Illuminated anatomical models and related methods

Abstract

The present disclosure relates to surgical systems, devices, and methods for planning and performing surgical procedures. The systems and methods disclosed in the present disclosure can be utilized to create a physical anatomical model of an anatomical structure. One or more light sources can be configured to illuminate the physical anatomical model.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This disclosure claims the benefit of U.S. Provisional Patent Application No. 63 / 488,846, filed March 7, 2023, which is incorporated herein by reference in its entirety. [Background technology]

[0002] The present disclosure relates to surgical systems, devices, and methods for planning and performing surgical procedures utilizing physical models of anatomical structures.

[0003] Deformations can be created along various bones and joints of the human musculoskeletal system. The surgeon can prepare for surgery by performing the procedure on a cadaver or femoral simulant. Summary of the Invention

[0004] FIELD OF THE DISCLOSURE The present disclosure relates to systems, devices, and methods for performing surgical procedures. The system can be utilized to perform one or more surgical procedures on a physical model representing an anatomical structure.

[0005] According to one embodiment, a system for surgical procedures may include a physical anatomical model including a body representing an anatomical structure. The body may include one or more bony components, each having a surface contour representing a respective bone. The body may include one or more soft tissue components on the one or more bony components. The one or more soft tissue components may represent soft tissue and may be transparent or translucent. A light source may be embedded within the body.

[0006] In one embodiment, a physical anatomical model for a surgical procedure may include an opaque bony component representing bone. A transparent or translucent soft tissue component may represent soft tissue. The soft tissue component may be disposed along the periphery of the bony component. A light source may be located between the bony component and the soft tissue component. The light source may include multiple light modules that may be distributed around the periphery of the bony component.

[0007] According to one embodiment, a training system for a surgical procedure may include a physical anatomical model including a body representing an anatomical structure, and an imaging instrument may be dimensioned to engage with an imaging device such that the imaging device faces the physical anatomical model.

[0008] According to one embodiment, a method for rehearsing a surgical procedure may include defining a virtual anatomical model associated with an anatomical structure. The method may include forming a plurality of layers of material to form a physical anatomical model representing the virtual anatomical model. The layers of material may form a body. The body may include a bony component having a surface contour representing bone. The bony component may comprise an opaque material. The body may include a soft tissue component representing soft tissue. The soft tissue component may comprise a transparent or translucent material. The method may include embedding a light source within the body.

[0009] The present disclosure may include any one or more of the individual features disclosed above and / or below, alone or in any combination thereof.

[0010] The various features and advantages of the present disclosure will become apparent to those skilled in the art from the following detailed description. The drawings that accompany the detailed description can be briefly described as follows. [Brief explanation of the drawings]

[0011] [Figure 1] FIG. 1 discloses a planning system. [Figure 2] FIG. 2 discloses another planning system including a user interface. [Figure 3] FIG. 3 discloses a system for surgical procedures that includes a physical anatomical model. [Figure 4] FIG. 4 discloses a cross-sectional view of the system taken along line 4-4 of FIG. [Figure 5] FIG. 5 discloses a perspective view of another system for a surgical procedure including a physical anatomical model connected to a physical anatomical model, a light source in a non-illuminating mode, and a positioning tool. [Figure 6] FIG. 6 discloses a perspective view of the system of FIG. 5 with the light source in illumination mode. [Figure 7] FIG. 7 discloses the physical anatomical model of FIG. 5 separated from the positioning tool. [Figure 8] FIG. 8 discloses another view of the physical anatomical model of FIG. [Figure 9] FIG. 9 discloses a side view of the physical anatomical model of FIG. 7 relative to the imaging instrument. [Figure 10] FIG. 10 discloses the physical anatomical model of FIG. 9 coupled to a positioning tool and positioned relative to an imaging device. [Figure 11] FIG. 11 discloses the physical anatomical model of FIG. 10 in another position relative to the imaging device. [Figure 12] FIG. 12 discloses a method for planning and performing a surgical procedure. [Figure 13] FIG. 13 discloses a system for creating a physical anatomical model.

[0012] Like reference numbers and designations in the various drawings indicate like elements. DETAILED DESCRIPTION OF THE INVENTION

[0013] SURGICAL SYSTEMS, APPARATUS, AND METHODS FOR PLANNING AND PERFORMING SURGICAL PROCEDURES USING PHYSICAL MODELS OF ANATOMY FIELD OF THE DISCLOSURE The present disclosure relates to surgical systems, apparatus, and methods for planning and performing surgical procedures utilizing physical anatomical models. Physical anatomical models may be utilized to practice and train on various surgical procedures.

[0014] The disclosed technology can be utilized to provide surgeons with a training experience that can be targeted or tailored to them based on their skill set, experience, etc. A surgeon can select a particular configuration of a virtual anatomical model that can be fabricated or otherwise configured to form a physical anatomical model based on the anatomical structure or pathology the surgeon may intend to treat. In a scenario, the surgeon may be unfamiliar with a particular deformity and may choose to train using that configuration of the physical anatomical model. The surgeon can utilize the physical anatomical model to train with specific instruments, implants, and other devices that may be intended for the planned surgery. Once training on the physical anatomical model is complete, the surgeon can select more challenging cases for subsequent training cycles. Unlike cadavers and femoral simulated bones, physical anatomical models can be associated with specific patients, which can improve the ability to determine how successfully the surgeon performed a surgical procedure on the intended anatomy.

[0015] A surgeon, assistant, or other user may interact with a graphical user interface (GUI) to select various parameters or characteristics of the physical anatomical model. Parameters may include anatomical structures, joint types, tissue types, bone density, defect types, color schemes, etc. to form a desired configuration of the physical anatomical model. A surgeon may adjust or select one or more patient-specific variables or parameters depending on what the surgeon wants to train. The specified parameters may be represented in the physical anatomical model.

[0016] The surgeon may interact with the user interface to select a desired case associated with each virtual anatomical model. The surgeon may interact with the user interface to review previous cases, such as those of a particular leading surgeon, who may be recognized as the "gold standard" for each procedure. The surgeon may select a case that corresponds to the intended patient or may select a case that may closely correspond to a particular classification.

[0017] The physical anatomical model may incorporate one or more light sources for illuminating the physical anatomical model. The light sources may be configured to selectively highlight various components of the physical anatomical model, such as bony components representing various bones and / or soft tissue components representing various soft tissues. The illumination may assist the surgeon in performing the procedure and / or evaluating the physical anatomical model. The imaging device may image modifications to the physical anatomical model. The modifications may be compared to the surgical plan to provide feedback to the surgeon.

[0018] According to one embodiment, a system for surgical procedures may include a physical anatomical model including a body representing an anatomical structure. The body may include one or more bony components, each having a surface contour representing a respective bone. The body may include one or more soft tissue components on the one or more bony components. The one or more soft tissue components may represent soft tissue and may be transparent or translucent. A light source may be embedded within the body.

[0019] In some embodiments, the light source may be at least partially embedded in one or more bone components.

[0020] In some embodiments, the light source may be positioned between one or more bony components and one or more soft tissue components.

[0021] In some embodiments, the light source may include first and second modes associated with first and second frequency ranges, respectively. One or more bone components may include a first material that may be responsive to light in a first frequency range but not a second frequency range. One or more soft tissue components may include a second material that may be responsive to light in a second frequency range but not the first frequency range.

[0022] In some embodiments, the light source may include a first light module and a second light module that may be spaced apart from the first light module, and the first and second light modules may be independently controllable.

[0023] In some embodiments, the body may extend along a first axis. The first optical module may extend along a first reference plane that may extend along the first axis. The second optical module may extend along a second reference plane that may extend along the first axis. The first and second reference planes may be circumferentially offset to form an angle.

[0024] In some embodiments, the first light module and / or the second light module may include an array of light emitting diodes that may be distributed along a respective one of the first and second reference planes.

[0025] In some embodiments, the angle may be greater than or equal to about 90 degrees.

[0026] In some embodiments, the first reference plane may be associated with an anterior-posterior view of the physical anatomical model, and the second reference plane may be associated with a lateral view of the physical anatomical model.

[0027] In some embodiments, at least one indicator may be embedded within the body, and the at least one indicator may be adapted to selectively illuminate in response to a light source.

[0028] In one embodiment, a physical anatomical model for a surgical procedure may include an opaque bony component representing bone. A transparent or translucent soft tissue component may represent soft tissue. The soft tissue component may be positioned along the periphery of the bony component. A light source may be located between the bony component and the soft tissue component. The light source may include multiple light modules that may be distributed around the periphery of the bony component.

[0029] In some embodiments, the light modules may be independently controllable.

[0030] In some embodiments, the plurality of optical modules may include a pair of optical modules that may be circumferentially offset by an angle of about 90 degrees or more relative to the axis of the bone component.

[0031] According to one embodiment, a training system for a surgical procedure may include a physical anatomical model including a body representing an anatomical structure, and an imaging instrument may be dimensioned to engage with an imaging device such that the imaging device faces the physical anatomical model.

[0032] In some embodiments, the imaging fixture may include one or more receptacles dimensioned to engage an imaging device.

[0033] In some embodiments, one or more of the receptacles may be a plurality of slots that may be positioned at a predetermined orientation relative to one another.

[0034] In some embodiments, the mount may be attached to the body. The mount may be adapted to removably secure the physical anatomical model to the positioning device.

[0035] According to one embodiment, a method for rehearsing a surgical procedure may include defining a virtual anatomical model associated with an anatomical structure. The method may include forming a plurality of layers of material to form a physical anatomical model representing the virtual anatomical model. The layers of material may form a body. The body may include a bony component having a surface contour representing bone. The bony component may include an opaque material. The body may include a soft tissue component representing soft tissue. The soft tissue component may include a transparent or translucent material. The method may include embedding a light source within the body.

[0036] In some embodiments, the layers of material may have respective moduli of elasticity that may substantially correspond to the moduli of elasticity of respective portions of the anatomy.

[0037] In some embodiments, the method may include operating the light source in a first mode to enhance the bony component, while operating the light source in a second mode to enhance the soft tissue component, and the first and second modes may be associated with different frequencies.

[0038] In some embodiments, the light source may include a first light module and a second light module, and the method may include independently activating the first light module and the second light module to illuminate respective regions of the body.

[0039] In embodiments, the body may be configured to extend along a first axis, and the first and second optical modules may be circumferentially offset from one another relative to the first axis.

[0040] In some embodiments, the method may include positioning a physical anatomical model relative to an imaging instrument. The method may include positioning an imaging device within the imaging instrument. The method may include modifying the physical anatomical model. The method may include causing the imaging device to capture one or more images of the modified physical anatomical model when illuminated by a light source.

[0041] In some embodiments, the method may include comparing one or more images of the modified physical anatomical model with another instance of the virtual anatomical model. The method may include generating an indicator in response to the comparing step.

[0042] 1 illustrates a planning system 20 that may be utilized to plan a surgical procedure. The system 20 may be used to plan orthopedic surgical procedures, including pre-operative, intra-operative, and / or post-operative, to create, edit, execute, and / or review surgical plans. The system 20 may be used to train and practice for various surgical procedures, including patient prior cases and surgical plans, as well as hypothetical cases.

[0043] System 20 may include a host computer 21 and one or more client computers 22. Host computer 21 may be configured to execute one or more software programs. In some embodiments, host computer 21 may include two or more computers collectively configured to process software instructions serially or in parallel.

[0044] Host computer 21 may be configured to communicate with one or more networks, such as network 23, which may comprise one or more computing devices. Network 23 may be a private local area network (LAN), a private wide area network (WAN), the Internet, or a mesh network.

[0045] The host computer 21 and each client computer 22 may include one or more of a computer processor, memory, storage means, network devices, and input and / or output devices and / or interfaces. Input devices may include a keyboard, mouse, etc. Output devices may include a monitor, speakers, printer, etc. Memory may include UVPROM, EEPROM, FLASH, RAM, ROM, DVD, CD, hard drive, or other computer-readable medium capable of storing data and / or other information related to the configurations and techniques disclosed in this disclosure. The host computer 21 and each client computer 22 may be a desktop computer, laptop computer, smartphone, tablet, or any other computing device. Interfaces may be configured to facilitate communication with other systems and / or components of the network 23.

[0046] Each client computer 22 may be configured to communicate with the host computer 21 either directly via a direct client interface 24 or via a network 23. The client computers 22 may be configured to execute one or more software programs, such as various surgical instruments. Each client computer 22 may be operable to access and execute a planning environment 26 locally and / or remotely. The planning environment 26 may be a standalone software package or may be integrated into another surgical instrument. The planning environment 26 may be configured to communicate with the host computer 21 either via the network 23 or directly via a direct client interface 24. In some embodiments, the client computers 22 may be configured to communicate directly with each other via a peer-to-peer interface 25.

[0047] The planning environment 26 may be configured to provide, via one or more graphical user interfaces (GUIs), a display or visualization of one or more virtual anatomical models 29 and associated images, and / or one or more implant models 30. Each anatomical model 29, implant model 30, and associated images and other information may be stored in one or more files or records according to a specified data structure.

[0048] System 20 may include at least one storage system 27, which may be operable to store or otherwise provide data to other computing devices. Storage system 27 may be a storage area network (SAN) configured to communicate with host computer 21 and / or client computer 22 over network 23. In some embodiments, storage system 27 may be incorporated within host computer 21 and / or client computer 22 or may be directly coupled to host computer 21 and / or client computer 22. Storage system 27 may be configured to store one or more of computer software instructions, data, database files, configuration information, etc.

[0049] In some embodiments, system 20 may be a client-server architecture configured to execute computer software on host computer 21, which may be accessible by client computer 22 using either a thin client application or a web browser running on client computer 22. Host computer 21 may be configured to load computer software instructions into memory from local storage or from storage system 27, and may be configured to execute the computer software using one or more computer processors.

[0050] System 20 may include one or more databases 28. Database 28 may be stored in a central location, such as storage system 27. In some embodiments, one or more databases 28 may be stored on host computer 21 and / or may be distributed databases hosted by one or more of client computers 22. Each database 28 may be a relational database configured to associate one or more anatomical models 29 and / or one or more implant models 30 with each other and / or with surgical plans 31. Each surgical plan 31 may be associated with a respective patient. Each anatomical model 29, implant model 30, and surgical plan 31 may be assigned a unique identifier or database entry. Database 28 may be configured to store data corresponding to anatomical models 29, implant models 30, and surgical plans 31 in one or more database records or entries, and / or may be configured to link or otherwise associate one or more files corresponding to each respective anatomical model 29, implant model 30, and surgical plan 31. The anatomical models 29 stored in the database 28 may correspond to respective patient anatomies from previous and / or planned surgical cases and may be classified into one or more predetermined categories such as gender, age, ethnicity, size, defect category, procedure type, etc. The anatomical models 29 and / or implant models 30 may be associated with respective instruments and devices for performing the associated surgical plan 31.

[0051] The system 10 may include or interface with one or more imaging devices 16. Each client computer 22 and / or host 21 computer may be coupled to one or more of the imaging devices 16. Each imaging device 16 may be configured to capture or acquire one or more images 41 related to anatomical structures present within the scan 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. Various imaging devices 16 may be used, including, but not limited to, X-ray devices, computed tomography (CT) devices, or magnetic resonance imaging (MRI) devices, for acquiring one or more images of a patient. The imaging device 16 may include a personal computer (e.g., a laptop or tablet), a mobile device such as a mobile phone, or a digital camera. The planning environment 28 may be configured to interact with one or more of the imaging devices 16 to capture or acquire the images 41.

[0052] Each anatomical model 29 may include information acquired from one or more medical devices or tools capable of acquiring one or more images of a patient's anatomy, including any of the imaging devices disclosed herein. The anatomical model 29 may include one or more digital images and / or coordinate information associated with the patient's anatomy, acquired or derived from a medical device. In some embodiments, one or more of the anatomical models 29 may be created by a designer and may represent a hypothetical anatomical structure. Each implant model 30 may include coordinate information associated with a predetermined design. The planning environment 26 may incorporate and / or interface with one or more modeling packages, such as a computer-aided design (CAD) package, to render the models 29, 30 as two-dimensional (2D) and / or three-dimensional (3D) volumes or constructs. Each anatomical model 29 and implant model 30 may correspond to 2D and / or 3D geometric shapes and may be used to generate wireframes, meshes, and / or solid constructs within a display.

[0053] The implant models 30 may correspond to implants and components of various configurations, shapes, sizes, procedures, instruments, etc. Each implant may include one or more components that can be placed at a surgical site, including plates, anchors, screws, nails, sutures, grafts, etc. Each implant model 30 may correspond to a single component or may include two or more components that can be configured to form an assembly. The implant models 30 may include a base plate coupled to an articulating member, a bone plate configured to interconnect adjacent bones or bone fragments, an intermedullary nail, a suture anchor, etc. The articulating member may have an articular surface sized to mate with the articular surface of an opposing bone or implant.

[0054] Each surgical plan 31 may be associated with one or more of the anatomical model 29 and / or the implant model 30. The surgical plan 31 may include information related to one or more modifications of the anatomical model 29 and the position of the implant model 30 relative to the original and / or modified anatomical model 29. The surgical plan 31 may include coordinate information related to the modified anatomical model 29 and the relative position of the implant model 30 in a predetermined data structure. Modifications to each anatomical model 29, implant model 30, and surgical plan 31 may be stored in the database 28 automatically and / or in response to user interaction with the system 20.

[0055] The planning environment 26 may be provided to one or more surgeons, assistants, and other clinical users via the client computers 22, and may allow one or more surgeons, assistants, and other clinical users to simultaneously access the anatomical models 29, implant models 30, and surgical plans 31 stored in the database 28. Each user may interact with the planning environment 26 to create, view, and / or modify various aspects of the surgical plan 31. Each client computer 22 may store a local instance of the anatomical model 29, implant models 30, and / or surgical plan 31, which may be synchronized with the database 28 in real time or periodically. The planning environment 26 may be a standalone software package running on the client computer 22 or may be provided as one or more services running on the host computer 21.

[0056] FIG. 2 illustrates a surgical system 120 according to one embodiment. The system 120 is utilized to facilitate planning, practice, and / or training for surgical procedures. The system 120 may be utilized to plan, practice, train, and perform various orthopedic and other surgical procedures, such as arthroplasty procedures to repair joints. The system 120 may be utilized in planning the resection or modification of one or more bones. The system 120 may be utilized in planning the placement of implants to restore bone and / or joint function. The planning system 120 may be utilized in repairs and surgical procedures of various locations on a patient, such as repairing joints, such as the shoulder, foot, ankle, wrist, hand, hip, or knee, and repairing other tissues, such as cartilage, muscles, tendons, and ligaments.

[0057] System 120 may be configured to generate one or more physical anatomical models 148, including any of the physical anatomical models disclosed in this disclosure. A surgeon may perform one or more modifications to the physical anatomical model 148 to practice or train for a surgical procedure. System 120 may be configured to generate one or more configurations 145 associated with each physical anatomical model 148. The configurations 145 may be utilized to form the physical anatomical model 148. Each physical anatomical model 148 may represent a virtual anatomical model 129, including a substantially or generally corresponding geometric shape, texture, density, porosity, color, etc., as a virtual anatomical model 129. Virtual anatomical model 129 may be associated with an anatomical structure, such as a patient's anatomy and / or a hypothetical anatomy. Anatomical model 129 may be a configuration including one or more anatomical features. The anatomical features may represent an anatomical structure, including one or more bones, including cartilage, cortical and / or cancellous bone tissue, soft tissue, including muscles, ligaments and / or tendons, and / or other tissues.

[0058] System 120 may include a computing device 132. Computing device 132 may include at least one processor 133 coupled to memory 134. Computing device 132 may include any of the computing devices disclosed herein, such as host computer 21 and / or client computer 22 of FIG. 1. Processor 133 may be configured to execute planning environment 126 for creating, editing, executing, and / or reviewing one or more surgical (e.g., pre-operative) plans 131 during pre-operative, intra-operative, and / or post-operative phases of a surgical procedure. Processor 133 may be configured to access one or more virtual anatomical models 129 from a storage location, such as memory 134. Anatomical models 129 and surgical plans 131 may be associated with actual patient cases or may be hypothetical cases created for practice and / or training of surgeons, assistants, medical staff, and other clinical users.

[0059] Planning environment 126 may include at least a data module 135, a display module 136, a spatial module 137, and a comparison module 138. Processor 133 may be configured to execute data module 135, display module 136, spatial module 137, and comparison module 138. While four modules are disclosed in the implementation of FIG. 2, it should be understood that fewer than three or more than four modules may be utilized and / or one or more of the modules may be combined to provide the disclosed functionality.

[0060] The data module 135 may be configured to access, retrieve, and / or store data and other information corresponding to one or more images 141, virtual anatomical models 129, implant models 130, and / or surgical plans 131 in one or more databases 128. The data and other information may be stored in the databases 128 as one or more records or entries 139. In various embodiments, the data and other information may be stored in one or more files that may be accessible by referencing one or more objects or memory locations referenced by the records 139.

[0061] Data module 135 may be configured to receive data and other information corresponding to at least one or more images 141, physical anatomical models 148, etc. from various sources, such as one or more imaging devices 16. Data module 135 may be further configured to instruct and command imaging devices 16 to capture or acquire images 141 automatically or in response to user interaction.

[0062] The memory 134 may be configured to access, load, edit, and / or store instances of one or more anatomical models 129, implant models 130, and / or surgical plans 131 in response to one or more commands from the data module 135. The data module 135 may be configured to cause the memory 134 to store local instances of the anatomical models 129, implant models 130, and / or surgical plans 131, which may be synchronized with records 139 in the database 128.

[0063] The display module 136 may be configured to display data and other information related to the one or more surgical plans 131 in at least one graphical user interface (GUI) 142. The computing device 132 may be coupled to the display device 140. The display module 136 may be configured to cause the display device 140 to display the virtual anatomical model 129 in the user interface 142. A surgeon or other clinical user may interact with the user interface 142 via the planning environment 126 to create, edit, and / or review aspects of the one or more anatomical models 129. A surgeon or other user may interact with the user interface 142 via the planning environment 126 to create, edit, execute, and / or review aspects of the one or more surgical plans 131.

[0064] Each surgical plan 131 may be associated with one or more (e.g., original) virtual anatomical models 129 prior to any modifications, which may substantially or generally approximate the anatomical structures. Each surgical plan 131 may be associated with one or more (e.g., modified or altered) virtual anatomical models 129, which may incorporate one or more modifications or changes to the anatomical structures and / or associated physical anatomical models. The original anatomical models 129 and the modified anatomical models 129 may be associated with each other in the surgical plan 131. In some embodiments, the modifications may be stored as one or more parameters of the original anatomical model 129.

[0065] The planning system 120 may be configured to generate a link to the surgical plan 131. A surgeon, assistant, or other clinical user may be configured to interact with the link to review and edit the surgical plan 131. Interacting with the link may cause the planning system 120 to display or otherwise present aspects of the surgical plan 131 in a graphical user interface 142.

[0066] Planning system 120 may be utilized to create one or more physical anatomical models 148, including any of the physical anatomical models disclosed in this disclosure. Physical anatomical model 148 may be representative of an associated virtual anatomical model 129. Imaging device 16 may be configured to capture one or more images 141 of physical anatomical model 148 before, during, and / or after any modifications. System 120 may be configured to associate images 141 with physical anatomical model 148, including in database 128.

[0067] 3-4 illustrate a system 250 for a surgical procedure according to one implementation. System 250 may include a physical anatomical model 248. Physical anatomical model 248 may include a body 252. Body 252 may represent an anatomical structure, such as one or more bones and / or joints, including any of those disclosed herein. Body 252 may include an exterior surface contour 252E. Body 252 may include one or more components (e.g., anatomical features) 254. Components 254 may represent an anatomical structure, including one or more bones, including cartilage, cortical and / or cancellous bone tissue, soft tissue, including muscle, ligament and / or tendon, and / or other tissue.

[0068] The components 254 may include one or more bone components 254B representing respective bones and / or one or more soft tissue components 254S representing soft tissue. In some embodiments, the bone components 254B may represent metatarsals or other bones of the foot. The metatarsals may be associated with a bunion or other deformity. Each bone component 254B may have a surface contour 254BC representing a respective bone. The bone components 254B may include a first portion 254B-1 forming the surface contour 254BC and a second portion 254B-2 embedded in the first portion 254B-2 ( FIG. 4 ). The first portion 254B-1 may represent cortical bone. The second portion 254B-2 may represent cancellous bone. The soft tissue components 254S may be disposed around and / or otherwise along the periphery of the bone components 254B.

[0069] The body 252 may extend along a (e.g., first) axis X. The axis X may be a longitudinal axis extending along the length of the body 252. The bone component 254B may be configured to extend along the body axis X.

[0070] The components 254 may be formed from any of the materials disclosed herein, including opaque, translucent, and / or transparent materials. In some embodiments, the bone component 254B may be translucent or substantially opaque. The soft tissue component 254S may be translucent or substantially transparent. For purposes of this disclosure, the term "substantially" means ±10 percent of a stated value or relationship, unless otherwise indicated. The bone component 245B may be formed from a substantially rigid material, such as a polymeric material, including photopolymers, silicone, and thermoplastics. The soft tissue component 254S may be formed from a relatively flexible material, such as an elastomeric material, such as rubber or silicone.

[0071] System 250 may include a light source 256 for illuminating physical anatomical model 248. Light source 256 may be embedded in body 252 of physical anatomical model 248. Light source 256 may be positioned between one or more bony components 254B and one or more soft tissue components 254S. In other examples, light source 256′ may be external to body 252 (shown in dashed lines). Various light sources can be utilized to illuminate the physical anatomical models disclosed herein, such as incandescent, fluorescent, halogen, and / or light-emitting diode (LED). Light source 256 may be coupled to a power source. The power source may be external or embedded in the physical anatomical model (e.g., battery-powered).

[0072] Light source 256 may be configured to generate light at one or more frequencies and / or frequency ranges of visible and / or invisible light. The frequencies and / or frequency ranges may be defined in the visual light spectrum (e.g., 400 nm to 700 nm), the near-infrared light spectrum (e.g., 2.5 μm to 750 nm), and / or the infrared light spectrum (e.g., 25 μm to 2.5 μm). Light source 256 may be configured to generate light characterized by various hues, saturations, and / or brightnesses.

[0073] Light source 256 may include multiple modes associated with distinct frequencies and / or frequency ranges of visible and / or invisible light. The multiple modes may include first and second modes associated with first and second frequency ranges, respectively. Components 254 may incorporate materials responsive to one or more of the frequencies and / or frequency ranges such that components 254 may be illuminated distinctly and independently of one another. In some embodiments, one or more bone components 254B may include a first material responsive to light in a first frequency range but not to light in a second frequency range. One or more soft tissue components 254S may include a second material responsive to light in a second frequency range but not to the first frequency range.

[0074] The physical anatomical model 248 may include one or more indicators I ( FIG. 3 ). The indicators I may be embedded within the body 252. The indicators I may be associated with one or more predetermined target zones and / or warning zones associated with the surgical procedure and / or surgical plan. The indicators I may represent one or more fracture paths associated with a bone fracture. The indicators I may be adapted to selectively illuminate in response to a light source 256 including any of the frequencies and / or frequency ranges disclosed herein to assist a surgeon or clinical user in performing a surgical procedure.

[0075] The light source 256 may include one or more light modules 258. The light modules 258 may be spaced apart from one another. The light modules 258 may be configured to follow the contours of one or more adjacent components 254, such as the surface contour 254BC of the bone component 254B. In an embodiment, one or more light modules 258″ may be at least partially embedded in one or more bone components 254B ( FIG. 4 ). The light modules 258 may be independently controllable. The system 250 may include a controller 259 ( FIG. 3 ). The controller 259 may be electrically coupled to each of the light modules 258. The controller 259 may be configured to independently control the light modules 258. The light modules 258 may be distributed around the circumference of the bone component 254B relative to the axis X. The light source 256 may include one or more pairs of light modules 258, such as a first light module 258-1 and a second light module 258-2 spaced apart from the first light module 258-1. The first and second light modules 258-1, 258-2 may be independently controllable.

[0076] With continued reference to FIG. 3 and with reference to FIG. 4 , the first optical module 258-1 may be configured to extend along a first reference plane REF1. The second optical module 258-2 may be configured to extend along a second reference plane REF2. The first and / or second reference planes REF1, REF2 may be configured to extend along an axis X of the body 252. The first and second reference planes REF1, REF2 may be circumferentially offset to form an angle α. The angle α may be acute, perpendicular, or obtuse. In some embodiments, the angle α may be approximately 90 degrees or greater. The first and second optical modules 258-1, 258-2 may be circumferentially offset at an angle α of approximately 90 degrees or greater relative to the axis of the bone component 254B and / or the axis X of the body 252.

[0077] In some embodiments, system 250 may include third and fourth optical modules 258-3, 258-4. Third optical module 258-3 may extend along first reference plane REF1. Fourth optical module 258-4 may extend along second reference plane REF1. First optical module 258-1 and third optical module 258-3 may be disposed on opposite sides of bony component 254B. Second optical module 258-2 and fourth optical module 258-4 may be disposed on opposite sides of bony component 254B. The positions of optical modules 258 may be associated with different planes of the anatomy (e.g., anterior-posterior, lateral, superior-inferior). Controller 259 may selectively activate optical modules 258 to highlight associated planes of physical anatomical model 248. In some embodiments, first reference plane REF1 may be associated with an anterior-posterior view of physical anatomical model 248. The second reference plane REF2 may be configured to be associated with a side view of the physical anatomical model 248.

[0078] One or more of the light modules 258 may include an array of light emitting diodes (LEDs) distributed along a respective one of the first and second reference planes REF1, REF2. In some embodiments, the first light module 258-1 and / or the second light module 258-2 may include an array of LEDs distributed along a respective one of the first and second reference planes REF1, REF2.

[0079] 5 discloses a system 350 for (e.g., training) a surgical procedure. System 350 may include a physical anatomical model 348. Physical anatomical model 348 may incorporate any of the features of the physical anatomical models disclosed in this disclosure. Physical anatomical model 348 may represent a foot. Physical anatomical model 348 may incorporate features representing one or more defects, such as a bunion.

[0080] The physical anatomical model 348 may include one or more model portions 353. In some embodiments, the model portions 353 may include a first model portion 353-1 and a second model portion 353-2. The first model portion 353-1 may be patient-specific and / or non-reusable. The first model portion 353-1 may be associated with a respective virtual anatomical model 129 ( FIG. 2 ). The second model portion 353-2 may be reusable and may have a structure that can approximate the geometry of an anatomical structure (e.g., an ankle). The second model portion 353-2 may not be associated with a particular patient. The first model portion 353-1 may be removably attached to the second model portion 353-2 or may be otherwise fixed.

[0081] Physical anatomical model 348 may include one or more components 354 associated with an anatomical structure, including any of the tissues disclosed in this disclosure. Components 354 may include one or more bone components 354B and / or soft tissue components 354S. System 350 may include a light source 356. Light source 356 may be formed in physical anatomical model 348 using any of the techniques disclosed in this disclosure. In some embodiments, first model portion 353-1 may incorporate component 354 and / or light source 356.

[0082] In the example of Figure 5, light source 356 may be configured to be operated in a first (e.g., non-illuminated) mode. In the example of Figure 6, light source 356 may be configured to be operated in a second (e.g., illuminated) mode to illuminate physical anatomical model 348, which includes one or more bony components 354B and one or more soft tissue components 354S.

[0083] System 350 may include a mount 360 attached to body 352 of physical anatomical model 348. Mount 360 may be adapted to removably secure physical anatomical model 348 to positioning device 362. In some embodiments, mount 360 may be fixedly attached to second model portion 353-2 or may be otherwise fixed. A surgeon or clinical user may configure positioning device 362 to position physical anatomical model 348 in a desired position and / or orientation. FIG. 7 discloses physical anatomical model 348 separated from positioning device 362. FIG. 8 discloses an isolated view of physical anatomical model 348 separated from positioning device 362.

[0084] 1-8 , and with reference to FIGS. 8-10 , a surgeon or clinical user may utilize an instrument 364 ( FIG. 11 ) to modify the physical anatomical model 348. The instrument 364 may be a guide or tool, such as a drill or saw. The instrument 364 may be utilized to position one or more surgical devices 366 ( FIG. 11 ), such as guide pins and / or compression screws or other fasteners.

[0085] System 350 may include an imaging device 316. Imaging device 316 may include any of the imaging devices disclosed herein, such as a mobile device with an integrated or external digital camera. Physical anatomical model 348 may be positioned relative to imaging device 316. Imaging device 316 may capture one or more digital images 341 of physical anatomical model 348. System 10 (FIGS. 1-2) may receive digital images 341 and associate digital images 341 with physical anatomical model 348.

[0086] System 350 may include imaging device 370 (shown in dashed lines). Imaging device 370 may be sized to engage with an imaging device, such as imaging device 316, such that the imaging device faces physical anatomical model 348 in a specified orientation. Imaging device 370 may include one or more receptacles 372. Each receptacle 372 may be sized to engage with an imaging device, such as imaging device 316. Receptacle 372 may include multiple slots arranged at a predetermined orientation relative to one another to capture images of physical anatomical model 348 in the predetermined orientation. The predetermined orientation may include any of the orientations disclosed herein, such as various planes of the anatomy (e.g., anterior-posterior, lateral, superior-inferior). A surgeon or clinical user may control imaging device 316 to capture one or more images of physical anatomical model 348 when light source 356 is in an illumination and / or non-illumination mode. In some embodiments, system 350 may include one or more stands 374. Stand 374 may extend from, be integrated into, and / or be attached to physical anatomical model 348. Stand 374 may be dimensioned to support physical anatomical model 348 and / or engage one or more surgical instruments. Stand 374 may be dimensioned to engage an imaging device, such as imaging device 316. Stand 374 may be positioned in a predetermined orientation, including any of the orientations disclosed in this disclosure. Stand 374 may be integrated into imaging instrument 370. In some embodiments, imaging instrument 370 may be omitted.

[0087] FIG. 12 discloses a method for planning and performing a surgical procedure in the form of a flowchart 380. The method 380 may be utilized to pre-operatively plan, practice, and / or train for various surgical procedures, such as arthroplasty procedures to restore function to the shoulder, ankle, foot, knee, hip, and other joints with one or more deformities. The method 380 may be utilized with any of the planning systems and virtual and physical anatomical models disclosed in this disclosure. The method 380 may be utilized to assess the accuracy with which a surgeon performs a surgical procedure on a physical anatomical model associated with a patient's anatomy. Fewer or additional steps than those described below may be implemented within the scope of this disclosure, and the order of the steps described is not intended to limit this disclosure. Reference is made to the planning system 10 and system 350, which include a physical anatomical model 348.

[0088] 2, with continuing reference to FIGURE 12, step 380-1 may comprise generating or otherwise defining one or more virtual anatomical models 129. Each virtual anatomical model 129 may be associated with a patient's anatomy and may be generated using any of the techniques disclosed in this disclosure.

[0089] In step 380-2, one or more virtual anatomical models 129 may be selected from the set of virtual anatomical models 129. The virtual anatomical models 129 may be stored in database 128 or in a memory of the computing device, such as memory 134 of computing device 132. Selecting the virtual anatomical models 129 may include selecting from various parameters associated with the set of virtual anatomical models 129. The parameters may include any of the parameters disclosed herein, including patient classification, anatomical structure, and / or defect. The parameters may be selected in response to user interaction with graphical user interface 142. The virtual anatomical models 129 may include any of the anatomical structures and tissue types disclosed herein, including bones, ligaments, tendons, cartilage, etc. In step 380-3, the selected one or more virtual anatomical models 129 may be viewed in graphical user interface 142.

[0090] In step 380-4, one or more implant models 130 may be selected and positioned relative to the selected virtual anatomical model 129. Each implant model 130 may be selected from a set of implant models 130. The implant models 130 may be stored in a memory of a computing device, such as the database 128 or the memory 134 of the computing device 132. The implant models 130 may be associated with any of the implants disclosed in this disclosure.

[0091] Step 380-5 may include defining one or more aspects of the virtual anatomical models 129. Each virtual anatomical model 129 may be defined before, during, and / or after generating the virtual anatomical models 129 in step 380-1, and / or a virtual anatomical model 129 may be selected in step 380-2. Defining the virtual anatomical models 129 may include setting one or more parameters of the virtual anatomical models 129, including any of the parameters disclosed in this disclosure. The parameters may be selected in response to user interaction with the graphical user interface 142. The parameters may be associated with one or more indicators I (FIG. 3).

[0092] Step 380-6 may generate one or more configurations (e.g., definitions). Each configuration may be associated with a physical anatomical model 148 and may be generated using any of the techniques disclosed in this disclosure. The configurations may represent selected virtual anatomical models 129. Each configuration may be generated in response to selecting a respective virtual anatomical model 129 in step 380-2 and / or defining a selected virtual anatomical model 129 in step 380-5. The configurations may be formed according to the selection or specification of any parameters associated with the selected virtual anatomical model 129. The configurations may include sufficient data and other information to form the physical anatomical model 148 based on the parameters of the selected virtual anatomical model 129, such as coordinate information, elastic moduli of associated tissues, color scheme, etc.

[0093] At step 380-7, one or more physical anatomical models 148 may be fabricated or otherwise formed based on the generated configurations 145. Each physical anatomical model 148 may be formed utilizing any of the techniques disclosed in this disclosure. The physical anatomical model 148 may be a monolithic structure or may have one or more portions removably secured to one another.

[0094] In the example of FIG. 13 , one or more layers of material L may be printed or otherwise formed on a substrate 482 to form a physical anatomical model 448. The physical anatomical model 448 may be a configuration representing the virtual anatomical model 129 ( FIG. 2 ). A device 484, such as a three-dimensional printer, may be configured to form the layers L according to data and other information associated with each of the configurations 145 (device 484 shown in dashed lines for illustrative purposes). The layers of material L may be configurations including any of the structures, materials, colorings, textures, porosities, etc. disclosed in this disclosure. The layers L may have respective elastic moduli that may substantially correspond to the elastic moduli of the respective biomaterials of the anatomical structures. The porosity of the material forming the physical anatomical model 448 may be a configuration that substantially approximates the porosity or density of the respective tissue.

[0095] Step 380-7 may include forming layers L of material to form the physical anatomical model 448. The layers L may be formed simultaneously and / or sequentially. Each layer L may be uniform or non-uniform. Non-uniform layers may incorporate different regions associated with respective tissue types, densities, porosities, colors, etc. Step 380-7 may include printing the layers L of material onto one another to form one or more components 454 of the physical anatomical model 448, including any of the components disclosed in this disclosure.

[0096] The layer of material L may form the body 452 of the physical anatomical model 448. The body 452 may include one or more model portions, one or more bone components, and / or one or more soft tissue components. The body 452 may form one or more model portions 453. The bone components may have a surface contour representative of bone. The bone components may include an opaque or translucent material. The soft tissue components may represent soft tissue. The soft tissue components may include a transparent or translucent material. The layer of material L may have respective moduli of elasticity that may substantially correspond to the moduli of elasticity of the respective portions of the anatomical structure.

[0097] Step 380-7 may include positioning one or more light sources 456 relative to physical anatomical model 448. Light source 456 may include any of the light sources and light modules disclosed in this disclosure. Light source 456 may include one or more light modules 458. Light source 456 and light module 458 may be arranged according to any of the teachings disclosed in this disclosure. Step 380-7 may include embedding light source 456 within body 452. Layer L of material may be formed such that model portion 453 and / or physical anatomical model 448 may be a monolithic structure. In some embodiments, one or more light sources 456′ and / or light modules 458′ may be positioned along an outer surface of physical anatomical model 448.

[0098] In step 380-8, physical anatomical model 348 may be configured to be positioned or otherwise created. Physical anatomical model 348 may be secured to one or more positioning devices (see, e.g., FIGS. 5-7).

[0099] 10-11 , with continued reference to FIG. 12 , one or more modifications to one or more physical anatomical models 348 may be performed in step 380-9. Step 380-9 may include removing a portion of physical anatomical model 348 to form a modified physical anatomical model 348. Various modifications may be performed to simulate a surgical procedure performed on the anatomical structure, including any of the modifications disclosed herein, such as one or more of dissection, cutting, drilling, reaming, resection, and implantation operations (see, e.g., FIG. 11 ). Each modification may result in a permanent change to the geometry of physical anatomical model 348.

[0100] Step 380-10 may include selectively activating one or more light sources 356 to illuminate the physical anatomical model 348. Step 380-10 may include activating the light sources 356 in one or more modes. Step 380-10 may include activating the light sources 356 in a first mode to highlight one or more bony components 354B and activating the light sources 356 in a second mode to highlight one or more soft tissue components 354S. The first and second modes may be associated with different frequencies and / or frequency ranges of light generated by the light sources 356.

[0101] Light source 356 may include a first light module and a second light module (see, e.g., light modules 258-1 and 258-2 in FIGS. 3-4). Step 380-10 may include independently activating the first light module and the second light module to illuminate respective regions of body 352 of physical anatomical model 348. Body 352 may extend along a first axis (see, e.g., axis X in FIGS. 3-4). The first light module and the second light module may be circumferentially offset from each other relative to the first axis (see, e.g., FIGS. 3-4).

[0102] In step 380-11, one or more modifications to one or more physical anatomical models 348 may be evaluated using any of the techniques disclosed in this disclosure. Step 380-11 may include positioning physical anatomical model 348 relative to imaging instrument 370. Step 380-11 may include positioning imaging device 316 within imaging instrument 370. A surgeon or clinical user may modify physical anatomical model 348. A surgeon or clinical user may cause imaging device 316 to capture one or more images 341 of physical anatomical model 348 when illuminated by light source 356, including before, during, and / or after modifying physical anatomical model 348. A surgeon or clinical user may cause imaging device 316 to capture a set of images 341 at one or more positions and orientations relative to physical anatomical model 348, including any of the positions and orientations disclosed in this disclosure. Each set of images 341 may include one or more images 341 captured in one or more lighting conditions of physical anatomical model 348 and / or one or more non-lighting conditions of physical anatomical model 348.

[0103] Step 380-11 may include generating a virtual anatomical model 129 (FIG. 2) based on the modified (e.g., revised) physical anatomical model 348. Step 380-11 may include comparing the modified one or more physical anatomical models 348 to the surgical plan 131. In some embodiments, step 380-11 may include comparing the modified one or more physical anatomical models to a predetermined geometry of one or more virtual anatomical models associated with the surgical plan. Step 380-11 may include generating one or more indicators, including any of the indicators disclosed in this disclosure.

[0104] The novel devices and methods of the present disclosure provide versatility in planning, practicing, and training surgical procedures using physical anatomical models, which may represent various anatomical structures, and which may utilize one or more light sources to selectively illuminate the physical anatomical models.

[0105] Although different non-limiting embodiments are illustrated as having particular components or steps, embodiments of the present disclosure are not limited to those particular combinations, and some of the components or features from any of the non-limiting embodiments may be used in combination with configurations or components from any of the other non-limiting embodiments.

[0106] It should be understood that like reference numerals identify corresponding or similar elements throughout the several views. Although particular component configurations are disclosed and illustrated in these exemplary embodiments, it should be understood that other configurations may also benefit from the teachings of the present disclosure.

[0107] The foregoing description should be construed as illustrative and not in any limiting sense. Those skilled in the art will recognize that certain variations may fall within the scope of the present disclosure. For these reasons, the following claims should be studied to determine the true scope and content of the present disclosure.

Claims

1. 1. A system for a surgical procedure, comprising:

1. A physical anatomical model comprising a body representing an anatomical structure, said body comprising: one or more bone components, each having a surface contour representing a respective bone; a physical anatomical model including one or more soft tissue components on the one or more bony components, the one or more soft tissue components representing soft tissue and being transparent or translucent; a light source embedded within the body.

2. The system of claim 1 , wherein the light source is at least partially embedded in the one or more bony components.

3. The system of claim 1 or 2, wherein the light source is positioned between the one or more bony components and the one or more soft tissue components.

4. the light source has first and second modes associated with first and second frequency ranges, respectively; the one or more bone components include a first material that is responsive to light in the first frequency range but not to light in the second frequency range; 4. The system of claim 1, wherein the one or more soft tissue components comprise a second material that responds to light in the second frequency range but not to light in the first frequency range.

5. 5. The system of claim 1, wherein the light source includes a first light module and a second light module spaced apart from the first light module, and the first light module and the second light module are independently controllable.

6. the body extends along a first axis; the first optical module extends along a first reference plane that extends along the first axis; the second optical module extends along a second reference plane that extends along the first axis; The system of claim 5 , wherein the first and second reference planes are circumferentially offset to form an angle.

7. 7. The system of claim 6, wherein the first optical module and / or the second optical module includes an array of light-emitting diodes distributed along a respective one of the first reference plane and the second reference plane.

8. 8. The system of claim 6 or 7, wherein the angle is greater than or equal to about 90 degrees.

9. 9. The system of claim 6, wherein the first reference plane is associated with an anterior-posterior view of the physical anatomical model and the second reference plane is associated with a lateral view of the physical anatomical model.

10. further comprising at least one indicator embedded in the body, the at least one indicator adapted to selectively illuminate in response to the light source; The system according to any one of claims 1 to 9.

11. 1. A physical anatomical model for a surgical procedure, comprising: an opaque bone component representing bone; a transparent or translucent soft tissue component representing soft tissue, the transparent or translucent soft tissue component being disposed along the periphery of the bone component; a light source between the bony component and the soft tissue component, the light source comprising a plurality of light modules distributed around the periphery of the bony component.

12. The physical anatomical model of claim 11 , wherein the plurality of light modules are independently controllable.

13. The physical anatomical model of claim 11 or 12, wherein the plurality of optical modules comprises a pair of optical modules circumferentially offset at an angle of about 90 degrees or greater relative to an axis of the bony component.

14. 1. A training system for a surgical procedure, comprising: a physical anatomical model including a body representing an anatomical structure; an imaging instrument sized to engage with the imaging device such that the imaging device faces the physical anatomical model.

15. The training system of claim 14 , wherein the imaging instrument includes one or more receptacles sized to engage the imaging device.

16. 16. The training system of claim 15, wherein the one or more receptacles are a plurality of slots arranged in a predetermined orientation relative to one another.

17. 17. The training system of claim 14, further comprising a mount attached to the body, the mount adapted to removably secure the physical anatomical model to a positioning device.

18. 1. A method of practicing for a surgical procedure, comprising: defining a virtual anatomical model associated with an anatomical structure; forming a plurality of layers of material to form a physical anatomical model representing the virtual anatomical model, the layers of material forming a body, the body comprising: a bone component having a surface contour representative of bone, said bone component comprising an opaque material; forming a physical anatomical model including a soft tissue component representing soft tissue, the soft tissue component including a transparent or translucent material; embedding a light source within the body.

19. 20. The method of claim 18, wherein the layers of material have respective moduli of elasticity that substantially correspond to moduli of elasticity of respective portions of the anatomical structure.

20. further comprising operating the light source in a first mode to enhance the bony component and operating the light source in a second mode to enhance the soft tissue component; 20. The method of claim 18 or 19, wherein the first and second modes are associated with different frequencies.

21. the light source includes a first light module and a second light module; 21. The method of any one of claims 18 to 20, further comprising independently activating the first light module and the second light module to illuminate respective regions of the body.

22. the body extends along a first axis; 22. The method of claim 21, wherein the first optical module and the second optical module are circumferentially offset from one another relative to the first axis.

23. positioning the physical anatomical model relative to an imaging instrument; Positioning an imaging device within the imaging fixture; modifying the physical anatomical model; causing the imaging device to capture one or more images of the modified physical anatomical model when illuminated by the light source; The method of any one of claims 18 to 22, further comprising:

24. comparing the one or more images of the modified physical anatomical model with a surgical plan; generating an indicator in response to said comparing step; 24. The method of claim 23, further comprising:

Images