Apparatus, system, and method for patient-specific models

Abstract

Disclosed are devices, systems, and methods for providing a three-dimensional (3D) physical model of a surgical procedure. In some aspects, the device, system, and / or method may include generating a computerized bone model of a patient's deformed bony anatomy based on medical image data of the deformed bony anatomy. The device may also include fabricating a 3D physical bone model of the deformed bony anatomy based on the computerized bone model. The device may further include generating a computerized instrument model of an instrument configured to be used in the surgical procedure to improve the deformed bony anatomy. In addition, the device may include fabricating the instrument based on the computerized instrument model. The device may further include providing the 3D physical bone model and the instrument to a user.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of and priority to U.S. Provisional Application No. 63 / 446,782, filed February 17, 2023, the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to surgical devices, systems, instruments, and methods. More particularly, the present disclosure relates to patient-specific guides, implants, instruments, and / or methods of their design and use. [Background technology]

[0003] Various bony conditions can be corrected using surgical procedures in which one or more tendons, ligaments, and / or bones may be cut, replaced, repositioned, reoriented, reattached, fixed, and / or fused. These surgical procedures require the surgeon to properly locate, position, and / or orient one or more osteotomies, fixation guides, fasteners, bone tunnels, attachment points for grafts or soft tissue edges, etc. Determining and locating the optimal or desired position and trajectory for one or more steps of a surgical procedure can be difficult given conventional techniques and instruments.

[0004] Hallux valgus or bunion conditions can cause discomfort, pain, and inconvenience to patients. Among the various different approaches to addressing hallux valgus or bunion conditions, Lapidus arthrodesis, or simply the Lapidus procedure, is a common surgical procedure to address this condition. Advances in medical imaging, preoperative planning, and modeling have led to improvements to help surgeons perform Lapidus surgical procedures. An increasing number of surgeons are using preoperative planning software and / or models, including virtual rehearsals, to prepare for surgical procedures. However, the convenience and precision offered by software tools, graphical user interfaces, augmented reality, or virtual reality are not the same as the tangible, three-dimensional experience of performing a surgical procedure. During an examination or surgical procedure, surgeons can handle and feel the patient's bones and other anatomical structures, providing important feedback on how anatomical parts move and interact.

[0005] Currently, three-dimensional models of a patient's anatomy exist. However, a surgeon's preparation could be enhanced if he or she could hold, review, inspect, manipulate, and / or rehearse a physical model that includes deformations that match those presented by the patient. Furthermore, a surgeon's preparation could be enhanced if, at one or more stages of a surgical procedure, the surgeon had a three-dimensional physical model of the patient's anatomy, including the post-operative state of the anatomy. What is needed is a solution that uses a three-dimensional physical model of the patient's anatomy to facilitate pre-operative planning, or modeled corrections, and / or modeled procedure implementation before, during, and after the actual surgical procedure. The present disclosure provides such a solution. Summary of the Invention

[0006] The various apparatus, devices, systems, and methods of this disclosure have been developed in response to the current state of the art, and in particular in response to problems and needs in the art that have not yet been fully solved by currently available apparatus, devices, systems, and / or methods.

[0007] One or more computer systems can be configured to perform particular operations or actions by having software, firmware, hardware, or a combination thereof installed on the system that causes the system to perform the actions during operation. One or more computer programs can be configured to perform particular operations or actions by containing instructions that, when executed by a data processing device, cause the device to perform the actions.

[0008] In general, in one aspect, a method may include generating a computer model of a patient's deformed bony anatomy based on medical image data of the deformed bony anatomy. The method may also include fabricating a 3D physical bone model of the deformed bony anatomy based on the computer model. The method may further include providing the 3D physical bone model to a user. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method.

[0009] Implementations may include one or more of the following features: In the method, the deformed bony anatomy may include a plurality of bones of the patient, and fabricating the 3D physical bone model may include coupling two physical bone models of the 3D physical bone model by interconnections such that the two physical bone models connect to corresponding bones of the patient of the deformed bony anatomy.

[0010] In the method, the interconnection may include an interface, and the interface may be configured to allow a user to reposition one physical bone model relative to another physical bone model coupled to the interface. In the method, the interconnection may include a rigid interconnection. In the method, the interconnection may include a detachable interconnection. In the method, fabricating the 3D physical bone model may include coupling multiple physical bone models of the 3D physical bone model by multiple interconnections, and the multiple interconnections may include rigid interconnections and detachable interconnections.

[0011] In the method, fabricating the 3D physical bone model may include providing an indicator to the physical bone model of the 3D physical bone model, the indicator may be configured to convey information about at least one of the bony anatomy, the patient, and the surgical procedure. In the method, the indicator identifies a physical bone model corresponding to a bone of the patient having a deformed bone condition. The method includes fabricating a 3D physical instrument of a patient-specific instrument configured for use with the patient's deformed bony anatomy for the surgical procedure. In the method, the 3D physical instrument may include a bone engaging member, the bone engaging member may be configured to engage a bone of the deformed bony anatomy and to engage the physical bone model of the 3D physical bone model corresponding to the bone of the deformed bony anatomy. Implementations of the described technology may include hardware, a method or process, or a tangible computer medium.

[0012] In general, in one aspect, a method may include generating a computer model of a patient's bony anatomy based on medical image data of the bony anatomy. The method may also include generating a modified computer model of the bony anatomy, where the modified computer model may be modified from the computer model of the bony anatomy such that the modified computer model represents the bony anatomy after the surgical procedure. The method may further include fabricating a pre-operative 3D physical bone model of the bony anatomy based on the computer model of the bony anatomy before the surgical procedure. Additionally, the method may include fabricating a post-operative 3D physical bone model of the bony anatomy after the surgical procedure based on the modified computer model. The method may further include providing at least one of the pre-operative 3D physical bone model and the post-operative 3D physical bone model to a user. Other embodiments of this aspect include corresponding computer systems, apparatuses, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method.

[0013] Implementations may include one or more of the following features. In the method, generating the modified computer model may include modifying the computer model based on a prescription provided by the surgeon. In the method, generating the modified computer model may further include modifying the computer model in response to user input. The method includes providing an indicator to one of the preoperative 3D physical bone model and the postoperative 3D physical bone model that distinguishes the preoperative 3D physical bone model from the postoperative 3D physical bone model. In the method, the modified computer model is configured to improve a deformed bony condition of the bony anatomical structure. The method includes fabricating a second postoperative 3D physical bone model based on the computer model of the bony anatomical structure. Implementations of the described techniques may include hardware, a method or process, or a tangible computer medium.

[0014] In general, in one aspect, a method may include generating a computerized bone model of a patient's deformed bony anatomy based on medical image data of the deformed bony anatomy. The method may also include fabricating a 3D physical bone model of the deformed bony anatomy based on the computerized bone model. The method may further include generating a computerized instrument model of an instrument configured for use in a surgical procedure to improve the deformed bony anatomy. Additionally, the method may include fabricating the instrument based on the computerized instrument model. The method may further include providing the 3D physical bone model and the instrument to a user. Other embodiments of this aspect include corresponding computer systems, apparatuses, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method.

[0015] Implementations may include one or more of the following features: In the method, the instrument is a patient-specific instrument including a bone engaging member, the bone engaging member configured to engage a bone of the deformed bony anatomy and to engage a physical bone model of the 3D physical bone model corresponding to the bone of the deformed bony anatomy. Implementations of the described technology may include hardware, a method or process, or a computer tangible medium.

[0016] In general, in one aspect, a kit may include a first 3D physical bone model of a patient's deformed bony anatomy for an osteotomy procedure. The kit may also include a pre-operative plan for the osteotomy procedure. Additionally, the kit may include a set of patient-specific instruments for one or more stages of the osteotomy procedure. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method.

[0017] Embodiments may include one or more of the following features. The kit may further include a second 3D physical bone model including a plurality of physical bone models connected by a plurality of interconnections, wherein the plurality of physical bone models may be connected according to a predetermined configuration. The kit may further include that the predetermined configuration is selected from the group including an anatomical upright position, a normal position, a weight-bearing position, a one-stage walking position, a one-stage running position, a one-stage jumping position, a one-stage gripping position, a dorsiflexion position, a plantarflexion position, an external rotation position, an internal rotation position, a pronation position, a supination position, a deformed state, a corrected state, a pre-operative state, and a post-operative state. Embodiments of the described technology may include hardware, a method or process, or a tangible computer medium.

[0018] Advantages, nature, and additional features of exemplary embodiments of the present disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings, in which: Exemplary embodiments of the present disclosure will be described with additional specificity and detail through the use of the accompanying drawings, with the understanding that these drawings represent exemplary embodiments only and therefore are not to be considered limiting of the scope of the disclosure. [Brief explanation of the drawings]

[0019] [Figure 1A] FIG. 1 is a flow chart diagram illustrating a method for improving a condition, according to one embodiment. [Figure 1B] FIG. 1 is a flow chart diagram illustrating a method for improving a condition, according to one embodiment. [Figure 2A] FIG. 1 is a dorsal perspective view of the bones of the foot. [Figure 2B] A lateral perspective view of the bones of the foot. [Figure 2C] A perspective view of the medial side of the foot bones. [Figure 2D] FIG. 1 is a dorsal perspective view of the bones of the foot. [Figure 2E] FIG. 1 is a diagram of the foot showing the common reference plane of the human foot. [Figure 3] FIG. 1 is a flowchart illustrating a method for creating one or more patient-specific devices configured to address a bone condition, according to one embodiment. [Figure 4] 1 illustrates an exemplary system configured to create one or more patient-specific devices configured to address a bone condition, according to one embodiment. [Figure 5] 1 illustrates an exemplary device configured to determine position, patient-specific characteristics, and / or trajectory, according to one embodiment. [Figure 6] 1 illustrates an exemplary provisioning module configured to provide a preliminary guide model, according to one embodiment. [Figure 7] 1 illustrates an exemplary design module configured to design a patient-specific guide model, according to one embodiment. [Figure 8] 1 illustrates an exemplary system configured to create one or more patient-specific devices configured to address a bone condition, according to one embodiment. [Figure 9] 1 illustrates a method for providing a customer with a three-dimensional (3D) physical bone model, according to one embodiment. [Figure 10] 1 illustrates a method for providing a customer with a 3D physical bone model, according to one embodiment. [Figure 11] 1 illustrates a method for providing a 3D physical model to a customer, according to one embodiment. [Figure 12] 1 illustrates a method for providing a customer with a 3D physical bone model, according to one embodiment. [Figure 13] 1 illustrates an exemplary system, according to one embodiment. [Figure 14A] 1 illustrates an exemplary model, according to one embodiment. [Figure 14B] 1 illustrates an exemplary model, according to one embodiment. [Figure 15A] 1 illustrates an exemplary model, according to one embodiment. [Figure 15B] 1 illustrates an exemplary physics instrument, according to one embodiment. [Figure 16] 1 illustrates an exemplary 3D physical bone model, according to one embodiment. [Figure 17] 1 illustrates an exemplary system, according to one embodiment. [Figure 18] 1 illustrates a method for providing a 3D physical model of a surgical procedure, according to one embodiment. [Figure 19] 1 illustrates a method for providing a 3D physical model of a surgical procedure, according to one embodiment. [Figure 20A] 1 illustrates an exemplary user interface for interfacing with a computer model of a surgical procedure, according to one embodiment. [Figure 20B] 1 illustrates an exemplary user interface for interfacing with a computer model of a surgical procedure, according to one embodiment. [Figure 20C] 1 illustrates an exemplary 3D physical bone model, according to one embodiment. [Figure 21] 1 illustrates a method for providing a 3D physical model of a surgical procedure, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0020] Exemplary embodiments of the present disclosure will be best understood by reference to the drawings, in which like parts are designated with like numerals throughout. It will be readily understood that the components, as generally described herein and illustrated in the drawings, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of embodiments of devices, systems, and methods is not intended to limit the scope of the present disclosure, but is merely representative of exemplary embodiments.

[0021] The phrases "connected to," "coupled to," and "in communication with" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interactions. Two components can be functionally coupled to one another even if they are not in direct contact with one another. The term "abutment" refers to items that are in direct physical contact with one another, although the items are not necessarily attached together. The phrase "fluid communication" refers to two features that are joined such that fluid in one feature can enter the other feature.

[0022] As used herein, "coupling," "coupling member," or "coupler" refers to a mechanical device, apparatus, member, component, system, assembly, or structure that is organized, configured, designed, arranged, or engineered to connect or facilitate the connection of two or more parts, objects, or structures. In certain embodiments, a coupling can connect adjacent parts or objects at their ends. In certain embodiments, a coupling can be used to connect two shafts together at their ends for the purpose of transmitting power. In other embodiments, a coupling can be used to join two parts of rotating equipment but allow for some misalignment or end movement, or both. In certain embodiments, a coupling may not allow the two parts, such as shafts, to decouple during operation. (Search "coupling" at Wikipedia.com. Revised July 26, 2021 under CC-BY-SA3.0. Accessed July 27, 2021). A coupler may be flexible, semi-flexible, pliable, elastic, or rigid. A coupler may join either of two structures directly, by directly coupling one structure and / or the other, or indirectly, by indirectly coupling one structure, the other, or both (through one or more intermediate structures).

[0023] The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. While various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.

[0024] Standard medical reference planes and descriptive terminology are used in this disclosure. These terms are generally used to refer to the human body, although specific terms are generally applicable to objects. A standard system of three mutually perpendicular reference planes is used. The sagittal plane divides the body into right and left portions. The coronal plane divides the body into anterior and posterior portions. The transverse plane divides the body into upper and lower portions. The midsagittal, midcoronal, or midtransverse planes divide the body into equal portions, which may be bilaterally symmetrical. The intersection of the sagittal and coronal planes defines the superior-inferior or craniocaudal axis. The intersection of the sagittal and transverse planes defines the anterior-posterior axis. The intersection of the coronal and transverse planes defines the medial-lateral axis. The superior-inferior or craniocaudal axis, the anterior-posterior axis, and the medial-lateral axis are mutually perpendicular.

[0025] Anterior means toward the front of the body. Posterior means toward the back of the body. Superior or cephalad means toward the head. Inferior or caudal means toward the feet or tail. Medial means toward the midline of the body, especially toward a bilateral plane of symmetry of the body. Lateral means away from the midline of the body or away from a bilateral plane of symmetry of the body. Axial means toward the central axis of the body. Dorsal means away from the central axis of the body. Ipsilateral means the same side of the body. Contralateral means the side of the body opposite to the side with a particular condition or structure. Proximal means toward the trunk. Proximal can also mean toward the user, viewer, or operator. Distal can also mean away from the trunk. Distal can also mean away from the user, viewer, or operator. Dorsal means toward the top of the foot or other body structure. Plantar means toward the sole of the foot or toward the bottom of a body structure.

[0026] Anterior means moving forward from a proximal position / location to a distal position / location, or in a forward direction. Reverse means moving backward from a distal position / location to a proximal position / location, or in a backward direction. Sagittal refers to the midline of a patient's anatomy, dividing the body into a left or right half. The sagittal plane can be in the center of the body, dividing the body in two. Prone means that the human body is lying face down. Supine means that the human body is lying face up.

[0027] "Patient-specific guide" refers to a guide that is designed, engineered, and / or manufactured for use by an individual patient. In one aspect, a patient-specific guide is unique to a patient and may include patient-specific features, such as surface contours or other features.

[0028] "Patient-specific cutting guide" refers to a cutting guide that is designed, engineered, and / or manufactured for use by an individual patient. In one aspect, a patient-specific cutting guide is unique to a patient and may include patient-specific features, such as surface contours or other features.

[0029] "Patient-specific resection guide" refers to a guide that is designed, engineered, and / or fabricated for use during resection for an individual patient. In one aspect, a patient-specific resection guide is patient-specific and may include patient-specific features, such as surface contours or other characteristics.

[0030] A "patient-specific instrument" (PSI) refers to a structure, device, guide, tool, instrument, apparatus, member, component, system, assembly, module, or subsystem that is tailored, adapted, modified, organized, configured, designed, arranged, engineered, and / or fabricated to individually address the anatomy, physiology, condition, abnormality, need, or desire of a particular patient. In certain embodiments, the patient is a single patient. In one embodiment, a patient-specific instrument is unique to a single patient and may include patient-specific characteristics such as surface contours, component locations, component orientations, and / or other features. In other embodiments, one patient-specific instrument may be usable by several patients with a particular class of characteristics.

[0031] "Instrument" refers to any apparatus, device, or object that can be used by a user. An instrument may be personalized or general-purpose. An instrument may also be referred to as a kit. A kit may refer to a single instrument and / or multiple instruments. An instrument may be individually designed, constructed, or manufactured for use by a particular user, for single use, and / or for multiple uses. A patient-specific instrument is an example of an instrument.

[0032] A "positioner" or "positioning guide" refers to any structure, apparatus, surface, device, system, feature, or aspect configured to position, move, translate, manipulate, or position one object relative to another object. In certain embodiments, a positioner can be used in a step during a surgical procedure to position, position, orient, and / or reduce one bone or bone fragment relative to another bone or bone fragment. In such embodiments, the positioner may be referred to as a bone positioner. In certain embodiments, the terms positioner or positioning guide may be preceded by an adjective identifying a structure, tool, component, or instrument that may be used in conjunction with, positioned by, and / or guided by the positioner. For example, a "pin positioner" may be configured to accept a pin or a wire, such as a K-wire, and function to position or place the pin relative to another structure, such as a bone.

[0033] As used herein, "preoperative plan" refers to a plan for performing a surgical procedure. Depending on the complexity of the surgery, a preoperative plan can be very simple and general, or very detailed and dedicated to a particular surgical procedure. In one aspect, a preoperative plan may include very detailed and specific step-by-step instructions for a surgical procedure. The instructions may be sequenced according to a dedicated sequence to achieve a desired outcome. In certain embodiments, a preoperative plan may dictate which instruments, machines, systems, tests, and / or personnel need to be used in a surgical procedure. A preoperative plan can take many forms and formats based on the needs and desires of the user of the preoperative plan. In one embodiment, a preoperative plan is a report that can be displayed on a screen or printed on paper. In another embodiment, a preoperative plan may include instructions for surgical planning software. In another embodiment, a preoperative plan may include instructions for a surgical rehearsal tool, including software. In another embodiment, a preoperative plan may include instructions for surgical planning using virtual reality or augmented reality software.

[0034] "Compressor" refers to any apparatus, device, or system that can function as an active compression appliance. A compressor functions to bring two objects into close proximity or contact with one another.

[0035] "Post" refers to any apparatus, structure, device, system, and / or component that extends from another structure. In certain embodiments, the post can be cylindrical.

[0036] "Anatomical position" refers to the standard and accepted reference position used in anatomy and medicine to describe the relative positioning of body structures and anatomical terms. (ChatGPT (Copyright) Rev. 3.5, accessed February 9, 2024 at chat.openai.com / chat).

[0037] A "cut surface" or "kerf" refers to the surface of an object created or formed by removing one or more portions of the object, including the original surface. The cut surface or kerf can be created using a variety of methods, tools, or devices and can be formed using a variety of removal actions, including, but not limited to, fenestrating, drilling, sanding, cutting, sawing, chiseling, scraping, scraping, etc. Tools and / or methods used to create the cut surface or kerf can include manual, mechanical, electric, hydraulic, automated, robotic, etc. In certain embodiments, the cut surface(s) are planar.

[0038] "Fiducial" refers to any apparatus, structure, device, system, component, marking, and / or indicator organized, configured, designed, engineered, and / or positioned to serve as a source of information or comparison point used to support or establish knowledge, truth, or quality. (ChatGPT (Copyright) Revised January 9, accessed January 28, 2023 at chat.openai.com / chat). In certain embodiments, a fiducial can serve as a starting point or initial location for one or more steps during a surgical procedure. In certain embodiments, "fiducial" can be combined with an adjective that describes the fiducial. For example, a "model fiducial" is a fiducial within a model, such as a computer model. A model fiducial refers to any feature, aspect, and / or component within a model. Examples of model fiducials include, but are not limited to, a point, a plane, a line, multiple points, a surface, an anatomical structure, a shape, etc. An "anatomical fiducial" is a fiducial within, on, near, or otherwise associated with an anatomical structure, such as a bone. The reference (eg, model, actual, virtual, and / or real) may also be referred to as a reference feature.

[0039] A "fiducial feature" refers to a feature configured to be used as a point, plane, axis, or line of reference (also known as a fiducial). A fiducial can be used to position, measure, orient, secure, couple, engage, and / or align one object or structure with another object or structure. In certain embodiments, a fiducial or fiducial feature can function as a baseline, ground truth, waypoint, control point, landmark, etc. A fiducial feature can facilitate translating from one coordinate system to a position or orientation on or within a real object, structure, device, apparatus, anatomical structure, etc. Advantageously, a fiducial feature can align an object, model, or structure in a digital or virtual model or representation with a corresponding object or structure (e.g., an anatomical structure) of the real object or structure. In other words, a fiducial feature can aid in mapping from a virtual or modeled object to a real or physical object.

[0040] "Reference feature guide" refers to a guide that serves to assist in forming and / or developing one or more reference features. Examples of reference feature guides include, but are not limited to, holes, round holes, channels, slots, multiple holes, fences, backstops, guards, fasteners, pilot holes, blind holes, chutes, ramps, etc.

[0041] "Anatomical structure" refers to any body part, or any portion of any body part, of a human, animal, or other patient. Examples of anatomical structures include, but are not limited to, a bone, bones, soft tissue, a joint, joints, skin, hard tissue, teeth, mouth, eyes, hair, nails, fingers, toes, legs, arms, torso, vertebrae, ligaments, tendons, organs, etc.

[0042] "Anatomical reference" or "anatomical landmark" refers to any reference or landmark that is, on, within, or otherwise associated with an anatomical structure. Examples of anatomical structures include, but are not limited to, a bone, bones, soft tissue, a joint, joints, skin, hard tissue, teeth, mouth, eye, hair, nail, finger, toe, leg, arm, torso, vertebrae, ligament, tendon, organ, hole, post, holes, posts, etc.

[0043] "Deformity" refers to an abnormality or deviation from the normal shape, structure, orientation, trajectory, or function of a body part. This may be due to a congenital condition, injury, disease, or other factor that alters the normal development or function of a body part. (ChatGPT (Copyright) January 30 version, Chat.openai.com / chat accessed February 7, 2023).

[0044] "Configuration" refers to the arrangement, setup, or values ​​of one or more parts, features, settings, components, aspects, structures, etc. as a module, component, apparatus, device, system, framework, platform, dashboard, assembly, etc. Examples of configurations may include how dials are set up on a dashboard, how levers on a control panel are set, how switches in a controller are set, how bones are arranged in a hand, foot, or limb, etc.

[0045] An "interconnect" refers to a structure configured to join at least two other structures. In one embodiment, the interconnect may be a mechanical structure that can physically connect one structure to another. In other embodiments, the interconnect may be embodied as a fastener that allows one structure to be permanently or temporarily joined to another structure. In yet other embodiments, the interconnect may be embodied as a joint or hinge that can be configured to allow one or both structures joined by the interconnect to move relative to one another while remaining joined. In one embodiment, the interconnect may be configured to convey fluid and / or transmit electrical signals between at least two other structures. For example, the interconnect may include a channel or tube configured to convey air between a first opening and a second opening in the channel or tube. Examples of interconnects include, but are not limited to, pipes, tunnels, chambers, channels, etc. Other examples of interconnects include, but are not limited to, solid materials that can be additively manufactured between two structures, snaps, hook-and-loop fastener systems, springs, tethers, etc.

[0046] As used herein, an “interface,” “user interface,” or “engagement interface” refers to an area, boundary, structure, or location where two separate and / or independent structures, members, devices, assemblies, components, and / or systems join, connect, couple, or otherwise abut, interact, or mechanically and / or electronically communicate with one another. In certain embodiments, an “interface” may refer to a surface that forms a common boundary between two objects, spaces, structures, members, devices, assemblies, components, or phases. (Search “interface” at Merriam-Webster.com. Merriam-Webster, 2021. Web. 15 Nov. Revised November 15, 2021.) In certain embodiments, the term interface may be used with an adjective that identifies the type or function of the interface. For example, an engagement or coupling interface may refer to one or more structures that interact, couple, or join to mechanically join or couple two separate structures, each coupled to its side. In another example, a user interface may refer to one or more mechanical, electrical, or electromechanical structures that interact with or enable a user to provide user input, instructions, input signals, data, or data values ​​and receive output, output data, or feedback.

[0047] As used herein, "handle" refers to a structure used to hold, control, or manipulate a device, apparatus, component, tool, etc. A "handle" may be designed to be grasped and / or held using one or both hands of a user.

[0048] A "rigid interconnect" refers to an interconnect that is rigid such that two structures connected by the interconnect remain in a single position and / or orientation and cannot be repositioned without severing, disconnecting, or unconnecting the interconnect.

[0049] A "removable interconnect" refers to an interconnect that is configured to allow two structures connected by the interconnect to be separated without damaging the interconnect. In certain embodiments, a removably interconnect may connect two structures such that the two structures remain in a single position and / or orientation until the two structures are separated by separating the interconnect.

[0050] An "adjustable interconnect" refers to an interconnect that connects or couples a first structure to a second structure in a single position and / or orientation relative to one another. Additionally, an adjustable interconnect includes devices, components, mechanisms, and / or systems configured to allow adjustment of a single position and / or orientation of at least one of the first structures relative to the second structure. In certain embodiments, the adjustable interconnect can also maintain a new position and / or orientation of the first structure relative to the second structure after an adjustment to the position and / or orientation of at least one of the first structure and the second structure.

[0051] As used herein, an “indicator” refers to an apparatus, device, component, system, assembly, mechanism, hardware, software, firmware, circuit, module, set of data, text, number, code, symbol, mark, marker, or logic that is structured, organized, configured, programmed, designed, arranged, or engineered to convey information or indicate a state, condition, mode, context, position, or location to a user of another apparatus, device, component, system, assembly, mechanism, hardware, software, firmware, circuit, module, and / or apparatus, device, component, system, assembly, mechanism, hardware, software, firmware, circuit, module that contains or is associated with the indicator. An indicator can include one or more of an audible signal, a token, signal presence, signal absence, tactile signal, visual signal or indication, visual marker, visual icon, visual symbol, visual code, visual mark, etc. In certain embodiments, “indicator” can be used with an adjective that describes the indicator. For example, a “mode indicator” is an indicator that identifies or indicates a mode.

[0052] As used herein, "marking" or "marker" refers to an intended, structured, organized, configured, programmed, arranged, or engineered symbol, character, lettering, word, phrase, icon, design, color, diagram, indicator, figure, structure, device, apparatus, surface, component, system, or combination thereof, designed to convey information and / or a message to a user who receives, views, or encounters the marking. Marking or "marker" can include one or more of a tactile signal, a visual signal or indication, an audible signal, or the like. In one embodiment, marking can include several or a set of characters, symbols, or words positioned on a surface, structure, color, color scheme, or device to convey a desired message or set of information.

[0053] As used herein, "graft," "tissue transplant," and / or "bone transplant" refer to a surgical procedure for transferring tissue (hard and / or soft) from one location on the body to another, or from another organism, without the tissue losing its own blood supply. Instead, a new blood supply is developed after the tissue is placed. A similar technique in which tissue is transplanted with an intact blood supply is called a skin flap. (Search "Graft (surgery)" at Wikipedia.com. Revised April 21, 2021. Accessed August 30, 2021.) "Graft" may also be used to refer to tissue and / or artificial compositions used in graft surgical procedures. Bone grafting is a surgical procedure that replaces missing bone to repair fractures. Bone generally has the ability to regenerate completely, but this may require a small fracture space and / or scaffolding. Bone grafts can be autologous (bone harvested from the patient's own body, often from the iliac crest), allograft (cadaveric bone, usually obtained from a bone bank), or artificial (often made from hydroxyapatite (HA) or other naturally occurring, biocompatible materials) with mechanical properties similar to bone. Generally, as the natural bone heals over several months, the grafted bone is expected to be resorbed and replaced. (Search "Bone Grafting" at Wikipedia.com. Revised April 21, 2021. Accessed August 30, 2021). Particular grafts may include autografts, syngrafts, allografts, xenografts, and / or combinations of artificial materials in a single bone graft composition. Examples of such compositions include, but are not limited to, demineralized bone matrix (DBM). The bone graft composition may include bone morphogenetic proteins (BMPs).

[0054] As used herein, "condition" refers to the state of something in terms of its appearance, quality, or working condition. In certain aspects, a condition may refer to the health or strength of a patient, or the health or strength of an organ or anatomical part of a patient. In certain embodiments, a condition may refer to an illness, defect, disease, or deformity of a patient, or an organ or anatomical part of a patient. (Search "condition" at wordhippo.com. WordHippo, 2021. Web. Accessed December 8, 2021.)

[0055] "Bone condition" refers to any of a variety of conditions of a patient's bones. Generally, bone condition refers to the orientation, position, and / or alignment of one or more bones of a patient relative to other anatomical structures in the patient's body. Bone conditions may be caused by or result from deformities, misalignments, malrotations, fractures, joint dysfunction, and the like. Bone conditions include, but are not limited to, any angular deformity of one or more bone segments in either the lower or upper limbs (e.g., tibial deformities, calcaneal deformities, femoral deformities, and radial deformities). Alternatively, or in addition, "bone condition" can refer to the anatomic structure and configuration of one or more bones of a patient. Thus, bone condition can refer to the condition or status of a bone or a region of a bone, such as the head, base, body, protuberances, projections, plates, pores, cortical thickness, bone density, thickness of an internal region, and / or porosity (e.g., calcaneal or solid), along the metaphyseal, epiphyseal, and / or diaphyseal regions.

[0056] "Masked bone condition" refers to any of a variety of conditions of a patient's bones that differ from normal, standard, or accepted bone conditions. Generally, a masked bone condition refers to the orientation, position, and / or alignment of one or more bones of a patient relative to other anatomical structures of the patient's body, and is atypical, abnormal, and / or different from average characteristics. A masked bone condition may be caused by or result from deformity, misalignment, malrotation, fracture, joint dysfunction, etc. A masked bone condition includes, but is not limited to, any angular deformity of one or more bone segments in either the lower or upper limbs (e.g., tibial deformity, calcaneal deformity, femoral deformity, and radial deformity).

[0057] "Data" refers to a set of information organized in a manner that facilitates communication of the information to a receiver. The receiver may be a human, an animal, or an electronic component, circuit, assembly, etc. Data can be represented as signals or values ​​represented by any number and / or alphabetic system. Data can be stored in one representation in analog or digital format and communicated to the receiver in another format suitable for the receiver to interpret and understand the data. Data can include both data that stores individual information and metadata, which is data that describes the data that stores individual information. Data can be organized in structured or unstructured formats. "Structured data" refers to data within a data structure, which is organized according to a predetermined format, protocol, or configuration that can be used to facilitate working with the data. Examples of structured data include, but are not limited to, files, databases, database records, database tables, database schemas, serialized objects, directories, etc. "Unstructured data" refers to data stored without a particular organization, predetermined format, protocol, or configuration. Examples of unstructured data include, but are not limited to, the content of a text message, the content of an email message, the text content of a file, the content of a document, etc. The term "data" is often used in conjunction with one or more adjectives that identify the type or purpose of the data, and examples include "user data," "input data," "output data," "sensor data," "patient data," "system data," "map data," etc. "Sensor data" refers to any data or information registered by one or more sensors. Examples of sensor data include the amount of current passing through a sensor, the amount of voltage across a sensor, the amount of electrical resistance through a sensor, the amount of strain experienced by a sensor, an acceleration vector, a deceleration vector, an orientation, an azimuth angle, a direction, etc.

[0058] As used herein, "implant" refers to a medical device manufactured to replace missing biological structures, support damaged biological structures, or reinforce existing biological structures. While medical implants are often artificial devices, implants can also be naturally occurring structures. The surface of the implant that contacts the body may be made from or include a biomaterial such as titanium, cobalt chromium, stainless steel, carbon fiber, another metal alloy, silicone, a polymer, a synthetic polyvinyl alcohol (PVA) hydrogel, a biomaterial, a biocompatible polymer such as polyetheretherketone (PEEK) or polylactic acid polymer (e.g., PLLA), or apatite, or any combination thereof, depending on whether it is functional and / or economical. Implants can have various configurations and may be entirely and / or include several components that are partially flexible, semi-flexible, pliable, elastic, soft, semi-rigid, or rigid. In some cases, implants, e.g., artificial pacemakers and cochlear implants, include electronic devices. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of an implantable pill or a drug-eluting stent. Orthopedic implants can be used to alleviate bone and / or joint problems in a patient's body. Orthopedic implants can be used to treat fractures, osteoarthritis, scoliosis, spinal stenosis, discomfort, and pain. Examples of orthopedic implants include, but are not limited to, a wide variety of pins, rods, screws, anchors, spacers, sutures, all-suture implants, ball-and-all-suture implants, self-locking suture implants, cross-threaded suture implants, plates used to anchor fractured bones during bone healing or union, and the like. (Search "implant" (medicine) on Wikipedia.com, Revised May 26, 2021, CC-BY-SA 3.0, Accessed June 30, 2021).

[0059] As used herein, "body" refers to the main or central portion of a structure. As a structural component, the body may function to connect, interconnect, surround, encapsulate, and / or protect one or more other structural components. The body may be made from a variety of materials, including, but not limited to, metal, plastic, ceramic, wood, fiberglass, acrylic, carbon, biocompatible materials, biodegradable materials, and the like. The body may be formed from any biocompatible material, including, but not limited to, biocompatible metals such as titanium, titanium alloys, stainless steel alloys, cobalt-chromium steel alloys, nickel-titanium alloys, shape memory alloys such as nitinol, biocompatible ceramics, and biocompatible polymers such as polyetheretherketone (PEEK), polylactic acid polymers (e.g., PLLA), nylon 12, and the like. In one embodiment, the body may comprise a housing or frame, or framework, of a larger system, component, structure, or device. The body may include modifiers that identify a particular function, position, orientation, operation, and / or particular structure associated with the body. Examples of such modifiers applied to the body include, but are not limited to, "lower body," "upper body," "outer body," "inner body," and the like.

[0060] As used herein, "side" refers to a structure or part of a structure, including, but not limited to, one of the boundary surfaces or lines of an object, especially one that is longer than an edge; a line or surface that forms the boundary or face of an object; any surface of a thin object; the boundary or structure of a geometric figure or shape; etc. (Search "side" at Merriam-Webster.com. Merriam-Webster, 2021. Web. Revised August 3, 2021). Side can also refer to the geometric edge of a polygon (a two-dimensional shape) and / or the face or surface of a polyhedron (a three-dimensional shape). (Search "side" at Wikipedia.com. Revised July 21, 2021, CC-BY-SA 3.0. Accessed August 3, 2021). Side can also refer to a location on a structure. For example, a side can be the location on a structure that is furthest from or near the central axis of the structure. As used herein, the term "side" may include one or more modifiers that define, orient, and / or distinguish a side of an object from another side based on the location and / or manner in which the object is deployed within or relative to a second object. For example, in the context of an implant in a patient, the side of the implant may be labeled based on the position of the side relative to the patient when the implant is deployed. As one example, the "anterior side" of an implant, instrument, anatomical structure, or other structure refers to the side that is more anterior than other sides of the structure relative to the patient when the structure is deployed within the patient. As another example, in the context of an instrument used on a patient, the side of the instrument may be labeled based on the position of the side when the instrument is being used for its purpose. As one example, the "front side" of an instrument refers to the side that faces the user of the instrument when the instrument is being used.

[0061] As used herein, a "bone-engaging surface" refers to a surface of an object, instrument, or device, such as an implant, that faces toward or faces one or more bones of a patient. In one aspect, the bone-engaging surface may abut, touch, or contact the surface of the bone. In another aspect, the bone-engaging surface, or portions of the bone-engaging surface, may be near but not abut, touch, or contact the surface of the bone. In certain aspects, the bone-engaging surface can be configured to engage the surface of one or more bones. Such bone-engaging surfaces may include protrusions and indentations that correspond to and match the protrusions and indentations of the one or more bone surfaces.

[0062] A "bone-engaging member" refers to an apparatus, instrument, structure, device, component, member, system, assembly, or module that is structured, organized, configured, designed, arranged, or engineered to connect, join, articulate, contact, touch, abut, interface with, bond to, or engage with bone, bone portions, bone topography (e.g., osteophytes and calcifications), anatomical bone features, and / or bone fragments. The connection, coupling, articulation, contact, or engagement may be a mechanical connection or interconnection. The bone-engaging member may enable temporary engagement with the bone or bone fragment, or permanent engagement with the bone or bone fragment. The bone-engaging member may include a bone-engaging surface, a bone-engaging feature, a body section supporting a bone-engaging surface, or the like. In certain embodiments, the bone-engaging member may include a bone probe or an arthrophilic nuclide. In one embodiment, the bone-engaging member may include a landmark registration feature. Alternatively, or in addition, the bone engaging member can include bone attachment features configured to engage bone and / or cooperate with a fastener to engage bone. A patient-specific bone engaging member is a bone engaging member that includes one or more aspects that are patient-specific. Patient-specific aspects can include, but are not limited to, surface contours, contours for portions of the surface, location of resection features, size, shape, and / or configuration of resection features, location, size, shape, and / or number of bone attachment features, etc.

[0063] As used herein, "bone-facing side" refers to the side of an object, structure, instrument, or apparatus, such as an implant or instrument, that faces toward or faces one or more bones of a patient when a device including the bone-facing side is in use. In one aspect, the bone-facing side may abut, touch, or contact the surface of the bone. In another aspect, the bone-facing side or a portion of the bone-facing side may be near but not abut, touch, or contact the surface of the bone.

[0064] "Non-bone-facing side" refers to the side of an object, structure, instrument, or device, such as an implant or implement, that is not oriented toward and / or faces one or more bones of a patient during use of the device that includes the non-bone-facing side. In certain embodiments, the non-bone-facing side can be the side directly opposite the bone-facing side of the same device, object, structure, or device.

[0065] "Cortical surface" refers to the surface of cortical bone. "Cortical bone" refers to a type of bone tissue. Cortical bone is a type of bone tissue typically found between the outer surface of a bone and the interior region of the bone. Cortical bone is denser and typically structurally stronger than other types of bone tissue.

[0066] A "predetermined position" refers to a position that is previously established, determined, finalized, and / or defined. In certain embodiments, the predetermined position is a desired, designed, and / or engineered position of a first object relative to a second object. Thus, the predetermined position is a planned position of two objects relative to one another. In certain embodiments, one or both of the two objects may move relative to one another to achieve the predetermined position, and the predetermined position may be a final position. In other embodiments, the two objects may move toward the predetermined position but may not reach the exact predetermined position due to some obstacle and / or interference, or a decision to change the predetermined position to a new position. In certain aspects, the predetermined position may be a position determined after a process of recommendation, review, and / or analysis, and final approval, and therefore the position may not become predetermined until the process is complete. For example, in the design process of a patient-specific medical device or technique, the position may not become predetermined until a surgeon or other physician gives final approval of the position. In certain embodiments, the predetermined location may be indicated, designated, illustrated, defined, and / or described in the pre-operative plan.

[0067] As used herein, "deploy" or "deployment" refers to an act, action, process, system, method, means, or apparatus for inserting an implant or prosthesis into a part, body region, and / or patient. "Deploy" or "deployment" can also refer to an act, action, process, system, method, means, or apparatus for placing something for therapeutic use. The device, system, component, agent, drug, compound, or nutrient may be deployed by a human operator, a mechanical device, an automated system, a computer system or program, a robotic system, etc.

[0068] "Joint" or "articulation" refers to the connection between bones in a human or animal body that articulates the skeletal system to form a functional whole. Joints may be classified biomechanically as simple, complex, or polyarticular. Joints may be anatomically classified into groups such as the hand, elbow, wrist, axillary, sternoclavicular, facet, temporomandibular, sacroiliac, hip, knee, and ankle. (Search for "joint" on Wikipedia.com. Revised December 19, 2021, CC-BY-SA3.0. Accessed January 20, 2022.)

[0069] "Contour" refers to the outline that represents or bounds the shape or form of an object. Contour can also refer to the outer boundary of an object, an area of ​​an object, or the surface of an object. (Search "contour" at wordhippo.com. WordHippo, 2023. Web. Revised. Accessed June 13, 2023.)

[0070] "Topographical" refers to the physical distribution of parts, structures, or features on or within the surface of an organ or other anatomical structure, or organism. (Search "define topographical" on google.com. Oxford Languages, Copyright 2022. Oxford University Press. Web. Revised. Accessed February 15, 2022.)

[0071] A "landmark alignment feature" refers to a structure configured to engage, contact, or abut a feature, aspect, attribute, or characteristic of a first object to orient and / or position a second object that includes the landmark alignment feature relative to the first object. A variety of structures can function as landmark alignment features. For example, surfaces, probes, fingers, wings, arms, retractors, etc. can function as landmark alignment features. Landmark alignment features can be of various shapes and therefore can include protrusions, projections, ridges, cavities, voids, divots, tabs, extensions, hooks, curves, etc.

[0072] A "landmark" refers to a structure on, within, or around a structure that can be used to serve as a reference for positioning, orienting, translating, rotating, or otherwise manipulating a second object or structure. For example, a landmark may include a protuberance, a projection, a ridge, a cavity, a void, a divot, a tab, an extension, a hook, a curve, or the like. In the context of a patient's bone, a landmark may include any protuberance, eminence, bone topography, anatomical feature, calcification, void, divot, concave section, sesamoid, osteophyte, or other feature on or extending from the patient's bone. A landmark refers to any structure of an anatomical structure that is referenced by, contacts, engages, and / or is associated with a landmark alignment feature. In certain embodiments, a landmark is unique to a single patient.

[0073] "Bone attachment feature" refers to a structure, feature, component, or aspect configured to fixedly connect, bond, attach, and / or engage a structure, component, object, or body with a bone and / or bone fragment. Examples of bone attachment features include, but are not limited to, pins, K-wires, screws, or other fasteners, alone or in combination with holes, passageways, and / or openings.

[0074] A "position indicator" refers to any apparatus, structure, device, system, and / or component organized, configured, designed, engineered, and / or arranged to act as an indicator of the location of one or more things, objects, structures, apparatus, systems, features, aspects, attributes, etc. Examples of position indicators include, but are not limited to, crosshairs, pins, wires, fasteners, holes, openings, posts, prongs, probes, needles, arrows, or markings, etc. In certain embodiments, an indicator may convey the location of one structure or component or system relative to another structure or component or system. A position indicator may indicate the location of one object relative to another, indicate the relationship between two objects, indicate the trajectory of one object relative to another, etc.

[0075] As used herein, a "stop" refers to an apparatus, implement, structure, member, device, component, system, or assembly that is structured, organized, configured, designed, arranged, or engineered to prevent, restrict, impede, stop, or limit the movement or movement and / or operation of another object, member, structure, component, part, apparatus, system, or assembly.

[0076] A "window" refers to an opening and / or multiple openings in a body, side, wall, side door, roof, vehicle, system, component, or other structure that allows the passage of electromagnetic radiation, including radiation passageways, x-rays, visible light, light, etc. A window may also allow the passage of sound, gases, fluids, liquids, or other elements. (Search "window" at Wikipedia.com. Revised August 31, 2022. Accessed September 21, 2022.) A window can be opaque, semi-opaque, translucent, radiolucent, or transparent. A window can include a single opening having a single geometric shape, or multiple openings, each of a single geometric shape or a combination of various geometric shapes. In certain embodiments, a window may be referred to as a radiolucent window. A radiolucent window may allow some or all radiation passageways to pass through the window.

[0077] "Radiotransparent window" refers to a window that allows the passage of radiant and electromagnetic radiation, particularly x-rays used in x-ray and / or fluoroscopic imaging devices.

[0078] As used herein, a "fastener," "fixation device," or "fastener system" refers to any structure configured, designed, or engineered to join two structures. Fasteners may be made from a variety of materials, including metals, plastics, composites, metal alloys, plastic composites, and the like. Examples of fasteners include, but are not limited to, screws, rivets, bolts, nails, snaps, hook-and-loop fasteners, set screws, bone screws, nuts, posts, pins, thumb screws, and the like. Other examples of fasteners include, but are not limited to, wires, Kirschner wires (K-wires), anchors, bone anchors, plates, bone plates, intramedullary nails or rods or pins, implants, sutures, soft sutures, soft anchors, tethers, interbody cages, fusion cages, and the like.

[0079] In certain embodiments, the term fastener may refer to a fastener system that includes two or more structures configured to combine to function as a fastener. An example of a fastener system is a rod or shaft having an external thread and an opening or hole in another structure having a corresponding internal thread configured to engage the external threads of the rod or shaft.

[0080] In certain embodiments, the term fastener may be used with an adjective that identifies an object or structure that the fastener may be specifically configured, designed, or engineered to engage, connect to, join, contact, or bond together with one or more other structures of the same or different type. For example, a "bone fastener" may refer to a device for joining or connecting one or more bones, one or more bone parts, soft tissue and bone or bone part, hard tissue and bone or bone part, a device and bone or bone part, etc.

[0081] In certain embodiments, the fasteners may be temporary fasteners. Temporary fasteners are configured to engage and perform a fastening function for a relatively short period of time. Typically, temporary fasteners are configured to be used until another procedure or surgery is completed and / or until a specific event. In certain embodiments, a user may remove or disengage the temporary fastener. Alternatively, or additionally, another structure, event, or machine may cause the temporary fastener to disengage.

[0082] As used herein, a "fixator" refers to an apparatus, instrument, structure, device, component, member, system, assembly, or module that is structured, organized, configured, designed, arranged, or engineered to connect two bones or bone fragments, or a single bone or bone fragment and another fixator, so as to position and retain the bones or bone fragments in a desired position and / or orientation. Examples of fixators include both external and internal fixators, and include, but are not limited to, pins, wires, Kirschner wires, screws, anchors, bone anchors, plates, bone plates, intramedullary nails or rods or pins, implants, interbody cages, fusion cages, etc.

[0083] As used herein, "fixation" or "fixation system" refers to an apparatus, instrument, structure, device, component, member, system, assembly, step, process, or module that is structured, organized, configured, designed, arranged, or engineered to connect two structures, either permanently or temporarily. The two structures may be, one or both, artificial and / or biological tissue, hard tissue (e.g., bone, tooth, etc.), soft tissue (e.g., ligament, cartilage, tendon, etc.). In certain embodiments, fixation is used as an adjective to describe a device or component or step in securing two structures together so that the structures remain interconnected in a desired position and / or orientation. Fixation systems can also help maintain a desired level of tension, compression, or redistribute loads and stresses experienced by the two structures, reducing relative movement of one part relative to the other. Examples of fixation devices are numerous and include both external and internal fixation, including, but not limited to, pins, wires, Kirschner wires (K-wires), screws, anchors, bone anchors, plates, bone plates, intramedullary nails or rods or pins, implants, interbody cages, fusion cages, and the like.

[0084] As used herein, an "anchor" refers to an apparatus, instrument, structure, member, part, device, component, system, or assembly structured, organized, configured, designed, arranged, or engineered to secure, retain, fasten, and / or hold an object to or at a fixed point, position, or location. An anchor may be coupled and / or connected to a flexible member such as a tether, chain, rope, wire, screw, suture, suture tape, or the like. Alternatively, or in addition, an anchor may be coupled, connected, and / or bonded to a rigid object or structure. In certain embodiments, an anchor can be a fixation device. Stated differently, a fixation device can function as an anchor. For example, an anchor pin is a pin, fastener, or K-wire that cooperates with a rigid structure to provide an anchor.

[0085] "Connector" refers to any structure that is engineered, designed, adapted, and / or arranged to connect one structure, component, element, or device to another structure, component, element, or device. Connectors can be rigid, pliable, elastic, flexible, and / or semi-flexible. Examples of connectors include, but are not limited to, any fastener.

[0086] As used herein, a "sleeve" refers to a structure that is narrow and longitudinally longer than its width. In certain embodiments, a sleeve functions to surround, enclose, wrap, and / or contain something else. In certain embodiments, a sleeve may surround, enclose, wrap, and / or contain a passageway or void. (Search "sleeve" at wordhippo.com. Revised WordHippo, 2021. Web. Accessed November 15, 2021). In certain embodiments, the term sleeve may be preceded by an adjective identifying a structure, tool, component, or instrument that may be used with, inserted into, or associated with the sleeve. For example, a "pin sleeve" may be configured to accept a pin or wire such as a K-wire, a "drive sleeve" may be configured to accept a drill or drill bit, and a "fixation member sleeve" may be configured to accept a fastener or fixation member.

[0087] As used herein, "long bone" refers to a patient's bone that has a length greater than its width. Long bones are one of five types of bones: long bones, short bones, flat bones, irregular bones, and sesamoid bones. Long bones, particularly the femur and tibia, can bear most of the load during daily activities. Long bones grow primarily by diaphyseal elongation, with an epiphysis at each end of the growing bone. The ends of the epiphysis are covered by hyaline cartilage ("articular cartilage"). The longitudinal growth of long bones is the result of endochondral ossification at the epiphyses. Categorical types of long bones include the femur, tibia, and fibula of the leg in humans or other patients; the humerus, radius, and ulna of the arm; the metacarpals and metatarsals of the hand or foot; the phalanges and phalanges of the fingers and toes; and the clavicle or collarbone. The exterior of long bones consists of a layer of connective tissue called the periosteum. Furthermore, the outer shell of a long bone is compact bone, followed by a deeper layer of spongy bone, which contains a medullary cavity with bone marrow. (Search "long bone" on Wikipedia.com. CC-BY-SA3.0 revised May 14, 2021. Accessed July 26, 2021.)

[0088] "Talal dome" refers to a portion of the talus. Specifically, the talar dome refers to the superior convex surface and / or region of the talus. The talar dome is also sometimes called the talar trochlea. The talar dome is part of the body of the talus.

[0089] A "bone fragment" or "fragment" generally refers to a portion of a bone that is part of another bone of a patient. A bone fragment may be separated from another bone of a patient due to deformation or trauma. In one aspect, the bone to which a bone fragment is typically connected or joined is referred to as the parent bone.

[0090] As used herein, a "manufacturing tool" or "fabrication tool" refers to a manufacturing or fabrication process, tool, system, or apparatus that uses one or more raw materials to create an object, device, apparatus, feature, or component. A manufacturing or fabrication tool can use a variety of manufacturing processes, including, but not limited to, additive manufacturing, subtractive manufacturing, forging, casting, etc. A manufacturing tool can use a variety of materials, including polymers, thermoplastics, metals, biocompatible materials, biodegradable materials, ceramics, biochemicals, etc. A manufacturing tool can be operated manually by an operator, automatically using a computer numerical controller (CNC), or by a combination of these techniques.

[0091] As used herein, "osteotomy procedure" or "surgical osteotomy" refers to surgery to cut one or more bones to shorten or lengthen them or change their alignment. The procedure may include removing one or more portions of bone and / or adding one or more portions of bone or replacement bone. (Search "osteotomy" on Wikipedia.com. Revised February 3, 2021, CC-BY-SA 3.0 on 22 February. Accessed February 15, 2022).

[0092] "Morbid bone anatomy" refers to one or more anatomical structures that include or are one or more bones of a patient. A malformed bone anatomy includes at least one bone that is in a malformed state. A malformed bone anatomy can include a single bone or a group of bones in a particular anatomical structure, including, but not limited to, the foot, ankle, leg, knee, hip, spine, hand, elbow, arm, shoulder, neck, and skull. A malformed bone anatomy can also include an abnormality or deviation from the typical or intended structure, shape, size, or alignment of bones in the body. A malformed bone anatomy involves a variation or distortion in bone morphology that can result from a congenital condition, genetic disorder, developmental abnormality, trauma, disease process, and / or other factors. (ChatGPT (Copyright) 3.5 Rev., accessed February 9, 2024 at chat.openai.com / chat).

[0093] "Bone anatomy" refers to one or more bones that are positioned, organized, oriented, connected, and / or related to one another within a patient. Bone anatomy includes any aspect of each of one or more bones of a patient's anatomy. Bone anatomy can refer to a single bone or a collection of bones of a particular anatomical structure, including, but not limited to, the foot, ankle, leg, knee, hip, spine, hand, elbow, arm, shoulder, neck, and skull. Bone anatomy can refer to one or more healthy bones, a collection of healthy and unhealthy bones, an anatomically positioned collection of bones, and / or a deformed collection of bones, etc.

[0094] As used herein, a "patient-specific osteotomy procedure" refers to an osteotomy procedure that is tailored, adapted, modified, or configured to individually address a particular patient's anatomy, physiology, condition, abnormality, needs, or desires. In certain aspects, a patient-specific osteotomy procedure may be usable in connection with only one patient. In other aspects, a patient-specific osteotomy procedure may be usable by several patients having a particular class of characteristics. In certain aspects, a patient-specific osteotomy procedure may refer to a non-patient-specific osteotomy procedure that includes one or more patient-specific implants and / or instrumentation. In other aspects, a patient-specific osteotomy procedure may refer to a patient-specific osteotomy procedure that includes one or more patient-specific implants, patient-specific surgical steps, and / or patient-specific instrumentation.

[0095] "Register" or "registration" refers to the act of aligning, mating, contacting, engaging, or joining one or more portions and / or surfaces of one object with one or more portions and / or surfaces of another object. Often, one or more portions and / or surfaces of one object include protrusions and / or recesses that are the inverse or mirror arrangement of the protrusions and / or recesses of one or more portions and / or surfaces of another object.

[0096] A "remedial procedure" refers to anything designed or performed with the purpose of improving the condition of a patient and / or one or more parts of the patient's body.

[0097] "Wedge osteotomy" refers to an osteotomy procedure in which one or more wedges are used as part of the procedure. Generally, wedge osteotomies can be one of two types: open wedge and closed wedge. The type of osteotomy refers to how the procedure changes the relationship between the two parts of the bone involved. In an open wedge osteotomy, a wedge of bone or graft or other material is inserted between two parts of the bone, resulting in a wedge-shaped "opening" within the bone. In a closed wedge osteotomy or closed wedge osteotomy, a wedge of bone is removed from the bone, resulting in a "closing" within the bone.

[0098] As used herein, "opening" refers to a gap, hole, aperture, port, portal, slit, space or recess in a structure, void in a structure, etc. In certain embodiments, an opening may refer to a structure specifically configured to receive something and / or allow access. In certain embodiments, an opening can pass through a structure. In such embodiments, an opening can be referred to as a window. In other embodiments, an opening can be present in a structure but cannot pass through the structure. In other embodiments, an opening can begin on a surface or at an edge or side of a structure and extend a distance within the structure but cannot pass through or extend to another side or edge of the structure. In other embodiments, an opening can begin on a surface or at an edge or side of a structure and extend within the structure until it passes through or extends to another side or edge of the structure. Openings can be two-dimensional or three-dimensional and can have a variety of geometric and / or cross-sectional shapes, including, but not limited to, rectangular, square, or other polygonal, as well as circular, elliptical, oval, or other circular or semicircular shapes. As used herein, the term "opening" may include one or more modifiers that define a particular type of "opening" based on the purpose, function, operation, position, or location of the "opening." As an example, a "fastener opening" refers to an "opening" that is adapted, configured, designed, or engineered to receive or accommodate a "fastener."

[0099] A "hole" refers to a gap, opening, aperture, port, portal, space or recess in a structure, void in a structure, etc. In certain embodiments, a hole can refer to a structure specifically configured to receive and / or allow access to something. In certain embodiments, a hole can pass through a structure. In other embodiments, an opening can exist in a structure but not pass through it. A hole can be two-dimensional or three-dimensional and can have a variety of geometric and / or cross-sectional shapes, including, but not limited to, rectangular, square, or other polygonal shapes, as well as circular, elliptical, oval, or other circular or semicircular shapes. As used herein, the term "hole" can include one or more modifiers that define a particular type of "hole" based on the purpose, function, operation, position, or location of the "hole." As an example, a "fastener hole" refers to a "hole" adapted, configured, designed, or engineered to receive or accommodate a "fastener." A "blind hole" is a hole with an opening on one side that does not extend entirely through the structure. In certain embodiments, holes, including blind holes, have a circular longitudinal cross-section. Alternatively, or in addition, holes can have cross-sections of various geometric shapes, including circular, oval, square, rectangular, slots with rounded ends, triangular, etc.

[0100] As used herein, "anatomical data" refers to data identified, used, collected, assembled, and / or generated in relation to a human or animal anatomy. Examples of anatomical data may include position data of both independent structures and structures connected to other structures within a coordinate system. Anatomical data may also include data that labels or identifies one or more anatomical structures. Anatomical data may include volume data, material composition data, etc. Anatomical data may be generated based on medical imaging data or measurements using various instruments, including monitors and / or sensors. Anatomical data may be gathered, measured, or collected from an anatomical model and / or used to generate, manipulate, or modify an anatomical model.

[0101] A bone or anatomical model of a patient's body or body part(s) can be generated by a computing device that analyzes medical imaging images. The structure of the patient's body can be determined using a process called segmentation.

[0102] A "set" refers to a collection of objects. A set can have zero or more objects in the collection. Generally, a set contains one or more objects in the collection.

[0103] "Trajectory guide" or "trajectory indicator" or "targeting guide" refers to any structure, apparatus, surface, device, system, feature, or aspect configured to indicate, identify, guide, place, position, or otherwise assist in marking or deploying a fastener or other structure along a desired trajectory of one or more subsequent steps during a procedure.

[0104] "Trajectory" refers to the path a body travels, or the path a body is configured to move through space. (Search "trajectory" at wordhippo.com. WordHippo, 2023. Web. Revised. Accessed June 13, 2023).

[0105] As used herein, a "guard" refers to an apparatus, implement, structure, member, device, component, system, or assembly that is structured, organized, configured, designed, arranged, or engineered to prevent, restrict, impede, stop, or limit the movement, action, or movement and / or operation of another object, member, structure, component, part, apparatus, system, or assembly beyond certain parameters, such as a boundary. Stated differently, a "guard" refers to an apparatus, implement, structure, member, device, component, system, or assembly that is structured, organized, configured, designed, arranged, or engineered to retain, maintain, hold, preserve, or limit the movement, action, or movement and / or operation of another object, member, structure, component, part, apparatus, system, or assembly within or at one or more parameters, such as a boundary.

[0106] As used herein, "artificial intelligence" refers to intelligence exhibited by machines, distinct from the natural intelligence exhibited by humans and animals, which involves consciousness and emotion. The distinction between the artificial intelligence and natural intelligence categories is often made clear by the acronyms chosen. "Strong" AI is typically labeled artificial general intelligence (AGI), while attempts to emulate "natural" intelligence have been called biological artificial intelligence (ABI). Major AI textbooks define the field as the study of "intelligent agents," i.e., any device that perceives its environment and takes actions that maximize its chances of achieving its goals. The term "artificial intelligence" can also be used to describe machines that mimic the "cognitive" functions humans associate with the human mind, such as "learning" and "problem-solving." (Search "artificial intelligence" on Wikipedia.com. Revised June 25, 2021, CC-BY-SA 3.0. Accessed June 25, 2021).

[0107] As used herein, "segmentation" or "image segmentation" refers to the process of partitioning an image into distinct, meaningful segments. These segments may correspond to different tissue classes, organs, pathologies, bones, or other biologically relevant structures. Segmenting medical images accounts for imaging ambiguities such as low contrast, noise, and other imaging ambiguities.

[0108] Certain computer vision techniques can be used or adapted for image segmentation. For example, segmentation techniques and / or algorithms can include, but are not limited to, atlas-based segmentation, which means that in many applications, clinical experts can manually label some images, and segmenting the unseen image is an extrapolation from these manually labeled training images. This style of method is typically referred to as atlas-based segmentation. Parametric atlas methods typically combine these training images into a single atlas image, while nonparametric atlas methods typically use all of the training images separately. Atlas-based methods typically require the use of image registration to align one or more atlas images to a single new unseen image.

[0109] Image registration is the process of properly aligning images, or shape-based segmentation. In shape-based segmentation, many methods parameterize a template shape for a given structure, often relying on control points along its boundary. The entire shape is then deformed to match the new image. Two of the most common shape-based techniques are active shape models and active appearance models. In image-based segmentation, some methods start with a template and refine its shape according to the image data while minimizing an integral error measure, such as active contour models and their variations. In interactive segmentation, interactive methods are useful when the clinician can provide some information, such as a seed region to be segmented or a rough outline of the region. The algorithm can then iteratively refine such a segmentation, with or without guidance from the clinician. Manual segmentation, which explicitly defines the tissue class for each pixel using a tool such as a paintbrush, remains the gold standard for many imaging applications. Recently, principles of feedback control theory have been incorporated into segmentation, giving users much greater flexibility and allowing for automatic error correction. In subjective surface segmentation, the method is based on the idea of ​​evolving a segmentation function governed by an advection-diffusion model. To segment an object, a segmentation seed is required (i.e., a starting point that determines the object's rough location in the image). As a result, an initial segmentation function is constructed. In subjective surface methods, the location of the seed is the primary factor determining the form of this segmentation function, as is the case in hybrid segmentation, which is based on a combination of methods. (Search "medical image computing" on Wikipedia.com. Revised June 24, 2021, CC-BY-SA 3.0. Accessed June 24, 2021.)

[0110] As used herein, "medical imaging" refers to techniques and processes for imaging the interior or exterior of the body for clinical analysis and medical intervention, as well as for visual representation of the function (physiology) of some organs or tissues. Medical imaging aims to reveal internal structures hidden by skin and bone, and to diagnose and treat disease. Medical imaging may also be used to establish a database of normal anatomy and physiology and enable the identification of abnormalities.

[0111] In its broadest sense, medical imaging is a subset of biological imaging and includes radiology, which uses imaging techniques such as x-rays, magnetic resonance imaging, ultrasound, endoscopy, elastography, tactile imaging, thermography, medical photography, and nuclear medicine functional imaging techniques such as positron emission tomography (PET) and single-photon emission computed tomography (SPECT). Another form of x-ray examination includes computed tomography (CT) scans, in which a computer may control the position of the x-ray source and detector. Magnetic resonance imaging (MRI) is another medical imaging technique. Fluoroscopy is an imaging technique that uses x-rays to obtain real-time video images of the interior of an object. In a primary application of medical imaging, a fluoroscope allows physicians to view the internal structures and functions of a patient, for example, to see the pumping action of the heart or the swallowing motion. This is useful for both diagnosis and treatment and is performed in general radiology, interventional radiology, and image-guided surgery. (Search for "medical imaging" on Wikipedia.com. CC-BY-SA3.0 Revised July 14, 2021. Accessed September 1, 2021.)

[0112] Data analyzed, generated, manipulated, interpolated, collected, stored, reviewed, and / or modified in connection with medical images or medical image processing may be referred to herein as medical imaging data or medical image data.

[0113] Measurement and recording techniques not primarily designed to produce images, such as electroencephalography (EEG), magnetoencephalography (MEG), electrocardiography (ECG), and others, represent other techniques that produce data that are amenable to representation as parameter graphs versus time or maps containing data related to measurement location. In certain embodiments, bone imaging involves devices that scan and collect bone density anatomical data. These techniques may be considered forms of medical imaging in certain fields. (Search "medical imaging" at Wikipedia.com. Revised June 16, 2021, CC-BY-SA 3.0. Accessed June 23, 2021.)

[0114] As used herein, "patient image data" refers to data identified, used, collected, assembled, and / or generated in connection with medical images of a particular patient. Patient image data is a type of medical image data. Patient image data can be shared among users, systems, patients, and professionals using a common data format called Digital Imaging and Communications in Medicine (DICOM) data. DICOM data is a standard format for storing, viewing, retrieving, and sharing medical images.

[0115] As used herein, "medical image computing" or "medical image processing" refers to systems, software, hardware, components, and / or devices that encompass and combine the fields of computer science, information engineering, electrical engineering, physics, mathematics, and medicine. Medical image computing develops computational and mathematical methods for working with medical images and using them in biomedical research and clinical care. One goal of medical image computing is to extract clinically relevant information or knowledge from medical images. Medical image computing is closely related to the field of medical imaging but focuses on the computational analysis of images rather than image acquisition. Methods can be grouped into several broad categories, such as image segmentation, image registration, and image-based physiological modeling. (Search "medical image computing" at Wikipedia.com. Revised June 24, 2021, CC-BY-SA3.0. Accessed June 24, 2021.) Medical image computing may involve one or more processors or controllers on one or more computing devices. Such a processor or controller may be referred to herein as a medical image processor. Medical imaging and medical image computing together can provide systems and methods for imaging, quantifying, and fusing both structural and functional information about a patient in vivo. These two technologies involve the transformation of computational models to represent individualized subjects / patients, thus paving the way for patient-individualized computational models. The personalization of generic computational models with images can be achieved in three complementary directions: defining the subject-individualized computational domain (anatomy) and associated subdomains (tissue types), defining boundaries and initial conditions from images (dynamic and / or functional), and characterizing structural and functional tissue properties. Medical imaging and medical image computing enable the translation of models into clinical environments with both diagnostic and therapeutic applications.(Ibid.) In certain embodiments, medical image computing can be used to generate bone models, patient-specific models, and / or patent-specific instruments from medical images and / or medical image data.

[0116] As used herein, a "model" refers to an informative representation of an object, person, or system. Representation models can be broadly divided into concrete (e.g., physical forms) and abstract (e.g., behavioral patterns, especially expressed in mathematical form). In abstract forms, a particular model may be based on data used in a computer system or software program to represent the model. Such models may be referred to as computer models. Computer models can be used to display the model, modify the model, and print the model (either on 2D media or using a 3D printer or additive manufacturing techniques). The printed physical form of the model may be referred to as a 3D physical bone model. Computer models can also be used in environments with models of other objects, people, or systems. Computer models can also be used to generate simulations, display in virtual environment systems, display in augmented reality systems, etc. Computer models can be used in computer-aided design (CAD) and / or computer-aided manufacturing (CAM) systems. A particular model may be identified by adjectives that identify the object, person, or system that the model represents. For example, a "bone" model is a model of a bone, and a "heart" model is a model of a heart. (Search "model" on Wikipedia.com. CC-BY-SA 3.0 revised June 13, 2021. Accessed June 23, 2021.)

[0117] "Bone model" or "anatomical model" refers to a model of a human bone. A bone model may model a single bone or multiple bones. The modeled bone(s) may be positioned in a standard anatomical form and / or may be positioned relative to other bones of a human (e.g., a bone model) such that the positions of the bones in the bone model are the same as or substantially the same as corresponding bones in a human, such as a patient.

[0118] A "3D physical bone model" refers to a bone model that is represented in a tangible physical form and has three dimensions. A 3D physical bone model may include or model a single bone, or may include or model multiple bones. A 3D physical bone model that includes multiple bone models may be configured such that when a corresponding bone is positioned and / or oriented within a subject (e.g., a patient) of the 3D physical bone model, the bone models of the multiple bone models are positioned and / or oriented together with the 3D physical bone model.

[0119] A 3D physical bone model that includes multiple bone models may be referred to as an assembly of 3D physical bone models, as each bone model in the assembly may also be a 3D physical bone model. In certain embodiments, the 3D physical bone models of the multiple 3D physical bone models may be connected, linked, or related to each other in the same or similar manner as the corresponding bones are connected, linked, or related to each other within the subject of the 3D physical bone model.

[0120] "Location" refers to an arrangement or location. (Search "position" at wordhippo.com. WordHippo, 2024. Web. Accessed January 8, 2024.) A location may be defined by a computing device and within a virtual environment, such as a presented model or set of models. Additionally, a location may be an arrangement or location within a tangible physical environment, such as in space, on land, or within or on a system, assembly, component, patient, or other structure.

[0121] An "original position" refers to the position of a structure, object, device, apparatus, component, or system before any action is taken to change its position. The original position may be defined by a computing device and defined within a virtual environment, such as a presented model or set of models. Alternatively, or in addition, the original position may be a position in, on, or part of a tangible physical object, such as a bone in a patient's foot. In certain embodiments, the original position is a transformed position. The original position may be contrasted with a predetermined position, which may be a planned position to implement a correction and correct the position of a structure from a transformed position to a corrected position.

[0122] "Deformed location" refers to an anatomical structure that creates, is positioned to contain, or is at least part of the deformity. "Corrected location" refers to an anatomical structure that is positioned to improve, correct, remove, and / or overcome the deformity. The predetermined location can be a corrected location.

[0123] "Feedback" refers to a reactive response to an action, product, service, or task. (Search "feedback" at wordhippo.com. WordHippo, 2023. Web. Revised. Accessed August 28, 2023.)

[0124] As used herein, "additive manufacturing" refers to a manufacturing process in which materials are bonded together in a process of repeatedly building one layer on another to generate a three-dimensional structure or object. Additive manufacturing can also be referred to using different terms, including additive process, additive fabrication, additive technology, additive layer manufacturing, layer manufacturing, freeform fabrication, ASTM F2792 (American Society for Testing and Materials), and 3D printing. Additive manufacturing can build three-dimensional structures or objects using computer-controlled equipment that applies successive layers of material(s) based on a three-dimensional model that can be defined using computer-aided design (CAD) software. Additive manufacturing can use a variety of materials, including polymers, thermoplastics, metals, ceramics, biochemicals, and the like. Additive manufacturing can offer unique advantages, such as the ability to directly manufacture implants with pores and / or lattices (without the need to generate molds, tool paths, perform any milling, and / or other manufacturing steps).

[0125] "Palpable feedback" refers to a type of feedback that is felt. In one embodiment, palpable feedback can refer to feedback that is easily recognized, tangible, or easily felt or perceived. During certain medical procedures, such as osteotomy, palpable feedback can include tactile sensations experienced by a healthcare provider as they move a bone or bone fragment. (ChatGPT © 3.5 Rev., accessed February 2, 2024 at Chat.openai.com / chat). Often, palpable feedback is feedback that a user, such as a surgeon, feels as they perform one or more steps or actions during a surgical procedure.

[0126] A "three-dimensional surface" refers to a surface defined by a collection of points having three coordinates (x, y, z), each point representing a location in space. In the medical context, a three-dimensional surface can include the surface of an implant or instrument that is customized for a specific purpose. In certain embodiments, the three-dimensional surface can be customized to fit a patient's anatomy or to accommodate handling by a user (e.g., a handle). (ChatGPT © 3.5 Rev., accessed February 2, 2024 at chat.openai.com / chat). In certain embodiments of the present disclosure, the three-dimensional surface can be the surface on the side of an instrument that is individually configured or customized to fit or match a patient's anatomy.

[0127] A "repository" refers to any data source or data set containing data or content. In one embodiment, the repository resides on a computing device. In another embodiment, the repository resides on a remote computing or storage device. A repository may include a file, a folder, a directory, a set of files, a set of folders, a set of directories, a database, an application, a software application, text content, email content, calendar entry content, etc. In one embodiment, a repository includes unstructured data. In one embodiment, a repository includes structured data such as a table, an array, a queue, a lookup table, a hash table, a heap, a stack, etc. A repository may store data in any format, including binary, text, encrypted, unencrypted, proprietary formats, etc.

[0128] As used herein, "bevel" refers to an edge of a structure that is not perpendicular to the plane of the portion of the structure, and the edge has a slope or bevel or angled profile and can refer to an inclined surface. Often, cutting tools, such as blades or cutting edges, can have a beveled edge that facilitates the cutting edge as it cuts into a target material. "Bevel" and "chamfer" can be used interchangeably herein. (Search "bevel" at Wikipedia.com. CC-BY-SA 3.0 Revised May 17, 2021. Accessed August 4, 2021; Search "bevel" at Merriam-Webster.com. Merriam-Webster, 2021. Web. Revised. Accessed August 4, 2021; Search "bevel" at wordhippo.com. WordHippo, 2021. Web. Revised. Accessed August 4, 2021).

[0129] As used herein, "registration" or "image registration" refers to a method, process, module, component, device, and / or system that attempts to achieve accurate alignment of two images. As used herein, "image" may refer to one or both of an image of a structure or object and another image or model (e.g., a computer-based model or a physical model, either two-dimensional or three-dimensional). In the simplest case of image registration, two images are aligned. One image may serve as a target image, and the other image may serve as a source image, where the source image is transformed, positioned, realigned, and / or modified to match the target image. An optimization procedure may be applied that updates the transformation of the source image based on a similarity value that assesses the current quality of the alignment. The iterative optimization procedure may be repeated until a (local) optimal solution is found. An example is the registration of CT and PET images to combine structural and metabolic information. Image registration can be used in various medical applications, i.e., time-varying studies. In time-varying studies, the study is longitudinal, and images may be acquired over months or years to study long-term processes, such as disease progression. A time series corresponds to images acquired within the same session (a few seconds or minutes). Time-series images can be used to study cognitive processes, cardiac deformation, and respiration. Combining complementary information from different imaging modalities. An example would be the fusion of anatomical and functional information.

[0130] Because structure size and shape vary across modalities, assessing alignment quality can be more challenging. Therefore, similarity measures such as mutual information can be used to characterize a population of subjects. In contrast to intrasubject alignment, a one-to-one mapping may not exist between subjects, depending on the structural variations of the organs of interest. Intersubject alignment can be used for atlas construction in computational anatomy. Here, the goal may be to statistically model the anatomical structure of organs across subjects, i.e., computer-assisted surgery. In this computer-assisted surgery, preoperative images, such as CT or MRI, may be registered to intraoperative images or tracking systems to facilitate image guidance or navigation. When performing image alignment, i.e., transformation models, several considerations may exist. Common choices are rigid, affine, and non-rigid transformation models. B-spline and thin-plate spline models are commonly used for parameterized transformation fields. Nonparametric or dense deformation fields preserve displacement vectors at all grid locations, which may use additional regularization constraints. A particular class of deformation fields is diffeomorphisms, i.e., similarity metrics, whose inverse is a smooth, reversible transformation. A distance function or similarity function is used to quantify the registration quality. This similarity can be calculated on either the original images or features extracted from the images. Common similarity measures are the sum-of-squares distance (SSD), correlation coefficient, and mutual information. The choice of similarity measure depends on whether the images are from the same modality, and acquisition noise may also play a role in this decision. For example, SSD may be the optimal similarity measure for images of the same modality with Gaussian noise. However, image statistics in ultrasound can differ significantly from Gaussian noise, leading to the introduction of ultrasound-specific similarity measures.

[0131] Multimodal registration may use more sophisticated similarity measures; alternatively, different image representations, i.e., optimization procedures, may be used, such as structural representations or alignment of adjacent anatomical structures. Either continuous or discrete optimization is performed. For continuous optimization, gradient-based optimization techniques are applied to improve convergence speed. (Search "medical image computing" at Wikipedia.com. Revised June 24, 2021, CC-BY-SA3.0. Accessed June 25, 2021.)

[0132] As used herein, "resection" refers to a method, technique, or step of removing tissue from another anatomical structure or the body. Resection is typically performed by a surgeon on a part of a patient's body. (Search "surgery" at Wikipedia.com. Revised May 26, 2021, CC-BY-SA3.0. Accessed May 26, 2021.) In certain embodiments, resection may remove little or no tissue, and in such circumstances may also be referred to as incision or dissection. Resection can be used as a noun or a verb. In the verb form, the term is "resection," which refers to the act of performing or making a resection. The past tense of the verb to resect is "resected."

[0133] "Resection feature" refers to any feature configured, designed, engineered, and / or intended to facilitate resection. Examples of resection guide features include, but are not limited to, slots, cutting channels, cutting slots, pivoting cutting guides, pivoting resection guides, openings, straight slots, angled slots, curved slots, etc.

[0134] "Patient-adapted" refers to features, aspects, attributes, characteristics, instruments, and / or devices selected from a set of predetermined, predefined, precalculated, preconfigured, prepositioned, and / or prefabricated structures, apparatus, devices, instruments, or devices to provide satisfactory service to a user based on a set of characteristics such as anatomical structure size, deformity, fracture, laceration, retraction, angle of a particular landmark, angle of deformity, type of deformity, bone size, etc. In certain embodiments, patient-adapted is different from patient-specific.

[0135] "Mortal rotation" refers to a condition in which a part, usually a part of a patient's body, has rotated from its normal position into a non-normal or abnormal position.

[0136] As used herein, a "guide" refers to a part, component, member, or structure that is designed, adapted, configured, or engineered to guide or direct one or more other parts, components, or structures. A guide may be part of, integrated with, coupled to, attachable to, or bonded to another structure, device, or instrument. In one embodiment, a guide may include a modifier that identifies a particular function, location, orientation, operation, type, and / or particular structure of the guide. Examples of such modifiers applied to guides include, but are not limited to, a "pin guide" that guides or directs one or more pins; a "cutting guide" that guides or directs the creation or one or more cuts; a placement, deployment, or insertion guide that guides or directs the placement, positioning, orientation, deployment, installation, or insertion of fasteners and / or implants; a "cruciate fixation guide" that guides the deployment of fasteners or fixation members; an "alignment guide" that guides the alignment of two or more objects or structures; a "resection guide" that functions to guide the resection of soft or hard tissue, such as in an osteotomy; a "reduction guide" that can function to guide the reduction of one or more bone segments or fragments; a "placement guide" that functions to identify how an object may be placed relative to another object or structure; and the like. Additionally, guides may include modifiers that apply due to the procedure or location within a patient in which the guide is used. For example, if a guide is used in a joint, the guide may be referred to herein as an "arthrodesis guide."

[0137] "Guide pin" refers to a pin, structure, or fastener type that can be used to guide an instrument or implant as part of a method, process, or procedure, such as a surgical procedure. In certain aspects, the guide pin may be designed for temporary use until a subsequent step in the method, process, or procedure. Examples of guide pins include, but are not limited to, pins, K-wires, and the like.

[0138] A "linear cut" is a type of cut that may be used in surgical procedures. Generally, a linear cut is a cut in tissue (soft or hard) that is perpendicular to the surface on which the cut is made and extends along a straight line into and / or through the tissue. Advantageously, linear cuts may be easier for a surgeon to perform than angled or curved cuts. In certain embodiments, linear cuts are made with the aid of a guide (e.g., a cutting guide, a resection guide, and / or a resection feature). Alternatively, or in addition, a user may make linear cuts freehand (without the aid of a guide, instrument, or instrument set).

[0139] As used herein, a "feature" refers to any characteristic attribute or aspect. (Search "feature" at google.com. Oxford Languages, 2021. Web. 20 Apr. 2021.) A feature may include one or more apparatuses, structures, objects, systems, subsystems, devices, etc. A feature may include a modifier that identifies a particular function or operation and / or a particular structure associated with the feature. Examples of such modifiers applied to a feature include, but are not limited to, "attachment feature," "anchor feature," "locating feature," "protruding feature," "engaging feature," "disengaging feature," "removal feature," "guiding feature," etc.

[0140] "Engaging feature" or "engaging member" refers to an apparatus, apparatus, apparatus, structure, device, component, member, system, assembly, or module that is structured, organized, configured, designed, arranged, or engineered to connect, join, articulate, couple to, or engage with another object, apparatus, apparatus, structure, device, component, member, system, assembly, or module, either permanently or temporarily. The connecting, coupling, articulating, or engaging may be a mechanical connection or an interconnection.

[0141] "Cortical bone" refers to a type of bone tissue. Cortical bone is a type of bone tissue that is typically found between the outer surface of a bone and the interior region of the bone. Cortical bone is denser and typically structurally stronger than other types of bone tissue. "Cortical surface" refers to the surface of the cortical bone.

[0142] "Transosseous positioning feature" refers to a positioning feature that extends through one or more bones to allow or facilitate the placement of another device, apparatus, or instrument.

[0143] "Patient-specific" refers to attributes, aspects, characteristics, properties, functions, structures, devices, guides, tools, instruments, apparatuses, members, components, systems, assemblies, modules, or subsystems that are tailored, adapted, modified, organized, configured, designed, arranged, engineered, and / or fabricated to individually address the anatomy, physiology, condition, abnormality, needs, or desires of a particular patient and / or surgeon's particular patient. In one aspect, patient-specific aspects or characteristics are unique to a single patient and may include patient-specific characteristics such as the number of cutting channels, the number of bone attachment features, the number of bone engaging surfaces, the number of resection features, the depth of one or more cutting channels, the angle of one or more resection channels, surface contours, component positions, component orientations, and / or other characteristics.

[0144] "Patient-specific characteristics" refers to features, functions, structures, devices, guides, tools, instruments, apparatuses, members, components, systems, assemblies, modules, or subsystems that are tailored, adapted, modified, organized, configured, designed, arranged, engineered, and / or fabricated to individually address the anatomy, physiology, condition, abnormality, needs, or desires of a particular patient or surgeon's particular patient. In one aspect, patient-specific characteristics are specific to a single patient and may include patient-specific characteristics such as the number of cutting channels, the number of bone attachment features, the number of bone-engaging surfaces, the number of resection features, the depth of one or more cutting channels, the angle of one or more resection channels, surface contours, component positions, component orientations, and / or other features. "Internal resection guide" refers to a resection guide designed, engineered, fabricated, or intended for use on, within, or around an interior part, section, surface, portion, or aspect of an anatomical structure, such as a bone, finger, limb, or other anatomical structure, for one or more steps of a resection procedure. "External resection guide" refers to a resection guide designed, engineered, fabricated, or intended for use by, on, within, or around an external part, section, surface, portion, or aspect of an anatomical structure such as a bone, finger, limb, or other anatomical structure for one or more steps of a resection procedure.

[0145] A "bone fragment" generally refers to a portion of a bone that is part of another bone of a patient. A bone fragment may be separated from another bone of a patient due to deformation or trauma. In one aspect, the bone to which a bone fragment is typically connected or joined is referred to as the parent bone.

[0146] "Orientation" refers to the direction, angle, position, state, condition, or configuration of a first object, component, part, device, system, or assembly relative to another object, component, part, device, system, assembly, reference point, reference axis, or reference plane.

[0147] "Longitudinal axis" refers to the axis of a structure, device, object, apparatus, or part thereof that extends from one end to the other end of its longest dimension. Typically, the longitudinal axis passes through the center of the structure, device, object, apparatus, or part thereof along the longitudinal axis. The center point used for the longitudinal axis may be the geometric center point and / or the center of mass.

[0148] Those skilled in the art will appreciate that a cutting feature may take a variety of forms and may include a single feature or one or more features that together form the cutting feature. In certain embodiments, a cutting feature may take the form of one or more slots. Alternatively, or in addition, a cutting feature may be referred to using other names, including, but not limited to, a channel, a cutting channel, etc.

[0149] "Cutting tool" refers to any tool that can be used to cut or ablate another object. In particular, a cutting tool can refer to a manual or power tool for cutting or ablat- ing tissue of a patient. Examples of cutting tools include, but are not limited to, burrs, oscillating saws, reciprocating saws, grating saws, drills, mills, side-cut burrs, and the like.

[0150] A "revised model" or "modified model" or "corrected model" refers to a model that has been altered from its original condition to a changed, altered, or revised condition. Generally, the original model is used to create the revised / corrected model. Alternatively, the revised model can be created from scratch. The revised model may include a computer model and / or a physical, tangible 3D model. Often, the original model exists in digital form on a computer. Such models may be referred to as CAD models.

[0151] A "corrected model" refers to a model in which a model object, structure, and / or subject has been modified from a distorted or inaccurate configuration to a corrected or revised configuration. A corrected model can be created from scratch, or can be generated by revising an existing model and / or by merging two or more models. As an example, an original model may represent one or more bones of a foot. The modeled foot bones may have deformations due to bone condition. A corrected model can be created or formed from the original model by revising or changing one or more aspects of the original model so that the modeled bones reflect the corrected orientation and / or configuration of the modeled bones.

[0152] A "prescription" or "issued prescription" refers to a command, request, instruction, decision, indication, approval, and / or order by a physician or clinical nurse to administer a medication, prepare an implant, prepare an instrument, prepare a model, or other intervention. Prescriptions are often written. A prescription can also refer to the medication or intervention for which the prescription is issued. (Search "prescription" at wordhippo.com. Revised WordHippo, 2023. Web. Accessed May 3, 2023.)

[0153] "User input" refers to any signal, action, or other indication from a user that provides direction, instruction(s), and / or information that the user wants to provide to a device, apparatus, member, component, system, assembly, module, subsystem, or circuit. In certain embodiments, user input may include input data provided by a user or operator. In certain embodiments, a user may provide user input using an input device such as a touchscreen, a mouse, a switch, a lever, or the like. Various signals, indicators, indications, gestures, movements, touches, keystrokes, and the like may function as user input.

[0154] The present disclosure discloses a method, system, and / or apparatus for providing a customer with a physical model of a patient's anatomy. In one embodiment, the physical model is a three-dimensional model of the patient's anatomy. In certain embodiments, the patient's anatomy is a foot, foot and ankle, hand, hand and wrist, shoulder, knee, neck, etc.

[0155] Medicine and medical technology continue to advance. Surgeons continue to find new ways to address patient needs while increasing the likelihood of desired outcomes and minimizing the risk of adverse outcomes, patient pain and discomfort, and recovery time. In particular, surgeons continue to strive for smaller incisions and the ability to perform surgical procedures within smaller spaces through minimally invasive surgical (MIS) techniques.

[0156] While MIS procedures can provide benefits to patients, they can also increase stress or present other challenges for surgeons. What is needed is a tool that provides surgeons with an accurate representation of a patient's hard and / or soft tissues before, during, and / or after a surgical procedure. Modern technology allows surgeons to visualize a particular patient's anatomy using two-dimensional photographs, images, paper, or video screens. Other technologies allow surgeons to view three-dimensional representations of the anatomy, again on a computer screen or using augmented reality technology.

[0157] While such techniques can be useful, they are not the same as, and do not offer the same benefits as, providing a surgeon with a physical, three-dimensional model of one or more anatomical structures of a particular patient. Embodiments of the present disclosure provide a customer, such as a patient, institution, and / or surgeon, with a physical, three-dimensional model of one or more anatomical structures of a particular patient.

[0158] The present disclosure describes devices, systems, and / or methods for creating and / or providing both a patient-specific physical three-dimensional model and / or a patient-specific instrument suite including instruments, guides, implants, etc.

[0159] 1A is a flow chart diagram illustrating a method 100 for correcting a bone condition, according to one embodiment. Method 100 may be used for any of a wide variety of bone conditions, including, but not limited to, deformity, fractures, joint dysfunction, etc. Furthermore, method 100 may provide correction through a wide variety of treatments, including, but not limited to, arthroplasty, joint fusion, fracture repair, etc.

[0160] As shown, method 100 may begin at step 102, in which a CT scan (or another three-dimensional image, also referred to as a medical image) of a patient's anatomy is acquired. Step 102 may involve capturing a scan of only the specific bone(s) to be treated, or may involve capturing additional anatomical information, such as surrounding tissue. Additionally or alternatively, step 102 may involve receiving a pre-captured image, for example, at a design and / or fabrication facility. Performance of step 102 may result in the acquisition of a three-dimensional model of the patient's anatomy, or three-dimensional surface points that can be used to construct such a three-dimensional model.

[0161] After step 102 is performed, method 100 may proceed to step 104, where a CAD model of the patient's anatomy (including one or more bones) is generated. The CAD model may be an example of a bone model. The CAD model may be in any known format, including, but not limited to, SolidWorks, Catia, AutoCAD, or DXF. In some embodiments, customized software may be used to generate the CAD model from the CT scan. The CAD model may include only the bone(s) to be treated and / or may include surrounding tissue. In alternative embodiments, step 104 may be omitted, as the CT scan may capture data that can be used directly in future steps without requiring conversion.

[0162] In one embodiment, the generated CAD model and / or patient-specific instrumentation, implants, and / or plan for performing the surgical procedure may be enhanced through the use of advanced computer analysis systems, machine learning, and / or automation / artificial intelligence. For example, these techniques may be used to revise the set of steps of the procedure so that a more desirable outcome is achieved.

[0163] In step 106, the CAD model and / or CT scan data may be used to model a patient-specific instrument suite that can be used to correct the condition as it exists in the patient's anatomy. In some embodiments, any known CAD program may be used to view and / or manipulate the CAD model and / or CT scan and generate one or more instruments that are individually fitted to the size and / or shape of the patient's bone(s). In some embodiments, such an instrument suite may include a targeting guide, trajectory guide, drill guide, cutting guide, tendon trajectory guide, positioner or positioning guide, or similar guide that can be attached to one or more bones and has one or more features that facilitate working with one or more bones according to a procedure such as arthroplasty or arthrodesis. In some embodiments, performing step 106 may include modeling an instrument having a bone-engaging surface that is shaped to fit the contours of the bone surface such that the bone-engaging surface can rest directly on the corresponding contours.

[0164] In step 108, the model(s) may be used to manufacture patient-specific instruments and / or implants. This may be done via any known manufacturing method, including casting, forging, milling, additive manufacturing, etc. Additive manufacturing may offer unique advantages because the model may be used directly to manufacture the instruments and / or implants (without the need to previously generate molds, tool paths, etc.). Such instruments may optionally include targeting guides, trajectory guides, drill guides, cutting guides, positioning guides, positioners, or tendon trajectory guides having bone-engaging surfaces and one or more features described herein.

[0165] In addition to, or as an alternative to, step 108, the model(s) may be used to select from available sizes of implants and / or instruments and advise the surgeon accordingly. For example, if a range of guides are available for a given procedure, analysis of the CAD data may facilitate preoperative selection of the optimal guide and / or optimal placement of the guide on the bone. Similarly, if a range of implants can be used for a given procedure, analysis of the CAD data may facilitate preoperative selection of the optimal implant(s). More specifically, appropriately sized spacers, screws, bone plates, and / or other hardware may be selected preoperatively.

[0166] Thus, the result of step 108 may be the preparation of one or more of the following for the surgeon: (1) one or more patient-specific instruments, (2) one or more patient-specific implants, (3) instruments selected from one or more available instrument sizes and / or configurations, (4) implants selected from one or more available implant sizes and / or configurations, (5) instructions regarding which instrument(s) to select from available instrument sizes and / or configurations, (6) instructions regarding which implant(s) to select from available implant sizes and / or configurations, (7) instructions for proper positioning or anchoring of one or more instruments to be used in the procedure, and (8) instructions for proper positioning or anchoring of one or more implants to be used in the procedure, which may be provided directly to the surgeon or to a medical device company or representative for subsequent delivery to the surgeon.

[0167] In step 110, the manufactured instrument may be used in a surgical procedure to facilitate treatment of a condition. In some embodiments, this may involve placing the modeled bone-engaging surface against the corresponding contour of the bone used to derive its shape, and then using the resection feature(s) to guide the resection of one or more bones. The bone(s) may then be further treated, for example, by attaching one or more joint replacement implants (in the case of arthroplasty) or by attaching bone segments together (in the case of arthrodesis or fracture repair). Prior to completion of step 110, the instrument may be removed from the patient and the surgical wound may be closed.

[0168] As mentioned above, method 100 can be used to correct a wide variety of bone conditions. One example of method 100 is shown and described in connection with FIG. 1B for the correction of a bunion deformity of the foot.

[0169] In certain embodiments, one or more of the methods, devices, and / or systems of the disclosed solutions may be used to train surgeons to perform patient-specific procedures or techniques. In one embodiment, the generated CAD models and / or patient-specific instruments, implants, and / or plans for performing a surgical procedure may be used to train surgeons to perform the patient-specific procedure or technique.

[0170] In one example embodiment, a surgeon may submit a CT scan of a patient's foot to a device or system implementing the disclosed solution. A manual or automated process may then be used to generate a CAD model and make the desired measurements and corrections for the patient. In an automated process, advanced computer analysis systems, machine learning, and automation / artificial intelligence may be used to generate the CAD model and / or one or more patient-specific instruments and / or surgical plans. For example, a computer-aided machining (CAM) tool may be used to fabricate a patient-specific guide that is aligned to the patient's anatomy. In addition, the CAM tool may be used to fabricate a 3D structure representing the patient's anatomy, referred to herein as a patient-specific cadaver (e.g., one or more bones of the patient's foot). The patient-specific guide and patient-specific cadaver may then be provided to the surgeon, who may partially or fully rehearse the surgical procedure before entering the operating room with the patient.

[0171] In certain embodiments, patient-specific guides or instruments may be used to facilitate pre-positioning and / or pre-drilling of holes in a plate system for fixation purposes. Such plate systems may be optimally positioned per CT scan after the corrective procedure for optimal fixation outcomes. In another embodiment, CAD models and / or automated processes, such as advanced computer analysis, machine learning, and automation / artificial intelligence, may be used to measure depth through a patient-specific resection guide for use with a robotic device and / or system that controls the depth of each cut within the guide to protect critical structures beneath or adjacent to the bone being cut. In another embodiment, CAD models and / or automated processes, such as advanced computer analysis, machine learning, and automation / artificial intelligence, may be used to define the length and / or trajectory of a desired fastener (e.g., bone screw) through a patient-specific guide and / or implant. Details of such lengths, trajectories, and components may be detailed in a report provided to the surgeon preparing to perform the procedure.

[0172] 1B is a flow chart diagram illustrating a method 120 for correcting or improving a bone condition, according to one embodiment. The method 120 may be used to prepare a patient for an orthopedic surgical procedure to correct or improve a bone, muscle, and / or tendon condition.

[0173] As shown, method 120 may begin at step 122, in which a CT scan (or another three-dimensional image) of the patient's foot is obtained. Step 122 may involve capturing a scan of only the first cuneiform and first metatarsal, or may involve capturing additional anatomical information, such as the entire foot. Additionally or alternatively, step 122 may involve receiving previously captured image data. Capturing the entire foot in step 122 may facilitate proper alignment of the first metatarsal with the remainder of the foot (e.g., with the second metatarsal). Performance of step 122 may result in the generation of a three-dimensional model of the patient's foot, or three-dimensional surface points that can be used to construct such a three-dimensional model.

[0174] After step 122 is performed, method 120 may proceed to step 124, where a CAD model of the relevant portion of the patient's anatomy is generated. The CAD model may optionally include the bones of the entire foot, as in the CT scan obtained in step 122. In alternative embodiments, step 124 may be omitted in favor of direct use of the CT scan data, as described in connection with step 104.

[0175] In step 126, the CAD model and / or CT scan data may be used to model patient-specific instruments that can be used to correct or improve the condition of the bone. Such instruments may include guides. In one example, the guides may seat, abut, or contact the surface of the bone, including openings that guide the trajectories of fasteners in the procedure. In some embodiments, performing step 126 may include modeling a guide with a bone-engaging surface shaped to match the contours of the bone surface so that the bone-engaging surface can sit directly on the corresponding contours of the bone.

[0176] In step 128, the model(s) may be used to manufacture a patient-specific instrument suite and / or instruments. This may include manufacturing guides with bone-engaging surfaces and / or other features, as described above. Similar to step 108, step 128 may additionally or alternatively involve preparing one or more instruments and / or implants from among a plurality of predetermined configurations or sizes. Further, step 128 may additionally or alternatively involve provisioning one or more instruments and / or instructions for instrument placement and / or anchoring to perform the procedure.

[0177] In step 130, the manufactured guide can be used in a surgical procedure to facilitate treatment of the condition. Specifically, the bone-engaging surface of the guide can be positioned relative to a corresponding contour of the bone. The guide can include openings and / or trajectory guides to guide the insertion of trajectory guides, such as temporary fasteners such as K-wires. The guide can then be removed, and the remaining steps of the surgical procedure can be performed.

[0178] Methods 100 and 120 are merely exemplary, and those skilled in the art will recognize that various steps of methods 100 and 120 may be rearranged, omitted, and / or supplemented with additional steps not specifically shown or described herein.

[0179] As noted above, method 120 is a type of method 100, and the present disclosure encompasses many different procedures performed on many different bones and / or joints of the body. Exemplary steps and instruments for method 120 are further shown and described in connection with the present disclosure. Those skilled in the art will recognize that method 120 may be used in connection with different instruments, and similarly, instruments of the present disclosure may be used in connection with methods other than methods 100 and 120.

[0180] 2A is a dorsal perspective view of a foot 200. The foot 200 may have, among other things, a medial cuneiform 202, an intermediate cuneiform 204, a lateral cuneiform 206, a first metatarsal 208, a second metatarsal 210, a third metatarsal 212, a fourth metatarsal 214, a fifth metatarsal 216, a navicular 218, a cuboid 220, and a calcaneus 222. The medial cuneiform 202 and the intermediate cuneiform 204 may be joined together at a first metatarsal-cuneiform joint, and the first metatarsal 208 and the second metatarsal 210 may be joined together at a second metatarsal-cuneiform joint. Foot 200 includes a set of proximal phalanges numbered first through fifth (230, 232, 234, 236, 238), a set of distal phalanges numbered first through fifth (240, 242, 244, 246, 248), and a set of intermediate phalanges numbered second through fifth (250, 252, 254, 256).

[0181] FIG. 2B is a lateral perspective view of a foot 200 with the bones of the foot labeled.

[0182] FIG. 2C is a medial perspective view of a foot illustrating the dorsal side 280 and plantar side 282. Dorsal refers to the top of the foot. Plantar refers to the bottom of the foot. Proximal 284 is defined as "near the primary attachment point." Distal 286 is defined as "far from the attachment point." Plantarflexion (plantarflexion or plantarflexion) 288 refers to movement toward the plantar or palmar side 282 of the foot or hand. Dorsiflexion (dorsiflexion or dorsiflexion) 290 refers to movement toward the top of the foot, toward the dorsal side 280 of the foot or hand. FIG. 2D is a dorsal perspective view of a foot 200. The cross-section is a plane showing the top of the foot. Lateral 292 refers to the side farthest from the body's midline or from the body's bilateral plane of symmetry. Medial 294 refers to the side closest to the body's midline or toward the body's bilateral plane of symmetry. For the Lapidus procedure, the intermetatarsal (IM) angle 296 is the angle that is corrected to eliminate the hallux valgus (bunion) deformity. The IM angle 296 is the angle between the longitudinal axes of the patient's first and second metatarsal bones.

[0183] Figure 2E is a diagram of a foot illustrating a common reference plane 260 for the human foot. Figure 2E illustrates a sagittal plane 262 that divides the foot into half right and left compartments. The sagittal plane 262 is perpendicular to a frontal or coronal plane 264 and a transverse plane 266. In the foot, the frontal plane 264 runs generally vertically through the ankle, and the transverse plane 266 runs generally horizontally through the midfoot and toes.

[0184] Because each patient and / or condition is different, the amount of angular adjustment required in each direction may vary from patient to patient. Use of a patient-specific guide may assist the surgeon in optimally realigning the bone hole, positioning the target or bone tunnel, positioning one or more resections and / or fasteners, etc. Thus, providing patient-specific guides, jigs, and / or instruments may provide unique advantages.

[0185] The patient-specific devices of the present invention can be used to correct a wide variety of bone conditions. Such conditions include, but are not limited to, any angular deformity from one bone segment in either the lower or upper limb (e.g., tibial deformity, calcaneal deformity, femoral deformity, and radial deformity). The present disclosure can also be used to treat the interface between two bone segments (e.g., the ankle, metatarsocuneiform joint, Lisfranc joint, complex Charcot deformity, wrist, knee, etc.). As an example, angular deformities or segmental malalignments in the forefoot, such as those found at the metatarsocuneiform level, midfoot level such as the navicular-cuneiform junction, calcaneocuboid joint, or subtalar joint, or in the hindfoot at the ankle between the tibia and talus junction, can be treated. Additionally, patient-specific devices can be used in the proximal leg between two bone segments, or in the upper limb, such as those found at the wrist or metacarpal level.

[0186] FIG. 3 illustrates a flowchart diagram illustrating a method 300 for generating one or more patient-specific devices configured to correct or address a bone or foot condition, according to one embodiment. Prior to the steps of method 300, a bone model (also referred to as a CAD model above) is generated. The bone model may be generated using medical images of the patient's foot and may also be referred to as an anatomical model. The medical imaging image(s) may be used by a computing device to generate patient image data. The patient image data may be used to measure and describe the orientation of one or more structures of the patient's anatomy. In certain embodiments, the patient image data may serve as or be part of the patient's anatomical data.

[0187] In one embodiment, method 300 begins after a bone model of a patient's body or body part(s) has been generated. In a first step 302, method 300 may review the bone model and data associated with the bone model to determine anatomical data for the patient's foot.

[0188] After step 302, method 300 can use the anatomical data to determine (304) a recommended position and / or trajectory angle and / or patient-specific characteristics for the procedure. A "recommended position" refers to a position for deployment of a guide or instrument on, in, between, or within one or more body parts (e.g., bones) of the patient. A "trajectory angle" refers to a recommended angle for deployment of an instrument, implant, body part, or resection feature relative to the patient's bones for the procedure. In certain embodiments, determining the recommended position may use advanced computer analysis systems, expert systems, machine learning, and / or automation / artificial intelligence. In another embodiment, method 300 may include determining one or more alternative positions and / or trajectory angles for the instrument.

[0189] The method 300 may then continue, where a preliminary guide model is provided from the repository of template instrument models 306. The preliminary guide model is a model of a preliminary guide.

[0190] As used herein, a "preliminary guide" refers to a guide configured, designed, and / or engineered to serve as a template, prototype, archetype, or starting point for creating, producing, or fabricating a patient-specific guide. In one aspect, a preliminary guide can be used as is without any further changes, modifications, or adjustments, thus becoming a patient-specific guide. In another aspect, a preliminary guide can be modified, adjusted, or configured to more individually address the goals, objectives, or needs of a patient or surgeon, thereby becoming a patient-specific guide. A patient-specific guide can be used by a user, such as a surgeon, to guide steps during a surgical procedure, such as an osteotomy. Thus, a preliminary guide model can be used to create a patient-specific guide. A patient-specific guide model can be used during a surgical procedure to facilitate one or more steps of the procedure and can be used to create a patient-specific guide that can be used during the patient's surgical procedure.

[0191] In certain embodiments, the preliminary guide model may be generated based on anatomical data and / or bone models, or a combination thereof, and is not a model or pre-designed structure, template, or prototype. Alternatively, or additionally, the preliminary guide model may be or be derived from a template guide model selected from a set of template guide models. Each model in the set of template guide models may be configured to fit an average patient's foot. The template guide model may then be modified or revised by an automated or manual process to generate the preliminary guide model used in the present disclosure.

[0192] As used herein, a "template guide" refers to a guide configured, designed, and / or engineered to serve as a template for creating, producing, or fabricating a patient-specific guide. In one aspect, a template guide can be used as is without any further changes, modifications, or adjustments, thus becoming a patient-specific guide. In another aspect, a template guide can be modified, adjusted, or configured to more individually address the goals, objectives, or needs of a patient or surgeon, thereby becoming a patient-specific guide. A patient-specific guide can be used by a user, such as a surgeon, to guide the performance of one or more resections of a structure, such as a bone, for a procedure. Thus, a template guide model can be used to generate a patient-specific guide model. A patient-specific guide model can be used in a surgical procedure to address, correct, or mitigate the effects of an identified deformity and can be used to generate a patient-specific guide that can be used in a surgical procedure for the patient.

[0193] Next, the method 300 may register the preliminary guide model with one or more bones of the bone model (308). This step 308 facilitates customization and modification of the preliminary guide model to generate a patient-specific guide model from which a patient-specific guide can be generated. The registration step 308 may combine the two models and / or patient image data and position both models for use within one system and / or one model.

[0194] Next, the method 300 may design 310 a patient-specific guide model based on the preliminary guide model. The design step 310 may be fully automated or may optionally allow a user to make changes to the preliminary or partially completed patient-specific guide model before the patient-specific guide model is completed. The preliminary guide model and the patient-specific guide model are two examples of an instrument model. As used herein, "instrument model" refers to a model, either physical or digital, that represents an instrument, tool, apparatus, or device. Examples of instrument models may include a cutting guide model, a resection guide model, an alignment guide model, a reduction guide model, a patient-specific tendon trajectory guide model, a positioner model, a positioning guide model, etc. In one embodiment, the patient-specific guide and the patient-specific guide model may be specific to a particular patient and their anatomy and / or condition.

[0195] The method 300 may conclude with step 312, in which a patient-specific guide may be manufactured based on the patient-specific guide model. Various manufacturing tools, devices, systems, and / or techniques may be used to manufacture the patient-specific guide.

[0196] 4 illustrates an exemplary system 400 configured to create one or more patient-specific instruments configured to facilitate a surgical procedure, according to one embodiment. System 400 may include an apparatus 402 configured to accept, review, receive, or reference a bone model 404 and provide a patient-specific guide 406. In one embodiment, apparatus 402 is a computing device. In another embodiment, apparatus 402 may be a combination of computing devices and / or software components, or a single software component, such as a software application.

[0197] The device 402 may include an anatomical data determination module 410, a position determination module 420, a provisioning module 430, an alignment module 440, a design module 450, and a manufacturing module 460, each of which may be implemented in one or more of software, hardware, or a combination of hardware and software.

[0198] The anatomical data determination module 410 determines anatomical data 412 from the bone model 404. In certain embodiments, if the anatomical data is available directly from the bone model 404, the system 400 may not include the anatomical data determination module 410. In certain embodiments, the anatomical data of the bone model 404 may include data identifying each anatomical structure within the bone model 404 and attributes related to the anatomical structure. For example, the anatomical data may include measurements of the length, width, height, and density of each bone within the bone model. Additionally, the anatomical data may include location information identifying where each structure, such as a bone, is located within the bone model 404 relative to other structures, including bones. The anatomical data may be in any suitable format and may be stored separately or together with the data defining the bone model 404.

[0199] In one embodiment, the anatomical data determination module 410 may use advanced computer analysis systems, such as image segmentation, to determine the anatomical data. The anatomical data determination module 410 may determine the anatomical data from one or more sources, such as medical imaging data, images, files, etc. Alternatively, or additionally, the anatomical data determination module 410 may use software and / or systems implementing one or more artificial intelligence methods (e.g., machine learning and / or neural networks) to derive, determine, or extrapolate anatomical data from medical images or bone models. In one embodiment, the anatomical data determination module 410 may perform anatomical mapping of the bone model 404 to determine each unique aspect of the intended osteotomy procedure and / or bone resection and / or bone translation. Anatomical mapping can be used to determine coordinates to be used for an osteotomy procedure, the location and style of resection to be performed manually or automatically or using robotic surgical assistance, the width for the bone cut, the angle for the bone cut, the predetermined depth for the bone cut, the dimensions and configuration of the resection instrument such as a saw blade, milling bit size and / or speed, depth markers on the saw blade, and / or instructions for an automated or robotic resection operation.

[0200] In one embodiment, the anatomical data determination module 410 may use advanced computer analysis systems, such as image segmentation, to determine anatomical data. The anatomical data determination module 410 may determine anatomical data from one or more sources, such as medical imaging data, images, files, etc. The anatomical data determination module 410 may perform image segmentation using a 3D modeling system and / or artificial intelligence (AI) segmentation tools. In certain embodiments, the anatomical data determination module 410 is configured to identify and classify bone portions based on bone conditions. Such classifications may include identifying bone stability, bone density, bone structure, bone deformation, bone structure, bone structure integrity, etc. Thus, the anatomical data determination module 410 may identify portions or sections or one or more bones based on bone quality metrics. Advantageously, the anatomical data determination module 410 can distinguish high bone quality bone, having viable structure, integrity, and / or density, from low bone quality bone, having non-viable structure, integrity, and / or density, and multiple bone quality levels therebetween.

[0201] Thus, the anatomical data determination module 410 can guide a surgeon in determining which regions of a patient's bones are within the "soft tissue envelope" (bone of undesirable bony quality) when the bone is associated with a particular deformity or condition. Identifying the bone quality of a patient's bone or bones can aid the surgeon in determining what type of correction or adjustment is needed. For example, an ulcer caused by a bone deformity can be mapped using the anatomical data determination module 410 in a way that correction can be performed to correct the deformity, reduce pressure on the area, and address the structure where the pressure caused the ulcer / skin breakdown.

[0202] Additionally, the anatomical data determination module 410 and / or other components of the device 402 can be used to perform anatomical mapping, which may include advanced medical imaging, such as the combined use of CT scans, ultrasound, MRI, and bone density scans to effectively create an anatomical map that determines the structural health of the underlying bone.

[0203] Identifying the structural integrity of the underlying bone can help determine where bone resections can be made to preserve the most dense bone for conditions where less dense bone can fracture and collapse, such as Charcot neuropathy, arthropathy, etc. It is well documented that failure to address and remove such less dense bone can ultimately lead to failure of the reconstruction and associated hardware.

[0204] The present disclosure, at least with the exemplary system 400, provides an anatomical map that may be part of the anatomical data. The anatomical map can combine anatomy, deformity, and bone density information to assist in planning osteotomy / osteotomy placement, can be utilized to determine effective bone density, and can help determine where bone should be resected to remove less dense bone while preserving more viable bone.

[0205] The positioning module 420 determines or identifies one or more recommended positions and / or trajectory angles for deployment of instruments, implants, and / or soft tissues based on the anatomical data 412 and / or bone model 404. In one embodiment, the positioning module 420 may compare the anatomical data 412 to a generic model that represents most patient anatomies and is free of deformations or abnormalities. The positioning module 420 may operate autonomously and / or may facilitate input and / or modification from a user. The positioning module 420 may be fully automated, partially automated, or fully manual. The user may control the degree to which the determination of the positions and / or trajectory angles is automated or manual.

[0206] Provisioning module 430 is configured to provide a preliminary guide model 438. Provisioning module 430 may use various methods to provide the preliminary guide model. In one embodiment, provisioning module 430 may generate the preliminary guide model. In the same or alternative embodiment, provisioning module 430 may select a template guide model for the surgical procedure configured to enable identifying the position of one or more instruments and / or providing the trajectory provided by positioning module 420. In one embodiment, provisioning module 430 may select the template guide model from a set of template guide models (e.g., a library, set, or repository of template guide models).

[0207] The registration module 440 registers the preliminary guide model with one or more bones or other anatomical structures of the bone model 404. As described above, registration is the process of combining medical image data, patient image data, and / or one or more models so that the preliminary guide model can be used with the bone model 404.

[0208] The design module 450 designs a patient-specific guide (or a patient-specific guide model) based on the preliminary guide model. The design operation of the design module 450 can be fully automated, partially automated, or fully manual. The user can control the degree to which the design of the patient-specific guide (or patient-specific guide model) is automated or manual.

[0209] The manufacturing module 460 may use the preliminary guide model to manufacture the patient-specific guide 406. The manufacturing module 460 may use a patient-specific guide model generated from the preliminary guide model. The manufacturing module 460 may provide the patient-specific guide model to one or more manufacturing and / or fabrication tools. The patient-specific guide model may be sent to the tools in any format, such as an STL file or any other CAD modeling or CAM file or method for data exchange. In one embodiment, a user may adjust default parameters of the patient-specific guide, such as material type and / or thickness, dimensions, etc., before the manufacturing module 460 provides the patient-specific guide model to the manufacturing tool.

[0210] Effective coupling of the guide to one or more bones can ensure that surgical steps are performed in a desired location and / or orientation, mitigating undesirable surgical outcomes.

[0211] 5 illustrates an exemplary position determination module 420 configured to determine recommended positions and / or trajectories for steps and / or instruments during a surgical procedure, according to one embodiment. The position determination module 420 may consider one or more landmarks on one or more surfaces of one or more bones of the patient in the bone model 404. The position determination module 420 may be fully automated, partially automated, or fully manual. A user may control the degree to which the determination of recommended positions is automated or manual. A user may provide instructions to the position determination module 420 to facilitate the automatic or partially automated determination of one or more recommended positions.

[0212] The position determination module 420 may include a position module 422. The position module 422 may be configured for automated determination of recommended positions for steps and / or instruments during a surgical procedure. For example, in one embodiment, the position module 422 includes an artificial intelligence or machine learning module 424. The artificial intelligence or machine learning module 424 is configured to implement one or more of various artificial intelligence modules that may be trained to identify bones within the bone model 404, determine the surfaces and / or sides of one or more bones, determine landmarks (both natural and / or abnormal), and determine bone axes, such as the longitudinal and / or horizontal axes of the bones, based on the anatomical data 412 and / or the bone model 404. In another embodiment, the position determination module 420 may receive patient image data, bone models, CAD models, etc., and may use these inputs to determine recommended positions and / or trajectories for one or more bones of the patient.

[0213] In one embodiment, the artificial intelligence or machine learning module 424 may be trained using a large dataset of anatomical data 412 for healthy bones and a large dataset of anatomical data 412 for bones with abnormalities and / or landmarks where the abnormalities and / or landmarks have been previously identified and labeled in the dataset. The artificial intelligence or machine learning module 424 may implement or use a neural network configured according to training such that once the artificial intelligence or machine learning module 424 receives the anatomical data 412 for a particular patient, the artificial intelligence or machine learning module 424 can determine what the one or more positions are (e.g., a recommended position and one or more alternative positions for a guide).

[0214] The position module 422 may interact with a patient-specific feature module 426. The patient-specific feature module 426 may obtain one or more positions provided by the position module 422 and the bone model 404 and / or the anatomical data 412 and determine appropriate patient-specific features. In certain embodiments, the patient-specific features provided by the patient-specific feature module 426 may include the number of resection features, the angle or trajectory of one or more resection features, the number, size, and / or location of bone attachment features, the number, size, or location of alignment guides, or a combination thereof. In certain embodiments, the patient-specific feature module 426 may focus on the resection features.

[0215] Like the location determination module 420, the patient specific characteristics module 426 may be fully automated, partially automated, or fully manual. A user may control the degree to which the determination of the trajectory is automated or manual. A user may provide instructions to the patient specific characteristics module 426 to facilitate the automated or partially automated determination of one or more trajectories. In one embodiment, the location module 422 includes an artificial intelligence or machine learning module 424 that facilitates determining one or more trajectories.

[0216] The position determination module 420 outputs position / patient specific features 428 for the orthopaedic surgical procedure.

[0217] 6 illustrates an exemplary provisioning module 430 configured to provide a preliminary guide model, according to one embodiment. The provisioning module 430 may accept anatomical data 412 and location / patient-specific characteristics 428. In the illustrated embodiment, the provisioning module 430 may generate the preliminary guide model 438 (e.g., from “scratch”), or the provisioning module 430 may automatically select a template guide model 436 from a set of template guide models 436 stored in the repository 602. The provisioning module 430 may incorporate various parameters to provision, generate, determine, or select the template guide model 436. For example, in addition to the anatomical data 412, the provisioning module 430 may include patient image data, deformation parameters for various angular deformations (in all three planes) of the midfoot or hindfoot and ankle, patient preferences, and / or surgeon-input parameters.

[0218] In one embodiment, the provisioning module 430 may include a generator 432 and / or a selection module 434. In one embodiment, the generator 432 is configured to generate a preliminary guide model 438. In certain embodiments, the generator 432 may generate or create the preliminary guide model based on anatomical data and / or bone models, or a combination thereof, and without other input (e.g., without a model or pre-designed structure, template, or prototype). Alternatively, or additionally, the generator 432 may generate or create the preliminary guide model using a standard set of features or components that can be combined to form the preliminary guide model. The generated preliminary guide model may then be modified or revised by automated and / or manual processes to generate the preliminary guide model used in the present disclosure.

[0219] The selection module 434 may be configured to select a template guide model 436 for an osteotomy procedure configured to correct the deformity identified by the positioning module 420. In one embodiment, the provisioning module 430 may select the template guide model 436 from a set of template guide models 436 (e.g., a library, set, or repository of template guide models 436). In one embodiment, the template guide model 436 may include a digital model. In another embodiment, the template guide model 436 may include a physical model. In such an embodiment, the repository 602 may be a warehouse or other inventory repository. When the template guide model 436 is a physical model, the systems, modules, and methods of the present disclosure may be used, and the physical model may be milled or machined (e.g., with a CNC machine) to form a patient-specific guide that conforms to the patient's bone surfaces.

[0220] The selection of a suitable template guide model 436 may be fully automated, and / or partially automated, and / or may rely on confirmation from a user before a generated or proposed preliminary guide model 436 becomes preliminary guide model 438. In another embodiment, selection module 434 may facilitate manual selection by a user of a template guide model 436 to become preliminary guide model 438. Selection module 434 may use anatomical data 412 or bone models 404, or a combination thereof, to select a suitable template guide model to become preliminary guide model 438.

[0221] In another embodiment, generator 432 may facilitate user revision or editing of the generated guide model, which becomes preliminary guide model 438. Selection module 434 may use anatomical data 412 or bone models 404, or a combination thereof, to select a suitable template guide model, which becomes preliminary guide model 438.

[0222] The repository 602 may include any number and / or variety of template guide models 436. The template guide models 436 may be differentiated based on the patient's gender or age, which joint in the midfoot, hindfoot, or ankle will be amputated, which material will be used for the template guide, etc. The template guide models 436 may differ from one another in the degree of deformity correction they are designed to provide. Additionally, the template guide models 436 may be differentiated based on how one or more features of the template guide model 436 are positioned, arranged, and / or configured relative to one another. For example, in a particular template guide model 436, the number, location, and / or configuration of alignment features and / or bone attachment features (e.g., holes) may vary based on the patient's needs or preferences, the nature of the deformity, and / or the surgeon's preferences.

[0223] In certain embodiments, template guide models 436 may vary in how slots for cuts (e.g., resection features) for use with the template guide model 436 are positioned, angled, and oriented relative to each other and / or relative to the longitudinal axes of the respective bones in the joint. For example, in one template guide model 436, slot 1352 for the metatarsal resection may be perpendicular to the longitudinal axis of the metatarsal, and slot 1350 may be angled relative to the longitudinal axis of the resection or cuboid bone, so that when the two bones are brought together, the deformity is corrected. Alternatively, in another template guide model 436, slot 1352 for the metatarsal resection may be angled relative to the longitudinal axis of the metatarsal, and slot 1350 may be perpendicular to the longitudinal axis of the cuneiform or cuboid bone, so that when the two bones are brought together, the deformity is corrected.

[0224] The selection module 434 may be configured to automatically select a template-guided model 436 and / or provide automatic template-guided model 436 recommendations that may be modified by a user, such as a surgeon. For example, in one embodiment, the provisioning module 430 and / or the selection module 434 include an artificial intelligence or machine learning module. The artificial intelligence or machine learning module is configured to implement one or more of various artificial intelligence modules that may be trained to select a template-guided model 436 based on the anatomical data 412 and / or other input parameters. In one embodiment, the artificial intelligence or machine learning module may be trained using a large dataset of anatomical data 412 for suitable template-guided models 436 identified and labeled in the dataset by an expert for use in treating a particular deformity. The artificial intelligence or machine learning module may implement or use a neural network configured according to the training so that the artificial intelligence or machine learning module can select a suitable template-guided model 436. The template-guided model 436 selected by the selection module 434 may become the preliminary guide model 438.

[0225] 7 illustrates an exemplary design module 450 configured to design a patient-specific guide model, according to one embodiment. The design module 450 can accept the preliminary guide model 438 and generate a patient-specific guide model 702. In one embodiment, the design module 450 includes a contour module 704, an apply module 706, and / or an optional modify module 708.

[0226] 7 , design module 450 may modify preliminary guide model 438 so that bone-facing and / or bone-contacting surfaces of preliminary guide model 438 conform to the contours of the surface of one or more bones and / or joint in which steps of the orthopaedic surgical procedure will be performed using preliminary guide model 438. Stated another way, design module 450 may modify preliminary guide model 438 to provide bone-engaging members on preliminary guide model 438.

[0227] The contour module 704 may determine the contour of the bone that will contact the preliminary guide model 438. The contour module 704 may determine the contour using the bone model 404 and / or the anatomical data 412. For example, the contour module 704 may determine the shape of the dorsal surface of the calcaneus 222.

[0228] The application module 706 may apply a contour to the provided preliminary guide model 438 to custom contour the bone-engaging surface of the preliminary guide model 438 to match the shape, contour, and / or one or more landmarks of a bone, such as the dorsal surface of the calcaneus 222. Applying the contour to the preliminary guide model 438 may transform the preliminary guide model 438 into a patient-specific guide model 702.

[0229] The generation of the contours of the bone-engaging surfaces of preliminary guide model 438 may be performed in various CAD programs. In some embodiments, the shape of the surface corresponding to the dorsal surface of calcaneus 222 may be obtained directly from bone model 404, anatomical data 412, CAD model, and / or CT scan data and simply copied to preliminary guide model 438. Various operations may be used to copy surfaces from one object to another. Additionally or alternatively, various Boolean operations, such as a Boolean subtraction operation, may be used to remove material from a model of the body of preliminary guide model 438 that has a shape that matches the dorsal surface of calcaneus 222.

[0230] In certain embodiments, design module 450 may include any module, such as modification module 708. Modification module 708 may enable a user, such as a technician or surgeon, to make additional modifications to the design and configuration of preliminary guide model 438. In one embodiment, a user may change any of the features, trajectories, fixation holes, handle engagement holes, angles, configurations, or parameters of preliminary guide model 438. For example, a surgeon may identify other concerns or anatomical aspects of the patient, e.g., in connection with the contralateral foot, or hip or other orthopedic joint, that motivate the surgeon to adjust the angle of one or more trajectories of preliminary guide model 438.

[0231] Alternatively, or additionally, a user may modify an instrument, such as a guide, using the modification module 708. The user may add, remove, or modify steps and / or instruments to create a patient-specific surgical procedure. In this manner, the user can configure the features of the preliminary guide model 438 or a modified preliminary guide model to the patient-specific osteotomy procedure that the surgeon is planning for the patient.

[0232] The user can review the preliminary guide model 438 and may or may not make adjustments or revisions. The output of the modification module 708 and / or application module 706 is a patient-specific guide model 702.

[0233] 8 illustrates an exemplary system 800 configured to generate one or more patient-specific instruments configured to correct a bone condition, according to one embodiment. System 800 may include components or modules similar to those described in connection with FIG. 4. Additionally, system 800 may include a fixture selector 802 and / or an export module 804.

[0234] The fixation device selector 802 allows a user to determine the fixation device(s) to use for the planned surgical procedure for the patient. In one embodiment, the fixation device selector 802 may recommend one or more fixation devices based on the bone model 404, position, trajectory, or input from the user or history of previous surgical procedures performed. The fixation device selector 802 may select a fixation device model from a set of predetermined fixation device models or select a physical fixation device from a set of fixation devices. Fixation devices may include plates and associated accessories such as screws, anchors, etc.

[0235] In one embodiment, the fixator selector 802 includes an artificial intelligence or machine learning module. The artificial intelligence or machine learning module is configured to implement one or more of a variety of artificial intelligence modules that may be trained to select fixator(s) based on the anatomical data 412 and / or other input parameters. In one embodiment, the artificial intelligence or machine learning module may be trained using a large dataset of anatomical data 412 for suitable fixator(s) to use to treat a particular condition, identified and labeled in the dataset by an expert. The artificial intelligence or machine learning module may implement or use a neural network configured according to the training such that the artificial intelligence or machine learning module can select or recommend suitable fixator(s).

[0236] The export module 804 is configured to enable export of the patient-specific guide model 702 for various purposes, including, but not limited to, fabricating / manufacturing the patient-specific guide 406 and / or fixture(s), generating a pre-operative plan, generating a physical bone model that fits the bone model 404, etc. In one embodiment, the export module 804 is configured to export the bone model 404, the anatomical data 412, the patient-specific guide model 702, the pre-operative plan 806, the fixture model 808, etc. In this manner, custom instruments and / or procedure steps of a surgical procedure may be used in other tools. The pre-operative plan 806 may include a set of step-by-step instructions or recommendations for a surgeon or other staff in performing a surgical procedure, such as an osteotomy. The pre-operative plan 806 may include images and text instructions and may include identification of instruments to be used for different steps of the surgical procedure. The instruments may include the patient-specific guide 406 and / or one or more fixtures. In one embodiment, the export module 804 can provide a fixture model that can be used to fabricate a fixture for a surgical procedure.

[0237] The exports (404, 412, 702, 806, and 808) may be input to various third-party tools 810, including manufacturing tools, simulation tools, virtual reality tools, augmented reality tools, surgical procedure simulation tools, robotic-assisted tools, etc. The surgeon can then use these tools when performing the surgical procedure or for rehearsing and preparing for the surgical procedure. For example, physical models of bones, patient-specific guide 406, and / or fixators can be fabricated and used for rehearsal surgical procedures. Alternatively, the surgeon can use bone models 404, preliminary guide models 438, and / or fixator models to perform a simulated surgical procedure using a surgical procedure simulation tool.

[0238] 9 illustrates a method 900 for providing a customer with a 3D physical bone model, according to one embodiment. FIG. 9 is a flowchart of exemplary process 900. In some implementations, one or more process blocks in FIG. 9 may be performed by a system, such as system 800.

[0239] 9, process 900 may include providing medical image data of a patient's anatomy (block 902). For example, system 800 may provide the medical image data of the patient's anatomy in the form of a CT scan or other type of medical image. In another embodiment, process 900 may include providing the patient image data. The source of the medical image data and / or the patient image data may be a medical image processing device, a medical image capture device, a storage device containing one or more digital files, etc.

[0240] 9 , the process 900 may include fabricating a 3D physical bone model of the anatomical structure based on the medical image data (block 904). For example, the system 800 may fabricate the 3D physical bone model of the anatomical structure based on the medical image data or signals in a third-party tool 810 for fabricating the 3D physical bone model. Advantageously, the 3D physical bone model is a physical representation of the anatomical structure. Alternatively, or in addition, the 3D physical bone model is a physical representation of a model of the anatomical structure.

[0241] In one embodiment, the system 800 and / or device may fabricate a single 3D physical bone model (904). The single 3D physical bone model may include an assembly of a set of one or more 3D physical bone models of one or more anatomical structures. In certain embodiments, the fabricated 3D physical bone model is based on the patient's medical image data. In this manner, the 3D physical bone model provides the surgeon with an accurate representation of one or more anatomical structures. The surgeon has a tangible representation of the patient's anatomy. The surgeon can inspect the 3D physical bone model, hold the 3D physical bone model, rotate or reorient the 3D physical bone model, rehearse one or more steps of a surgical procedure using the 3D physical bone model, manipulate the 3D physical bone model, combine the 3D physical bone model with an implant, engage the 3D physical bone model with one or more instruments, and perform various other steps with the 3D physical bone model as part of pre-operative, intra-operative, and / or post-operative steps in providing patient care.

[0242] Alternatively, or in addition, the system 800 and / or device may fabricate 904 multiple 3D physical bone models. Each of the multiple 3D physical bone models may be separate and independent from one another. Each of the multiple 3D physical bone models, or portions thereof, may then be bonded or connected to a substrate and / or framework to form an assembly of 3D physical bone models, the entire assembly of which may be referred to as a 3D physical bone model.

[0243] The 3D physical bone model may be made from any material, including a single material, a composite material, a mixture of materials, multiple materials, etc. In one embodiment, one or more bone models of the 3D physical bone model may be made from a variety of materials (e.g., rubber or silicone) that can be easily peeled and / or excised. For example, the bone model of the bone to be excised may be made from a flexible and / or easily peeled material such as rubber or silicone, while other bone models of the 3D physical bone model may be made from a stronger material such as nylon or bone substitute material.

[0244] In certain embodiments, the 3D physical bone model is made from a material suitable for use in sterilization equipment, such as an autoclave. Because the 3D physical bone model can be easily sterilized, a surgeon can use, visualize, and / or interact with the 3D physical bone model in the operating room (e.g., during a surgical procedure).

[0245] One example of a material for one or more components of the 3D physical bone model is a polymer known as nylon 12. Nylon 12 may also be used as an economical alternative to materials such as metals, such as titanium or stainless steel. Additionally, in certain embodiments, the 3D physical bone model is made from a material that can be used in additive manufacturing processes and / or machines to "print" the 3D physical bone model.

[0246] The 3D physical bone model may include a single 3D physical bone model and / or a combination of two or more 3D physical bone models. Each 3D physical bone model may include a body. In certain embodiments, the body is solid. The body may be transparent, translucent, or opaque. Alternatively, or in addition, the body may include one or more openings that allow structures on the opposite side of the body to be visible.

[0247] 9 , process 900 may include providing the 3D physical bone model to a customer, such as a patient, a surgeon, or a facility. In certain embodiments, this block 906 may include providing the 3D physical bone model to a surgeon, a patient, or a facility for a surgical procedure (block 906). For example, system 800 may prepare and / or package the 3D physical bone model for delivery to a user, a customer, a patient, a surgeon, a facility, and / or a technician. In certain embodiments, system 800 may prepare and deliver a duplicate copy of the 3D physical bone model to one or more of the user, a customer, a patient, a surgeon, a facility, and / or a technician.

[0248] Advantageously, because the patient is the source of the medical image data, the 3D physical bone model represents the anatomical structure(s) of a particular patient. In certain embodiments, this block 906 may include providing the 3D physical bone model to a surgeon, patient, or institution for purposes other than the surgical procedure. For example, a patient, institution, and / or insurance company may receive the 3D physical bone model and / or a copy of the 3D physical bone model for use in research, record-keeping, audit or review processes, pre-approval of a surgical procedure, mementos, etc. In certain embodiments, only the 3D physical bone model is provided. Alternatively, or in addition, the 3D physical bone model may be provided with one or more other components, such as in a system that may include one or more implants, one or more instruments, pre-operative planning, etc.

[0249] Process 900 may include additional embodiments, such as any single embodiment or any combination of embodiments in connection with one or more other processes described below and / or elsewhere herein. In a first embodiment, the anatomical structure may include a structure selected from the group including the foot, ankle, knee, lower leg, upper leg, buttocks, hand, wrist, elbow, shoulder, neck, head, skull, and / or combinations thereof.

[0250] In a second embodiment, alone or in combination with the first embodiment, the medical image data may include data from a computed tomography (CT) scan of the patient's anatomy. Of course, certain embodiments may use other forms of medical imagery. In a third embodiment, alone or in combination with the first and second embodiments, the process 900 may include fabricating an implant or instrument for use with the anatomy during a surgical procedure. In certain embodiments, the instrument and / or implant is a patient-specific instrument and / or patient-specific implant. In one embodiment, the fabricated instrument and / or implant may be based on the medical image data and / or patient image data.

[0251] In a fourth embodiment, alone or in combination with one or more of the first through third embodiments, the process 900 may include generating a CAD model of the patient's anatomical structure. In a fifth embodiment, alone or in combination with one or more of the first through fourth embodiments, the 3D physical bone model may include two or more interconnected physical bone models. In a sixth embodiment, alone or in combination with one or more of the first through fifth embodiments, the process 900 further includes fabricating at least one additional 3D physical bone model of the anatomical structure based on the medical image data, the at least one additional 3D physical bone model having two or more interconnected physical bone models interconnected according to a second configuration, to provide the at least one additional 3D physical bone model for the surgical procedure.

[0252] In a seventh embodiment, alone or in combination with one or more of the first to sixth embodiments, the anatomical structure may include a plurality of bones of the patient, and further, fabricating the 3D physical bone model may include interconnecting two or more bone models of the 3D physical bone model to model the interconnection of two or more bones of the plurality of bones of the patient.

[0253] 9 illustrates example blocks of process 900, in some implementations, process 900 may include additional, fewer, different, or differently arranged blocks than those shown in FIGURE 9. Additionally or alternatively, two or more of the blocks of process 900 may be performed in parallel.

[0254] 10 illustrates a method 1000 for providing a customer with a 3D physical bone model, according to one embodiment. FIG. 10 is a flowchart of exemplary process 1000. In some implementations, one or more process blocks in FIG. 10 may be performed by a system, such as system 800 or system 400.

[0255] 10 illustrates exemplary blocks of process 1000, in some implementations, process 1000 may include the same, additional, fewer, different, or different arrangement of blocks as those in exemplary process 900 illustrated in FIG. 9. For example, in one embodiment, blocks 1002 and 1004 may be the same as corresponding blocks 902 and 904. Block 1008 may be the same as corresponding block 906.

[0256] In addition to blocks 1002, 1004, and 1008, process 1000 may include fabricating 1006 an instrument for a customer, such as a patient, a surgeon, or a facility (block 1006). In one embodiment, the instrument is an implant that can be used in a surgical procedure. In another embodiment, the instrument is a tool that can be used in a surgical procedure.

[0257] In certain embodiments, the instrument is fabricated based on medical imaging data and / or anatomical data 412. In certain embodiments, this may mean that the instrument is patient-specific. In other words, the instrument is a three-dimensional (3D) physical instrument that is based on, similar to, and / or identical to a patient-specific instrument designed using embodiments of the present disclosure. In particular, the 3D instrument includes one or more patient-specific features. For example, the angles of resection guides, pin holes, and bone-engaging members may be custom-made to fit a particular patient's anatomy. In one embodiment, the 3D physical instrument is a patient-specific instrument configured for use with a patient's deformed bony anatomy during a surgical procedure.

[0258] Alternatively, or in addition, the device may be fabricated to meet a common or accepted set of specifications such as size, dimensions, thickness, durability, materials, etc. The device may be single use or may be reusable.

[0259] The devices may be made from a variety of materials, including but not limited to metal, plastic, nylon, nylon 12, ceramic, wood, fiberglass, acrylic, carbon, biocompatible materials, biodegradable materials, etc. The devices may be formed from any biocompatible material, including but not limited to biocompatible metals such as titanium, titanium alloys, stainless steel alloys, cobalt-chromium steel alloys, nickel-titanium alloys, shape memory alloys such as nitinol, biocompatible ceramics, and biocompatible polymers such as polyetheretherketone (PEEK) or polylactic acid polymers (e.g., PLLA).

[0260] As with the other 3D physical bone models described herein, the device may be fabricated using additive manufacturing processes and / or equipment. Alternatively, or in addition, the device may be fabricated using subtractive manufacturing processes and / or equipment.

[0261] In another embodiment, the instrument is a 3D physical bone model of another instrument, such as an implant, guide, or tool used during a surgical procedure. For example, suppose the instrument is an implant for use during a surgical procedure. A surgeon may plan to harvest the implant from a patient's tissue. Process 1000 allows the surgeon to obtain a physical example of the implant to be harvested. The surgeon can then evaluate whether the planned implant will achieve the goals of the surgical procedure or whether revisions to the surgical procedure plan need to be made.

[0262] In certain embodiments, block 1008 of process 1000 may include providing an implant or instrument to a customer. Alternatively, or in addition, process 1000 may include providing an implant or instrument for a surgical procedure. Alternatively, or in addition, process 1000 may include additional blocks (not shown) that include providing an implant or instrument for a customer and / or surgical procedure.

[0263] 11 illustrates a method 1100 for providing a customer with a 3D physical bone model, according to one embodiment. FIG. 11 is a flowchart of exemplary process 1100. In some implementations, one or more process blocks in FIG. 11 may be performed by a system, such as system 800 or system 400.

[0264] Although FIG. 11 illustrates exemplary blocks of process 1100, in some implementations, process 1100 may include the same, additional, fewer, different, or differently arranged blocks as exemplary process 900, exemplary process 1000, and / or exemplary process 1200.

[0265] 11, process 1100 may include receiving a prescription of a 3D bone model (block 1102). For example, system 800, system 400, a digital computing device / system, or a manual system may receive a written, physical, or digital prescription of the 3D bone model from a doctor or surgeon. In certain embodiments, block 1102 may be required. In other embodiments, block 1102 may be optional.

[0266] 11, process 1100 may include capturing patient image data of the patient's anatomy (block 1104). For example, a CT scanner may be used to collect CT images of the patient's body parts. In one embodiment, the CT scanner collects CT images of the patient's feet and ankles, hands and wrists, elbows, knees, hips, shoulders, spine, neck, head, etc. Those skilled in the art will appreciate that other patient body parts can be used in process 1100. Alternatively, block 1104 may not be required, as an alternative source of CT images of the patient's body parts (e.g., deformed bony anatomy) can be used in process 1100.

[0267] In certain embodiments, process 1100 may include capturing patient image data of the patient's anatomy under different conditions or using different configurations and / or different positions. For example, CT images may be collected while a user bears their weight on their ankle and / or foot. Alternatively, or additionally, CT images may be collected while the user is dorsiflexing, plantarflexing, externally rotating, or internally rotating their ankle and / or foot. Those skilled in the art will appreciate that a variety of different conditions, configurations, and / or positions may be used when capturing patient image data of the patient's anatomy.

[0268] 11, process 1100 may include converting the patient image data into a model of the individual bones of the patient's anatomy (block 1106). For example, in one embodiment, process 1100 includes generating a computer model, such as a CAD model, of the patient's anatomy (e.g., anatomical structures). The computer model may represent the model of the individual bones of the patient's anatomy.

[0269] In certain embodiments, block 1106 may include segmenting the patient image data to generate a computer model. For example, an image segmentation tool, including image segmentation software, such as artificial intelligence, may be used to examine the patient image data and identify the boundaries of individual bones within the patient image data. The position, size, orientation, and relationship of each of the individual bones within the image may be captured, stored, and represented in the generated computer model. The computer model may include a single model that includes an individual bone model for each bone within the patient image data. Alternatively, or additionally, the computer model may include multiple models for each of the individual bones within the patient image data.

[0270] As also shown in FIG. 11 , process 1100 may include modifying the model according to the prescription (block 1108). For example, in one embodiment, the patient's anatomy or anatomical structure may include a deformed bone condition. In such an embodiment, block 1108 and / or process 1100 may further include generating a modified computer model of the patient's anatomy or anatomical structure. The modified computer model may be altered from the patient's anatomy or the computer model of the patient's anatomy such that the modified computer model improves the bone condition. Block 1108 and / or process 1100 may further include fabricating a corrected 3D physical bone model based on the modified computer model and providing the corrected 3D physical bone model to a customer. Alternatively, or in addition, the corrected 3D physical bone model may be provided for a surgical procedure. "Corrective 3D physical bone model" refers to a 3D physical bone model that is designed, constructed, engineered, and / or arranged to represent what a patient's anatomy or anatomical structure will be or look like after a surgical procedure has performed a correction. With respect to an orthopedic surgical procedure, the corrective 3D physical bone model can represent one or more bones of the patient after the corrective surgical procedure is completed.

[0271] Thus, in certain embodiments, a customer may receive both a 3D physical bone model (representing the patient's anatomy before the surgical procedure (e.g., a pre-operative 3D physical bone model)) and a corrective 3D physical bone model (representing a plan of the patient's anatomy resulting after the surgical procedure (e.g., a post-operative 3D physical bone model)). The 3D physical bone model may represent the patient's anatomy before the surgical procedure. This can be useful to the surgeon because the surgeon can view and manipulate the 3D physical bone model and the corrective 3D physical bone model to confirm that the pre-operative plan of the surgical procedure achieves the desired results. Alternatively, the surgeon may determine that the corrective 3D physical bone model provides insufficient correction or provides over-correction. Thus, the surgeon can request or make changes to the surgical procedure to refine the surgical procedure.

[0272] The 3D physical bone model and / or corrective 3D physical bone model provide a tangible representation of the patient's anatomy. The ability to view, rotate, hold, and / or manipulate the 3D physical bone model and / or corrective 3D physical bone model can significantly assist a surgeon in the planning, preparation, and / or visualization stages of a surgical procedure. Furthermore, a surgeon may identify potential issues that they may not have noticed before having access to the 3D physical bone model and / or corrective 3D physical bone model.

[0273] Alternatively, or additionally, if process 1100 does not include receiving a prescription (block 1102), process 1100 may include modifying 1108 the computer model according to criteria other than those that may result from the prescription. For example, the computer model may be modified to include an indicator, such as a label or other indicator, to assist the surgeon in verifying that the surgical procedure is being performed on the desired anatomical structures (e.g., applying a "left" marking to a 3D physical bone model for a surgical procedure on a patient's left foot). Alternatively, or in addition, the model may be modified based on accepted standard procedures and / or standards of care.

[0274] In addition to the modifications described in other embodiments, in certain embodiments, the model may be modified (1108) to provide one or more structures and / or features that further facilitate the usefulness of the 3D physical bone model, the correction model, and / or one or more physical representations thereof. As an example, the anatomical structure (e.g., the patient's anatomical structure) involved in process 1100 may include multiple bones of the patient. As a result, the computer model representing the patient's bones may also include multiple independent bone models. In such embodiments, process 1100 and / or block 1108 may further include modifying the computer model such that two or more of the multiple independent bone models are interconnected within the computer model. In certain embodiments, this may be achieved by forming two or more interconnecting structures that interconnect two or more of the multiple independent bone models of the computer model. Alternatively, or in addition, interconnections and / or other structures and / or fasteners may be added to the computer model to interconnect two or more independent bone models of the computer model.

[0275] By interconnecting the bone models of the computer model, the one or more 3D physical bone models generated using process 1100 include two or more interconnected structures representing two or more of the multiple independent bone models of the computer model.

[0276] The interconnection structure can include any combination of bone models of the model. In one embodiment, the interconnection structure includes bone models of the first ray of the foot. In another embodiment, the interconnection structure includes bone models of the midfoot of the foot. In another embodiment, the interconnection structure includes bone models of the hindfoot of the foot. In another embodiment, the interconnection structure includes bone models of all bones of a particular patient's foot. In certain embodiments, the bone models may be connected using hidden or less visible interconnects so that the user can clearly visualize the joints, joint gaps between the bones, etc. Alternatively, or in addition, the interconnects may be visible and clearly recognizable to the user so that the presence and / or purpose of the interconnects is apparent. Alternatively, or in addition, the interconnects may connect adjacent bone models, such as models that are part of one or more joints. Alternatively, or in addition, the interconnects may connect any two bone models of the model.

[0277] In one embodiment, one or more structures and / or features formed or added by modifying the model may include interconnections, i.e., connections formed between adjacent bones (bone models) of the model. In certain embodiments, a computing device or user may interact with the computer model to form interconnections between one or more bone models of the model. In one example, a computing device or user may "draw" or form a solid structure between the cortical surfaces of two adjacent bones. For example, a computing device or user may form a solid structure between the articular surfaces of two adjacent bone models, such as a joint. Alternatively, or in addition, a computing device or user may form any number of connections and / or interconnections between one or more portions of two or more bone models. The structures and / or interconnections may be represented in the model as being made from the same material as the bone models. Alternatively, or in addition, when the model is fabricated, the material of the interconnections may be selected to match the material used to fabricate the physical representation of the bone models.

[0278] In certain embodiments, a computing device may interconnect two or more bone models. Alternatively, or in addition, a computing device, e.g., an artificial intelligence system, may operate alone and / or in collaboration with one or more users to provide automated, semi-automated, and / or user-assisted process steps for interconnecting one or more portions of two or more bone models.

[0279] In certain embodiments, the computing device or user may form a fastener (formed in the models), interconnect, or other structure that joins the two bone models. The fastener may be a temporary fastener or a permanent fastener. In one embodiment, the fastener is an internal thread in a hole in one bone and a post or protrusion with corresponding external threads. Other examples of interconnects and / or fasteners include, but are not limited to, snaps, hook-and-loop fasteners, adhesives, tethers and anchors, springs anchored at one or both ends, flexible tethers (e.g., rubber bands), rods and sockets, balls and sockets, interfaces (such as mechanical interfaces), etc.

[0280] In one embodiment, process 1100 includes providing interconnections in the form of adjustable interconnections and / or adjustable interfaces at block 1108. These types of interconnections may be advantageous because, when providing adjustable interconnections to the 3D physical bone model, the surgeon may be able to reposition one or more physical bone models of the 3D physical bone model to a new location, where the one or more physical bone models may remain in the new location until repositioned.

[0281] In one embodiment, the one or more structures and / or features formed or added by modifying the model may include cutout or disconnected sections of one or more bone models. For example, in the case of the distal tibia, block 1108 may include forming a cut surface between two bone fragments of the tibia, such as between the medial malleolus and the tibia, and / or an interconnection that reduces and reconnects the two bone fragments. Advantageously, such modifications to the bone model may result in a physical representation of the tibia that allows the surgeon to easily connect or disconnect the medial malleolus and expose an interior bone surface, such as the superior cortex of the talus.

[0282] In one embodiment, the one or more structures and / or features formed or added by modifying the model may include one or more cuts, channels, holes, bone tunnels, or other similar features formed in one or more bone models. For example, one or more channels may be formed in the bone model to represent a planned resection. Alternatively, or in addition, the channels may be formed to form wedges that separate the bone of the bone model. These cuts, channels, holes, and bone tunnels may be formed based on best practices, standard operating procedures, surgeon preferences, preoperative planning, etc. In certain embodiments, bone fragments of the bone model formed by the cuts, channels, holes, and bone tunnels may be partially separated or completely separated in different embodiments. The completely separated bone model fragments may be completely separated or may include interconnections to maintain two or more bone fragments of the bone model in place.

[0283] Those skilled in the art will recognize various other structures and / or features that may be created or added by modifying the model in block 1108. Each of these other structures and / or features is within the scope of this disclosure.

[0284] 11, process 1100 may include generating a physical representation of the modified model (block 1110). For example, in one embodiment, a computing device and / or a user may send instructions to a fabrication system, apparatus, or device (e.g., a fabricator) instructing the fabricator to fabricate a physical representation of the modified model and / or portions of the modified model (e.g., one or more bone models of the model). Those skilled in the art will appreciate that a variety of different fabricators can be used and may be available to third parties on-site or off-site. Furthermore, the fabricator may fabricate the physical representation using additive manufacturing methods, subtractive manufacturing methods, molded manufacturing methods, etc.

[0285] Advantageously, generating the physical representation of the modified model may include generating one or more interconnects and / or fasteners to be added to the model and / or the modified model, such that one or more of the 3D physical bone models may be interconnected to one another by the interconnects.

[0286] In certain embodiments, block 1110 includes sending instructions to a 3D printer that uses an additive manufacturing process to fabricate a physical representation of the modified model using a medium such as polymer beads, sand, feedstock, cable, etc. In one embodiment, the 3D printer prints the physical representation (also referred to as a 3D physical bone model) from a feed material called Nylon 12 in the form of beads, powder, and / or sand. Using a material such as Nylon 12 is advantageous because it is economical, contains relevant detail, can be easily cleaned, is ready to use, can be sterilized for use in the operating room, etc.

[0287] In certain embodiments, the anatomical structures may be the patient's bones, and may exclude soft tissues such as tendons, cartilage, ligaments, muscles, and skin. As a result, certain anatomical structures, such as bones, may be separate and independent from any other structures in the model, as the model positions, sizes, and / or configures the bones to fit the patient's configuration, position, and alignment. Advantageously, the computing device and / or user may modify the model to include one or more interconnections that structurally join one or more bones to one or more other bones.

[0288] Because the 3D physical bone model is an accurate physical representation of the bone models in the model, the 3D physical bone model also includes two or more physical bone models joined by one or more interconnects. For example, if the model is a patient's foot, the 3D physical bone model may be an accurate physical representation of the bones in the foot, and the model may not include a model of the patient's soft tissue. The model may be modified to include interconnects at each joint that correspond to the actual joints of the patient's bones. In one embodiment, the interconnects are solid materials connecting one bone to another bone in the joint. Furthermore, in certain embodiments, the interconnects may be formed near the midpoint or center point between the two bones. In this way, details of the surface contours of each bone in the joint can be seen and / or used to fit or position one or more instruments or implants used in the surgical procedure.

[0289] In certain embodiments, one or more of the 3D physical bone models may include at least one physical bone model with an indicator that identifies the at least one physical bone model for a user, such as a surgeon. Those skilled in the art will appreciate that the indicator may identify various features and / or aspects of the one or more physical bone models. For example, the 3D physical bone model may be 3D printed from a material such as nylon 12, which may have a black color.

[0290] Alternatively, or in addition, one or more physical bone models of an assembly (e.g., 3D physical bone models) may be made from a different material or may be colored (e.g., by painting or staining the fabrication material) to give one or more physical bone models a different color than the other physical bone models. For example, a physical bone model involved in a corrective surgical procedure may be colored blue to indicate its position, orientation, and / or condition before the corrective surgical procedure, and one or more physical bone models may be colored pink to indicate its position, orientation, and / or condition after the corrective surgical procedure. In this example, the indicator comprises a color imparted by the color of the material used during fabrication. One skilled in the art will understand that other techniques, such as painting, can be used to associate indicators with one or more physical bone models.

[0291] Other indicators may include symbols, letters, words, etc. formed on the surface of one or more of the 3D physical bone models.

[0292] Alternatively, or in addition, the indicators can indicate various aspects, for example, the indicators can indicate which bones have a deformity, which are misaligned, and which are misaligned by x degrees relative to an angle, such as the intermetatarsal (IM) angle, where x is a number between 2 and 90 degrees.

[0293] In certain embodiments, the indicators are indicators related to the locations where the surgeon plans to make one or more cuts in one or more bones of the patient. As described above, these indicators may be included separately from or in addition to features such as channels, cuts, holes, or other structures in, on, or associated with one or more physical bone models. Thus, the surgeon may obtain a 3D physical bone model that indicates where the cuts will be made and / or a 3D physical bone model that includes the cuts so that the surgeon can see the possible results.

[0294] As described above, two or more of the physical bone models of the 3D physical bone model can be interconnected. In one embodiment, two or more of the physical bone models can be interconnected according to a first configuration. The first configuration can be selected from the group including an anatomical upright position, a normal position, a weight-bearing position, a one-stage walking position, a one-stage running position, a one-stage jumping position, a one-stage grasping position, a dorsiflexion position, a plantarflexion position, an external rotation position, an internal rotation position, a deformed state, a corrected state, a pre-operative state, and a post-operative state. In certain embodiments, the surgeon may specify in a prescription the desired configuration of one or more 3D physical bone models provided using process 1100.

[0295] In certain embodiments, the interconnects used to couple one physical bone model to another may be rigid and may maintain the configuration of the bones once the 3D physical bone model is fabricated. In certain embodiments, the interconnects may be couplers. In other embodiments, the interconnects may be flexible, semi-flexible, pliable, elastic, and / or rigid. A rigid interconnect may be advantageous because it retains the original configuration the physical bone model had at the time of fabrication. A flexible, semi-flexible, pliable, adjustable, and / or elastic interconnect may be advantageous because it allows a user, such as a surgeon, to change the configuration of the physical bone model from the original configuration to an alternative configuration to aid in planning and / or performing a surgical procedure.

[0296] In an embodiment, process 1100 may include additional steps, and / or block 1110 may include fabricating at least one additional 3D physical bone model of the anatomical structure based on the medical image data. The at least one additional 3D physical bone model may include two or more physical bone models interconnected according to a second configuration.

[0297] Process 1100 and / or block 1110 may further include providing at least one additional 3D physical bone model for the surgical procedure. For example, a surgeon may request a 3D physical bone model of the patient's foot bones including a deformity and a 3D physical bone model of the patient's foot bones including the bones repositioned and / or reduced to provide a correction to address the deformity. The second configuration may be selected from the group including an anatomical position, a normal position, a weight-bearing position, a one-stage walking position, a one-stage running position, a one-stage jumping position, a one-stage grasping position, a dorsiflexion position, a plantarflexion position, an external rotation position, an internal rotation position, a deformed state, a corrected state, a pre-operative state, and a post-operative state.

[0298] 11 , process 1100 may include providing a physical representation of the model to a customer (block 1112). For example, in one embodiment, a fabricator or other person or entity may send a physical representation of the model (e.g., 3D physical bone model(s)) or multiple physical representations of the model to a surgeon, to a surgeon's office, to a hospital or other facility, or to another customer. In particular embodiments, the surgeon, customer, hospital, or other facility may include means for fabricating the physical representation of the model on-site, in which case block 1110 may include sending fabrication instructions to a site having the capability to generate the physical representation of the model.

[0299] 12 illustrates a method for providing a customer with a 3D physical bone model, according to one embodiment. As shown in FIG. 12, process 1200 may include capturing a CT scan of all or a portion of a patient's anatomy (block 1202). For example, the patient's foot and ankle may be scanned by medical imaging equipment to generate a CT scan of one or more images of the patient's foot and / or ankle structures.

[0300] Although FIG. 12 illustrates exemplary blocks of process 1200, in some implementations, process 1200 may include the same, additional, fewer, different, or differently arranged blocks as exemplary process 900, exemplary process 1000, and / or exemplary process 1100.

[0301] 12, process 1200 may include segmenting the CT scan to identify sets of individual bones of the patient (block 1204). Block 1204, which includes segmentation and / or image segmentation, can be performed by a programmed computing device, an artificial intelligence computer analysis system, machine learning, and / or an automated system alone or in conjunction with an operator, technician, etc.

[0302] As also shown in FIG. 12 , process 1200 may include interconnecting one or more bones of the set of individual bones (within the model) to create a bone assembly (block 1206). A bone assembly or bone assembly model includes a bone model, such as a collection of bones or a collection of bone models. In one embodiment, the bone models of a bone assembly may be interconnected to have an individualized configuration. Block 1204, which includes interconnecting and / or joining the bones of the assembly, may be performed in whole or in part by a programmed computing device, an artificial intelligence computer analysis system, machine learning, and / or an automated system, alone or in conjunction with an operator, technician, or the like.

[0303] In certain embodiments, process 1200 may include a decision 1208 regarding whether a corrected bone assembly is desired. A corrected bone assembly is one in which one or more bones of an assembly of bone models are adjusted, revised, repositioned, or modified to form a corrected bone set (e.g., modeled bones). Stated differently, one or more bones of the assembly are in a desired position that is different from their original position(s).

[0304] If a decision 1208 to provide a corrected bone assembly is made, process 1200 may continue to the next step, in which the computing device and / or user modifies (1210) the bone assembly (or generates a new bone assembly) to create the corrected bone assembly. For example, if the patient has a hallux valgus condition, the bone assembly may model the patient's bones and include that condition, and the corrected bone assembly may model the patient's bones where the condition is improved, removed, and / or corrected. Process 1200 may continue to step 1212, in which the user and / or computing device and / or system creates (1212) the corrected bone assembly. In certain embodiments, the user, computing device, and / or system creates (1212) a 3D physical bone model of the corrected bone assembly.

[0305] If a decision 1208 is made not to provide a corrected bone assembly, process 1200 may continue at step 1214, where the user and / or computing device and / or system fabricates 1214 a 3D physical bone model of the bone assembly. Process 1200 then ends at step 1216, where one or more 3D physical bone models (e.g., the bone assembly and the corrected bone assembly) are provided 1216 to the customer.

[0306] 13 illustrates an exemplary system 1300, according to one embodiment. The system 1300 may include a storage device and a processor that executes program instructions stored on the storage device, where the processor may be configured to provide medical image data of a patient's anatomy, fabricate a 3D physical bone model of the anatomy based on the medical image data, and provide the 3D physical bone model of the surgical procedure.

[0307] Alternatively, or in addition, the system 1300 may include one or more 3D physical bone models 1302 and one or more components 1304. As described herein, the 3D physical bone model 1302 may include various features and / or attributes and / or aspects. For example, the 3D physical bone model 1302 may include a set of physical bone models combined or interconnected according to one or more configurations 1306, may include one or more features 1308, such as cut channels, holes, etc., may include one or more indicators 1310, and / or may include one or more interconnections 1312 of the same and / or different types.

[0308] The components 1304 include one or more items that can be used by a surgeon in a surgical procedure. For example, in one embodiment, the components 1304 can include one or more instruments 1314, one or more implants 1316, and / or one or more pre-operative plans 1318. The one or more instruments 1314 can include positioners, aligners, resection guides, cutting tools, fasteners, compressors, distractors, rotation guides, targeting guides, etc. The one or more implants 1316 can include patient-specific implants, generic implants, pre-sized implants, intra-operatively sized implants, grafts such as bone grafts, etc. The one or more pre-operative plans 1318 may include a single plan with alternative steps depending on symptoms presented by the patient. Alternatively, or additionally, the one or more pre-operative plans 1318 can include multiple pre-operative plans 1318, each prepared to address a specific situation that may arise before or during the surgical procedure. Of course, one or more pre-operative plans 1318 can be physical printed pages and / or digital plans 1318 that can be presented to the surgeon on a display device before, during, and / or after surgery.

[0309] In certain embodiments, system 1300 may be a kit that a surgeon can use before, after, or during a surgical procedure. For example, kit 1300 can be sterilized for use in an operating room. Alternatively, or in addition, kit 1300 can be sent to a surgeon for review, pre-operative protocol implementation, to share with a patient, or sent to a facility for inclusion in a set of instruments provided for a surgical procedure.

[0310] FIG. 14A is a top-down view of a computer model 1400, according to one embodiment. The computer model 1400 is a representation of the bones of a particular patient's foot. The computer model 1400 includes a set of bone models, each of which is a model of a particular bone of the foot. For example, the computer model 1400 includes bone models of the medial cuneiform 202, the first metatarsal 208, the second metatarsal 210, the navicular 218, the cuboid 220, the calcaneus 222, and the talus 224. Of course, other bone models of other bones of the foot are also shown in the computer model 1400 and / or FIG. 14A , although not all bones are labeled for the sake of brevity.

[0311] In certain embodiments, the bone models are solid model representations of the respective bones. Alternatively, or in addition, the bone models may include surfaces that match the same surfaces of the patient's corresponding bones and have hollow interiors. In the illustrated embodiment, the bone models are solid models of the patient's bones. In certain embodiments, the bone models of computer model 1400 may be of the same color and / or may be colored to match the color of the known or understood patient anatomy that the bone models represent. Such coloring is an example of an indicator provided on computer model 1400 that may be provided on the 3D physical bone model. In one embodiment, certain bone models may be colored to indicate a particular state to the user. For example, a blue bone model may represent one or more bones of the patient that are in a deformed state. Bone models representing bones that are not in a deformed state may be colored a neutral color, such as brown, beige, gray, or white.

[0312] 14A includes first metatarsal 208, second metatarsal 210, and / or third metatarsal 212 colored blue to indicate that these bones and their associated bones are in a deformed state. Advantageously, the blue coloring allows a surgeon to easily identify that these bones and / or their associated bones have a deformed state.

[0313] Those skilled in the art will appreciate that, in one embodiment, a CT scan is segmented to identify the patient's bones within the scan, including the position and / or orientation of each bone included within the scan relative to one or more other bones. Because the segmentation focuses on the patient's bones, the patient's soft tissue may not be segmented and / or may not be included in computer model 1400. As a result, the bone models in computer model 1400 are not connected to each other. As described above, a user or an automated system, such as an artificial intelligence system, may add interconnects, fasteners, or other devices or features that connect the bone models in computer model 1400.

[0314] FIG. 14A shows a computer model 1400 in which the bone models of the computer model 1400 have not yet been interconnected. This can be seen by the gaps between the bone models shown in FIG. 14A. Arrows 1410 indicate examples of gaps between the bone models. Thus, if the computer model 1400 were printed as is, for example using a 3D printer, the result would be a collection of physical bone models or 3D bone models that are not interconnected to each other. The present disclosure includes steps for interconnecting, bonding, or joining the bone models so that the resulting interconnected 3D physical bone models are obtained.

[0315] The computer model 1400 may be defined by data stored on a storage device such as a memory, a hard drive, an SSD, etc. The computer model 1400 may be visible by using a computing device that presents the computer model 1400 on a graphical user interface, a screen, an augmented reality environment, a virtual reality environment, etc.

[0316] Figure 14B is a top-to-bottom view of computer model 1400 after one or more bone models have been interconnected, according to one embodiment. The same bone models of Figure 14A are shown in Figure 14B, but the gaps indicated by arrows 1410 are now filled with interconnects 1420 joining adjacent bone models. Those skilled in the art will understand that interconnects 1420 may be used between each bone model and adjacent bone models, or that particular bone models may not be interconnected such that they can be freely separated for use by a surgeon to further inspect and / or utilize the 3D physical bone models resulting from (or generated from) computer model 1400.

[0317] Alternatively, or in addition, different types of interconnects can be used between different bone models in the computer model 1400. For example, in one embodiment, the interconnects 1420 are solid structural interconnects between adjacent bones, which can be fabricated from the same material as that used to fabricate the physical bone models representing the bone models. In another example, the interconnects 1420 can be some form of fastener, such as adhesive, screws and sockets, hook-and-loop fasteners, snaps, elastic tethers, magnets and magnetic contacts, swivel joints, ball-and-socket joints, etc. In certain embodiments, interconnects, such as adjustable interconnects, can be configured to maintain a set position between two connected physical bone models until a user applies an external force to reposition one or more of the connected physical bone models. In this way, a surgeon can reposition the physical bone models and visualize the trajectory and / or spacing and / or orientation of the repositioned physical bone models relative to each other and other anatomical structures without the physical bone models shifting out of position.

[0318] 15A is a top-to-bottom view of a computer model 1400 including several examples of model resection guides 1510, 1520. The first resection guide 1510 is a model of an instrument that can be used in a surgical procedure on a patient. In one example, the first resection guide 1510 can be used to address a metatarsus adduction condition. In one embodiment, the first resection guide 1510 is a patient-specific instrument. Another exemplary resection guide 1520 can be used to perform a Lapidus procedure. The resection guide 1520 may also be a patient-specific instrument. Advantageously, the model resection guides 1510, 1520 are positioned in the locations where the surgeon intends to use them on the patient during the procedure.

[0319] In one embodiment, the model resection guides may be separate from the bone model. Thus, when reviewing the 3D physical bone model of computer model 1400, the surgeon may remove, replace, and / or reposition first resection guide 1510 and / or resection guide 1520. In this manner, the surgeon can rehearse how a surgical procedure can be performed using first resection guide 1510 and / or resection guide 1520. Alternatively, or additionally, the surgeon may test or review how first resection guide 1510 and / or resection guide 1520 interfaces with and / or engages one or more bones of the 3D physical bone model of computer model 1400.

[0320] In one embodiment, one or the other of first resection guide 1510 or resection guide 1520 may include bone engagement members (e.g., bone engagement surfaces, arthrotropic dopants, landmark alignment features, etc.) that may be configured to engage the patient's bones and / or joints and / or other anatomical structures, as well as the 3D physical bone model of computer model 1400. Advantageously, a surgeon may perform engagement of the bone engagement members with one or more bones of the 3D physical bone model of computer model 1400 before using the same first resection guide 1510 and / or resection guide 1520 on a patient during a surgical procedure.

[0321] Of course, computer model 1400 can include various other instruments in the computer model, including, but not limited to, alignment guides, rotation guides, reduction guides, compression guides, positioning guides, fixation guides, one or more navigation guides, one or more implants, etc. Similar to resection guides, a surgeon can inspect, place, position, and / or rehearse these other instruments in connection with a surgical procedure. Those skilled in the art will appreciate that while computer model 1400 is provided with exemplary instruments, first resection guide 1510 and / or resection guide 1520, these instruments are models of actual instruments that can be fabricated and configured and prepared for use in a surgical procedure. When fabricated, the instruments can be made from different materials, such as metal, and the 3D physical bone model of computer model 1400 can be made from an inexpensive material, such as a polymer.

[0322] Alternatively, or in addition, one or more model instruments may be coupled to one or more bones that the actual instruments will contact when used in the surgical procedure. In other words, a particular model instrument may be positioned in a predetermined / desired location relative to one or more bones of the computer model 1400. This may be useful for the surgeon to ascertain the location where the actual instruments need to be used in the surgical procedure.

[0323] 15B shows an exemplary physical instrument, according to one embodiment. As described in connection with FIG. 15A, embodiments of the present disclosure can be used to fabricate both a three-dimensional (3D) physical model of a patient's bony anatomy and one or more 3D physical instruments for use in a surgical procedure on the patient. FIG. 15B shows just a few examples of 3D physical instruments that can be provided using embodiments of the present disclosure.

[0324] FIG. 15B shows a non-bone-facing view of an exemplary resection guide 1502, a bone-facing view of an exemplary resection guide 1502, a non-bone-facing view of an exemplary positioning guide (e.g., positioner) 1512, and a bone-facing view of an exemplary positioning guide (e.g., positioner) 1512.

[0325] Details of exemplary embodiments of the resection guide 1502 can be found at least in U.S. patent application Ser. No. 17 / 020,630, entitled "PATIENT-SPECIFIC SURGICAL METHODS AND INSTRUMENTATION," filed September 14, 2020, and U.S. patent application Ser. No. 17 / 681,674, entitled "PATIENT-SPECIFIC SURGICAL METHODS AND INSTRUMENTATION," filed February 25, 2022, each of which is incorporated by reference in its entirety into this specification.

[0326] Details of exemplary positioner 1512 embodiments can be found at least in U.S. patent application Ser. No. 18 / 439,454, entitled "APPARATUS, SYSTEM, AND METHOD FOR LAPIDUS CORRECTION," filed Feb. 12, 2024, and U.S. provisional patent application Ser. No. 63 / 484,492, entitled "APPARATUS, SYSTEM, AND METHOD FOR LAPIDUS CORRECTION," filed Feb. 11, 2023, each of which is incorporated by reference in its entirety into this specification.

[0327] Advantageously, the exemplary resection guide 1502 is a 3D physical instrument based on a patient-specific instrument designed using embodiments of the present disclosure. In particular, a system such as system 400 can be used to fabricate the patient-specific guide 406. The patient-specific guide 406 may be based on a patient-specific guide model of the exemplary resection guide 1502. The patient-specific instrument is configured for use with a specific patient's bony anatomy for a surgical procedure. In certain embodiments, the patient-specific instrument is configured for use with a specific patient's deformed bony anatomy for a surgical procedure. In certain embodiments, the 3D physical instrument (e.g., the exemplary resection guide 1502) is a physical embodiment of the patient-specific instrument. As such, the 3D physical instrument includes attributes, aspects, and characteristics of the patient-specific instrument.

[0328] Similarly, the exemplary positioner 1512 is a 3D physical instrument based on a patient-specific instrument designed using embodiments of the present disclosure. In particular, a system such as the system 400 can be used to fabricate a patient-specific guide 406. The patient-specific guide 406 may be based on the patient-specific guide model of the exemplary positioner 1512. The patient-specific instrument is configured for use with a particular patient's bony anatomy for a surgical procedure. In certain embodiments, the patient-specific instrument is configured for use with a particular patient's deformed bony anatomy for a surgical procedure. In certain embodiments, the 3D physical instrument (e.g., the exemplary positioner 1512) is a physical embodiment of the patient-specific instrument. As such, the 3D physical instrument includes attributes, aspects, and characteristics of the patient-specific instrument.

[0329] In the illustrated embodiment, the exemplary resection guide 1502 is an instance of a 3D physical instrument and includes a non-bone-facing side 1504 and a bone-facing side 1506. In the illustrated embodiment, the non-bone-facing side 1504 is opposite the bone-facing side 1506. The bone-facing side 1506 includes a bone-engaging member 1508. The bone-engaging member 1508 is configured to engage one or more bones of the patient's bony anatomy. Alternatively, or in addition, the bone-engaging member 1508 is configured to engage one or more bones of the patient's deformed bony anatomy.

[0330] Additionally, the bone engagement member 1508 is also configured to engage one or more bones of the 3D physical bone model (see FIG. 16 ) that correspond to the bony anatomy (or deformed bony anatomy). Advantageously, in one embodiment, the bone engagement member 1508 engages a first physical bone model of the 3D physical bone model that corresponds to a first bone of the bony anatomy (or deformed bony anatomy). For example, a portion of the bone engagement member 1508 (e.g., a bone engaging surface) may engage with a physical bone model of the medial cuneiform bone 202 of the 3D physical bone model when the exemplary resection guide 1502 is positioned at a desired and / or predetermined location on the 3D physical bone model. This same portion of the bone engagement member 1508 (e.g., a bone engaging surface) also engages with the physical bone of the patient's medial cuneiform bone 202 when the exemplary resection guide 1502 is positioned at a desired and / or predetermined location on the bony anatomy (or deformed bony anatomy). Of course, the exemplary resection guide 1502 may include multiple bone engaging members 1508 .

[0331] In the illustrated embodiment, the exemplary positioner 1512 is an instance of a 3D physical instrument and includes a non-bone-facing side 1514 and a bone-facing side 1516. In the illustrated embodiment, the non-bone-facing side 1514 is opposite the bone-facing side 1516. The bone-facing side 1516 includes a bone-engaging member 1518. The bone-engaging member 1518 is configured to engage one or more bones of the patient's bony anatomy. Alternatively, or in addition, the bone-engaging member 1518 is configured to engage one or more bones of the patient's deformed bony anatomy.

[0332] Additionally, the bone engagement member 1518 is also configured to engage one or more bones of the 3D physical bone model (see FIG. 16 ) that correspond to the bony anatomy (or deformed bony anatomy). Advantageously, in one embodiment, the bone engagement member 1518 engages a first physical bone model of the 3D physical bone model that corresponds to a first bone of the bony anatomy (or deformed bony anatomy). For example, a portion of the bone engagement member 1518 (e.g., a bone engaging surface) may engage with a physical bone model of the medial cuneiform bone 202 of the 3D physical bone model when the exemplary positioner 1512 is positioned at a desired and / or predetermined location on the 3D physical bone model. This same portion of the bone engagement member 1518 (e.g., a bone engaging surface) also engages with the physical bone of the patient's medial cuneiform bone 202 when the exemplary positioner 1512 is positioned at a desired and / or predetermined location on the bony anatomy (or deformed bony anatomy). Of course, the exemplary positioner 1512 may include multiple bone engaging members 1518.

[0333] Figure 16 shows exemplary 3D physical bone models, according to one embodiment. Figure 16 shows 3D physical bone model 1610 and 3D physical bone model 1620. Advantageously, the 3D physical bone models are physical representations of the bone models in computer model 1400.

[0334] The 3D physical bone model 1610 is a model that includes multiple physical bone models of a patient's foot. The 3D physical bone model 1610 may include two or more physical bone models in a first configuration. The first configuration may be in a deformed state. Alternatively, or additionally, the first configuration may match or substantially match the patient's deformed bony anatomy.

[0335] 3D physical bone model 1620 is a model that includes multiple physical bone models of the same patient's foot as 3D physical bone model 1610. 3D physical bone model 1620 may include more than one physical bone model in a second configuration, which may be a corrective state.

[0336] In one embodiment, the first configuration may match or substantially match the patient's bony anatomy. In such an embodiment, the bony anatomy may be the patient's healthy, normal anatomy. For example, the patient may be undergoing a surgical procedure to shorten or lengthen one or more bones. In such an embodiment, the disclosed methods, systems, and / or devices can be used by a surgeon and / or patient to facilitate the surgical procedure. The second configuration may model how the patient's bones will be positioned and / or oriented after a surgical procedure (e.g., a bone distraction or bone shortening procedure). The first and / or second configurations can be selected from the group including an anatomical upright position, a normal position, a weight-bearing position, a one-stage walking position, a one-stage running position, a one-stage jumping position, a one-stage grasping position, a dorsiflexion position, a plantarflexion position, an external rotation position, an internal rotation position, a deformed state, a corrected state, a pre-operative state, and a post-operative state.

[0337] The 3D physical bone model 1610 represents the bone in a deformed state. Specifically, the 3D physical bone model 1610 accurately models the patient's deformed bony anatomy. For illustrative purposes, FIG. 16 includes a first digit row longitudinal axis 1612 indicating the position of the longitudinal axis for the first digit row (e.g., the first metatarsal 208 of the 3D physical bone model 1610 / 1620) and a second digit row longitudinal axis 1614 indicating the position of the longitudinal axis for the second digit row (e.g., the first metatarsal 208 of the 3D physical bone model 1610 / 1620). The angle between the first digit row axis 1612 and the second digit row axis 1614 is the IM angle 296. In the illustrated embodiment, in 3D physical bone model 1610, IM angle 296 is approximately 5.82 degrees, and in 3D physical bone model 1620, IM angle 296 is approximately 0.63 degrees. As the differences in this example illustrate, 3D physical bone model 1620 is a correction model, and 3D physical bone model 1610 is a deformation model.

[0338] In certain embodiments, devices, systems, and / or methods according to the present disclosure include providing indicators on the 3D physical bone model 1610 / 1620. The indicators may inform a surgeon or other user which bones are part of a deformed bone condition. In particular, the indicators may identify physical bone models corresponding to bones of a patient having a deformed bone condition. The patient's bones may be bones of the bony anatomy and / or of the deformed bony anatomy. Advantageously, the indicators are configured to convey information regarding one or more of the bony anatomy, the patient, the surgical procedure, etc. Thus, the indicators may be or convey patient ID, patient name, body side of the anatomy (e.g., left or right), the procedure for which the 3D physical bone model is intended, etc. Those skilled in the art will understand that a variety of different means, techniques, and / or mechanisms may be used to provide and / or include indicators on, within, or associated with either or both of the 3D physical bone model 1610 and / or the 3D physical bone model 1620.

[0339] As an example, Figure 16 shows two different types of indicators: a bone indicator 1616 and an angle indicator 1618. In one embodiment, the bone indicator 1616 is an indicator that includes a mark or symbol that indicates the state of the physical bone model that includes the bone indicator 1616.

[0340] In the illustrated embodiment, bone indicator 1616a is a D1 symbol provided on the surface of a first bone model representing a first bone of the patient (e.g., first metatarsal 208) in a deformed state. Similarly, bone indicator 1616b is a D2 symbol provided on the surface of a second bone model representing a second bone of the patient (e.g., proximal phalanx 230) in a deformed state. The D in bone indicator 1616 may indicate that the associated bone model is in a deformed bone state, and the number may be a sequentially increasing serial number. Bone indicators 1616a, 1616b may be printed (embossed or debossed) or otherwise fabricated or affixed to the surface of the physical bone models of 3D physical bone model 1610.

[0341] Similarly, in the illustrated embodiment, bone indicator 1616c is a C1 symbol provided on the surface of a first bone model representing a first bone of the patient (e.g., first metatarsal 208) in a corrected or repositioned state. Similarly, bone indicator 1616d is a D2 symbol provided on the surface of a second bone model representing a second bone of the patient (e.g., proximal phalanx 230) in a corrected or repositioned state. The C of bone indicator 1616 may indicate that the associated bone model is in a corrected or repositioned state, and the number may be a sequentially increasing serial number. Bone indicators 1616c, 1616d may be printed (embossed or debossed) or otherwise fabricated or affixed to the surface of the physical bone models of 3D physical bone model 1620.

[0342] In one embodiment, angle indicator 1618 is an indicator including a mark or symbol indicating IM angle 296 between the first and second toe rows of 3D physical bone model 1610 and / or 3D physical bone model 1620. In the illustrated embodiment, angle indicator 1618a is a numerical value indicating the degree of IM angle 196 provided on the surface of the physical bone model of 3D physical bone model 1610, and angle indicator 1618b is a numerical value provided on the surface of the physical bone model of 3D physical bone model 1620. In this example, angle indicator 1618a is 5.82 degrees, and angle indicator 1618b is 0.63 degrees. Angle indicators 1618a, 1618b may be printed (embossed or debossed) or otherwise fabricated or affixed to the surface of the physical bone model of 3D physical bone model 1610 or 3D physical bone model 1620.

[0343] The indicators provide the surgeon with a clear indication of the bone and / or other properties of 3D physical bone model 1610 and / or 3D physical bone model 1620, and thus information about the patient's bony anatomy. In one embodiment, the indicators may be implemented by coloring used on, within, or for the physical bone models of 3D physical bone model 1610 and / or 3D physical bone model 1620. For example, in one embodiment, blue may be used to represent bones in a deformed state. Alternatively, or additionally, in another example, pink may be used to represent bones in a corrected state.

[0344] 17 illustrates an exemplary system 1700, according to one embodiment. In this exemplary embodiment, the system 1700 may include a pre-operative plan 1702 and / or a surgical tray 1704. The pre-operative plan 1702 may be provided electronically in a digital format. Alternatively, or in addition, the pre-operative plan 1702 may be printed and provided in a printed format. The pre-operative plan 1702 may include recommendations, suggestions, images, measurements, medical images, information, features, etc., set up specifically for the planned surgical procedure.

[0345] The surgical tray 1704 may include each of the components used in the planned surgical procedure. In one embodiment, the components of the surgical tray 1704 may be sterilized so that they can be safely brought into the operating room. In the exemplary surgical tray 1704, the components include an exemplary 3D physical bone model 1706 and one or more resection guides 1708. The 3D physical bone model 1706 may be in a predetermined configuration, a configuration requested by the surgeon, and / or a modified configuration.

[0346] In the illustrated embodiment, the 3D physical bone model 1706 is in a deformed configuration / state. In the illustrated embodiment, the 3D physical bone model 1706 is fabricated from the polymer nylon 12, which has a black color. In certain embodiments, multiple resection guides 1708 may be provided, and each resection guide 1708 may be a trial guide intended to show the surgeon how the guide will fit onto the patient's bone. Using the trial guides, the surgeon can see where the cut will be made using each resection guide 1708 once the resection guide 1708 is in the desired position.

[0347] The recommended resection guide 1708a may be positioned on and / or coupled to the 3D physical bone model 1706. Alternatively, or in addition, the recommended resection guide 1708a may be imprinted with an indicator identifying it as a recommended resection guide 1708a. Alternatively, or in addition, multiple alternative resection guides 1708b may be included on the surgical tray 1704. These alternative resection guides 1708b may provide different angles, different size cuts, and other differences that a surgeon may want to consider either pre-operatively or intra-operatively during a surgical procedure.

[0348] Of course, those skilled in the art will understand that resection guide 1708 need not be a trial resection guide 1708, but may instead be one or more resection guides 1708 intended for use during a surgical procedure. As a result, resection guide 1708 may be made of another material, such as a metal, such as stainless steel and / or titanium.

[0349] In the illustrated embodiment, the system 1700 may be a kit for use in an osteotomy procedure. The kit includes a first 3D physical bone model 1706 of a patient's deformed bony anatomy for the osteotomy procedure. Advantageously, the first 3D physical bone model 1706 is a highly accurate three-dimensional model of the patient's physical bone. The kit also includes a pre-operative plan 1702 for the osteotomy procedure. In certain embodiments, the pre-operative plan 1702 is configured for patient-specific use. The kit also includes a set of patient-specific instruments (e.g., resection guide 1708) for one or more stages of the osteotomy procedure.

[0350] In certain embodiments, the kit may also include a second 3D physical bone model. The second 3D physical bone model may include multiple physical bone models connected to each other by multiple interconnections. In one embodiment, the multiple physical bone models are connected according to a predetermined configuration. Those skilled in the art will appreciate that various predetermined configurations may be used. For example, the predetermined configuration may be selected from the group including an anatomical upright position, a normal position, a weight-bearing position, a one-stage walking position, a one-stage running position, a one-stage jumping position, a one-stage gripping position, a dorsiflexion position, a plantarflexion position, an external rotation position, an internal rotation position, a pronation position, a supination position, a deformed state, a corrected state, a pre-operative state, and a post-operative state.

[0351] Figure 18 is a flowchart of an example method 1800. In some implementations, one or more of the method steps of Figure 18 may be performed by an apparatus, a device, a computing device, or a system, such as system 800.

[0352] As shown in FIG. 18 , method 1800 may include generating a computer model of the patient's deformed bony anatomy based on medical image data of the deformed bony anatomy (step 1802). Advantageously, the fidelity and accuracy of the medical imagery allows the computer model to accurately represent the deformed bony anatomy. Alternatively, or additionally, the medical imagery may be used to generate anatomical data 412, which may then be used to form the computer model. In yet another alternative, method 1800 may generate the computer model using anatomical data 412, which may be from one or more sources that may or may not include the patient's medical image data.

[0353] In certain embodiments, each bone of the deformed bony anatomy may be modeled by a separate virtual (e.g., computer-generated and / or defined) bone model within the computer model. Multiple virtual bone models may be organized together into an assembly of bone models such that the bones of the computer model have the same or substantially the same size, shape, orientation, configuration, and / or positioning as the corresponding bones of the deformed bony anatomy. In certain embodiments, the computer model may not include the soft tissue of the deformed bony anatomy. Instead, if soft tissue joins or connects the bones of the deformed bony anatomy, the computer model may include gaps or spaces that can be connected using interconnections.

[0354] 18, method 1800 may include fabricating a 3D physical bone model (e.g., 3D physical bone model 1610) of the deformed bony anatomy based on the computer model (step 1804). In certain embodiments, the 3D physical bone model is configured to represent or model physical attributes, properties, and / or aspects of the deformed bony anatomy with a high degree of accuracy.

[0355] In certain embodiments, a user may provide instructions to method 1800 so that certain bone models in the computer model have a higher degree of fidelity and / or accuracy in representing the patient's bone than other models. In this manner, a user may efficiently use computational and / or fabrication resources to create suitable 3D physical bone models at lower cost and in less time. As described herein, fabricating the 3D physical bone models may be performed using additive manufacturing techniques, subtractive manufacturing techniques, molded manufacturing techniques, etc.

[0356] As further shown in FIG. 18 , method 1800 may include providing the 3D physical bone model to a user (step 1806). In one embodiment, providing the 3D physical bone model to the user may include preparing the 3D physical bone model for shipment and initiating delivery to the user by a courier. Alternatively, or in addition, providing the 3D physical bone model to the user may include providing the user with credentials to access the 3D physical bone model from a fabrication system, facilitation, printer, etc. Note that the user may be a surgeon, technician, patient, etc. Providing the 3D physical bone model to the patient can help reassure the patient that the planned surgical procedure is in the patient's best interest and may help calm patient anxieties. In particular, the patient may be able to visualize the planned correction and how the change may improve their health.

[0357] In certain embodiments, step 1806 of method 1800 may not be included or may be an optional step. For example, if a user has the means to fabricate 3D physical bone model 1610 at a location where the user lives, works, or visits, method 1800 may not include step 1806. In such an embodiment, the user may perform steps 1802 and 1804 at their desired location and then access or use 3D physical bone model 1610 as needed.

[0358] Advantageously, the 3D physical bone model (e.g., 3D physical bone model 1610) includes details, aspects, properties, and / or characteristics of the deformed bone anatomy. This 3D physical bone model can assist a surgeon in planning and preparing for a surgical procedure. For example, the ability to hold, handle, review, and / or manipulate the 3D physical bone model of the deformed bone anatomy may allow a surgeon to identify challenges that may arise during the surgical procedure in advance of the surgical procedure, giving the surgeon time to prepare and plan how to address those challenges. Furthermore, the ability to handle and review the 3D physical bone model with the deformed bone anatomy may allow a surgeon to visualize potential challenges of the surgical procedure and / or how the planned deformity correction may affect the patient's quality of life and / or address the patient's needs.

[0359] Method 1800 may include additional embodiments, such as any single embodiment or any combination of embodiments associated with one or more other methods or processes described below or above and / or elsewhere herein. In a first embodiment, the deformed bony anatomy may include multiple bones of the patient, and fabricating the 3D physical bone model (e.g., 3D physical bone model 1610) may include coupling two physical bone models of the 3D physical bone model by interconnection such that the two physical bone models connect to corresponding bones of the patient of the deformed bony anatomy.

[0360] For example, consider a deformed bony anatomy as a set of bones in a patient's foot and ankle. The deformity may be a bunion condition affecting the first metatarsal 208, the proximal phalanx 230, the second metatarsal 210, and the third metatarsal 212. The surgical procedure may be either an Akin procedure and / or a Lapidus procedure separately and / or combined with a metatarsal adduction (MTA) correction.

[0361] As noted herein, in certain embodiments, soft tissues such as cartilage, tendons, ligaments, and / or skin may be omitted from the computer model generated using method 1800 and / or 3D physical bone model 1610. Thus, modeling individual physical bones of the deformed bony anatomy with physical bone models of 3D physical bone model 1610 may include coupling, joining, connecting, combining, and / or otherwise associating one physical bone model with another physical bone model using interconnections.

[0362] In a second embodiment, alone or in combination with the first embodiment, the interconnection may include an interface configured to allow a user to reposition one physical bone model relative to another physical bone model coupled to the interface. In one embodiment, the interconnection is an interface between one physical bone model and another physical bone model. In certain embodiments, the interface may function as an articular interface. An articular interface may allow one physical bone model to be articulated to an adjacent physical bone model. An example of an interface interconnection is a ball-and-socket. Another example is a hook-and-loop connector. Another example is a hinge. Another example is a swivel. In certain embodiments, the interconnection allows the two coupled physical bone models to move freely relative to each other. In another embodiment, the interconnection includes a friction fit or other resistance that maintains the position of the two coupled physical bone models once they are positioned relative to each other.

[0363] Those skilled in the art will appreciate that the interconnects used can be one or more of a variety of different types, kinds, and / or technologies, ranging from simply fixed interconnects made from the same material as the physical bone models of the 3D physical bone model 1610 to more complex interconnects such as mechanical hinges, biological hinges, ball-and-socket interconnects, fasteners, springs, hook-and-hook connectors, magnetic connectors, and various examples provided herein. Furthermore, those skilled in the art will appreciate that various permutations and / or combinations of interconnects may be used. For example, the physical bone models of the 3D physical bone model 1610 (those not directly involved in the deformation and / or surgical procedure) included for the context and / or completeness of the 3D physical bone model 1610, such as three to five of the ankle and / or toes, may be connected by fixed or rigid interconnects. In this way, these bones of the 3D physical bone model 1610 cannot be moved or repositioned but can remain in their positions as the corresponding bones of the patient.

[0364] Alternatively, or in addition, other physical bone models of the 3D physical bone model 1610 that are directly involved in the deformation and / or surgical procedure may be interconnected using flexible, detachable, or removable interconnections, or adjustable interconnections that allow one physical bone model to be repositioned relative to the coupled physical bone model. This distinction between rigidly coupled physical bone models and physical bone models that are freely repositionable and / or detachable can also serve as an indicator to the user as to which physical bone models are involved in the surgical procedure.

[0365] In certain embodiments, a separate interconnection may be used between the first and second physical bone models. The interconnection may be fabricated separately from the physical bone models. Alternatively, or in addition, the interconnection may be fabricated together with the physical bone models. In one embodiment, the interconnection may be generated and / or included in a computer model of the deformed bone anatomy.

[0366] In embodiments where the interconnect is separate from the first physical bone model and the second physical bone model, method 1800 may include coupling or connecting the interconnect to a distal end of the first physical bone model and coupling or connecting the interconnect to a proximal end of the second physical bone model. Advantageously, method 1800 includes interconnecting one or more physical bone models of 3D physical bone model 1610 such that the physical bone models have the same position, orientation, trajectory, and / or relationship relative to other physical bone models of 3D physical bone model 1610 as bones of the patient's deformed bony anatomy.

[0367] In a third embodiment, alone or in combination with the first and second embodiments, the interconnects may include rigid interconnects. Rigid interconnects can be useful to a user in maintaining the state of the deformed bone within the 3D physical bone model 1610. Advantageously, a user can be assured that the anatomical structure of the deformed bone within the 3D physical bone model 1610 is maintained even when the 3D physical bone model 1610 is manipulated, allowing the user to frequently refer to the deformed bone anatomy of the 3D physical bone model 1610 without concern that the anatomical structure of the deformed bone in the 3D physical bone model 1610 has been accidentally altered. In certain embodiments, this advantage may be so important to a user that the user prefers that all interconnects in the 3D physical bone model 1610 be rigid interconnects. Alternatively, or in addition, a user may desire and / or use one or more other embodiments of the method 1800 to generate a correction model, such as the 3D physical bone model 1620. The interconnects in the 3D physical bone model 1620 can also be rigid interconnects to preserve the planned positions of the patient's bones.

[0368] In a fourth embodiment, alone or in combination with the first through third embodiments, the interconnection may include a detachable interconnection. In certain embodiments, the detachable interconnection may be requested by a user and / or may be included by 3D physical bone model 1610 and / or 3D physical bone model 1620. The detachable interconnection may be useful for rehearsing a surgical procedure, gaining access to other bones covered by the bone, visualizing different repositioning plans or orientations, etc. Examples of detachable interconnections include, but are not limited to, snaps, ball-and-socket fasteners, hook-and-loop fasteners, elastomers such as rubber bands, snap hooks, spring hooks, snap-in connectors, threaded fasteners, quick-connect couplings, bayonet connectors, clevis fasteners, other fasteners, etc.

[0369] In a fifth embodiment, alone or in combination with one or more of the first through fourth embodiments, fabricating the 3D physical bone model may include connecting a plurality of physical bone models of the 3D physical bone model with a plurality of interconnects, and the plurality of interconnects may include rigid interconnects and adjustable interconnects. Certain interconnects may be adjustable or detachable. Other interconnects may be adjustable or non-detachable. Examples of adjustable interconnects include, but are not limited to, friction-fit ball-and-sockets, friction-fit swivel connectors, and the like.

[0370] In a sixth embodiment, alone or in combination with one or more of the first to fifth embodiments, fabricating the 3D physical bone model may include providing an indicator on or within the 3D physical bone model, the indicator may be configured to convey information regarding at least one of the bone anatomy, the patient, and the surgical procedure.

[0371] In a seventh embodiment, alone or in combination with one or more of the first through sixth embodiments, the indicator identifies a physical bone model corresponding to a patient's bone having a deformed bone condition. In certain embodiments, the identified patient's bone is a patient's bone of bony anatomy.

[0372] In an eighth embodiment, alone or in combination with one or more of the first through seventh embodiments, the method 1800 may also include fabricating a 3D physical instrument of a patient-specific instrument configured for use on the patient's deformed bony anatomy for the surgical procedure. Alternatively, or in addition, the method 1800 may also include fabricating a 3D physical instrument of a patient-matched instrument configured for use on the patient's deformed bony anatomy for the surgical procedure.

[0373] Advantageously, the patient-specific and / or patient-tailored instruments are configured for use with the bones of a particular patient and / or group of patients. In this manner, the patient-specific and / or patient-tailored instruments are ready for use in a surgical procedure on the patient. Furthermore, the patient-specific and / or patient-tailored instruments are configured for use with the physical bone models of the 3D physical bone model 1610 and / or the 3D physical bone model 1620. Thus, the surgeon can use the same patient-specific and / or patient-tailored instruments not only while planning with the 3D physical bone model 1610 and / or the 3D physical bone model 1620, but also throughout the surgical procedure. This may be advantageous because the 3D physical bone model may enable the surgeon to identify specific challenges or obstacles associated with using the patient-specific and / or patient-tailored instruments. Based on this discovery, the surgeon may then request changes in the patient-specific and / or patient-tailored instruments and / or modify the plan for the surgical procedure to overcome the challenges or obstacles.

[0374] In a ninth embodiment, alone or in combination with one or more of the first through eighth embodiments, the patient-specific instrument can include a bone engaging member configured to engage a bone of the deformed bony anatomy and to engage a physical bone model of the 3D physical bone model corresponding to the bone of the deformed bony anatomy. As described herein, the bone engaging member can assist the surgeon in positioning and / or orienting the patient-specific instrument during the surgical procedure as well as during rehearsal or planning using the 3D physical bone model.

[0375] While Figure 18 illustrates exemplary steps of method 1800, in some implementations, method 1800 may include additional, fewer, different, or differently ordered steps than those set forth in Figure 18. Additionally or alternatively, two or more of the steps of method 1800 may be performed in parallel.

[0376] 19 is a flowchart of an example method 1900. In some implementations, one or more of the method steps of FIG. 19 may be performed by an apparatus, a device, a computing device, or a system, such as system 800 or system 400.

[0377] 19 , method 1900 may include generating a computer model of the patient's bony anatomy based on medical image data of the bony anatomy (step 1902). In another embodiment, method 1900 may include generating anatomical data 412 from medical image data obtained from the patient's bony anatomy and / or generating the computer model from anatomical data 412, either in conjunction with or instead of step 1902. In certain embodiments, the medical image data is recent such that the bony anatomy includes the patient's current condition.

[0378] In one embodiment, the bony anatomy may represent a patient's bones in a deformed bone state. Alternatively, or in addition, the bony anatomy may represent a patient's bones in a healthy bone state. In one embodiment, a patient and / or surgeon may use one or more methods, systems, and / or devices of the present disclosure to assist in a surgical procedure on the healthy anatomy. For example, a patient may desire to lengthen or shorten one or more bones.

[0379] 20A and 19, Fig. 20A shows an example user interface 2000 presenting a computer model 2010 of bony anatomy on a three-dimensional environment pane 2012, according to one or more examples of the present disclosure. Fig. 20A shows an example user interface for interfacing with a computer model of a surgical procedure, according to one embodiment.

[0380] The user interface 2000 may include a three-dimensional environment pane 2012 and a user input pane 2014. The user input pane 2014 may include a patient ID 2016 that indicates the patient associated with the current computer model 2010. The user input pane 2014 may include a set of user input controls 2018 that allow a user to open, save, and export information about the current computer model 2010. The user input pane 2014 may include a prescription input box 2020 that allows a user to enter a prescription to be used by the current computer model 2010.

[0381] In one embodiment, the user interface 2000 may be presented to a user in response to a request or other user input. A user may initiate the creation of the computer model 2010 or the display of the computer model 2010 by entering a patient ID using the patient ID 2016 and / or user input controls 2018. In one embodiment, the computer model 2010 is generated after a user indicates the location of the medical imaging data and / or anatomical data 412. Alternatively, or additionally, the user interface 2000 may display or render a previously generated computer model 2010.

[0382] In certain embodiments, the computer model 2010 responds to user input via keyboard, mouse, or touchscreen gestures. The user may be able to rotate and / or translate the computer model 2010 on the three-dimensional environment pane 2012 and may be able to hide or display specific computer model bones of the computer model 2010 as desired by the user. In one embodiment, the user interface 2000 may display the computer model 2010 in the dorsal anatomical position shown in FIG. 20A by default. Advantageously, the user interface 2000 can be presented to a user on a variety of computing devices, including, but not limited to, mobile or handheld devices, laptops, tablets, desktops, etc. The user interface 2000 is an example, and it should be understood that the user interface 2000 may include various other user input controls and / or features beyond those shown in this example.

[0383] In certain embodiments, the computer model 2010 may be presented with indicators that identify particular bones of the deformed bony anatomy (e.g., blue for bones in a deformed state, tan for bones in a non-deformed state), and of course, other indicators, such as shading, cross-hatching, letters, arrows, lines, etc., may be used as well or in addition.

[0384] In the illustrated embodiment, the user interface 2000 includes a first toe row longitudinal axis 1612 and a second toe row longitudinal axis 1614, as well as an intermetatarsal IM angle 296 measured therebetween. The user interface 2000 may report the measurement of the intermetatarsal IM angle 296 so that the user can compare this value with the value of a modified computer model. Measurements of the first toe row longitudinal axis 1612, the second toe row longitudinal axis 1614, and the intermetatarsal IM angle 296 may help the user diagnose a condition and / or assess the severity of a condition, such as a deformity. Alternatively, or in addition, the user interface 2000 may report or display the value of the intermetatarsal IM angle 296. In one embodiment, the computer model 2010 represents a pre-operative computer model of the patient's bony anatomy. The three-dimensional model and the nature of the computer model 2010 may provide useful information to the surgeon.

[0385] In certain embodiments, the user interface 2000 may include a prescription input box 2020 to indicate a prescription to be used in the design and / or development of the 3D physical bone model 1610, the 3D physical bone model 1620, and / or one or more instruments (e.g., patient-specific, patient-adapted, or conventional instruments). By entering a prescription number in the prescription input box 2020, the user may be able to access prescription details and / or apply the prescription to the computer model 2010 and / or to an instrument model for use by the computer model 2010.

[0386] Referring back to FIG. 19 , method 1900 may also include generating a modified computer model of the bony anatomy, where the modified computer model may be modified from the computer model of the bony anatomy (step 1904) such that the modified computer model represents the bony anatomy after the surgical procedure. Those skilled in the art will appreciate that the modified computer model may be generated or provided in a variety of ways. First, the modified computer model may be generated from medical images and / or anatomical data 412 of the bony anatomy. Second, the modified computer model may be generated by modifying the computer model of the bony anatomy 2010. Third, the modified computer model may be generated based on a prescription from a physician. In the illustrated embodiment, the modified computer model is modified so that the modified computer model represents the bony anatomy after the surgical procedure.

[0387] Generating the modified computer model may be performed by a computing device, a technician, a user, a patient, a physician, a surgeon, and / or a combination thereof. In one embodiment, a computing device may create a preliminary modified computer model, which is then refined and / or revised by a user, such as a technician and / or a physician. For example, a computing device may create the preliminary modified computer model based on a prescription or algorithm or decision made using artificial intelligence, etc.

[0388] Method 1900 may include additional embodiments, such as any single embodiment or any combination of embodiments in connection with one or more other methods or processes described below and / or elsewhere herein. In a first embodiment, generating the modified computer model may further include modifying the computer model based on a prescription provided by a surgeon. For example, the prescription may indicate a desired intermetatarsal IM angle 296 of the first metatarsal 208 relative to the second metatarsal 210. The computing device may initially reposition the first metatarsal 208 within the computer model 2010 to create a modified computer model 2022 that includes the intermetatarsal IM angle 296 indicated in the prescription from the surgeon.

[0389] FIG. 20B shows an exemplary user interface for interfacing with a computer model of a surgical procedure, according to one embodiment. FIG. 20B depicts the same user interface 2000 as FIG. 20A , displaying a modified computer model 2022. The modified computer model 2022 includes the same model bones as the computer model 2010. Certain bones of the modified computer model 2022 have been repositioned to improve the bone condition, for example, to improve a deformed bone condition of the bony anatomy. In one embodiment, the deformed bone condition is a bunion. Thus, the modified computer model 2022 is configured to improve the deformed bone condition of the bony anatomy.

[0390] In certain embodiments, the modified computer model 2022 may be generated and / or created by a computing device with or without the assistance of a user, such as a technician and / or surgeon. Alternatively, a user may create or generate the modified computer model 2022 by manipulating and / or revising the computer model 2010 and / or by changing one or more of the medical imaging data and / or anatomical data 412.

[0391] 20B , the user interface 2000 includes the first toe row longitudinal axis 1612 and the second toe row longitudinal axis 1614, as well as the intermetatarsal IM angle 296 measured therebetween. The user interface 2000 may report the measured intermetatarsal IM angle 296 so that the user can compare this value with the value in the computer model 2010. In one embodiment, the surgeon may review the modified computer model 2022 and the reported intermetatarsal IM angle 296 to determine whether the new positioning is satisfactory. If not, the user may request further modifications and / or perform the repositioning themselves using the user interface 2000.

[0392] Similar to the user interface 2000 of Figure 20A, in Figure 20B the modified computer model 2022 may be presented with indicators identifying specific bones of the deformed bony anatomy that are being moved or altered to improve the condition or achieve the goals of the surgical procedure (e.g., pink for bones in a corrected or repositioned state, and tan for bones in their original position). Of course, other indicators, such as shading, cross-hatching, letters, arrows, lines, etc., may be used as well or in addition.

[0393] In certain embodiments, once the modified computer model 2022 is created, the modified computer model 2022 can be stored and saved for later review and / or use. Additionally, the modified computer model 2022 can be further modified as needed. Advantageously, in one embodiment, a user, such as a surgeon or technician, can modify versions of the computer model 2010 and / or the modified computer model 2022 to create another or further modified computer model. In this manner, a user can create multiple modified computer models 2022, each representing a different surgical procedure and / or a different degree of repositioning of one or more of the bones of the computer model 2010. These multiple modified computer models 2022 can be stored and later referenced by the surgeon as needed. For example, in one embodiment, a surgeon may request or create a modified computer model 2022 for one or more stages of a surgical procedure.

[0394] Advantageously, user interface 2000 allows a user, such as a surgeon, to modify computer model 2010 and / or modified computer model 2022 in response to user input. For example, a user may input a desired value for intermetatarsal IM angle 296, and the computing device may revise modified computer model 2022 to reflect the desired measurement. Alternatively, or in addition, a user may further modify computer model 2010 using a mouse, keyboard, or touch gestures to reposition the bones of computer model 2010 to form modified computer model 2022, or a modified version of modified computer model 2022.

[0395] The steps of modifying and / or reviewing may be repeated until the desired modified computer model 2022 is achieved. At this stage, the surgeon may approve not only the modified computer model 2022, but also any instruments (e.g., patient-specific or conventional) that may be prepared and / or planned for use with the modified computer model 2022.

[0396] As further shown in FIG. 19 , method 1900 may include fabricating a preoperative 3D physical bone model of the bony anatomy based on the computer model of the bony anatomy before the surgical procedure. FIG. 20C illustrates an exemplary 3D physical bone model, according to one embodiment. FIG. 20C illustrates an example of a preoperative 3D physical bone model 2040. Note that the physical bone models in the preoperative 3D physical bone model 2040 are in the same position as the computer model 2010. Similar to the 3D physical bone model 1610, the preoperative 3D physical bone model 2040 may also include one or more indicators, such as, for example, bone indicator 1616a D1, bone indicator 1616b D2, and angle indicator 1618a. Alternatively, or in addition, the deformed model bones in the preoperative 3D physical bone model 2040 may be color-coded (e.g., blue) to indicate which are in the deformed position (e.g., the first metatarsal 208 and / or the proximal phalanx 230).

[0397] The pre-operative 3D physical bone model 2040 provides a three-dimensional model that a user can handle, inspect, rotate, and / or manipulate to assist in planning a surgical procedure. In the illustrated embodiment, the pre-operative 3D physical bone model 2040 is a 1:1 replica of the patient's bone.

[0398] As also shown in FIG. 19 , method 1900 may include fabricating a post-operative 3D physical bone model of the bony anatomy after the surgical procedure based on the modified computer model (step 1908). FIG. 20C shows an example of a post-operative 3D physical bone model 2050. Note that the physical bone models in post-operative 3D physical bone model 2050 are in the same positions as those in modified computer model 2022. Similar to 3D physical bone model 1620, post-operative 3D physical bone model 2050 may also include one or more indicators, such as bone indicator 1616c C1, bone indicator 1616d C2, and angle indicator 1618b. Alternatively, or in addition, the repositioned and / or corrected model bones in post-operative 3D physical bone model 2050 may be color-coded (e.g., pink) to indicate which are in the corrected or repositioned positions (e.g., first metatarsal 208 and / or proximal phalanx 230).

[0399] The post-operative 3D physical bone model 2050 provides a three-dimensional model that a user can handle, inspect, rotate, and / or manipulate to assist in planning a surgical procedure. In the illustrated embodiment, the post-operative 3D physical bone model 2050 is a 1:1 replica of the patient's bones. In certain embodiments, the post-operative 3D physical bone model 2050 may include model bones including cut planes thereon to model the locations where planned cuts will be made during the surgical procedure. For example, in the post-operative 3D physical bone model 2050, the distal end of the medial cuneiform bone 202 may include a planar cut plane, and the proximal end of the first metatarsal bone 208 may include a planar cut plane. In the post-operative 3D physical bone model 2050, the two cut planes may abut one another, and the post-operative 3D physical bone model 2050 may include model fasteners, such as a bone plate and / or one or more bone screws and / or bone staples, positioned as planned during pre-operative planning. In certain embodiments, the fasteners may be removable to allow the surgeon to trial different fasteners. In one embodiment, the fasteners are models, and in another embodiment, the fasteners are the fasteners used in the surgical procedure. Other osteotomies in the patient may also be modeled into the post-operative 3D physical bone model 2050, such as an Akin closing wedge osteotomy.

[0400] 19 , method 1900 may include providing at least one of a pre-operative 3D physical bone model and a post-operative 3D physical bone model to a user (step 1910). In certain embodiments, method 1900 may provide both a pre-operative 3D physical bone model 2040 and a post-operative 3D physical bone model 2050 to the user. Thus, the user may receive two 3D physical models: the pre-operative 3D physical bone model 2040 and the post-operative 3D physical bone model 2050.

[0401] In one embodiment, at least one of the pre-operative 3D physical bone model 2040 and the post-operative 3D physical bone model 2050 may include an indicator that distinguishes the pre-operative 3D physical bone model 2040 from the post-operative 3D physical bone model 2050. In one embodiment, the indicator may be printed, embossed, debossed, etc. on the models 2040, 2050. For example, the text "Pre-op" may be placed on the pre-operative 3D physical bone model 2040 and the text "Post-op" may be placed on the post-operative 3D physical bone model 2050.

[0402] Additionally, the models 2040, 2050 may include indicators such as angle indicator 1618a and angle indicator 1618. By having both the pre-operative 3D physical bone model 2040 and the post-operative 3D physical bone model 2050, the surgeon can be assisted in verifying that his or her surgical procedure plan is appropriate and provides the best likelihood of achieving the desired outcome.

[0403] Further, angle indicator 1618a may include an IM measurement (e.g., 5.82 degrees), and angle indicator 1618b may include an IM measurement (e.g., 0.63 degrees). The surgeon can compare these measurements for each of pre-operative 3D physical bone model 2040 and post-operative 3D physical bone model 2050 to determine whether the angle change is a desired and / or necessary amount. Furthermore, the surgeon may be able to handle and / or manipulate one or more of pre-operative 3D physical bone model 2040 and post-operative 3D physical bone model 2050 to further confirm and / or validate the pre-operative plan.

[0404] In certain embodiments, the surgeon may inspect the pre-operative 3D physical bone model 2040 and the post-operative 3D physical bone model 2050 and determine that changes are needed to the pre-operative plan and / or prescription. In such cases, the surgeon may revise the computer model 2010 and generate a new revised computer model 2022, which can then be used to generate the revised post-operative 3D physical bone model 2050. The surgeon may then compare the revised post-operative 3D physical bone model 2050 with the pre-operative 3D physical bone model 2040 to confirm that the additional changes are satisfactory.

[0405] As shown in FIG. 19 , method 1900 may include generating a computer model of a patient's bony anatomy based on medical image data of the bony anatomy (step 1902). Also shown in FIG. 19 , method 1900 of FIG. 19 may also include generating a modified computer model of the bony anatomy, which may be modified from the computer model of the bony anatomy such that the modified computer model represents the bony anatomy after the surgical procedure (step 1904). Further shown in FIG. 19 , method 1900 may include fabricating a pre-operative 3D physical bone model of the bony anatomy based on the computer model of the bony anatomy before the surgical procedure (step 1906). Also shown in FIG. 19 , method 1900 may include fabricating a post-operative 3D physical bone model of the bony anatomy after the surgical procedure based on the modified computer model (step 1908). As also shown in FIG. 19, the method 1900 may include providing at least one of a pre-operative 3D physical bone model and a post-operative 3D physical bone model to a user (step 1910).

[0406] Method 1900 may include additional embodiments, such as any single embodiment or any combination of embodiments in connection with one or more other methods or processes described below and / or described elsewhere herein. In a first embodiment, generating the modified computer model may further include modifying the computer model based on a prescription provided by the surgeon.

[0407] In a second embodiment, alone or in combination with the first embodiment, the method 1900 may include generating a modified computer model and may further include modifying the computer model in response to user input.

[0408] In a third embodiment, the method 1900, alone or in combination with the first and second embodiments, may include providing an indicator to one of the preoperative 3D physical bone model and the postoperative 3D physical bone model that distinguishes the preoperative 3D physical bone model from the postoperative 3D physical bone model.

[0409] In a fourth embodiment, alone or in combination with one or more of the first through third embodiments, the method 1900 may include the modified computer model being configured to improve a deformed bone condition of the bony anatomy.

[0410] In a fifth embodiment, alone or in combination with one or more of the first through fourth embodiments, the method 1900 may include fabricating a second post-operative 3D physical bone model based on a computer model of the bony anatomy. FIG. 20C shows an example of the second post-operative 3D physical bone model 2060. In certain embodiments, the surgeon may desire the post-operative 3D physical bone model 2050 in addition to the second post-operative 3D physical bone model 2060 because the second post-operative 3D physical bone model 2060 may represent an alternative direction of the surgical procedure. For example, in the illustrated embodiment, the second post-operative 3D physical bone model 2060 may represent a smaller change in the intermetatarsal IM angle 296 (e.g., from 5.82 degrees to 1.03 degrees). Similar to the post-operative 3D physical bone model 2050, the second post-operative 3D physical bone model 2060 may include one or more indicators for the benefit of the user, including bone indicator 1616e, bone indicator 1616f, and angle indicator 1618c indicating the post-operative IM angle.

[0411] Alternatively, or in addition, the second post-operative 3D physical bone model 2060 may represent one or more bones at a stage within a surgical procedure. This version of the second post-operative 3D physical bone model 2060 may be useful for a surgeon to understand how the anatomy may change during a surgical procedure. In yet another embodiment, the second post-operative 3D physical bone model 2060 may represent the patient's anatomy with bones in a non-post-operative configuration, such as a plantarflexed or dorsiflexed position, or any other configuration, such as the examples included in this disclosure.

[0412] While Figure 19 illustrates exemplary steps of method 1900, in some implementations, method 1900 may include additional, fewer, different, or differently ordered steps than those set forth in Figure 19. Additionally or alternatively, two or more of the steps of method 1900 may be performed in parallel.

[0413] Figure 21 illustrates a method for providing a 3D physical model of a surgical procedure, according to one embodiment. Figure 21 is a flowchart of an exemplary method 2100. In some implementations, one or more method steps of Figure 21 may be performed by an apparatus, device, computing device, or system, such as system 800, system 400, etc.

[0414] As shown in FIG. 21 , method 2100 may include generating a computerized bone model of the patient's deformed bony anatomy based on medical image data of the deformed bony anatomy (step 2102). Also shown in FIG. 21 , method 2100 may include fabricating a 3D physical bone model of the deformed bony anatomy based on the computerized bone model (step 2104). As further shown in FIG. 21 , method 2100 may include generating a computerized instrument model of an instrument configured for use in a surgical procedure to improve the deformed bony anatomy (step 2106). Also shown in FIG. 21 , method 2100 may include fabricating the instrument based on the computerized instrument model (step 2108). Also shown in FIG. 21 , method 2100 may include providing the 3D physical bone model and the instrument to a user (step 2110).

[0415] Method 2100 may include additional embodiments, such as any single embodiment or any combination of embodiments in connection with one or more other methods or processes described below and / or described elsewhere herein. In a first embodiment, the instrument is a patient-specific instrument including a bone engaging member configured to engage a bone of the deformed bony anatomy and to engage a physical bone model of the 3D physical bone model corresponding to the bone of the deformed bony anatomy.

[0416] While Figure 21 illustrates exemplary steps of method 2100, in some implementations, method 2100 may include additional, fewer, different, or differently ordered steps than those depicted in Figure 21. Additionally or alternatively, two or more of the steps of method 2100 may be performed in parallel.

[0417] Any method disclosed herein includes one or more steps or actions for performing the described method. Method steps and / or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of an embodiment, the order and / or use of specific steps and / or actions may be modified.

[0418] Alternatively, or in addition, any of the systems, devices, and / or apparatuses herein may be implemented using fewer elements and / or components than described in the illustrated embodiment. Furthermore, elements and / or components and / or structures in one embodiment may be used in other embodiments to replace components or structures and / or to extend the embodiment within the scope of the claims and this disclosure.

[0419] References throughout this specification to an "embodiment" or "the present embodiment" mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the cited phrases, or variations thereof, listed throughout this specification do not necessarily all refer to the same embodiment.

[0420] Similarly, in the above description of the embodiments, it should be understood that various features may be grouped together in a single embodiment, figure, or description for the purpose of streamlining the disclosure. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Rather, as the following claims reflect, the inventive aspect lies in a combination of fewer than all features of any single prior disclosed embodiment. As such, the claims following this Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. The present disclosure includes all combinations of independent claims with their dependent claims.

[0421] The recitation of the term "first" with respect to a feature or element in a claim does not necessarily imply the presence of a second or additional such feature or element. Elements described in means-plus-function form are intended to be construed in accordance with 35 U.S.C. § 112, §6. Those skilled in the art will recognize that changes can be made in the details of the above-described embodiments without departing from the underlying principles described herein.

[0422] While particular embodiments and applications of the present disclosure have been illustrated and described, it should be understood that the scope of the present disclosure is not limited to the precise structure and components disclosed herein. Various modifications, changes, and variations apparent to those skilled in the art may be made in the arrangement, operation, and details of the methods and systems of the present disclosure described herein without departing from the spirit and scope thereof.

Claims

1. 1. A method for providing a three-dimensional (3D) physical model of a surgical procedure, comprising: generating a computer model of the patient's deformed bony anatomy based on medical image data of the deformed bony anatomy; creating a 3D physical bone model of the deformed bony anatomy based on the computer model; providing the 3D physical bone model to a user; The method comprising:

2. 2. The method of claim 1, wherein the deformed bony anatomy includes a plurality of bones of the patient, and wherein fabricating the 3D physical bone model includes coupling two physical bone models of the 3D physical bone model by interconnections such that the two physical bone models are linked to corresponding bones of the patient of the deformed bony anatomy.

3. The method of claim 2 , wherein the interconnections include interface surfaces configured to allow a user to reposition one physical bone model relative to another physical bone model coupled to the interface surfaces.

4. The method of claim 2 , wherein the interconnect comprises a rigid interconnect.

5. The method of claim 2 , wherein the interconnection comprises a detachable interconnection.

6. 6. The method of claim 1, wherein fabricating the 3D physical bone model comprises connecting a plurality of physical bone models of the 3D physical bone model by a plurality of interconnects, the plurality of interconnects comprising rigid interconnects and adjustable interconnects.

7. 7. The method of claim 1, wherein fabricating the 3D physical bone model comprises providing indicators on the 3D physical bone model, the indicators configured to convey information about at least one of the bone anatomy, the patient, and the surgical procedure.

8. The method of claim 7 , wherein the indicator identifies a physical bone model corresponding to a patient's bone having an altered bone condition.

9. 9. The method of any one of claims 1 to 8, comprising fabricating a 3D physical instrument of a patient-specific instrument configured for use with the deformed bony anatomy of the patient for the surgical procedure.

10. 10. The method of claim 9, wherein the 3D physical instrument includes a bone engagement member configured to engage a bone of the deformed bony anatomy and to engage a physical bone model of the 3D physical bone model that corresponds to the bone of the deformed bony anatomy.

11. 1. A method for providing a three-dimensional (3D) physical model of a surgical procedure, comprising: generating a computer model of a patient's bony anatomy based on medical image data of the bony anatomy; generating a modified computer model of the bony anatomy, the modified computer model being altered from the computer model of the bony anatomy such that the modified computer model represents the bony anatomy after a surgical procedure; creating a pre-operative 3D physical bone model of the bony anatomy based on the computer model of the bony anatomy before the surgical procedure; creating a post-operative 3D physical bone model of the bony anatomy after the surgical procedure based on the modified computer model; and providing at least one of the preoperative 3D physical bone model and the postoperative 3D physical bone model to a user; The method comprising:

12. The method of claim 11 , wherein generating the modified computer model further comprises modifying the computer model based on a prescription provided by a surgeon.

13. The method of claim 11 or 12, wherein generating the modified computer model further comprises modifying the computer model in response to user input.

14. 14. The method of claim 11, comprising providing an indicator in one of the preoperative 3D physical bone model and the postoperative 3D physical bone model that distinguishes the preoperative 3D physical bone model from the postoperative 3D physical bone model.

15. The method of any one of claims 11 to 14, wherein the modified computer model is configured to improve a deformed bone condition of the bony anatomy.

16. The method of any one of claims 11 to 15, comprising producing a second post-operative 3D physical bone model based on the computer model of the bony anatomy.

17. 1. A method for providing a three-dimensional (3D) physical model of a surgical procedure, comprising: generating a computer bone model of the patient's deformed bony anatomy based on medical image data of the deformed bony anatomy; creating a 3D physical bone model of the deformed bony anatomy based on the computer bone model; generating a computer instrument model of an instrument configured for use in a surgical procedure to improve the deformed bone anatomy; fabricating the appliance based on the computer appliance model; providing the 3D physical bone model and the tool to a user; The method comprising:

18. 18. The method of claim 17, wherein the instrument is a patient-specific instrument including bone engaging members configured to engage bones of the deformed bony anatomy and to engage physical bone models of the 3D physical bone model that correspond to the bones of the deformed bony anatomy.

19. 1. A kit for an osteotomy procedure, comprising: a first 3D physical bone model of the patient's deformed bony anatomy of the osteotomy procedure; a patient-specific set of instruments for one or more stages of the osteotomy procedure; The kit comprises:

20. 20. The kit of claim 19, further comprising pre-operative planning of the osteotomy procedure.

21. 21. The kit of claim 19 or 20, further comprising a second 3D physical bone model including a plurality of physical bone models connected by a plurality of interconnections, the plurality of physical bone models being connected according to a predetermined configuration.

22. 22. The kit of any one of claims 19 to 21, wherein the predetermined configuration is selected from the group comprising an anatomical upright position, a normal position, a weight-bearing position, a one-stage walking position, a one-stage running position, a one-stage jumping position, a one-stage grasping position, a dorsiflexion position, a plantar flexion position, an external rotation position, an internal rotation position, a pronation position, a supination position, a deformed state, a corrected state, a pre-operative state, and a post-operative state.

23. The kit of any one of claims 19 to 22, wherein the deformed bony anatomical structure is a bunion and the osteotomy procedure is a bunion correction procedure.

Images