Devices, systems, and methods for Lapidus correction

Abstract

Disclosed are devices, systems, and methods for improving a condition present in a patient. In some embodiments, the device may include a body. Additionally, the device may include bone-engaging members on bone-facing sides of the body, the bone-engaging members configured to engage the first and second bones such that the first and second bones are in a predetermined position when engaged by the device. The device may include a fiducial feature guide, configured with the body to guide formation of a fiducial feature in one of the first and second bones.

Description

[Technical Field]

[0001] Related Applications This application claims the benefit of U.S. Provisional Application No. 63 / 484,492, filed February 11, 2023, which is incorporated herein by reference in its entirety.

[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 be a source of 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.

[0005] Advances in medical imaging, preoperative planning, modeling, and the like have led to improvements to help surgeons perform Lapidus surgical procedures. What is needed is a solution that facilitates preoperative planning or modeled corrections and / or implementation of the modeled procedure during 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] In one general aspect, an apparatus can include a device for facilitating an osteotomy procedure. The apparatus can also include a body and bone engaging members on bone-facing sides of the body, the bone engaging members configured to engage a first bone and a second bone. The apparatus can further include a fiducial feature guide configured with the body to guide formation of a fiducial feature in one of the first bone and the second bone.

[0008] The described embodiments may also include one or more of the following features: In the device, the bone engaging member is configured to fully engage both the first bone and the second bone when both bones are in place; In the device, the bone engaging member is configured to partially engage one of the first bone and the second bone when one of the first bone and the second bone is in place; In the device, the bone engaging member may include a bone engaging surface configured to engage a cortical surface of at least one of the first bone and the second bone, and the bone engaging surface may have a contour determined at least in part based on a bone model of the patient's foot.

[0009] In the device, the bone-engaging surfaces can include a first bone-engaging surface configured to engage a first bone and a second bone-engaging surface configured to engage a second bone, wherein when at least one of the first bone and the second bone is repositioned from an original position to a predetermined position, the first bone-engaging surface engages the first bone and the second bone-engaging surface engages the second bone.

[0010] In the device, when the first bone maintains its original position and the second bone is repositioned from its original position to a predetermined position, the first bone-engaging surface engages the first bone and the second bone-engaging surface engages the second bone. In the device, when the second bone is moved to a predetermined position and the second bone-engaging surface engages the second bone, the second bone-engaging surface is configured to provide palpable feedback to the user. In the device, the bone-engaging surface may include a three-dimensional surface having a patient-specific aspect. In the device, the bone-engaging member may include an opening in the body, the opening configured to receive at least a portion of one of the first bone and the second bone, and may be determined at least in part based on a bone model. In the device, the fiducial feature guide may include at least one opening in the body, the at least one opening extending from an opposing side of the bone to an opposite side of the bone.

[0011] The device may further include a handle configured with the body to extend the handle away from the body, a landmark alignment feature extending from the bone-facing side of the body configured to engage a landmark of the patient, a position indicator indicating the position of the body relative to the first bone and the second bone, and a window extending from the bone-facing side of the body to an opposite side of the body.

[0012] Some embodiments herein relate to a system. For example, a system for an osteotomy procedure may include a positioner for providing fiducial features for the osteotomy procedure, the fiducial features corresponding to model fiducials of the model, and the positioner may have a positioner body having a bone-facing side and a non-bone-facing side, a first bone-engaging surface on the bone-facing side, the first bone-engaging surface shaped to engage a surface of a first bone of the patient, the surface shaped to be based at least in part on a model of the first bone, a second bone-engaging surface on the bone-facing side, the second bone-engaging surface shaped to engage a surface of a second bone of the patient, the surface shaped to be based at least in part on a model of the second bone, a first fiducial feature guide formed in the positioner body and configured to guide formation of the first fiducial feature of the first bone, a second fiducial feature guide formed in the positioner body and configured to guide formation of the second fiducial feature of the second bone, and / or a handle coupled to the positioner body.

[0013] The system for the osteotomy procedure may also include a resection guide coupled to the reference feature, the resection guide may include a resection body having a bone-facing side and a non-bone-facing side, a first resection feature extending through the resection body from the non-bone-facing side to the bone-facing side of the resection body, the first resection feature configured to guide a cutting tool to form a first osteotomy in the first bone, a second resection feature extending through the resection body from the non-bone-facing side to the bone-facing side of the resection body, the second resection feature configured to guide a cutting tool to form a second osteotomy in the second bone, and a bone attachment feature configured to secure the resection guide to at least one of the first bone and the second bone.

[0014] The described embodiments may also include one or more of the following features: the system, wherein the first bone-engaging surface is configured to engage the first bone when the first bone maintains its original position, and the second bone-engaging surface does not engage the second bone until the second bone is repositioned in place; the system may further include a compressor configured to compress the cut surface of the first bone against the cut surface of the second bone by engaging a first reference feature of the first bone and a second reference feature of the second bone; and an alignment guide coupled to the positioner and configured to secure a position indicator, the position indicator identifying a trajectory of one of the first bone and the second bone after resection of the first bone and the second bone. In the system, the first and second fiducial feature guides may include sets of holes extending from the non-bone-facing side to the bone-facing side of the positioner body, at least a first hole of the set of holes having a first trajectory perpendicular to a surface of the first bone and at least a second hole of the set of holes having a second trajectory perpendicular to a surface of the second bone. In the system, the bone attachment feature may include holes extending from the non-bone-facing side to the bone-facing side of the resection body and having a third trajectory oblique to a surface of at least one of the first bone and the second bone. In the system, the positioner is a patient-specific instrument made from a polymer, the first resection feature is configured to form a linear cut relative to a distal end of the first bone and the second resection feature is configured to form a linear cut relative to a proximal end of the second bone, and the bone-facing side of the resection guide is a planar surface. The system includes a plurality of positioners, each positioner configured to engage a first bone in its original position and a second bone in a different predetermined position.

[0015] Some embodiments herein relate to methods, for example, a method for improving the condition of bones in a patient's foot, which may include releasing soft tissue around the patient's tarsometatarsal (TMT) joint so that the metatarsals of the TMT joint can be repositioned.

[0016] The method may also include positioning the positioner so that a first bone-engaging surface of the positioner engages a cuneiform bone of the TMT joint. The method may further include moving a metatarsal bone so that a second bone-engaging surface of the positioner engages the metatarsal bone. The method may further include deploying a first set of guide pins through a first fiducial feature guide of the positioner and into the cuneiform bone so that the first set of guide pins form the first fiducial feature.

[0017] The method may further include deploying a second set of guide pins through a second fiducial feature guide of the positioner and into the metatarsal bones such that the second set of guide pins form the second fiducial feature. The method may also include positioning a non-patient-specific resection guide relative to the cuneiform bone and the metatarsal bones using the first fiducial feature and the second fiducial feature, and securing the non-patient-specific resection guide to the cuneiform bone and the metatarsal bones. The method may further include resecting the cuneiform bone using the first resection feature of the non-patient-specific resection guide and the metatarsal bone using the second resection feature of the non-patient-specific resection guide. The method may further include deploying a fixation procedure to secure the cuneiform bone to the metatarsal bones.

[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 the position and / or trajectory of a suite of instruments, 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 mapping from model references to reference features, according to one embodiment. [Figure 10] 1 illustrates a method for facilitating a surgical procedure, according to one embodiment. [Figure 11] 1 illustrates a method for performing a surgical procedure, according to one embodiment. [Figure 12] 1 illustrates a method for performing a surgical procedure, according to one embodiment. [Figure 13] 1 illustrates an exemplary system, according to one embodiment. [Figure 14] 1 illustrates an exemplary system, according to one embodiment. [Figure 15A] FIG. 1 is a top perspective view of an apparatus according to one embodiment. [Figure 15B] FIG. 1 is a top view of an apparatus according to one embodiment. [Figure 15C] FIG. 1 is a bottom view of an apparatus according to one embodiment. [Figure 15D] FIG. 1 is a front view of an apparatus according to one embodiment. [Figure 15E] FIG. 1 is a posterior view of an appliance according to one embodiment. [Figure 15F] FIG. 1 is an interior view of an apparatus according to one embodiment. [Figure 15G] FIG. 1 is an exterior view of an apparatus according to one embodiment. [Figure 16A] FIG. 1 is a top perspective view of an apparatus according to one embodiment. [Figure 16B] FIG. 1 is a top view of an apparatus according to one embodiment. [Figure 16C] FIG. 1 is a bottom view of an apparatus according to one embodiment. [Figure 16D] FIG. 1 is a front view of an apparatus according to one embodiment. [Figure 16E] FIG. 1 is a posterior view of an appliance according to one embodiment. [Figure 16F] FIG. 1 is an interior view of an apparatus according to one embodiment. [Figure 16G] FIG. 1 is an exterior view of an apparatus according to one embodiment. [Figure 17A] 1A-1C show different views of the stages of providing an instrument according to one embodiment. [Figure 17B] 1A-1C show different views of the stages of providing an instrument according to one embodiment. [Figure 17C] 1A-1C show different views of the stages of providing an instrument according to one embodiment. [Figure 17D] 1A-1C show different views of the stages of providing an instrument according to one embodiment. [Figure 17E] 1A-1C show different views of the stages of providing an instrument according to one embodiment. [Figure 17F] 1A-1C show different views of the stages of providing an instrument according to one embodiment. [Figure 18A] 1A-1D show different views of stages of a surgical procedure, according to one embodiment. [Figure 18B]1A-1D show different views of stages of a surgical procedure, according to one embodiment. [Figure 18C] 1A-1D show different views of stages of a surgical procedure, according to one embodiment. [Figure 18D] 1A-1D show different views of stages of a surgical procedure, according to one embodiment. [Figure 18E] 1A-1D show different views of stages of a surgical procedure, according to one embodiment. [Figure 18F] 1A-1D show different views of stages of a surgical procedure, according to one embodiment. [Figure 19] 1 illustrates an exemplary system, according to one embodiment. [Figure 20A] 20A-20C show different views of the instrument of the system of FIG. 19, according to one embodiment. [Figure 20B] 20A-20C show different views of the instrument of the system of FIG. 19, according to one embodiment. [Figure 20C] 20A-20C show different views of the instrument of the system of FIG. 19, according to one embodiment. [Figure 21] 1 illustrates a surgical procedure method, 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 and / or for a single use. 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] "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.

[0034] "Post" refers to any apparatus, structure, device, system, and / or component that extends from another structure. In certain embodiments, the post can be cylindrical.

[0035] 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.

[0036] "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.

[0037] 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.

[0038] "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.

[0039] "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.

[0040] "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.

[0041] "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).

[0042] "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.

[0043] 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.

[0044] 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.

[0045] 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, 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.

[0046] 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.

[0047] 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).

[0048] 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.)

[0049] "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.

[0050] "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.

[0051] 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).

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] "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.

[0058] "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.

[0059] 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.

[0060] 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.

[0061] "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.)

[0062] "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.)

[0063] "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.)

[0064] 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.

[0065] 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.

[0066] "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.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] "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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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.

[0075] 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.

[0076] 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.

[0077] 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.

[0078] "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.

[0079] 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.

[0080] 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.)

[0081] "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 a portion of the body of the talus.

[0082] 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.

[0083] 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.

[0084] 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).

[0085] 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.

[0086] "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.

[0087] "Improvement 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.

[0088] "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.

[0089] 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."

[0090] 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, rounded-ended slots, triangular, etc.

[0091] 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.

[0092] 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.

[0093] 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.

[0094] "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.

[0095] "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).

[0096] 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.

[0097] 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).

[0098] 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.

[0099] 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.

[0100] 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.)

[0101] 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.

[0102] 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.)

[0103] 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.

[0104] 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.)

[0105] 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.

[0106] 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.

[0107] 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 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.)

[0108] "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.

[0109] "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.

[0110] 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.

[0111] "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.

[0112] "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.)

[0113] 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).

[0114] "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.

[0115] 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.

[0116] 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.

[0117] 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).

[0118] 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.

[0119] 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.

[0120] 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.)

[0121] 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."

[0122] "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.

[0123] "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.

[0124] "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. "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.

[0125] 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."

[0126] "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.

[0127] 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).

[0128] 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.

[0129] "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.

[0130] "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.

[0131] "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.

[0132] "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.

[0133] "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.

[0134] 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.

[0135] "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.

[0136] "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.

[0137] 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.

[0138] "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.

[0139] A "revised 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 model. Alternatively, the revised model may be created from scratch. Often, the original model exists in digital form on a computer. Such models may be referred to as CAD models.

[0140] 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.

[0141] 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.

[0142] Medicine and medical technology continue to advance. Surgeons continue to find new ways to address patient needs while increasing the likelihood of a desired outcome and minimizing the risk of adverse outcomes, patient pain and discomfort, and recovery time. In particular, surgeons continue to strive to reduce incisions and perform surgical procedures within smaller spaces through minimally invasive surgical (MIS) procedures.

[0143] 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.

[0144] 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.

[0145] 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.

[0146] 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.

[0147] 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.

[0148] 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.

[0149] 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.

[0150] 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.

[0151] 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.

[0152] 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.

[0153] 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.

[0154] 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.

[0155] 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 correcting a bunion deformity of the foot.

[0156] 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.

[0157] 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.

[0158] 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.

[0159] 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 procedure to correct or improve a bone, muscle, and / or tendon condition.

[0160] 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.

[0161] 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.

[0162] 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.

[0163] 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.

[0164] 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.

[0165] 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.

[0166] 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.

[0167] 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.

[0168] FIG. 2B is a lateral perspective view of a foot 200 with the bones of the foot labeled.

[0169] 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.

[0170] 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.

[0171] 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.

[0172] 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.

[0173] 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.

[0174] 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.

[0175] 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.

[0176] 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.

[0177] 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.

[0178] 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.

[0179] 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.

[0180] 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.

[0181] 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.

[0182] The method 300 may conclude with step 312, where 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.

[0183] 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.

[0184] The apparatus 402 may include a determination module 410, a location 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.

[0185] The 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 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.

[0186] In one embodiment, the determination module 410 may use advanced computer analysis systems, such as image segmentation, to determine the anatomical data. The determination module 410 may determine the anatomical data from another source, such as medical imaging data, images, files, etc. Alternatively, or additionally, the 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 determination module 410 may perform anatomical mapping of the bone model 404 to determine each specific 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.

[0187] In one embodiment, the determination module 410 may use an advanced computer analysis system, such as image segmentation, to determine the anatomical data. The determination module 410 may determine the anatomical data from another source, such as medical imaging data, images, files, etc. The determination module 410 may perform image segmentation using a 3D modeling system and / or an artificial intelligence (AI) segmentation tool. In certain embodiments, the determination module 410 is configured to identify and classify portions of bone based on bone condition. Such classification may include identifying bone stability, bone density, bone structure, bone deformation, bone structure, bone structure soundness, etc. Thus, the determination module 410 may identify portions or sections or one or more bones based on bone quality metrics. Advantageously, the determination module 410 can distinguish high bone quality bones with viable structure, soundness, and / or density from low bone quality bones with non-viable structure, soundness, and / or density, and multiple bone quality levels therebetween.

[0188] Thus, the determination module 410 can guide the surgeon in determining which regions of a patient's bone or bones are within the "soft tissue envelope" (bone of undesirable bony quality) when the bone or bones are associated with a particular deformity or condition. Identifying the bone quality of the 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 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.

[0189] Additionally, the 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.

[0190] 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.

[0191] 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.

[0192] The position 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 position 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 position module 420 may operate autonomously and / or may facilitate input and / or modification from a user. The position 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.

[0193] 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 position 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).

[0194] 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.

[0195] 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.

[0196] 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.

[0197] 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.

[0198] 5 illustrates an exemplary location module 420 configured to determine recommended locations and / or trajectories for steps and / or instruments during a surgical procedure, according to one embodiment. The location 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 location module 420 may be fully automated, partially automated, or fully manual. A user may control the degree to which the determination of recommended locations is automated or manual. A user may provide instructions to the location module 420 to facilitate the automatic or partially automated determination of one or more recommended locations.

[0199] The position 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 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.

[0200] 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).

[0201] 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.

[0202] Like the location 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.

[0203] The location module 420 outputs location / patient specific features 428 for the orthopaedic surgical procedure.

[0204] 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.

[0205] 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.

[0206] 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 position 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.

[0207] 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.

[0208] 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.

[0209] 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.

[0210] 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.

[0211] 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.

[0212] 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.

[0213] Now referring to FIG. 7, the design module 450 may modify the preliminary guide model 438 so that the bone-facing and / or bone-contacting surfaces of the preliminary guide model 438 conform to the contours of one or more bone surfaces and / or joints in which steps of the orthopedic surgical procedure will be performed using the preliminary guide model 438.

[0214] 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.

[0215] 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.

[0216] 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.

[0217] 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.

[0218] 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.

[0219] 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.

[0220] 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.

[0221] 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.

[0222] 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).

[0223] 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 for a surgical procedure can 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.

[0224] 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.

[0225] 9 is a flowchart of an exemplary method 900. In some embodiments, one or more method steps of FIG. 9 may be performed by system 400, system 800, and / or a user. The present disclosure utilizes models, such as computer models, and in particular, individualized patient models to provide and / or generate instruments, implants, and / or surgical plans that advance patient care. Advantageously, these models are unique and customized to a particular patient. Thus, the models reflect the patient's actual anatomical features and aspects.

[0226] One challenge with such solutions is how to transfer, map, or translate from a model of a surgical procedure to the real world. Stated another way, how to transfer, map, or translate from one or more fiducials in a model (e.g., model fiducials) to one or more fiducial features on, within, or associated with the patient's anatomy in the operating room or in the surgical field. The present disclosure addresses this challenge by providing devices, systems, and methods that enable a surgeon to identify, create, create, and / or use fiducial features of a surgical procedure. The fiducial features provide a reference and / or starting point on, in, or associated with the patient's anatomy so that steps, stages, features, or aspects planned and configured in the model can be accurately performed on, by, or against the patient's anatomy. Method 900 provides an example of steps that can be used to implement changes, corrections, adjustments, or revisions set up, designed, or engineered in a model of the patient's anatomy during a surgical procedure.

[0227] One aspect of method 900 that aids in accomplishing the task is by designing, creating, and / or engineering one or more model instruments within a model that uses one or more fiducials (e.g., model fiducials). The one or more model instruments may use the one or more fiducials to position and / or orient the one or more model instruments so that other steps of the surgical procedure can be performed with respect to those one or more model instruments and / or model fiducials. Method 900 may then manufacture actual instruments and / or implants that are instantiations or real-world implementations of the model instruments. Advantageously, model fiducials that interact with, are part of, or are integrated with the model instruments have this same relationship to the real-world, actual implementation of the model instruments produced according to method 900.

[0228] For example, in one embodiment, pin locations for temporary fasteners such as K-wires may be defined within the model. Model instruments are also defined within the model and include one or more holes sized just right to engage and / or slide over the K-wires. The holes in the model instruments may be model fiducials.

[0229] Alternatively, or in addition, the model instrument may include other features that are part of or cooperate with the model fiducials. In one embodiment, the model instrument may include features such as tissue-engaging surfaces configured to engage tissue at a single position and / or orientation. In certain embodiments, the tissue-engaging surfaces are bone-engaging surfaces. In other embodiments, the tissue-engaging surfaces are patient-specific bone-engaging surfaces. Thus, in certain embodiments, other features, such as holes and / or tissue-engaging surfaces, of the model instrument can function as model fiducials.

[0230] The model instrument can then be fabricated to form an actual instrument that includes the same features as the model reference (e.g., one or more holes that can indicate where pins need to be placed, or one or more posts for engaging holes or other features of the patient and / or tissue-engaging surfaces, such as bone-engaging surfaces). In this way, the instrument guides the user in placing, identifying, determining, and / or forming reference features on, in, or associated with the patient's anatomy.

[0231] For example, a surgeon can position and manipulate a real instrument during a surgical procedure until the instrument contacts, seats, and / or aligns with or against tissue, such as one or more bone surfaces of a patient on a single bone and / or multiple bones. With the instrument in place (a position that corresponds to and matches the position of the model instrument in the model), the surgeon can mark, identify, form, or create fiducial features that successfully map the model fiducials to fiducial features on the patient.

[0232] 9, method 900 may include providing a revised computer-aided design (CAD) model of one or more patient bones that improves the condition of the bones, where the revised CAD model may have model references (block 902). For example, system 400, system 800, and / or a user may provide a revised computer-aided design (CAD) model of one or more patient bones that improves the condition of the bones, where the revised CAD model may have model references. For example, if the patient has a bone deformity, system 400, system 800, a computer program device, and / or a user may reposition one or more bones, resect one or more bone portions, deploy implants, remove grafts, and / or make various changes to the model until the model represents the correct condition of the patient's bones.

[0233] 9, method 900 may include manufacturing an instrument that identifies fiducial features of the surgical procedure, where the fiducial features may correspond to the model fiducials (block 904). The fiducial features may be K-wire locations, hole locations, or bone tunnel locations during the surgical procedure, among other embodiments of fiducial features. For example, system 400, system 800, and / or a user may manufacture an instrument that identifies fiducial features of the surgical procedure, where the fiducial features may correspond to the model fiducials, as described above. In one embodiment, the instrument may be a positioner, also referred to as a positioning guide.

[0234] 9 , method 900 may include fabricating other instruments for the surgical procedure (block 906). For example, system 400, system 800, and / or a user may fabricate other instruments for the surgical procedure as described above. The other instruments may be any of resection guides, fasteners, and / or complementary components, examples of which are described herein. In one embodiment, the other instruments are multiple resection guides. Each of the multiple resection guides may include resection features (e.g., cutting channels) that are designed and / or angled to remove different amounts of bone in three or more planes and / or to resect at different angles.

[0235] 9, the method 900 may include providing surgical and other instrumentation (block 908). For example, the system 400, the system 800, and / or a user may provide the surgical and other instrumentation as described above. The surgical and other instrumentation may be provided in a surgical kit or tray and may be sterilized and / or packaged for use in the surgical procedure.

[0236] 9 illustrates example blocks or steps of a process or method 900, in some implementations, method 900 may include additional, fewer, different, or differently arranged steps than those in FIG. 9. Additionally or alternatively, two or more of the steps of method 900 may be performed in parallel.

[0237] Figure 10 is a flowchart of an example method 1000. In some implementations, one or more of the method steps of Figure 10 may be performed by system 400, system 800, and / or a user.

[0238] 10 , method 1000 may include generating a corrected model of one or more patient bones, the corrected model including model pin locations for the surgical procedure (block 1002). For example, system 400, system 800, and / or a user may generate a corrected model of one or more patient bones, the corrected model including model pin locations for the surgical procedure, as described above. The model pin locations and / or corresponding pins may serve as examples of model references, as used in method 900.

[0239] As also shown in FIG. 10 , method 1000 may include fabricating a positioner (also known as a positioning guide) to identify anatomical pin locations and / or reposition bones for a surgical procedure. The anatomical pin locations may correspond to model pin locations (block 1004). For example, system 400, system 800, and / or a user may fabricate a positioner (also known as a positioning guide) to identify anatomical pin locations and / or reposition bones for a surgical procedure, where the anatomical pin locations may correspond to model pin locations, as described above. The anatomical pin locations and / or corresponding pins may serve as examples of fiducial features, for example, as used in method 900. In one embodiment, the positioner may be fabricated by additive manufacturing. Additionally, the positioner may be fabricated from a material (e.g., a polymer such as nylon 12) that is transparent to medical imaging, such as fluoroscopy. Alternatively, or in addition, the positioner may be made from a material (eg, a polymer such as nylon 12) that is radiolucent for medical imaging such as fluoroscopy.

[0240] As further shown in FIG. 10 , method 1000 may include manufacturing one or more cutting guides and / or one or more resection guides based on the anatomical pin locations for the surgical procedure (block 1006). For example, system 400, system 800, and / or a user may manufacture cutting guides or resection guides based on the anatomical pin locations for the surgical procedure, as described above. The resection guides may include one or more holes configured to engage or receive pins, slide down to cover the pins, and / or slide up to remove the pins during the surgical procedure. In one embodiment, the one or more resection guides may be fabricated by additive manufacturing. Furthermore, the one or more resection guides may be fabricated from a material (e.g., a polymer such as nylon 12) that is transparent for medical imaging, such as fluoroscopy. Using a positioner and / or resection guide that is transparent for medical imaging allows a surgeon to check medical images intraoperatively to confirm that the planned resection will achieve the desired level of correction. Alternatively, or in addition, the positioner and / or resection guide may include one or more alignment guides that are visible in the medical image so that the surgeon can use them to confirm that the planned correction will achieve the desired level of correction.

[0241] 10, method 1000 may include providing a surgical positioner (also known as a positioning guide) and / or a cutting or resection guide (block 1008). For example, system 400, system 800, and / or a user may provide a surgical positioner (also known as a positioning guide) and a cutting and / or resection guide, as described above. The surgical positioner, cutting and / or resection guide may be provided in a surgical kit or tray and may be sterilized and / or packaged for use in the surgical procedure.

[0242] 10 illustrates example blocks or steps of a process or method 1000, in some implementations, method 1000 may include additional, fewer, different, or differently ordered steps than those depicted in FIGURE 10. Additionally or alternatively, two or more of the steps of method 1000 may be performed in parallel.

[0243] 11 is a flowchart of an exemplary method 1100 for performing a surgical procedure. Specifically, method 1100 can be used to perform a Lapidus arthrodesis. In some embodiments, one or more of the method steps of FIG. 11 can be performed by system 400, system 800, a medical robot, and / or a user.

[0244] 11 , method 1100 may include deploying a positioner to reposition the bottom of the patient's first metatarsal to a corrective position and identifying one or more reference features for the surgical procedure (block 1102). In one embodiment, the patient may present with the first metatarsal 208 in a deformed position. After making an incision in the skin and soft tissue on the medial side of the TMT joint, the surgeon may place the positioner against the cortical surface of the bottom of the first metatarsal 208 and / or against the cortical surface of the medial cuneiform 202. In certain embodiments, a portion of the positioner may extend at least partially into the TMT joint space between the medial cuneiform 202 and the first metatarsal 208.

[0245] Optionally, or in certain embodiments, the surgeon may "loosen" or "release" the joint by resecting, burring, or otherwise removing portions of connective tissue between the medial cuneiform 202 and the first metatarsal 208 of the TMT joint. Those skilled in the art will understand that this process of loosening or releasing a joint may involve incisions, resections, and / or dissections aimed at freeing soft tissue so that one or more bones of the joint can translate and / or rotate (e.g., be repositioned or moved). Thus, in certain embodiments and / or surgical procedures, this step may be referred to as releasing the joint or releasing the joint, or releasing the metatarsal or cuneiform bones.

[0246] In one example, system 400, system 800, and / or a user may deploy a positioner, as described above, that repositions the bottom of the patient's first metatarsal to a corrective position and identifies one or more reference features for the surgical procedure. Advantageously, positioning the positioner at a location defined in the model allows the surgeon to identify where the reference features are located on the patient's anatomy.

[0247] 11 , method 1100 may include creating one or more reference features for the surgical procedure (block 1104). For example, system 400, system 800, and / or a user may create one or more reference features for the surgical procedure. In one embodiment, the positioner may include holes that identify locations where retractions can be created in one or more bones and / or locations where pins can be deployed. The holes in the bone(s) and / or pins deployed in the bone(s) can serve as reference feature(s) for subsequent steps during the surgical procedure.

[0248] In one embodiment, the positioner includes holes for pins, and the surgeon deploys pins through these holes in the positioner. As the pins are deployed, the surgeon ensures that the anatomical reference features match the model references used to pre-plan the surgical procedure. In another embodiment, the surgeon may use the holes in the positioner as guides to drill holes in one or more bone(s). The holes in the bone(s) may serve as reference features and may be configured to receive protrusions in one or more other instruments and / or implants used in the surgical procedure.

[0249] 11, method 1100 may include removing the positioner (block 1106). For example, system 400, system 800, and / or a user may remove the positioner. In one embodiment, the positioner may be removed leaving only one or more reference features (e.g., pins, holes, anchors, etc.) because the positioner has achieved its purpose in the surgical procedure.

[0250] 11 , method 1100 may include deploying a cutting guide or resection guide that engages one or more fiducial features (block 1108). For example, system 400, system 800, and / or a user may deploy a cutting guide or resection guide that engages one or more fiducial features. In embodiments where the fiducial features are one or more pins extending from one or more bones, the resection guide may slide down over the pins and contact the bone(s). The resection guide may include resection features that guide a surgeon in performing resections of one or more bones of a patient in a surgical procedure.

[0251] 11 , method 1100 may include resecting one or more bones of the patient (block 1110). For example, system 400, system 800, and / or a user may resect one or more bones of the patient. For example, a surgeon may use a cutting tool to resect bone or bone sections aligned with the resection features of the deployed resection guide.

[0252] 11, method 1100 may include securing the first bone segment to the second bone segment (block 1112). For example, system 400, system 800, and / or a user may secure the first bone segment to the second bone segment. Those skilled in the art will appreciate that a surgeon may use a variety of different types of fasteners to complete the securement step, and that these fasteners may be permanent or temporary.

[0253] 11 illustrates example blocks or steps of process or method 1100, in some implementations, method 1100 may include additional, fewer, different, or differently ordered steps than those depicted in FIG. 11. Additionally or alternatively, two or more of the steps of method 1100 may be performed in parallel. Alternatively, or in addition, certain steps of method 1100 may be the same as corresponding steps of method 1000.

[0254] Figure 12 is a flowchart of an example method 1200. In some implementations, one or more of the method steps of Figure 12 may be performed by system 400, system 800, and / or a user.

[0255] As shown in FIG. 12 , method 1200 may include deploying a positioner, which repositions the bottom of the patient's first metatarsal to a corrective position and identifies one or more reference features for the surgical procedure (block 1202). For example, system 400, system 800, and / or a user may deploy a positioner, which repositions the bottom of the patient's first metatarsal to a corrective position and identifies one or more reference features for the surgical procedure. Also shown in FIG. 12 , method 1200 may include creating one or more reference features for the surgical procedure (block 1204). For example, system 400, system 800, and / or a user may create one or more reference features for the surgical procedure. Further shown in FIG. 12 , method 1200 may include removing the positioner (block 1206). For example, system 400, system 800, and / or a user may remove the positioner.

[0256] 12, method 1200 may include deploying a navigation guide that engages one or more fiducial features (block 1208). In contrast to method 1100, method 1200 may use a navigation guide in conjunction with one or more resection guides. The resection guide may engage and / or couple with the navigation guide. For example, system 400, system 800, and / or a user may deploy a navigation guide that engages one or more fiducial features. The navigation guide may include examples and / or embodiments described in U.S. Provisional Patent Application No. 63 / 482,038, entitled "APPARATUS, SYSTEM, AND METHOD FOR OSTEOTOMIES," filed January 28, 2023, and U.S. Patent Application No. 18 / 422,933, entitled "APPARATUS, SYSTEM, AND METHOD FOR OSTEOTOMIES," filed January 25, 2024, each of which is incorporated by reference in its entirety for all purposes.

[0257] As further shown in FIG. 12 , method 1200 may include deploying a cutting guide engaging the navigation guide (block 1210). For example, system 400, system 800, and / or a user may deploy the cutting guide engaging the navigation guide. Also shown in FIG. 12 , method 1200 may include resecting one or more bones of the patient (block 1212). For example, system 400, system 800, and / or a user may resect one or more bones of the patient. Also shown in FIG. 12 , method 1200 may include fixating a first bone to a second bone (block 1214). For example, system 400, system 800, and / or a user may fixate the first bone to the second bone. Alternatively, or in addition, method 1200 may include fixating a first bone fragment to a second bone fragment.

[0258] 12 illustrates example blocks or steps of a process or method 1200, in some implementations, method 1200 may include additional, fewer, different, or differently ordered steps than those depicted in FIGURE 12. Additionally or alternatively, two or more of the steps of method 1200 may be performed in parallel.

[0259] 13 illustrates an exemplary system 1300, according to one embodiment. The system 1300 may include one or more navigation guides 1302, one or more resection guides 1320, one or more complementary components 1330, and one or more fasteners 1346. While the system 1300 can be used for a variety of procedures, one or more features, components, and / or aspects of the system 1300 may be particularly suited for one or more osteotomies on one or more bones of a patient's anatomy, such as the patient's foot, ankle, wrist, hand, shoulder, etc. In certain embodiments, the system 1300 may not include the navigation guide 1302.

[0260] The navigation guide 1302 may function to guide the surgeon during one or more stages of a surgical procedure. In one embodiment, the navigation guide 1302 may provide the surgeon with a guide or template of where one or more fiducial features need to be formed, provided, positioned, and / or oriented.

[0261] In the present disclosure, fiducial feature(s) (also referred to as anatomical fiducials) can provide intraoperative features that enable a surgeon to model a patient's anatomy, model instruments, model implants, and / or perform a surgical procedure either virtually or using a physical model, and then configure, position, orient, and / or align instruments, implants, and / or other surgical components during surgery and perform the surgery using the aligned / positioned instruments, implants, and / or other surgical components developed, designed, and / or refined for the virtual or simulated procedure. In one exemplary embodiment, the fiducial feature can be realized by a hole, tunnel, or other opening in bone or other hard and / or soft tissue. In another exemplary embodiment, the fiducial feature can be realized by aligning a hole, tunnel, or other opening in bone or other hard and / or soft tissue with another structure, e.g., a fastener such as a bone screw or K-wire.

[0262] Advantageously, the navigation guide 1302 facilitates providing, forming, establishing, and / or configuring one or more reference features for a surgical procedure. The navigation guide 1302 may include a body 1304, an opening 1306, and one or more position indicators 1308. In certain embodiments, the navigation guide 1302 may include a bone attachment feature 1310. In such embodiments, the bone attachment feature 1310 may be used to at least temporarily secure the navigation guide 1302 to a bone or bone fragment.

[0263] The one or more resection guides 1320 assist the surgeon in performing one or more different resection steps of the osteotomy procedure. In certain embodiments, the resection guide 1320 includes one or more resection features 1322 and one or more bone attachment features 1324. The resection features 1322 can take various forms and / or embodiments. Similarly, the bone attachment features 1324 can take various forms and / or embodiments. The bone attachment features 1324 can be similar to, the same as, or different from the bone attachment features 1310 that can be used with the navigation guide 1302. In one embodiment, the resection guide 1320 can include bone attachment features 1324 that are beveled relative to one or more reference features. The beveled bone attachment features 1324 can provide the resection guide 1320 with greater stability during resection.

[0264] The resection feature 1322 provides a guide for a surgeon to use a cutting tool to resect a bone, one or more bones, or other tissue of a patient. The bone attachment feature 1324 serves to secure the resection guide 1320 to one or more bones, one or more bone fragments, and / or one or more other structures. In one example, the bone attachment feature 1324 can include holes in the resection guide 1320 in conjunction with temporary fasteners such as K-wires or pins.

[0265] The resection guide 1320 can be engaged, coupled, or attached to one or more bones or bone fragments of the patient using bone attachment features 1324. The bone attachment features 1324 can include any of a wide variety of fasteners, including, but not limited to, holes, prongs, spikes, fastening devices, etc. Effective engagement or coupling of the resection guide 1320 to one or more bones along a single bone, such as across a single joint or across multiple joints, can ensure that cuts are made in the desired location and orientation and can mitigate hard and / or soft tissue removal in undesirable locations.

[0266] In certain embodiments, the resection guide 1320 may include one or more bone-engaging surfaces 1326 and / or one or more landmark alignment features 1328. In certain embodiments, the landmark alignment features 1328 may extend from one or more sides of the resection guide 1320 and engage with one or more landmarks on the patient's bones. Alignment of the landmark alignment features 1328 with the bony landmarks may serve to confirm that the surgeon has located the desired placement and / or orientation of the resection guide 1320. In certain embodiments, the navigation guide 1302 may include one or more bone-engaging surfaces 1326 on a surface of the navigation guide 1302 that faces the bone or bone fragment. In other embodiments, the resection guide 1320 may not include a bone-engaging surface 1326 or a landmark alignment feature 1328.

[0267] In certain embodiments, the bone-engaging surface 1326 is patient-specific and contoured to fit the surface of one or more bones that the resection guide 1320 will contact during a procedure. Alternatively, or in addition, the bone-engaging surface 1326 may not be patient-specific and may or may not contact a bone surface during use of the resection guide 1320. Those skilled in the art will understand that one or more sides of any of the components of the system 1300 may include one or more bone-engaging surfaces 1326. Consequently, one or more sides of the navigation guide 1302, the resection guide(s) 1320, the complementary component 1330, the fastener 1346, and / or the implant 1396 may include one or more bone-engaging surfaces 1326.

[0268] In certain embodiments, other components of system 1300 may be configured such that the bone-engaging surface 1326 of resection guide 1320 may not be required. Instead, positioning guide 1340 may include the bone-engaging surface 1326. Furthermore, positioning guide 1340 may be made from a less expensive material, such as a polymer, and may include the bone-engaging surface 1326, so that resection guide 1320 is not patient-specific. Instead, resection guide 1320 may be made from a more durable material, such as a metal. In such embodiments, positioning guide 1340 may be disposable or patient-specific, such that resection guide 1320 is reusable and can be used by many different patients. In one embodiment, resection guide 1320 may be patient-matched.

[0269] Alternatively, or additionally, the resection guide 1320 may be selected from a kit, collection, or repository of several resection guides 1320, each with a different configuration for resecting one or more portions of one or more bones. For example, each member of the repository / kit may include one or more numbers. The first number may indicate the number of millimeters that an individual resection feature of the resection guide 1320 removes, and the second number may indicate the number of millimeters that another resection feature of the resection guide 1320 removes. For example, the resection guide 1320 may include a +1 near the proximal end of the resection guide 1320 and a +1 near the distal end (denoted +1:+1), or may include a proximal resection feature and a distal resection feature. In such an example, the resection guide 1320 removes 1 millimeter from the distal end of the medial cuneiform bone 202 and 1 millimeter from the proximal end of the first metatarsal bone 208. Thus, a kit may include resection guides 1320 with configurations such as +2:+1, or +1:+3. In certain embodiments, the kit may include a configuration of resection guide 1320 such as +0:+1, or 0:+3, where 0 indicates that resection will occur according to the preoperative plan developed using the model, and the + number indicates the amount of additional tissue to be resected beyond the amount planned in the preoperative plan.

[0270] Having multiple different resection guides 1320 can be advantageous if the surgeon encounters something during surgery that causes them to decide to change their pre-operative plan. Often, surgeons seek to minimize the amount of tissue removed during the surgical procedure and create resected bone surfaces that aid in effective fusion, and pre-operative planning also addresses these goals. However, during surgery, the surgeon may change their plan based on what they encounter, and so may choose to use a different resection guide 1320 than was originally planned. Advantageously, the present disclosure facilitates this.

[0271] Alternatively, or in addition, the resection guide 1320 may be configured to resect one or another of the bones of the joint.

[0272] By varying the number of positioning angles (repositioning or correction angles), these angles may differ by, for example, 2 degrees or 5 degrees. In such embodiments, each positioning guide 1340 may not be patient-specific for a particular patient, but may provide the desired amount of positioning to achieve the surgeon's goals. In certain embodiments, a pre-operative plan generated based on the present disclosure may include a recommendation for a positioning guide 1340 to be used, even if the recommended positioning guide 1340 is not patient-specific for a particular patient.

[0273] The complementary component 1330 may function to assist the surgeon during one or more steps of the procedure. Those skilled in the art will appreciate that several components may function as complementary component 1330. One or more of the features, functions, or aspects of the complementary component 1330 may include patient-specific features.

[0274] Examples of complementary components 1330 include, but are not limited to, an alignment guide 1332, a rotation guide 1334, a reduction guide 1336, a compressor 1338, a positioning guide 1340, a fixation guide 1342, and / or one or more implants 1344. Generally, complementary components 1330 function to assist a surgeon in performing the function included in the name of the complementary component 1330. Thus, alignment guide 1332 can help a surgeon align a patient's bones, bone segments, anatomical body parts, or other parts as part of a procedure. Rotation guide 1334 can help a surgeon rotate one or more bones, bone segments, or other body parts of a patient as part of a procedure.

[0275] The reduction guide 1336 can assist the surgeon in positioning and / or orienting one or more bones, bone fragments, or other portions of a patient as part of a procedure to reduce the bone, bones, bone fragments, or other portions and / or to position and / or orient the bone, bones, bone fragments, or other portions in a desired position and / or orientation. The compressor 1338 can assist the surgeon in compressing one or more bones, bone fragments, or other portions of a patient with or against an implant as part of a procedure. The positioning guide 1340 can assist the surgeon in positioning one or more bones, bone portions, other portions, instruments, or other structures of a patient as part of a procedure. An example of a positioning guide 1340 is the positioner described above.

[0276] In certain embodiments, the positioning guide 1340 may be designed or manufactured to be patient-specific. Patient-specific aspects may include patient-specific bone-engaging surfaces, predetermined angles for reorienting one or more bones or bone portions in one or more planes, predetermined locations of bone attachment features 1324 or fasteners 1346, etc. Alternatively, or additionally, the positioning guide 1340 may be selected from a kit, collection, or repository of several positioning guides 1340, each having a different configuration of one or more aspects / attributes of the positioning guide 1340. For example, each member of the repository / kit may include different positioning angles (repositioning angles or offset angles), and these angles may differ by, for example, 2 degrees or 5 degrees. In such embodiments, each positioning guide 1340 may not be patient-specific for a particular patient but may provide the desired amount of positioning to achieve the surgeon's goals. In certain embodiments, a pre-operative plan generated based on the present disclosure may include a recommendation of a positioning guide 1340 to be used, even if the recommended positioning guide 1340 is not patient-specific for a particular patient.

[0277] The fixation guide 1342 can assist a surgeon in completing one or more temporary or permanent fixation steps on one or more bones, bone portions, or other portions of a patient as part of a procedure. The fixation guide 1342 can include and / or use one or more components of a fastener or fixation system, including implant hardware of the fastener or fixation system.

[0278] An example of complementary component 1330 may include a compressor / distractor, which is an example of compressor 1338. A compressor / distractor may be used to compress and / or distract the bone or portions of the bone involved in the procedure.

[0279] Advantageously, system 1300 can help a surgeon overcome one or more challenges in performing osteotomy procedures, particularly on bones of a patient's hand or foot, e.g., on the forefoot, midfoot, or hindfoot. One of the challenges during an osteotomy procedure can be maintaining control, positioning, and / or orientation of a bone, one or more bones, and / or bone pieces / fragments, particularly once a resection or incision is made. Advantageously, navigation guide 1302, resection guide(s) 1320, and / or complementary components 1330 can be configured to help overcome this challenge.

[0280] Advantageously, system 1300 can assist a surgeon in accurately positioning, placing, and / or aiming instruments for a procedure. Modern technology may also include preoperative planning, simulation, or practice using computer models, 3D printed models, virtual reality systems, augmented reality systems, etc. However, simulations and models are still different from actually positioning one or more instruments on a patient's bones, joints, or body parts during a procedure. System 1300 can include several features to assist the surgeon in positioning, including, for example, fiducial features, patient-specific features (which may include fiducial features).

[0281] Advantageously, system 1300 can aid the surgeon in not only securing the osteotomy system 1300 guides, but also in easily removing instruments without interfering with the reduction, displacement, reorientation, or repositioning of one or more bones or bone portions during guide removal. In certain embodiments, system 1300 is configured to allow removal of instruments while maintaining temporary fasteners in place for use in subsequent steps of the osteotomy procedure. Alternatively, or in addition, system 1300 facilitates the positioning of temporary or permanent fasteners during one step of the osteotomy procedure for use in subsequent steps of the osteotomy procedure. For example, holes or openings formed in the bone during one step of the osteotomy procedure can serve as pilot or starter holes for subsequent permanent fasteners and / or other hardware. Removing instruments during an osteotomy procedure can be particularly difficult when translational and / or rotational movement of the bones involved in the osteotomy procedure is required for the osteotomy procedure to be successful. Advantageously, the system 1300 accommodates translational and / or rotational movement of the bone during the osteotomy procedure while promoting successful outcome of the osteotomy procedure.

[0282] Advantageously, the components of system 1300 can be designed specifically for a particular patient. Alternatively, or additionally, the components of system 1300 can be designed specifically for a class of patients (e.g., patient-matched). Each component of system 1300 can be designed, adapted, engineered, and / or manufactured such that each feature, attribute, or aspect of the component is individually designed to address one or more individual indications present in the patient. Advantageously, the cuts made for the osteotomy procedure can be sized, positioned, oriented, and / or angled to produce an optimal osteotomy and / or outcome that minimizes the risk of undesired resection. In one embodiment, the components of system 1300 can be configured to perform osteotomies that allow for correction in more than one plane for a patient's body part. For example, the cutting channel resection guide 1320 can be oriented and configured to allow correction to occur as a result of translational, rotational, and / or movement of the bone or bone portion in two or more planes (e.g., sagittal and transverse planes) as the bone fuses / fixes.

[0283] In certain embodiments, the one or more fasteners 1346 can include both one or more permanent fasteners and one or more temporary fasteners. Generally, the fasteners 1346 can be used during a variety of different steps of the procedure. Temporary fasteners are often used because they can hold a bone or bone fragment in place while a step of the procedure is being performed. A common temporary fastener that can be used with the system 1300 is a K-wire, also known as a pin.

[0284] In certain embodiments, the exemplary system 1300 may include multiple navigation guides 1302, resection guides 1320, complementary components 1330, and / or fasteners 1346. For example, a surgeon may plan to resect multiple wedge segments from one or more bone(s) to achieve a desired correction. One or more wedge segments may be resected from the medial side of the patient's foot, and another one or more wedge segments may be resected from the lateral side of the patient's foot. These wedge segments may extend halfway through the foot or from one side of the foot to the other. Of course, multiple wedge segments may also be formed on one side of the foot.

[0285] In certain embodiments, the components of system 1300 may be made as small as possible to minimize the amount of soft tissue that is retracted or obstructed within the patient for the osteotomy procedure. Alternatively, or in addition, the walls and / or sides of the components may be beveled and / or angled to avoid contact with other hard or soft tissue within the operative field of the osteotomy procedure and / or to facilitate handling and positioning by the user.

[0286] Those skilled in the art will understand that in a particular osteotomy procedure, a particular complementary component 1330 may not be required or may be optional for use in the osteotomy procedure. Similarly, those skilled in the art will understand that particular features of the navigation guide 1302, resection guide 1320, complementary component 1330, fastener 1346 may be combined into one or more of the apparatus or devices or may be provided using multiple separate devices.

[0287] 14 shows an exemplary osteotomy system 1400, according to one embodiment. The osteotomy system 1400 may include the navigation guide 1302 (an example of which is navigation guide 1402), one or more resection guides 1320 (an example of which is resection guide 1420), one or more other complementary components 1330, such as a positioning guide 1340 (an example of which is positioning guide 1440) and / or a compressor 1338 (an example of which is compressor / distractor 1438), and one or more fasteners 1346, such as fastener 1446. The osteotomy system 1400 can be used in a variety of surgical procedures.

[0288] In certain embodiments, the positioning guide 1440 can be used to create, form, establish, or provide one or more reference features or anatomical references. Specifically, the reference features may be formed, created, established, or provided in a single bone, one or more bones of a joint, one or more bones of multiple joints, etc. Initially, the positioning guide 1440 can be positioned before the reference features are formed, created, established, or provided. In one embodiment, after using the positioning guide 1440, the surgeon can use the navigation guide 1402 to validate and / or confirm the positioning and / or trajectory of the reference features before proceeding with the surgical procedure.

[0289] In one embodiment, a user may position the navigation guide 1402 before the fiducial features are formed, created, established, or provided. Alternatively, or additionally, the navigation guide 1402 can be used to form, create, establish, or provide the fiducial features. In one embodiment, a user, such as a surgeon, may first position the navigation guide 1402 in an approximate location where the fiducial features need to be established. The surgeon may then use medical imaging, such as fluoroscopy, to determine where the navigation guide 1402 is relative to one or more bones of the patient and / or relative to one or more bones and one or more joints of the patient. In the illustrated embodiment, the position indicator 1408 can be made from a material that is visible under fluoroscopy. One example of a material is metal.

[0290] Advantageously, the navigation guide 1402 may include two position indicators 1408 that overlap to form a line of sight within an opening in the navigation guide 1402. The surgeon can visually compare the position of the line of sight to one or more anatomical structures and / or reference features of the patient.

[0291] In one exemplary embodiment, the surgeon may position the line of sight relative to a joint, multiple joints, one or more bones, or another reference feature of the patient to form, create, establish, or provide one or more reference features for the surgical procedure. By comparing the line of sight to an approximate initial position, the surgeon can determine whether the initial placement of the navigation guide 1402 is in the desired location. If the initial placement is not in the desired location, the surgeon may adjust the position of the navigation guide 1402 and check the line of sight again visually or with the aid of medical images such as fluoroscopy to determine whether the navigation guide 1402 is now in the desired location. If not, this process of repositioning and rechecking can be repeated until the surgeon positions one or more of the line of sight, first position indicator 1408, and / or second position indicator 1408 in the desired location for forming, creating, establishing, or providing one or more reference features.

[0292] In the illustrated embodiment, the positioning guide 1440 may include one or more position indicators. (See, e.g., FIG. 19.) The position indicators function to indicate the position of one or more objects relative to one or more other objects. In certain embodiments, two position indicators may cooperate to indicate position information regarding one or more objects.

[0293] In certain embodiments, the exemplary osteotomy system 1400 may include both the navigation guide 1402 and the positioning guide 1440. In such embodiments, the surgeon may choose to use both the navigation guide 1402 and the positioning guide 1440, or only one of the navigation guide 1402 or the positioning guide 1440. Those skilled in the art will understand that either the navigation guide 1402 or the positioning guide 1440 may be used to form, create, establish, or provide one or more reference features. In another embodiment, the exemplary osteotomy system 1400 may include only the positioning guide 1440 and not the navigation guide 1402.

[0294] Osteotomy system 1400 includes a resection guide 1420. The resection guide 1420 facilitates the resection of hard and / or soft tissue of a patient in a surgical procedure. In one embodiment, the resection guide 1420 can be a stand-alone, separate device. In another embodiment, the resection guide 1420 can be a device that couples to, is integrated with, and / or cooperates with the navigation guide 1402 to assist the surgeon in resecting patient tissue.

[0295] The osteotomy system 1400 may include multiple complementary components 1330. The osteotomy system 1400 includes a positioning guide 1440 that facilitates positioning one bone or bone fragment relative to another bone, bone fragment, another joint, multiple joints, or another reference or anatomical feature. In certain embodiments, the positioning guide 1440 may function to provide, guide, form, create, establish, or provide one or more reference features. Alternatively, or in addition, the positioning guide 1440 may function to position one or more bones in a surgical procedure. For example, in one embodiment, the positioning guide 1440 may be used to position the metatarsal bones in a Lapidus arthrodesis surgical procedure.

[0296] In certain embodiments, the positioning guide 1440 may include one or more position indicators 1408. In the illustrated embodiment, the positioning guide 1440 may include one or more position indicators. (See, e.g., FIG. 19 ) A position indicator functions to indicate the position of one or more objects relative to another object. In certain embodiments, two position indicators may cooperate to indicate position information regarding one or more objects. In the illustrated embodiment, a position indicator may be used to indicate the position of a first metatarsal relative to a second metatarsal before the corrective osteotomy is completed. Of course, one or more position indicators may be used to indicate the position of a first metatarsal relative to a second metatarsal after the first metatarsal has been repositioned to a corrective position (e.g., a predetermined position).

[0297] The osteotomy system 1400 may include a compressor / distractor 1438 to facilitate compressing one bone or bone fragment toward or into contact with another bone, bone fragment, joint, joints, or another reference or anatomical feature. In certain embodiments, the compressor / distractor 1438 may also be used to extend one bone or bone fragment away from another bone, bone fragment, joint, joints, or another reference or anatomical feature.

[0298] In certain embodiments, the one or more fasteners 1446 can include one or more permanent fasteners and / or one or more temporary fasteners. Generally, the fasteners 1446 can be used during a variety of different steps of the procedure. Temporary fasteners are often used because they can hold a bone or bone portion / fragment in place while a step of the procedure is being performed. A common temporary fastener that can be used with the osteotomy system 1400 is a K-wire, also known as a pin or guide pin.

[0299] An osteotomy system 1400 for improving the condition of an existing bone in a patient includes a positioning guide 1440. The positioning guide 1440 includes a body 1448 and includes a proximal side 1450, a distal side 1452, a medial side 1454, a lateral side 1456, an inferior side 1458, and an superior side 1460.

[0300] The positioning guide 1440 also includes at least one opening 1462 extending from one side of the body 1448 to the opposite side of the body 1448. The opening(s) 1462 are one exemplary embodiment of a fiducial feature guide or fiducial for creating fiducial features on the patient's anatomy. The fiducial feature guide functions to guide the creation, deployment, and / or formation of fiducial features on one bone, another bone, or both one bone and another bone. In one embodiment, a fiducial feature guide can be used to create a single fiducial feature. In another embodiment, a single fiducial feature guide can be used to create multiple fiducial features. In another embodiment, multiple fiducial feature guides can be used to create multiple fiducial features. The fiducial feature guide may extend through the body such that it includes the opening 1462; alternatively, or in addition, the fiducial feature guide may extend from, be coupled to, or be connected to the body 1448, for example, by including a spike or prong extending from the body 1448.

[0301] In one embodiment, the openings 1462 are anatomical pin locations for the surgical procedure that correspond to model pin locations in the model. In certain embodiments, one or more openings 1462 may represent pin locations for fiducial features, and one or more of the same openings 1462 and / or one or more other openings 1462 may allow for alignment or other repositioning of bone fragments as part of the surgical procedure. For example, certain openings 1462 may be positioned more distally or at another location so that pins within the bones at those openings 1462 can be used to rotate, reposition, align, compress, and / or realign one or more bones of the patient. In the illustrated embodiment, the openings 1462 have a circular cross-section.

[0302] The system 1400 also includes one or more instruments configured to participate in addressing bone conditions present in the patient. Examples of instruments include, but are not limited to, one or more of a resection guide 1420, a positioning guide 1440, a compressor / distractor 1438, a fastener 1446, etc.

[0303] 15A-15G illustrate a top perspective view, a top view, a bottom view, a front view, a rear view, a medial view, and a lateral view, respectively, of a positioning guide 1440 according to one embodiment. The positioning guide 1440 includes a body 1448, a proximal side 1450, a distal side 1452, a medial side 1454, a lateral side 1456, a lower side 1458, an upper side 1460, at least one opening 1462, and an optional handle 1464. Those skilled in the art will appreciate that the proximal side 1450 and the distal side 1452 may be reversed from the illustrated example based on whether the positioning guide 1440 is for a left or right foot.

[0304] The body 1448 provides structural integrity to the positioning guide 1440. The body 1448 can be of various shapes and sizes. The size, shape, and configuration of the positioning guide 1440 can be determined by the surgical harvesting procedure in which the positioning guide 1440 is to be used, by the surgeon's preferences, by the patient's individual characteristics, a combination of these factors, and the like. For example, in the Lapidus procedure, the body 1448 can be configured with an optional handle 1464 extending inward to provide convenience for the surgeon when using the positioning guide 1440. In one embodiment, the body 1448 can be made from a polymer and can be intended for use with a specific patient. Furthermore, the body 1448 can be fabricated using additive or subtractive manufacturing techniques. Alternatively, or in addition, the body 1448 can be fabricated using molding methods.

[0305] In certain embodiments, the openings 1462 are sized, shaped, and configured to receive K-wires or pins or other fasteners 1446 or drill bits. In certain embodiments, the positioning guide 1440 is patient-specific and is manufactured, designed, and / or contoured to suit the needs of the individual patient and / or the preference of the surgeon. In one embodiment, the body 1448 includes a single proximal opening 1462 a and a single distal opening 1462 b. Alternatively, the body 1448 includes multiple proximal openings 1462 a and multiple distal openings 1462 b. The multiple proximal openings 1462 a and the multiple distal openings 1462 a may be vertically aligned such that they are perpendicular to the long axis of the bone, such as the metatarsal, when the metatarsal is in position (e.g., in a corrected or non-deformed position).

[0306] In one embodiment, when the metatarsal is in a deformed position (not in place), the plurality of openings 1462 may not align with the bones of the joint to provide the reference features. In such a condition, the surgeon may reposition one or more of the bones of the joint until one or more of the bones is in place, and then the positioning guide 1440 can be used to provide the reference features because the reference features fit the model references used to design the positioning guide 1440.

[0307] Of course, in another embodiment, when the metatarsal is in a deformed position (not in place), the plurality of openings 1462 may align with the bones of the joint to provide reference features that can be used to guide a surgical procedure prior to repositioning one or more bones of the joint. In such an embodiment, the reference features may be used with instruments that facilitate resecting the bone and / or repositioning the resected bone(s) and / or reducing the bone and / or fixating the bone. Thus, the present disclosure supports embodiments of the positioning guide 1440 that can be used after a bone or joint has been moved into place and / or embodiments of the positioning guide 1440 that can be used before a bone or joint has been moved into place.

[0308] In one embodiment, the body 1448 may be as small as possible to facilitate easy handling by a user while still fulfilling its function. In certain embodiments, the body 1448 and / or the handle 1464 may include one or more bevels that can facilitate handling and positioning of the positioning guide 1440 by a user. With reference to FIGS. 15D and 13E , the outer side 1456 of the body 1448 may be flat, while the outer side 1454 may be rounded. The flat side may facilitate use of the positioning guide 1440 without interference from other bones (e.g., the second metatarsal 210).

[0309] In another embodiment, the body 1448 may be transparent or at least transparent (e.g., radiolucent) for medical imaging. The positioning guide 1440 may include or be configured to receive one or more position indicators. At least one position indicator is positioned, configured, and / or arranged to indicate the position of the positioning guide 1440 relative to a reference feature and / or anatomical structure. For example, the position indicator may indicate the position of the positioning guide 1440 relative to a joint (e.g., a reference feature) of the patient.

[0310] In one embodiment, the positioning guide 1440 may include one or more openings 1462 extending into the body 1448. The one or more openings 1462 may be configured to accommodate one or more fasteners 1446. In the illustrated embodiment, the one or more openings 1462 may be embodied as passages, holes, or openings extending from one side of the body 1448 to another side. The openings 1462 may function as fiducial feature guides that may extend from a bone-facing side, such as the lower side 1458, to the opposite side of the bone-facing side, such as the upper side 1460.

[0311] In certain embodiments, the osteotomy system includes a positioning guide 1440, which includes one or more features that can be used to provide, determine, deploy, locate, configure, and / or establish at least one reference feature and / or anatomical reference. The at least one reference feature can serve as an interface between an instrument used in a surgical procedure and a patient's bone or bone fragment. Those skilled in the art will understand that the reference feature may be implemented and / or embodied in a variety of different ways and / or with a variety of different apparatuses, devices, structures, and / or systems that are considered within the scope of the present disclosure.

[0312] In the illustrated embodiment, the at least one reference feature may be embodied as a hole or retraction in one or more bones and / or one or more bone fragments. In another embodiment, the at least one reference feature may be embodied as a protrusion or other structure (e.g., a pin, post, bone screw, etc.) that couples to or engages with one or more bones and / or one or more bone fragments.

[0313] Advantageously, the positioning guide 1440 can be used to provide one or more different types of reference features. In one embodiment, the positioning guide 1440 includes one or more openings or holes that can serve to provide reference features (holes in the bone and / or posts or protrusions extending from the bone). The one or more openings or holes can extend from the upper side 1460 to the lower side 1458 of the positioning guide 1440.

[0314] In the illustrated embodiment, the positioning guide 1440 includes one set of proximal openings 1462 a and one set of distal openings 1462 b. Those skilled in the art will understand that the positioning guide 1440 can include zero, one, or more proximal openings 1462 a and zero, one, or more distal openings 1462 b. Furthermore, those skilled in the art will understand that the proximal openings 1462 a and / or distal openings 1462 b can be positioned at various locations within the body 1448. Advantageously, the number, size, location, and orientation of the proximal openings 1462 a and / or distal openings 1462 b can be patient-specific and / or can be determined or dictated by the surgeon based on the patient's needs and / or surgeon's preferences using the devices, systems, and / or methods of the present disclosure.

[0315] The illustrated embodiment includes two proximal openings 1462a near the proximal end and two distal openings 1462b near the distal end. The two proximal openings 1462a can be adjacent to each other, spaced apart, aligned, or have a variety of configurations that can assist a surgeon in performing a surgical procedure. The two distal openings 1462b can be adjacent to each other, spaced apart, aligned, or have a variety of configurations that can assist a surgeon in performing a surgical procedure.

[0316] Advantageously, the proximal opening 1462a and / or the distal opening 1462b provide the surgeon with options as to what type of reference feature they want to use. In one embodiment, the surgeon may deploy a pin or other fastener through the proximal opening 1462a and / or the distal opening 1462b and use the pin as a reference feature for one or more other steps of the surgical procedure. Alternatively, the surgeon may drill holes in one or more bones positioned adjacent the positioning guide 1440 that align with the proximal opening 1462a and / or the distal opening 1462b and use the holes in these one or more bones as reference features for one or more other steps of the surgical procedure. When the proximal opening 1462a and / or the distal opening 1462b are used to form reference features, the holes formed using the proximal opening 1462a and / or the distal opening 1462b can be referred to as anchor holes. Alternatively, or in addition, the surgeon may perform a combination of deploying pins and / or drilling holes in one or more bones to provide hole and protrusion reference features for one or more other steps of the surgical procedure. In one embodiment, the positioning guide 1440 can include a single proximal opening 1462 a and two or more distal openings 1462 b. In another embodiment, the positioning guide 1440 can include a single distal opening 1462 a and two or more distal openings 1462 b.

[0317] 15A and 15B, the positioning guide 1440 can include a first fiducial feature guide, such as proximal opening 1462a, and a second fiducial feature guide, such as distal opening 1462b. In the illustrated embodiment, the first fiducial feature guides are a set of holes extending from the non-bone-facing side (e.g., top side 1460) of the (positioner) body 1448 to the bone-facing side of the positioner body 1448. Thus, the first and second fiducial feature guides can be implemented by sets of through-holes.

[0318] In the illustrated embodiment, the first fiducial feature guide includes a first proximal opening 1462 c and a second proximal opening 1462 d positioned within the body 1448 such that a pin or drill bit will contact one of the bones of the joint (e.g., the medial cuneiform 202 of the TMT joint) when the positioning guide 1440 is used. Similarly, the second fiducial feature guide includes a first distal opening 1462 e and a second distal opening 1462 f positioned within the body 1448 such that a pin or drill bit will contact one of the bones of the joint (e.g., the first metatarsal 208 of the TMT joint) when the positioning guide 1440 is used. In one embodiment, at least one of the first proximal opening 1462 c and the second proximal opening 1462 d (proximal hole set) has a first trajectory configured to be orthogonal to the first bone of the joint (e.g., the medial cuneiform 202) and its bone surface. Similarly, at least one of the first distal opening 1462e and the second distal opening 1462f (distal hole set) has a second track configured to be perpendicular to the surface of a second bone of the joint (e.g., the first metatarsal 208).

[0319] Aligning at least one of the first proximal opening 1462c and the second proximal opening 1462d perpendicular to the bone surface of one bone and at least one of the first distal opening 1462e and the second distal opening 1462f perpendicular to the bone surface of the second bone can be used in later stages of the surgical procedure to promote a favorable outcome. For example, the compressor / distractor 1438 can engage a reference feature (e.g., a pin, K-wire, bone hole, etc.) known to be perpendicular to the longitudinal axis of the bone on the opposite side of the joint and compress the two bones together to achieve bony union.

[0320] However, one skilled in the art will appreciate that orienting each of the openings 1462 perpendicular to the bone surface may allow the resection guide 1420 (cutting guide) to engage a fiducial feature to move or slide away from the bone during an osteotomy. Thus, in certain embodiments, at least one of the at least one proximal opening 1462a and / or distal opening 1462b may extend through the body 1448 and obliquely intersect the bone surface of one or both of the first and second bones in a trajectory. In this manner, the openings 1462 at an oblique angle may be used to secure fiducial features, such as pins deployed in the resection guide 1420 or prongs / spikes extending from the resection guide 1420, to prevent the resection guide 1420 from moving away from the bone(s) during an osteotomy.

[0321] A surgeon can use positioning guide 1440 to establish or provide one or more reference features for use in one or more steps or stages of a surgical procedure. In one embodiment, the one or more reference features abut or provide an interface between one or more bones and / or bone fragments and an instrument configured to participate in addressing the patient's bony condition. Stated differently, the instrument is configured to engage, couple to, offset from, or otherwise associate with or use the reference features as the instrument performs its function for the surgical procedure.

[0322] In one embodiment, an osteotomy system according to the present disclosure (e.g., osteotomy system 1400) may include multiple positioning guides 1440 (e.g., in a kit). Each of the multiple positioning guides 1440 may have a different set of configurations, positions, angles, and / or features that may be patient-specific and / or general-purpose and / or may meet the surgeon's preferences. The multiple positioning guides 1440 may be used intraoperatively by a surgeon for a surgical procedure. For example, a surgeon may use one or more bone models and / or instrument models when developing preoperative planning, as described above. However, while the surgeon approves the preoperative plan and the instruments manufactured and provided for the surgical procedure, the surgeon may want to have one or more alternative options available during surgery. For example, a patient-specific positioning guide 1440 may be fabricated based on a preoperative plan that varies the IM angle from approximately 10 degrees to approximately 7 degrees. However, the surgeon may also want the option to vary the IM angle to about 5 degrees, or about 3 degrees, or even 0 degrees (parallel to the second metatarsal 210). As such, the surgeon may prescribe the fabrication of two or three additional positioning guides 1440 that result in the IM angle between the first metatarsal 208 and the second metatarsal 210 varying from 10 degrees to 7 degrees, 5 degrees, 3 degrees, or 0 degrees.

[0323] Because the positioning guides 1440 can be fabricated using additive manufacturing and can be made from relatively inexpensive materials such as polymers, the surgeon has the advantage of being able to choose which positioning guide 1440 to use during the surgical procedure. Thus, the surgeon may first position the first metatarsal 208 using the first positioning guide 1440 and then reconsider the change in the IM angle. If this is not satisfactory, the surgeon may position the first metatarsal 208 using a second positioning guide 1440 (e.g., positioning guide 1440) of the multiple positioner and then reconsider the change in the IM angle. With each of the multiple positioning guides 1440 of the exemplary system, the positioning guide 1440 engages the first bone (e.g., the medial cuneiform 202) in its original position and engages the second bone (e.g., the first metatarsal 208) in a predetermined position. Because each positioning guide 1440 of the multiple positioning guides 1440 is designed to result in a different IM angle, each predetermined location of the second bone is different for each of the positioning guides 1440. Once the surgeon has identified a satisfactory positioner / positioning guide 1440 from the multiple positioners, he or she may use this positioner with its reference feature guide to provide reference features for subsequent stages of the surgical procedure.

[0324] 15A is a top perspective view of one embodiment of the positioning guide 1440. In the illustrated embodiment, the positioning guide 1440 includes a handle 1464. The handle 1464 may be an elongated structure extending from the inner side 1454 away from the body 1448. In one embodiment, the handle 1464 is coupled to the body 1448. In another embodiment, the handle 1464 and the body 1448 may each include corresponding portions of a coupler (e.g., a threaded female hole in the body and corresponding male threads on the distal end of the handle 1464) such that the handle 1464 can be coupled to the body 1448. The handle 1464 can have a round or circular cross-section, or a geographically shaped cross-section. In one embodiment, the handle 1464 may be a recess and / or a curved recess in the surface of the body 1448 sized to accommodate a user's thumb or index finger. Alternatively, the handle 1464 may include a set of recesses and / or curvatures in the surface of the body 1448 sized to accommodate a user's thumb and index finger.

[0325] FIG. 15B is a top view of one embodiment of positioning guide 1440.

[0326] 15C is a bottom view of one embodiment of positioning guide 1440. In one embodiment, positioning guide 1440 includes a bone engaging member 1465 on the bone-facing side of body 1448. Bone engaging member 1465 functions to engage one or more bones when positioning guide 1440 is in use. Advantageously, bone engaging member 1465 is on the bone-facing side of body 1448 such that bone engaging member 1465 can easily engage the bone.

[0327] In certain embodiments, the bone engaging member 1465 is configured to engage a single bone. In other embodiments, the bone engaging member 1465 is configured to engage two bones (e.g., a first bone and a second bone). In other embodiments, the bone engaging member 1465 is configured to engage multiple bones. Furthermore, in certain embodiments, the bone engaging member 1465 engages a single surface of one or more bones. Alternatively, or in addition, the bone engaging member 1465 engages multiple surfaces of one or more bones. The bone engaging member 1465 can also be configured to engage a patient landmark, such as a depression or protrusion on a surface of a bone, a joint or space between the patient's bones or soft tissue. In the illustrated embodiment, the bone engaging member 1465 is configured to engage a first bone and a second bone. In one embodiment, the bone engaging member 1465 is configured to engage the patient's medial cuneiform bone 202 and the patient's first metatarsal bone 208 as part of a Lapidus surgical procedure.

[0328] In another embodiment, the bone engaging member 1465 is configured to easily engage a first bone and then engage a second bone that is moved into position. In this manner, the bone engaging member 1465 can align with the first bone and use that alignment to guide the positioning of the second bone until the second bone is in a predetermined position relative to the second bone, or a predetermined position defined relative to both the first and second bones.

[0329] In certain embodiments, engagement of the bone engaging member 1465 with a first bone but not a second bone may be referred to as partial engagement. When the bone engaging member 1465 engages the second bone and the second bone is moved (e.g., translated and / or rotated) into position such that the bone engaging member 1465 remains engaged with the first bone, the bone engaging member 1465 is fully engaged with both the first bone and the second bone. In this state, both the first bone and the second bone are in position. Alternatively, each of the first bone and the second bone may have a predetermined position that is individual to that particular bone. In one embodiment, the predetermined position of a bone may be the same as its original position. When the bone engagement member 1465 is fully engaged with both the first bone and the second bone, the surgeon ensures that the placement or formation of the reference feature using the one or more reference feature guides ensures that the one or more reference features are positioned and / or oriented in the same position as the one or more model references used in the model of the patient's one or more bones prior to the surgical procedure.

[0330] Alternatively, or in addition, bone engagement member 1465 may be configured to engage both the first bone and the second bone once both are positioned or repositioned in place for each bone.

[0331] As used herein, full engagement by the positioning guide 1440 refers to a state in which the positioning guide 1440 engages at least both a first bone and a second bone. The first bone and the second bone may be in a predetermined position, or one or the other may have been moved into a predetermined position. Furthermore, the predetermined position may be the original position of the bone. Partial engagement is a state in which the positioning guide 1440 is not fully engaged with both the first bone and the second bone (regardless of whether either bone is moved from its original position to the predetermined position). If one or the other of the first bone and the second bone, or both, moves from their original position to a predetermined position, and in doing so, the positioning guide 1440 engages both the first bone and the second bone into a predetermined position, this state is full engagement; however, while one of the two bones is not yet in its predetermined position, the positioning guide 1440 is partially engaged with one or the other of the first bone and the second bone, or both.

[0332] In one embodiment, the bone engaging member 1465 includes a bone engaging surface 1466 configured to engage a cortical surface of at least one of the first bone and the second bone. The bone engaging surface 1466 may include a contour determined at least in part based on a bone model of the patient's foot. As described above, the bone model may be defined based on medical images of the patient's foot.

[0333] In the illustrated embodiment, the bone engaging surface 1466 may be the entire underside 1458 of the body 1448. In the illustrated embodiment, the bone engaging surface 1466 is on the underside 1458. In another embodiment, the bone engaging surface 1466 may include two or more bone engaging surfaces, for example, a first bone engaging surface 1466a and a second bone engaging surface 1466b. The first bone engaging surface 1466a is configured to engage a first bone, such as the medial cuneiform bone 202. The second bone engaging surface 1466b is configured to engage a second bone, such as the first metatarsal bone 208. In one embodiment, the first bone engaging surface 1466a may be configured to engage only the medial cuneiform bone 202 of one foot of the patient, and the second bone engaging surface 1466b may be configured to engage only the first metatarsal bone 208 of the same foot of the patient.

[0334] In another embodiment, the bone-engaging surface comprises a three-dimensional surface. The three-dimensional surface may include aspects that are patient-specific. Referring now to Figures 15C and 15G, an example of a bone-engaging surface that is a three-dimensional surface is shown. The bone-engaging surface 1466 may include the entire underside 1458, or one or both of the first bone-engaging surface 1466a and the second bone-engaging surface 1466b, or entirely different structures.

[0335] When the bone-engaging surface is a three-dimensional surface, the bone-engaging surface includes a height H, a width W, and a depth D. Each of these dimensions H, W, and D may be patient-specific. In one embodiment, each of the dimensions H, W, and D may be defined based on and / or using at least a portion of a bone model of the bone that the three-dimensional surface accommodates. Of course, other attributes and / or characteristics of the bone-engaging surface may be patient-specific in addition to or instead of the dimensions H, W, and D. In one embodiment, the three-dimensional surface includes variables H, W, and / or depth that accommodate variations in the contour of the cortical surface of the bone positioned within the three-dimensional surface. In another embodiment, one or more of the H, W, and / or depth of the three-dimensional surface are constant within the three-dimensional surface. In such an embodiment, the constant H, W, and / or depth of the three-dimensional surface may be greater than a required distance such that a portion of the three-dimensional surface may not contact a portion of the bone's surface.

[0336] In certain embodiments, the bone engaging member 1465 can be used to position the positioning guide 1440 in a desired location (e.g., a predetermined position) relative to one or more bones of the patient and / or across one or more joints of the patient (a process called alignment or alignment to the bone).

[0337] In certain embodiments, the positioning guide 1440 can include one or more landmark alignment features 1468. In one embodiment, the landmark alignment feature 1468 can extend from opposing sides of the bone (e.g., the underside 1458 in the illustrated embodiment). The landmark alignment feature 1468 is configured to engage a landmark of the patient. In one embodiment, the landmark can be a joint, such as a tarsometatarsal ("TMT") joint of the patient's foot. In one embodiment, the landmark alignment feature 1468 is part of the bone engagement member 1465. In another embodiment, the landmark alignment feature 1468 is a structure separate from the bone engagement member 1465. In one embodiment, the landmark alignment feature 1468 is defined at least in part based on a bone model or one or more bones of the patient. As such, the landmark alignment feature 1468 can be patient-specific and / or include one or more patient-specific aspects. In one embodiment, the landmark alignment feature 1468 is configured to fit between articular surfaces of a first bone and a second bone of a joint. For example, the landmark alignment feature 1468 may be configured to fit into the TMT joints (e.g., the medial cuneiform 202 and the first metatarsal 208) of the patient's foot.

[0338] Those skilled in the art will appreciate that the bone engaging members 1465 and / or landmark alignment features 1468 can be positioned on either surface or side of the positioning guide 1440 .

[0339] FIG. 15D is a front view of positioning guide 1440. FIG. 15E is a rear view of positioning guide 1440. With reference to FIGS. 15C-15G, note that the shape and size of first bone-engaging surface 1466a differs from the shape and size of second bone-engaging surface 1466b due to the different bones that each bone-engaging surface 1466 is configured to engage. Advantageously, the surgeon can provide instructions regarding the depth of bone-engaging surface 1466 (or three-dimensional surface) for each bone. In this way, the surgeon can require bone-engaging surface 1466 to extend further around one or more surfaces of a bone during use.

[0340] Figure 15F is a medial view of the positioning guide 1440. In the illustrated embodiment, the medial side 1454 is a rounded surface. Figure 15G is a lateral view of the positioning guide 1440. In the illustrated embodiment, the lateral side 1456 is a flat surface. The flat surface may facilitate positioning of the positioning guide 1440 without interference from other bones (e.g., the second metatarsal 210), soft tissue, etc.

[0341] 15C-15G show an example of one embodiment of a positioning guide 1440 including a bone-engaging member 1465. In certain embodiments, the bone-engaging member 1465 is one or more bone-engaging surfaces 1466. Alternatively, or in addition, the bone-engaging member 1465 may also be implemented as one or more openings 1470 extending into the body 1448 from the underside 1458 (e.g., the bone-facing side), but not extending completely through the body 1448. The one or more openings 1470 are configured to receive or accommodate one or more bones and / or portions of one or more bones. Furthermore, the one or more openings 1470 may be configured to receive or accommodate a single surface or multiple surfaces of one or more bones. Similar to a three-dimensional surface, the one or more openings 1470 may be defined based on a height H, a width W, and a depth D. In one embodiment, the one or more openings 1470 may be defined by a surface of the body 1448. The surface may be smooth, may include flat sections, and / or may include edges.

[0342] Alternatively, or in addition, the surface can be contoured to match (mirror) the surface of the bone or portion of the bone that the one or more openings 1470 receive. In one embodiment, the size, shape, and / or contour of the one or more openings 1470 can be defined based at least in part on a bone model of one or more bones. As described herein, in certain embodiments, the bone model can be a bone model of a patient's bone, which can be defined and / or derived from medical images of the patient. In one embodiment, the surface of the one or more openings 1470 is contoured to be patient-specific.

[0343] Alternatively, the surfaces of the one or more openings 1470 may be shaped to engage (e.g., may be curved or have a depth to engage) one or more surfaces of the bone, but may not be shaped to conform to one or more surfaces of the one or more bones. In such embodiments, the one or more openings 1470 may be non-patient-specific. Alternatively, portions of the one or more openings 1470 may be patient-specific, while other portions are non-patient-specific.

[0344] Because the one or more openings 1470 receive or are configured to receive one or more bones, the one or more openings 1470 may also be referred to as bone-engaging shape openings. One skilled in the art will understand that the one or more openings 1470 in the positioning guide 1440 may include two bones of a joint, but may also include openings configured to receive one or more bones adjacent or surrounding the joint, or even other bones in the patient's foot.

[0345] In the illustrated embodiment, the exemplary positioning guide 1440 includes a first opening 1470 a and a second opening 1470 b. Each opening 1470 a, b is configured to receive at least a portion of one of a first bone (e.g., the medial cuneiform 202) and a second bone (e.g., the first metatarsal 208). Alternatively, or in addition, each opening 1470 a, b is determined based at least in part on bone models of one or two bones of the joint. In the illustrated embodiment, the bone models include bone models of the medial cuneiform 202 and the first metatarsal 208. In certain embodiments, the bone models may be dedicated to a particular patient set (e.g., patient-matched). In other embodiments, the bone models may be dedicated to a particular patient (e.g., patient-individualized).

[0346] 16A-16G are top perspective, top, bottom, anterior, posterior, medial, and lateral views, respectively, of a resection guide 1420, according to one embodiment. The resection guide 1420 includes a body 1648, a proximal side 1650, a distal side 1652, a medial side 1654, a lateral side 1656, a lower side 1658, an upper side 1660, at least one opening 1662, and at least one resection feature 1664.

[0347] Body 1648 provides structural integrity to resection guide 1420. Body 1648 can be of various shapes and sizes. The size, shape, and configuration of resection guide 1420 can be determined by the surgical procedure in which resection guide 1420 is used, by the surgeon's preference, by the patient's individual characteristics, a combination of these factors, and the like.

[0348] In the illustrated embodiment, the body 1648 is rectangular shaped. Such a shape may be advantageous due to its simplicity and ease of manufacture. The resection guide 1420 may be non-patient specific.

[0349] In one embodiment, an osteotomy system according to the present disclosure may include multiple resection guides 1420 (e.g., in a kit). Each of the multiple resection guides 1420 may have a different set of configurations, positions, angles, and / or features that may be patient-specific and / or general-purpose and / or may meet surgeon preferences. The multiple resection guides 1420 can be used by a surgeon during a surgical procedure. In one embodiment, the resection guide 1420 may be one of multiple in a kit that is patient-adaptable.

[0350] In certain embodiments, the resection guide 1420 may be reusable and made of a durable material, such as metal. Thus, after use, the resection guide 1420 can be cleaned and prepared for reuse with another patient. In one osteotomy system 1400, the resection guide 1420 may be reusable, and the positioning guide 1440 may be patient-specific and / or patient-adapted. In an alternative embodiment, the resection guide 1420 may be patient-specific and may be manufactured, designed, and / or contoured to suit the needs of an individual patient and / or surgeon's preferences.

[0351] In one embodiment, the resection guide 1420 may include one or more openings 1662 extending into the body 1648. The one or more openings 1662 are configured to accommodate one or more fasteners 1646. In the illustrated embodiment, the one or more openings 1662 may be embodied as passages extending from one side of the body 1648 to another side.

[0352] In certain embodiments, the opening 1662 is sized, shaped, and configured to engage one or more reference features provided using the positioning guide 1440. For example, a surgeon may deploy a pin or K-wire using the positioning guide 1440, and the opening 1662 is configured to receive the K-wire, or pin, or other fastener 1646, or drill bit.

[0353] In one embodiment, the body 1648 may be as small as possible to easily handle it by a user while still performing its function. In certain embodiments, the body 1648 and / or a handle coupled to the body 1648 may include one or more bevels that can facilitate handling and positioning of the resection guide 1420 by a user.

[0354] In another embodiment, body 1648 may be transparent or at least transparent (e.g., radiolucent) for medical imaging. Alternatively, or in addition, body 1648 may include markers that are opaque for medical imaging. The markers may be positioned within the body such that, once resection guide 1420 is in place, the markers indicate the location where the cut will be made relative to other anatomical structures of the body. In one embodiment, the markers are made from a tantalum material or other radiopaque material that is visible in medical images. Alternatively, the markers are in the shape of a crosshair.

[0355] Resection guide 1420 may include or be configured to receive one or more position indicators. At least one position indicator is positioned, configured, and / or arranged to indicate the position of resection guide 1420 relative to a reference feature and / or anatomical structure. For example, the position indicator may indicate the position of resection guide 1420 relative to a patient's joint (e.g., a reference feature).

[0356] In certain embodiments, the osteotomy system includes a resection guide 1420, which includes one or more features that can be used to provide, determine, deploy, locate, configure, and / or establish at least one reference feature. The at least one reference feature can serve as an interface between an instrument used in a surgical procedure and a patient's bone or bone fragment. Those skilled in the art will understand that the reference feature may be implemented and / or embodied in a variety of different ways and / or with a variety of different apparatuses, devices, structures, and / or systems that are considered within the scope of the present disclosure.

[0357] In the illustrated embodiment, the at least one reference feature may be embodied as a hole or retraction in one or more bones and / or one or more bone fragments. In another embodiment, the at least one reference feature may be embodied as a protrusion or other structure (e.g., a fastener, pin, post, bone screw, etc.) that couples to or engages with one or more bones and / or one or more bone fragments.

[0358] Advantageously, the resection guide 1420 can be used to provide one or more different types of reference features. In one embodiment, the resection guide 1420 includes one or more openings or holes (either holes in the bone and / or posts or protrusions extending from the bone) that can serve to provide reference features. The one or more openings or holes can extend from the upper side 1660 to the lower side 1658 of the resection guide 1420.

[0359] In the illustrated embodiment, the resection guide 1420 includes one set of proximal openings 1662a and one set of distal openings 1662b. Those skilled in the art will understand that the resection guide 1420 can include zero, one, or more proximal openings 1662a and zero, one, or more distal openings 1662b. Furthermore, those skilled in the art will understand that the proximal openings 1662a and / or distal openings 1662b can be positioned at various locations within the body 1648. Advantageously, the number, size, location, and orientation of the proximal openings 1662a and / or distal openings 1662b can be patient-specific and / or can be determined or dictated by the surgeon based on the patient's needs and / or surgeon's preferences using the devices, systems, and / or methods of the present disclosure.

[0360] A surgeon can use resection guide 1420 to establish or provide one or more reference features for use in one or more steps or stages of a surgical procedure. In one embodiment, the one or more reference features abut or provide an interface between one or more bones and / or bone fragments and an instrument configured to participate in addressing the patient's bony condition. Stated differently, the instrument is configured to engage, couple to, offset from, or otherwise associate with or use the reference features as the instrument performs its function for the surgical procedure.

[0361] FIG. 16A is a top perspective view of one embodiment of a resection guide 1420. FIG. 16B is a top view of one embodiment of a resection guide 1420. FIG. 16C is a bottom view of one embodiment of a resection guide 1420. In one embodiment, the resection guide 1420 may be generic, patient-adaptive, rather than patient-specific, or may be provided in a kit of multiple resection guides 1420, each configured differently. FIGS. 16B and 16C show an example of a resection feature 1664. The resection feature 1664 may extend through the body 1648 at a right angle to the upper side 1660 of the body 1648 and at a right angle to the lower side 1658 of the body 1648. Further, in the embodiment of FIGS. 16B and 16C, the resection features 1664 are shown to be linear and parallel to one another. The linear resection features 1664 allow the surgeon to make a linear cut on the bone positioned on the lower side 1658 of the resection guide 1420. A straight cut is easier for the surgeon to complete than a non-straight cut (eg, a curved cut).

[0362] In certain embodiments, the resection features 1664 are configured to make straight cuts and cuts that are perpendicular to the underside 1658 of the resection guide 1420 and perpendicular to the top side 1660 of the resection guide 1420. When a surgeon uses the resection guide 1420 with these resection features 1664 on a joint such as the TMT joint, the osteotomy made using the proximal resection feature 1664a makes a straight cut to the distal end of a first bone (e.g., the medial cuneiform bone 202), and the osteotomy made using the distal resection feature 1664b makes a straight cut to the proximal end of a second bone (e.g., the first metatarsal bone 208). This means that the cut plane made using the proximal resection feature 1664a will be parallel to the cut plane made using the distal resection feature 1664b. Because the cut planes are parallel, the two resected bones of the joint maintain the same alignment in the sagittal plane 262 when they fuse. Straight, perpendicular cuts such as these are easier for the surgeon to complete. The present disclosure allows for the use of linear cuts because the bone to be cut is positioned prior to performing the osteotomy. Specifically, a positioning guide 1440 is used to form or create reference features to position one or both bones for the osteotomy. The reference features are positioned in a location where the bone is once in a predetermined and / or corrected position. These same reference features can then be utilized for use with a resection guide 1420 to provide for the creation of linear, parallel cuts and / or perpendicular cuts.

[0363] Those skilled in the art will appreciate that different resection guides 1420 can be used with the present system. These other resection guides 1420 may include resection features 1664 that may not be perfectly parallel and / or perpendicular to the bone(s). Such resection guides 1420 may be selected by the surgeon preoperatively or intraoperatively to further adjust the orientation of one or more bones of the joint beyond what was originally planned in the preoperative planning. Furthermore, these adjustments can be made in the sagittal plane 262, transverse plane 266, and / or coronal plane 264.

[0364] In the illustrated embodiment, the resection guide 1420 does not include a bone engaging member 1465, such as a bone engaging surface 1666, one or more openings 1470, or a three-dimensional surface. In other embodiments, the resection guide 1420 may include a bone engaging member 1465. Alternatively, or in addition, the resection guide 1420 may include one or more landmark alignment features.

[0365] Figure 16D is an anterior view of resection guide 1420. Figure 16E is a posterior view of resection guide 1420. Figure 16F is a lateral view of resection guide 1420. Figure 16G is a medial view of resection guide 1420.

[0366] 17A-17E show different views of the stages of providing an instrument, according to one embodiment. FIG. 17A shows a model 1700 of a patient's anatomy. The model includes multiple bone models organized and configured to match the patient's placement and configuration. In other words, the model bones in model 1700 are in their original positions, the positions the patient initially presented when seeking medical assistance. Advantageously, as noted above, the original positions of the model bones can be derived from anatomical data 412, which can be provided and / or generated using medical images.

[0367] When the present disclosure is used to correct a deformity, the orientation and position of the model bones in model 1700 may include the deformity. Therefore, model 1700 may also be referred to as deformed model 1700. Model 1700 in FIG. 17 includes, among other model bones, a medial cuneiform 202′, a first metatarsal 208′, a second metatarsal 210′, a navicular 218′, a talus 224′, and a tibia 226′. The diagram in FIG. 17 shows models representing actual, tangible physical objects, specifically bones such as a patient's bones, and may include models of instruments used in a surgical procedure. The illustrated objects and models are identified by reference numbers and prime symbols to distinguish them from the actual objects (e.g., bones and instruments) shown in FIG. 18, which include the same numbers without the prime symbols.

[0368] 17A further illustrates that one or more bones of the foot have a bone condition, specifically, the first metatarsal 208′ and the big toe bone are deformed. This is indicated by the first metatarsal 208 extending medially rather than parallel to the second metatarsal 210. The deformation may also include the phalanges of the first metatarsal 208 being directed laterally rather than parallel to the phalanges of the second metatarsal 210. In certain embodiments, the model bones of the deformed model 1700 may be color-coded to easily indicate that a deformation is present. For example, in one embodiment, the model bones in the deformed state may be colored blue.

[0369] FIG. 17B shows the same model 1700 or models 1700 of FIG. 17A , except that a computing device (e.g., using a software program, a programmed hardware device, machine learning, artificial intelligence, etc.) and / or a user has revised model 1700 to create revised model 1710, also referred to as a correction model and / or revised CAD model. Generating revised model 1710 may be based on model 1700 or may be performed using anatomical data 412 and / or other resources. In one embodiment, a computing device may reposition bone models within model 1700 to create revised model 1710. Alternatively, or in addition, a user (e.g., a surgeon) and / or a technician, either alone, in collaboration with each other, and / or in collaboration with a computing device, may reposition bone models using a computer input device to generate revised model 1710. In certain embodiments, the model bones of revised model 1710 may be marked with indications / indicators so that a user can easily understand which model bones have been repositioned. In one embodiment, the indicator is a surface coloration of the model bone that has been repositioned to create revised model 1710. For example, the surface coloration may be pink.

[0370] In the exemplary embodiment of FIG. 17B , the first metatarsal 208′ and other bones of the big toe have been translated and / or rotated so that the first metatarsal 208′ is substantially parallel to the second metatarsal 210′. The revised model 1710 shows a bone model configuration that improves the bone condition (e.g., a deformity such as a bunion). The revised model includes a model reference. In the illustrated example, the model reference is a new position of the first metatarsal 208′. The model reference (the predetermined or new positions of one or more bones in the revised model 1710) can be used to design steps and / or tools to correct the bone condition. At this stage, a user or a computing device can determine the location of holes or deployment of pins within one or more of the first metatarsal 208′ and / or medial cuneiform 202′. The holes and / or pins can serve as reference features for a surgical procedure (e.g., an osteotomy using the resection guide 1420).

[0371] FIG. 17B and revised model 1710 illustrate one meaning of a predetermined position. In FIG. 17B, each model bone in revised model 1710 is shown in its predetermined position, which is a position that is determined before a surgical procedure begins or is completed. For certain model bones, the original position is the same as the predetermined position. For other model bones, the model bones have been moved (e.g., translated and / or rotated) from their original position to the predetermined position.

[0372] 17C, which shows a close-up view of the bone model(s) of FIG. 17B, in which positioning guide 1440′ can be used to determine the locations where one or more model fasteners 1446′ need to be deployed within the model bone of revised model 1710.

[0373] The computing device and / or the user may, alone and / or together, design and / or configure the model positioning guide 1440' with reference to the medial cuneiform 202', the first metatarsal 208', and / or the second metatarsal 210' (e.g., to measure the IM angle).

[0374] 17C shows a model positioning guide 1440' positioned on the TMT joint between the medial cuneiform 202' and the first metatarsal 208'. The positioning guide 1440' is configured to include a model opening 1462 that receives a model fastener 1446'. Additionally, the underside 1458 is configured to include bone engaging members 1465, such as a first bone engaging surface 1466a and a second bone engaging surface 1466b.

[0375] In one embodiment, the first bone engaging surface 1466a and the second bone engaging surface 1466b may be formed by a Boolean subtraction operation between the body of the model positioning guide 1440' and the model medial cuneiform 202' and the model first metatarsal 208'. Note that the model positioning guide 1440' is formed such that the bone engaging member 1465 fully engages both the medial cuneiform 202' and the first metatarsal 208'. In this example, the medial cuneiform 202' and the first metatarsal 208' are in a predetermined position. The medial cuneiform 202' has not moved from its original position to the predetermined position, and the first metatarsal 208 has moved from its original position to the predetermined position.

[0376] 17C shows that when the first metatarsal 208' is not in place and the positioning guide 1440' is fully engaged with the medial cuneiform 202', the positioning guide 1440' does not fully engage with the first metatarsal 208'. Instead, the positioning guide 1440' is partially engaged with the medial cuneiform 202' and the first metatarsal 208'. However, when the positioning guide 1440' is fully engaged with the medial cuneiform 202' and the first metatarsal 208' has been moved into place, the positioning guide 1440' fully engages both the medial cuneiform 202' and the first metatarsal 208'.

[0377] In one embodiment, with the positioning guide 1440' in the desired position, with each of its openings 1462' and bone engaging members 1465 defined, the user is ready to identify one or more model fiducials for use in determining fiducial features during the surgical procedure. In the illustrated embodiment, the model fiducials are model fasteners 1446'. The model fasteners 1446' are deployed into the openings 1462', and the next phase in the design / development process is shown in FIG. 17D.

[0378] 17D , the computing device and / or user may, alone and / or together, design and / or model a model resection guide 1420′ with reference to and / or use of a model fastener 1446′ deployed using positioning guide 1440′. One or more proximal openings in model positioning guide 1440′ and / or model resection guide 1420′ are configured to engage a model fastener 1446′ of medial cuneiform bone 202′. One or more distal openings in model positioning guide 1440′ and / or model resection guide 1420′ are configured to engage a model fastener 1446′ of first metatarsal bone 208′.

[0379] 17D shows two model fasteners 1446' deployed in the first metatarsal 208' and two model fasteners 1446' deployed in the medial cuneiform 202'. The model fasteners 1446' can serve as model fiducials that can be used to provide reference features.

[0380] FIG. 17E shows the next stage in which the resection guide 1420' is removed, leaving the model fastener 1446' in the bone. FIGS. 17C-17E include a revised model 1710 showing the bone in place. In the revised model 1710, the bone may remain in place at this stage. Alternatively, or in addition, the model may include features that simulate the deformed bone moving back toward its original position. In such an embodiment, the first metatarsal 208' may be rotated and / or reoriented. However, this is not an issue because the fastener 1446' is positioned where necessary for the desired correction.

[0381] 17F shows the stage where the resection guide 1420' is determined. The resection guide 1420' is positioned by sliding the opening 1662' over the fastener 1446'.

[0382] In certain embodiments, the user may use the illustrated resection guide 1420′ and modify the resection guide 1420′ as needed, or the user may try different configurations of the resection guide 1420′ until the guide provides resection features (e.g., proximal resection feature 1664a′, distal resection feature 1664b′) that produce the correct configuration of the revised model 1710 shown in FIG. 17B .

[0383] At this stage, the modeled bone and / or modeled instruments can be fabricated or manufactured for use in the surgical procedure. In certain embodiments, the instruments are manufactured using additive manufacturing. Alternatively, or additionally, the instruments may be made from a material that is transparent for medical imaging.

[0384] 18A-18F show different views of stages of a surgical procedure, according to one embodiment. FIG. 18A shows a patient's bone during a surgical procedure. In this example, the bone is in its original position and includes a deformation. In certain embodiments, the original position is the position of the patient's bone when the patient undergoes the surgical procedure. Alternatively, or in addition, the original position may be the position where the patient's bone is placed in preparation for the surgical procedure. In one embodiment, the original position is the initial or starting position of the bone used in the bone model during pre-operative planning of the surgical procedure.

[0385] 18B illustrates a stage during a surgical procedure in which the surgeon deploys a positioning guide / positioner 1340, such as positioning guide 1440 (also referred to as positioner 1440). In this stage, the surgeon seeks to reposition one or more bones of the patient from their original position to a predetermined position. In certain embodiments, this predetermined position is a position that will improve the patient's condition. In one embodiment, the predetermined position may correct a deformity.

[0386] A surgeon can use a variety of techniques to reposition bones into place. While several examples are provided herein, one skilled in the art will understand that other techniques can be used that fall within the scope of the present disclosure. Advantageously, the present disclosure provides a positioner 1440 that assists a surgeon in repositioning the bones of the foot so that certain bones translate and / or rotate into a predetermined position. Specifically, the bone engaging members 1465 can facilitate and / or confirm / validate if one or more bones of a surgical procedure have been moved into their predetermined positions.

[0387] In each of these examples, the surgeon may dissect soft tissue to gain access to the cortical surface of one or more bones. Alternatively, or in addition, the surgeon may dissect and / or release certain soft tissues on or around the joint to allow for repositioning of one or more bones. In the illustrated embodiment, the surgeon may dissect ligaments, tendons, periosteum, cartilage, and / or other connective tissue. One or more of the following examples can then be used by the surgeon:

[0388] In one example, a surgeon positions a positioner 1440, such as the patient-specific positioner 1440, across a joint, such as the TMT joint, so that the bone engaging member 1465 of the positioner 1440 engages a first bone, such as the medial cuneiform bone 202. As shown, while the bone engaging member 1465 engages the first bone, a portion of the bone engaging member 1465 or a portion of the positioner 1440 may contact a second bone, such as the first metatarsal bone 208. This contact may be engagement with the second bone depending on the amount of deformation present and / or whether the second bone has moved from its original position. Often, the bone engaging member 1465 engages the first bone and the bone engaging member 1465 does not engage the second bone until the user repositions the second bone.

[0389] Thus, in one example, a user may engage a first bone using the bone engaging member 1465 and then reposition the second bone until it is in place. When the second bone is repositioned in place with the first bone engaged with the bone engaging member 1465, the bone engaging member 1465 engages both the first bone and the second bone. In such a state / condition, the bone engaging member 1465 is now fully engaged with both the first bone and the second bone. Once the positioner 1440 is fully engaged with both the first bone and the second bone with the bone engaging member 1465, the user is now assured that the bones are in positions corresponding to the predetermined positions planned during pre-operative planning using the methods, systems, and / or devices of the present disclosure.

[0390] Furthermore, when the bone engaging member 1465 engages one of the first bone or the second bone in a predetermined position (which may include an original position) and does not engage the second bone (meaning that the bone engaging member 1465 is aligning, seating, or joining to the bone), this condition or state is a state of partial engagement between the bone engaging member 1465 and the first bone and the second bone. Often, when the bone engaging member 1465 partially engages the first bone and the second bone, the user may further reposition one or more of the bones until full engagement is achieved between the bone engaging member 1465 and the first bone and the second bone. Alternatively, or additionally, the surgeon may determine that partial engagement between the bone engaging member 1465 and the first bone and the second bone is sufficient and may then proceed to the next stage of the surgical procedure.

[0391] Advantageously, partial engagement and full engagement of the bone engaging member 1465 with one of the bones are conditions that can be easily determined by a surgeon. Specifically, when partial engagement exists, the bone can be easily repositioned relative to the bone engaging member 1465 (minimal repositioning force is applied). In contrast, when full engagement exists, the bone cannot be easily repositioned (moderate to greater repositioning force is required). In the full engagement state, the bone is said to be "locked" in engagement with the bone engaging member 1465.

[0392] In certain embodiments, the bone engaging member 1465 may be embodied as a first bone-engaging surface and a second bone-engaging surface. In such embodiments, similar aspects of partial and full engagement may be determined based on whether the bones engaged by the first and second bone-engaging surfaces are moved from their original positions to the predetermined position. In one example, full engagement of the first and second bones may include the first bone-engaging surface engaging the first bone and the second bone-engaging surface engaging the second bone when the first bone maintains its original position and the second bone is repositioned or repositioned from its original position to the predetermined position. In another example, partial engagement of the first and second bones may include the first bone-engaging surface engaging the first bone and the second bone engaging the second bone when one or both bones are repositioned from their original positions to the predetermined position.

[0393] As used herein, engagement between bone engaging member 1465, bone engaging surface 1466, three-dimensional opening, and / or opening refers to the relationship between the member and bone such that the member is aligned with the bone. Thus, when a device such as positioner 1440 includes more than one engaging member, one engaging member may engage the bone and another may not (partial engagement), or each engaging member may engage the bone (full engagement).

[0394] 18B, some examples of engagement between the positioner 1440 and the bones of a joint are described. In this example, the positioner 1440 includes a first bone-engaging surface 1466a and a second bone-engaging surface 1466b.

[0395] In one aspect, the surgeon may position the positioner 1440 on the medial cuneiform 202 such that the first bone engaging surface 1466a engages or aligns with the dorsal surface (and / or lateral surface and / or medial surface) of the medial cuneiform 202. In this example, the medial cuneiform 202 maintains its original position. The second bone engaging surface 1466b does not engage the first metatarsal 208. Thus, the positioner 1440 partially engages the medial cuneiform 202 and the first metatarsal 208.

[0396] Next, the surgeon repositions the first metatarsal 208 while maintaining engagement between the first bone engaging surface 1466a and the medial cuneiform 202 until the second bone engaging surface 1466b engages the first metatarsal 208. The positioner 1440 is now fully engaged with both the medial cuneiform 202 and the first metatarsal 208. Advantageously, the first metatarsal 208 is now in place. The first metatarsal 208 is in the desired position for the surgical procedure. At this stage, the bone and positioner 1440 are ready for the development and / or formation of fiducial features. The surgeon ensures that the bone is in substantially the same position as the model bone used in preoperative planning.

[0397] In one variation of the above example, once the surgeon engages the first bone engaging surface 1466a with the medial cuneiform 202, the surgeon may deploy one or more fasteners 1446 through the proximal opening 1462a, which may secure the positioner 1440 to the medial cuneiform 202. The first metatarsal 208 may continue to move freely relative to the positioner 1440 until the second bone engaging surface 1466b engages the first metatarsal 208.

[0398] In another variation, the surgeon may revisit the position of the medial cuneiform 202 and the first metatarsal 208 once the positioner 1440 has fully engaged both bones and determine that a different amount of bone repositioning / correction is required. Thus, the surgeon may replace the positioner 1440 with another positioner configured to provide a different predetermined position for one or more bones (e.g., the first metatarsal 208). In this way, the surgeon may intraoperatively choose to use a different positioner 1440 to provide a desired outcome without being limited to a single positioner 1440.

[0399] In another aspect, the surgeon may position the positioner 1440 on the first metatarsal 208 such that the second bone engaging surface 1466b engages or aligns with the dorsal surface (and / or lateral surface and / or medial surface) of the first metatarsal 208. In this example, the medial cuneiform 202 may maintain its original position, and the first metatarsal 208 with which the positioner 1440 is engaged may be repositioned until the positioner 1440 engages the medial cuneiform 202. The first bone engaging surface 1466a may not yet engage the medial cuneiform 202. Thus, the positioner 1440 partially engages the medial cuneiform 202 and the first metatarsal 208.

[0400] Next, the surgeon repositions the first metatarsal 208 while maintaining engagement between the second bone engaging surface 1466b and the first metatarsal 208 until the first bone engaging surface 1466a engages the medial cuneiform 202. The positioner 1440 is now fully engaged with both the medial cuneiform 202 and the first metatarsal 208. Advantageously, the first metatarsal 208 is now in place. The first metatarsal 208 is in the desired position for the surgical procedure. At this stage, the bone and positioner 1440 are ready for the development and / or formation of fiducial features. The surgeon ensures that the bone is in substantially the same position as the model bone used in preoperative planning.

[0401] In one variation of the above example, once the surgeon engages the second bone engaging surface 1466b with the first metatarsal 208, the surgeon may deploy one or more fasteners 1446 through the distal opening 1462b, which may secure the positioner 1440 to the first metatarsal 208. The first metatarsal 208 may continue to move freely relative to the medial cuneiform 202 until the first bone engaging surface 1466a engages the medial cuneiform 202.

[0402] Advantageously, the engagement between the positioner 1440 and the two bones is of sufficient fidelity and conformance that the engagement between the bone engaging member 1465 and the bones locks or snaps the bones into place to engage the bone engaging member 1465. In one embodiment, the interface between the bone engaging member 1465 and the bones is such that tactile feedback is generated as the bone transitions from disengaged to engaged with the bone engaging member 1465. This tactile feedback may also be referred to as palpable feedback. In the illustrated example of FIG. 18B , as the surgeon moves the first metatarsal 208, the surgeon can feel the first metatarsal 208 as it moves into a predetermined, pre-operatively planned, position. Once the first metatarsal 208 is in position, the bone engaging member 1465 (e.g., second bone engaging surface 1466b) engages (e.g., fully engages) the first metatarsal 208. This palpable feedback provides the surgeon with confirmation that the first metatarsal 208 is in the desired position for the surgical procedure. Of course, engagement between the bone engaging member 1465 and the first bone (e.g., medial cuneiform 202) may also provide palpable feedback to the surgeon.

[0403] In certain embodiments, the positioner 1440 may also include an alignment guide (see FIGS. 19 and 20). In one example, the alignment guide may be implemented as a strategically placed hole in the handle of the positioner 1440 through which a K-wire passes to identify the trajectory of the first metatarsal 208 after the surgical procedure is complete.

[0404] In certain embodiments, a surgical procedure may allow a surgeon to perform one or more osteotomies and then reposition the patient's bone to achieve a desired outcome (e.g., deformity correction). Alternatively, a surgeon may reposition the patient's bone to achieve a desired outcome (e.g., deformity correction) and then perform one or more osteotomies. In certain embodiments, for certain surgical procedures, positioning the bone before performing one or more osteotomies can simplify the type and variety of osteotomies needed to achieve a desired outcome. The present disclosure supports surgeons in using either technique.

[0405] Additionally, the present disclosure assists the surgeon in recognizing, validating, and / or confirming that a repositioned bone (either before or after an osteotomy) is in a desired (e.g., predetermined) position. Specifically, the present disclosure assists the surgeon in determining and confirming the desired position of a bone in relation to an osteotomy through pre-operative planning, the use of anatomical data 412, intra-operative visualization (e.g., windows, alignment guides, positioners, etc.), surgical instruments and / or guides tailored to the particular surgical procedure and / or particular patient, and tactile feedback (e.g., the surgeon can feel when a positioner engages both a first bone and a second bone).

[0406] 18B illustrates one method of positioning a patient's bones for a surgical procedure. Specifically, a surgeon manipulates the positioner 1440 to position, deploy, and / or position the positioner 1440. The surgeon may also move and / or reposition one or more of the patient's bones to achieve full engagement between the positioner 1440 and the bones. Of course, those skilled in the art will understand that manually using the positioner 1440 with a handle is just one of various methods for positioning a patient's bones as part of a surgical procedure.

[0407] For example, a jig may be associated with and / or coupled to a patient such that the jig can position and / or orient one or more bones and / or one or more instruments for a surgical procedure. The jig may be secured to the patient's ankle, one or more metatarsals, and / or one or more other metafoot bones. The jig may include one or more arms, struts, etc. that can be coupled to an instrument, such as the positioner 1440. In such embodiments, the positioner 1440 may have a coupler instead of or in addition to the handle 1464. The surgeon may manipulate one or more arms and / or struts and / or mechanisms of the jig to position the positioner 1440 in a desired position. Additionally, the surgeon may manipulate the jig to reposition one or more bones of the patient. In one example, the jig may be coupled to the first metatarsal 208 such that manipulating the jig moves and / or repositions the first metatarsal 208. Thus, the jig can be used by the surgeon to position the positioner 1440 and / or one or more bones used by the positioner 1440.

[0408] 18C, once the positioner 1440 is in the desired position and the bone engaged by the positioner 1440 is in place, the openings 1462 (e.g., fiducial feature guides) in the positioner 1440 provide guides for forming fiducial features in the bone for the surgical procedure. FIG. 18C shows an example of forming fiducial features in the bone. In one embodiment, the fiducial features are fasteners 1446 deployed in one or more bones. In the illustrated embodiment, the bones are opposing bones of a joint such as a TMT joint. Now referring to FIG. 18C, at this stage, the surgeon has the first metatarsal 208 in a predetermined position (e.g., a desired position) that matches the corrected position of the bone model.

[0409] Next, the surgeon can use the openings 1462 (e.g., fiducial feature guides) to form one or more fiducial features in the bone. In this embodiment, the fiducial features are pins, such as fasteners 1446 or K-wires, that are deployed through the openings 1462 in the positioner 1440. With the fasteners 1446 deployed, the surgeon now has fiducial features that can be used in subsequent stages of the surgical procedure. At this stage, the surgeon can remove the positioner 1440. Once the positioner 1440 is removed, one or more bones (e.g., the first metatarsal 208) may move out of position due to tension or stress in soft tissue or gravity. However, this is not a problem because the fasteners 1446 remain in place as fiducial features for subsequent steps of the surgical procedure.

[0410] FIG. 18D shows the resection guide 1420 deployed over the fastener 1446. The surgeon can then perform one or more osteotomies of one or more bones of the joint. FIG. 18E shows a stage of the surgical procedure after the resection has been performed. The surgeon has removed the resection guide 1420. The fastener 1446 may remain in place or may be removed. The remaining fastener 1446 can be used in further subsequent steps of the surgical procedure. For example, the fastener 1446 can be used by a compressor / distractor, such as compressor / distractor 1438. The arms of the compressor / distractor 1438 can slide over the fastener 1446, which can be actuated to either distract (preparing for fusion of the cut surfaces) or compress (preparing for fixation) the first metatarsal 208 and medial cuneiform 202. In one embodiment, the compressor / distractor 1438 compresses the cut surface of a first bone against the cut surface of a second bone by engaging a first reference feature (e.g., fastener 1446) of a first bone (e.g., medial cuneiform bone 202) and a second reference feature (e.g., fastener 1446) of a second bone (e.g., first metatarsal bone 208).

[0411] 18F shows the patient's bones after the surgical procedure is completed. The cut surface of the medial cuneiform 202 abuts the cut surface of the first metatarsal 208. Fixation in the form of a bone plate is secured to both the medial cuneiform 202 and the first metatarsal 208. Note that the first metatarsal 208 is in a corrected position relative to the other bones of the foot.

[0412] Figure 19 illustrates an exemplary osteotomy system 1900, according to one embodiment. System 1900 may include components or modules similar to those described in connection with Figure 14. The structure, features, and functionality, operation, and configuration of system 1900 may be similar to or identical to the components or modules of system 1400, such as parts identified by like reference numbers.

[0413] Osteotomy system 1900 may include resection guide 1302 (an example of which is resection guide 1920 (similar to resection guide 1420)), one or more other complementary components 1330, such as positioning guide 1340 (an example of which is positioner 1940), compressor 1338 (an example of which is compressor / distractor 1938), and / or alignment guide 1332 (an example of which is alignment guide 1932), and one or more fasteners 1346, such as fastener 1946. Osteotomy system 1900 can be used for a variety of surgical procedures. In one embodiment, resection guide 1920 is patient-matched. In one embodiment, resection guide 1920 is not patient-specific. In one embodiment, osteotomy system 1900 may include multiple resection guides 1920. One of the multiple resection guides 1920 may be configured to make a linear cut perpendicular to a respective bone surface. Another of the plurality of resection guides 1920 may be configured to make a linear cut that is angled relative to the bone surface, and another of the plurality of resection guides 1920 may be configured to make two linear cuts that are parallel to one another.

[0414] 20A-20C show different views of the instruments of the system of FIG. 19, according to one embodiment. Positioner 1940 and resection guide 1920 may include similar components or modules as described with respect to other embodiments. The structure, features, and functions, operation, and configuration may be similar or identical to the components or modules of system 1400 or system 1900, including parts identified by like reference numbers.

[0415] 20A shows a bottom perspective view of one embodiment of a positioner 1940. The positioner 1940 provides one or more fiducial features for the osteotomy procedure (e.g., fasteners deployed within openings 1462). In certain embodiments, the fiducial features may include fasteners deployed within fiducial feature guides 1462 formed within the body of the positioner 1940. Each fiducial feature guide 1462 is configured to guide the formation of a fiducial feature of the bone. Advantageously, these fiducial features correspond to one or more model fiducials of the model.

[0416] The positioner 1940 includes a body 1448 having a bone-facing side (e.g., lower side 1458) and a non-bone-facing side (e.g., upper side 1460). The positioner 1940 includes a first bone-engaging surface 1466a, a second bone-engaging surface 1466b, and a handle 1464. The first bone-engaging surface 1466a is on the bone-facing side and is shaped to engage a surface of a first bone. The surface of the first bone-engaging surface 1466a is based at least in part on a model of the first bone. In one embodiment, the surface of the first bone is a surface of a bone. In another embodiment, the surface of the first bone is a surface of a bone including a periosteal covering.

[0417] In one embodiment, the positioner 1940 is patient-specific. The positioner 1940 may be made from a variety of materials. In one embodiment, the positioner 1940 is made from a material such as a polymer or plastic, one example of which is Nylon 12.

[0418] The second bone-engaging surface 1466b is on the bone-facing side and is shaped to engage the surface of the second bone. The surface of the second bone-engaging surface 1466b is based at least in part on a model of the second bone. In one embodiment, the surface of the second bone is a surface of a bone. In another embodiment, the surface of the second bone is a surface of a bone including a periosteal covering. Similar to the embodiment described above, in the illustrated embodiment, the first bone-engaging surface 1466a is configured to engage the first bone so that the first bone (e.g., medial cuneiform 202) maintains its original position and the second bone-engaging surface 1466b does not initially engage the second bone until the second bone (e.g., metatarsal 208) is repositioned in a predetermined position (e.g., a corrective position). The second bone engaging surface 1466b may contact the second bone, but the second bone engaging surface 1466b is configured not to engage and / or align with the second bone until the second bone is moved to its predetermined position or to one of multiple predetermined positions. In one embodiment, the surgeon may define multiple predetermined positions for the bone during pre-operative planning.

[0419] The handle 1464 extends from the body 1448. In the illustrated embodiment, the handle 1464 extends from the interior side 1454 of the body 1448.

[0420] FIG. 20B shows a bottom perspective view of one embodiment of resection guide 1920. Resection guide 1920 is configured to couple to one or more reference features (e.g., fastener 1446 via opening 1662). Resection guide 1920 includes a resection body 1648, which includes a bone-facing side (e.g., lower side 1658) and a non-bone-facing side (e.g., upper side 1660) opposite the bone-facing side. FIG. 20B shows that in this embodiment, lower side 1658 is flat. In other words, lower side 1658 is free of patient-specific surfaces and / or bone-engaging members. In certain embodiments, this may be because resection guide 1920 is not patient-specific. Alternatively, resection guide 1920 may be patient-adaptable and / or reusable. The resection guide 1920 includes a first resection feature (eg, proximal resection feature 1664a), a second resection feature (eg, distal resection feature 1664b), and one or more bone attachment features 1922a,b.

[0421] The first resection feature 1664a extends through the resection body 1648 from the non-bone-facing side to the bone-facing side and is configured to form a first osteotomy in a first bone. The second resection feature 1664b extends through the resection body 1648 from the non-bone-facing side to the bone-facing side and is configured to form a second osteotomy in a second bone. In one embodiment, with the patient's bones in place, the proximal resection feature 1664a and the distal resection feature 1664b can be less complex resection cutting guides than might otherwise be required. In the illustrated embodiment, the proximal resection feature 1664a is configured to form a linear cut on the distal end of the first bone (e.g., the medial cuneiform bone 202), and the distal resection feature 1664b is configured to form a linear cut on the proximal end of the second bone (e.g., the first metatarsal bone 208).

[0422] The bone attachment feature 1922 functions to hold the resection guide 1920 in place while one or more osteotomies are being performed. In one embodiment, the bone attachment feature 1922 is one or more holes or openings extending from the bone-facing side (e.g., the lower side 1658) to the non-bone-facing side (e.g., the upper side 1660) with fasteners 1446 deployed through the holes / openings and into the bone. The bone attachment feature 1922 is configured to secure the resection guide 1920 to one or more bones, such as a first bone and a second bone. In one embodiment, the openings and / or holes in the bone attachment feature 1922 intersect the corresponding bones obliquely. The intersection of the openings / holes in the bone attachment feature 1922 may be along a third trajectory. In this manner, the resection guide 1920 remains fixed in place by the fasteners 1446 in the openings of the bone attachment feature(s) 1922, even when the fasteners 1446 in the openings 1662 are perpendicular to the bone.

[0423] 20C shows an alternative embodiment of a positioner 2040. The positioner 2040 may include similar components or modules to those described with respect to other embodiments (e.g., resection guide 1920). The structure, features, and functions, operation, and configuration may be similar or identical to those components or modules, including parts identified by like reference numbers. In the illustrated embodiment, the positioner 2040 is similar in many respects to those described herein.

[0424] In the illustrated embodiment, the positioner 2040 may differ from other embodiments because it includes a position indicator 2042 and a window 2044. The position indicator 2042 indicates the position of the body (e.g., body 1448) of the positioner 2040 relative to the first and second bones. In certain embodiments, the position indicator 2042 may be configured to be positioned directly over and aligned with a patient's joint (e.g., the TMT joint). In one embodiment, the position indicator 2042 includes a pair of pins or wires positioned within the body 1448 such that the pins or wires are aligned with and / or perpendicular to a particular anatomical feature of the patient, for example, the gap in the joint between the medial cuneiform bone 202 and the first metatarsal bone 208. In one embodiment, the position indicator 2042 is a line of sight positioned to mark the center of the joint and the longitudinal axis of the joint.

[0425] Advantageously, the surgeon can position the positioner 2040 and then check the position indicator 2042 to confirm that the positioner 2040 is in the desired and / or predetermined position. Of course, other structures can be used and can function as the position indicator 2042. For example, a line of radiopaque material, such as tantalum, can be positioned in or on the body 1448 and can function as the position indicator 2042. In certain embodiments, a window 2044 can function as the position indicator 2042.

[0426] In the illustrated embodiment, the window 2044 extends from the bone-facing side (e.g., the underside 1458) to the opposite side of the body 1448. The window 2044 functions to allow the surgeon to visualize one or more bones on one side of the positioner 2040. In the illustrated embodiment, the window 2044 is positioned between the proximal opening 1462a and the distal opening 1462b.

[0427] The window 2044 can be comprised of a single opening, a pair of openings, or multiple openings. In one embodiment, the window 2044 includes multiple openings extending through the body. Of course, the window 2044 can have a variety of forms, shapes, sizes, and / or configurations. In one embodiment, the window 2044 may be a rectangular or other polygonal opening. The window 2044 allows the surgeon to see beyond the positioner 2040 to visualize progress before, during, or after one or more steps.

[0428] In one embodiment, the size and / or shape of window 2044 may at least partially determine the surgeon's plan for using positioner 2040. In certain embodiments, window 2044 is sized and / or shaped to allow visualization of the patient's anatomy as much as possible while maintaining the structural integrity of positioner 2040. Alternatively, or additionally, window 906 may be a solid structure that is opaque to light but radiolucent to electromagnetic waves (e.g., x-rays, both static x-ray and fluoroscopy).

[0429] 20C also shows an alignment guide 1932 that the surgeon can use to check the alignment between two or more bones of the patient. For example, once the surgeon has positioned the positioner 2040, the surgeon may want to check the alignment between the bone engaging the positioner 2040 and other bones of the patient. For example, in a Lapidus surgical procedure, the surgeon may position the positioner 2040 on the medial cuneiform bone 202 and the first metatarsal 208 and then use the alignment guide 1932 to check the IM angle between the repositioned first metatarsal 208 and the second metatarsal 210.

[0430] The alignment guide 1932 is coupled to the positioner 2040 and is configured to secure one or more position indicators (e.g., pins or K-wires). The position indicators coupled to the alignment guide 1932 identify a trajectory for one or more of the first bone and the second bone. The identified trajectory may be the trajectory after resection of one or more of the first bone and the second bone. Alternatively, the identified trajectory may be the trajectory before resection of one or more of the first bone and the second bone.

[0431] In the illustrated embodiment, the positioner 2040 includes one member 2046 of a coupler configured to engage a corresponding member of a coupler coupled to the alignment guide 1932. One skilled in the art will appreciate that various coupler designs may be used. In the illustrated embodiment, the coupler includes an opening, such as member 2046, that may extend through the body 1448 and the post 2048. In one embodiment, the opening 2046 may include a portion of the window 2044. The post 2048 may include an engagement member 2050.

[0432] In one embodiment, opening 2046 and post 2048 engage one another with a friction fit. For example, post 2048 may slide into window 2044 and engagement member 2050 may slide into opening 2046. In one embodiment, engagement member 2050 may include tabs that are outwardly biased and larger than the diameter of opening 2046 so that the tabs engage opening 2046 upon insertion and release the opening when the tabs are pressed together.

[0433] The alignment guide 1932 includes a body 2052, a lower end 2054, and an upper end 2056, as well as one or more openings 2058 near the upper end 2056. The openings 2058 may be aligned. A surgeon may use the alignment guide 1932 to couple the alignment guide 1932 to the positioner 2040 by engaging a coupler. The surgeon may then insert one or more K-wires through the openings 2058. The openings 2058 and alignment guide 1932 may be configured so that the K-wires extend along the anterior-posterior axis within the openings to indicate the orientation and alignment of the first cuneiform bone and the first metatarsal bone after the osteotomy procedure is complete. The surgeon may compare this alignment to the orientation and alignment of other bones of the patient (e.g., the second metatarsal bone). In this way, the surgeon can confirm that they will achieve a desired outcome after the osteotomy procedure is complete.

[0434] 21 is a flowchart of a method 2100 according to one example of the present disclosure. According to an example, one or more method blocks of FIG. 21 may be performed by a user, such as a surgeon.

[0435] As shown in FIG. 21, the method 2100 may include releasing soft tissue around the patient's tarsometatarsal (TMT) joint so that the metatarsals of the TMT joint can be repositioned (block 2102).

[0436] 21, the method 2100 may include positioning the positioner so that a first bone-engaging surface of the positioner engages a cuneiform bone of the TMT joint (block 2104). For example, the device may position the positioner so that the first bone-engaging surface of the positioner engages a cuneiform bone of the TMT joint, as described above.

[0437] As also shown in FIG. 21 , the method 2100 may include moving the metatarsal so that the second bone-engaging surface of the positioner engages the metatarsal (block 2106). For example, the surgeon may move the metatarsal so that the second bone-engaging surface of the positioner engages the metatarsal, as described above. In one embodiment, the surgeon may move the metatarsal so that the second bone-engaging surface of the positioner fully engages the metatarsal. Alternatively, or additionally, in one embodiment, the surgeon may move the first metatarsal 208 until the surgeon feels that the first metatarsal 208 fully engages the second bone-engaging surface of the positioner. This moving step (block 2106) may include feeling (e.g., as palpable feedback) that the first metatarsal 208 engages the second bone-engaging surface. Alternatively, method 2100 may include the additional step of feeling or checking whether the first metatarsal 208 is fully engaged with the second bone engaging surface of the positioner and / or checking whether the medial cuneiform 202 is fully engaged with the first bone engaging surface of the positioner.

[0438] As further shown in FIG. 21 , method 2100 may include deploying a first set of guide pins through a first fiducial feature guide of the positioner and into the cuneiform bones so that the first set of guide pins form a first fiducial feature (block 2108). For example, the surgeon may deploy a first set of guide pins through a first fiducial feature guide of the positioner and into the cuneiform bones so that the first set of guide pins form a first fiducial feature, as described above. As further shown in FIG. 21 , method 2100 may include deploying a second set of guide pins through a second fiducial feature guide of the positioner and into the metatarsals so that the second set of guide pins form a second fiducial feature (block 2110). For example, the surgeon may deploy a second set of guide pins through a second fiducial feature guide of the positioner and into the metatarsals so that the second set of guide pins form a second fiducial feature, as described above.

[0439] 21 , the method 2100 may include positioning a non-patient-specific resection guide relative to the cuneiform and metatarsal bones using the first and second reference features and securing the non-patient-specific resection guide to the cuneiform and metatarsal bones (block 2112). For example, the surgeon may position the non-patient-specific resection guide relative to the cuneiform and metatarsal bones using the first and second reference features and secure the non-patient-specific resection guide to the cuneiform and metatarsal bones, as described above.

[0440] 21, the method 2100 may include resecting the cuneiform bone with a first resection feature of the non-patient-specific resection guide and the metatarsal bone with a second resection feature of the non-patient-specific resection guide (block 2114). For example, the surgeon may resect the cuneiform bone with a first resection feature of the non-patient-specific resection guide and the metatarsal bone with a second resection feature of the non-patient-specific resection guide, as described above.

[0441] 21, the method 2100 may include deploying a fixation procedure to secure the cuneiform bone to the metatarsal bone (block 2116). For example, the surgeon may deploy a fixation procedure to secure the cuneiform bone to the metatarsal bone, as described above.

[0442] It should be noted that while Figure 21 illustrates example blocks of method 2100, in some implementations method 2100 may include additional, fewer, different, or differently arranged blocks than those illustrated in Figure 21. Additionally or alternatively, two or more of the blocks of method 2100 may be performed in parallel.

[0443] Any method disclosed herein includes one or more steps ...

Claims

1. 1. A device for facilitating an osteotomy procedure, comprising: The main body and a bone-engaging member on a bone-facing side of the body, the bone-engaging member configured to engage a first bone and a second bone; a reference feature guide configured with the body to guide formation of a reference feature on one of the first bone and the second bone; The device comprising:

2. The device of claim 1 , wherein the bone engaging member is configured to fully engage both the first bone and the second bone when both bones are in place.

3. 3. The device of claim 1, wherein the bone engaging member is configured to partially engage one of the first bone and the second bone when the one of the first bone and the second bone is in position.

4. 4. The device of claim 1, wherein the bone engaging member includes a bone engaging surface configured to engage a cortical surface of at least one of the first bone and the second bone, the bone engaging surface having a contour determined at least in part based on a bone model of the patient's foot.

5. 5. The device of claim 4, wherein the bone engaging surfaces include a first bone engaging surface configured to engage the first bone and a second bone engaging surface configured to engage the second bone.

6. 6. The device of claim 5, wherein the first bone engaging surface is configured to engage the first bone and the second bone engaging surface is configured to engage the second bone when at least one of the first bone and the second bone is repositioned from an original position to a predetermined position.

7. 6. The device of claim 5, wherein the first bone engaging surface is configured to engage the first bone and the second bone engaging surface is configured to engage the second bone when the first bone maintains its original position and the second bone is repositioned from its original position to a predetermined location.

8. The device of any one of claims 5 to 7, wherein the second bone engaging surface is configured to provide palpable feedback to a user when the second bone is moved into position.

9. The device of any one of claims 4 to 8, wherein the bone engaging surface comprises a three-dimensional surface having a configuration that is patient-specific.

10. 10. The device of claim 1, wherein the bone engaging member includes an opening in the body, the opening configured to receive at least a portion of one of the first bone and the second bone, and determined at least in part based on a bone model.

11. 11. The device of claim 1, wherein the reference feature guide includes at least one opening in the body, the at least one opening extending from a bone-facing side to an opposite side of the bone-facing side.

12. a handle configured with the body to extend the handle away from the body; and a landmark registration feature extending from a bone-facing side of the body, the landmark registration feature configured to engage a landmark of a patient; The apparatus of any one of claims 1 to 11, further comprising:

13. a position indicator indicating the position of the body relative to the first bone and the second bone; a window extending from the bone-facing side of the body to the opposite side of the body; The apparatus of any one of claims 1 to 12, further comprising:

14. The device of any one of claims 1 to 13, wherein the first bone is a cuneiform bone and the second bone is a metatarsal bone.

15. 15. The device of claim 14, wherein the cuneiform bone is a medial cuneiform bone and the metatarsal bone is a first metatarsal bone separated from the medial cuneiform bone by a tarsometatarsal joint.

16. The device according to any one of claims 1 to 13, wherein the first bone and the second bone are two different parts of a metatarsal bone divided by an osteotomy.

17. 1. A system for an osteotomy procedure, comprising:

1. A positioner for providing fiducial features for an osteotomy procedure, the fiducial features corresponding to model fiducials of a model, the positioner comprising: a positioner body having a bone-facing side and a non-bone-facing side; a first bone-engaging surface on the bone-facing side, the first bone-engaging surface shaped to engage a surface of a first bone of a patient, the surface shaped based at least in part on a model of the first bone; a second bone-engaging surface on the bone-facing side, the second bone-engaging surface shaped to engage a surface of a second bone of the patient, the surface shaped based at least in part on a model of the second bone; a first reference feature guide formed within the positioner body and configured to guide formation of a first reference feature for the first bone; a second reference feature guide formed within the positioner body and configured to guide formation of a second reference feature for the second bone; a handle coupled to the positioner body; the positioner, a resection guide coupled to the fiducial feature, a cutting body having a bone-facing side and a non-bone-facing side; a first cutting feature extending through the cutting body from the non-bone-facing side to the bone-facing side of the cutting body, the first cutting feature configured to guide a cutting tool to create a first osteotomy in the first bone; a second cutting feature extending through the cutting body from the non-bone-facing side to the bone-facing side of the cutting body, the second cutting feature configured to guide a cutting tool to create a second osteotomy in the second bone; and a bone attachment feature configured to secure the resection guide to at least one of the first bone and the second bone; the resection guide, The system comprising:

18. 18. The system of claim 17, wherein the first bone engaging surface is configured to engage the first bone when the first bone maintains its original position, and the second bone engaging surface does not engage the second bone until the second bone is repositioned in place.

19. a compressor configured to compress the cut surface of the first bone against the cut surface of the second bone by engaging the first reference feature of the first bone with the second reference feature of the second bone; an alignment guide coupled to the positioner and configured to secure a position indicator, the position indicator identifying a trajectory relative to one of the first bone and the second bone after resection of the first bone and the second bone; and 19. The system of claim 17 or 18, further comprising:

20. 20. The system of claim 17, wherein the first and second fiducial feature guides comprise sets of holes extending from the non-bone-facing side to the bone-facing side of the positioner body, at least a first hole in the set of holes having a first trajectory perpendicular to a surface of the first bone, and at least a second hole in the set of holes having a second trajectory perpendicular to a surface of the second bone.

21. 21. The system of claim 20, wherein the bone attachment feature includes a hole extending from the non-bone-facing side to the bone-facing side of the resection body and has a third trajectory oblique to a surface of at least one of the first bone and the second bone.

22. the positioner is a patient-specific device made from a polymer; the first cutting feature is configured to make a linear cut to the distal end of the first bone; the second cutting feature is configured to make a straight cut to the proximal end of the second bone; The system of any one of claims 17 to 21, wherein the bone-facing side of the resection guide is flat.

23. 23. The system of any one of claims 17 to 22, comprising a plurality of positioners, each positioner configured to engage the first bone in its original position and the second bone in a different predetermined position.

24. The system of any one of claims 17 to 23, wherein the first bone is a cuneiform bone and the second bone is a metatarsal bone.

25. 25. The system of claim 24, wherein the cuneiform bone is a medial cuneiform bone and the metatarsal bone is a first metatarsal bone separated from the medial cuneiform bone by a tarsometatarsal joint.

26. The system of any one of claims 17 to 23, wherein the first bone and the second bone are two different parts of a metatarsal bone split by an osteotomy.

27. 1. A method for improving the condition of bone present in a patient's foot, comprising: releasing soft tissue around the patient's tarsometatarsal ("TMT") joint so that the metatarsals of the TMT joint can be repositioned; positioning a positioner such that a first bone engaging surface of the positioner engages a cuneiform bone of the TMT joint; moving the metatarsal bone so that a second bone engaging surface of the positioner engages the metatarsal bone; deploying a first set of guide pins through first reference feature guides of the positioner and into the cuneiform bone such that the first set of guide pins form first reference features; deploying a second set of guide pins through second reference feature guides of the positioner and into the metatarsals such that the second set of guide pins form second reference features; positioning a non-patient-specific resection guide relative to the cuneiform and metatarsal bones using the first and second reference features and securing the non-patient-specific resection guide to the cuneiform and metatarsal bones; resecting the cuneiform bone with a first resection feature of the non-patient-specific resection guide and the metatarsal bone with a second resection feature of the non-patient-specific resection guide; developing a fixation procedure to secure the cuneiform bone to the metatarsal bone; The method comprising:

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