect to the first bone model. One or more fragments may be associated with one or more corresponding fragments of the first bone.
[0099] In any embodiment, the processor may be configured to establish an implant plan based on the registration status of a fragmented bone model.
[0100] In any embodiment, the processor may be configured to select a second three-dimensional bone model from a second set of bone models associated with a second bone of a representative patient population. The processor may be configured to establish a registration location for the second bone model by at least partially registering the second bone model with respect to the three-dimensional bone model of the patient's second bone. In response to establishing a registration location for the second bone model, the processor may be configured to select a first bone model from a first set of bone models.
[0101] In any embodiment, the processor may be configured to analyze a representative patient population within a statistical shape model.
[0102] In any embodiment, the processor may be configured to create multiple anatomical body size classifications based on multiple predefined modes in a statistical shape model that characterize anatomical differences within a representative patient population, and further based on multiple standard deviations of anatomical variances contained within each of the multiple predefined modes. The processor may be configured to assign the anatomical body size classifications to a bone model. A storage system may be configured to store the anatomical body size classifications.
[0103] In any embodiment, the processor may be configured to establish an implant plan based on the registration state of a fragmentary bone model. The implant plan may be associated with at least one implant configured to fix one or more bone fragments.
[0104] In any embodiment, the processor may be configured to select a second three-dimensional bone model from a second set of bone models associated with a second bone of a representative patient population. The processor may be configured to establish a registration location for the second bone model by at least partially registering the second bone model with respect to the three-dimensional bone model of the patient's second bone. Based on the registration location of the second bone model, the processor may be configured to select a first bone model from a first set of bone models.
[0105] In any embodiment, the first bone may be the humerus.
[0106] In any embodiment, one or more bone fragments may be associated with the proximal portion of the humerus.
[0107] A computer-aided surgical planning method according to one embodiment may include selecting a first three-dimensional bone model associated with a first bone. The method may also include selecting a fragmentary three-dimensional bone model of the patient's first bone. The fragmentary bone model may include one or more fragmentary bone portions associated with one or more corresponding bone fragments of the first bone. The method may include establishing the registration status of the fragmentary bone model by at least partially registering one or more fragmentary bone portions of the fragmentary bone model with respect to the volume of the first bone model. The method may also include analyzing the first bone based on the registration status of the fragmentary bone model.
[0108] In any embodiment, the method may include establishing an implant plan based on the registered state of a fragmentary bone model, the implant plan may include positioning at least one implant model adjacent to one or more bone fragments of the fragmentary bone model in the registered state.
[0109] In any embodiment, the first bone may be a long bone. The fragmentary bone model may include a diaphysis portion related to the diaphysis of the long bone. The method may include establishing the registration status of the fragmentary bone model by at least partially registering the diaphysis portion of the fragmentary bone model with respect to the diaphysis portion of the first bone model.
[0110] In any embodiment, the method may include accessing multiple three-dimensional bone models associated with one or more bones and / or one or more joints of a representative patient population. The method may also include selecting a first bone model from a set of bone models associated with a first bone of a representative patient population.
[0111] In any embodiment, the method may include selecting a second three-dimensional bone model from a second set of bone models associated with a second bone of a representative patient population. The method may also include establishing the registration location of the second bone model by at least partially registering it with the bone model of the patient's second bone. In response to establishing the registration location of the second bone model, the method may also include selecting a first bone model from a first set of bone models.
[0112] In any embodiment, the method may include analyzing a representative patient population within a statistical shape model.
[0113] In any embodiment, the method may include identifying several predefined modes within a statistical shape model of a representative patient population. The method may also include establishing several standard deviations of the anatomical variances contained within each of the several predefined modes. The step of selecting a first bone model may be performed in response to changing one or more predefined modes within the statistical shape model.
[0114] Figure 1 illustrates an exemplary surgical planning system 10 (hereinafter referred to as "System 10"). System 10 may be used to plan orthopedic procedures, including preoperative, intraoperative, and / or postoperative stages, in order to create, edit, review, refine, and / or execute surgical plans. System 10 may be used for various orthopedic procedures, such as arthroplasty for joint repair, and for other surgical procedures.
[0115] Shoulder arthroplasty may be referenced periodically throughout this disclosure to illustrate or highlight specific features of System 10. However, it will be understood that the teachings of this disclosure are not intended to be limited to any particular joint in the human musculoskeletal system and are therefore applicable to the shoulder, knee, hip, ankle, wrist, etc. Furthermore, the teachings of this disclosure are not intended to be limited to arthroplasty procedures and are therefore applicable to repairing fractures and / or other deformities within the scope of this disclosure.
[0116] System 10 may include, in particular, 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 more or fewer subsystems within the scope of this disclosure.
[0117] The host computer 12 may be configured to run one or more software programs. In some embodiments, the host computer 12 may be two or more computers configured to work together to process software instructions sequentially or in parallel.
[0118] The host computer 12 may communicate with the network 20 and may itself include one or more computing devices. The network 20 may be, for example, a private local area network (LAN), a private wide area network (WAN), the internet, or a mesh network.
[0119] The host computer 12 and each client computer 14 may include one or more computer processors, memory, storage means, network devices, input / output devices, and input / output interfaces. Input devices may include keyboards, mice, etc. Output devices may include monitors, speakers, printers, etc. Memory may include, for example, UVPROM, EEPROM, FLASH, RAM, ROM, DVD, CD, hard drive, or other computer-readable media capable of storing data and / or other information related to surgical plans and techniques disclosed herein. The host computer 12 and each client computer 14 may be desktop computers, laptop computers, smartphones, tablets, virtual machines, or any other computing devices. Interfaces may facilitate communication to and / or other components of the network 20.
[0120] Each client computer 14 may be configured to communicate with the host computer 12 either directly, such as through a direct client interface 22, or through the network 20. In other embodiments, the client computers 14 are configured to communicate directly with each other via a peer-to-peer interface 24.
[0121] 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 the patient's anatomical structures present within the scanning field (e.g., window) of the imaging device 16. The imaging device 16 may be configured to capture or acquire two-dimensional (2D) and / or three-dimensional (3D) grayscale and / or color images 26. Various imaging devices 16 may be used to acquire one or more images 26 of the patient, including but not limited to X-ray machines, computed tomography (CT) machines, or magnetic resonance imaging (MRI) machines.
[0122] The client computer 14 may also be configured to run one or more software programs, such as those related to various surgical planning tools. Each client computer 14 may be operable to access a planning environment 28 for creating, editing, executing, improving, and / or reviewing one or more surgical plans 36 during the preoperative, intraoperative, and / or postoperative phases of surgery, and to perform this locally and / or remotely. The planning environment 28 may be a standalone software package or may be integrated 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.
[0123] The planning environment 28 may be further configured to interact with one or more imaging devices 16 to capture or acquire images 26 of the patient's anatomical structure. The planning environment 28 may provide display or visualization of one or more images 26, bone models 30, implant models 32, transfer models 34, and / or surgical plans 36 via one or more graphical user interfaces (GUIs). Each image 26, bone model 30, implant model 32, transfer model 34, surgical plan 36, and other data and / or information may be stored in one or more files or records according to a specific data structure.
[0124] The planning environment 28 may include various modules for performing desired planning functions. For example, as will be further discussed below, the planning environment 28 may include a data module for accessing, retrieving, and / or storing data relating to the surgical plan 36; a display module (e.g., in one or more GUIs) for displaying the data; a spatial module for modifying the data displayed in the display module; and a comparison module for determining one or more relationships between selected bone models and selected implant models. However, more or fewer modules may be used, and / or one or more modules may be combined to provide the functions disclosed.
[0125] The storage system 18 may be operable to store data or otherwise provide data to other computing devices of the system 10, such as the host computer 12 and / or one or more client computers 14. The storage system 18 may be a storage area network device (SAN) configured to communicate with the host computer 12 and / or client computers 14, for example, through the network 20. Although shown as a separate device of the system 10, in some embodiments the storage system 18 may be built into or directly coupled to the host computer 12 and / or client computers 14. The storage system 18 may be configured to store one or more computer software instructions, data, database files, configuration information, etc.
[0126] In some embodiments, system 10 may be a client-server architecture configured to run computer software on a host computer 12, which may be accessible by a client computer 14 using either a thin-client application or a web browser that can run on the client computer 14. The host computer 12 may load computer software instructions into memory from local storage or from a storage system 18, and may also run the computer software using one or more computer processors.
[0127] 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, one or more databases 38 may be stored on the host computer 12 and / or distributed databases provided by one or more 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 their respective corresponding surgical plans 36. Each surgical plan 36 may be associated with the corresponding anatomical structure of a patient. 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 within one or more database records or entries, and / or to link or otherwise associate one or more files corresponding to the respective images 26, bone models 30, implant models 32, transfer models 34, and surgical plans 36. The various data stored in the database 38 may correspond to the anatomical structures of the corresponding patients from previous surgical cases and may be placed within one or more predetermined classifications such as sex, age, race, defect classification, procedure type, anatomical size classification, surgeon, facility or organization, etc.
[0128] Each image 26 and bone model 30 may include data and other information obtained from one or more medical devices or tools, such as the imaging device 16. The bone model 30 may include one or more digital images and / or coordinate information related to the patient's anatomical structure, such as those obtained from or derived from the image 26 captured by the imaging device 16 or obtained in another manner.
[0129] Each implant model 32 and transmission model 34 may include coordinate information relating to a predetermined design or to a design established or modified by the planning environment 28. The predetermined design may correspond to one or more components. The planning environment 28 may incorporate, and / or interface with, one or more modeling packages, such as computer-aided design (CAD) packages, to render the models 30, 32, and 34 as two-dimensional (2D) and / or three-dimensional (3D) volumes or structures, which may overlay one or more images 26 within the GUI display screen.
[0130] The implant model 32 may correspond to implants and components of various shapes and sizes. Each implant may include one or more components, such as screws, anchors, grafts, etc., which can be placed at the surgical site. Each implant model 32 may correspond to a single component, or it may include two or more components that can be configured to establish an assembly. Each implant and associated component 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 used to generate wireframe, mesh, and / or solid structures within the GUI.
[0131] Each surgical plan 36 may be associated with one or more of the image 26, bone model 30, implant model 32, and / or transmission model 34. The surgical plan 36 may include various parameters related to the image 26, bone model 30, implant model 32, and / or transmission model 34. For example, the surgical plan 36 may include parameters related to bone density and bone quality related to the anatomical structure of the patient captured in the image 26. The surgical plan 36 may also include parameters including spatial information related to the relative positioning and coordinate information of the selected bone model 30, implant model 32, and / or transmission model 34.
[0132] The surgical plan 36 may define one or more corrections to the bone model 30, and information relating to the positions of the implant model 32 and / or the transfer model 34 relative to the original and / or corrected bone model 30. The surgical plan 36 may also include coordinate information relating to the corrected bone model 30, and the relative positions of the implant model 32 and / or the transfer model 34 within one or more predetermined data structures. The planning environment 28 may be configured to perform one or more corrections to various models, either automatically or in response to user interaction with the user interface. The corrections to each bone model 30, implant model 32, transfer model 34, and / or the surgical plan 36 may be stored in one or more databases 38, either automatically or in response to user interaction with the system 10.
[0133] One or more surgeons and / or other staff users may be presented with the planning environment 28 via a client computer 14 and simultaneously access each image 26, bone model 30, implant model 32, transfer model 34, and surgical plan 36 stored in the database 38. Each user may interact with the planning environment 28 to create, observe, improve, 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 model 30, implant model 32, transfer model 34, and / or surgical plan 36, which may be synchronized with the database 38 in real time or periodically. The planning environment 28 may be a standalone software package running on the client computer 14, or it may be provided as one or more web-based services running on, for example, a host computer 12.
[0134] The system 10 described above may be configured to preoperatively plan surgical procedures. The preoperative planning provided by system 10 may include, but is not limited to, features such as constructing a virtual model of the patient's anatomical structure, classifying the virtual model, identifying landmarks within the virtual model, selecting and orienting virtual implants within the virtual model, and so on.
[0135] Referring here to Figure 2, continuing with reference to Figure 1, the system 10 may include a computing device 40 which includes at least one processor 42 operably coupled to a memory 44 capable of storing computer executable instructions. The computing device 40 may be representative of any computing device disclosed herein, including but not limited to a host computer 12 and / or a client computer 14. The processor 42 may be configured to run one or more planning environments 28 for creating, editing, executing, improving, and / or reviewing one or more surgical plans 36 and any associated bone models 30, implant models 32, and transfer models 34 during the preoperative, intraoperative, and / or postoperative stages of a surgical procedure.
[0136] The processor 42 may be a custom-made or commercially available processor, a central processing unit (CPU), or any device for executing software instructions in general. The memory 44 may include one or a combination of volatile and / or non-volatile memory elements. The processor 42 may be operablely coupled to the memory 44 and may be configured to execute one or more programs stored in the memory 44 based on various inputs received from other devices or data sources.
[0137] The 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 will be understood that more or fewer modules may be available, and / or one or more modules may be combined to provide the disclosed functions.
[0138] The data module 46 may be configured to access, read, and / or store data and other information in the database 38 that corresponds to one or more images 26 of the patient's anatomical structure, bone model 30, implant model 32, transfer model 34, and / or surgical plan 36. The data and other information may be stored in 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 that are accessible by referencing one or more objects or memory locations referenced by the entries 54.
[0139] Memory 44 may be configured to access, load, edit, and / or store one or more instances of images 26, bone models 30, implant models 32, transfer models 34, and / or surgical plans 36 in response to one or more commands from data module 46. Data module 46 may be configured to cause memory 44 to store local instances of images 26, bone models 30, implant models 32, transfer models 34, and / or surgical plans 36, which may be synchronized with entries 54 stored in database 38.
[0140] 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 anatomical structure from various sources, such as the imaging device 16. The data module 46 may be further configured to instruct the imaging device 16 to capture or acquire the images 26 automatically or in response to user interaction.
[0141] The display module 48 may be configured to display data and other information related to one or more surgical plans 36, including one or more images 26, bone models 30, implant models 32, and / or transfer models 34, within at least one graphical user interface (GUI) 56. The computing device 40 may incorporate the display device 58 or be coupled to the display device 58. The display module 48 may be configured to cause the display device 58 to display information within the user interface 56. A surgeon or other user may interact with the user interface 56 in the planning environment 28 to view one or more images 26 relating to the patient's anatomical structure and / or any related bone models 30, implant models 32, and transfer models 34. A surgeon or other user may interact with the user interface 56 via the planning environment 28 to create, edit, execute, improve, and / or review one or more surgical plans 36.
[0142] The user interface 56 may include one or more display windows 60 and one or more objects 62 that can be presented within the display windows 60. The display windows 60 may include any number of windows, and the objects 62 may include any number of objects within the scope of this disclosure.
[0143] A surgeon or user may interact with the user interface 56, including objects 62 and / or display windows 60, to read, display, edit, store, etc., various aspects of the corresponding surgical plan 36, which may include information from selected images 26, bone models 30, implant models 32, and / or transfer models 34. Objects 62 may include graphics such as menus, tabs, buttons, drop-down lists, directional indicators, etc. Objects 62 may be organized within one or more menu items associated with their respective display windows 60. Geometric objects, including selected images 26, bone models 30, implant models 32, transfer models 34, and / or other information related to the surgical plan 36, may be displayed within one or more 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.
[0144] The surgeon may interact with object 62 to specify various aspects of the surgical plan 36. For example, the surgeon may select one tab to observe or specify aspects of the surgical plan 36 for a part of a joint, such as the glenoid cavity, and another tab to observe or specify aspects of the surgical plan 36 for another part of the joint, such as the humerus. The surgeon may further perform various measurements of the joint (e.g., linearity, angle, tissue density, etc.) as part of specifying aspects of the surgical plan 36.
[0145] The surgeon may interact with menu items to select and specify various aspects of the bone model 30, implant model 32, and / or transmission 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 corresponding images 26 of the patient's anatomical structure and implant model 32, respectively, selected in response to user 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 the resection plane.
[0146] The user may also interact with various buttons to change the excision angle (e.g., increase or decrease). The user may also interact with buttons adjacent to the selected implant model 32 to change the size (e.g., increase or decrease) of the components of the selected implant model 32. The buttons may be superimposed on the display window 60 or positioned adjacent to the display window 60.
[0147] The user may further interact with directional indicators to move a portion of the selected implant model 32 in different orientations (e.g., up, down, left, right) within a single display window 60. The surgeon may, for example, use a mouse or other input device to drag the selected implant model 32 to a desired position in the display window 60, or move it in other manner. The surgeon may interact with one of the drop-down lists to specify the type and / or size of the components of the selected implant model 32.
[0148] The display module 48 may be configured to superimpose one or more bone models 30, implant models 32, and transfer models 34 onto one or more images 26 within one or more 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 within the volume of a selected bone model 30. In some embodiments, the implant model 32 may have articular surfaces dimensioned to engage with the articular surfaces of opposing bone or implants.
[0149] The display window 60 may be configured to display the image 26, bone model 30, implant model 32, and / or transmission model 34 in various orientations. The display module 48 may be configured to display a two-dimensional (2D) representation of the selected bone model 30, implant model 32, and / or transmission model 34 in several display windows 60, and may also be configured to display a 3D representation of the selected bone model 30, implant model 32, and / or transmission model 34 in, for example, another display window 60. The surgeon may interact with the user interface 56 to move the selected bone model 30, selected implant model 32, and / or selected transmission model 34 in 2D space and / or 3D space (e.g., up, down, left, right, rotate, etc.). Other embodiments for displaying 2D and / or 3D representations in various display windows 60 are further envisioned within the scope of this disclosure.
[0150] The display module 48 may further be configured such that the selected image 26, bone model 30, implant model 32, and / or transmission model 34 can be selectively shown or hidden (e.g., toggled) in one or more display windows 60 in response to user interaction with the user interface 56, thereby providing the surgeon with improved flexibility in reviewing aspects of the surgical plan 36. For example, the surgeon may interact with a drop-down list of objects 62 to selectively show or hide components of the selected implant model 32 within one display window 60.
[0151] The selected bone model 30 may correspond to joint-related bones, including any exemplary joints disclosed herein. The display module 48 may be configured to display, for example, a cross-sectional view of the selected bone model 30 and the selected implant model 32 within one or more display windows 60. The cross-sectional view of the bone model 30 may be presented or displayed together with relevant images 26 of the patient's anatomical structure.
[0152] The spatial module 50 may be configured to establish one or more resection planes along the selected bone model 30. The volume of the selected implant model 32 may be at least partially received within the volume of the selected bone model 30 along the resection plane. The resection plane may be defined by the resection angle.
[0153] The spatial module 50 may further be configured to cause the display module 48 to display the excised portion of the selected bone model 30 that is the subject of display within a single display window 60 in a manner different from the remainder of the bone model 30 on both sides of the excision plane. For example, the excised portion of the bone model 30 may be hidden in the display within the display window 60 so as to show the corresponding portion of each of the 26 anatomical structures of the patient. In other embodiments, the excised portion of the selected bone model 30 may be displayed as a relatively dark shadow. The spatial module 50 may determine the excised portion, for example, by comparing the coordinates of the bone model 30 with the position on the excision plane. The user may interact with one or more buttons on the object 62 to switch between the volume of the selected bone model 30 in its previous state and the volume in its modified (e.g., excised) state.
[0154] The planning environment 28 may also be configured such that changes within one display window 60 are synchronized with each of the other windows 60. These changes may be synchronized automatically and / or manually across the display windows 60 in response to user interaction.
[0155] The surgeon may use a variety of instruments and devices to carry out each surgical plan 36, including preparing the surgical site and fixing one or more implants to bone or other tissue in order to restore the function of the corresponding joint. Each of the transmission models 34 may be associated with a corresponding surgical instrument or device (e.g., a transmission guide, etc.) or with a corresponding implant model 32.
[0156] 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 fixed in tissue for positioning and orienting various instruments, devices, and / or implants. The display module 48 may be configured to display virtual positions and virtual axes in one or more display windows 60. The virtual position may be associated with a specified position of the positioning object relative to the patient's anatomical structure (as represented by image 26). The virtual axis may extend through the virtual position and may be associated with a specified orientation of the positioning object relative to the patient's anatomical structure. The spatial module 50 may be configured to set the virtual position and / or virtual axis in response to the placement of the bone model 30 and the corresponding implant model 32 relative to the associated patient's anatomical structure. The virtual position and / or virtual axis 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.
[0157] The spatial module 50 may further be configured to determine one or more collision or contact points related to the patient's anatomical structure. The contact points may be associated with one or more landmarks or other surface features along the bone model 30 and / or along other parts of the patient's anatomical structure. Each contact point may be established along the articular or non-articular surfaces of a joint. The spatial module 50 may be configured to set contact points based on virtual position, virtual axis, and / or the position and orientation of the corresponding implant model 32 relative to the patient's anatomical structure. 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 position, virtual axis, and / or contact points may be stored in one or more entries 54 in the database 38 and associated with the corresponding surgical plan 36.
[0158] The comparison module 52 may be configured to generate or set one or more parameters related to the execution of the surgical plan 36. The parameters may include one or more settings or dimensions related to the corresponding transmission model 34. The parameters may be based on virtual position, virtual axis, and / or contact point. The comparison module 52 may be configured to determine one or more settings or dimensions related to the corresponding transmission model 34 for the patient's anatomical structure, bone model 30, implant model 32, virtual position, virtual axis, and / or contact point CP. The dimensions and settings may be used to form a physical instance of each corresponding transmission model 34. The settings may be used to specify the position and orientation of each corresponding transmission model 34 relative to the implant model 32 and / or bone model 30. The settings may be used to configure one or more transmission members (e.g., objects) and associated instruments or devices related to the transmission model 34. The comparison module 52 may be configured to generate settings and / or dimensions such that, when the transmission model 34 is coupled to its corresponding implant model 32, it contacts one or more predetermined locations at or along the bone model 30 or the patient's anatomical structure at the mounting position. The predetermined locations may include one or more contact points. The settings and dimensions may be communicated using various techniques, including one or more graphics in the user interface 56 or in an output file. The settings and / or dimensions may be stored in one or more entries 54 in a database 38 associated with the transmission model 34.
[0159] The user may interact with a list of objects 62 associated with a single display window 60 to select a transmission model 34 from a database 38. The display module 48 may be configured to display the selected transmission model 34 in various positions and orientations within the display window 60. The spatial module 50 may be configured to set the initial position of the selected transmission model 34 according to a virtual position, virtual axis, and / or contact point.
[0160] The user may interact with the user interface 56 to set or adjust the position and / or orientation of the selected transmission model 34. The user may interact with the direction indicators of object 62 to move the selected transmission model 34 and / or virtual position in different orientations (e.g., up, down, left, right) within the display window 60. The surgeon may, for example, use a mouse or other input device to drag or otherwise move the selected transmission model 34 and / or virtual position to a desired position within the display window 60. The user may interact with the object's rotation indicators to adjust the position and / or orientation of the transmission model 34 around a virtual axis relative to the selected bone model 30 and / or implant model 32. The user may interact with the object 62's tilt indicators to adjust the orientation of the selected transmission model 34 and its associated virtual axis at its virtual position relative to the selected bone model 30 and / or implant model 32. The user may interact with other buttons and / or direction indicators to move the transmission model 34 jointly or otherwise. The transmission model 34 can be moved jointly independently or synchronously, or in other ways, which may be triggered manually in response to user interaction and / or automatically in response to the placement of the transmission model 34 relative to the bone model 30 and / or the implant model 32. The movement of the transmission model 34 may automatically adjust the corresponding contact points.
[0161] Various transmission members may be used in conjunction with the planning environment 28 to carry out the surgical plan 36. Each transmission member may be associated with a corresponding transmission model 34. The transmission members may be incorporated into the transmission guide, into the implant, and / or into the assembly to set the corresponding implant position and orientation before the implant is fixed or otherwise attached to the surgical site.
[0162] Now, referring to Figure 3 while continuing to refer to Figure 2, the computing device 40, including the processor 42, may be operablely coupled to a storage system such as the storage system 18. The computing device 40 may interface with the storage system 18 through the network 20 to access various databases 38 stored on the storage system 18 for the purpose of establishing and performing surgical plans 36.
[0163] The database 38 of the storage system 18 may include a patient profile database 64, a surgeon profile database 65, a surgical outcome database 66, a range of motion database 68, and an anatomical body size classification database 70. Within the scope of this disclosure, additional databases may be stored in and accessed from the storage system 18. Furthermore, although shown as separate databases, one or more databases may be combined or linked together. For example, the anatomical body size classification database 70 may be combined or linked with the surgical outcome database 66, the range of motion database 68, or both.
[0164] The patient profile database 64 may include information that is part of an indexed and stored record or entry relating 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, category of defect, type of procedure, surgeon, facility or organization, major joints, activity of daily living / lifestyle target profile (e.g., desired postoperative range of motion for abduction, adduction, external rotation, internal rotation, extension, flexion, external rotation combined with 60° abduction, internal rotation with 60° abduction, etc.), current surgical plan information, etc. The patient profile database 64 may further store or link to images 26 for a given patient.
[0165] The surgeon profile database 65 may include information that is part of an indexed and stored record or entry relating to one or more surgeon users associated with the system 10. The information stored on the surgeon profile database 65 may include the surgeon's name, facility or organization, historical data on the types of previous surgical procedures planned by the surgeon using the system 10, data on the types of implants included in the surgeon's preoperative surgical plan, data on the actual implants used in the surgeon's previous surgical procedures, and so on. In some embodiments, the surgeon profile database 65 may interface with the patient profile database 64 to link each surgeon from the surgeon profile database 65 to that surgeon's patients enumerated in the patient profile database 64.
[0166] The surgical outcome database 66 may include information that is part of indexed and stored records or entries related to one or more previous patients associated with system 10. The surgical outcome database 66 may be created based on information recorded by the surgeon and / or other staff users after each surgical procedure and at each follow-up visit to show the progress of the previous patient. The information stored on the surgical outcome database 66 may include, for each previous patient, sex, age, race, height, weight, defect category, procedure type, specific implant used, surgeon, facility or tissue, major joint, visual analog pain score, ASES score, achieved activity of daily living / lifestyle profile (e.g., desired postoperative range of motion for abduction, adduction, external rotation, internal rotation, extension, flexion, external rotation combined with 60° abduction, internal rotation with 60° abduction, etc.), surgical plan information, etc. The surgical outcome database 66 may additionally store pre- and post-operative images 26 for each previous patient, or may be linked to pre- and post-operative images 26.
[0167] The range of motion database 68 may include information that is part of an indexed and stored record or entry relating to one or more current and past patients associated with the system 10. The range of motion database 68 may store the range of range of motion data derived from range of motion simulations performed by the computing device 40 for each surgical procedure plan 36. The range of motion data may include information relating to simulated joint movements (e.g., abduction / adduction, flexion / extension, internal / external rotation, etc.), contact or collision points identified for various implant positions, angular arcs and collision modes for various implant positions (e.g., between implants, between implants and bone, between bones, etc.), adjusted centers of rotation of implants in multiple incremental and offset directions for various implant positions, etc.
[0168] The anatomical body size classification database 70 may store multiple anatomical body size classifications that characterize anatomical differences within a representative patient population and anatomical variances within anatomical differences with respect to one or more intended surgical procedures (e.g., whole shoulder, 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 on a surgical outcome database 66 and / or any other imaging source, relating to a number of previous patients who have already undergone the intended surgical procedure. Each of the multiple anatomical body size classifications is a numerical classification of the anatomical size of bones or joints in a representative patient population.
[0169] Referring to Figure 4, continuing to refer to Figures 1 to 3, the computing device 40 may interface with a statistical shape modeler 72 to create an anatomical body size classification database 70. The statistical shape modeler 72 may be a software package stored in the memory 44 of the computing device 40 or in the storage system 18, and may be executed by the processor 42.
[0170] The statistical shape modeler 72 may receive multiple sets of image data 74 related to the bone or joint of interest. In some embodiments, the set of image data 74 consists of tens of thousands of sets of image data. Each set of image data 74 may include 2D and / or 3D anatomical images that are specific to a previous patient in a representative patient population for the bone or joint of interest and are related to a given type of surgical procedure. The statistical shape modeler 72 may analyze multiple sets of image data 74 to construct a statistical shape model 75.
[0171] As input, the statistical shape modeler 72 may receive a number of predefined modes 76 to be used to analyze multiple sets of image data 74. Each of the modes 76 is a descriptor configured to characterize anatomical differences within bones or joints related to the statistical shape model 75. Exemplary modes 76 that may be provided for the statistical shape modeler 72 may include, but are not limited to, the size of the glenoid cavity, the size of the scapula, the amount of inclination, the number of versions, the predicted amount of the length of the glenoid cavity and sagittal neck, the angle of the glenoid cavity relative to the scapular neck, the important shoulder angle, the prediction of the acromion and / or coracoid, the size of the humeral head, varus / valgus of the humeral head, varus / valgus of the femur and / or tibia, internal / external rotation of the femur and / or tibia, the integrity of the subscapularis, deltoid, and / or supraspinatus muscles, ML width and AP width, intercondylar notch depth, tibial inclination, Q angle of the knee, 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 mineral density, bone subluxation rate, anatomical landmarks, joint cavity, preoperative range of motion, any combination of the above, etc.
[0172] In some embodiments, at least seven different modes may be utilized by the statistical shape modeler 72 to characterize the statistical shape model 75. However, more or fewer modes may be provided within the scope of this disclosure.
[0173] In some embodiments, mode 76 may not be predefined. Rather, the statistical shape modeler 72 may be programmed to estimate the mode best associated with the bone or joint modeled in the statistical shape model 75 by utilizing artificial intelligence (e.g., a neural network) or machine learning.
[0174] As an alternative input, the statistical shape modeler 72 may receive a plurality of predetermined standard deviations 78 to be used to analyze a plurality of sets of image data 74. Each standard deviation 78 may represent an anatomical variance (e.g., distance between features, orientation of features, relative features, etc.) contained within each of a plurality of predefined modes 76. The standard deviations 78 may be used to verify the percentile coverage 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 variances contained within the anatomical structures described within the statistical shape model 75. However, within the scope of this disclosure, a larger or smaller number of standard deviations may be utilized.
[0175] The statistical shape modeler 72 may, in response to instructions from the processor 42, assign multiple anatomical body type classifications 80N to bones or joints associated with the statistical shape model 75 in order to classify the anatomical body type of an entire patient population represented in the statistical shape model 75 by combining multiple standard deviations 78 with multiple predefined modes 76, where N is any number. Each anatomical body type classification 80N may then be stored in the anatomical body type classification database 70 of the storage system 18.
[0176] Figure 5 illustrates an exemplary anatomical body type classification 80 assigned to a specific bone model 30 derived from a statistical shape model 75. In one embodiment, the bone model 30 is a 3D model of the scapula of the shoulder joint. However, other bones and joints can also be classified in a similar manner.
[0177] The statistical shape modeler 72 in Figure 4 may analyze the bone model 30 for each of several modes 761-767 to characterize any anatomical differences within the bone model 30 compared to other similar bones / joints associated with the statistical shape model 75. Naturally, more or fewer modes are possible.
[0178] The statistical shape modeler 72 may further characterize any anatomical variances contained within each of the multiple predefined modes 761-767 by analyzing each mode against multiple standard deviations 781-787. Naturally, more or fewer standard deviations are possible.
[0179] In the embodiment shown in Figure 5, the bone model 30 is assigned the numerical value 0213120 as its anatomical physique classification 80. This numerical value represents a standard deviation of 0 in the first mode 761, a standard deviation of 2 in the second mode 762, a standard deviation of 1 in the third mode 763, a standard deviation of 3 in the fourth mode 764, a standard deviation of 1 in the fifth mode 765, a standard deviation of 2 in the sixth mode 766, and a standard deviation of 0 in the seventh mode 767. The anatomical physique classification 80 is a unique numerical identifier for describing the anatomical structure associated with the bone model 30.
[0180] Figure 6 schematically illustrates Method 84 for creating the anatomical body size classification database 70 described above, with continued reference to Figures 1 to 5. Method 84 may be performed as part of a surgical planning procedure. Within the scope of this disclosure, fewer steps or additional steps may be performed compared to those described below, and the order in which the steps are described is not intended to limit this disclosure. System 10 may be configured to perform each step of Method 84 via any associated computing devices and modules. In an exemplary embodiment, the computing device 40 of the host computer 12 may be programmed to perform Method 84. However, other embodiments are further conceivable within the scope of this disclosure.
[0181] In step 86, a statistical shape model 75 representing a patient population with pathological anatomical structures associated with the intended surgical procedure may be constructed. Multiple modes 76 may be identified within the statistical shape model 75 in step 88. The modes 76 may characterize anatomical differences within the statistical shape model 75.
[0182] Next, in step 90, multiple standard deviations 78 of the anatomical variances contained within each mode 76 may be established. The standard deviations 78 may be used to verify the percentile coverage of a representative patient population associated with the statistical shape model 75.
[0183] The standard deviation of 78, combined with mode 76, may create multiple unique anatomical body classifications 80 in step 92. In step 94, the anatomical body classifications 80 may be integrated to form an anatomical body classification database 70. Thus, the anatomical body classification database 70 may represent large variances within a representative patient population that may affect implant function.
[0184] As a further part of Method 84, an implant model 32 of appropriate size may be selected and positioned in step 96 to a default starting position and orientation relative to a bone or joint associated with each of several anatomical body classifications 80. Thus, the default starting position and orientation of the implant model 32 may also be linked and stored to the anatomical body classifications 80 as part of the anatomical body classification database 70 in step 97.
[0185] Once constructed, the anatomical body classification database 70 may enable additional features, processes, and / or capabilities that should be implemented within or performed by the system 10 to enhance surgical planning. Exemplary embodiments of such features are described below.
[0186] Figure 7 illustrates a method 98 for extending a range of motion database 68 with information contained in, for example, an anatomical body size classification database 70. Method 98 may be performed as part of a surgical planning procedure. Within the scope of this disclosure, fewer steps or additional steps may be performed compared to those described below, and the order in which the steps are described is not intended to limit this disclosure. System 10 may be configured to perform each step of Method 98 via any associated computing devices and modules. In an exemplary embodiment, a computing device 40 of a host computer 12 may be programmed to perform Method 98. However, other embodiments are further conceivable within the scope of this disclosure.
[0187] Firstly, in step 100, one or more motion simulations may be performed for each anatomical body classification 80 stored in the anatomical body classification database 70. The motion simulations may be performed within the range of motion modeler 101, which may be a software package stored in the memory 44 of the computing device 40 or in the storage system 18, and may also be executed by the processor 42 (see, for example, Figure 8). When the range of motion modeler 101 performs a motion simulation, it may receive each of the anatomical body classifications 80 (as well as each associated bone model 30 and implant model 32, including the default implant start position and orientation) as input from the anatomical body classification database 70.
[0188] The range of motion simulation actually performed in step 100 depends, among other criteria, particularly on the type of bone or joint being analyzed. Examples of the 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.
[0189] Contact points or collision points may be identified in step 102 to identify the range of motion endpoint for each range of motion simulation performed on each anatomical body classification 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.
[0190] The rotational centers of the implant models 32 positioned within the bone model 30 for each anatomical body size classification 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., intermediate, medial, and posterior) relative to the corresponding bone model 30 in order to simulate different positions of the implant models 32.
[0191] In step 108, the rotation center of the implant model 32 for each anatomical body size classification 80 may be adjusted in multiple increments relative to the corresponding bone model 30 to record the angular arc and collision mode associated with the adjusted position. Then, all range of motion data derived from the simulations performed in steps 100-108 may be stored in the range of motion database 68 in step 110.
[0192] Figure 9 schematically illustrates Method 112 for planning orthopedic procedures for corresponding patients using System 10. Method 112 may be performed as part of a surgical planning procedure for preparing a surgical plan for a patient. Within the scope of this disclosure, fewer steps or additional steps may be performed compared to those described below, and the order in which the steps are described is not intended to limit this disclosure. System 10 may be configured to perform each step of Method 112 via any associated computing devices and modules. In exemplary embodiments, one or more computing devices 40 of a client computer 14 may be programmed to perform Method 112. However, other embodiments are further conceivable within the scope of this disclosure.
[0193] Image data relating to the target bone or joint of the patient may be received in step 114. The image data may be received directly from the imaging device 16, or it may be obtained by accessing patient-related records or inputs from the patient profile database 64.
[0194] A 3D model 30 (Figure 2) of the target bone or joint may be generated in step 116. The planning environment 28 of the computing device 40 may render the 3D model of the target bone or joint by incorporating and / or interfaceing with one or more modeling packages, such as a computer-aided design (CAD) package.
[0195] Next, in step 118, the computing device 40 may query the anatomical body classification database 70 to find a bone model stored internally that has a similar anatomical body classification. Then, the anatomical body classification 80 (Figure 4) that is closest to the anatomical structure contained in the 3D model 30 (Figure 2) may be assigned to the 3D model 30 in step 120 and may be displayed on the range of motion user interface of the computing device 40 in step 122. As part of displaying the anatomical body classification 80, a confidence level indicator may be displayed within the range of motion user interface to visually show the similarity between the assigned anatomical body classification 80 and the anatomical structure being analyzed. The confidence level indicator may be displayed as a percentage or as any other visual indicator.
[0196] The range of motion database 68 may be queried in step 124 to obtain range of motion data associated with the assigned anatomical body size classification 80. The range of motion data associated with the assigned anatomical body size classification 80, including information such as angular arcs and collision modes, may be displayed on the range of motion user interface in step 126.
[0197] In step 128, the surgeon or other staff user of system 10 may select the patient's desired activity of daily living (ADL) goals by querying. The positioning of the implant model 32 may be automatically adjusted relative to the bone model based on the ADL selected in step 130. The system 10 may then output the recommended implant size / type, as well as position and orientation, to meet the ADL selected in step 132.
[0198] In step 134, the surgeon may be prompted to modify the recommended implant type, positioning, and / or orientation according to their clinical judgment. Method 112 may terminate in 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 stored in the ROM database 68 with the range of motion achieved by the position and orientation planned by the surgeon 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 impacts that the proposed changes may have, based on past surgical outcome data related to previous patients with similar anatomical body classifications.
[0199] Figure 10 illustrates an exemplary range of motion user interface 105 that may be provided in the method 112 described above. The range of motion user interface 105 may be presented, for example, within the planning environment 28.
[0200] 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 the user with various range of motion data. The range of motion dashboard 107 may include several selectable buttons 113 related to expected basic joint movements for the patient. Expected basic joint movements that can be represented by the buttons 113 may include, but are not limited to, desired postoperative ranges of motion for abduction, adduction, external rotation, internal rotation, extension, flexion, external rotation combined with 60° abduction, and internal rotation combined with 60° abduction.
[0201] The range of motion dashboard 107 may further include bar graphs 115 for illustrating range of motion data for each of the predicted basic joint movements. For example, the bar graphs 115 may provide a visual representation of the range of motion achieved for a selected predicted basic joint movement with respect to one or more AMCs 80 (Figure 4) closest to the anatomical structure of the patient for which the surgical plan is being developed.
[0202] The display window 109 may include a 3D window 117 and a plurality of 2D windows 119. A virtual bone model 121 of the patient's anatomical structure may be displayed in the 3D window 117 and in the 2D windows 119. The positioning of both virtual guide pins 123 and virtual implants 125 necessary to achieve the desired joint movement may be displayed relative to the virtual bone model 121, thereby providing the user with information on the optimal approach to the planned surgical procedure.
[0203] The display window 109 may be operated using the control panel 111. For example, the control panel 111 may include a number of toggles, buttons, sliders, etc., that allow the user to modify various settings, such as the positioning of virtual guide pins 123 and / or virtual implants 125 relative to the virtual bone model 121. In one embodiment, the back sheet amount 127 and a color-coded back sheet map 129 may be provided on the display window 109 and may be automatically updated when 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 on the display window 109 may also be automatically updated as a user page through each of the buttons 113.
[0204] Figure 11 schematically illustrates another method 138 for planning orthopedic procedures for corresponding patients using System 10. Method 138 may be performed as part of a surgical planning procedure for preparing a surgical plan for a patient. Within the scope of this disclosure, fewer steps or additional steps may be performed compared to those described below, and the order in which the steps are described is not intended to limit this disclosure. System 10 may be configured to perform each step of Method 138 via any associated computing devices and modules. In exemplary embodiments, one or more computing devices 40 of a client computer 14 may be programmed to perform Method 138. However, other embodiments are further conceivable within the scope of this disclosure.
[0205] Image data relating to the target bone or joint of the patient may be received in step 140. The image data may be received directly from the imaging device 16, or it may be obtained by accessing patient-related records or inputs from the patient profile database 64.
[0206] A 3D model of the target bone or joint may be generated in step 142. The planning environment 28 of the computing device 40 may render the 3D model of the target bone or joint by incorporating and / or interfaceing with one or more modeling packages, such as a computer-aided design (CAD) package.
[0207] Next, in step 144, the computing device 40 may query the anatomical body type classification database 70 to find a bone model stored internally that has an anatomical body type classification 80 similar to the anatomical body type classification 80 of the patient's bone or joint. The anatomical body type classification 80 that is closest to the anatomical structure contained in the 3D model may then be assigned to the 3D model in step 146 and displayed on the surgical outcome user interface of the computing device 40 in step 148. As part of displaying the anatomical body type classification 80, a confidence level indicator may be displayed within the graphical user interface to visually show the similarity between the assigned anatomical body type classification and the anatomical structure being analyzed. The confidence level indicator may be displayed as a percentage or as any other visual indicator.
[0208] The surgical outcome database 66 may be queried in step 150 to obtain surgical outcome data most relevant to the assigned anatomical body classification. Surgical outcome data related to the assigned anatomical body classification 80 may be displayed on the surgical outcome user interface in step 152. The surgical outcome data displayed to the user may be automatically updated in response to user prompts, for example, when the user changes the planned procedure type.
[0209] In one embodiment, the surgical outcome database 66 may, by querying, find previous surgical procedures involving patients who had comparable average bone density to the estimated average bone density of the bone related to the patient's anatomical structure. Using this comparison, for example, it may be possible to recommend a specific surgical implant that is not incompatible with the average bone density of the bone under study.
[0210] Next, in step 154, one or more survival prediction indices may be determined by utilizing data from a surgical outcome database 66 relating to comparable anatomical body size classifications 80 and several variables related to the surgical plan for the patient's surgery. These variables may include factors such as the type of surgical implant, the size of the surgical implant, the orientation of the surgical implant, the type of surgical procedure, the configuration of the back sheet of the surgical implant, the orientation of the fastening members, or any combination thereof. These variables are inputs to the system 10, which can be selected by a surgeon or staff user within the surgical outcome user interface.
[0211] The determined survival prediction index may be displayed on the surgical outcome user interface in step 156. Each survival prediction index may represent a percentile of confidence that a surgical plan will result in a successful surgical outcome for at least a predetermined time. For example, based on comparable anatomical body classification data 80 and relevant variables selected / set by the surgeon, the system 10 may determine and display a 3-year postoperative survival prediction index of 40% for comparable patients who underwent standard total shoulder arthroplasty and a 3-year postoperative survival prediction index of 85% for comparable patients who underwent reverse shoulder arthroplasty, thereby indicating to the surgeon that a more successful outcome for the patient is more likely to be obtained by performing reverse shoulder arthroplasty rather than standard total shoulder arthroplasty.
[0212] After displaying the survival prediction index shown in step 156, the system 10 may prompt the surgeon in step 158 to make any adjustments to the variables related to the current surgical plan. If the adjustments are received as input to the system 10, the updated survival prediction index may be displayed in step 160.
[0213] System 10 may output recommended procedure type, implant size / type, and implant position / orientation in step 162 to best match with respect to comparable anatomical body size classifications. The surgeon may be prompted in step 164 to modify the recommended implant type, position, and / or orientation according to their clinical judgment. Method 138 may be terminated after receiving the surgeon's approval of the surgical plan in step 166.
[0214] Figure 12 illustrates an exemplary surgical outcome user interface 141 that may be provided in the manner described above in method 138. The surgical outcome user interface 141 may be presented, for example, within the planning environment 28.
[0215] The surgical outcome user interface 141 may include a graphical list 143 for displaying the anatomical body type classification 80 most similar to the anatomical body type classification of the patient's bones or joints, a display window 145, and a control panel 147.
[0216] The graphical list 143 may include a graph 149 of ASES score versus time for each of the enumerated comparable anatomical body size classifications 80. Although two anatomical body size classifications 80 are shown as enumerated in Figure 12, the graphical list 143 may provide more or fewer anatomical body size classifications 80 within the scope of this disclosure.
[0217] The graphical list 143 may further include confidence level indicators 151 that can be displayed adjacent to each comparable anatomical physique classification 80. The confidence level indicators 151 may be percentages or other arbitrary visual indicators for visually showing the similarity between the assigned anatomical physique classification and the anatomical structure being analyzed. The user may select the desired comparable anatomical physique classifications 80, for example, using the input selector 153.
[0218] The display window 145 may include a 3D window 155 and a plurality of 2D windows 157. A virtual bone model 159 of the patient's anatomical structure may be displayed in the 3D window 155 and in the 2D windows 157. Virtual guide pins 161 and virtual implants 163 associated with a selected comparable anatomical body classification 80 may be displayed relative to the virtual bone model 159 to provide the user with information about previous surgical procedures performed on patients with comparable anatomical body classifications 80.
[0219] The display window 145 may be operated using the control panel 147. For example, the control panel 147 may include multiple toggles, buttons, sliders, etc., that allow the user to modify various settings, such as the positioning of virtual guide pins 161 and / or virtual implants 163 relative to the virtual bone model 159. In one embodiment, the back sheet amount 165 and a color-coded back sheet map 167 may be displayed on the display window 145 and may be automatically updated when adjustments are made to the virtual positions of the virtual guide pins 161 and virtual implants 163 relative to the virtual bone model 159.
[0220] The surgical outcome user interface 141 may further include a consultation schedule button 199. The user may press or otherwise activate the consultation schedule button 199 to arrange a consultation with the surgeon who performed the previous surgery, with respect to a comparable anatomical body classification 80. After the consultation schedule button 199 is activated, the user and the relevant surgeon may be presented with a series of prompts for scheduling and conducting the consultation. The consultation may be conducted via a chat room, telephone, video conference, etc. If necessary, the identity of one or both of the requesting surgeon and the consulting surgeon may be kept confidential during the consultation.
[0221] Figure 13A schematically illustrates yet another method 168 for planning an orthopedic procedure for each corresponding patient using System 10. Method 168 may be performed as part of a surgical planning procedure for preparing a surgical plan for a patient. Within the scope of this disclosure, fewer steps or additional steps may be performed compared to those described below, and the order in which the steps are described is not intended to limit this disclosure. System 10 may be configured to perform each step of Method 168 via any associated computing devices and modules. In an exemplary embodiment, a computing device 40 of a host computer 12 may be programmed to perform Method 168. However, other embodiments are further conceivable within the scope of this disclosure.
[0222] Method 168 may be initiated in step 170 in response to receiving a preoperative surgical plan approved by the respective surgeon. Next, in step 172, the surgeon profile database 65 may be queried for data on the surgeon's previous surgeries planned using System 10 with respect to the procedures outlined in the approved preoperative surgical plan. The data analyzed from the surgeon profile database 65 may include the types and quantities of implants actually used in the surgeon's previous surgeries and the types and quantities of implants included as part of the preoperative surgical plan for each of the surgeon's relevant previous surgeries.
[0223] In step 174, the system 10 may determine, for example, based on a comparison of the preoperative and postoperative data analyzed in step 172, whether the surgeon deviated from his previous preoperative surgical plan by less than a predetermined percentage of his previous surgical procedures. In some embodiments, the predetermined percentage may be defined as 5% of the previous surgical procedures. However, other thresholds may be established within the scope of this disclosure. In one embodiment, “deviation” is assumed to occur when the surgeon changes the type of pre-planned procedure, changes the type of pre-planned implant, or uses a size deviation of two or more sizes in a previous surgical procedure.
[0224] If a YES flag is returned in step 174, a first surgical kit containing only the implants and instruments necessary to perform the approved preoperative surgery may be recommended in step 176. Alternatively, if a NO flag is returned in step 174, a second surgical kit containing more implants and instruments than the first surgical kit may be recommended in step 178. An order for assembling the associated surgical kits may then be issued in step 180.
[0225] Figure 13B illustrates an exemplary deviation user interface 169 that may be provided in the method 168 described above. The deviation user interface 169 may be presented, for example, within the planning environment 28.
[0226] The deviation user interface 169 may be configured to present various surgical-related information about a selected surgeon in relation to the frequency with which the surgeon deviated from their past preoperative surgical plans. The deviation user interface 169 may provide a list of the surgeon's previous surgical cases 171 and various bar graphs 173A-173F designed to convey deviation-related information to the user. For example, bar graph 173A may illustrate the percentage of previous surgeries performed as planned, bar graph 173B may illustrate the percentage of implants implanted as planned during previous surgeries, bar graph 173C may illustrate planned implants versus implanted implants, bar graph 173D may illustrate the deviation type, bar graph 173E may illustrate different implant families used in previous surgeries, and bar graph 173F may illustrate different sized implants used during previous surgeries. Other deviation-related information may be conveyed to the user via the deviation user interface 169, either alternatively or additionally.
[0227] Figure 14 schematically illustrates a method 182 for postoperatively updating one or more databases 38 associated with system 10. Method 182 may be performed after a patient's surgical plan has been created using system 10, or after the surgical plan has been executed during the actual surgical procedure. Within the scope of this disclosure, fewer steps or additional steps may be performed compared to those described below, and the order in which the steps are described is not intended to limit this disclosure. System 10 may be configured to perform each step of method 182 via any associated computing devices and modules. In an exemplary embodiment, a computing device 40 of a host computer 12 may be programmed to perform method 182. However, other embodiments are further conceivable within the scope of this disclosure.
[0228] In step 184, system 10 may receive postoperative patient outcome data from the user. In some embodiments, postoperative patient outcome data may be manually entered by a surgeon or other staff after performing the intraoperative surgical procedure on the patient in accordance with a preoperative surgical plan previously created within system 10. In other embodiments, postoperative patient outcome data may be automatically communicated to system 10 after performing the surgical procedure as part of a closed feedback loop, which may be implemented, for example, via a neural network. The postoperative outcome data may include information such as the size and type of implant used during the currently completed surgical procedure, the position and orientation of the implant used, implant failure data, data related to the achievement or failure of preoperative activities of daily living goals, etc.
[0229] An anatomical body size classification 80 may be assigned in step 186 to each anatomical structure associated with the postoperative patient outcome data. This may be achieved, for example, by querying the anatomical body size classification database 70 to find a bone model stored internally that has an anatomical body size classification similar to the anatomical body size classification of the anatomical structure shown in the postoperative patient outcome data.
[0230] In step 188, the surgical outcome database 66 may be updated with information contained in the postoperative patient outcome data. For example, the surgical outcome database 66 may be updated with the size and type of implant used in the currently completed surgical procedure, the position and orientation of the implant used, etc.
[0231] The size, type, position, and orientation of the implants shown in the postoperative 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 with respect to the anatomical structures and implants associated with the postoperative patient outcome data. Contact points or collision points may be identified in step 194 to identify the range of motion endpoints 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.
[0232] The center of rotation of the implant, related to postoperative patient outcome data, may be adjusted in step 198. In step 200, the center of rotation of the implant may be adjusted in multiple increments relative to the corresponding bone model to record the angular arc and collision mode associated with the adjusted position. Then, all range of motion data derived from the simulations performed in steps 190-200 may be stored in the range of motion database 68 in step 202.
[0233] Referring to Figure 15, 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, the patient's anatomical structures may be associated with corresponding postures. A range of postures may be assigned to a set of posture types (e.g., A, B, C) of anatomical structures. Figure 15 discloses a set of posture types (e.g., A, B, C). Posture type A may be representative of perfect posture. Posture types B and C may be deviations from posture type A.
[0234] Using the techniques disclosed herein, one or more characteristics related to a patient's posture can be determined. Although three posture types are disclosed, it will be understood that fewer or more posture types may be used in accordance with the teachings disclosed herein. A patient's posture can affect the relative positions between two or more bones, including non-adjacent bones and / or adjacent bones, and / or between joints. A patient's posture can affect the relative positions 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.
[0235] Figures 16A–16C disclose anatomical models 229 (shown as models 229-1, 229-2, and 229-3). Anatomical models 229-1–229-3 may be associated with corresponding patients, respectively. Anatomical models 229 may include one or more bone models 230, which may be associated with any bone of the anatomical structure. Bone models 230 may represent bones associated with the shoulder joint, such as the scapula and / or humerus, as well as one or more bones of associated limbs, such as the ulna and / or radius of the forearm. The scapula may be associated with scapular 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. The anatomical model 229 and / or related bone model 230 may be established and positioned using any of the techniques disclosed herein.
[0236] Referring to Figures 17A to 17C, continuing with Figures 15 and 16A to 16C, the anatomical models 229-1 to 229-3 may be associated with corresponding patient postures. The patient's posture may be characterized by the use of various techniques. The planning system 10 (Figures 1 to 2) may be configured to determine one or more properties related to the patient's posture based on the orientation of one or more bone models 230 of the anatomical model 229. The bone models 230 of the humerus 230H, ulna 230U, and / or radius 230R may be positioned at a static (e.g., start) angle relative to the scapula model 230S, including during image acquisition.
[0237] Anatomical models 229-1 to 229-3 may establish one or more angles α that may be related to the posture of the patient's anatomical structures. Angles α may be defined by utilizing various techniques. The first bone model 230, related to the patient's first bone, may extend along the first reference plane REF1. The second bone model 230, related to the patient's second bone, may extend along the second reference plane REF2. The first reference plane REF1 and the second reference plane REF2 may intersect to establish angle α. In embodiments, angle α may be established with respect to the first reference plane REF1 and with respect to the patient's axis X. Angles α may be related to the patient's posture.
[0238] A scapular angle related to the patient's scapula may be established. The scapular angle may include one or more components relative to the patient's anatomical structure (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 inclination. The scapular angle may be determined when the patient is standing or positioned in a resting position (e.g., horizontal position). In embodiments, the first bone model 230 may be a scapular model 230S related to the patient's scapula. The second bone model 230 may be a humeral model 230H related to the patient's humerus. The angle α may be defined as the angle between the axis of the scapular spine and the humeral shaft relative to the patient's medial plane. The spine of the scapular model 230S may extend along the first reference plane REF1. The shaft of the humeral model 230H may extend along the second reference plane REF2. The spatial module 50 and / or another part of the planning system 10 may be configured to determine a first reference plane REF1 and / or a second reference plane REF2, and an associated angle α. In an embodiment, a surgeon or clinical user may specify the first reference plane REF1 and / or the second reference plane REF2 by interacting with the user interface 56.
[0239] The anatomical model 229 may include one or more bone models 230 arranged relative to an axis X. The axis X may be a vertical axis associated with a patient in an upright position (e.g., standing position), and may be normalized with respect to a coordinate system. The anatomical model 229 may include two or more bone models 230 arranged relative to each other to establish a scapular angle. The axis X may extend along the one or more bone models 230. The axis X may be established along an intersection between movement planes of the patient (e.g., between a sagittal plane and a coronal plane). A first reference plane REF1 may extend along another bone model 230, such as along the spine of the scapula model 230S. The first reference plane REF1 may intersect the patient's axis X to establish the scapular angle. The orientation of the first reference plane REF1 may be established based on internal rotation, upward rotation, and / or anterior tilt of the scapula. In embodiments, the scapular angle may be a set of values defined for internal rotation of the scapula, upward rotation of the scapula, and / or anterior tilt of the scapula. For the purposes of the present disclosure, the terms "about", "substantially", and "approximately" mean ±10% of the stated value or stated relationship, unless otherwise specified. The humerus model 230H, ulna model 230U, and / or radius model 230R may be substantially perpendicular or transverse relative to the patient's axis X. In the embodiment of FIGS. 17A to 17C, the ulna model 230U and the radius model 230R may be substantially parallel to the axis X.
[0240] The scapular angles of the anatomical models 229-1 to 229-3 may be the same as each other or may be different from each other. The postures of the respectively corresponding anatomical models 229-1 to 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 relating to one or more posture parameters (e.g., characteristics), such as scapular angle. In an embodiment, posture type A may be associated with scapular internal rotation of about 32 degrees ±6 degrees, upward scapular rotation of about -3 degrees ±6 degrees, and medial (e.g., anterior) scapular tilt of about 23 degrees ±11 degrees. Posture type B may be associated with scapular internal rotation of about 42 degrees ±3 degrees, upward scapular rotation of about -12 degrees ±7 degrees, and medial scapular tilt of about 24 degrees ±8 degrees. Posture type C may be associated with scapular internal rotation of about 53 degrees ±5 degrees, upward scapular rotation of about -15 degrees ±13 degrees, and medial scapular tilt of about 33 degrees ±7 degrees.
[0241] The scapular angles in FIGS. 17A to 17C may be associated with the posture types in FIG. 15 and / or FIGS. 16A to 16C. The anatomical model 229-1 in FIG. 17A may be associated with posture type A in FIG. 15 and FIG. 16A. The anatomical model 229-2 in FIG. 17B may be associated with posture type B in FIG. 15 and FIG. 16B. The anatomical model 229-3 in FIG. 17C may be associated with posture type C in FIG. 15 and FIG. 16C. In an embodiment, the anatomical model 229-1 may be associated with posture type A and / or may be associated with a scapular angle having a value within any of the ranges disclosed in connection with posture type A. The anatomical model 229-2 may be associated with posture type B and / or may be associated with a scapular angle having a value within any of the ranges disclosed in connection with posture type B. The anatomical model 229-3 may be associated with posture type C and / or may be associated with a scapular angle having a value within any of the ranges disclosed in connection with posture type C.
[0242] Referring to Figures 18A-18C, continuing with Figures 17A-17C, the patient's posture may restrict the range of motion of the limbs, such as the humerus and associated forearm. Anatomical models 229-1-229-3 may be associated with examples of the humerus model 230H', ulna model 230U', and radius model 230R' in a high position. The range of motion may be characterized by a reference (e.g., scapula) plane REF1 and / or associated scapular angles. Upward movement of the humerus may generally be restricted to approximately the reference plane REF1.
[0243] Image data associated with the anatomical model 229 and the bone model 230 may be acquired in an acquisition orientation associated with one or more imaging devices 16 (Figures 1-2). Each imaging device 16 may be associated with an acquisition reference system. The acquisition reference systems of two or more imaging devices 16 may be the same or different from each other. The patient may be positioned relative to reference points in the acquisition reference system, which may differ among patients based on anatomical size, posture, pathological condition, etc. The bone model 230 may be the patient's resting (e.g., starting) position at the time of acquisition. The resting position may be associated with the patient's upright (e.g., vertical) position or recumbent (e.g., horizontal or supine) position at the time of acquisition of the associated image data. Figure 16D discloses anatomical model 229-4. Anatomical model 229-4 may include one or more bone models 230 that can be associated with any bone of an anatomical structure. Anatomical model 229-4 may be associated with the patient's lateral (e.g., horizontal) position (e.g., on the imaging device bed) when acquiring the relevant image data. Anatomical model 229-4 may be associated with the same patient as one of the anatomical models 229-1 to 229-3, such as anatomical model 229-2. The orientation of one or more bones, such as the scapula and humerus, of a patient in an upright position may be determined based on a transformation associated with the patient's lateral position. In embodiments, the orientation of the scapula 230S and / or humerus 230H in anatomical model 229-2 (Figure 16B) may be established based on a transformation applied to the orientation of the scapula 230S and / or humerus 230H in anatomical model 229-4 (Figure 16D). The orientation of the scapula may be non-perpendicular to the axis of the acquisition reference system. The orientation of the scapula in the acquisition reference system may be characterized by the patient's posture. The transformation may take into account the effects on the anatomical structure of the patient in the lateral recumbent position, such as muscle tissue relaxation. In embodiments, the transformation may include one or more predefined transformation angles. The predefined transformation angles may include three rotation angles with respect to the axis of the reference system. The predefined transformation angles may be established for one or more imaging positions, such as the lateral recumbent position and / or the upright position.A predefined set of transformation angles may be established for each corresponding bone in the anatomical structure. The spatial module 50 may be configured to transform the bone models 330 from a lateral position to an upright position, or vice versa, by applying transformations to each corresponding bone model 330.
[0244] By incorporating patient posture-related information into the systems and methods disclosed herein, such as System 10 (Figures 1-2), a surgical (e.g., preoperative) plan may be established, and / or a patient-related range of motion (ROM) configuration may be determined and / or verified, by utilizing any of the techniques disclosed herein. System 10 may establish a preoperative plan 36 based on one or more determined postural characteristics (e.g., parameters) related to the patient's posture. The position and / or orientation of one or more implants specified in the preoperative plan 36 may be determined based on the determined postural characteristics. By incorporating postural information into the systems and methods disclosed herein, a surgeon or clinical user may plan the placement of one or more implants, taking into account the resting (e.g., initial) angle of the scapula ("scapula"). Implants may be assigned a default starting position and / or orientation relative to adjacent bones. System 10 may determine correction values to adjust the default starting position and / or orientation of the implants based on the determined postural characteristics. Postural information may be used to determine the range of motion, including activities of daily living.
[0245] System 10 may be configured to determine one or more postural parameters related to the patient's posture. System 10 may be configured to adjust the implant plan based on one or more postural parameters. The implant plan may include any parameters disclosed herein, such as the type of implant, the dimensions of the implant, and the position of the implant.
[0246] Referring to Figures 19-20, patient posture can affect retroversion, as disclosed in Moroder, 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 disclose a clinical case of shoulder arthroplasty in a patient. The orientation of the implant relative to the humerus may be adjusted to change retroversion from 0 degrees to a value equal to scapular internal rotation (IRO). Setting the implant orientation to scapular internal rotation (IRO) may provide a relatively large range of motion and / or reduce the possibility of implant collision.
[0247] In embodiments, a postural change may be established. The postural change may be based on a postural classification and / or on one or more measured postural parameters, including any postural parameters disclosed herein. The postural parameters may include one or more markers on the scapula, the distance or relative position between two or more markers, the scapular angle, and / or the dimensions of one or more bones of an anatomical structure (e.g., the length of the humerus). In embodiments, the postural change may be used to adjust or otherwise set the position and / or orientation of a planned implant in order to treat a patient, thereby improving range of motion and activities of daily living.
[0248] One or more range of motion parameters may be used to establish postural changes. In embodiments, the parameters may be associated with one or more activities of daily living and / or lifestyle goals (e.g., desired postoperative 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.). Defined values for one or more activities of daily living and / or lifestyle goals may be used as criteria for establishing postural changes.
[0249] System 10 may be configured to perform range of motion simulations based on one or more parameters related to the patient's posture. Storage system 18 may be configured to store range of motion data derived from the range of motion simulations. The parameters may include scapular angles related to the patient's scapula.
[0250] The method may include performing a range of motion simulation based on one or more parameters related to the patient's posture. The method may also include storing the range of motion data derived from the range of motion simulation in the storage system 18 of the surgical planning system 10. The parameters may include scapular angles related to the patient's scapula.
[0251] Referring to Figures 21-25, continuing with Figure 2, the planning system 10 may be configured to display a selected anatomical model 329 in one or more display windows 360 of the graphical user interface 356. The anatomical model 329 may include one or more bone models 330, each associated with a corresponding joint. The display module 48 may be configured to display the anatomical model 329 in the display window 360. The spatial module 50 may be configured to adjust the relative positions of one or more bone models 330, and / or other parts of the anatomical model 329, and / or the reference frame.
[0252] Figures 21-26 disclose anatomical models 329 associated with one or more patients. Anatomical model 329 may include a first anatomical model 329-1 (Figures 21-23) and / or a second anatomical model 329-2. Anatomical model 329 may include a shoulder model 329SM and one or more implant models 332 associated with various anatomical structures and scapular angles. Shoulder model 329SM may include a scapular model 330S and a humerus model 330H.
[0253] The spatial module 50 may be configured to position one or more implant models 332 relative to each other and / or relative to 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 and 332H may engage with 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, abduction and external rotation. Values may be assigned to each parameter, and these values may be displayed to the user. The sum of the values may be displayed to the surgeon or clinical user within the user interface 356 (see, for example, Figures 22 and 25). Postural transformations may be applied to adjust the default starting position and / or orientation of the implant 332 based on the determined parameters.
[0254] 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 within the display windows 360-1 and 360-2. In one embodiment, the display module 48 may be configured to display an anterior (or posterior) view of the anatomical model 329-1 in the first display window 360-1. The display module 48 may be configured to display a lateral view of the anatomical model 329-1 in the second display window 360-2. The spatial module 50 may be configured to set the positions of the bone models 330 relative to each other and / or relative to a reference frame based on the patient's determined posture. A surgeon or clinical user may select one or more bone models 330 by interacting with the display window 360 and / or another part of the user interface 356. 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 parts of the anatomical model 329.
[0255] Referring to Figure 22, with continued reference to Figures 2 and 21, the spatial module 50 may be configured to adjust the position of the selected bone model 330 relative to each other and / or relative to another part 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 located on 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 related to the anatomical model 329-1. A surgeon or clinical user may adjust one or more values displayed in the text box 362T in response to the selection of the corresponding text box 362T, button 362B, and / or radial button 362R, respectively. Buttons 362B, 362R may be associated with various properties of the selected bone model 330 (e.g., angular relationships), including any properties disclosed herein. In embodiments, the characteristics 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 of their respective columns. A surgeon or clinical user may adjust the position and / or orientation of one or more selected bone models 330 by specifying values in one or more text boxes 362T. A surgeon or clinical user may also adjust the position and / or orientation of one or more selected bone models 330 and any associated values in the control panel 311 by interacting with the display window 360. The display window 360 and the control panel 311 may be dynamically linked such that changes to one trigger corresponding changes to the other, including values specified in the text boxes 362T.
[0256] In the embodiments shown in Figures 21 to 23, the anatomical model 329-1 may be associated with a scapular angle of 0 degrees (e.g., medial tilt). The spatial module 50 may be configured to assign default values for each property associated with the object 362 of the control panel 311 based on the determined and / or selected scapular angle. The spatial module 50 may be configured to position the selected bone models 330 relative to each other based on the assigned values. A posture type (e.g., type A) may be assigned to the posture associated with the scapular angle and the anatomical model 329-1 in Figure 21.
[0257] Referring to Figure 23, continuing with Figure 22, a surgeon or clinical user may adjust the position of a selected bone model 330, such as a humerus model 330H, by interacting with one or more objects 362. The surgeon or clinical user may also adjust the adduction of the humerus model 330H from a first position (e.g., Figure 22) to a second position (e.g., Figure 23) by interacting with one or more objects 362. The spatial module 50 may be configured such that, when a selected bone model 330 is adjusted, an unselected bone model 330 remains in a fixed position, thereby providing flexibility in determining one or more parameters of the preoperative plan, such as the position and / or orientation of an implant, each associated with a corresponding implant model 332. The surgeon or clinical user may, by interacting with the user interface 356, observe the effects of various properties with respect to range of motion and one or more activities of daily living and / or lifestyle goals, including any of those disclosed herein.
[0258] Figures 24 to 26 disclose embodiments of the second anatomical model 329-2 within the display window 360 of the graphical user interface 356. The posture associated with the second anatomical model 329-2 may differ from the posture 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., medial tilt). A posture type (e.g., type C) may be assigned to the posture associated with the scapular angle and the anatomical model 329-2 in Figure 24.
[0259] The planning system 10 may be configured to establish a surgical plan 36 based on the determined posture and / or scapular angle of each corresponding 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 position). The planning system 10 may be configured to apply transformations to the patient's acquired position in order to predict or otherwise determine the posture and / or scapular angle of a patient in an 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, thereby enabling the achievement of one or more activities of daily living and / or lifestyle goals, and / or improving the patient's mobility by evaluating the range of motion for the planned implant positioning.
[0260] Figure 27 discloses a method for a surgical procedure in flowchart 382. Method 382 may be used to preoperatively plan, perform, evaluate, and / or verify various aspects of surgical procedures, such as arthroplasty to restore function to the shoulder, ankle, knee, hip, and other joints. Method 382 may be used in conjunction with any planning system and method, virtual anatomical models, and / or bone models, such as planning system 10, as disclosed herein. Method 382 may be used to determine the patient's posture. Method 382 may be used to establish the position and / or orientation of one or more implants based on the orientation of anatomical structures, such as the orientation of the scapula. The orientation of anatomical structures may be associated with the patient's posture. Method 382 may be used to determine the patient's posture. In embodiments, planning method 382 may be used to predict, or otherwise determine, the position, alignment, and / or angles of bones based on the geometry of one or more other bones, including adjacent and / or non-adjacent bones of the patient. Method 382 may be configured to predict or otherwise determine the position, alignment, and / or angle of bones based on the bone's relationship to a (e.g., global) reference system and / or to one or more motion planes and / or axes of a patient. Within the scope of this disclosure, fewer steps or additional steps may be performed compared to those described below, and the order in which the steps are described is not intended to limit this disclosure. System 10 and any associated modules may be configured to perform features of any method disclosed herein, including Method 382. See System 10.
[0261] Referring to Figures 2 and 27, in step 382A, a digital image of a patient's anatomy may be captured or otherwise obtained by an imaging device 16 (Figures 1 to 2), including any of the imaging devices disclosed herein such as a computed tomography (CT) or magnetic resonance imaging (MRI) device. The digital image may include image data, and the image data may be captured or otherwise obtained to establish one or more images 26 of the anatomy, such as by the imaging device 16. Data module 46 may receive image data directly from imaging device 16, or may obtain image data by accessing a patient-related record or entry from database 38 (Figure 2) and / or from patient profile database 64 (Figure 3). The digital image may include any anatomy disclosed herein, such as the anatomy represented by bone model 330 and / or anatomical model 329 of Figures 21 to 23. Imaging device 16 may be associated with an acquisition coordinate system. The acquisition coordinate system may be associated with an axis and a set of coordinate values. Each image 26 may be associated with an acquisition coordinate system of a corresponding imaging device 16.
[0262] Referring to Figure 28 with continued reference to Figures 2 and 27, image 26 may be associated with anatomical model 329 and / or bone model 330. Spatial module 50 may be configured to associate anatomical model 329 with an acquisition coordinate system. Although Figure 28 discloses anatomical model 329 relative to a set of implant models 332, it will be understood that implant models 332 may be positioned relative to anatomical model 329 after establishing a modified instance of anatomical model 329 associated with surgical plan 36. Data module 46 may be configured to store one or more instances of anatomical models and bone models, such as anatomical model 329 and / or bone model 330, and associated coordinate values, in memory 44.
[0263] Digital images may be captured for various imaging positions of the patient relative to the imaging device 16. The patient's acquisition position may be entirely horizontal. In some embodiments, patient acquisition may be entirely vertical. The patient's image may be captured with the patient standing. The posture of a patient in an upright position may deviate from a perfect posture. The image may be captured by an imaging device set upright.
[0264] In step 382B, the digital image 26 may be segmented using various techniques, such as applying segmentation to the image 26 automatically, semi-automatically, or manually. The system 10 may be configured to segment the image 26.
[0265] In step 382C, one or more anatomical models and / or bone models may be generated. Stem 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 the bone models 330 relative to each other.
[0266] Anatomical model 329 may include shoulder model 329SM. Shoulder joint model 329SM may be associated with the first anatomical model 329-1 in Figures 21-23. Bone model 330 may include scapular model 330S, which is associated with the patient's scapula, and humeral model 330H, which is associated with the patient's humerus.
[0267] In the embodiment, 3D meshes of the scapula and humerus may be reconstructed to establish the scapula model 330S and the humerus model 330H. The scapula model 330S may be established with respect to a local (e.g., scapula) reference system. The local reference system may be associated with a set of coordinate values. The spatial module 50 may be configured to associate the scapula reference system with the scanning (e.g., acquisition) position of the scapula relative to the imaging device 16.
[0268] Various techniques may be used to orient anatomical structures, including the scapula. Anatomical structures, including the scapula, may remain in their local orientation for planning (e.g., at the time of acquisition). The orientation at the time of acquisition may be associated with the acquisition reference system of the imaging device 16. In embodiments, the Z-axis of the acquisition reference system may be horizontal for imaging device 16 and other acquisition systems that can acquire image data of a patient in a horizontal (e.g., recumbent) position. The Z-axis of the acquisition reference system may be vertical for acquisition systems that can acquire image data of a patient in an upright position (e.g., vertical or standing position). Patient postural characteristics, such as scapular angle, may differ between the horizontal and upright positions.
[0269] In step 382D, the anatomical model and / or bone model may be reoriented (e.g., registered) from a first reference frame to a different second reference frame. In embodiments, the anatomical model and / or bone model may be reoriented based on the patient's posture and related postural characteristics. By reoriented the patient's anatomical model and / or bone model based on posture, the implant plan may be improved to achieve range of motion and activity of daily living and / or lifestyle goals. The acquisition positions of the patient's anatomical structures, including the scapula, may be determined directly from digital images. The disclosed systems and methods may normalize and / or reposition the scapula relative to the scapular plane in a three-dimensional (3D) computer-aided design (CAD) model. One or more patient-related measurements and / or other information may be captured preoperatively to manually and / or optically determine the patient's preoperative posture. In other embodiments, in step 382D, the reoriented (e.g., registered) of the anatomical model and / or bone model from a first reference frame to a second reference frame may be performed without determining the patient's posture.
[0270] The spatial module 50, or another part of the planning system 10, may be configured to reorient (e.g., register) at least one or more anatomical and / or bone models from a first reference system to a second reference system. The first reference system may be a local reference system or an acquisition reference system. The second reference system may be any reference system disclosed herein, such as a global reference system. The spatial module 50 may be configured to reorient bone models 330 in a global reference system based on selected representative bone models 30 that may be associated with different patients. The spatial module 50 may be configured to register one or more bone models 330 of a patient from the first reference system to the second reference system in response to adjustments of one or more coordinate values associated with the corresponding bone models 330 based on the patient's posture, including any postural parameters disclosed herein. The comparison module 52 may be configured to determine postural parameters associated with the patient's posture. The spatial module 50 may be configured to register the patient bone models 330 in a global reference system based on the determined postural parameters.
[0271] The planning system 10 may be configured to normalize one or more datasets in a global reference system, including any 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 reference system to the global reference system. The scapula model 330S may be reoriented using any technique disclosed herein. The orientation of the scapula model 330S in the global reference system may be associated with the anatomical position of the scapula when the patient may be upright, and such anatomical position may be influenced by the patient's posture.
[0272] Various techniques may be used to reorient the anatomical and / or skeletal models. The spatial module 50 and / or another part of system 10 may be configured to register the skeletal models from a first (e.g., local or acquired) reference system to a second (e.g., global) reference system based on one or more postural parameters related to the patient's posture. One or more postural parameters may be used to establish a transformation between the first and second reference systems. One or more postural parameters may include scapular angles related to the scapula (see, for example, Figures 17A-17C). Various techniques may be used to establish one or more transformations such as parametric equations and / or matrices.
[0273] In step 382D-1, a global reference frame may be defined (see, for example, Figure 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 the anatomical position of the patient, which may differ from the acquisition position associated with the image data acquired by the imaging device 16. The anatomical position may correspond to the posture of the patient, which is set to an upright (e.g., standing) position. The global reference frame may be established with respect to the Z axis (0,0,1), Y axis (0,1,0), and X axis (1,0,0). 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 the horizontal plane in their corresponding horizontal directions, respectively. The global reference frame may be associated with the upright position of the patient. In embodiments, the global reference frame may be established with respect to one or more motion planes of the patient, including any motion planes disclosed herein. The X, Y, and Z axes may be established along the patient's corresponding plane of motion. By utilizing the techniques disclosed herein, activity of daily living and / or lifestyle goals may be set and / or evaluated based on the patient's posture. The planning system 10 may be configured to set and / or evaluate the patient's implant position and orientation, range of motion, and / or activity of daily living / lifestyle goals relative to a global reference system. In embodiments, a range of motion modeler 101 (Figure 8) may determine the range of motion relative to a global reference system. Various databases disclosed herein, including the surgical outcome database 66, the range of motion database 68, and / or the anatomical body size classification database 70 (Figure 3), may be normalized relative to a global reference system.
[0274] The spatial module 50 may be configured to register a scapular reference system associated with the scapula module 330S to a global reference system, which may include translating and / or rotating the scapular model 330S. The scapular reference system may be established for a set of markers associated with the scapula of the scapula model 330S, such as three or more markers.
[0275] Referring to Figure 29, while continuing to refer to Figures 2 and 27-28, a scapular axis SA may be established. The scapular axis SA may extend through reference points along the articular surfaces of the scapular model 330S. The articular surfaces may be associated with the glenoid fossa of the scapula. The scapular axis SA may extend between a first point P1 (e.g., the center of the glenoid fossa) and a second point P2 (e.g., the scapular triangle) of the scapular model 330S.
[0276] Referring to Figures 28 and 31, while continuing to refer to Figures 2 and 27-28, an anatomical (e.g., scapular) plane REF-A may be established. The scapular plane REF-A may be fitted through the scapular model 330S. The scapular plane REF-A may be determined by landmarks or by the best fit of the scapular plane. The scapular plane REF-A (Figure 31) may be established along the scapular axis SA and may extend between a first point P1 at the glenoid center and a second point P2 in 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 to determine one or more anatomical landmarks along the scapular model 330S, including the first point P1, the second point P2, and / or the third point P3. The spatial module 50 may be configured to determine the scapular plane REF-A such that the scapular plane REF-A extends along the scapular axis SA.
[0277] Referring to Figure 30, while continuing to refer to Figures 2 and 27-29, the scapular model 330S may be associated with a first (e.g., local, scapular, or acquired) reference system. The scapular reference system may have an origin PL. The spatial module 50 may be configured to apply a predefined transformation to the scapular model 330S in order to reorient it from the first reference system to a different second reference system. The first reference system may be a local reference system. The second reference system may be a global reference system established in step 382D-1. System 10 may establish a surgical plan 36 related to the bone model 330 with respect to the global reference system. The surgical plan 36 may include an implant plan related to the 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 related to the implant model.
[0278] Referring to Figure 31 with continued reference to Figures 2 and 27-30, registering the scapula model 330S in step 382D may include adjusting the orientation of the scapula model 330S. In embodiments, the spatial module 50 may apply a predefined transformation so that the scapula model 330S can be translated and / or rotated, thereby aligning (e.g., registering) the scapula reference system of the scapula model 330S with respect to the global reference system. The origin PL of the scapula reference system may be established at a first point P1 at the center of the glenoid fossa of the scapula model 330S. In the embodiment of Figure 31, the alignment may be performed so that the first point P1 at the center of the glenoid fossa can be positioned at the origin P0 of the global reference system. The system 10 may be configured to perform a predefined transformation of the humerus model 330H from a local (e.g., humerus) reference system to a global reference system using any of the techniques disclosed herein with respect to the scapula model 330. In the embodiment, the spatial module 50 may be configured to apply the same predefined transformation associated with the glenoid bone model 330G to the humerus model 330H, such that the relative positions between the glenoid bone model 330G and the humerus model 330H remain the same between the reference systems. The orientation of the scapula model 330S and the humerus model 330H relative to the global reference system may represent the patient's posture in an anatomical position.
[0279] System 10 may be configured to register one or more implant models 32 in a global reference system according to any techniques disclosed herein. In the embodiment of Figure 30, System 10 may be configured to register the position of one or more implant models 332 in a global reference system. The implant model 332 may be positioned along the glenoid head and / or humeral head of the associated bone models 330S, 330H. The implant model 332 may be registered simultaneously with the registration of the scapula model 330S and / or humeral model 330H. In other embodiments, the implant model 332 may be positioned relative to the glenoid model 330S and humeral model 330H after the scapula model 330S and / or humeral model 330H have been registered in the global reference system.
[0280] Further techniques may be used to reorient anatomical and / or skeletal models from one reference system to another. The planning system 10 may be configured to determine the position of bones associated with corresponding skeletal models based on the geometry of one or more other bones, including adjacent and / or non-adjacent bones of the patient, and based on the associated skeletal and / or anatomical models. In embodiments, the planning system 10 may be configured to determine the position, alignment, and / or angle of bones associated with corresponding skeletal models based on the geometry of one or more other bones, including adjacent and / or non-adjacent bones of the patient, and based on the associated skeletal and / or anatomical models. In embodiments, the planning system 10 may be configured to determine the position, alignment, and / or angle of bones associated with corresponding skeletal models based on the relationship of bones to a reference system (e.g., global), and / or the relationship of bones to one or more motion planes and / or axes of the patient. In step 382D-2, the anatomical model and / or bone model may be reoriented from the first reference frame to the second reference frame based on one or more predetermined correlations to anatomical landmarks and / or to the anatomical models of one or more other patients. The planning system 10 may be configured to establish a surgical plan in response to a comparison of the patient's anatomical model and / or bone model with the anatomical models and / or bone models of one or more other patients and / or a patient population. The patient population may exclude the patient.
[0281] System 10 may be configured to reorient bone models 330 and / or anatomical models 329, such as scapula model 330S, based on the relationships between two or more adjacent and / or non-adjacent bones of an anatomical structure. System 10 may be configured to determine the position of bones relative to bone model 330 based on the geometry of another bone, including adjacent bones such as the humerus and / or non-adjacent bones such as the clavicle and / or one or more ribs of a patient (e.g., minor ribs) relative to the scapula.
[0282] Step 382D-2 may include reorienting (X, Y, Z) the scapular plane REF-A (see, for example, Figure 31) of the scapular model 330S based on one or more predetermined correlations. The predetermined correlations may be established for anatomical landmarks and / or for SSM / numerical composition classifications. The SSM / numerical composition classifications may be established using any technique disclosed herein, such as by a statistical shape modeler 72. The planning system 10 may be configured to establish transformations for each anatomical body classification 80 and related parameters of the transformations based on predetermined correlations, and by utilizing these transformations, the associated bone models and / or anatomical models may be registered from one reference system to another.
[0283] In embodiments, a global (e.g., common) reference system may be established in step 382D-1 using any of the techniques disclosed herein. The scapular model 330S may be registered with respect to the global reference system using one or more defined markers, including any anatomical markers disclosed herein. System 10 may be configured to determine the location of one or more markers along the scapula and / or along other parts of the anatomical structure. By utilizing the markers, a transformation from the scapular reference system to the global coordinate system may be defined (see, for example, Figure 30). The orientation of the scapular model 330S and the humeral model 330H relative to the global reference system may represent the anatomical position of the patient. Markers along the scapula may include the center of the glenoid fossa (e.g., point P1 in Figure 29), the inferior angle of the scapula (e.g., point P3 in Figures 29 and 31), and / or the scapular triangle (e.g., point P2 in Figure 29).
[0284] Landmarks may be determined by utilizing various techniques, including any techniques disclosed herein. A surgeon or clinical user may specify markers for corresponding bone models 330, including the scapula model 330S, by interacting with the display window 360 and / or other parts of the user interface 356 (e.g., Figures 21-23). In embodiments, the spatial module 50 may be configured to determine markers along the scapula model 330S and / or other bone models 330 of the anatomical model 329.
[0285] Referring to Figures 2 and 4, and continuing to refer to Figures 27 and 28, the scapula model 330S may be registered in the global reference system based on a statistical shape model (SSM) 75 and an assigned numerical configuration classification 80. One or more corresponding SSMs 75 may be established for the scapula, humerus, and / or other bones of the anatomical structure. In embodiments, an anatomical SSM 75 may be established for two or more bones of the anatomical structure, including non-adjacent and / or adjacent bones such as the scapula and humerus. The statistical shape modeler 72 may be configured to analyze a set of image data 74 to construct the corresponding SSM 75. The statistical shape modeler 72 may be configured to determine the location of each marker in the SSM 75, which can be used to convert the bone model 30 from the local reference system to the global reference system. In this embodiment, the statistical shape modeler 72 may assign an anatomical body type classification 80 to one or more bone models 330, including a scapula model 330S (for example, Figures 27-28).
[0286] The statistical shape modeler 72 may query the anatomical body size classification database 70 to find bone models 30 stored internally that have similar anatomical body size classifications 80. The coordinate information of the bone models 30 associated with the anatomical body size classification database 70 may be normalized with respect to a global reference system. In embodiments, normalizing the coordinate information may include applying a transformation from the acquired reference system to the global reference system to the associated bone models 30 using any of the techniques disclosed herein.
[0287] 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 statistical shape model 75 and the patient bone model 330 may be associated with bones that are common to anatomical structures, such as the scapula or humerus. 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 patient bone model 330. Within a set of representative bone models 30, each corresponding representative bone model 30 may be assigned a corresponding 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.
[0288] The statistical shape modeler 72 may be configured to assign to a bone model 330 an anatomical physique classification 80 associated with another patient that is closest to the anatomical structure contained in the bone model 330. The anatomical physique classification database 70 may contain stored information that specifies one or more markers of the bone model 30 associated with the assigned anatomical physique classification 80. The bone model 30 associated with the assigned anatomical physique classification 80 may be registered in a global reference system.
[0289] In some 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 a corresponding statistical shape model 75. The statistical shape model 75 and the representative bone model 30 may be associated with anatomically common bones. Establishing a surgical plan 36 may also include comparing a patient bone model 330 with a selected representative bone model 30 associated with SSM75. The surgical plan 36 may be established based on a bone model 330 within a global reference system.
[0290] The markers on bone model 330 may be paired with the corresponding markers on bone model 30 for the assigned anatomical body size classification 80. The patient's bone model 330 may be reoriented so that pairs of markers on representative bone model 30 and markers on the patient's bone model 330 can be substantially aligned within the global reference system. The patient's posture may be determined based on the position of the markers on representative bone model 30.
[0291] In one embodiment, an example of a bone model 30 of an anatomical body size classification 80 assigned within a global reference system may be substantially aligned with a patient bone model 330 in a local reference system to determine values for one or more correction angles. The correction angles may include three rotation angles with respect to the axes of the reference system. Based on the determined values of the correction angles, a transformation may be established. The spatial module 50 may be configured to register the bone models 330 in the global reference system by applying the transformation to each corresponding bone model 330 of a patient. In another embodiment, the patient bone model 330 may be registered in the global reference system by substantially aligning the patient bone model 330 with a selected bone model 30 of another patient within the global reference system.
[0292] The statistical shape modeler 72 may be configured to use SSM 75 to assign an anatomical mass classification (AMC) 80 to an anatomical model and / or a bone model based on one or more bones of an anatomical structure such as the scapula. Each AMC 80 may be established for multiple bones of an anatomical structure, including adjacent bones such as the scapula and humerus, and / or non-adjacent bones of a joint. In an embodiment, the statistical shape modeler 72 may be configured to determine the position of bones relative to the bone model 30 based on the geometry of another (e.g., adjacent) bone, including adjacent bones such as the humerus, and / or non-adjacent bones such as the clavicle, or including one or more ribs of a patient (e.g., minor ribs). In an embodiment, the system 10 may be configured to determine the angle of the ribs relative to a reference, such as the Z-axis of a reference system. The system 10 may be configured to determine posture based on the determined rib angles. In other embodiments, each AMC 80 may be established with respect to a single bone of the patient, such as the scapula or humerus. The statistical shape modeler 72 may be configured to determine the position of the bone relative to the skeletal anatomical structure based on one or more characteristics of the bone and associated landmarks.
[0293] Multiple AMC80 NTo establish the anatomical physique classification, the patient's posture may be used. The patient's posture may be defined with respect to one or more parameters, including any parameters disclosed herein, such as scapular angles (e.g., angles in Figures 17A-17C). The statistical shape modeler 72 may be configured to establish the anatomical physique classification 80 based on one or more predefined modes (e.g., variation modes) 76. The posture-related parameters may establish one or more predefined modes 76, including any posture parameters disclosed herein, such as scapular angles. The posture-related predefined modes 76 may include relationships between two or more adjacent and / or non-adjacent bones. The statistical shape modeler 72 may be configured to accept the posture-related predefined modes 76 as input. The statistical shape modeler 72 may be configured to assign the AMC 80 to the corresponding anatomical structures and associated bone models 30, respectively, based on the posture-related predefined modes 76. In other embodiments, the patient's posture may be omitted from the predefined modes 76.
[0294] The AMC80 may be selected based on the (e.g., best) degree of fit between the bone model 30 associated with the AMC80 and the patient bone model 330. The markers of the selected bone model 30 associated with the AMC80 may be used to determine the patient's posture. In embodiments, the markers associated with the selected AMC80 may be used to determine various postural characteristics, such as scapular angles relative to a global reference frame. The patient bone model 330 may be reoriented from the acquired posture to the global reference frame by applying a transformation based on the determined posture.
[0295] The disclosed systems and methods may be used to orient a scapular model to substantially match the patient's preoperative posture, and may be used to determine and / or verify the range of motion. Various embodiments may be used in accordance with the teachings disclosed herein, including determining the range of motion based on postural information.
[0296] System 10 may be configured to overlay a representative bone model 30 corresponding to an assigned anatomical body size classification 80 onto a corresponding bone model 330 for each patient (see, for example, bone models 430H-1 and 430H-2 in Figure 35, bone models 530S-1 and 530S-2 in Figures 42-43, and bone models 530H-1 and 530H-2 in Figure 45). A surgeon or clinical user may interact with the user interface 356 to switch the visibility of the overlaid bone model 30 associated with SSM75 on (and off). The overlaid bone model 30 associated with SSM75 may also provide a pre-morbid representation of the patient's anatomical structure, which the surgeon may evaluate and establish, edit, and / or approve a surgical plan.
[0297] In some embodiments, step 382D may include replacing the patient bone model 330 with a bone model 30 corresponding to an anatomical body size classification 80 assigned to the patient bone model 330. The anatomical body size classification database 70 may include adjustment information related to the position of the alternative bone model 30 within a global reference system. The alternative bone model 30 may function as a pre-pathological representation of the patient's anatomical structure. The pre-pathological representation may omit osteophytes and / or other surface irregularities that may interfere with the range of motion of the associated bone. The surgeon may remove osteophytes and / or treat surface irregularities in other manner during the surgical procedure. By analyzing the range of motion using the alternative bone model 30, including within a global reference system, a relatively accurate prediction of postoperative range of motion may be provided with surface irregularities removed or otherwise treated.
[0298] Referring to Figure 32, continuing with Figure 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 the scapula model 330S. System 10 may be configured to determine the position of one or more implants, and the position of an associated implant model 332, based on the orientation of the anatomical model 329 and / or bone model 330, including the scapula model 330S, within their respective corresponding reference systems, including any reference systems disclosed herein. The implant model 332 may include the glenoid implant model 332G and / or the humerus implant model 332H.
[0299] The spatial module 50 may be configured to position the implant model 332 and the bone model 330 relative to each other within a global reference system based on the implant position specified in the surgical plan 36. The system 10 may be configured to determine the optimal implant position based on the patient's predicted posture. In embodiments, the retroversion of the humeral implant model 332H may be adjusted to improve the clinical range of motion. The position and orientation of each implant model 332 relative to the respective corresponding bone model 330 may be established within the global reference system 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. The determination of the implant position in step 382E may be based on the relationship between two or more adjacent and / or non-adjacent bones, which can be predicted or otherwise determined using any of the techniques disclosed herein, and this may be done additionally or alternatively to determine the patient's posture.
[0300] In step 382F, the range of motion associated with each corresponding implant model 332 may be determined. Step 382F may include performing a range of motion simulation based on one or more parameters that may be related to the patient's posture. In embodiments, the parameters may omit the patient's posture. The bone model 330 may be associated with the patient's scapula. The parameters may include scapular angles related to the scapula. System 10 may be configured to perform a range of motion simulation based on determined postural parameters, such as the humerus model 330H. System 10 may be configured to determine the range of motion based on an anatomical body size classification 80 assigned to the bone model 330, including the scapula model 330S and the humerus model 330H, utilizing 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 model 330 in a global reference system based on postural parameters and / or the assigned anatomical body size classification 80.
[0301] Step 382F may also include storing the range of motion data derived from the range of motion simulation in the storage system 18 of system 10. The data module 46 may be configured to store the range of motion data in the storage system 18.
[0302] Figure 33 discloses a method for a surgical procedure in flowchart 482. Method 482 may be used to preoperatively plan, perform, evaluate, and / or verify various aspects of surgical procedures, such as arthroplasty to restore function to the shoulder, ankle, knee, hip, and other joints. Method 482 may be used in conjunction with any planning system and method, virtual anatomical models, and / or bone models, such as planning system 10, as disclosed herein. Method 482 may be used to determine the position and / or orientation of one or more implants based on the orientation of anatomical structures of the patient, such as the scapula and humerus. The orientation of anatomical structures may be associated with the patient's posture. Method 482 may be used to determine the patient's posture. In embodiments, planning method 482 may be used to predict, or otherwise determine, the position, alignment, and / or angles of bones based on the geometry of one or more other bones, including adjacent and / or non-adjacent bones of the patient. Method 482 may be configured to predict or otherwise determine the position, alignment, and / or angle of bones based on the bone's relationship to a (for example, global) reference system and / or to one or more motion planes and / or axes of a patient. Within the scope of this disclosure, fewer steps or additional steps may be performed compared to those described below, and the order in which the steps are described is not intended to limit this disclosure. Method 482 may incorporate any step in Method 382 disclosed herein, and vice versa. Refer to System 10.
[0303] Referring to Figure 2 with continued reference to Figure 33, in step 482A, a digital image of the patient's anatomical structure may be captured by the imaging device 16. The imaging device 16 may include any imaging device disclosed herein. The computing device 40 may be configured to receive patient-related image data. In embodiments, a shoulder CT scan or MRI may be acquired by the imaging device 16, for example, to establish one or more images 26 of the anatomical structure. The images 26 may be associated with an anatomical model 29. The computing device 40 may be configured to generate an anatomical model 29 and / or a bone model 30 of the patient and / or one or more other patients based on image data including the patient related to a representative patient population. In step 482B, the digital image 26 may be segmented using various techniques, such as applying segmentation automatically, semi-automatically, or manually.
[0304] In step 482C, the planning system 10 may be configured to generate one or more anatomical models 29. The anatomical model 29 may include one or more bone models 30. The bone models 30 may each represent corresponding bones, including any bones disclosed herein, such as the scapula and the humerus. The anatomical model 29 may include information specifying the relative positions of the bone models 30. A three-dimensional (3D) mesh of related bones (e.g., the scapula and the humerus) may be reconstructed.
[0305] In step 482D, the orientation of one or more (e.g., first) bones, such as the scapula, may be determined. The bones may be associated with an anatomical model, such as the anatomical model 329 in Figure 34. The anatomical model 329 in Figure 34 may be associated with the anatomical model 329 in Figure 28. The bones may be associated with their respective corresponding bone models, such as the scapula model 330S. Various techniques for determining the orientation of the scapula may be used, including any techniques disclosed herein.
[0306] Step 482D may include defining a global reference system in Step 482D-1. The global reference system may be defined using any of the technologies disclosed herein.
[0307] The orientation of bones such as the scapula may be determined by measurement or otherwise by utilizing a variety of techniques, including any techniques disclosed herein. The planning system 10 may be configured to measure or otherwise determine the orientation of bones by performing any techniques disclosed in each step of method 382.
[0308] Various techniques may be used to determine the orientation of bones related to the anatomical model in step 482D. Referring to Figures 35-36, with continued reference to Figures 2, 4, and 33, an anatomical model 429 according to another embodiment is disclosed. Step 482D may include determining the orientation of a bone model 430 (e.g., scapula) based on one or more predetermined correlations to anatomical landmarks and / or to the anatomical structures of one or more other patients and / or to the anatomical structures of a representative patient population in step 482D-2. The representative patient population may exclude patients. The predetermined correlations may be established to anatomical landmarks and / or to SSM / numerical composition classifications. SSM / numerical composition classifications may be established using any techniques disclosed herein. In embodiments, a global reference system may be established in step 482D-1 using any techniques disclosed herein.
[0309] 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 an anatomical structure. The second set of bone models 30 may be associated with a second bone of an anatomical structure. The bone models 30 in the first set and the second set may be associated with a common anatomical model 29 of the patient.
[0310] A representative patient population bone model 30 and associated bones may be associated with one or more statistical shape models (SSMs) 75. In embodiments, two or more adjacent and / or non-adjacent bones associated with bone model 30 may be associated with the same SSM 75. The planning system 10 may be configured to determine the position, alignment, and / or angles of bones associated with corresponding bone models, based on the geometry of one or more other bones, including adjacent and / or non-adjacent bones of the patient, and based on the associated bone model and / or anatomical model. Step 482D-2 may include analyzing a representative patient population within the SSM 75. The planning environment 28 may be configured to analyze a representative patient population within the associated SSM 75. The SSM 75 may be established based on a statistically significant number of past cases to characterize the variability of associated bones in anatomical structures. In embodiments, the SSM75 may be established based on at least 100 to 1,000 prior cases, or more rigorously, at least 10,000 to 20,000 prior cases. The statistical shape modeler 72 may be configured to create multiple anatomical body size classifications 80 based on multiple predefined modes (e.g., variability modes) 76 within the statistical shape model 75. The statistical shape modeler 72 may be configured to accept one or more predefined modes 76 as input. The predefined modes 76 can characterize anatomical differences within a representative patient population and the standard deviation 78 of the anatomical variances contained within each predefined mode 76. The statistical shape modeler 72 may be configured to assign the anatomical body size classifications 80 to the bone model 30. The storage system 18 may be configured to store the anatomical body size classifications 80. Step 482D-2 may include identifying the predefined modes 76 within the SSM75 for a representative patient population.
[0311] The predefined modes 76 that may be provided to the statistical shape modeler 72 may include, but are not limited to, any predefined modes disclosed herein, including the size and / or bone portion of a bone (e.g., scapula, glenoid cavity, humerus, humeral head, shaft, etc.), inclination, rotation, retroversion (e.g., retroversion of the humerus), projection of the glenoid cavity and sagittal neck length, angle of the glenoid cavity relative to the scapular neck, critical shoulder joint angle, projection of the acromion and / or coracoid, varus / valgus of the humeral head, anatomical landmarks, joint cavity, preoperative range of motion, any combination of the above, etc. In embodiments, the predefined modes 76 related to the scapula and humerus may be the same or different. The number of predefined modes 76 may be selected based on the variability associated with individual modes and / or combinations of modes. The variability of the modes may differ based on the selected anatomical structure. The predefined modes 76 may include postural modes related to the patient's posture. Postural modes may be established based on two or more adjacent and / or non-adjacent bones of an anatomical structure. In embodiments, the predefined mode 76 may omit the patient's posture.
[0312] Referring to Figures 36 and 45, continuing with reference to Figures 2, 4, 33, and 35, Method 482 may include accessing a first patient three-dimensional model 430S-1 / 530S-1 from memory. The first patient model 430S-1 / 530S-1 may be associated with a first bone of the patient. Method 482 may also include accessing a second patient three-dimensional model 430H-1 / 530H-1 from memory. The second patient model 430H-1 / 530H-1 may be associated with a different second bone of the patient. The statistical shape modeler 72 may be configured to select a first representative (e.g., scapula) three-dimensional bone model (e.g., 530S-2 in Figure 45) and / or a second representative (e.g., humerus) three-dimensional bone model 430H-2 / 530H-2, associated with representative anatomical models 429-2 / 529-2, in response to a change in one or more of the predefined modes 76 within the SSM 75. The selection of anatomical models 429-2 / 529-2 may be performed in response to a change in one or more of the predefined modes 76 within the SSM 75.
[0313] The statistical shape modeler 72 may be configured to assign an anatomical physique classification 80 associated with a first representative model 530S-2 to a first patient bone model 430S-1 / 530S-1. The statistical shape modeler 72 may be configured to assign an anatomical physique classification 80 associated with a second representative model 430H-2 / 530H-2 to a second patient bone model 430H-1 / 530H-1. The range of motion modeler 101 may be configured to perform range of motion simulations with respect to the assigned anatomical physique classification 80 for each corresponding bone. The statistical shape modeler 72 may be configured to assign an anatomical physique classification 80 to bone models 430S-1 / 530S-1 and / or 430S-2 / 530S-2 based on the posture mode. The statistical shape modeler 72 and / or comparison module 52 may be configured to determine one or more postural parameters related to a patient's posture based on an anatomical body size classification 80 related to a representative model 430S-2 / 530S-2 of the scapula and / or a second representative model 430H-2 / 530H-2 of the humerus, such as related to another patient in a representative patient population.
[0314] The orientation of the selected bone model 430 / 530 for the patient may be measured based on SSM75. In embodiments, the orientation of the scapula of the scapula model 530S in 3D space may be measured based on SSM75 associated with the scapula. In embodiments of Figures 36 and 45, the scapula model 430S-1 / 530S-1 and the humerus model 430H-1 / 530H-1 may be associated with the patient's anatomical model 429-1 / 529-1. The scapula model 430S-2 / 530S-2 and the humerus model 430H-2 / 530H-2 may be representative bone models associated with a representative anatomical model 429-2 / 529-2 for another patient in a representative patient population.
[0315] The anatomical body size classification database 70 may include coordinate information related to the position of each bone model 30 within the global reference system and / or within the corresponding acquisition reference system. By utilizing the scapula SSM75, a bone model 30 associated with the anatomical body size classification database 70 that is closest to the anatomical structure contained in the corresponding bone model 430 / 530 may be selected. The selected bone model 30 may be associated with the corresponding AMC80. One or more postural parameters associated with the selected bone model 30, such as scapular angle, may be predetermined.
[0316] The comparison module 52 may be configured to select the first representative model 530S-2 from the first set of bone models 30 in response to a comparison of the first representative bone model 530S-2 with the first patient bone model 430S-1 / 530S-1 associated with the patient's first bone, such as the scapula. The first representative model 530S-2 may be associated with the second representative model 430H-2 / 530H-2 of the second set of bone models 30. The first patient model 430S-1 / 530S-1 and the second patient model 430H-1 / 530H-1 may establish a first spatial relationship with each other. The second patient model 430H-1 / 530H-1 may be associated with the patient's second bone, such as the humerus. The first representative bone model 530S-2 and the second representative bone model 430H-2 / 530H-2 may establish a second spatial relationship. The first and second bones may be adjacent or non-adjacent bones, including any bones disclosed herein. The first and second spatial relationships may be based on one or more markers associated with the first and / or second bones, including any markers disclosed herein.
[0317] The comparison module 52 may be configured to determine at least one or more patient characteristics related to the patient's first and / or second bones in response to a comparison of the first spatial relationship with the second spatial relationship. The patient characteristics may be associated with the patient's posture. The comparison module 52 may be configured to establish an implant plan based on the patient characteristics. The spatial module 50 may be configured to determine the (e.g., spatial) deviation between the first spatial relationship established by patient bone models 430S-1 / 530S-1, 430H-1 / 530H-1 and the second spatial relationship established by representative bone models 530S-2, 430H-2 / 530H-2 related to another patient in a representative patient population. The comparison module 52 may be configured to determine the patient characteristics based on the spatial deviation.
[0318] The comparison module 52 may be configured to compare the first representative bone model 430S-2 / 530S-2 with the patient bone model 430S-1 / 530S-1 in response to the spatial module 50 fitting the volume of the first representative bone model 530S-2 with the volume of the patient bone model 430S-1 / 530S-1 to each other at least partially or substantially. The comparison module 52 may be configured to compare the second representative bone model 430H-2 / 530H-2 with the patient bone model 430H-1 / 530H-1 in response to the spatial module 50 fitting the volume of the representative bone model 430H-2 / 530H-2 with the volume of the patient bone model 430H-1 / 530H-1 to each other at least partially or substantially.
[0319] A transformation may be applied to the selected bone model 30. 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 to substantially align with the patient's scapula model 430S-1 / 530S-1 (see, for example, patient bone model 530S-1 and representative bone model 530S-2 in Figure 42). After completion, the orientation of the patient's scapula in the associated scapula model 430S-1 / 530S-1 may be calculated based on the transformation applied to the assigned bone model 30. In embodiments, the spatial module 50 may be configured to adjust the position of patient bone model 430S-1 and / or patient bone model 430H-1 based on determined patient characteristics.
[0320] The spatial module 50 may be configured to register a first patient bone model 430S-1 / 530S-1 and / or a second patient bone model 430H-1 / 530H-1 from a local reference system to a global reference system based on determined patient characteristics. The planning environment 28 may be configured to establish a surgical plan within the global reference system related to the scapular patient bone model 430S-1 / 530S-1 and / or the humeral patient bone model 430H-1 / 530H-1.
[0321] Step 482D-2 may include selecting anatomical three-dimensional model 429-2 / 529-2 from a plurality of three-dimensional anatomical models 29 based on the first patient model 430S-1 / 530S-1 and the second patient model 430H-2 / 530H-2. The anatomical model 29 may be associated with one or more bones and / or one or more joints of a representative patient population. The anatomical model 29 may be associated with the first and second bones of a representative patient population. The selection of anatomical model 429-2 / 529-2 may be done in response to fitting bone models 530S-2 and 430H-2 / 530H-2 of anatomical model 429-2 / 529-2 to their corresponding patient bone models 430S-1 / 530S-1 and 430H-1 / 530H-1 of anatomical model 429-1 / 529-1, respectively, at least partially within the same reference system.
[0322] In step 482E, the patient's posture relative to the anatomical model 429 may be determined. The posture may be determined based on the orientation of the scapular model 430S / 530S relative to the anatomical model 429 / 529. Step 482E may include determining one or more characteristics related to the patient's posture based on the selected anatomical model 429-2 / 529-2. In embodiments, step 482E may be omitted.
[0323] Method 482 may include predicting or otherwise determining the position, alignment, and / or angle of a bone (e.g., humerus) associated with a corresponding bone model, based on the geometry of one or more other bones (e.g., scapula), including adjacent and / or non-adjacent bones of the patient, and based on the associated bone model and / or anatomical model. In step 482F, the initial anatomical position of another (e.g., a second) bone of an anatomical structure associated with anatomical model 429, such as the humerus associated with humerus model 430H / 530H, may be determined. Various techniques, including any techniques disclosed herein, such as the technique disclosed in step 482D, may be used to determine the initial anatomical position of the humerus. The initial anatomical positions of other bones (e.g., humerus) may be determined based on the posture determined in step 482E. In embodiments, the initial anatomical position of the humerus may be based on the bone's relationship to a (e.g., global) reference system and / or to one or more motion planes and / or axes of the patient, and determining the patient's posture may be omitted. Although the technique of step 482F primarily refers to the humerus relative to the scapula, it will be understood that this technique can be used with respect to any two anatomically adjacent and / or non-adjacent bones. In embodiments, step 482D may be used to determine the orientation of the humerus, and step 482E may be used to determine the orientation of the scapula.
[0324] Step 482F may include determining the initial anatomical position of other bone models 430 / 530, such as humeral model 430H-1 / 530H-1, based on anatomical SSM75 associated with two or more anatomical bones (e.g., scapula and humerus). Step 482F-1 may include determining the initial anatomical position of humeral model 430H-1 / 530-1 relative to selected bone model 30 associated with AMC80 assigned to scapular model 430S-1 / 530-1. Bone models 430H-2 / 530H-2 assigned to humeral model 430H-1 / 530H-1 may be associated with the same patient as bone model 530S-2 assigned to scapular model 430S-1 / 530S-1. The initial anatomical positions may be determined based on the relative positions between the corresponding bone models.
[0325] The humerus model 430H-1 / 530H-1 may be associated with the same patient as the scapula model 430S-1 / 530S-1. The representative humerus model 430H-2 / 530H-2 may be associated with a different patient, including an actual patient related to a past case, or a hypothetical patient. The humerus model 430H-2 / 530H-2 may be assigned based on SSM75 using any of the techniques disclosed herein. In embodiments, the planning system 10 may determine one or more bone-related landmarks based on the assigned bone model 430H-2 / 530H-2 associated with SSM75.
[0326] Continuing to refer to Figures 2, 4, and 33, and further referring to Figures 35-36, one or more parts of a bone may be omitted from the image data associated with image 26. The distal portion of a long bone, such as the humerus, may be included in the image and / or in the humerus model of the anatomical structure (see, for example, humerus model 330H in Figure 34). Another part of a bone, such as the distal (or proximal) portion of humerus model 430H, may be omitted from the image data and / or from the humerus model. The planning system 10 may be configured to determine the initial anatomical positions of other adjacent and / or non-adjacent bones (e.g., humerus) in the anatomical model 429 based on the completeness of the acquired information.
[0327] In step 482F-1, determining the initial anatomical position of other bones, such as the humerus, may include determining the geometry and / or orientation of the omitted portion of the bone in step 482F-2. Step 482F-2 may include determining the geometry and / or orientation of the omitted portion based on the bone-associated SSM75. System 10 may be configured to predict or calculate the distal portion of the humerus based on the humerus SSM75. In embodiments, the SSM75 may be associated with two or more bones adjacent to and / or not adjacent to an anatomical structure, such as the scapula and the humerus. In embodiments, the humerus SSM75 may be used to select a representative bone model 430H-2 associated with an anatomical body size classification database 70 that is closest to the anatomical structure associated with the patient's (e.g., partial) bone model 430H-1. The planning system 10 may be configured to replace the patient's humerus model 430H-1 with a bone model 430H-2 corresponding to the assigned AMC 80. The representation of the omitted portion of the bone may be established by a selected bone model 30 associated with the statistical shape model 75, such as the humerus model 430H-2.
[0328] The planning system 10 may be configured to associate the patient's anatomical model 429-1 with two or more examples of bone models 430 related to the same bone of the anatomical structure in order to establish representations of omitted portions of the bone, such as the patient bone model 430H-1 and the representative bone model 430H-2. The planning system 10 may be configured to determine the geometry and / or orientation of the omitted portion of the bone using any techniques disclosed herein. Step 482F-2 may include determining the geometry and / or orientation of the omitted (e.g., distal) portion of the humerus based on the representative humerus model 430H-2.
[0329] Referring to Figures 36 and 37A-37B, continuing with reference to Figures 2 and 33, the spatial module 50 may be configured to orient the humerus models 430H-1 and 430H-2 relative to each other. The spatial module 50 may be configured to align the bone models 430H-1 and 430H-2 relative to each other using any of the techniques disclosed herein. The spatial module 50 may be configured to reorient or otherwise move the bone models 430H-1 and 430H-2 together with respect to the other bone model 430 and / or a reference point (e.g., the origin) of the reference system to determine the initial anatomical positions of the related bones (see, for example, Figures 38A-38B). The spatial module 50 may be configured to reorient or otherwise move the bone models 430H-1 and 430H-2 by applying a predetermined transformation. In an embodiment, the spatial module 50 may be configured to reorient or otherwise move a representative bone model 430H-2, rather than the patient bone model 430H-1, in order to determine the initial anatomical position of the humerus. In an embodiment, the planning system 10 may be configured to determine one or more markers related to the omitted portion of the bone based on the assigned representative bone model 430H-2 associated with the SSM75.
[0330] System 10 may be configured to calculate the initial anatomical positions of adjacent or non-adjacent bones, such as the humerus. In the embodiments of Figures 37A-37B and 38A-38B, System 10 may be configured to align the shaft of the humerus model 430H with respect to the Z-axis of the global reference system by rotating the shaft around the center of the humeral head. System 10 may also be configured to align the epicondyle axis of the humerus with respect to the coronal plane of the scapula model 430S by applying external or internal rotation.
[0331] The display module 48 may be configured to display a representation of the omitted portion within the display window 460 of the user interface 456. The display module 48 may be configured to display the humerus models 430H-1 and 430H-2 superimposed on each other within the display window 460. In the embodiment, a surgeon or clinical user may selectively observe the first humerus model 430H-1 and / or the second humerus model 430H-2 within the display window 460 by interacting with the user interface 456.
[0332] The system 10 may be configured to automatically create a preoperative surgical plan 36 (Figure 2) based on the anatomical scapular position and / or the anatomical humeral position. The preoperative plan 36 may specify various parameters (e.g., implant type, size, and orientation). The surgical plan 36 may include an implant plan associated with one or more implants to treat the patient.
[0333] In step 482G, the position and / or orientation of one or more implant models 432 may be determined. The implant models 432 may include a first (e.g., glenoid) implant model 432G and / or a second (e.g., humerus) implant model 432H. The implant models 432G and 432H may be configured to engage with each other. System 10 may be configured to determine the optimal implant position based on the predicted posture which may be determined in step 482E. System 10 may be configured to establish an implant plan based on one or more postural parameters which may be determined using any of the techniques disclosed herein. Step 482G may include establishing an implant plan related to the patient's first and / or second bones in response to the determination of patient-related characteristics such as posture. Step 482G may include applying a correction factor to the default implant position and / or orientation based on the determined postural characteristics. The correction factor may be established based on a specific postural value (e.g., scapular angle). Determining the implant position in step 482G may be based on the relationships between two or more adjacent and / or non-adjacent bones, which may be predicted or otherwise determined using any of the techniques disclosed herein, and this may be done in addition or alternatively to determining the patient's posture.
[0334] In step 482H, range of motion related to one or more bones of the anatomical structure may be determined. The range of motion may be based on the position and / or orientation of the implant model 432 determined in step 482F. In embodiments, retroversion of the humeral implant related to the humeral implant model 432H may be adjusted to improve the clinical range of motion. The range of motion modeler 101 and / or another part of the planning environment 28 may be configured to perform a range of motion simulation based on one or more patient characteristics that can be determined using any of the techniques disclosed herein. Based on the anatomical scapular posture, the initial position of the anatomical humerus, and / or the selected implant (e.g., type, size, and orientation), the system 10 may be configured to predict or calculate the range of motion result for the current patient related to the patient's anatomical model 429-1.
[0335] Other techniques may be used to determine the geometry and / or orientation of the omitted portion of a bone, and / or to determine the initial anatomical position of the bone. The planning system 10 may be configured to predict or otherwise determine the geometry and / or orientation of the omitted portion of a bone, including the distal or proximal portion of a long bone such as the humerus. In embodiments, the system 10 may be configured to determine the geometry and / or orientation of a bone, such as being related to the omitted bone information or incomplete bone information, based on its relationship to other adjacent and / or non-adjacent bones, such as the scapula. The predicted geometry and / or orientation of the omitted portion of a bone may be used to determine the patient's pre-morbid anatomical structure. The predicted geometry and / or orientation of the omitted portion of a bone may be used to determine the patient's posture, including the pre-morbid length of a long bone such as the humerus, and the position and / or orientation of related joints, such as the patient's elbow. Information regarding the predicted geometry and / or orientation may be used to establish a patient bone-related implant plan, including adjusting the default initiation position and / or orientation of the implant.
[0336] Figure 39 discloses a method for a surgical procedure in flowchart 582. Method 582 may be used to preoperatively plan, perform, evaluate, and / or verify various aspects of surgical procedures, such as arthroplasty to restore function to the shoulder, ankle, knee, hip, and other joints. Method 582 may be used in conjunction with any planning system and method, virtual anatomical models, and / or bone models, such as planning system 10, as disclosed herein. Method 582 may be used to predict or otherwise determine the geometry and / or orientation of a omitted portion of a bone, including the distal or proximal portion of a long bone such as the humerus. The bone orientation may be associated with the patient's posture. In embodiments, Method 582 may be used to predict or otherwise determine the position, alignment, and / or angle of a bone related to the omitted portion based on the geometry of one or more other bones, including adjacent and / or non-adjacent bones of the patient, which may additionally or alternatively be done to determine the patient's posture. Within the scope of this disclosure, fewer steps or additional steps may be performed compared to those described below, and the order in which the steps are described is not intended to limit this disclosure. Method 582 may incorporate any step in Method 382 and / or Method 482 disclosed herein, and vice versa. In embodiments, the steps of Method 582 may be incorporated into step 482F of Method 482 (Figure 33). Refer to System 10.
[0337] Referring to Figure 40, continuing with reference to Figures 2 and 39, Method 582 may include accessing one or more three-dimensional bone models 530 from memory, such as a database 38 and / or a storage device 18. The bone models 530 may be associated with real or virtual patients, including patients from a representative patient population.
[0338] Method 582 may include receiving patient-related imaging data in which a portion of the patient's bone may be omitted. The planning environment 28 may be configured to receive patient-related imaging data in which a portion of the bone may be omitted. Such portions may be omitted due to the acquired field of view of the associated imaging device 16, bone trauma, etc.
[0339] Referring to Figures 41 and 45, with continued reference to Figures 2 and 39, the bone model 530 may include a first bone model 530S-1 related to the patient's first bone. The bone model 530 may also include a second bone model 530H-1 related to the patient's second bone (see, for example, Figure 45). The first and second bones may be adjacent or non-adjacent bones, including any bones disclosed herein, such as the scapula and the humerus. In the embodiment of Figure 41, the bone model 530 may be a first (e.g., scapula) bone model 530S-1 related to the patient's scapula. In other embodiments, the bone model 530 may be a second (e.g., humerus) bone model 530H-1 related to the patient's humerus (see, for example, Figure 45). The humerus model 530H-1 may be a partial three-dimensional bone model related to a portion of the patient's humerus, such as the proximal (or distal) humerus.
[0340] Method 582 may include generating a partial humerus model 530H-1 based on image data, which may omit parts of the corresponding bones of the patient. The spatial module 50 may be configured to generate a partial bone model 530H-1 based on image data. The comparison module 52 may be configured to select a scapula model 530S-1 and / or a partial humerus model 530H-1 associated with the patient's first and second bones.
[0341] Referring to Figures 41 and 44-45, continuing with reference to Figures 2 and 39, the planning environment 28 may be configured to compare bone models 530S-1 and 530H-1 with one or more bone models 30 associated with other patients, including patients from a representative patient population. Bone model 530 may include a first representative three-dimensional bone model 530S-2 and / or a second representative three-dimensional bone model 530H-2 associated with another patient. Bone model 530S-2 may be associated with the scapula. Bone model 530H-2 may be associated with the humerus. A partial bone model 530H-1 of a patient may represent a smaller portion of the second bone compared to a representative bone model 530H-2 of another patient.
[0342] In step 582A, one or more bone models 530 of the patient's anatomical structure, including the patient's bone models 530S-1, 530H-1 and / or representative bone models 530S-2, 530H-2, may be registered or otherwise aligned to a global reference system. The global reference system may be defined in step 582A-1. The global reference system may be defined using any of the techniques disclosed herein, and the bone models 530 may be aligned to the global reference system.
[0343] Referring to Figure 42, with continued reference to Figures 2, 4, 39, and 41, in step 582B, the representative bone model 530S-2 may be selected from a set of bone models 30 associated with the first bone of an anatomical structure. The set of bone models 30 may be associated with the first bone of a representative patient population, such as the scapula. The comparison module 52 may be configured to select the representative bone model 530S-2 from a set of bone models 30 associated with the first bone of an anatomical structure. Various techniques may be used to select one or more representative bone models 530S-2 from the set of bone models 30 (e.g., initial or refined). Method 582 may also include analyzing a representative patient population in a statistical shape model 75. In embodiments, the statistical shape modeler 72 may be configured to analyze a representative patient population in a statistical shape model 75 associated with corresponding bones, utilizing any of the techniques disclosed herein.
[0344] In embodiments, step 582B may include selecting a representative (e.g., initial) bone model 530S-2 associated with SSM75. SSM75 may be associated with the scapula and / or the humerus. Step 582B may also include selecting a representative bone model 530S-2 from a set of bone models 30 associated with corresponding bones in a representative patient population, such as the scapula. The representative scapular model 530S-2 may be associated with a different patient or may represent a hypothetical anatomical structure. The representative scapular model 530S-2 may be selected based on various parameters, such as the relative size between the patient scapular model 530S-1 and the representative scapular model 530S-2.
[0345] Referring to Figures 42-43, and continuing with Figures 2, 4, and 39, the statistical shape modeler 72, and / or another part of the planning system 10, may be configured to modify one or more predefined variation modes 76 to minimize or otherwise reduce the volume deviation between the patient scapula model 530S-1 and the selected representative scapula model 530S-2. The statistical shape modeler 72 may be configured to select the representative scapula model 530S-2 in response to a modification of one or more of the predefined modes 76. The predefined modes 76 may include a first variation mode 76 (e.g., mode 761 in Figure 5). The first variation mode 76 may be associated with corresponding bone sizes. In embodiments, the statistical shape modeler 72 may be configured to modify the first variation mode 76 to select a representative scapula model 530S-2 that can be substantially equivalent to, or otherwise approximate, the geometry (e.g., size) of the patient's scapula model 530S-1. In embodiments, step 582B may include modifying one or more modes 76, such as the first mode, in step 582B-1 to minimize or otherwise reduce the volume deviation between the patient's scapula model 530S-1 and the representative scapula model 530S-2 selected from a set of bone models 30 associated with the SSM 75. The statistical shape modeler 72 may further be configured to iteratively select bone model 30 / 530S-2 from a set of bone models 30 and determine the corresponding volume deviations.
[0346] The statistical shape modeler 72 and / or spatial module 50 may be configured to determine the volume deviation between each of the patient scapula model 530S-1 and representative scapula models 530S-2 selected from a set of bone models 30 associated with the scapula SSM 75. The statistical shape modeler 72 and / or comparison module 52 may be configured to select a representative scapula model 530S-2 from the set of bone models 30 based on the determined volume deviation.
[0347] Various techniques may be used to determine the minimum volume deviation between the patient bone model 530 and a set of bone models 30 associated with the corresponding bone SSM 75. In embodiments, the statistical shape modeler 72 may be configured to evaluate one or more bone models 30 against the patient bone model 530S-1 in response to a change in the first variation mode 76 over a predefined range of standard deviations 78 associated with the first mode 76 (e.g., a standard deviation of -3.0 to 3.0). For each value of the first mode 76, the spatial module 50 may be configured to determine the deviation between one or more dimensions of the corresponding orientation constraint boxes (OBBs) (shown as dashed lines in Figure 40) of the patient bone model 530S-1 and a selected representative bone model 530S-2 (e.g., Figure 42). The OBBs may have two-dimensional or three-dimensional geometry. The comparison module 52 may be configured to select a representative bone model 530S-2 from a set of bone models 30, such that the difference between the OBB dimensions is minimized or otherwise reduced, including the first dimension D1 (e.g., maximum length) and / or second dimension D2 (e.g., maximum width) of the bone models 530S-1 and 530S-2, and is related to a value of standard deviation 78 that can minimize or otherwise reduce the difference between the OBB dimensions. In embodiments, the maximum length may be established in the upper / lower direction of the anatomical structure. In embodiments, the comparison module 52 may be configured to identify a subset of bone models 30 having deviations below a predefined threshold, which may be used for subsequent selection and / or adjustment based on one or more predefined modes 76 (see, for example, step 582D-1).
[0348] Referring to Figure 42 with continued reference to 2 and 39, in step 582C, a representative (e.g., second) bone model 530S-2 may be registered, or otherwise substantially aligned or fitted, to a patient (e.g., first) bone model 530S-1 in order to establish the registration state of the representative bone model 530S-2. The spatial module 50 may be configured to register the representative bone model 530S-2 at least partially to the patient bone model 530S-1 in order to establish the registration state (e.g., position) of the representative bone model 530S-2. The spatial module 50 may be configured to register a selected representative bone model 530S-2 to the patient bone model 530S-1 using any of the techniques disclosed herein.
[0349] Various techniques may be used to adjust the position of the representative bone model 530S-2 relative to the patient bone model 530S-1 by registration or other means. Referring to Figure 41, with continued reference to Figures 2 and 39, step 582C may include aligning one or more common anatomical points (e.g., landmarks) PL between the patient bone model 530S-1 and the representative bone model 530S-2 in step 582C-1. The anatomical point PL may include any anatomical points disclosed herein (see, for example, points P1-P3 in Figure 29). The anatomical point PL may include a set of points such as points P1, P2, and P4. The first point P1 may be established at the center of the glenoid fossa. The second point P2 may be established at the scapular triangle. Point P4 may be established at the suprascapular angle.
[0350] Referring to Figure 42, with continued reference to Figures 2, 39, and 41, in step 582C-2, the position and / or orientation of the representative bone model 530S-1 may be adjusted based on the degree of fit between the volume of the patient bone model 530S-1 and the volume of the representative bone model 530S-2 in order to establish the registered state (e.g., position) of the representative bone model 530S-2. The spatial module 50 may be configured to fit the volume of the patient's scapula model 530S-1 and the volume of the selected representative bone model 530S-2 to each other. The spatial module 50 may be configured to determine a transformation that establishes the best-fit mapping between defined anatomical points PL (Figure 41). The best-fit mapping may be established using the least squares method. The spatial module 50 may be configured to approximate the shapes of bone models 530S-1 and 530S-2 with each other and / or to fit the volumes of those bone models with each other by applying the Repeated Nearest Neighbor (ICP) technique.
[0351] Referring to Figure 43, with continued reference to Figures 2, 39, and 41-42, the degree of fit between the patient bone model 530S-1 and the representative bone model 530S-2 may be improved by refining (e.g., minimizing) the registration state (e.g., position) of the representative bone model 530S-2. In step 582D, subsequent (e.g., refined) selection and / or positional adjustment of the representative bone model 530S-2 from a set of bone models 30 may be performed. The representative bone model 530S-2 selected and / or positioned in step 582D may be the same as or different from the representative bone model 530S-2 previously selected from a set of bone models 30 in step 582B.
[0352] Subsequent selection and / or adjustment may be made by utilizing various techniques. Step 582D may include modifying one or more other variation modes 76 associated with the SSM75 in step 582D-1, including any mode 76 disclosed herein. In embodiments, the first mode 76 of the SSM75 may be associated with the location of an anatomical structure. The remaining modes 76 of the SSM75 may be associated with the shape of an anatomical shape and may be constrained to the (e.g., registered) location of the anatomical shape associated with the first mode 76. In embodiments, the statistical shape modeler 72 may be configured to modify the first (e.g., eight) variation modes 76 of the SSM75. It will be understood that more or fewer variation modes 76 than eight may be available. Modifying fewer variation modes 76 of the SSM75 may reduce computation time, while modifying more variation modes 76 may improve accuracy. In embodiments, the first eight variation modes 76 may be associated with about 85 percent of the variation of the SSM75. The order of modes 76 may be associated with the relative variability of SSM 75 (e.g., the first mode is considered to have the maximum variability, and the last mode to have the minimum variability). The variability modes 76 associated with the first bone (e.g., the scapula) may be the same as the variability modes 76 associated with the second bone (e.g., the humerus). The statistical shape modeler 72 may be configured to modify the same or different number of modes 76 with respect to the relevant bones of the anatomical structure. The statistical shape modeler 72 may be configured to restrict subsequent selections to a subset of the bone model 30 based on a limited range (e.g., within ±1SD) of the standard deviation 78 from the corresponding mode values of the previously selected representative bone model 530S-2. The statistical shape modeler 72 may utilize various techniques for evaluating modes 76, such as Simplex Nelder-Mead optimization (e.g., Amoebah Search) techniques.In embodiments, step 582D-1 may include changing only the variation mode 76 related to the position and / or orientation of the representative bone model 530S-2 previously selected in step 582B, including any variation modes disclosed herein.
[0353] The comparison module 52 may be configured to select a representative bone model 530S-2 from a set of bone models 30 (or a subset thereof) in response to determining a volume deviation (e.g., the smallest) within a set of volume deviations. The set of volume deviations may be established between the patient's scapula model 530S-1 and the corresponding representative bone models 530S-2 selected from the set of bone models 30 in response to the statistical shape modeler 72 changing one or more of the predefined modes 76 in the SSM 75.
[0354] Referring to Figure 44, with continued reference to Figures 2, 39, and 41-43, in step 582E, a second (e.g., initial) representative bone model 530H-2 associated with the second bone may be selected or otherwise identified. The selected representative bone models 530S-2, 530H-2 may be associated with the same anatomical model 529-2 and / or with the same patient. Step 582E may include accessing multiple three-dimensional bone models 30 associated with one or more bones and / or one or more joints in a representative patient population. Step 582E may include selecting a representative bone model 530H-2 from a set of representative bone models 30 associated with corresponding bones in a representative patient population, such as the humerus. The comparison module 52 may be configured to select a representative bone model 530H-2 from a set of representative bone models 30.
[0355] The comparison module 52 may be configured to select a representative bone model 530H-2 based on a selected representative model 530S-2 associated with the first bone. The selected representative bone model 530H-2 may include an omitted portion of the second bone. The partial bone model 530H-1 of the patient may omit the distal portion of the humerus. The representative bone model 539H-2 may include the distal portion of the humerus.
[0356] The comparison module 52 may be configured to select a representative bone model 530H-2 from a set of representative bone models 30 associated with a representative patient population, or otherwise identify it, based on the selected representative bone model 530S-2 (e.g., in steps 582B and / or 582D), and vice versa. The comparison module 52 may be configured to select a representative bone model 530H-2 from a set of bone models 30 in response to establishing the registration status (e.g., location) of the selected representative bone model 530S-2.
[0357] Step 582E may include selecting a representative bone model 530H-2 from a set of representative bone models 30 in response to the selection of a representative bone model 530S-2 in step 582B (for example, initially), establishing the registration status of the selected representative bone model 530S-2 in step 582C, and / or refining the position and / or selection of the representative bone model 530S-2 from the set of representative bone models 30 in step 582D.
[0358] Referring to Figure 45, with continued reference to Figures 2, 39, and 41-44, in step 582F, the registration status (e.g., position) of the patient bone model 530H-1 may be established by at least partially aligning (e.g., registering) the patient's partial bone model 530H-1 with respect to a selected representative bone model 530H-2. The partial bone model 530H-1 may be associated with a long bone such as the humerus. The bone models 530H-1 and 530H-2 may each include a corresponding diaphysis portion 530HD related to the diaphysis of a long bone, and / or a head portion 530HH related to the head of a long bone. The spatial module 50 may be configured to establish the registration status of the partial bone model 530H-1 by registering, at least partially, the diaphysis portion 530HD-1 of the partial bone model 530H-1 with respect to the diaphysis portion 530HD-2 of the representative bone model 530H-2, or by aligning it in other ways.
[0359] A partial bone model 530H-1 of the patient may be registered using various techniques. Step 582F may include aligning one or more markers of the partial bone model 530H-1, or other points of the partial bone model 530H-1, with respect to a representative bone model 530H-2 in step 582F-1. The markers may include the center point 530CP of the head portion 530HH. Step 582F-1 may also include substantially aligning the center point 530CP-1 of the head portion 530HH-1 of the partial bone model 530HH-1 with the center point 530CP-2 of the head portion 530HH-2 of the representative bone model 530HH-2. Step 582F may include rotating the partial bone model 530H-1 of the patient with respect to the representative bone model 530H-2 in step 582F-2, which may be performed following step 582F-1. Step 582F-2 may include rotating the head portion 530HH-1 of the partial bone model 530H-1 around the corresponding center point 530CP in order to at least partially register the partial bone model 530H-1 with respect to the representative bone model 530H-2. In embodiments, the spatial module 50 may be configured to approximate the shapes of the bone models 530H-1 and 530H-2 with respect to each other and / or to fit the volumes of the bone models with respect to each other by applying the Iterative Nearest Neighbor (ICP) technique.
[0360] To improve the overall fit between patient bone models 530S-1 and 530H-1 and representative bone models 530S-2 and 530H-2, relationships between two or more bones of an anatomical structure may be utilized. The selected representative bone models 530S-2 and 530H-2 may be associated with the patient's corresponding representative anatomical (e.g., shoulder) model 529-2. By registering the selected representative bone models 530S-2 and 530H-2 with respect to patient bone models 530S-1 and 530H-1, the registration status (e.g., position) of the representative anatomical model 529-2 with respect to the patient (e.g., shoulder) anatomical model 529-1 may be established. In some embodiments, the planning environment 28 may be configured to register a representative anatomical model 529-2 with respect to patient anatomical model 529-1, or otherwise substantially align it, in order to improve the overall fit between patient bone models 530S-1 and 530-2 and their corresponding representative bone models 530S-2 and 530H-2, respectively.
[0361] In step 582G, subsequent (e.g., refined) selection and / or repositioning may be performed with representative bone models 530S-2, 530H-2 associated with representative anatomical model 529-2 in order to improve the overall fit between patient anatomical model 529-1 and representative anatomical model 529-2. The representative anatomical model 529-2 selected in step 582G may be the same as or different from the representative anatomical model 529-2 associated with representative bone models 530S-2, 530H-2 previously selected in steps 582B, 582D, and / or 582E.
[0362] Various techniques may be used to select and / or reposition a representative anatomical model 529-2. The anatomical SSM 75 may be established with respect to an anatomical group consisting of two or more adjacent and / or non-adjacent bones of an anatomical structure. In embodiments, the anatomical SSM 75 may be established with respect to the shoulder, including the scapula and humerus. One or more variability modes 76 and associated standard deviations 78 may be established with respect to the anatomical SSM 75. The variability modes 76 and / or standard deviations 78 may be the same as or different from the variability modes 76 and / or standard deviations 78 of individual bones associated with an anatomical bone group. The statistical shape modeler 72 may be configured to assign AMC 80 to one or more anatomical models 29 according to the anatomical SSM 75.
[0363] In step 582G-1, in response to a change in one or more predefined modes 76 within the statistical shape model 72 associated with the anatomical SSM 75, a representative anatomical model 529-2 may be selected and / or repositioned. The statistical shape modeler 72 may be configured to fit the bone models 530S-2 and 530H-2 of the representative anatomical model 529-2 together (e.g., simultaneously) with the bone models 530S-1 and 530H-1 of the patient anatomical model 529-1. The statistical shape modeler 72 may be configured to reposition and / or select a representative anatomical model 529-2 from a set of anatomical models 29 in response to a change in one or more predefined modes 76 associated with the anatomical SSM 75. The comparison module 52 may be configured to select an anatomical model 529-2 from a set of anatomical models 29 in response to determining a set of volume deviations (e.g., the smallest) between a aligned patient bone model 530S-1, 530H-1 of the associated anatomical model 529-1 and one or more corresponding representative anatomical models 529-2 within a set of anatomical models 29. The set of volume deviations may be established between the patient anatomical model 529-1 and each of the corresponding representative anatomical models 529-2 in the set of anatomical models 29 in response to the statistical shape modeler 72 changing one or more predefined modes 76 of the anatomical SSM 75.
[0364] In embodiments, the statistical shape modeler 72 may be configured to modify the variation mode 76 and the associated standard deviation 78 in order to perform iterative position adjustments of previously selected anatomical models 529-2 and / or to select a representative anatomical model 529-2 within a set of anatomical models 29. The statistical shape modeler 72 may also be configured to calculate the corresponding distances between the faces of the patient anatomical model 529-1 and the faces of the representative anatomical model 529-2. The comparison module 52 and / or the statistical shape modeler 72 may determine a value (e.g., standard deviation) of the mode 76 such that the distance between the faces of the bone models 530S-2, 530H-2 of the selected representative anatomical model 529-2 and the faces of the bone models 530S-1, 530H-1 of the patient anatomical model 529-1 can be minimized or otherwise reduced.
[0365] The bone associated with the patient's partial bone model 530H-1 may be analyzed based on the registration status (e.g., position) of the representative bone model 530H-2. In step 582H, one or more postural parameters related to the patient's posture may be determined based on the registration status of the representative bone model 530H-2. The planning environment 28 may be configured to establish an implant plan in response to the establishment of the registration status of the representative bone model 530H-2 for the patient's partial bone model 530H-1. The implant plan may be established using any of the techniques disclosed herein. The implant plan may be established based on the determined postural parameters. Method 582 may include establishing an implant plan based on the registration status of the partial bone model 530H-2.
[0366] The geometry and / or orientation of other omitted parts of the anatomical structure may be predicted or otherwise determined. In the embodiments of Figures 46A-46B, the planning system 10 may acquire local image data related to one or more bones of the anatomical structure, such as a portion of the scapula associated with scapular model 630S-1. Scapular model 630S-1 may be associated with patient anatomical model 629-1. Parts of the scapula, such as the distal portion of the scapula including the inferior angle, may be omitted from the image data. The patient's humerus may also be omitted from the image data. By utilizing the techniques disclosed herein, including Method 582, a representative anatomical model 629-2, including associated scapular model 630S-2 and humerus model 630H-2, may be selected so that the omitted portions of the scapula and associated humerus are predicted or otherwise determined.
[0367] In the transplants shown in Figures 47A and 47B, the planning system 10 may acquire local image data related to a portion of the humerus associated with the humerus model 730H-1. The humerus model 730S-1 may be associated with the patient's anatomical model 729-1. A portion of the humerus, such as the distal portion of the humerus, may be omitted from the image data. The patient's scapula may also be omitted from the image data. By utilizing the techniques disclosed herein, including Method 582, a representative anatomical model 729-2, including the associated scapula model 730S-2 and the humerus model 730H-2, may be selected, thereby predicting or otherwise determining the omitted portions of the humerus and associated scapula.
[0368] Referring to Figures 48A-48C, continuing with Figure 2, the techniques disclosed herein, including any step of Method 582, may be used to determine one or more axes and / or other aspects related to the patient's anatomical structure. The axes may correspond to the corresponding bones, joints, and / or limbs of the anatomical structure, including any of those disclosed herein, such as the shoulder joint, ankle joint, hip joint, knee joint, elbow joint, and / or associated bones. In the embodiment of Figure 48A, the planning system 10 may acquire local image data related to one or more bones of the anatomical structure. Local image data can reduce acquisition costs and patient radiation exposure because it may omit parts of the anatomical structure.
[0369] The planning system 10 may establish an anatomical model 829 that includes one or more bone models 830. In the embodiment of Figure 48A, the anatomical model 829 may be associated with the knee joint. The bone models 830 may include a first (e.g., femur) bone model 830FE, a second (e.g., tibia) bone model 830T, and / or a third (e.g., fibula) bone model 830FI. The image data may include localized parts of anatomical structures, such as parts of the limb adjacent to the knee joint. One or more parts of anatomical structures, such as the proximal part of the femur associated with the femur model 830FE, the distal part of the tibia associated with the tibia model 830T, and / or the distal part of the fibula associated with the fibula model 830FI, may be omitted from the image data.
[0370] Referring to Figure 48B, with continued reference to Figures 2, 4, and 48A, the anatomical model 829 may be a first anatomical model 829-1 related to the patient. A representative anatomical model 829-2 related to an anatomical structure may be selected or otherwise specified. The representative anatomical model 829-2 and the associated bone model 830 may include bone portions omitted from the first anatomical model 829-1. The representative anatomical model 829-2 may be selected or otherwise specified from a set of representative anatomical models 29 (Figure 2) using any of the techniques disclosed herein. The planning system 10 may be configured to select the representative anatomical model 829-2 from a set of representative anatomical models 29 related to corresponding bones in a representative patient population, such as the femur, tibia, and / or fibula. In embodiments, the planning system 10 may be configured to select a representative anatomical model 829-2 using any techniques disclosed herein, including a statistical shape modeler 72. The representative anatomical model 29 may be associated with a statistical shape model (SSM) 75 (Figure 4).
[0371] The planning system 10 may be configured to register or, in other embodiments, substantially align with each other anatomical models 829-1, 829-2 and / or associated bone models 830 using any of the techniques disclosed herein. In the embodiment of Figure 48A, one or more anatomical points (e.g., landmarks) PL may be identified. The anatomical point PL may include a set of points such as points P5-P7. The anatomical point PL may be identified using any of the techniques disclosed herein, including in embodiments such as manually in response to user interaction with the user interface 856 and / or automatically by the planning system 10. The planning system 10 may be configured to substantially align with each other anatomical points PL that may be common between the patient bone model 830 and representative anatomical models 829-1 and 829-2 in order to establish the registration state (e.g., position) of representative anatomical model 829-2. The planning system 10 may be configured to minimize the distance between each corresponding pair of anatomical point PLs. One or more predefined variation modes 76 of the statistical shape model 75 related to anatomical shape may be modified to fit or otherwise approximate the shape of an anatomical structure.
[0372] By using the registered representative anatomical model 829-2, one or more aspects of the patient's anatomical structure may be determined. By using the bone model 830 associated with the representative anatomical model 829-2, the shape and / or orientation of the bone portions omitted from the registered patient anatomical model 829-1 may be predicted or otherwise determined. The relative positions and / or distances between landmarks associated with the omitted portions of the anatomical structure may be determined. In embodiments relating to the knee joint, extension and / or rotation may be determined by using the representative anatomical model 829-2. In embodiments relating to the ankle joint, internal / external rotation and / or varus / valgus of the bone may be determined by using a representative anatomical model that includes the corresponding omitted portions of the bone.
[0373] Referring to Figure 48C, continuing with Figures 2 and 48A-48B, the planning system 10 may be configured to determine one or more axes associated with the corresponding bones of the anatomical structures associated with the anatomical model 829, such as the anatomical axes and / or mechanical axes of the corresponding bones or limbs, based on the registration position of the bone model 330 of the representative anatomical model 829-2. The axes may include a mechanical axis A1, an anatomical axis A2, and / or an anatomical axis A3. The anatomical axis A2 may be associated with the anatomical axis of the femur. The anatomical axis A3 may be associated with the anatomical axis of the tibia. The mechanical axis A1 may be the mechanical axis of the limb (e.g., leg), which may be established between the proximal femur and the distal tibia. Mechanical axis A1 may be used to determine one or more corrections to restore the mechanical axis of bone and / or limb, and / or the position and / or orientation of an implant, including in knee arthroplasty or high tibial osteotomy (HTO) procedures.
[0374] In the embodiments shown in Figures 49A to 49B, the image data may omit the femur and parts of the tibia and fibula. The representative anatomical model 929-2 may include a femoral model 930F-2 related to the femur, a tibia model 930T-2 related to the tibia, and a fibula model 930FI-2 related to the fibula. The representative anatomical model 929-2 may include the omitted bone portions of the patient anatomical model 929-1. In the embodiments shown in Figures 50A to 50B, the image data may omit the tibia and fibula and parts of the femur. The representative anatomical model 1029-2 may include a femoral model 1030FE-2 related to the femur, a tibia model 1030T-2 related to the tibia, and a fibula model 1030FI-2 related to the fibula. Representative anatomical model 1029-2 may include omitted bone portions of patient anatomical model 1029-1. The bone configuration of patient anatomical models 929-1, 1029-1, including landmarks and axes, may be predicted or otherwise determined using representative anatomical models 929-2, 1029-2 in accordance with any technique disclosed herein.
[0375] Other joints may also benefit from the teachings disclosed herein. Figures 51A and 51B disclose an anatomical model 1129 relating to the hip joint. The anatomical model 1129 may be associated with one or more bones of the pelvis. In embodiments, the anatomical model 1129 may include at least one lumbar model 1130HP relating to a corresponding lumbar bone, a sacral model 1130SC relating to the sacrum, and a femoral model 1130FE relating to the femur. A representative anatomical model 1129-2 may include the omitted bone portion of the patient anatomical model 1129-1.
[0376] By utilizing a representative anatomical model 1129-2, one or more landmarks and / or axes associated with the anatomical structures omitted from the patient's image data may be predicted or otherwise determined. In one embodiment, (e.g., horizontal) axis A4 may be determined based on the predicted shape and position of the patient's omitted femur.
[0377] The acquisition orientation of various bones of the patient may be determined by utilizing other techniques. In an embodiment, the imaging device 16 (Figure 2) may acquire one or more two-dimensional images 26 of the patient's anatomical structure. The images 26 may be oriented differently from each other (e.g., perpendicular). The system 10 may be configured to determine the acquisition orientation based on a comparison between a three-dimensional anatomical model 29 and the patient's anatomical profile in the two-dimensional images 26. The anatomical model 29 may be associated with a different patient than the one associated with the two-dimensional images 26.
[0378] Figure 52 discloses a method for a surgical procedure in flowchart 1282. Method 1282 may be used to preoperatively plan, perform, evaluate, and / or verify various aspects of surgical procedures, such as arthroplasty to restore function to the shoulder, ankle, knee, hip, and other joints. Method 1282 may be used in conjunction with any planning system and method, virtual anatomical models, and / or bone models, such as planning system 10, as disclosed herein. Method 1282 may be used to determine the position and / or orientation of one or more implants based on the orientation of the patient's anatomical structures, such as the scapula and humerus. The orientation of the anatomical structures may be associated with the patient's posture. Within the scope of this disclosure, fewer steps or additional steps may be performed compared to those described below, and the order in which the steps are described is not intended to limit this disclosure. Method 682 may incorporate any step in Methods 382, 482, and / or 582 disclosed herein, and vice versa. See System 10.
[0379] Referring to Figures 2 and 4, while continuing to refer to Figure 52, various techniques may be used to determine one or more characteristics of the patient, such as posture, based on the shoulder SSM75. A 2D profile of the patient's anatomical structure may be captured within each X-ray image. By using the scapular SSM75, a bone model 30 associated with an anatomical body size classification database 70 that is likely to be the closest to the anatomical structure captured in the X-ray image may be selected. The bone models 30 of the scapula and humerus may be selected by projecting the silhouette of the 3D model onto a 2D plane associated with each X-ray image. The scapular SSM75 may select each bone model 30 in each 2D plane that has the silhouette that best fits the 2D profile of the patient's anatomical structure. The scapular SSM75 may be configured to adjust the camera angle to adjust the projection of the silhouette. The adjusted camera angle associated with the best-fitting silhouette may represent the patient's posture at the acquisition location and / or anatomical location, or may be otherwise associated with such patient posture. By utilizing the adjusted camera angle, in addition to and / or in lieu of determining the patient's posture, the relative anatomical position, alignment, and / or orientation of adjacent and / or non-adjacent bones of the patient may be determined, whether by prediction or otherwise.
[0380] Referring to Figures 53-54, continuing with reference to Figures 2 and 52, in step 1282A, digital images of the patient's anatomical structures may be captured by the imaging device 16. The imaging device 16 may include any imaging device disclosed herein. The data module 46 may be configured to receive patient-related image data. In embodiments, one or more two-dimensional (e.g., X-ray) images 26 of the patient's anatomical structures may be acquired by the imaging device 16. The data module 46 may be configured to receive image data including first and second two-dimensional images 26 of one or more bones of the patient. The two-dimensional images 26 may be substantially perpendicular to the acquisition reference system of the imaging device 16, or they may be oriented transversely to each other in other embodiments.
[0381] In the embodiments shown in Figures 53 and 54, the two-dimensional image 26 may include a first image 26-A and a second image 26-B, respectively, associated with corresponding reference (e.g., image) planes REFP-A and REFP-B. The image planes REFP-A and REFP-B may be substantially perpendicular to each other with respect to the acquisition reference system of the imaging device 16. One or more bones of the patient may be non-perpendicular to the image planes REFP-A and REFP-B, and / or to the acquisition direction of the imaging device 16.
[0382] In step 1282B, one or more profiles 1283 related to the patient's anatomical structure may be generated for the image planes REFP-A and REFP-B. Each profile 1283 may be associated with a corresponding anatomical model 29 in the database 38 and / or one or more bone models 30. The spatial module 50 may be configured to establish one or more profiles 1283 related to one or more bones of the anatomical structure.
[0383] In the embodiment shown in Figure 53, the spatial module 50 may be configured to determine a first (e.g., bone) profile 1283S-A related to a first bone of the patient, such as the scapula. The spatial module 50 may be configured to determine a second (e.g., bone) profile 1283H-A related to a second bone of the patient, such as the humerus. The spatial module 50 may be configured to establish a third (e.g., anatomical) profile 1283-A that can be associated with two or more bones of an anatomical structure. The anatomical profile 1283-A may include bone profiles 1283S-A, 1283H-A. The bone profiles 1283S-A, 1283H-A and / or the anatomical profile 1283-A may be associated with corresponding bone models 30 and / or anatomical models 29, respectively. The spatial module 50 may be configured to establish profiles 1283S-A, 1283H-A, and 1283-A along the first image plane REFP-A associated with the first image 26-A.
[0384] In the embodiment of Figure 54, the spatial module 50 may be configured to determine a fourth (e.g., bone) profile 1283S-B related to a first bone of the patient, such as the scapula. The spatial module 50 may be configured to determine a fifth (e.g., bone) profile 1283H-B related to a second bone of the patient, such as the humerus. The spatial module 50 may be configured to establish a sixth (e.g., anatomical) profile 1283-B that can be associated with two or more bones of an anatomical structure. The anatomical profile 1283-B may include bone profiles 1283S-B, 1283H-B. The bone profiles 1283S-B, 1283H-B and / or the anatomical profile 1283-B may be associated with corresponding bone models 30 and / or anatomical models 29, respectively. The spatial module 50 may be configured to establish profiles 1283S-B, 1283H-B, and 1283-B along the second image plane REFP-B associated with the second image 26-B. Bone profiles 1283S-A and 1283S-B may be associated with a common bone such as the scapula, but may differ in shape. Bone profiles 1283H-A and 1283H-B may be associated with a common bone such as the humerus, but may differ in shape. Anatomical profiles 1283-A and 1283-B may be associated with a pair of common bones such as the scapula and humerus, but may differ in shape. Multiple sets of bone profiles 1283S-A / 1283S-B, 1283H-A / 1283H-B, and / or anatomical profiles 1283-A / 1283-B may have different geometric shapes due to differences in the acquisition position of the imaging device 16 relative to the acquisition reference system.
[0385] The planning environment 28 may be configured to select an anatomical model 29 from a database 38. The anatomical model 29 may be associated with one or more bones of an anatomical structure. In one embodiment, the planning environment 28 may be configured to select an anatomical model 29 associated with a bone contained within a patient image 26.
[0386] In step 1282C, the direction of acquisition of the patient's anatomical structure may be determined. Step 1282C may include selecting (e.g., representative) anatomical model 1229 from a set of anatomical models 29 in database 38. Anatomical model 1229 may be associated with one or more bones of anatomical structures, such as the scapula and humerus. In embodiments, anatomical model 1229 may include a first (e.g., scapula) bone model 1230S and a second (e.g., humerus) bone model 1230H. Representative anatomical model 1229 may be associated with another patient, such as a patient from a representative patient population.
[0387] System 10 may be configured to select a representative anatomical model 1229 using any of the techniques disclosed herein. In embodiments, an anatomical (e.g., shoulder) SSM75 may be established. The anatomical SSM75 may be associated with an anatomical shoulder including the scapula and humerus. The representative anatomical model 1229 may be associated with the anatomical SSM75. Based on the shoulder SSM75, System 10 may be configured to predict or determine the shape, position, and / or orientation of the scapula and humerus.
[0388] System 10 may be configured to determine the orientation of the patient's first and second bones related to images 26-A and 26-B based on a representative anatomical model 1229. In step 1282C-2, one or more profiles 1283 of the patient's anatomical structure may be compared to the projection of the representative anatomical model 1229 and related bone models 1230S and 1230H onto image planes REFP-A and REFP-B. Spatial module 50 may be configured to establish one or more silhouettes 1285 related to the anatomical model 1229 and / or related to bone models 1230H and 1230S.
[0389] Silhouette 1285 may be established by utilizing various techniques. The spatial module 50 may be configured to project the first silhouette 1285-A of a representative anatomical model 1229 onto the first profile 1283-A of the patient's anatomical structure along the first image plane REFP-A (Figure 53). The spatial module 50 may be configured to project the second silhouette 1285-B of a representative anatomical model 1229 onto the second profile 1283-B of the patient's anatomical structure along the second image plane REFP-B (Figure 54). The spatial module 50 may be configured to set the acquisition direction (e.g., camera angle or source) AO in order to establish the projection.
[0390] The comparison module 52 may be configured to compare the patient's anatomical profile 1283-A and 1283-B with the projections of their corresponding silhouettes 1285-A and 1285-B, respectively. The comparison module 52 may be configured to compare the patient's anatomical profile 1283-A and 1283-B with the projections of their corresponding silhouettes 1285-A and 1285-B, respectively.
[0391] The spatial module 50 may be configured to adjust (e.g., X, Y, Z) the projection of silhouette 1285-A onto the first image plane REFP-A and / or the projection of silhouette 1285-B onto the second image plane REFP-B by adjusting the acquisition direction AO. The comparison module 52 may be configured to determine a first goodness of fit between the first profile 1283-A and the first silhouette 1285-A. The comparison module 52 may be configured to determine a second goodness of fit between the second profile 1283-A and the second silhouette 1285-A. The comparison module 52 may be configured to determine the overall area deviation between the first and / or second goodness of fit. The spatial module 50 may be configured to minimize or otherwise reduce the overall area deviation to below a predetermined threshold by adjusting the acquisition direction AO. The comparison module 52 may be configured to determine the minimum value of the overall area deviation. The comparison module 52 may be configured to determine the acquisition direction of the imaging device 16 based on the acquisition direction AO associated with the minimum value of the overall area deviation.
[0392] The spatial module 50 may be configured to determine a first acquisition direction AO1 (Figure 53) of the imaging device 16 associated with the first image 26-A based on a comparison of the overall fit between the first silhouette 1285-A and the first profile 1283-A. The spatial module 50 may be configured to determine a first acquisition direction AO1 in response to iterative adjustments of the projection of the first silhouette 1283-A onto the first profile 1283-A along the first image plane REFP-A. The spatial module 50 may be configured to determine a second acquisition direction AO2 (Figure 54) of the imaging device 16 associated with the second image 26-B based on a comparison of the overall fit between the second silhouette 1285-B and the second profile 1283-B. The spatial module 50 may be configured to determine a second acquisition direction AO2 in response to iterative adjustments of the projection of the second silhouette 1285-B onto the second profile 1283-B of the patient's anatomical structure along the second image plane REFP-B. System 10 may be configured to determine the shape, position, and orientation of the bones of the anatomical structures associated with images 26-A, 26-B, based on the determined acquisition directions AO1, AO2, and also based on the overall degree of fit between the patient's anatomical structure profiles 1283-A, 1283-B and the corresponding silhouettes 1285-A, 1285-B of the anatomical model 1229, respectively.
[0393] In step 1282D, the patient's posture may be determined. System 10 may be configured to determine one or more postural characteristics of the patient, including any postural characteristics disclosed herein, based on the determined acquisition direction. System 10 may be configured to determine one or more postural characteristics based on a first acquisition direction AO1 associated with the first image 26-A and / or a second acquisition direction AO2 associated with the second image 26-B.
[0394] System 10 may be configured to communicate one or more planning parameters to the surgeon or clinical user based on the determined postural characteristics. The surgical plan 36 may be established based on the determined posture. System 10 may be configured to automatically generate the preoperative plan 36 based on the determined posture. System 10 may be configured to establish the surgical plan 36 related to the first and / or second bones of the patient's anatomical structure based on one or more determined postural characteristics. In step 1282E, the implant position may be determined based on the determined postural characteristics. The implant position may be associated with the implant model 32. The implant position may be determined using any of the techniques disclosed herein. System 10 may be configured to generate one or more indicators (e.g., suggestions) based on the detected posture, and the indicators may be communicated to the surgeon or clinical user. In embodiments, the surgeon or clinical user may establish the preoperative surgical plan 36 based on the indicators, which may include the selection of various parameters, including the type, size, position, and / or orientation of the implant. Based on the determined postural characteristics, the surgeon may establish, modify, revise, and / or approve the surgical plan36, including the selection of the type, size, location, and / or orientation of the implant.
[0395] In step 1282F, the range of motion may be determined based on the position and / or orientation of the implant model 32 in relation to the implant position determined in step 1282E. The range of motion may also be determined using any technique f disclosed herein. System 10 may be configured to calculate or determine the shoulder joint range of motion for preoperative planning based on parameters specified by the surgeon and / or System 10. The selected bone model 1230 may be associated with a corresponding AMC 80. The range of motion may be determined using the selected bone model 1230 and / or associated AMC 80.
[0396] One or more bones in a patient's anatomical structure may fracture as a result of trauma. A fracture may produce one or more bone fragments. Depending on the scenario, some fragments may be too small to be used for bone reconstruction. The techniques disclosed herein allow for the determination of the pre-fracture state of the bone in fracture repair techniques, enabling the bone to be reconstructed by reducing or otherwise arranging the fragments. The fragments may be arranged relative to the volume of a three-dimensional model of the bone, which can serve as a template. The techniques disclosed may help predict the type of fracture and select treatment options. The techniques disclosed may allow for the treatment of various bones and joints of anatomical structures, including any bones and joints disclosed herein, including long bones such as the humerus, tibia, femur, etc.
[0397] Figure 55 discloses a method for a surgical procedure in flowchart 1382. Method 1382 may be used to preoperatively plan, perform, evaluate, and / or verify various aspects of surgical procedures, such as arthroplasty to restore function to the shoulder, ankle, knee, hip, and other joints. Method 1382 may be used in conjunction with any planning system and method, virtual anatomical models, and / or bone models, such as planning system 10, as disclosed herein. Method 1382 may be used to register one or more bone fragments for bone reconstruction in fracture repair techniques. Method 1382 may be used to determine the position and / or orientation of one or more implants for fixing bone fragments together. Within the scope of this disclosure, fewer steps or additional steps may be performed compared to those described below, and the order in which the steps are described is not intended to limit this disclosure. Method 1382 may incorporate any step in Methods 382, 482, 582, and / or Method 1282 disclosed herein, and vice versa. See System 10.
[0398] Referring to Figure 2, and continuing to refer to Figure 55, in step 1382A, one or more anatomical models 29 and / or bone models 30 may be generated. System 10 may be configured to generate the anatomical models 29 and / or bone models 30 using any of the techniques disclosed herein.
[0399] Referring to Figures 56A-56C, continuing with reference to Figures 2 and 55, in an embodiment, the anatomical model 29 may include a patient-related three-dimensional anatomical model 1329 (shown in 1329-1). The anatomical model 1329-1 may include at least one (e.g., fragmentary) three-dimensional bone model 1330-1 related to the patient's bones. The fragmentary bone model 1330-1 may be associated with any bones and joints disclosed herein, including long bones such as the humerus. The data module 46 may be configured to access the fragmentary bone model 1330-1. The anatomical model 1329-1 may include other bone models, such as the scapula model 530S-1 (see, for example, Figures 41-43). Each bone model 1330 may include a main body (e.g., diaphysis) portion 1330M that may extend between a proximal portion 1330P and a distal portion 1330D. The main body portion 1330M may be associated with the shaft of a long bone, such as the humerus.
[0400] The patient bone model 1330-1 may include one or more three-dimensional bone fragment portions 1330F-1. Each bone fragment portion 1330F-1 may be associated with one or more corresponding bone fragments. The patient's main body portion 1330M-1 may be associated with the non-fragmentary portion of the bone (e.g., the remainder). Each bone fragment portion 1330F-1 may be associated with the proximal portion 1330P-1 of the humerus, including the humeral head. The main body portion 1330M-1 may be associated with the distal portion of the humerus, including the diaphysis. The system 10 may be configured to receive patient-related image data. The system 10 may be configured to generate a fragmentary bone model 1330-1 based on the image data.
[0401] Various techniques may be used to reposition the bone fragment portion 1330F-1 relative to the main body portion 1330M-1 of the patient's fragmentary bone model 1330-1. In step 1382B, a second bone model 30 (Figure 2) related to another bone of an anatomical structure may be selected. The second bone model 30 may be associated to a non-adjacent or adjacent bone of an anatomical structure such as the scapula. The bone model 30 may be associated to another patient, such as a patient from a representative patient population. The bone model 30 may be selected using any techniques disclosed herein, including step 582B of method 582 (Figure 39). In embodiments, the selected bone model 30 may be a scapular model 530S-2 (see, for example, Figures 42-43). The scapular model 530S-2 may be associated to SSM75. The statistical shape modeler 72 may be configured to analyze a representative patient population within the SSM 75, which can be associated with one or more bones of the patient, such as the scapula and / or humerus, in an anatomical model 1329-1.
[0402] In step 1382C, a representative scapula model 530S-2 may be registered against a patient-related scapula model 530S-1 to establish the registration status of scapula model 530S-2 (see, for example, Figures 42-43). Scapula model 530S-2 may be registered using any technique disclosed herein, such as in steps 582C and / or 582D of method 582 (Figure 39). Step 1392C may include registering a representative scapula model 530S-2 against a patient's scapula model 530S-1 to establish the registration status (e.g., position) of scapula model 530S-2.
[0403] Referring to Figures 57A-57B, continuing with reference to Figures 2 and 55, in step 1382D, a representative three-dimensional bone model 1330-2 (e.g., the initial or humerus) associated with another bone of an anatomical structure may be selected or otherwise identified. The data module 46 may be configured to access the representative bone model 1330-2 from memory. The bone associated with the representative bone model 1330-2 may be the same bone as the fragmented bone of the patient. The representative bone model 1330-2 may be associated with the humerus. The data module 46 may be configured to access the representative bone model 1330-2 from memory. The system 10 may select or otherwise identify the representative bone model 1330-2 using any techniques disclosed herein, including any techniques associated with step 582E of method 582 (Figure 39). The system 10 may be configured to select a representative bone mode 1330-2 from a set of three-dimensional bone models 30 associated with the patient's bones, such as the humerus, and a representative patient population.
[0404] Step 1382D may include selecting a representative bone model 1330-2 from a set of bone models 30 associated with the same bone as the patient's fragmented bone, in response to establishing the registration status of representative bone model 530S-2 (see, for example, Figure 44). The selected representative bone model 1330-2 may be associated with the same anatomical model 1329-2 as representative bone model 530S-2, so that it can be associated with another patient in a representative patient population.
[0405] In step 1382E, the main body portion 1330M-1 and / or distal portion 1330D-1 of the fragmentary bone model 1330-1 may be at least partially registered with respect to the representative bone model 1330-2, or otherwise substantially aligned, in order to establish the registration state (e.g., position) of the fragmentary bone model 1330-1. The spatial module 50 may be configured to register or otherwise substantially align the fragmentary bone model 1330-1 with respect to the representative bone model 1330-2, utilizing any techniques disclosed herein, including any techniques related to step 582F of method 582 (Figure 39). Step 1382E may include at least partially registering the main body portion 1330M-1 of the fragmentary bone model 1330-1 with respect to the main body portion 1330M-2 of the representative bone model 1330-2, in order to establish the registration state of the fragmentary bone model 1330-1. The spatial module 50 may be configured to at least partially register the main body portion 1330M-1 of the fragmentary bone model 1330-1 with respect to the main body portion 1330M-2 of the representative bone model 1330M-2 in order to establish the registration state of the fragmentary bone model 1330-1. In embodiments, the spatial module 50 may be configured to substantially align the first (e.g., epicondyle) axis AA of the distal portions 1330D-1 and 1330D-2 of the bone models 1330-1 and 1330-2. The spatial module 50 may be configured to substantially align the main body portion 1330M-1 of the fragmentary bone model 1330-1 with respect to the main body portion 1330M-2 of the representative bone model 1330-2 by rotating the main body portion 1330M-1 of the fragmentary bone model 1330-1 in a rotational direction R1 around the corresponding axis AA.
[0406] In step 1382F, the registration of the initially selected representative bone model 1330-2 to the registration location of the patient's fragmentary bone model 1330-1 may be refined. System 10 may be configured to refine the registration of the representative bone model 1330-2 to the registration location of the fragmentary bone model 1330-1 using any of the techniques disclosed herein. In embodiments, the representative bone model 1330-2 may be repositioned and / or another representative bone model 1330-2 may be selected from a set of representative bone models 30 using any of the techniques disclosed herein. The set of representative bone models 30 may be associated with SSM75. In embodiments, a representative anatomical model 1329-2 associated with the bones of an anatomical structure (e.g., the scapula and humerus) may be repositioned and / or selected using any of the techniques disclosed herein. The representative anatomical model 29 may be the same as or different from the previously selected anatomical bone model 1329-2. System 10 may be configured to refine the selection of a representative bone model 1330-2 based on the degree of fit between a patient's anatomical model 1329-1 and another anatomical model 1329-2 selected from a set of anatomical models 29 that may be associated with the anatomical SSM75. In embodiments, one or more steps of Method 1382 may include analyzing a representative patient population within the SSM75, including step 1382C and / or step 1382F. The representative patient population may be analyzed within the SSM75 using any of the techniques disclosed herein.
[0407] In embodiments, one or more variation modes 76 of the SSM75 may be modified to minimize, or otherwise reduce, the volume deviation between a representative anatomical model 1329-2 selected from a set of anatomical models 29 and the registration (e.g., alignment) position of the patient anatomical model 1329-1, including the scapula model 530S-1 (Figure 44), and the registration (e.g., alignment) position of the fragmentary bone model 1330-1. The system 10 may be configured to refine, or otherwise reposition, and / or select, the anatomical model 1329-2 and the associated humerus model 1330-2 by modifying the variation mode 76 using any technique disclosed herein, such as step 482G of method 482 (Figure 33). Steps 1382B, 1382C, 1382D, and / or 1382F may include repositioning and / or selecting a representative bone model 530S-2 (e.g., Figure 42) and / or representative bone model 1330-2 in response to a change in one or more of the predefined variation modes 76 within the associated SSM75.
[0408] Referring to Figures 58A-58C, continuing with Figures 2, 4, and 55, various techniques may be used to position the bone fragments. In step 1382G, one or more bone fragment portions 1330F-1 of the fragmentary bone model 1330-1 may be at least partially registered, or otherwise substantially aligned, with respect to the volume of a representative bone model 1330-2, in order to establish the registration state (e.g., position) of the fragmentary bone model 1330-1'. Figures 58A-58C disclose the registration state of a patient's fragmentary bone model 1330-1' positioned with respect to a representative bone model 1330-2. Figures 59A-59C disclose the registration state of a patient's fragmentary bone model 1330-1' with the representative bone model 1330-2 omitted.
[0409] Various techniques may be used to fit the bone fragment portion 1330F-1 of the patient bone model 1330-1 to the volume of a representative bone model 1330-2, or to position it in other ways. The bone fragment portion 1330F-1 may be fitted automatically by the system 10 and / or manually in response to user interaction with the user interface 56. The spatial module 50 may be configured to at least partially register the volume of one or more bone fragment portions 1330F-1 of the fragment bone model 1330-1 to the volume of the representative bone model 1330-2 in order to establish the registration state of the fragment bone model 1330-1'.
[0410] The spatial module 50 may be configured to determine the total volume of the bone fragment portion 1330F-1 of the fragmentary bone model 1330-1' which may be located outside the volume of the representative bone model 1330-2. The comparison module 52 may be configured to select an arrangement of the bone fragment portion 1330F-1 that can minimize or otherwise reduce the total volume of the bone fragment portion 1330F-1 of the fragmentary bone model 1330-1' which may be located outside the volume of the representative bone model 1330-2.
[0411] Method 1382 may include analyzing the patient's fragmented bone based on the registration status of the fragmented bone model 1330-1'. In step 1382H, the patient's posture may be determined using any of the techniques disclosed herein. In step 1382I, the position and / or orientation of one or more implant models 1332 may be determined using any of the techniques disclosed herein (models 1332 shown as dashed lines in Figures 59A and 59C). Step 1382I may incorporate any techniques related to step 482G (Figure 33). System 10 may be configured to establish an implant plan related to implant models 1332 based on the registration status of the fragmented bone model 1330-1'. The implant plan may be associated with at least one implant configured to fix one or more bone fragments. Step 1382I may include establishing an implant plan based on the registration status of the fragmented bone model 1330-1'. Step 1382I may include positioning at least one implant model 1332 adjacent to one or more bone fragment portions 1330F-1 of the registered fragmentary bone model 1330-1'. Figure 60 discloses an implant model 1332 fixed to the fragmentary bone model 1330-1' using one or more fastener model F associated with corresponding fasteners such as compression screws.
[0412] In step 1382J, the range of motion may be determined using any of the techniques disclosed herein. The range of motion may be associated with the registered state of the fragmentary bone model 1330-1'. Step 1382J may incorporate any techniques related to step 482H (Figure 33).
[0413] Although the techniques disclosed herein with respect to posture refer to the patient's scapula, it will be understood that the teachings herein may be used to determine range of motion and / or to establish or adjust preoperative plans with respect to other bones and joints.
[0414] The surgical planning system and method proposed in this disclosure may be used to create and implement individualized surgical plans for each patient, thereby potentially improving healing. The disclosed system and method may reduce the complexity of implementing surgical plans, including reducing packaging and instruments. In certain embodiments, the system and method may utilize a feedback loop to continuously improve the recommendations provided when developing surgical plans. Thus, the proposed system and method offer improved functionality compared to conventional planning systems.
[0415] Although different non-limiting embodiments are illustrated as having certain components or steps, the embodiments of this disclosure are not limited to any particular combination thereof. Some 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.
[0416] It will be understood that similar reference numerals identify corresponding or similar components across several drawings. Furthermore, although specific configurations of components are disclosed and illustrated in those exemplary embodiments, it will be understood that other configurations may also benefit from the teachings of this disclosure.
[0417] The above description is to be interpreted as illustrative and not in any restrictive sense. Those skilled in the art will understand that certain modifications may fall within the scope of this disclosure. For these reasons, the following claims should be considered in determining the true scope and content of this disclosure. [Explanation of Symbols]
[0418] 10 Surgical Procedure Planning System 12 Host computer 14 client computers 16 Imaging devices 18 Storage Systems 20 Networks 22 Client Interface 24 Peer-to-peer interface 26 images 28 Planning Environment 29 Anatomical Models 30 Bone Models 32 Implant Models 34 Transfer Models 36. Surgical Plan 38 Databases 40 Computing Devices 42 processors 44 memory 46 Data Modules 48 display modules 50 Space Modules 52 Comparison Modules 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 Outcome Database 68 Range of Motion (ROM) Database 70. Anatomical Physiological Classification (AMC) Database 72 Statistical Shape Modeler 74 Image data 75 Statistical Shape Models 76 Modes 78 standard deviations 80N Anatomical Body Classification (AMC) 101 Range of Motion (ROM) Modeler
Claims
1. A surgical planning system, Includes one or more processors that are operablely connected to memory and configured to run a planning environment, The aforementioned planned environment is Accessing a first representative three-dimensional bone model in the memory, wherein the first representative three-dimensional bone model is related to the first bone of a first patient, and accessing this model is... Accessing a partial three-dimensional bone model of the first bone of a second patient, wherein, unlike the first patient, the partial three-dimensional bone model represents a smaller portion of the first bone compared to the first representative three-dimensional bone model, and the first representative three-dimensional bone model includes the smaller portion and the omitted portion of the first bone that has been excluded from the partial three-dimensional bone model. Adjusting the relative position between the volume of the partial three-dimensional bone model of the first bone and the volume of the first representative three-dimensional bone model, In the user interface, based on the position of the first representative three-dimensional bone model, the partial three-dimensional bone model is displayed along with a representation of the omitted portion of the first bone. A surgical planning system configured to perform the following actions.
2. The aforementioned planned environment is Based on the position of the first representative three-dimensional bone model, establish the second patient-related implant plan. A surgical planning system according to claim 1, configured to perform the following:
3. The aforementioned planned environment is Based on the position of the first representative three-dimensional bone model, one or more postural parameters related to the posture of the second patient are determined. Based on the one or more posture parameters, establish an implant plan. A surgical planning system according to claim 1, configured to perform the following:
4. The aforementioned planned environment is Receiving image data related to the second patient in which the omitted portion of the first bone is omitted, Based on the aforementioned image data, the aforementioned partial three-dimensional bone model is generated. A surgical planning system according to claim 1, configured to perform the following:
5. The first bone is the humerus, The surgical planning system according to claim 1, wherein the omitted portion includes the distal portion of the humerus.
6. The aforementioned planned environment is Based on the position of the first representative three-dimensional bone model, the axis of the second patient associated with the first bone is determined. A surgical planning system according to claim 1, configured to perform the following:
7. A surgical planning system, One or more processors configured to run a planning environment and are operablely connected to a storage system, The storage system is configured to store multiple three-dimensional bone models associated with one or more bones and / or one or more joints of a representative patient population. Includes, The aforementioned planned environment is From a first set of three-dimensional bone models associated with the first bone of the aforementioned representative patient population, select the first representative three-dimensional bone model of the first patient. The adjustment involves adjusting the relative position of the volume of a partial three-dimensional bone model of the first bone and the volume of a representative three-dimensional bone model of the first patient, wherein, unlike the first patient, the partial three-dimensional bone model of the second patient represents a smaller portion of the first bone compared to the representative three-dimensional bone model of the first patient, and the representative three-dimensional bone model of the first patient includes the smaller portion and the omitted portion of the first bone that has been excluded from the partial three-dimensional bone model. In the user interface, based on the position of the first representative three-dimensional bone model, the partial three-dimensional bone model is displayed along with a representation of the omitted portion of the first bone. A surgical planning system configured to perform the following actions.
8. The aforementioned planned environment is Receiving image data related to the second patient in which the omitted portion of the first bone is omitted, Based on the aforementioned image data, the aforementioned partial three-dimensional bone model is generated. A surgical planning system according to claim 7, configured to perform the following:
9. The aforementioned partial three-dimensional bone model relates to a long bone, and the aforementioned partial three-dimensional bone model includes a diaphysis portion related to the diaphysis of the long bone and a head portion related to the head of the long bone. The aforementioned planned environment is Adjusting the relative position between the diaphysis portion of the partial three-dimensional bone model and the diaphysis portion of the first representative three-dimensional bone model, and / or The center point of the head portion of the partial three-dimensional bone model is substantially aligned with the center point of the head portion of the first representative three-dimensional bone model, and the head portion of the partial three-dimensional bone model is rotated around their respective center points to adjust the relative position of the partial three-dimensional bone model and the first representative three-dimensional bone model. A surgical planning system according to claim 7, configured to perform the following:
10. The aforementioned planned environment is Selecting a second representative three-dimensional bone model of the first patient from a second set of three-dimensional bone models associated with the second bone of the aforementioned representative patient population, Adjusting the relative position between the second representative three-dimensional bone model and the second three-dimensional bone model of the second patient's second bone, Based on the position of the second representative three-dimensional bone model, the first representative three-dimensional bone model is selected from the first set of three-dimensional bone models. A surgical planning system according to claim 7, configured to perform the following:
11. The surgical planning system according to claim 8, wherein the first bone and the second bone are adjacent bones.
12. The aforementioned planned environment is Analyzing the aforementioned representative patient population within a statistical shape model. A surgical planning system according to claim 8, configured to perform the following:
13. The aforementioned planned environment is To create multiple anatomical body size classifications based on multiple predefined modes within the statistical shape model that characterize anatomical differences within the aforementioned representative patient population, and multiple standard deviations of anatomical variances included within each of the multiple predefined modes, Assigning the aforementioned anatomical body size classification to the aforementioned multiple three-dimensional bone models It is configured to do the following: The surgical planning system according to claim 12, wherein the storage system is configured to store the anatomical body size classification.
14. The aforementioned planned environment is Selecting the first representative three-dimensional bone model and / or the second representative three-dimensional bone model in response to changing one or more of the aforementioned predefined modes. A surgical planning system according to claim 13, configured to perform the following:
15. The aforementioned planned environment is Based on adjusting the relative positions of the partial three-dimensional bone model and the first representative three-dimensional bone model, the second patient-related implant plan is established. A surgical planning system according to claim 14, configured to perform the following:
16. The partial three-dimensional bone model and the second three-dimensional bone model relate to the anatomical model of the second patient, and the first representative three-dimensional bone model and the second representative three-dimensional bone model relate to the representative anatomical model of the first patient. The aforementioned planned environment is Selecting a representative anatomical model of the first patient from a set of representative anatomical models associated with the first bone and the second bone, Adjusting the relative position between the representative anatomical model of the first patient and the anatomical model of the second patient. A surgical planning system according to claim 14, configured to perform the following:
17. The aforementioned planned environment is The selection of the representative anatomical model in response to determining the minimum volume deviation within a first set of volume deviations, wherein the first set of volume deviations is established between the anatomical model of the second patient and the respective representative anatomical models in the set of representative anatomical models in response to changing one or more of the multiple predefined modes in the statistical shape model. A surgical planning system according to claim 16, configured to perform the following:
18. A surgical planning method performed by computer, A step of selecting a first representative three-dimensional bone model associated with the first bone of the first patient, A step of selecting a partial three-dimensional bone model of the first bone of a second patient, wherein, unlike the first patient, the partial three-dimensional bone model represents a smaller portion of the first bone compared to the first representative three-dimensional bone model, and the first representative three-dimensional bone model includes the smaller portion and the omitted portion of the first bone that has been excluded from the partial three-dimensional bone model. A step of adjusting the relative position between the volume of the partial three-dimensional bone model of the first bone and the volume of the first representative three-dimensional bone model, A step of analyzing the first bone based on the position of the first representative three-dimensional bone model, In the user interface, the steps include displaying the partial three-dimensional bone model along with a representation of the omitted portion of the first bone, based on the position of the first representative three-dimensional bone model. A method that includes this.
19. A step of establishing a second patient-related implant plan based on the position of the first representative three-dimensional bone model. The method according to claim 18, further comprising:
20. A step of accessing multiple three-dimensional bone models associated with one or more bones and / or one or more joints of a representative patient population, The steps include selecting a first representative three-dimensional bone model from a first set of three-dimensional bone models associated with the first bone of the representative patient population, and The method according to claim 18, further comprising:
21. The steps include selecting a second representative three-dimensional bone model of the first patient from a second set of three-dimensional bone models associated with the second bone of the aforementioned representative patient population, A step of adjusting the relative position between the volume of the second representative three-dimensional bone model and the volume of the second three-dimensional bone model of the second patient's second bone, The steps include selecting the first representative three-dimensional bone model from the first set of three-dimensional bone models based on the position of the second representative three-dimensional bone model, and The method according to claim 20, further comprising:
22. Steps to analyze the representative patient population within a statistical shape model. The method according to claim 21, further comprising:
23. The steps include identifying multiple predefined modes within the statistical shape model of the representative patient population, The steps include establishing multiple standard deviations of anatomical variances included within each of the aforementioned multiple predefined modes, and It further includes, The method according to claim 22, wherein the step of selecting the first representative three-dimensional bone model is performed in response to a change in one or more of the plurality of predefined modes in the statistical shape model.
24. The first bone is the humerus, The second bone mentioned above is the scapula. The method according to claim 22, wherein the omitted portion includes the distal portion of the humerus.