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 Mar. 7, 2023, which is hereby incorporated by reference in its entirety.

Background Art

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

[0003] Deformations can form along various bones and joints of the human musculoskeletal system. A surgeon can prepare for a surgical procedure by performing procedures on cadavers or femur - mimicking bones.

Summary of the Invention

[0004] This 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] A system for a surgical procedure according to one embodiment may comprise a physical anatomical model including a body representing an anatomical structure. The body may comprise one or more bone components each having a surface contour representing a respective bone. The body may comprise one or more soft - tissue components on the one or more bone 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] A physical anatomical model for surgical procedures according to one embodiment may include opaque bone components representing bone. Transparent or translucent soft tissue components may represent soft tissue. The soft tissue components may be arranged around the bone components. A light source may be located between the bone components and the soft tissue components. The light source may include a plurality of light modules that can be distributed around the bone components.

[0007] A training system for surgical procedures according to one embodiment may include a physical anatomical model, which includes a body representing an anatomical structure. The imaging device may be sized to engage with the imaging device so that the imaging device can face the physical anatomical model.

[0008] A method for rehearsing a surgical procedure according to one embodiment may include defining a virtual anatomical model relating to an anatomical structure. The method may include forming layers of multiple materials to form a physical anatomical model representing the virtual anatomical model. The layers of materials may form a main body. The main body may include bone components having a surface contour representing bone. The bone components may include an opaque material. The main body may include soft tissue components representing soft tissue. The soft tissue components may include a transparent or translucent material. The method may include embedding a light source within the main body.

[0009] This disclosure may include one or more of the individual components disclosed above and / or below, either individually or in any combination thereof.

[0010] Various features and advantages of this disclosure will become apparent to those skilled in the art from the following embodiments for carrying out the invention. The drawings accompanying the embodiments for carrying out the invention can be briefly described below. [Brief explanation of the drawing]

[0011] [Figure 1] Figure 1 discloses the planning system. [Figure 2] Figure 2 discloses another planning system, including a user interface. [Figure 3] Figure 3 discloses a system for surgical procedures that includes a physical anatomical model. [Figure 4] Figure 4 discloses a cross-sectional view of the system cut along line 4-4 in Figure 3. [Figure 5] Figure 5 discloses a perspective view of another system for surgical procedures, including a physical anatomical model, a light source in non-illumination mode, and a physical anatomical model connected to a positioning device. [Figure 6] Figure 6 discloses a perspective view of the system in Figure 5, where the light source is in illumination mode. [Figure 7] Figure 7 discloses the physical anatomical model of Figure 5, separated from the positioning device. [Figure 8] Figure 8 discloses another diagram of the physical anatomical model shown in Figure 7. [Figure 9] Figure 9 discloses a side view of the physical anatomical model of Figure 7 relative to the imaging device. [Figure 10] Figure 10 discloses the physical anatomical model of Figure 9, which is connected to a positioning device and positioned relative to the imaging device. [Figure 11] Figure 11 discloses the physical anatomical model of Figure 10 in a different position relative to the imaging device. [Figure 12] Figure 12 discloses a method for planning and performing surgical procedures. [Figure 13] Figure 13 discloses a system for forming a physical anatomical model.

[0012] Similar reference numbers and names within various drawings refer to the same elements. [Modes for carrying out the invention]

[0013] This disclosure relates to surgical systems, apparatus, and methods for planning and performing surgical procedures using physical models of anatomical structures. Various surgical procedures can be practiced and trained using these physical anatomical models.

[0014] The disclosed techniques may be used to provide surgeons with training experiences that can be tailored to or adapted to them, based on their skill set, experience, etc. Surgeons may select specific configurations of a virtual anatomical model, which may be fabricated or otherwise formed, to create a physical anatomical model based on the anatomical structure or pathology that the surgeon may intend to treat. In a scenario, a surgeon may be unfamiliar with a particular deformation and may choose to train using that configuration of the physical anatomical model. Surgeons may use the physical anatomical model to train with specific instruments, implants, and other devices that may be intended for a planned surgery. Once training with the physical anatomical model is complete, surgeons may select more challenging cases in subsequent training cycles. Unlike cadavers and femoral mock bones, the physical anatomical model may be associated with a specific patient, which may improve the surgeon's ability to determine how well they performed a surgical procedure on the intended anatomical structure.

[0015] A surgeon, assistant, or other user may interact with a graphical user interface (GUI) to select various parameters or features of a physical anatomical model. Parameters may include anatomical structures, joint types, tissue types, bone density, defect types, color schemes, etc., to form the 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 wishes to train. The specified parameters may be represented in the physical anatomical model.

[0016] The surgeon can interact with the user interface to select a desired case associated with each virtual anatomical model. The surgeon can interact with the user interface to consider previous cases, such as cases of certain excellent surgeons that can be recognized as "absolute criteria" for each treatment. The surgeon may select a case corresponding to the intended patient, or may select a case that closely corresponds to a specific classification.

[0017] The physical anatomical model may be configured to 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 bone 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 can image modifications to the physical anatomical model. The modifications can be compared with a surgical plan to provide feedback to the surgeon.

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

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

[0020] In multiple embodiments, the light source may be configured to be located between one or more bone components and one or more soft tissue components.

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

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

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

[0024] In some embodiments, the first optical module and / or the second optical module may be configured to include an array of light-emitting diodes that can be distributed along one of the first and second reference planes, respectively.

[0025] In some embodiments, the angle may be approximately 90 degrees or greater.

[0026] In some embodiments, the first reference plane may be associated with the front-to-back view of the physical anatomical model. The second reference plane may be associated with the lateral view of the physical anatomical model.

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

[0028] A physical anatomical model for surgical procedures according to one embodiment may include opaque bone components representing bone. Transparent or translucent soft tissue components may represent soft tissue. The soft tissue components may be arranged around the bone components. A light source may be located between the bone components and the soft tissue components. The light source may include a plurality of light modules that can be distributed around the bone components.

[0029] In some embodiments, multiple optical modules may be independently controllable.

[0030] In some embodiments, the optical modules may be configured to include a pair of optical modules that can be offset circumferentially at an angle of about 90 degrees or more with respect to the axis of the structural element.

[0031] A training system for surgical procedures according to one embodiment may include a physical anatomical model, which includes a body representing an anatomical structure. The imaging device may be sized to engage with the imaging device so that the imaging device can face the physical anatomical model.

[0032] In some embodiments, the imaging device may be configured to include one or more receptacles sized to engage with an imaging apparatus.

[0033] In some embodiments, one or more receptacles may consist of multiple slots that can be arranged in a predetermined orientation relative to one another.

[0034] In several embodiments, the mount may be attached to the main body. The mount may be adapted to detachably secure a physical anatomical model to a positioning device.

[0035] A method for rehearsing a surgical procedure according to one embodiment may include defining a virtual anatomical model related to anatomical structures. The method may include forming layers of material to form a physical anatomical model representing the virtual anatomical model. The layers of material may form a main body. The main body may include bone components having a surface contour representing bone. The bone components may include opaque material. The main body may include soft tissue components representing soft tissue. The soft tissue components may include transparent or translucent material. The method may include embedding a light source within the main body.

[0036] In some embodiments, the layers of material may have different elastic moduli that substantially correspond to the elastic moduli of each part of the anatomical structure.

[0037] In several embodiments, the method may be configured to include activating the light source in a first mode to highlight bone components, and activating the light source in a second mode to highlight soft tissue components. The first and second modes may be associated with different frequencies.

[0038] In some embodiments, the light source may be configured to include a first optical module and a second optical module. The method may also be configured to operate the first optical module and the second optical module independently to illuminate the respective areas of the main body.

[0039] In this embodiment, the main body may be configured to extend along a first axis. The first and second optical modules may be offset from each other circumferentially with respect to the first axis.

[0040] In some embodiments, the method may include a configuration in which a physical anatomical model is positioned relative to an imaging device. The method may also include a configuration in which an imaging device is positioned within the imaging device. The method may also include a configuration in which a physical anatomical model is modified. The method may also include a configuration in which the imaging device captures one or more images of the modified physical anatomical model when illuminated by a light source.

[0041] In some embodiments, the method may be configured to include comparing one or more images of a modified physical anatomical model with another instance of a virtual anatomical model. The method may also be configured to generate indicators in response to the comparison step.

[0042] Figure 1 shows a planning system 20 that may be used to plan surgical procedures. System 20 may be used to plan orthopedic procedures, including preoperative, intraoperative, and / or postoperative stages, in order to create, edit, execute, and / or review surgical plans. System 20 may be used for training and practice for various surgical procedures, including previous patient cases and surgical plans, as well as hypothetical cases.

[0043] The system 20 may be configured to include a host computer 21 and one or more client computers 22. The host computer 21 may be configured to run one or more software programs. In some embodiments, the host computer 21 may be configured to include two or more computers jointly configured to process software instructions sequentially or in parallel.

[0044] The host computer 21 may be configured to communicate with one or more networks, such as a network 23 consisting of 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 be configured to include one or more of the following: a computer processor, memory, storage means, network devices, and input and / or output devices and / or interfaces. The input devices may include a keyboard, mouse, etc. The output devices may include a monitor, speaker, printer, etc. The memory may include UVPROM, EEPROM, FLASH, RAM, ROM, DVD, CD, hard drive, or other computer-readable media capable of storing data and / or other information related to the configurations and technologies disclosed herein. The host computer 21 and each client computer 22 may be a desktop computer, laptop computer, smartphone, tablet, or any other computing device. The 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 the client interface 24 or via the network 23. Each client computer 22 may be configured to run one or more software programs, such as various surgical instruments. Each client computer 22 may be able to access the planning environment 26 and operate it locally and / or remotely. The planning environment 26 may be a standalone software package or may be configured to 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 the 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 the display or visualization of one or more virtual anatomical models 29 and associated images, and / or one or more implant models 30, via one or more graphical user interfaces (GUIs). 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 be configured to include at least one storage system 27 which may be capable of operating to store data on other computing devices or otherwise provide data. The storage system 27 may be a storage area network (SAN) configured to communicate with the host computer 21 and / or client computers 22 via the network 23. In some embodiments, the storage system 27 may be configured to be embedded within the host computer 21 and / or client computers 22, or it may be directly coupled to the host computer 21 and / or client computers 22. The storage system 27 may be configured to store one or more of the following: computer software instructions, data, database files, configuration information, etc.

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

[0050] The system 20 may be configured to include one or more databases 28. The databases 28 may be configured to be stored in a central location, such as a storage system 27. In some embodiments, one or more databases 28 may be configured to be stored on a host computer 21 and / or distributed databases provided by one or more 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. The database 28 may be configured to store data corresponding to the anatomical models 29, implant models 30, and surgical plans 31 in one or more database records or entries and / or 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 the anatomical structures of each patient from previous and / or planned surgical cases and may be classified into one or more predetermined categories such as sex, age, ethnicity, size, defect category, and type of procedure. The anatomical models 29 and / or implant models 30 may be associated with their respective instruments and devices in order to carry out the relevant surgical plan 31.

[0051] System 10 may be configured to include one or more imaging devices 16, or to interface with one or more imaging devices 16. Each client computer 22 and / or host computer 21 may be configured to be coupled to one or more of the imaging devices 16. Each imaging device 16 may be configured to acquire or capture one or more images 41 relating to anatomical structures present within the scan field (e.g., window) of the imaging device 16. The imaging device 16 may be configured to acquire or capture two-dimensional (2D) and / or three-dimensional (3D) grayscale and / or color images. Various imaging devices 16 can be used, including but not limited to X-ray machines, computed tomography (CT) machines, or magnetic resonance imaging (MRI) machines for acquiring one or more images of a patient. The imaging device 16 may be configured to include personal computers (e.g., laptops or tablets), mobile devices such as mobile phones or digital cameras. The planning environment 28 may be configured to interact with one or more of the imaging devices 16 to acquire or capture images 41.

[0052] Each anatomical model 29 may include information obtained from one or more medical devices or tools capable of obtaining one or more images of a patient's anatomical structure, including any imaging device disclosed herein. The anatomical model 29 may include one or more digital images and / or coordinate information related to a patient's anatomical structure, obtained 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 given design. The planning environment 26 may be configured to incorporate and / or interface with one or more modeling packages, such as computer-aided design (CAD) packages, to render the models 29, 30 as two-dimensional (2D) and / or three-dimensional (3D) volumes or structures. 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 structures within a display.

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

[0054] Each surgical plan 31 may be configured to be associated with one or more anatomical models 29 and / or implant models 30. The surgical plan 31 may include information relating to one or more modifications of the anatomical model 29, as well as the position of the implant model 30 relative to the original and / or modified anatomical model 29. The surgical plan 31 may also 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 automatically and / or in response to user interaction with the system 20, stored in the database 28.

[0055] The planning environment 26 may be provided to one or more surgeons, assistants, and other clinical users via a client computer 22, and may be configured so that one or more surgeons, assistants, and other clinical users can simultaneously access each anatomical model 29, implant model 30, and surgical plan 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 be configured to store local instances of the anatomical models 29, implant models 30, and / or surgical plans 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 it may be provided as one or more services running on the host computer 21.

[0056] Figure 2 shows a surgical system 120 according to one embodiment. System 120 is used to facilitate the planning, practice, and / or training for surgical procedures. System 120 can be used to plan, practice, train, and perform various orthopedic and other surgical procedures, such as arthroplasty to repair joints. System 120 can be used when planning the excision or modification of one or more bones. System 120 can be used when planning the placement of implants to restore the function of bone and / or joints. Planning system 120 can be used for repair and surgical procedures at various locations in the patient, such as the repair of joints such as the shoulder, foot, ankle, wrist, hand, hip, or knee, and the repair of other tissues such as cartilage, muscle, tendon, and ligament.

[0057] System 120 may be configured to generate one or more physical anatomical models 148, including any of the physical anatomical models disclosed herein. A surgeon may make one or more modifications to the physical anatomical models 148 to practice or train for surgical procedures. System 120 may be configured to generate one or more configurations 145 associated with each physical anatomical model 148. The configurations 145 may be used to form the physical anatomical models 148. Each physical anatomical model 148 may represent a virtual anatomical model 129, including substantially or generally corresponding geometric shapes, textures, densities, porosity, colors, etc. The virtual anatomical model 129 may be associated with anatomical structures such as the anatomical structures of a patient and / or hypothetical anatomical structures. The anatomical model 129 may be a configuration that includes one or more anatomical features. The anatomical features may represent anatomical structures including one or more bones including cartilage, cortex and / or cancellous bone tissue, soft tissues including muscles, ligaments and / or tendons, and / or other tissues.

[0058] System 120 may be configured to include a computing device 132. The computing device 132 may be configured to include at least one processor 133 coupled to memory 134. The computing device 132 may be configured to include any of the computing devices disclosed herein, such as the host computer 21 and / or client computer 22 in Figure 1. The processor 133 may be configured to run a planning environment 126 for creating, editing, executing, and / or reviewing one or more surgical (e.g., preoperative) plans 131 during the preoperative, intraoperative, and / or postoperative stages of a surgical procedure. The processor 133 may be configured to access one or more virtual anatomical models 129 from a storage location, such as memory 134. The anatomical models 129 and surgical plans 131 may be associated with actual patient cases or may be hypothetical cases formed for the practice and / or training of surgeons, assistants, medical staff, and other clinical users.

[0059] The planning environment 126 may be configured to include at least a data module 135, a display module 136, a spatial module 137, and a comparison module 138. The processor 133 may be configured to run the data module 135, the display module 136, the spatial module 137, and the comparison module 138. Although four modules are disclosed in the embodiment of Figure 2, it should be understood that three or fewer or five or more modules may be used, 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, read, 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 some embodiments, the data and other information may be stored in one or more files that can be accessed by referencing one or more objects or memory locations referenced by the records 139.

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

[0062] 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 data module 135. Data module 135 may be configured to cause memory 134 to store local instances of anatomical models 129, implant models 130, and / or surgical plans 131, which may be synchronized with records 139 in database 128.

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

[0064] Each surgical plan 131 may be associated with one or more (e.g., original) hypothetical anatomical models 129 prior to any modifications that can substantially or generally approximate the anatomical structure. Each surgical plan 131 may be associated with one or more (e.g., modified or altered) hypothetical anatomical models 129 that may incorporate one or more modifications or changes to the anatomical structure and / or related physical anatomical models. The original anatomical model 129 and the modified anatomical model 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. The system may also be configured to allow a surgeon, assistant, or other clinical user to interact with the link to review and edit the surgical plan 131. The interaction with the link may be configured to cause the planning system 120 to display aspects of the surgical plan 131 in the graphical user interface 142 or to present them in another way.

[0066] The planning system 120 may be used to form one or more physical anatomical models 148, including any of the physical anatomical models disclosed herein. The physical anatomical models 148 may represent an associated virtual anatomical model 129. The imaging device 16 may be configured to be used to acquire one or more images 141 of the physical anatomical models 148 before, during, and / or after any modifications. The system 120 may be configured to associate the images 141 with the physical anatomical models 148, including those in the database 128.

[0067] Figures 3 and 4 disclose a system 250 for a single-act surgical procedure. The system 250 may include a physical anatomical model 248. The physical anatomical model 248 may include a body 252. The body 252 may represent one or more anatomical structures, such as bones and / or joints, including any of those disclosed herein. The body 252 may include an external surface contour 252E. The body 252 may include one or more components (e.g., anatomical features) 254. The components 254 may represent anatomical structures, such as one or more bones including cartilage, cortex and / or cancellous bone tissue, soft tissues including muscles, ligaments and / or tendons, and / or other tissues.

[0068] Component 254 may be configured to include one or more bone components 254B representing each bone and / or one or more soft tissue components 254S representing soft tissue. In some embodiments, 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 each bone. Bone component 254B may be configured to include a first portion 254B-1 forming the surface contour 254BC and a second portion 254B-2 embedded in the first portion 254B-2 (Figure 4). The first portion 254B-1 may represent cortical bone. The second portion 254B-2 may represent cancellous bone. Soft tissue components 254S may be configured to be arranged around and / or otherwise along the periphery of bone components 254B.

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

[0070] Component 254 may be formed from any of the materials disclosed herein, including opaque materials, translucent materials, and / or transparent materials. In some embodiments, bone component 254B may be translucent or substantially opaque. Soft tissue component 254S may be translucent or substantially transparent. For the purposes of this disclosure, the term “substantially” means ±10 percent of the stated values ​​or relationships unless otherwise indicated. Bone component 245B may be formed from substantially rigid materials such as polymer materials including photopolymers, silicones, and thermoplastics. Soft tissue component 254S may be formed from relatively flexible materials such as elastomer materials such as rubber or silicone.

[0071] The system 250 may be configured to include a light source 256 for illuminating the physical anatomical model 248. The light source 256 may be embedded in the body 252 of the physical anatomical model 248. The light source 256 may be positioned between one or more bone components 254B and one or more soft tissue components 254S. In other embodiments, the light source 256' may be outside the body 252 (indicated by a dashed line). Various light sources, such as incandescent, fluorescent, halogen, and / or light-emitting diodes (LEDs), can be used to illuminate the physical anatomical models disclosed herein. The 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] The light source 256 may be configured to produce 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 by the visible 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). The light source 256 may be configured to produce light characterized by various hues, saturations, and / or luminances.

[0073] The light source 256 may be configured to include multiple modes associated with separate frequencies and / or frequency ranges of visible and / or invisible light. The multiple modes may be configured to include first and second modes, each associated with a first and second frequency range. The components 254 may be configured to incorporate materials that respond to one or more frequencies and / or frequency ranges, so that the components 254 can be illuminated independently and distinctly from one another. In some embodiments, one or more bone components 254B may be configured to include a first material that responds to light in a first frequency range but does not respond to light in a second frequency range. One or more soft tissue components 254S may be configured to include a second material that responds to light in a second frequency range but does not respond to the first frequency range.

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

[0075] The light source 256 may be configured to include one or more optical modules 258. The optical modules 258 may be spaced apart from each other. The optical 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 the embodiment, one or more optical modules 258” may be at least partially embedded within one or more bone components 254B (Figure 4). The optical modules 258 may be independently controllable. The system 250 may include a control device 259 (Figure 3). The control device 259 may be electrically coupled to each of the optical modules 258. The control device 259 may be configured to independently control the optical modules 258. The optical modules 258 may be distributed around the bone components 254B with respect to axis X. The light source 256 may include one or more pairs of optical modules 258, such as a first optical module 258-1 and a second optical module 258-2 spaced apart from the first optical module 258-1. The first and second optical modules 258-1 and 258-2 may be independently controllable.

[0076] Referring to Figure 4, continuing with Figure 3, the first optical module 258-1 may be configured to extend along the first reference plane REF1. The second optical module 258-2 may be configured to extend along the second reference plane REF2. The first and / or second reference planes REF1, REF2 may be configured to extend along the axis X of the body 252. The first and second reference planes REF1, REF2 may be offset circumferentially to form an angle α. The angle α may be acute, perpendicular, or obtuse. In some embodiments, the angle α may be about 90 degrees or more. The first and second optical modules 258-1, 258-2 may be offset circumferentially at an angle α of about 90 degrees or more with respect to the axis of the frame component 254B and / or the axis X of the body 252.

[0077] In several embodiments, the system 250 may be configured to include third and fourth optical modules 258-3 and 258-4. The third optical module 258-3 may be configured to extend along a first reference plane REF1. The fourth optical module 258-4 may be configured to extend along a second reference plane REF1. The first optical module 258-1 and the third optical module 258-3 may be configured to be located on both sides of the bone component 254B. The second optical module 258-2 and the fourth optical module 258-4 may be configured to be located on both sides of the bone component 254B. The positions of the optical modules 258 may be configured to be associated with different planes of the anatomical structure (e.g., anterior-posterior, lateral, superior-inferior). The control device 259 may selectively activate the optical modules 258 to highlight the relevant planes of the physical anatomical model 248. In several embodiments, the first reference plane REF1 may be configured to be associated with the anterior-posterior view of the 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 optical modules 258 may include an array of light-emitting diodes (LEDs) distributed along one of the first and second reference planes REF1 and REF2, respectively. In some embodiments, the first optical module 258-1 and / or the second optical module 258-2 may include an array of LEDs distributed along one of the first and second reference planes REF1 and REF2, respectively.

[0079] Figure 5 discloses a system 350 for (e.g., training) surgical procedures. The system 350 may include a physical anatomical model 348. The physical anatomical model 348 may be configured to incorporate any of the physical anatomical model features disclosed herein. The physical anatomical model 348 may represent a foot. The physical anatomical model 348 may be configured to incorporate features representing one or more defects, such as a bunion.

[0080] The physical anatomical model 348 may be configured to include one or more model parts 353. In some embodiments, the model part 353 may be configured to include a first model part 353-1 and a second model part 353-2. The first model part 353-1 may be patient-specific and / or non-reusable. The first model part 353-1 may be associated with each virtual anatomical model 129 (Figure 2). The second model part 353-2 may be reusable and may have a structure that can approximate the geometric shape of an anatomical structure (e.g., an ankle). The second model part 353-2 may be configured not to be associated with a particular patient. The first model part 353-1 may be detachably attached to the second model part 353-2, or it may be fixed otherwise.

[0081] The physical anatomical model 348 may be configured to include one or more components 354 associated with an anatomical structure, including any of the tissues disclosed herein. The components 354 may be configured to include one or more bone components 354B and / or soft tissue components 354S. The system 350 may be configured to include a light source 356. The light source 356 may be formed in the physical anatomical model 348 utilizing any of the techniques disclosed herein. In some embodiments, the first model portion 353-1 may be configured to incorporate the components 354 and / or the light source 356.

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

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

[0084] Referring to Figures 1-8 and continuing to Figures 8-10, a surgeon or clinical user may use instrument 364 (Figure 11) to modify the physical anatomical model 348. Instrument 364 may be a guide or tool such as a drill or saw. Instrument 364 may be used to position one or more surgical devices 366 (Figure 11), such as guide pins and / or compression screws or other fasteners.

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

[0086] The system 350 may include an imaging device 370 (shown by a dashed line). The imaging device 370 may be sized to engage with an imaging device, such as an imaging device 316, so that the imaging device can face the physical anatomical model 348 in a specified orientation. The imaging device 370 may include one or more receptacles 372. Each receptacle 372 may be sized to engage with an imaging device, such as an imaging device 316. The receptacles 372 may include a plurality of slots arranged in a predetermined orientation relative to one another for capturing images of the physical anatomical model 348 in a predetermined orientation. The predetermined orientation may include any of the orientations disclosed herein, such as various planes of the anatomical structure (e.g., anterior-posterior, lateral, superior-inferior). A surgeon or clinical user may control the imaging device 316 to acquire one or more images of the physical anatomical model 348 when the light source 356 is in illumination and / or non-illumination mode. In some embodiments, the system 350 may include one or more stands 374. The stand 374 may extend from the physical anatomical model 348, be incorporated into the physical anatomical model 348, and / or be attached to the physical anatomical model 348. The stand 374 may be sized to support the physical anatomical model 348 and / or to engage with one or more surgical instruments. The stand 374 may be sized to engage with an imaging device, such as an imaging device 316. The stand 374 may be positioned in a predetermined orientation, including any of the orientations disclosed herein. The stand 374 may be incorporated into an imaging device 370. In some embodiments, the imaging device 370 may be omitted.

[0087] Figure 12 discloses a flowchart 380 for planning and performing surgical procedures. Method 380 may be used to preoperatively plan, practice, and / or train for various surgical procedures, such as arthroplasty to restore function to the shoulder, ankle, foot, knee, hip, and one or more other joints with malformations. Method 380 may be used with either the planning systems and virtual and physical anatomical models disclosed herein. Method 380 may be used to evaluate the accuracy with which a surgeon performs a surgical procedure on a physical anatomical model associated with the patient's anatomical structure. Fewer or additional steps may be performed within the scope of this disclosure than those described below, and the order of the steps described is not intended to limit this disclosure. Refer to planning systems 10 and 350, including physical anatomical model 348.

[0088] Referring to Figure 2, and continuing to refer to Figure 12, step 380-1 may involve generating or otherwise defining one or more virtual anatomical models 129. Each virtual anatomical model 129 may be associated with the anatomical structures of a patient and may be generated using any of the techniques disclosed herein.

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

[0090] In step 380-4, one or more implant models 130 may be selected and positioned relative to a 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 the memory of a computer, such as in a database 128 or the memory 134 of a computer 132. The implant models 130 may be associated with any of the implants disclosed herein.

[0091] Step 380-5 may be configured to define one or more embodiments 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 a virtual anatomical model 129 may be configured to set one or more parameters of the virtual anatomical model 129, including any of the parameters disclosed herein. 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 (Figure 3).

[0092] In step 380-6, a configuration 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 herein. A configuration may represent a selected virtual anatomical model 129. Each configuration may be generated in response to selecting a virtual anatomical model 129 in step 380-2 and / or defining a selected virtual anatomical model 129 in step 380-5. A configuration may be formed according to a selection or specification of any parameters associated with the selected virtual anatomical model 129. A configuration may include sufficient data and other information to form a physical anatomical model 148 based on the parameters of the selected virtual anatomical model 129, such as coordinate information, elastic modulus of the associated tissues, and color scheme.

[0093] In step 380-7, one or more physical anatomical models 148 may be fabricated based on the generated configuration 145 or otherwise formed. Each physical anatomical model 148 may be formed using any of the techniques disclosed herein. The physical anatomical models 148 may be monolithic structures or may have one or more parts that are detachably fixed to one another.

[0094] In the embodiment of Figure 13, one or more layers L of material may be printed onto a substrate 482 or otherwise formed to form a physical anatomical model 448. The physical anatomical model 448 may be a configuration representing a virtual anatomical model 129 (Figure 2). A device 484, such as a three-dimensional printer, may be configured to form layers L according to data and other information associated with each configuration 145 (device 484 shown by dashed lines for illustrative purposes). Layers L of material may be configurations that include any of the structures, materials, colorings, textures, porosity, etc., disclosed herein. Layers L may be configurations having respective elastic moduli that substantially correspond to the elastic moduli of each biomaterial of the anatomical structure. 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 tissues.

[0095] Step 380-7 may be configured to form layers L of material to form a 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 relating to their respective tissue types, densities, porosity, color, etc. Step 380-7 may be configured to print the layers L of material onto each other to form one or more components 454 of the physical anatomical model 448, which include any of the components disclosed herein.

[0096] A layer L of material may form the main body 452 of the physical anatomical model 448. The main body 452 may consist of one or more model parts, one or more bone components, and / or one or more soft tissue components. The main body 452 may also consist of one or more model parts 453. The bone components may have a surface contour representing bone. The bone components may consist of an opaque or translucent material. The soft tissue components may represent soft tissue. The soft tissue components may consist of a transparent or translucent material. The layer L of material may consist of a respective elastic modulus that substantially corresponds to the elastic modulus of each part of the anatomical structure.

[0097] Step 380-7 may include a configuration in which one or more light sources 456 are positioned relative to the physical anatomical model 448. The light source 456 may include any of the light sources and optical modules disclosed herein. The light source 456 may include one or more optical modules 458. The light source 456 and optical modules 458 may be positioned according to any of the teachings disclosed herein. Step 380-7 may include a configuration in which the light source 456 is embedded within the body 452. The layer L of material may be formed so that the model portion 453 and / or the physical anatomical model 448 may be monolithic in structure. In some embodiments, one or more light sources 456' and / or optical modules 458' may be positioned along the outer surface of the physical anatomical model 448.

[0098] In step 380-8, the physical anatomical model 348 may be positioned, or otherwise created. The physical anatomical model 348 may be fixed to one or more positioning devices (see, for example, Figures 5-7).

[0099] Referring to Figures 10-11, and continuing to refer to Figure 12, step 380-9 may be configured to perform one or more modifications to one or more physical anatomical models 348. Step 380-9 may be configured to include removing a portion of the physical anatomical model 348 to form a modified physical anatomical model 348. Various modifications may be performed to simulate surgical operations performed on anatomical structures, including one or more modifications disclosed herein, such as incisions, cuts, drilling, reaming, excisions, and transplants (see, for example, Figure 11). Each modification may result in a permanent change to the geometric shape of the physical anatomical model 348.

[0100] In step 380-10, one or more light sources 356 may be selectively activated to illuminate the physical anatomical model 348. Step 380-10 may also include activating the light sources 356 in one or more modes. Step 380-10 may also include activating the light sources 356 in a first mode to highlight one or more bone 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] The light source 356 may be configured to include a first optical module and a second optical module (see, for example, optical modules 258-1 and 258-2 in Figures 3 and 4). Step 380-10 may be configured to operate the first optical module and the second optical module independently to illuminate the respective regions of the body 352 of the physical anatomical model 348. The body 352 may be configured to extend along a first axis (see, for example, axis X in Figures 3 and 4). The first optical module and the second optical module may be configured to be circumferentially offset from each other with respect to the first axis (see, for example, Figures 3 and 4).

[0102] Step 380-11 may be configured to evaluate one or more modifications to one or more physical anatomical models 348 using any of the techniques disclosed herein. Step 380-11 may include positioning the physical anatomical model 348 relative to the imaging device 370. The imaging device 316 may be positioned within the imaging device 370. The configuration may involve a surgeon or clinical user modifying the physical anatomical model 348. The configuration may involve the surgeon or clinical user causing the imaging device 316 to acquire one or more images 341 of the physical anatomical model 348 when illuminated by the light source 356, including before, during, and / or after modification of the physical anatomical model 348. The configuration may involve the surgeon or clinical user causing the imaging device 316 to acquire a set of images 341 of the physical anatomical model 348 at one or more positions and orientations, including any of the positions and orientations disclosed herein. Each set of images 341 may consist of one or more images 341 capturing one or more illuminated states and / or one or more unilluminated states of the physical anatomical model 348.

[0103] Step 380-11 may be configured to generate a virtual anatomical model 129 (Figure 2) based on a modified (e.g., revised) physical anatomical model 348. Step 380-11 may be configured to compare one or more modified physical anatomical models 348 with a surgical plan 131. In some embodiments, one or more modified physical anatomical models may be configured to compare a predetermined geometric shape of one or more virtual anatomical models associated with a surgical plan. Step 380-11 may be configured to generate one or more indicators, including any of the indicators disclosed herein.

[0104] The novel apparatus and methods of this disclosure provide versatility in planning, practicing, and training surgical procedures using physical anatomical models. The physical anatomical models may represent various anatomical structures. One or more light sources may be used to selectively illuminate the physical anatomical models.

[0105] While 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. It is possible to use some components or features from any of the non-limiting embodiments in combination with components or features from any of the other non-limiting embodiments.

[0106] It should be understood that similar reference numerals are used to identify corresponding or similar elements throughout several drawings. While the configurations of specific components are disclosed and illustrated in these exemplary embodiments, it should also be understood that other configurations may also benefit from the teachings of this disclosure.

[0107] The foregoing statements should be interpreted as illustrative and not in any restrictive sense. Those skilled in the art will understand that certain modifications may also fall within the scope of this disclosure. For these reasons, the following claims should be considered to determine the true scope and content of this disclosure.

Claims

1. A training system for surgical procedures, A physical anatomical model that includes the main body representing the anatomical structure, The imaging device comprises an imaging instrument sized to engage with the imaging device so that the imaging device faces the physical anatomical model, The imaging device includes one or more receptacles sized to engage with the imaging apparatus, The one or more receptacles described above are a plurality of slots arranged in a predetermined orientation relative to one another, A training system in which the light source is operable in a first frequency range and in a second frequency range, the bone components are made of a material that reacts to light in the first frequency range, the soft tissue components are made of a material that reacts to light in the second frequency range, and the first and second frequency ranges are included in a predetermined frequency range.

2. One or more images of the physical anatomical model that has been trained for the surgical procedure are captured by the imaging device, compared with the surgical plan, and an indicator is generated in response to the result of the comparison. The training system according to claim 1.

3. The training system according to claim 1, further comprising a mount attached to the main body, which is adapted to detachably secure the physical anatomical model to a positioning device.

4. A method of practicing for surgical procedures, Defining a hypothetical anatomical model associated with anatomical structures, Forming layers of multiple materials to form a physical anatomical model representing the virtual anatomical model, wherein the layers of materials form a main body, and the main body is A bone component having a surface contour representing bone, wherein the bone component includes an opaque material, To form a physical anatomical model that includes soft tissue components representing soft tissue, which include soft tissue components made of transparent or translucent material, The light source is embedded within the main body, Positioning the aforementioned physical anatomical model relative to the imaging device, Positioning the imaging device within the imaging apparatus, When practice for the surgical procedure is performed using the physical anatomical model, the imaging device is made to capture one or more images of the physical anatomical model being practiced when illuminated by the light source. A method including, The above method further, This includes emitting light from the light source in a first frequency range and emitting light from the light source in a second frequency range. A method wherein the bone components are made of a material that responds to light in the first frequency range, and the soft tissue components are made of a material that responds to light in the second frequency range, and the first and second frequency ranges are included in a predetermined frequency range.

5. The method according to claim 4, wherein each layer of the material has a corresponding elastic modulus substantially corresponding to the elastic modulus of each part of the anatomical structure.

6. The light source includes a first optical module and a second optical module, and the first and second optical modules are arranged adjacent to the structural component. The method according to claim 4 or 5, further comprising operating the first optical module and the second optical module independently to illuminate the respective areas of the main body.

7. The aforementioned body extends along the first axis, The method according to claim 6, wherein the first optical module and the second optical module are offset from each other in the circumferential direction of the bone component around the first axis.

8. Comparing one or more images of the physical anatomical model on which the practice was performed with the surgical plan, In response to the aforementioned comparison step, an indicator is generated, The method according to claim 4 or 5, further comprising:

Images