Devices, systems, and methods for patient-specific collection guidance

Abstract

Disclosed are devices, systems, and methods for improving a condition present in a patient. In some embodiments, the device may include a body. The device may also include a bone attachment feature. The device may further include a first resection feature configured to guide a first osteotomy in the donor bone. Additionally, the device may include a second resection feature configured to guide a second osteotomy in the donor bone, the second osteotomy being offset from the first resection feature by a dimension that meets a predetermined bone graft dimension.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of and priority to U.S. Provisional Application No. 63 / 447,257, filed February 21, 2023, the entire contents of which are incorporated herein by reference.

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

[0003] Various bone 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.

[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] A patient may present with a condition that can be improved using a surgical procedure requiring the insertion of a bone graft between one or more bones, bone fragments, incisions, or into a joint. For example, the patient and surgeon may determine that one bone needs to be lengthened. Alternatively, in another example, a surgical procedure, such as a Lapidus procedure, joint replacement, or arthrodesis procedure, may be expected to leave one appendage unacceptably shorter than another. In these situations, the patient and / or surgeon may plan to harvest a bone segment or bone block and insert it into the retraction between two or more bone fragments to improve the length discrepancy. In particular, the surgeon may plan to harvest a bone segment, bone fragment, or bone block from the patient's site.

[0006] Determining and locating the optimal or desired position and trajectory for one or more steps of a bone graft harvesting surgical procedure can be difficult given conventional techniques and instruments. Advances in medical imaging, preoperative planning, modeling, and the like have provided improvements to assist surgeons in performing Lapidus surgical procedures. However, devices, systems, and / or methods for harvesting bone grafts from patients are lacking or limited. What is needed is a solution that facilitates harvesting bone grafts from patients for use in connection with another surgical procedure. The present disclosure provides such a solution. Summary of the Invention

[0007] The various apparatus, devices, systems, and / or methods of this disclosure have been developed in response to the state of the art, and particularly in response to problems and needs in the art that have not yet been fully solved by currently available technology.

[0008] In one general aspect, a device may include a body. The device may also include a bone attachment feature. The device may further include a first resection feature configured to guide a first osteotomy in the donor bone. The device may additionally include a second resection feature configured to guide a second osteotomy in the donor bone, the second osteotomy being offset from the first resection feature by a dimension that meets a predetermined graft bone dimension. Other embodiments of this aspect include corresponding computer systems, devices, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method.

[0009] Embodiments may include one or more of the following features: In the device, the predetermined bone graft dimension is one of a set of predetermined dimensions determined for retraction during the planned surgical procedure; In the device, the body may include a bone engaging surface configured to engage a surface of the donor bone; In the device, the bone engaging surface may have a contour determined at least in part based on a bone model of the donor bone, the bone model being defined based on a medical image of the donor bone; In the device, the bone engaging surface is configured to engage at least two cortical surfaces of the donor bone.

[0010] The device may include a landmark alignment feature configured to engage a landmark on the donor bone. The device may include a guard pin guide configured to receive the guard pin into the donor bone to prevent the guard pin from cutting beyond the boundary of the donor bone. In the device, the guard pin guide is positioned at an end of at least one of the first resection feature and the second resection feature. The device may include an alternative resection feature offset from the first resection feature by a second dimension, the second dimension being different from the aforementioned dimension. In the device, the first resection feature and the second resection feature each extend through the body from the bone-facing side of the body to the non-bone-facing side of the body, and the first resection feature and the second resection feature extend parallel to each other through the body. In the device, the first resection feature and the second resection feature extend through the body at an angle such that the first osteotomy and the second osteotomy form a wedge-shaped bone graft. In the device, the donor bone is the calcaneus of a patient in a Lapidus surgical procedure. Implementations of the described techniques may include hardware, a method or process, or a computer tangible medium.

[0011] In one general aspect, a system may include a harvest guide having a body, a bone attachment feature, a first resection feature configured to guide a first osteotomy in the donor bone, and a second resection feature configured to guide a second osteotomy in the donor bone, the first resection feature extending parallel to the second resection feature through the body and separated from the second resection feature by a distance determined based on a patient-specific graft bone insertion site. The system may also include a guard configured to prevent cutting beyond a boundary into the donor bone. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method.

[0012] Implementations may include one or more of the following features: In the system, the harvest guide may include a third resection feature extending from the bone-facing side to the non-bone-facing side of the body, the third resection feature guiding the third osteotomy connecting the first osteotomy and the second osteotomy; In the system, the third resection feature may include an edge; The system may include a jig configured to guide the creation of a shape of the graft bone resected from the donor bone using the harvest guide; Implementations of the described technology may include hardware, a method or process, or a tangible computer medium.

[0013] In one general aspect, a method may include performing an osteotomy on a patient using an instrument to form a retraction having a set of predetermined dimensions in one or more bones of the patient. The method may also include deploying a harvest guide on a donor bone, the harvest guide having a body, a bone attachment feature, a first resection feature configured to guide the osteotomy of the donor bone, and a second resection feature configured to guide the osteotomy of the donor bone, the first resection feature and the second resection feature configured relative to each other such that the osteotomy formed using the first resection feature and the osteotomy formed using the second resection feature facilitate resection of a bone graft having at least one dimension that substantially matches one of the set of predetermined dimensions.

[0014] The method may further include resecting the bone graft from the donor bone using the first resection feature and the second resection feature of the harvest guide. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method.

[0015] Implementations may include one or more of the following features: The method may include preparing a bone graft for reduction within the retraction and reducing at least one bone fragment with the bone graft within the retraction. In the method, the body may include a bone-engaging surface configured to engage at least two cortical surfaces of the donor bone. Implementations of the described technology may include hardware, a method or process, or a computer tangible medium.

[0016] In one general aspect, the method may include providing a set of predetermined dimensions for a retractor to receive a bone graft, the set of predetermined dimensions being patient-specific. The method may also include determining a location of a bone graft harvest site on the donor bone. The method may further include developing a patient-specific harvest guide model having a bone-engaging surface configured to engage with a surface of the bone graft harvest site. The method may additionally include fabricating the patient-specific harvest guide based on the patient-specific harvest guide model. The method may further include providing the patient-specific harvest guide for a surgical procedure. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs stored on one or more computer storage devices, each configured to perform the actions of the method.

[0017] 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]

[0018] [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 providing a patient-specific collection guide, according to one embodiment. [Figure 10] 1 illustrates a method for harvesting bone graft for a surgical procedure, according to one embodiment. [Figure 11] 1 illustrates an exemplary system, according to one embodiment. [Figure 12] 1 illustrates an exemplary system, according to one embodiment. [Figure 13A] FIG. 12 illustrates a top perspective view of a harvesting guide according to one embodiment. [Figure 13B] FIG. 12 is a top view of a harvesting guide according to one embodiment. [Figure 13C] FIG. 12 is a bottom view of a harvesting guide according to one embodiment. [Figure 13D] FIG. 12 is a rear view of a harvest guide according to one embodiment. [Figure 13E] FIG. 12 is a front view of a harvesting guide according to one embodiment. [Figure 13F] FIG. 1 illustrates a superior view of a harvesting guide according to one embodiment. [Figure 13G] FIG. 10 is an underside view of a harvest guide according to one embodiment. [Figure 13H] 10A-10C are views of alternative embodiments of a harvesting guide, in accordance with certain embodiments. [Figure 13I] 10A-10C are views of alternative embodiments of a harvesting guide, in accordance with certain embodiments. [Figure 13J] 10A-10C are views of alternative embodiments of a harvesting guide, in accordance with certain embodiments. [Figure 13K] 10A-10C are views of alternative embodiments of a harvesting guide, in accordance with certain embodiments. [Figure 13L] 10A-10C are views of alternative embodiments of a harvesting guide, in accordance with certain embodiments. [Figure 13M] 10A-10C are views of alternative embodiments of a harvesting guide, in accordance with certain embodiments. [Figure 13N] 10A-10C are views of alternative embodiments of a harvesting guide, in accordance with certain embodiments. [Figure 14A] 1A-1D show different views of stages of a surgical procedure, according to one embodiment. [Figure 14B] 1A-1D show different views of stages of a surgical procedure, according to one embodiment. [Figure 14C] 1A-1D show different views of stages of a surgical procedure, according to one embodiment. [Figure 14D] 1A-1D show different views of stages of a surgical procedure, according to one embodiment. [Figure 14E] 1A-1D show different views of stages of a surgical procedure, according to one embodiment. [Figure 14F] 1A-1D show different views of stages of a surgical procedure, according to one embodiment. [Figure 14G] 1A-1D show different views of stages of a surgical procedure, according to one embodiment. [Figure 14H] 1 illustrates an exemplary cut for use according to one embodiment. [Figure 14I] 1 illustrates an exemplary jig for use according to one embodiment. [Figure 15A] 1A-1C illustrate different views and information of a planned surgical procedure that includes not only one or more osteotomies, but also autograft harvesting using a patient-specific harvest guide, according to one embodiment. [Figure 15B] 1A-1C illustrate different views and information of a planned surgical procedure that includes not only one or more osteotomies, but also autograft harvesting using a patient-specific harvest guide, according to one embodiment. [Figure 15C] 1A-1C illustrate different views and information of a planned surgical procedure that includes not only one or more osteotomies, but also autograft harvesting using a patient-specific harvest guide, according to one embodiment. [Figure 15D] 1A-1C illustrate different views and information of a planned surgical procedure that includes not only one or more osteotomies, but also autograft harvesting using a patient-specific harvest guide, according to one embodiment. [Figure 15E] 1A-1C illustrate different views and information of a planned surgical procedure that includes not only one or more osteotomies, but also autograft harvesting using a patient-specific harvest guide, according to one embodiment. [Figure 15F] 1A-1C illustrate different views and information of a planned surgical procedure that includes not only one or more osteotomies, but also autograft harvesting using a patient-specific harvest guide, according to one embodiment. [Figure 15G] 1A-1C illustrate different views and information of a planned surgical procedure that includes not only one or more osteotomies, but also autograft harvesting using a patient-specific harvest guide, according to one embodiment. [Figure 15H] 1A-1C illustrate different views and information of a planned surgical procedure that includes not only one or more osteotomies, but also autograft harvesting using a patient-specific harvest guide, according to one embodiment. [Figure 15I] 1A-1C illustrate different views and information of a planned surgical procedure that includes not only one or more osteotomies, but also autograft harvesting using a patient-specific harvest guide, according to one embodiment. [Figure 15J] 1A-1C illustrate different views and information of a planned surgical procedure that includes not only one or more osteotomies, but also autograft harvesting using a patient-specific harvest guide, according to one embodiment. [Figure 15K] 1A-1C illustrate different views and information of a planned surgical procedure that includes not only one or more osteotomies, but also autograft harvesting using a patient-specific harvest guide, according to one embodiment. [Figure 15L] 1A-1C illustrate different views and information of a planned surgical procedure that includes not only one or more osteotomies, but also autograft harvesting using a patient-specific harvest guide, according to one embodiment. [Figure 15M] 1A-1C illustrate different views and information of a planned surgical procedure that includes not only one or more osteotomies, but also autograft harvesting using a patient-specific harvest guide, according to one embodiment. [Figure 15N] 1A-1C illustrate different views and information of a planned surgical procedure that includes not only one or more osteotomies, but also autograft harvesting using a patient-specific harvest guide, according to one embodiment. [Figure 15O] 1A-1C illustrate different views and information of a planned surgical procedure that includes not only one or more osteotomies, but also autograft harvesting using a patient-specific harvest guide, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0019] 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.

[0020] 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.

[0021] 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, 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).

[0022] 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.

[0023] 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.

[0024] 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.

[0025] 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.

[0026] "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.

[0027] "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.

[0028] "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.

[0029] "Harvesting guide," "graft harvesting guide," or "harvester" refers to an instrument designed, engineered, and / or fabricated to facilitate the removal of autografts, allografts, and / or xenografts from a harvest site. In one aspect, the harvesting guide is specific to a single patient and may include patient-specific features such as surface contours, bone-engaging surfaces, resection guides for resecting a graft of a size, shape, configuration, and / or orientation specific to the needs of a single patient, or other features. In one aspect, the harvesting guide includes one or more patient-specific features and / or aspects designed, engineered, and / or fabricated to harvest a graft for a personalized surgical procedure for a unique patient. Alternatively, the harvesting guide may not be patient-specific.

[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] As used herein, "allograft" refers to a type of tissue and / or organ transplant in which the transplanted tissue or organ is derived from a donor of the same species but not the same genotype. The tissue can be soft tissue, such as skin, ligaments, tendons, fascia, fatty muscles, fibrous tissue, blood vessels, lymphatic vessels, or nerves, or hard tissue, such as bone, tooth enamel, dentin, cementum, or cartilage. The bone graft may be of the allograft type or a mixture of other graft types, including allografts, autografts, and xenografts. An autograft refers to a type of tissue and / or organ transplant in which the transplanted tissue or organ is derived from the patient. A xenograft refers to a type of tissue and / or organ transplant in which the transplanted tissue or organ is derived from a donor of another species.

[0032] "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.

[0033] A "patient-specific bone graft insertion site" refers to a location or area within a patient that is or can be prepared to receive a graft. Often, a patient-specific bone graft insertion site is a tissue retraction, an organ, a joint, one or more osteotomies, a set of bones, or a single bone.

[0034] "Bone graft harvest site" refers to a location or area within a donor, in or on a donor anatomy, or within a graft source that is used to obtain a bone graft.

[0035] "Donor bone" refers to bone used as a source of bone graft. The bone may be the patient's bone, in which case the bone graft is an autograft. The donor bone may be the bone of a donor of the same species as the patient but not the same genotype, in which case the bone graft is an allograft. The donor bone may be the bone of a donor of a different species than the patient, in which case the bone graft is a xenograft.

[0036] "Jig" refers to a device, system, structure, and / or apparatus in manufacturing, fabrication, surgery, or other endeavors for controlling the position, path of motion, or both, of either a workpiece or a tool acting on the workpiece. Subsets of this general class include machining jigs, graft harvesting jigs, woodworking jigs, welder's jigs, lapidary jigs, and many others. (Search "jig" at wordhippo.com. WordHippo, 2023. Web. Rev. Accessed February 17, 2023.) In the context of surgical procedures, a jig can facilitate the removal and / or shaping of a workpiece, such as implant tissue, also known as a graft.

[0037] 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.

[0038] "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.

[0039] "Post" refers to any apparatus, structure, device, system, and / or component that extends from another structure. In certain embodiments, the post can be cylindrical.

[0040] 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.

[0041] "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.

[0042] A "reference 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 reference or reference feature can function as a baseline, ground truth, waypoint, control point, landmark, etc. A reference 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 reference 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 reference feature can aid in mapping from a virtual or modeled object to a real or physical object. As used herein, "feature" refers to any distinctive attribute or aspect. (Search "feature" on 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.

[0043] "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.

[0044] "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.

[0045] "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, eyes, hair, nails, fingers, toes, legs, arms, torso, vertebrae, ligaments, tendons, organs, a hole, a post, holes, posts, etc.

[0046] "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).

[0047] "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.

[0048] 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.

[0049] As used herein, a "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.

[0050] 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.

[0051] 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.

[0052] 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 for replacing missing bone to repair a fracture. Bone can generally 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).

[0053] 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.)

[0054] "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 of 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.

[0055] "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.

[0056] 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).

[0057] 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 related to 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.

[0058] 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.

[0059] 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.

[0060] 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.

[0061] 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.

[0062] "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.

[0063] 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.

[0064] 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.

[0065] "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.)

[0066] "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.)

[0067] "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.)

[0068] 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.

[0069] 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.

[0070] "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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] "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.

[0075] 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.

[0076] 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.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] "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.

[0083] 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.

[0084] 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.)

[0085] "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.

[0086] 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.

[0087] 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.

[0088] As used herein, "osteotomy procedure" or "surgical osteotomy" or "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).

[0089] 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.

[0090] "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.

[0091] "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.

[0092] "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-shaped piece of bone is removed from the bone, resulting in a "closing" within the bone.

[0093] 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."

[0094] 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.

[0095] As used herein, "end" refers to a portion or structure of an area or span that exists at a boundary or edge. End can also refer to a point that marks the extent of something and / or the point where something ceases to exist. End can also refer to the longitudinal extremity or final portion of a structure or surface. (Search "end" at Merriam-Webster.com. Merriam-Webster, 2021. Web. Updated August 4, 2021).

[0096] "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.

[0097] 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.

[0098] 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.

[0099] 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.

[0100] "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.

[0101] "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).

[0102] 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.

[0103] 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).

[0104] 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.

[0105] 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.

[0106] 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.)

[0107] 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.

[0108] 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.)

[0109] 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.

[0110] 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.)

[0111] 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.

[0112] 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.

[0113] 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.)

[0114] "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.

[0115] "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.

[0116] 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.

[0117] "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.

[0118] "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.)

[0119] 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).

[0120] "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.

[0121] 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.

[0122] 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.

[0123] 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 a beveled 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.)

[0124] 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.

[0125] 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.

[0126] 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.)

[0127] 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."

[0128] "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.

[0129] "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.

[0130] "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 deformity, misalignment, malrotation, fracture, joint dysfunction, etc. 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 deformity, calcaneal deformity, femoral deformity, and radial deformity). 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.

[0131] 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."

[0132] "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.

[0133] 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).

[0134] 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.

[0135] "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.

[0136] "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.

[0137] "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.

[0138] "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.

[0139] "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.

[0140] 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.

[0141] "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.

[0142] "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.

[0143] 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.

[0144] "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.

[0145] 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.

[0146] 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.

[0147] As used herein, "edge" refers to a structure, boundary, or line where an object, surface, or region begins or ends. An edge can also refer to the boundary or perimeter between two structures, objects, or surfaces. An edge can also refer to a narrow portion adjacent to a boundary. (Search "edge" at Merriam-Webster.com. Merriam-Webster, 2021. Web. Revised August 3, 2021.) In certain embodiments, an edge can be a one- or two-dimensional structure that joins two adjacent structures or surfaces. Furthermore, an edge can be at the perimeter of an object or within the perimeter or boundary of an object.

[0148] "Boundary" refers to a structure, line, or area where an object, surface, line, area, or action begins and / or ends, or is expected to do so. A boundary may be similar to a border.

[0149] "Dimension" refers to a measure of spatial size in a particular direction, such as height, width or breadth, span, thickness, or depth. (Search "dimension" at wordhippo.com. WordHippo, 2023. Web. Revised. Accessed February 17, 2023.)

[0150] The present disclosure discloses methods, systems, and / or devices for harvesting bone grafts. In one embodiment, the present disclosure describes a method of providing a harvest guide. In certain embodiments, the present disclosure describes a method of providing a patient-specific harvest guide. In certain embodiments, the harvest guide may be used to harvest an autograft bone graft. For example, the harvest guide may be used to harvest an autograft bone graft from a patient's calcaneus. Advantageously, the harvest guide may be configured to harvest an autograft bone graft of a customized, patient-specific size (length / depth / span / thickness, width, height) having dimensions required for a retraction created by one or more osteotomies.

[0151] In certain embodiments, the present disclosure describes a method for harvesting bone grafts for surgical procedures. In one example, a patient-specific harvesting guide can be used to harvest an autograft bone graft from a patient's bone. The autograft bone graft is sized by the patient-specific harvesting guide to fit dimensions that meet predetermined bone graft dimensions. In one embodiment, the dimensions are the same as the predetermined bone graft dimensions. In another embodiment, the dimensions are substantially the same as the predetermined bone graft dimensions within an acceptable tolerance level. The present disclosure describes devices, systems, and / or methods for harvesting bone for surgical procedures that address the shortcomings of conventional solutions.

[0152] 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.

[0153] 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.

[0154] 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.

[0155] 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.

[0156] 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.

[0157] 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, graft harvesting guides, or tendon trajectory guides having bone-engaging surfaces and / or one or more features described herein.

[0158] 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.

[0159] 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.

[0160] 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.

[0161] 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.

[0162] 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.

[0163] 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.

[0164] 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.

[0165] 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.

[0166] 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.

[0167] 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.

[0168] 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.

[0169] 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.

[0170] 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.

[0171] 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.

[0172] 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.

[0173] 2A is a dorsal perspective view of a foot 200. The foot 200 may have, among other things, a medial cuneiform 202, an intermediate cuneiform 204, a lateral cuneiform 206, a first metatarsal 208, a second metatarsal 210, a third metatarsal 212, a fourth metatarsal 214, a fifth metatarsal 216, a navicular 218, a cuboid 220, and a calcaneus 222. The medial cuneiform 202 and the intermediate cuneiform 204 may be joined together at a first metatarsal-cuneiform joint, and the first metatarsal 208 and the second metatarsal 210 may be joined together at a second metatarsal-cuneiform joint. Foot 200 includes a set of proximal phalanges numbered first through fifth (230, 232, 234, 236, 238), a set of distal phalanges numbered first through fifth (240, 242, 244, 246, 248), and a set of intermediate phalanges numbered second through fifth (250, 252, 254, 256).

[0174] FIG. 2B is a lateral perspective view of a foot 200 with the bones of the foot labeled.

[0175] 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.

[0176] 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.

[0177] 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.

[0178] 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.

[0179] 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.

[0180] 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.

[0181] 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.

[0182] 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.

[0183] 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.

[0184] 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.

[0185] 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.

[0186] 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.

[0187] 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.

[0188] The method 300 may conclude with step 312, in which a patient-specific guide may be manufactured based on the patient-specific guide model. Various manufacturing tools, devices, systems, and / or techniques may be used to manufacture the patient-specific guide.

[0189] 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.

[0190] 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.

[0191] 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.

[0192] 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 one or more sources, 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 the 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 depth / length / span / thickness 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.

[0193] 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 one or more sources, 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 classifications 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.

[0194] 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.

[0195] 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.

[0196] 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.

[0197] 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.

[0198] 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.

[0199] 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).

[0200] 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.

[0201] 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.

[0202] 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.

[0203] 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.

[0204] 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.

[0205] 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.

[0206] 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).

[0207] 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.

[0208] 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.

[0209] The location module 420 outputs location / patient specific features 428 for the orthopaedic surgical procedure.

[0210] 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.

[0211] 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.

[0212] 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.

[0213] 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.

[0214] 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.

[0215] 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.

[0216] 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.

[0217] 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.

[0218] 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.

[0219] 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.

[0220] 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.

[0221] 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.

[0222] 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.

[0223] 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.

[0224] Alternatively, or additionally, a user may use the modification module 708 to modify a given osteotomy procedure. The user may add, remove, or modify steps and / or instruments used in the graft harvest procedure to create a patient-specific or customized graft harvest procedure and / or patient-specific graft harvest instrument. In this manner, the user can configure the individualized preliminary guide model 438 or modified preliminary guide model and / or graft harvest procedure features to the patient-specific osteotomy procedure the surgeon is planning for the patient.

[0225] 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.

[0226] 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.

[0227] The fixture selector 802 allows a user to determine the fixture(s) to use for the graft harvesting procedure planned for the patient. In one embodiment, the fixture selector 802 may recommend one or more fixtures based on the bone model 404, the position, the trajectory, or input from the user or history of previous graft harvesting procedures performed. The fixture selector 802 may select a fixture model from a set of predetermined fixture models or may select a physical fixture from a set of fixtures. Fixtures may include plates and associated accessories such as screws, anchors, etc.

[0228] 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).

[0229] The export module 804 is configured to enable export of the patient-specific guide model 702 for various purposes, including, but not limited to, fabrication / manufacturing of the patient-specific guide 406 and / or fixture(s), generation of a pre-operative plan, generation of 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 procedure (e.g., a graft harvesting procedure) may be used in other tools. The pre-operative plan 806 may include a set of step-by-step instructions or recommendations for a surgeon or other staff in performing the procedure (e.g., a graft harvesting procedure). 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 procedure (e.g., a graft harvesting procedure). The instruments may include a patient-specific guide 406 and / or one or more fixtures / fasteners. In one embodiment, the export module 804 may provide a fixture model that may be used to fabricate a fixture for the procedure.

[0230] The exports (404, 412, 702, 806, and 808) can 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 procedure or for rehearsal and preparation of the 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 procedure using a surgical procedure simulation tool.

[0231] 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.

[0232] Using an individualized model for a particular patient, a preoperative surgical plan for the planned surgical procedure can be prepared, engineered, and / or designed. The preoperative surgical plan can include one or more surgical osteotomies. Those skilled in the art will appreciate that a variety of surgical osteotomies can be performed, including open wedge osteotomies, complete resections, deformity corrections, nonunion corrections, malunions, etc. In certain embodiments, the surgical procedure includes deploying a graft at an implantation site that includes one or more surgical osteotomies. The graft can be an autograft, an allograft, or a xenograft. The graft can be of various shapes, sizes, and other dimensions. For example, the graft can be an open wedge osteotomy. The purpose of the implant can be manifold or single-fold and includes goals such as filling a retraction caused by the removal of a deformed, fractured, damaged, weak, or otherwise undesirable section of one or more bones in, on, or around one or more joints, changing the orientation of one or more bones, lengthening or shortening one or more bones, and fusing one or more joints.

[0233] One of the challenges associated with surgical osteotomies or procedures involving graft deployment is determining the size and / or dimensions and / or configuration of the graft to be deployed. Preferably, the graft is harvested from the patient's bone (referred to herein as "donor bone"). A conventional approach to overcoming this challenge involves harvesting an autograft larger than the planned graft and then shaping or resizing this larger autograft on the operating room back table during the surgical procedure. One problem with this conventional approach is that the surgeon must estimate how much bone tissue needs to be removed on which side of the autograft. If the surgeon removes too much, they may ruin the autograft and a new autograft must be procured. Consequently, to mitigate such risks, surgeons may choose to remove only small amounts of the autograft, repeatedly checking and rechecking the size of the autograft depending on the size of the retractor to receive it, until enough bone tissue has been removed and / or the size of the autograft is suitable for deployment within the retractor. This trial and error approach can add time to the surgical procedure and stress to the surgeon performing the procedure.

[0234] Another challenge is determining how and where the bone graft needs to be resected from the donor bone. Often, the calcaneus is a desirable donor bone for bone grafts. However, the calcaneus may have limited landmarks and may present a smooth surface that may require a high degree of precision and expertise for the surgeon to secure the desired size and shape of the bone graft. Advantageously, the present disclosure provides a harvest guide that facilitates resecting the bone graft from a bone graft harvest site, including, but not limited to, the patient's calcaneus.

[0235] Advantageously, because the present disclosure teaches embodiments based on a model of the patient's anatomy and / or preoperative planning to plan a surgical procedure from start to finish prior to the surgical procedure, the surgeon can determine one or more dimensions of the retraction to receive the autograft during preoperative planning. Indeed, the surgeon, user, computing device, automated system, and / or semi-automated system can determine not only the shape but also the size of the autograft during the preoperative planning stage. For example, the retraction formed by a surgical osteotomy can be measured to determine the exact or approximate depth / length / span / thickness, width, and height of the retraction. The ability to preoperatively plan the size and configuration of the retraction also enables the surgeon to preoperatively plan and prepare for bone graft harvest, particularly autograft harvest.

[0236] A model of the autograft can be constructed using modeling software so that the autograft has the same or approximately the same dimensions as the retractor. Alternatively, or in addition, a surgeon or technician can have an autograft graft model designed so that one or more of the autograft's dimensions are larger or smaller than the retractor's dimensions to provide an autograft that achieves the desired outcome of the surgical procedure. For example, to ensure adequate compression during healing, the harvested autograft graft can be slightly larger than the depth / length / span / thickness of the retractor so that fixation of the graft within the retractor provides sufficient compression to promote new bone growth. Larger sizes can be useful, for example, when the graft is a wedge-shaped graft positioned between two bone sections connected by a living hinge.

[0237] Preoperative planning software, which may include modeling software, can be used to design a bone graft model. Based on the bone graft model, a harvest guide can be designed to assist the surgeon in harvesting an autograft bone graft having the same or substantially the same dimensions as the bone graft model. In this manner, the dimensions of the harvested autograft bone graft are predetermined and / or predefined. In one embodiment, the dimensions are the same as the retraction defined in the bone model representing one or more stages of the planned surgical procedure for the patient. Advantageously, the model bone is substantially identical in all relevant aspects to the patient's bone. The dimensions of the retraction to be filled by the autograft bone graft and / or the dimensions of the harvested autograft bone graft are referred to herein as the predetermined bone graft dimensions.

[0238] In this disclosure, embodiments are described with respect to surgical osteotomies on one or more bones of the foot and / or ankle, however, one skilled in the art will understand that the devices, systems, and methods can readily be used and / or applied to surgical osteotomies involving autograft harvesting from bones other than those of the foot and ankle, and such embodiments are within the scope of this disclosure.

[0239] By way of example only, surgical osteotomy may be performed on the patient's hand, wrist, shoulder, or knee, as well as the ankle or foot. Similarly, the bone used to harvest the autograft (also known as the "bone graft harvest site") may be any bone of the foot, such as the calcaneus, the distal portion of the tibia, the distal portion of the fibula, the proximal portion of the tibia, any bone of the ankle, such as the proximal portion of the tibia, etc. The bone graft harvest site may also be on the gluteal bone.

[0240] As shown in FIG. 9 , method 900 may include providing a set of predetermined graft dimensions for a retractor that will receive the bone graft, where the set of predetermined graft dimensions may be patient-specific (block 902). Specifically, the set of predetermined graft dimensions may include the length / span / thickness and / or depth of the retraction to be formed during the planned surgical procedure. For example, system 400, system 800, and / or a user may calculate a set of predetermined graft dimensions for a retractor that will receive the bone graft, including an autograft, where the set of predetermined graft dimensions may be patient-specific, as described above. The retraction may be formed as part of the planned surgical procedure. In one embodiment, pre-operative planning software may be used to review a model of the patient's bones, one or more instruments to be used in the surgical procedure, and a sequence of stages of the surgical procedure, including the formation of one or more retractions between bones, bone fragments, joints, etc.

[0241] Advantageously, for example, a computing device running pre-operative planning software may automatically or via a user determine one or more predetermined graft dimensions of a retraction formed by one or more osteotomies of a surgical procedure. In one embodiment, the predetermined graft dimension may include the distance from the distal cut surface of one bone to the proximal cut surface of another bone on the opposite side of the retraction. Stated differently, one of the predetermined graft dimensions may be measured between the cut bone fragments of the bone model and may be the distance or span across the retraction along a line perpendicular to the surface of each bone fragment.

[0242] In certain embodiments, the computing device may automatically calculate the predetermined bone graft dimensions. In other embodiments, the computing device may calculate the predetermined bone graft dimensions in response to user input. For example, a user may identify a start surface and an end surface, and the computing device may automatically calculate the distance between the two surfaces. This distance may represent the thickness of the autograft bone graft that can be deployed within the retraction. Alternatively, or in addition, the computing device may calculate the height and / or length of the retraction based on the perimeter of each surface identified by the user. In this manner, the computing device may calculate the height, length, and / or depth of the retraction between two bone fragments. Advantageously, the computing device can calculate the height, length, and / or depth of the autograft bone graft sized to adequately fit within the retraction between the bone fragments.

[0243] Those skilled in the art will appreciate that the set of predetermined dimensions may be the predetermined dimensions of a retraction associated with a surgical procedure. In one embodiment, the retraction is formed by a step in the surgical procedure. In another embodiment, the retraction may be a pre-existing retraction that a patient has when they seek the surgical procedure. Dimensions that may be included in the set of predetermined dimensions include, but are not limited to, each dimension that a computing device, either alone or in conjunction with a user, can measure, define, and / or calculate. For example, such dimensions may include length, thickness, span length, depth, height, width, density, volume, surface area, porosity, brightness, etc.

[0244] Advantageously, one or more predetermined bone graft dimensions can be used when designing and / or manufacturing the harvest guide. Furthermore, using a computing device and / or a model of the bone for the surgical procedure and / or the modeled bone graft insertion site, a user, such as a surgeon, can change the planned dimensions of the bone graft and thus adjust the dimensions of the harvest guide features. In one embodiment, a surgeon may prescribe specific dimensions for the bone graft to fill the resected bone and / or the joint cavity to be healed in the surgical procedure. In one embodiment, a surgeon may prescribe specific dimensions for the bone graft to fulfill a purpose other than filling the wound created in the surgical procedure. For example, a surgeon may require a certain height to harvest a particular type and / or composition of bone for one or more portions of the surgical procedure.

[0245] As also shown in FIG. 9 , method 900 may include determining the location of the bone graft harvest site on the donor bone (block 904). For example, system 400, system 800, and / or a user may determine the location of the bone graft harvest site on the donor bone automatically or together based on user input. In one embodiment, the system, computing device, and / or user may reference anatomical data 412 regarding the patient's donor bone to be used for the bone graft harvest site. Alternatively, or in addition, the system, computing device, and / or user may reference a bone model generated based on medical images of the same bone of the patient. In this manner, the system, computing device, and / or user may determine the dimensions of the donor bone and use these dimensions to recommend the location of the bone graft harvest site on the donor bone.

[0246] In certain embodiments, the location on the donor bone can be determined based on the bone type and / or bone composition in or around the retraction where the autograft will be deployed. A surgeon, a user, a computing device, an automated system, and / or a semi-automated system can determine the location of the donor bone and / or the bone graft harvest site on the donor bone.

[0247] For example, if the surgical osteotomy involves a Lapidus arthrodesis, the bone surrounding the retraction created during the surgical procedure may include the distal end of the medial cuneiform bone and / or the amputated proximal end of the base of the first metatarsal bone. These bones comprise a hard cortex or cortical surface surrounding a softer inner portion of the bone. Surgeons may prefer to deploy an autograft with a similar bone structure, a hard outer cortex with a softer inner bone. As a result, surgeons may request an autograft from the region of the calcaneus where the dorsal cortex transitions to the lateral cortex.

[0248] Such an autograft is referred to as a bicortical graft. Those skilled in the art will appreciate that a surgeon may desire a tricortical autograft. In such embodiments, the tricortical autograft may be harvested from the patient's hip bone. In certain embodiments, the surgeon may choose to harvest the autograft from the fibula to harvest surrounding bone, such as full cortical bone, for use as the autograft. Thus, the surgeon, user, computing device, automated system, and / or semi-automated system may operate together and / or based on instructions from the surgeon regarding donor bone selection and / or location of the graft harvest site on the donor bone.

[0249] As further shown in FIG. 9 , method 900 may include developing a patient-specific harvest guide model having a bone-engaging surface configured to engage with a surface of the bone graft harvest site (block 906). For example, system 400, system 800, and / or a user may define a predetermined depth / span / thickness (e.g., predetermined span) of the retraction to receive the autograft graft. In one embodiment, the harvest guide model may include a body, a set of bone attachment features, and a set of resection features (e.g., channels, cut channels, slots, holes, or other openings configured to receive or interact with a cutting tool). Advantageously, the set of resection features are positioned relative to one another to form an autograft graft at the bone graft harvest site by performing one or more osteotomies using the resection features. Advantageously, the autograft graft has the same span / depth / thickness (also referred to as width) as the predetermined span / depth / thickness (also referred to as width) of the retraction to receive the autograft graft. The patient-specific harvest guide model may comprise a computer-aided design (CAD) model within a computing device.

[0250] Alternatively, or in addition, the patient-specific harvest guide model may include other features that are part of or cooperate to facilitate tissue harvesting. In one embodiment, the patient-specific harvest guide model may include features such as bone attachment features configured to facilitate attachment of the patient-specific harvest guide model to the harvest procedure. One example of a bone attachment feature is a hole extending through the patient-specific harvest guide model with a fastener, such as a K-wire. The hole can be sized to accept the fastener, such as a K-wire. For example, in one embodiment, pin locations for temporary fasteners, such as K-wires, may be defined within the patient-specific harvest guide model and function as a bone attachment feature.

[0251] Alternatively, or in addition, the patient-specific harvest guide model may also include one or more guards. The guards may function to prevent resection beyond the boundaries defined by the guard. In one embodiment, the guards may be implemented as fasteners, such as pins or guard pins.

[0252] 9, the method 900 may include fabricating a patient-specific harvest guide based on the patient-specific harvest guide model (block 908). For example, the system 400, the system 800, and / or a user may fabricate the patient-specific harvest guide based on the patient-specific harvest guide model described above. In one embodiment, the computing device may transmit instructions to an additive manufacturing system to fabricate the patient-specific harvest guide based on the definition of the patient-specific harvest guide model. Advantageously, the patient-specific harvest guide includes a set of resection features that, when used, provide an autograft bone graft having one or more dimensions that match a set of predetermined bone graft dimensions.

[0253] For example, the span / depth / thickness (also referred to as width) of the autograft bone graft conforms to a predetermined span / depth / thickness. In certain embodiments, the predetermined span / depth / thickness is defined using a computing device when the surgical procedure is planned. For example, a retraction defined after one or more osteotomies can be measured using a computing device (e.g., before the surgical procedure) to predefine a set of predetermined dimensions for the retraction. The set of predetermined dimensions for the retraction can then be used to determine one or more dimensions of the autograft bone graft planned to be fixed within the retraction. In certain embodiments, one or more dimensions (e.g., thickness) of the autograft bone graft can increase beyond the span of the retraction to accommodate the bone allowance resulting from the cutting tool kerf.

[0254] In this way, the surgeon can harvest the autograft bone graft while reducing stress or concern that the resulting autograft bone graft will be too small or not the proper shape. Additionally, the surgeon can be assured that the harvested autograft bone graft will be usable and will not be ruined due to imprecise harvesting of the autograft bone graft.

[0255] Alternatively, or in addition, the patient-specific harvest guide can be configured to fit into or over a single location on the donor bone. In this way, the surgeon can ensure that the autograft graft has a desired configuration (e.g., several cortical surfaces, etc.). Alternatively, or in addition, the features and / or configuration of the patient-specific harvest guide can facilitate resecting the autograft graft that meets one or more additional predetermined graft dimensions (e.g., height, length, cross-sectional diameter). As described herein, the patient-specific harvest guide can be fabricated using a variety of fabrication techniques and / or materials, including ceramic, plastic, and / or metal.

[0256] 9 , the method 900 may include providing a patient-specific collection guide for the surgical procedure (block 910). For example, the system 400, the system 800, and / or a user may provide the patient-specific collection guide for the surgical procedure by sending the patient-specific collection guide to the surgeon, the facility performing the surgical procedure, etc. The patient-specific collection guide may be provided alone or together with one or more pre-operative plans and / or one or more instruments (e.g., conventional instruments and / or patient-specific instruments). In certain embodiments, a technician, laboratory, factory, manufacturing facility, vendor, and / or medical service facility may provide the patient-specific collection guide to the surgeon.

[0257] 9 illustrates example blocks or steps of process 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.

[0258] 10 is a flowchart of an exemplary method 1000 for harvesting a graft, such as an autograft bone graft. Specifically, method 1000 can be used to harvest an autograft bone graft as part of a Lapidus arthrodesis. For example, a Lapidus arthrodesis may result in shortening of the toes due to joint fusion. Advantageously, the disclosed devices, systems, and methods can be used to provide an autograft bone graft that a surgeon can position within a retraction created by resecting both bones of the tarsometatarsal (TMT) joint to mitigate the potential for toe shortening.

[0259] 10 may be performed by system 400, system 800, a medical robot, and / or a user. Those skilled in the art will appreciate that the present disclosure may be used to harvest a graft from a patient, from donor bone, such as from a cadaver, and / or from donor bone from different species.

[0260] As shown in FIG. 10 , method 1000 may include performing an osteotomy on a patient using an instrument to create a retraction having a set of predetermined bone graft dimensions in one or more bones of the patient (block 1002). The osteotomy may be performed on a single bone or multiple bones of the patient (e.g., the medial cuneiform bone 202 and the first metatarsal bone 208). If the osteotomy is performed on a single bone, a diseased or damaged portion of the bone may be removed, leaving a retraction having a set of predetermined dimensions. Alternatively, or in addition, an osteotomy may be performed on a single bone to create a retraction that is filled with a bone graft that is greater than the span / depth / thickness of the retraction to lengthen the bone.

[0261] In certain embodiments, performing an osteotomy may include multiple osteotomies performed on two or more bones. For example, in a Lapidus arthrodesis, an osteotomy may be performed on the medial cuneiform bone 202, and an osteotomy may be performed on the first metatarsal bone 208 at the TMT joint. Often, the osteotomies create planar cuts on each bone. In situations where the surgeon desires the planar cuts to remain parallel, the surgeon may desire an autograft bone graft with two opposing, parallel, planar ends.

[0262] Typically, harvesting an autograft bone graft having two opposing, parallel, planar edges by freehand cutting (without the use of a guide) can be very difficult, especially when the opposing edges are truly parallel. Advantageously, the present disclosure provides harvest guide embodiments that allow a surgeon to easily harvest an autograft having two opposing, parallel, planar edges, at least one of which dimensions substantially matches a set of predetermined dimensions of a retraction to be created by an osteotomy. This is achieved, at least in part, by designing the harvest guide in a computing device that has access to the predetermined dimensions of the retraction.

[0263] In certain circumstances, a surgeon may desire a wedge-shaped autograft bone graft for insertion into a retraction created by one or more osteotomies. Advantageously, the same methods, devices, and / or systems of the present disclosure can be used to design and / or fabricate a harvest guide that facilitates the harvest of a wedge-shaped autograft bone graft sized and / or configured to fit as needed within the retraction created by one or more osteotomies.

[0264] In one embodiment, the instrument is a cutting tool. In another embodiment, the instrument is a cutting tool that includes a resection guide.

[0265] In one embodiment, the osteotomy may be a stage during a Lapidus arthrodesis. For example, the retraction may be created by removing a portion of the proximal base of the first metatarsal and / or a portion of the distal end (e.g., articular surface) of the medial cuneiform. The retraction may be defined as the space between the first metatarsal 208 and the medial cuneiform 202, where they are positioned prior to creating the osteotomy on each bone. In other words, the retraction is the space between the bones when they are in their natural position relative to each other after a portion of bone has been removed from one or the other of the two bones of the joint by the osteotomy.

[0266] Advantageously, the present disclosure can be used to define a bone graft (e.g., in certain embodiments, an autograft bone graft) that will fit as desired within the retraction. Of course, the surgeon can determine and pre-plan how they want the autograft bone graft to fit within the retraction. For example, the surgeon may want the autograft to be a loose fit, a snug fit, or an interference fit. In some cases, an interference fit may be desirable to ensure stability, but the surgeon may take care to size the autograft to avoid excessive compression, which could potentially cause pressure, unwanted extension of the toe, or displacement of surrounding bone.

[0267] Advantageously, the surgeon can determine the desired shape and size of the autograft bone graft. In certain embodiments, the bone graft can be cylindrical and have two bottom sides connected by a curved outer surface. In another embodiment, the bone graft can be wedge-shaped and have five sides and one edge (four sides connected to the edge and one side opposite the edge). In one embodiment, the bone graft can have six sides. Using the disclosed systems, methods, and devices, a bone graft is designed to provide a desired fit within a retractor. Alternatively, or in addition, embodiments according to the present invention allow the harvest guide to assist the surgeon in creating an autograft having a desired number of sides with a desired set of dimensions to properly fit into a retractor having a predetermined set of dimensions.

[0268] In one embodiment, for a Lapidus arthrodesis retraction, the dimensions of the retraction may include a depth (also called a span or thickness) measured between the cut surface of the medial cuneiform 202 and the cut surface of the first metatarsal 208 along the anterior-posterior axis (the proximal-distal line of the foot), a height measured between the dorsal surface of the medial cuneiform 202 and one of the first metatarsal 208 and the plantar surface of the medial cuneiform 202 and one of the first metatarsal 208 along the cranio-caudal axis, and a width measured between the lateral surface of the medial cuneiform 202 and one of the first metatarsal 208 and the medial surface of the medial cuneiform 202 and one of the first metatarsal 208 along the medial-lateral axis. In one embodiment, these dimensions are measured within a bone model using a computing device that defines the retraction as part of pre-operative planning of the surgical procedure.

[0269] It will be appreciated that the height from the dorsal surface of the medial cuneiform 202 along the cut surface of the medial cuneiform 202 to the plantar surface of the medial cuneiform 202 along that cut surface may differ from the height from the dorsal surface of the first metatarsal 208 along the cut surface of the first metatarsal 208 to the plantar surface of the first metatarsal 208 along that cut surface. In certain embodiments, these two heights may be averaged for a set of predetermined dimensions of the retraction. Alternatively, or in addition, the actual height of each cut surface may be used as part of the predetermined dimension of the retraction.

[0270] Similarly, the width from the lateral surface of the medial cuneiform 202 along the cut surface of the medial cuneiform 202 to the medial surface of the medial cuneiform 202 along that cut surface may differ from the width from the lateral surface of the first metatarsal 208 along the cut surface of the first metatarsal 208 to the medial surface of the first metatarsal 208 along that cut surface. In certain embodiments, these two widths may be averaged for a set of predetermined dimensions of the retraction. Alternatively, or in addition, the actual width of each cut surface may be used as part of the predetermined dimension of the retraction.

[0271] In another embodiment, each of these retraction dimensions (e.g., depth / span / thickness, height, width) can have different lengths along the side that will be the face of the autograft (first implemented as an autograft model). The retraction can include a proximal end, a distal end, a dorsal end, a plantar end, a medial end, and a lateral end.

[0272] In one example, the height of the proximal end of the retractor can be substantially the same as the height of the cut surface of the medial cuneiform bone, and the height of the distal end of the retractor can be substantially the same as the height of the cut surface of the first metatarsal bone. Similarly, the depth along the medial end of the retractor can be substantially the same as the length between the medial side of the cut surface of the medial cuneiform bone and the medial side of the cut surface of the first metatarsal bone, and the depth along the lateral end of the retractor can be substantially the same as the length between the lateral side of the cut surface of the medial cuneiform bone and the lateral side of the cut surface of the first metatarsal bone. Similarly, the width of the retractor along the proximal end can be substantially the same as the length between the lateral side of the cut surface of the medial cuneiform bone and the lateral side of the cut surface of the medial cuneiform bone, and the width of the retractor along the distal end can be substantially the same as the length between the lateral side of the cut surface of the first metatarsal bone and the lateral side of the cut surface of the first metatarsal bone.

[0273] Those skilled in the art will understand that using a computing device and a bone model of the bones involved in the planned surgical procedure, each of these six sides of the retraction can be measured or calculated, and each measurement can be used to define the dimensions of the graft bone model that will fit into the retraction. In certain embodiments, the model bone can be the patient's model bone for the surgical procedure. Alternatively, or in addition, one or more of these measurements / calculations can be increased or decreased over the corresponding dimensions of the retraction to provide correction and / or adjustment for the patient's anatomy.

[0274] As also shown in FIG. 10 , method 1000 may include deploying a harvest guide on the donor bone (block 1004). For example, system 400, system 800, and / or a user may deploy the harvest guide on the donor bone. In certain embodiments, the harvest guide may include one or more of the aspects, features, and / or configurations of the harvest guide embodiments described herein and / or encompassed by the claims contained herein. Specifically, the harvest guide may include a first resection feature and a second resection feature. Furthermore, the first resection feature and the second resection feature may be configured relative to one another such that the osteotomy formed using the first resection feature and the osteotomy formed using the second resection feature facilitate the resection of a graft having at least one dimension that substantially matches one dimension of a set of predetermined dimensions. For example, in one embodiment, the harvest guide may guide a surgeon in making two opposing parallel cuts in the donor bone. These may be more difficult cuts for forming an autograft. The surgeon may then make one or more additional cuts without the harvest guide to complete the formation and / or harvest of the autograft bone graft.

[0275] In one embodiment, deploying can include deploying one or more fasteners that couple the harvest guide to the donor bone. In one embodiment, the harvest guide includes two cut features, each spaced apart such that the graft has a dimension that substantially matches one dimension of a set of predetermined bone graft dimensions.

[0276] In certain embodiments, the harvest guide includes a bone-engaging surface configured to engage a surface of the donor bone at the bone graft harvest site. In one embodiment, the bone-engaging surface is configured to engage at least two cortical surfaces of the donor bone. In certain embodiments, the two cortical surfaces are adjacent, such as all or a portion of the lateral and dorsal surfaces, all or a portion of the dorsal and medial surfaces, all or a portion of the lateral and plantar surfaces, or all or a portion of the plantar and medial surfaces. In another embodiment, the bone-engaging surface is configured to engage at least three cortical surfaces of the donor bone (e.g., all or a portion of the plantar, lateral, and dorsal surfaces).

[0277] Cortical bone sections for bone grafting may be desirable due to their increased strength compared to medullary bone. Accordingly, deploying 1004 the harvest guide may include positioning and / or adjusting the position of the harvest guide until the bone-engaging surfaces are aligned with one or more surfaces of the donor bone. Advantageously, aligning the harvest guide with the donor bone provides the surgeon with assurance that the harvest guide will be positioned in the same or substantially the same location as in the pre-operative plan developed using the computing device.

[0278] As further shown in FIG. 10 , method 1000 may include resecting a bone graft from a donor bone using the first resection feature and / or the second resection feature of the harvest guide to form a bone graft. For example, system 400, system 800, and / or a user may perform one or more osteotomies by cutting bone with a cutting tool inserted into one or more of the first and second resection features to resect the bone graft. Of course, the surgeon can determine the extent to which the harvest guide is used. For example, the surgeon may use each of the resection features of the harvest guide. Alternatively, the surgeon may use one of the multiple resection features to form one of the osteotomies in the donor bone. Then, the surgeon may perform another osteotomy to form the bone graft without the harvest guide.

[0279] The method 1000 may include removing / resecting the graft from the donor bone. In one embodiment, performing an osteotomy using one or more resection features may separate the graft from the donor bone (e.g., may cut three sides separating the graft). In other embodiments, performing an osteotomy using one or more resection features may form more difficult osteotomies, particularly one or more of the osteotomies that are most difficult to achieve without a guide (e.g., may cut two or three of the four sides that need to be cut to separate the graft). In certain embodiments, the graft may remain connected to the donor bone despite resection using one or more resection features; in those embodiments, the surgeon may use another tool, such as an osteotome or other cutting tool (without a harvesting guide), to separate the graft from the donor bone.

[0280] Although FIG. 10 illustrates exemplary blocks or steps of a process or method 1000, in some implementations, method 1000 may include additional steps, fewer steps, different steps, or steps in a different order than those depicted in FIG. 10.

[0281] Additionally or alternatively, two or more of the steps of method 1000 may be performed in parallel. For example, in one embodiment, method 1000 may further include preparing the bone graft for reduction within the retraction and reducing the graft and at least one bone fragment within the retraction. Preparing the bone graft may include cutting or creating the bone graft to a desired size and / or shape.

[0282] Preparing the bone graft may also include using a jig and cutting tools to shape and / or size the bone graft. Advantageously, the jig may be configured to guide the shaping of the bone graft to be resected using the harvest guide. For example, the jig may include an opening and be sized and shaped to fit any of a desired set of predetermined bone graft dimensions for the opening and / or surgical procedure. Similar to the harvest guide, the jig may first be modeled and / or designed into a desired configuration using a computing device and then fabricated for use in the surgical procedure.

[0283] Repositioning at least one bone fragment within the retraction with a bone graft may be part of deploying the bone graft within the retraction.

[0284] 11 illustrates an exemplary system 1100, according to one embodiment. System 1100 may include one or more navigation guides 1102, one or more resection guides 1120, one or more complementary components 1130, and one or more fasteners 1180. While system 1100 can be used for a variety of procedures, one or more features, components, and / or aspects of system 1100 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, system 1100 may not include navigation guide 1102.

[0285] The navigation guide 1102 may function to guide the surgeon during one or more stages of a surgical procedure. In one embodiment, the navigation guide 1102 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.

[0286] 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. Within the computer model and / or the three-dimensional physical model, a user can define one or more model fiducials. A fiducial feature corresponds to a particular model fiducial. In one exemplary embodiment, a 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, K-wire, etc. The fiducial feature maps a model reference from the virtual environment to the physical environment.

[0287] Advantageously, the navigation guide 1102 facilitates providing, forming, establishing, and / or configuring one or more reference features for a surgical procedure. The navigation guide 1102 may include a body 1104, an opening 1106, and one or more position indicators 1108. In certain embodiments, the navigation guide 1102 may include a bone attachment feature 1110. In such embodiments, the bone attachment feature 1110 may be used to at least temporarily secure the navigation guide 1102 to a bone or bone fragment.

[0288] The one or more resection guides 1120 assist the surgeon in performing one or more different resection steps of the osteotomy procedure. In certain embodiments, the resection guide 1120 includes one or more resection features 1122 and one or more bone attachment features 1124. The resection features 1122 can take various forms and / or embodiments. Similarly, the bone attachment features 1124 can take various forms and / or embodiments. The bone attachment features 1124 can be similar to, the same as, or different from the bone attachment features 1110 that can be used with the navigation guide 1102. In one embodiment, the resection guide 1120 can include bone attachment features 1124 that are beveled relative to one or more anatomical references. The beveled bone attachment features 1124 can provide the resection guide 1120 with greater stability during resection.

[0289] The resection feature 1122 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 1124 serves to secure the resection guide 1120 to one or more bones, one or more bone fragments, and / or one or more other structures. In one example, the bone attachment feature 1124 can include a hole in the resection guide 1120 in conjunction with a temporary fastener such as a K-wire or pin.

[0290] The bone attachment features 1124 can be used to engage, couple, or attach the resection guide 1120 to one or more bones or bone fragments of the patient. The bone attachment features 1124 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 1120 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.

[0291] In certain embodiments, the resection guide 1120 may include one or more bone-engaging members, which may be embodied as one or more bone-engaging surfaces 1126 and / or one or more landmark alignment features 1128. In certain embodiments, the landmark alignment features 1128 may extend from one or more sides of the resection guide 1120 and engage with one or more landmarks on the patient's bones. Alignment of the landmark alignment features 1128 with the bony landmarks may serve to confirm that the surgeon has located the desired placement and / or orientation of the resection guide 1120. In certain embodiments, the navigation guide 1102 may include one or more bone-engaging surfaces 1126 on a surface of the navigation guide 1102 that faces the bone or bone fragment. In other embodiments, the resection guide 1120 may not include a bone-engaging surface 1126 or a landmark alignment feature 1128.

[0292] In certain embodiments, the bone-engaging surface 1126 is patient-specific and contoured to fit the surface of one or more bones that the resection guide 1120 will contact during a procedure. Alternatively, or in addition, the bone-engaging surface 1126 may not be patient-specific and may or may not contact a bone surface during use of the resection guide 1120. Those skilled in the art will understand that one or more sides of any of the components of the system 1100 may include one or more bone-engaging surfaces 1126. Consequently, one or more sides of the navigation guide 1102, the resection guide(s) 1120, the complementary component 1130, the fastener 1180, and / or the implant 1144 may include one or more bone-engaging surfaces 1126.

[0293] Alternatively, or additionally, the resection guide 1120 may be selected from a kit, collection, or repository of several resection guides 1120, 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 1120 removes, and the second number may indicate the number of millimeters that another resection feature of the resection guide 1120 removes. For example, the resection guide 1120 may include a +1 near the proximal end of the resection guide 1120 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 1120 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 1120 with configurations such as +2:+1, or +1:+3. In certain embodiments, the kit may include a configuration of resection guides 1120 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 that planned in the preoperative plan.

[0294] Having multiple different resection guides 1120 can be advantageous if the surgeon encounters something during surgery that causes them 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 may therefore choose to use a different resection guide 1120 than was originally planned. Advantageously, the present disclosure facilitates this.

[0295] Alternatively, or in addition, the resection guide 1120 may be configured to resect one or another of the bones of the joint.

[0296] The complementary component 1130 can function to assist the surgeon during one or more steps of the procedure. Those skilled in the art will appreciate that several components can function as complementary component 1130. One or more of the features, functions, or aspects of the complementary component 1130 can include patient-specific features.

[0297] Examples of complementary components 1130 include, but are not limited to, an alignment guide 1132, a rotation guide 1134, a reduction guide 1136, a compression guide 1138, a positioning guide 1140, a fixation guide 1142, one or more implants 1144, and / or a harvest guide 1146. Generally, complementary components 1130 function to assist a surgeon in performing the function included in the name of the complementary component 1130. Thus, the alignment guide 1132 can help the surgeon align a patient's bones, bone segments, anatomical body parts, or other parts as part of a procedure. The rotation guide 1134 can help the surgeon rotate one or more patient's bones, bone segments, or other body parts as part of a procedure. The harvest guide 1146 can help the surgeon harvest a graft.

[0298] The reduction guide 1136 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 compression guide 1138 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 1140 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 1140 is the positioner described above.

[0299] The fixation guide 1142 can assist a surgeon in completing one or more temporary or permanent fixation steps to one or more bones, bone portions, or other portions of a patient as part of a procedure. The fixation guide 1142 can include and / or use one or more components of a fastener or fixation system, including implant hardware of the fastener or fixation system.

[0300] An example of a complementary component 1130 may include a compressor / distractor, which is an example of a compression guide 1138. The compressor / distractor may be used to compress and / or distract the bone or portions of the bone involved in the procedure.

[0301] Advantageously, system 1100 can help a surgeon overcome one or more challenges in performing osteotomy procedures and / or harvesting grafts, 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 and / or positioning and / or orientation of the bone, one or more bones, and / or bone pieces / fragments, particularly once a resection or incision is made. Advantageously, navigation guide 1102, resection guide(s) 1120, and / or complementary component 1130 can be configured to help overcome this challenge.

[0302] Advantageously, system 1100 can assist a surgeon in accurately positioning, placing, and / or aiming instruments for a procedure. Modern technology may include preoperative planning, simulation, or even practice using computer models, 3D printed models, virtual reality systems, augmented reality systems, and the like. 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 1100 can include several features, including, for example, fiducial features, patient-specific features (which may include fiducial features), to assist the surgeon in positioning.

[0303] Advantageously, system 1100 can aid the surgeon in not only securing the osteotomy system 1100 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 1100 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 1100 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 1100 accommodates translational and / or rotational movement of the bone during the osteotomy procedure while promoting successful outcome of the osteotomy procedure.

[0304] Advantageously, the components of system 1100 can be designed specifically for a particular patient. Alternatively, or additionally, the components of system 1100 can be designed specifically for a class of patients. Each component of system 1100 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 result in an optimal osteotomy and / or outcome that minimizes the risk of undesired resection. In one embodiment, the components of system 1100 can be configured to perform osteotomies that allow correction in more than one plane for a patient's body part. For example, the resection guide 1120 of the cut channel can be oriented and configured to cause correction 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) once the bone has healed / fused.

[0305] In one embodiment, system 1100 can include a harvest guide 1146, a jig 1148, and a guard 1150. Harvest guide 1146 can include a body, a bone attachment feature, a first resection feature configured to guide osteotomy of the donor bone, and a second resection feature configured to guide osteotomy of the donor bone, the first resection feature extending parallel to the second resection feature through the body and separated from the second resection feature by a distance determined based on the patient-specific graft bone insertion site. In certain embodiments, step 110 can also include guard 1150.

[0306] The harvest guide 1146 can function to clearly identify a location for harvesting a bone graft and to guide one or more resection cuts made to form a graft from donor bone. Those skilled in the art will appreciate that the harvest guide 1146 can be configured to facilitate the resection of grafts of various sizes, shapes, and / or configurations.

[0307] The guard 1150, also known as a stop, is an apparatus, device, or structure that serves to assist the surgeon by preventing the resection, incision, or cutting of portions of tissue where resection is not planned or desired. Stated another way, the guard prevents the cutting tool from resecting beyond the boundary. In certain embodiments, the boundary is a line, plane, or point. In one embodiment, the boundary may be predefined using a computing device and / or a model of the patient's bones and / or one or more models of the instruments to be used in the patient's surgical procedure.

[0308] Advantageously, the harvest guide 1146 can include holes that cooperate with one or more fasteners that function as guards 1150. The fasteners can be made of a rigid and hard material, such as metal, that cannot be or is not easily cut by a surgical cutting tool. When the fasteners are deployed, they function as guards 1150 or cutting boundaries to prevent resection of donor bone through or beyond the location of the fasteners. Advantageously, the fasteners can function as bone attachment feature fasteners, as trajectory guides, and / or as guards 1150. The features and advantages of using the system 1100 can significantly reduce the stress or strain a surgeon may experience when performing graft harvesting. Furthermore, the harvest guide 1146 and / or guards 1150 can facilitate smooth, efficient, and rapid performance of the surgical procedure, which may improve outcomes from the surgical procedure.

[0309] In certain embodiments, the one or more fasteners 1180 can include both one or more permanent fasteners and one or more temporary fasteners. Generally, the fasteners 1180 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 1100 is a K-wire, also known as a pin.

[0310] In certain embodiments, the exemplary system 1100 may include multiple navigation guides 1102, resection guides 1120, complementary components 1130, and / or fasteners 1180. 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.

[0311] In certain embodiments, the components of system 1100 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.

[0312] Those skilled in the art will understand that in a particular osteotomy procedure, a particular complementary component 1130 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 1102, resection guide 1120, complementary component 1130, fastener 1180 may be combined into one or more of the apparatus or devices or may be provided using multiple separate devices.

[0313] 12 shows an exemplary osteotomy system 1200 for harvesting bone for a surgical procedure, according to one embodiment. Osteotomy system 1200 may include one or more resection guides 1120, an example of which is resection guide 1220, one or more other complementary components 1130, such as harvest guide 1146, an example of which is harvest guide 1246 and / or jig 1148, an example of which is jig 1248, and one or more fasteners 1180. Osteotomy system 1200 can be used in a variety of surgical procedures.

[0314] Osteotomy system 1200 includes a resection guide 1220. The resection guide 1220 facilitates the resection of hard and / or soft tissue of a patient in a surgical procedure. In one embodiment, the resection guide 1220 can be a stand-alone, separate device. In another embodiment, the resection guide 1220 can be a device that couples to, is integrated with, and / or cooperates with the navigation guide 1202 to assist the surgeon in resecting patient tissue. In certain embodiments, the resection guide 1220 is patient-specific.

[0315] The osteotomy system 1200 includes multiple complementary components 1130. The osteotomy system 1200 includes a harvest guide 1246 that facilitates making one or more osteotomies in a donor bone to form a graft, particularly an autograft. The harvest guide 1246 may include a bone attachment feature, a bone engaging surface, and / or one or more resection features. In certain embodiments, the harvest guide 1246 is patient-specific.

[0316] In certain embodiments, the one or more fasteners 1180 can include one or more permanent fasteners and / or one or more temporary fasteners. Generally, the fasteners 1180 can be used during a variety of different steps of a 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 1200 is a K-wire, also known as a pin or guide pin.

[0317] The osteotomy system 1200 includes a harvest guide 1246. The harvest guide 1246 includes a body 1250 and includes an anterior portion 1252, a posterior portion 1254, a top portion 1256, a bottom portion 1258, a left portion 1260, and a right portion 1262. The harvest guide 1246 also includes at least one resection feature 1264, 1266 extending from one side of the body 1250 to the opposite side of the body 1250. The at least one resection feature may be referred to as a first resection feature 1264. The resection feature 1264 facilitates making one or more osteotomies in the donor bone. The first resection feature 1264 is configured to guide the first osteotomy of the donor bone. The harvest guide 1246 may also include a second resection feature 1266 extending from one side of the body 1250 to the opposite side of the body 1250. In one embodiment, the second cutting feature 1266 is configured to guide a second osteotomy of the donor bone. In one embodiment, the second cutting feature 1266 extends through the body 1250 parallel to the first cutting feature 1264. Alternatively, the first cutting feature 1264 and the second cutting feature 1266 may extend from the body 1250 at an angle such that the cutting features 1264, 1266 are used to cut into the donor bone to form a wedge-shaped bone graft. The harvest guide 1246 also includes a bone attachment feature 1268 and, in certain embodiments, a bone engaging surface 1270 and / or bone engaging member.

[0318] 13A-13G are front perspective, front, rear, left side, right side, top, and bottom views, respectively, of harvest guide 1246a, according to one embodiment. Harvest guide 1246a includes a body 1250, a front side 1252, a rear side 1254, a top side 1256, a bottom side 1258, a left side 1260, and a right side 1262, at least one resection feature 1264, 1266, a bone attachment feature 1268, and / or an optional bone engaging surface 1270.

[0319] Body 1250 provides structural integrity to harvest guide 1246a. Body 1250 can be of various shapes and sizes. The size, shape, and configuration of harvest guide 1246a can be determined by the surgical harvesting procedure in which harvest guide 1246a is used, by surgeon preference, by patient individual characteristics, a combination of these factors, and the like.

[0320] In certain embodiments, the bone attachment feature 1268 may be embodied as an opening 1272 sized, shaped, and configured to receive a K-wire or pin or other fastener 1180 or drill bit. In one embodiment, the bone attachment feature 1268 includes an opening 1272 and a fastener 1180 deployed within the opening 1272. In certain embodiments, the harvest guide 1246a is patient-specific and is manufactured, designed, and / or contoured to suit the needs of the individual patient and / or surgeon preferences.

[0321] In one embodiment, an osteotomy system according to the present disclosure may include (e.g., in a kit) multiple harvest guides 1246a. Each of the multiple harvest guides 1246a 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 positioning guides 1240 may be used intraoperatively by a surgeon for a surgical procedure (e.g., a bone graft harvesting surgical procedure).

[0322] In one embodiment, the body 1250 may be as small as possible to easily handle it by a user while still performing its function. In certain embodiments, the body 1250 may include one or more bevels that can facilitate handling and positioning of the harvesting guide 1246a by a user.

[0323] In another embodiment, body 1250 may be transparent or at least transparent (e.g., radiolucent) for medical imaging. Harvesting guide 1246a 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 harvesting guide 1246a relative to anatomical references and / or anatomical structures. For example, the position indicator may indicate the position of harvesting guide 1246a relative to a joint (e.g., anatomical reference) of the patient.

[0324] In one embodiment, the harvest guide 1246a may include one or more openings 1272 extending into the body 1250. The one or more openings 1272 are configured to accommodate one or more fasteners 1180. In the illustrated embodiment, the one or more openings 1272 may be embodied as passageways extending from one side of the body 1250 to another side.

[0325] In certain embodiments, the osteotomy system includes a harvest guide 1246a, 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.

[0326] 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.

[0327] Advantageously, the harvest guide 1246a can be used to provide one or more different types of reference features. In one embodiment, the harvest guide 1246a 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 anterior side 1252 to the posterior side 1254 of the harvest guide 1246a.

[0328] Figure 13A is a perspective view of one embodiment of the harvest guide 1246a. Figure 13B is a front view of one embodiment of the harvest guide 1246a. The first resection feature 1264 can include a first end 1274 and a second end 1276. The second resection feature 1266 can include a third end 1278 and a fourth end 1280. In one embodiment, the first resection feature 1264 is configured to guide an osteotomy (e.g., a first osteotomy) of the donor bone. The second resection feature 1266 is configured to guide an osteotomy (e.g., a second osteotomy) of the donor bone. One of the first end 1274 and the second end 1276 is spaced from one of the third end 1278 and the fourth end 1280 by a distance determined based on the patient-specific graft insertion site. In the illustrated embodiment, first end 1274 is spaced apart from third end 1278 by a first predetermined distance. Second end 1276 is spaced apart from fourth end 1280 by a second predetermined distance. In one embodiment, the first predetermined distance and the second predetermined distance are the same. Alternatively, or in addition, the first predetermined distance and the second predetermined distance may be different. In one embodiment, first end 1274, third end 1278, second end 1276, and fourth end 1280, respectively, are spaced apart from each other by the same distance.

[0329] 13B , in one embodiment, the first cutting feature 1264 and the second cutting feature 1266 each extend through the body 1250 from the anterior side 1252 (e.g., the non-bone-facing side) to the posterior side 1254 (e.g., the bone-facing side). The first cutting feature 1264 extends through the body parallel to the second cutting feature 1266. Furthermore, in this embodiment, both the first cutting feature 1264 and the second cutting feature 1266 are configured such that their trajectories are perpendicular to the surface of the donor bone.

[0330] 13B illustrates that the positions of the first and second cutting features 1264, 1266 relative to one another within the body can be offset from one another by a distance. This distance can be the length along the anterior portion 1252 between the first and second cutting features 1264, 1266. In certain embodiments, this distance can be defined by and / or based on a patient-specific implant insertion site. This distance, which can be an offset, can be defined by and / or based on a dimension that meets a predetermined implant size.

[0331] In one example, the predetermined graft dimension may be a depth, span, and / or thickness defined for the retraction and / or the patient-specific graft insertion site. In some cases, the predetermined graft dimension of a retraction may include the distance from the proximal end of the retraction to the distal end of the retraction. The proximal end is adjacent to the medial and lateral sides of the retraction, and the distal end is adjacent to the medial and lateral sides of the retraction. Depending on the perspective used to view and / or measure this distance, in certain contexts and / or embodiments, this distance may be referred to as a width. For example, when a retraction in a bone is viewed from the lateral and / or medial sides of the bone on the distal and medial ends of the retraction, the space between the bones may be referred to as a width. Generally, this space is referred to herein as the span, depth, or thickness of the graft. Thickness or span is useful for describing the magnitude of the distance between two bones when viewed perpendicular to the longitudinal axis of one or both bones.

[0332] In certain embodiments, the distance that the first resection feature 1264 is offset from the second resection feature 1266 within the body 1250 may be the same as or greater than a predetermined graft dimension of a planned retraction between bones or bone fragments as part of a surgical procedure. Alternatively, or additionally, the distance that the first resection feature 1264 is offset from or separated from the second resection feature 1266 within the body 1250 may be the same as or greater than a depth / span / thickness dimension of a planned retraction between bones or bone fragments as part of a surgical procedure. Alternatively, or additionally, the distance that the first resection feature 1264 is offset from or separated from the second resection feature 1266 within the body 1250 may be the same as or greater than a depth / span / thickness dimension of a planned autograft graft to be harvested for use during the surgical procedure.

[0333] Advantageously, the surgeon can use dimensions and / or measurements from the planned surgical procedure to define one or more dimensions of the bone graft to be harvested using a harvest guide fabricated based on those one or more dimensions. In this way, the surgeon can ensure that they can and will harvest the appropriate bone graft that will result in the desired outcome.

[0334] In certain embodiments, the distance between the first resection feature 1264 and the second resection feature 1266 along the anterior surface 1252 can be dictated by the dimensions of the retraction within the planned retraction of the surgical procedure and / or the dimensions (e.g., depth / span / thickness dimensions) of the model bone graft planned to be inserted between the two bone fragments. Alternatively, or in addition, the surgeon may make the distance slightly larger than the predetermined bone graft dimensions to account for the thickness of the blade or bit that will overcut and / or to account for the kerf of bone material created during the osteotomy.

[0335] In the illustrated embodiment, the resection features 1264 and 1266 may be parallel to one another to form a block-shaped autograft (e.g., a cylindrically shaped autograft with two planar opposing sides and a circular exterior between the two planar opposing sides). In this manner, an autograft with a uniform thickness between the two planar opposing sides / cut surfaces can be formed. Having the autograft can help ensure that the autograft provides a filling and / or distraction function without altering the trajectory of the bone fused to the autograft. This can be useful to the surgeon, as other aspects of the surgical procedure may be individually planned to correct or alter the trajectory of the bone. Therefore, the uniform thickness of the autograft does not interfere with those plans.

[0336] Alternatively, or in addition, resection feature 1264 and / or resection feature 1266 and one or more other resection features may be included so that an autograft of virtually any shape can be formed from the donor bone. For example, resection feature 1264 and resection feature 1266 may be angled opposite one another on one end, the other end, or both ends, or on the distal end of the resection feature near the posterior side 1254 of harvest guide 1246a. One skilled in the art will understand that the position and / or orientation and / or angle of the resection feature can be defined to form a three-dimensional autograft that includes three planes of bone and / or includes three cortical surfaces of the donor bone.

[0337] Those skilled in the art will appreciate that the distance that satisfies the predetermined bone graft size can include various relationships between the distance and the predetermined bone graft size. In one embodiment, the distance that satisfies the predetermined bone graft size can mean that the distance is the same size as the predetermined bone graft size. In another embodiment, the distance that satisfies the predetermined bone graft size can mean that the distance is somewhat larger than the predetermined bone graft size. In another embodiment, the distance that satisfies the predetermined bone graft size can mean that the distance is somewhat smaller than the predetermined bone graft size. In another embodiment, the distance that satisfies the predetermined bone graft size may not be exactly the same as the predetermined size, but falls within an acceptable variation from the predetermined size.

[0338] As discussed, in certain embodiments, the predetermined graft size may be determined based on one or more of a model of the patient's bone, a model of the retraction to be created during the surgical procedure, the configuration of the patient-specific graft insertion site, and / or a model of the graft to be positioned between two bone fragments. However, in other embodiments, the predetermined graft size may be provided by the user. For example, the required size may be a known accepted size for a particular surgical procedure. Alternatively, the surgeon may determine the predetermined graft size based on their professional judgment.

[0339] Embodiments according to the present disclosure enable surgeons to preoperatively plan surgical procedures, plan autograft graft harvesting procedures, and plan and / or fabricate graft harvesting instruments, such as patient-specific harvesting guides, with confidence that optimal bone material will be harvested, that the planned graft will be more easily resected, and that the planned graft, when positioned between one or more bone fragments and within the planned retraction, will produce the desired correction and / or improvement desired by the patient. The surgeon can proceed to schedule and perform the surgical procedure, understanding that harvesting the appropriate autograft graft is not expected to be a trial-and-error procedure and is likely not to involve significant trimming or adjustment of the harvested autograft graft.

[0340] 13C is a bottom view of one embodiment of harvest guide 1246a. In certain embodiments, harvest guide 1246a may include one bone-engaging surface 1270. Alternatively, or in addition, harvest guide 1246a may include one or more bone-engaging surfaces 1270. In the illustrated embodiment, bone-engaging surface 1270 is on posterior side 1254 (e.g., the bone-facing side). Bone-engaging surface 1270 is configured to engage a surface of the donor bone. In certain embodiments, bone-engaging surface 1270 is configured to engage one or more surfaces of the donor bone. In certain embodiments, bone-engaging surface 1270 is configured to engage at least two cortical surfaces of the donor bone. In certain embodiments, engagement of a surface of the donor bone by bone-engaging surface 1270 may mean that bone-engaging surface 1270 aligns with or is aligned with that surface. In certain cases, the surgeon may feel the bone engaging surface 1270 "lock" or "slide" into place as the mirror contour of the bone engaging surface 1270 matches and engages with the corresponding contour of the donor bone surface.

[0341] In certain embodiments, the donor bone is the calcaneus 222. Specifically, a surgeon may desire to harvest a bone graft from the outside of the calcaneus 222, behind the ankle, and include cortical bone from the lateral and dorsal cortices. Given the general topography of the calcaneus 222 in this region, it may be difficult to match a location selected during preoperative planning with substantially the same location on the patient. However, this difficulty can be reduced or overcome because the bone engaging surface 1270 is configured to engage more than one cortical surface. Specifically, engaging more than one cortical surface can enhance the ease with which the bone engaging surface 1270 and / or the harvest guide 1246a engage with the surface of the donor bone.

[0342] In certain embodiments, the bone engaging surface 1270 can be used to position the harvest guide 1246a at a desired location and / or relative to one or more bones of a patient and / or across one or more joints of the patient (a process called registration or alignment to the bone). The bone engaging surface 1270 that contacts the patient's anatomy can be contoured to mate with the patient's anatomy. In one embodiment, the bone engaging surface 1270 includes a contour that is determined at least in part by a bone model of a donor bone. The bone model of the donor bone can be defined based on medical images of the donor bone. The donor bone can be a bone of the patient for the surgical procedure.

[0343] In certain embodiments, the harvest guide 1246a can include one or more landmark alignment features 1282. In one embodiment, the one or more landmark alignment features 1282 can extend from the posterior side 1254 and / or can extend between the posterior side 1254 and one of the top side 1256 and bottom side 1258. The landmark alignment features 1282 are configured to engage landmarks on the donor bone. One skilled in the art will understand that the bone engaging surface 1466 and / or the landmark alignment features 1282 can be positioned on any surface or side of the harvest guide 1246a.

[0344] Figure 13D is a left side view (i.e., posterior view) of harvest guide 1246a. Figure 13D shows an exemplary harvest guide 1246a that is contoured to engage both the lateral cortical surface of the donor bone (e.g., calcaneus 222) and the dorsal cortical surface of the donor bone.

[0345] Figure 13E is a right side view (i.e., anterior view) of harvest guide 1246a. Referring now to Figures 13D and 13E, the illustrated embodiment may include a third cutting feature 1284 between the top side 1256 and the posterior side 1254, and a fourth cutting feature 1286 between the bottom side 1258 and the posterior side 1254. The first cutting feature 1264 extends from the anterior side 1252 to the posterior side 1254, and the second cutting feature 1266 extends from the anterior side 1252 to the posterior side 1254.

[0346] In certain embodiments, the third cutting feature 1284 and / or the fourth cutting feature 1286 may be implemented as or include an edge, and rather than a slot or channel to guide a cutting tool, the edge may serve as a guide for the surgeon to perform the osteotomy. An edge (e.g., that of the fourth cutting feature 1286) may be an edge between the bottom side 1258 and the posterior side 1254. Another edge (e.g., that of the third cutting feature 1284) may be an edge between the top side 1256 and the posterior side 1254.

[0347] FIG. 13F is a top view (i.e., top view) of harvest guide 1246a. FIG. 13G is a bottom view (i.e., bottom view) of harvest guide 1246a. Those skilled in the art will understand that a variety of designs may be designed and / or fabricated using embodiments of the present disclosure. Advantageously, the computing devices, computer models, and rapid prototyping and / or additive manufacturing systems and / or processes used in embodiments of the present disclosure allow for significant flexibility and many design options for harvest guide 1246. Some alternative exemplary embodiments are shown in FIGS. 13H-13N.

[0348] 13H-13N are illustrations of alternative embodiments of harvest guides according to certain embodiments. FIGS. 13H-13I show harvest guide 1246b according to one embodiment. FIG. 13J shows harvest guide 1246c according to one embodiment. FIG. 13K shows harvest guide 1246d according to one embodiment. FIGS. 13L-13N show harvest guide 1246e according to one embodiment. These alternative embodiments may have similar or identical structure, features, functions, operation, and configurations as other harvest guides described herein (e.g., harvest guide 1246). Where these structures are substantially the same, like numerals have been used to identify corresponding parts. In the illustrated alternative embodiments, the harvest guide may include one or more features that other embodiments may not include.

[0349] 13H shows a front side view of harvest guide 1246b, which includes a first cut feature 1264 and a second cut feature 1266 offset from one another along anterior side 1252 by a predetermined distance or dimension D1 to meet a predetermined bone graft size. Offset D1 may be the same as the offset between first cut feature 1264 and second cut feature 1266 in harvest guide 1246a.

[0350] The harvest guide 1246b may include one or more guard pin guides 1290. The guard pin guides 1290 function to guide the guard pins deployed into the bone. Specifically, the guard pin guides are configured to receive guard pins deployed into the bone, such as the donor bone. The guard pins prevent cutting of the bone, such as the donor bone, beyond the boundary. Generally, the guard pin guides 1290 guide the guard pins to enter the bone at or near the boundary. The guard pins are one embodiment of a guard. Often, the guard pins are made of a material that resists cutting or breaking when contacted by a cutting tool. In one embodiment, the guard pins are metal fasteners, such as K-wires. Advantageously, the guard pins function as a barrier that prevents cutting of the bone on one side or past the guard pin, but allows cutting of the bone on the other side of the guard pin.

[0351] In the illustrated embodiment, the first cutting feature 1264 has a closed end 1276 and the second cutting feature 1266 has a closed end 1280. The first cutting feature 1264 includes a guard pin guide 1290 at or near the end 1274. Similarly, the second cutting feature 1266 includes a guard pin guide 1290 at or near the end 1278. The diameter of the guard pin guide 1290 is sized to accommodate a guard pin deployed through the guard pin guide 1290.

[0352] In certain embodiments, the guard pin guide 1290 extends through the body 1250 from the anterior portion 1252 to the posterior portion 1254. The guard pin guide 1290 can orient the deployed guard pin perpendicular to the bone surface or at a non-perpendicular angle to the bone surface. The angle or trajectory of the guard pin guide 1290 can be determined by the surgical procedure, the patient's needs, and / or the surgeon's discretion.

[0353] In certain embodiments, harvest guide 1246b may include guard pin guides 1290 at the ends of first cutting feature 1264 and / or second cutting feature 1266. Alternatively, or in addition, harvest guide 1246b may include one or more guard pin guides 1290 at other locations within body 1250. For example, if the offset between first cutting feature 1264 and second cutting feature 1266 is of sufficient length, a user may choose to include another guard pin guide 1290 between first cutting feature 1264 and second cutting feature 1266. This other guard pin guide 1290 may be aligned with guard pin guides 1290a and 1290b.

[0354] 13I shows a top side view 1256 of an alternative embodiment harvest guide 1246b. In the illustrated embodiment, the harvest guide 1246b includes a first cutting feature 1264, a second cutting feature 1266, and a third cutting feature 1292. The third cutting feature 1292 extends from the bone-facing side to the non-bone-facing side. In this embodiment, the third cutting feature 1292a extends from the posterior side 1254 to the apical side 1256.

[0355] In another embodiment, the third cutting feature 1292b can extend between two sides different from the posterior side 1254 and the apical side 1256. For example, in FIG. 13J, the third cutting feature 1292b extends from the anterior side 1252 to the posterior side 1254.

[0356] Generally, the harvest guide 1246, when including the third resection feature 1292, functions to facilitate removal of the harvested bone graft. Depending on the location of the bone graft harvest site on the donor bone and / or the planned dimensions for the donor bone graft (e.g., autograft), the third resection feature 1292 may or may not be useful.

[0357] In one embodiment, if the harvest guide 1246 includes a third resection feature 1292, the third resection feature 1292 can be configured to guide the performance or creation of a third osteotomy. In one embodiment, such as the illustrated harvest guide 1246b, the third resection feature 1292a is configured to connect the first osteotomy formed using the first resection feature 1264 and the second osteotomy formed using the resection feature 1266. In other embodiments, the third resection feature 1292 may not connect the osteotomies. In certain instances, the first and second osteotomies may result in a planar cut, leaving only one side of the graft bone connected to the donor bone. In such cases (e.g., FIGS. 14D and 14E), the third resection feature 1292a may enable a final, third osteotomy to separate the graft bone from the donor bone. In another example, a fourth osteotomy may be required to separate the graft bone from the donor bone, and such embodiments are within the scope of this disclosure.

[0358] In the illustrated embodiment, the third cutting feature 1292a is implemented as a linear slot in the apical side 1256 near the posterior side 1254. In this embodiment, the linear slot includes two closed ends. Of course, in other embodiments, one of the ends may be open. Alternatively, or in addition, the harvest guide 1246b may include an alternative version of the third cutting feature 1292. Specifically, the third cutting feature 1292b may be implemented by an edge of the body 1250 between the apical side 1256 and the posterior side 1254. In one embodiment, the edge may be straight. In another embodiment, the edge may be curved. A surgeon may insert a cutting tool into the donor bone at the edge and use this edge as a guide to complete the osteotomy.

[0359] 13J illustrates an alternative embodiment harvest guide 1246. In this embodiment, the harvest guide 1246c includes many of the same structures, features, and aspects as the other embodiments. Additionally, the harvest guide 1246c includes an alternative version of a resection guide. In the illustrated embodiment, the harvest guide 1246c includes a first resection feature 1264, a second resection feature 1266, and a third resection feature 1292c. The third resection feature 1292c extends from the anterior portion 1252 to the posterior portion 1254 and is positioned at or near the ends 1274 and 1278 of the first and second resection features 1264 and 1266. The third resection feature 1292c is configured to connect the first osteotomy formed using the first resection feature 1264 and the second osteotomy formed using the second resection feature 1266.

[0360] Figure 13K shows an embodiment of a harvest guide 1246 similar to harvest guide 1246b shown in Figure 13H. However, in this embodiment, harvest guide 1246d includes an alternative cutting feature 1294. In certain embodiments, alternative cutting feature 1294 provides similar functionality and / or benefits as first cutting feature 1264 and / or second cutting feature 1266. Alternative cutting feature 1294 may also include a guard pin guide 1290c, similar to first cutting feature 1264 and second cutting feature 1266.

[0361] In certain embodiments, such as harvest guide 1246d, the alternate cutting feature 1294 is offset from the first cutting feature 1264. The predetermined distance or dimension, offset D1, may be the same as the offset between the first cutting feature 1264 and the second cutting feature 1266 in harvest guide 1246a and / or harvest guide 1246b. Additionally, the alternate cutting feature 1294 is offset from the first cutting feature 1264 by a second dimension D2. In one embodiment, D2 is greater than D1. Alternatively, D2 can be less than D1.

[0362] In certain embodiments, the surgeon may request, and / or the harvest guide 1246d may include, alternative resection features 1294 to provide more than one option for at least one dimension of the resected bone graft. For example, the surgeon may have concerns about the bone quality at the bone graft harvest site. For example, the patient may have very porous or spongy bone at the bone graft harvest site. Therefore, the surgeon may want to harvest a larger bone graft in an attempt to obtain enough bone to provide a suitable graft.

[0363] Alternatively, the surgeon may plan the osteotomy at the graft insertion site so that the span / depth / thickness of the retraction can be one of two different possible dimensions. The actual size (e.g., span / depth / thickness) of the retraction may depend on decisions the surgeon makes during an earlier stage of the surgical procedure. Thus, the surgeon may want two possible resection features in the harvest guide 1246d that can be used depending on the progress of the surgical procedure.

[0364] Figure 13L shows a perspective view of a harvest guide 1246e according to one embodiment. In this embodiment, the harvest guide 1246e includes a single opening 1272 rather than the two openings used in, for example, harvest guide 1246a. Additionally, the first cutting feature 1264 includes an open end 1276 and an open end 1280. Figure 13M shows a front side view of the harvest guide 1246e. Figure 13N shows a rear side view of the harvest guide 1246e. Figure 13N shows that the harvest guide 1246e includes a bone-engaging surface 1270 on the posterior side 1254.

[0365] FIG. 14A shows a perspective view of a patient's foot and ankle, including the medial cuneiform bone 202, first metatarsal bone 208, navicular bone 218, talus 224, tibia 226, and fibula 228. Advantageously, embodiments of the present disclosure can be used to model each of the bones, instruments, retractors, and / or implants for a given surgical procedure before the procedure begins. The models can be used to design and / or fabricate instruments, physical models, and / or implants used during the surgical procedure. In one embodiment, as shown in FIGS. 14A-14G, the surgical procedure is a Lapidus surgical procedure, which involves harvesting an autograft bone graft from the patient's calcaneus 222. Advantageously, a harvest guide 1246 is provided because harvesting from the calcaneus 222 can be difficult due to the topography of the calcaneus 222.

[0366] FIG. 14A shows an example of a resection guide 1220 positioned on a patient's first TMT joint. The resection guide 1220 can be coupled to the bone using bone attachment features including fasteners 1180, such as K-wires. In one embodiment, the surgeon forms a medial incision near the first TMT joint via a medial approach. The surgeon forms an incision in the soft tissue down to the cortical bone surface of both the medial cuneiform 202 and the first metatarsal 208 of the TMT joint. The surgeon then cuts or laterally displaces the soft tissue overlying the cortical bone surface of the bone sufficient to seat the resection guide 1220 on and / or within the TMT joint. With the resection guide 1220 secured, the surgeon can make one or more cuts using the resection guide 1220.

[0367] FIG. 14B illustrates a stage of the procedure after osteotomy of the medial cuneiform 202 and the first metatarsal 208. The osteotomy created a retraction 1410 or gap 1410 between the distal end of the medial cuneiform 202 and the proximal end of the first metatarsal 208. Advantageously, using embodiments of the present disclosure, the size, shape, and / or dimensions of this retraction 1410 can be measured or calculated in a model prior to the surgical procedure. From these measurements, predetermined graft dimensions for a graft or implant to be placed within the retraction 1410 can be defined. In certain surgical procedures, it may be desirable to fill the retraction 1410 with a graft and / or implant. Filling the retraction 1410 can help provide desired biomechanics for the appendage, avoid the undesirable aesthetic effects of bone set shortening, and / or provide other benefits.

[0368] In the illustrated embodiment, the surgeon plans to fill the wound 1410 with a graft, an autograft, harvested from the patient's calcaneus 222. FIG. 14C shows the calcaneus 222 with an exemplary harvest guide 1246 secured to the calcaneus 222 by bone attachment features including fasteners 1180. Advantageously, the location on the calcaneus 222, the size and dimensions of the harvest guide 1246, as well as the size, shape, dimensions, and bone type composition of the graft to be harvested using the harvest guide 1246, are pre-planned, pre-designed, and pre-configured so that the surgeon can rely on the harvest guide 1246 to engage the calcaneus 222 in place and guide one or more osteotomies of the calcaneus 222 to form the autograft 1420 (see FIG. 14D). In the illustrated embodiment, the harvest guide 1246 overlies the lateral cortex and wraps around, including the plantar cortex, of the calcaneus 222. In this manner, the harvest guide 1246 facilitates the harvesting of the bilayered cortical autograft 1420.

[0369] FIG. 14D shows the calcaneus 222 after two osteotomies. The autograft 1420 is shown between two parallel incisions, but is still connected to the calcaneus 222 on one side. The surgeon may then use an osteotome to separate the autograft 1420 from the calcaneus 222. In certain embodiments, the surgeon may select a bone graft harvest site to maximize the amount of cortical bone contained in the autograft 1420. FIG. 14E shows the calcaneus 222 after the surgeon has extracted the autograft 1420. Depending on the size of the autograft 1420, the surgeon may decide to fill the opening left in the calcaneus 222 by the extraction of the autograft 1420.

[0370] In certain embodiments, the surgeon may choose to harvest allograft bone from a bone donor, such as a cadaver. Advantageously, the surgeon can use harvest guide 1246 to harvest allograft from a cadaver. In such embodiments, pre-operative planning may include a cadaver model and / or anatomical data. Alternatively, or in addition, conventional alternative methods can be used to fill the wound left by the autograft 1420.

[0371] 14F shows a patient's foot bones with an autograft 1420 positioned within a retraction 1410. Again, embodiments of the present disclosure can be used to position models of the autograft 1420 within the retraction between the bones in the model. Using these models, an engineer, computing device, user, or surgeon can determine the optimal size, shape, dimensions, configuration, and orientation of the autograft 1420 within the retraction 1410.

[0372] 14G is a close-up view of an autograft 1420 within the wound 1410 between the first metatarsal 208 and the medial cuneiform 202. Note that in this embodiment, the autograft 1420 is oriented so that the cortical surface of the autograft 1420 faces medially. In certain embodiments, the size and shape of the autograft 1420 may be sufficient for use in filling the wound 1410 with a graft that meets the patient's needs, even though one or more portions 1430 of the autograft 1420 may extend above or below the surface of the bone adjacent to the wound 1410 (referred to as overhang). These one or more portions 1430 may naturally fill into, interface with, and connect to the adjacent bone during post-operative healing. The surgeon may then fix the first metatarsal 208, the autograft 1420, and the medial cuneiform 202 together using conventional fixation hardware and / or techniques, including bone screws, bone plates, bone staples, and the like.

[0373] In certain embodiments, a surgeon and / or patient may desire an autograft 1420 that more closely matches the size and configuration of the bone to which it will connect and fuse. FIG. 14H shows an end view of the first metatarsal 208 after an osteotomy near the proximal end of the first metatarsal 208. The osteotomy creates a cut surface having an irregularly shaped perimeter 1440 due to the shape of the first metatarsal 208. Advantageously, embodiments of the present disclosure can be used to measure or calculate the shape of the irregularly shaped perimeter 1440. This measured shape can be used to define the shape of the side of the autograft 1420 that will be joined to the first metatarsal 208. Alternatively, or additionally, an approximate shape can be measured or calculated by determining the length of the major axis 1442 and the minor axis 1444 of the irregularly shaped perimeter 1440.

[0374] 14I , in certain embodiments, a jig 1148, such as jig 1248, can be designed and fabricated using embodiments of the present disclosure to assist a surgeon or other user in shaping an autograft 1420 into a desired shape and / or configuration. In the illustrated embodiment, the jig 1248 can include an opening 1445 having a major diameter 1446 and / or a minor diameter 1448 that are substantially the same as or slightly larger than the major diameter 1442 and / or the minor diameter 1444. In the illustrated embodiment, the opening 1445 is oval-shaped. In another embodiment, a computing device and / or a model of the bones involved in the surgical procedure can be used to define the opening 1445 to have substantially the same shape as the cross-section of a cut surface that contacts one side of the autograft 1420. In certain embodiments, the same jig 1248 is patient-specific.

[0375] In one embodiment, jig 1248 can be used with a burr or other cutting tool to create the shape of autograft 1420. The same jig 1248 is configured to guide the creation of the shape of a bone graft, such as autograft 1420. Alternatively, or additionally, the opposite end of autograft 1420 can be shaped using the same jig 1248 or a different jig 1248 configured based on the bone (e.g., medial wedge 202) that contacts the opposite end of autograft 1420.

[0376] In another embodiment, one or more jigs may be used. For example, in one embodiment, the harvest guide 1246 can be configured to assist in performing osteotomies to harvest more than one autograft 1420. For example, the harvest guide 1246 may include slots (resection features) for resectioning to form two or more autografts 1420. In one embodiment, two or more autografts 1420 may be deployed within the retractor.

[0377] Alternatively, or in addition, two or more autografts 1420 may be used together to form a single autograft having more than two cortical surfaces, such as three, four, or a single autograft with a surrounding cortical surface. For example, the present disclosure may provide one or more jigs that can be used together to form matching autografts that can be used to form a single autograft for use during a surgical procedure. For example, a first jig can be used to create a first autograft in the shape of a negative symbol. Then, a second jig can be used to create a second autograft in the shape of a positive symbol, with the first and second autografts including longer surfaces that are cortical bone. A user can then join the first autograft to the second autograft by contacting the non-cortical surface of the negative-shaped first autograft with the non-cortical surface of the positive-shaped second autograft to form a single autograft with a surrounding surface made of cortical bone. Those skilled in the art will understand that rather than a yin and yang configuration, the same concept can be applied to an interlocking arrangement where two autografts join like puzzle pieces to form a combined autograft that meets the specific needs of the surgical procedure.

[0378] Advantageously, embodiments of the harvest guide disclosed herein can greatly improve a surgeon's ability to harvest an appropriate autograft from a patient's donor bone, such as the calcaneus. The harvest guide can be used to make one or more of the cuts to remove the autograft. In certain embodiments, the harvest guide may be used for more difficult cuts, and other instruments, such as an osteotome, or a cutting tool without a guide, may be used to make the other cuts in the autograft.

[0379] Once the autograft is separated from the donor bone, one or more of the same jigs 1248 can be used to trim or more precisely adjust the shape and / or other dimensions of the autograft. In this manner, the present disclosure allows a surgeon to harvest an autograft sized to a desired dimension for use in filling a retraction between two bones in a patient. Advantageously, the more precise and accurate the autograft the surgeon can harvest, the greater the likelihood of a successful patient outcome.

[0380] 15A-15O show different views and information regarding a planned surgical procedure that includes not only one or more osteotomies but also autograft harvesting using a harvest guide, such as a patient-specific harvest guide. In certain embodiments, the views and information in FIGS. 15A-150 may be presented to a user using a computing device and display device. In one embodiment, the computing device presents a model of the bone, instruments, and / or implants to the user so that pre-operative planning and / or adjustments can be made. Thus, the bones shown in FIGS. 15A-150 may be models of the patient's bones.

[0381] Those skilled in the art will appreciate that these same images (e.g., FIGS. 15A-15O) can be used for digital or hard copy pre-operative planning provided to surgeons prior to a surgical procedure. These images can be created using models of the patient's bones as well as models of patient-specific instruments.

[0382] Figure 15A shows a resection guide 1220 positioned on a patient's TMT joint. Figure 15B is a medial / lateral view of the resection guide 1220 on the patient's bone. Figure 15C is a medial / lateral view of the resection guide 1220 on the patient's bone. Advantageously, using the methods, systems, and / or devices of the present disclosure, the resection guide 1220 can be designed and / or fabricated such that the resection guide 1220 is patient-specific and / or patient-adapted.

[0383] 15D is a dorsal view of a model of the first metatarsal 208 and a model of the medial cuneiform 202 with a retraction 1410 formed therebetween. FIG. 15D shows the retraction 1410 formed using the resection guide 1220 during a surgical procedure. The retraction 1410 can include a proximal end 1502, a distal end 1504, a dorsal end / dorsal side 1506, a plantar end / plantar side 1508, a medial end / medial side 1510, and a lateral end / lateral side 1512.

[0384] It should be noted that with the embodiments of the present disclosure in use, the surgeon is able to see one or more dimensions of the retraction 1410. In the illustrated embodiment, Figure 15D shows that the gap or retraction 1410 has a span S that is approximately 10 mm long and has a depth of 10 mm.

[0385] FIG. 15E is a medial / medial-perspective view of a model of the first metatarsal 208 and a model of the medial cuneiform 202, with a retractor 1410 between them. Similarly, FIG. 15E shows that the gap or retractor 1410 has a height (between the dorsal end 1506 and the plantar end 1508) of approximately 30 mm. This span / depth and height are examples of predetermined graft dimensions that can be used to define the dimensions of the autograft 1420. Thus, the harvest guide 1246 can be fabricated to facilitate the harvest of an autograft 1420 having a length of 10 mm along one side and a height of at least 30 mm at its distal end.

[0386] Referring to Figures 15D and 15E, in one example, the height of the retractor 1410 at the proximal end 1502 can be substantially the same as the height of the cut surface of the medial cuneiform bone 202, and the height of the retractor 1410 at the distal end 1504 can be substantially the same as the height of the cut surface of the first metatarsal bone 208.

[0387] Similarly, the length along the medial end 1510 of the retractor 1410 can be substantially the same as the length between the medial side of the cut surface of the medial cuneiform 202 and the medial side of the cut surface of the first metatarsal 208, and the length along the lateral end 1512 of the retractor 1410 can be substantially the same as the length between the lateral side of the cut surface of the medial cuneiform and the lateral side of the cut surface of the first metatarsal. The lengths along the medial end 1520 and the lateral end 1512 can be the same as or approximately the same as the span (e.g., length / depth / span / thickness) dimension of the retractor 1410.

[0388] Similarly, the width of the proximal end 1502 of the retractor 1410 can be substantially the same as the length between the medial side of the cut surface of the medial cuneiform bone 202 and the lateral side of the cut surface of the medial cuneiform bone 202, and the width of the distal end 1504 of the retractor 1410 can be substantially the same as the length between the medial side of the cut surface of the first metatarsal bone 208 and the lateral side of the cut surface of the first metatarsal bone 208.

[0389] Advantageously, the dimensions of this retraction 1410 (e.g., gap) are determined using a computing device and one or more models, anatomical data 412, etc. In one embodiment, the retraction 1410 can be defined based on the patient's bones being positioned and oriented in their original positions when the surgical procedure begins. The retraction 1410 can be defined as a retraction formed by an osteotomy that removes the distal end of one bone of a joint and the proximal end of a second bone opposing the one bone and on the opposite side of the joint. The surgeon is provided with the dimensions of this retraction 1410 and can then determine what size bone graft is desired if the surgeon wishes to fill the retraction 1410 with a bone graft. Alternatively, or additionally, the surgeon can modify the size (e.g., dimensions) of the retraction 1410 for any reason and use the modified retraction dimensions to plan the bone graft. Specifically, at least one dimension of the bone graft can be predetermined and defined, and the harvest guide can be designed and / or fabricated to harvest a bone graft having that at least one dimension. Thus, the surgeon preparing and planning the surgical procedure has control over one or more dimensions of the bone graft to be harvested, particularly the bone graft to be harvested from the patient's donor bone.

[0390] 15F shows a patient's calcaneus 222 with a harvest guide 1246 secured to the outside of the calcaneus 222. The harvest guide 1246e includes resection features (also known as slots) that can guide the surgeon in making one or more osteotomies to harvest the autograft 1420.

[0391] The embodiment of the harvest guide 1246e in Figure 15F includes holes near the first end 1274 and the third end 1278. These holes are an example of guard pin guides 1290. The holes can accept fasteners that can function as guards or guard pins 1450 (see Figure 15H).

[0392] Note that this exemplary harvest guide 1246e is configured to harvest autograft 1420 from both the dorsal and lateral cortices of the calcaneus 222. The resulting autograft 1420 is a bi-cortical autograft 1420. Also note that in the illustrated embodiment, the harvest guide 1246e includes a resection guide that is open on the plantar side (second end 1276 and / or fourth end 1280). One skilled in the art will understand that the resection feature can be closed on one end or the other, open on both ends, or open on one end or the other.

[0393] FIG. 15G illustrates a top view (eg, a dorsal perspective view) of the harvest guide 1246e, showing the harvest guide 1246e secured to the calcaneus 222 and including the guard pin 1450 deployed.

[0394] FIG. 15H shows a perspective view of the harvest guide 1246e secured to the calcaneus 222, including the deployed guard pin 1450. In one embodiment, the surgeon can remove the harvest guide 1246e after performing the osteotomy using two parallel resection features (e.g., first resection feature 1264, second resection feature 1266). The surgeon can leave the guard pins 1450 in place and use them to guide the horizontal cuts that proceed from one vertical cut to the other. The guard pins 1450 can help the surgeon prevent the cutting tool from cutting further into the plantar surface than desired. Alternatively, or in addition, the surgeon can use the holes for the guard pins 1450 to drill holes in the calcaneus 222 and use these holes in the calcaneus to guide the formation of cuts between the holes drilled in the calcaneus 222 using an osteotome or another cutting tool.

[0395] Figure 15I shows the calcaneus 222 with the osteotomy completed and the harvest guide 1246e removed. An exemplary autograft 1420 is identified. Figure 15J shows a top view of the calcaneus 222 with the exemplary autograft 1420 still connected to the calcaneus 222.

[0396] FIG. 15K illustrates an exemplary autograft 1420 that has been separated and harvested from the calcaneus 222 of FIG. 15L. The autograft 1420 includes one side comprised of a portion of the dorsal cortex of the calcaneus 222 and a portion of the lateral cortex of the calcaneus 222. Advantageously, the autograft 1420 includes two opposing planar cut surfaces 1470 a, b that can be used to fuse with planar cut surfaces created by one or more osteotomies in the patient's bone. The ability of the harvest guide 1246 to provide a uniform, planar cut surface 1470 a that is parallel to the uniform, planar cut surface 1470 a, b, according to certain embodiments of the present disclosure, allows the surgeon to have increased confidence that the planned surgical procedure will result in a desired positive outcome. The surgeon can make adjustments and / or corrections to the patient's anatomy through other steps, instruments, and / or implants of the surgical procedure, knowing that the autograft 1420 will have the desired dimensions and desired uniformity to serve its purpose during the surgical procedure. Figure 15L illustrates an exemplary autograft 1420, with the other bones of the patient's foot shown in phantom.

[0397] 15M illustrates the use of an autograft 1420 from the calcaneus 222 to fill the retraction 1410 between the first metatarsal 208 and the medial cuneiform 202 created by an osteotomy. Advantageously, the dimensions of the autograft 1420 are predetermined and achieved by using a customized harvest guide 1246e to harvest the autograft 1420. One dimension of the autograft 1420 (and / or the spacing of the resection features used to harvest the autograft 1420), which directly affects the distance between the two bone fragments that will be fused to the autograft 1420, may be selected to meet the predetermined graft dimensions.

[0398] FIG. 15N shows an autograft 1420 deployed between the first metatarsal 208 and the medial cuneiform 202. FIG. 15O shows the overall change in length L of the first metatarsal 208 relative to the second metatarsal 210 as a result of deploying the autograft 1420 in a surgical procedure. This change in length L can be reviewed by the surgeon before finalizing the preoperative plan. If the size of length L is acceptable, the preoperative plan can be finalized and the device can be fabricated. If the size of length L is not acceptable, the surgeon or technician may review the preoperative plan until the size of length L is acceptable. Reviewing the preoperative plan can include changing the dimensions of the graft to reduce the size of length L, for example, increasing the span of the graft.

[0399] Advantageously, embodiments of the present disclosure solve the problem of how to harvest a graft, such as an autograft, having a desired size. Embodiments of the present disclosure reduce operating room time and the risk of undercutting the graft, eliminating the need to resect an oversized graft and reshape it to fit the desired size of the surgical procedure. Advantageously, the dimensions of the osteotomy retraction can be successfully transferred or mapped to the harvest site and used to resect a graft sized to meet the needs of the surgical procedure. Embodiments of the present disclosure minimize or eliminate the need for a surgeon to perform a freehand osteotomy when harvesting a graft. Furthermore, a harvest guide, according to one embodiment, may be predefined and / or patient-specific to harvest a graft according to a predetermined graft size. In certain embodiments, the harvest guide may include a stop that prevents a cutting tool from exceeding a certain depth within the donor bone. The stop may be defined by the distance between the anterior and posterior surfaces of the harvest guide.

[0400] Any method disclosed herein includes one or more steps or actions for performing the described method. Method steps and / or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of an embodiment, the order and / or use of specific steps and / or actions may be modified.

[0401] Alternatively, or in addition, any of the systems, devices, and / or apparatuses herein may be implemented using fewer elements and / or components than described in the illustrated embodiment. Furthermore, elements and / or components and / or structures in one embodiment may be used in other embodiments to replace components or structures and / or to extend the embodiment within the scope of the claims and this disclosure.

[0402] References throughout this specification to an "embodiment" or "the present embodiment" mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the cited phrases, or variations thereof, listed throughout this specification do not necessarily all refer to the same embodiment.

[0403] Similarly, in the above description of the embodiments, it should be understood that various features may be grouped together in a single embodiment, figure, or description for the purpose of streamlining the disclosure. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Rather, as the following claims reflect, the inventive aspect lies in a combination of fewer than all features of any single prior disclosed embodiment. As such, the claims following this Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. The present disclosure includes all combinations of independent claims with their dependent claims.

[0404] The recitation of the term "first" with respect to a feature or element in a claim does not necessarily imply the presence of a second or additional such feature or element. Elements described in means-plus-function form are intended to be construed in accordance with 35 U.S.C. § 112, §6. Those skilled in the art will recognize that changes can be made in the details of the above-described embodiments without departing from the underlying principles described herein.

[0405] While particular embodiments and applications of the present disclosure have been illustrated and described, it should be understood that the scope of the present disclosure is not limited to the precise structure and components disclosed herein. Various modifications, changes, and variations apparent to those skilled in the art may be made in the arrangement, operation, and details of the methods and systems of the present disclosure described herein without departing from the spirit and scope thereof.

Claims

1. 1. A device for harvesting bone for a surgical procedure, comprising: Main body, Bone attachment features, a first resection feature configured to guide a first osteotomy of the donor bone; a second resection feature configured to guide a second osteotomy of the donor bone, the second resection feature being offset from the first resection feature by a dimension set according to a harvest guide model to provide a predetermined bone graft dimension; The device comprising:

2. The device of claim 1 , wherein the predetermined bone graft size is one of a set of predetermined sizes determined for retraction during a planned surgical procedure.

3. The device of claim 1 , wherein the body includes a bone-engaging surface configured to engage a surface of the donor bone.

4. The apparatus of claim 3 , wherein the bone-engaging surface has a contour that is determined at least in part based on a bone model of the donor bone, the bone model being defined based on a medical image of the donor bone.

5. The device of claim 3 or 4, wherein the bone engaging surface is configured to engage at least two cortical surfaces of the donor bone.

6. The apparatus of any one of claims 1 to 5, further comprising a landmark registration feature configured to engage a landmark of the donor bone.

7. The apparatus of any one of claims 1 to 6, further comprising a guard pin guide configured to receive the guard pin in the donor bone to prevent the guard pin from cutting beyond the boundary into the donor bone.

8. The apparatus of claim 7 , wherein the guard pin guide is positioned at an end of at least one of the first cutting feature and the second cutting feature.

9. The apparatus of any one of claims 1 to 8, further comprising an alternative ablation feature offset from the first ablation feature by a second dimension, the second dimension being different from the dimension.

10. 10. The device of claim 1, wherein the first cutting feature and the second cutting feature each extend through the body from a bone-facing side of the body to a non-bone-facing side of the body, and the first cutting feature and the second cutting feature extend parallel to each other through the body.

11. 11. The device of claim 10, wherein the first and second cutting features extend through the body at an angle such that the first and second osteotomies form a wedge-shaped bone graft.

12. The device according to any one of claims 1 to 11, wherein the donor bone is the calcaneus of a patient in a Lapidus surgical procedure.

13. 1. A system for harvesting bone for a surgical procedure, comprising: A collection guide, Main body, Bone attachment features, a first resection feature configured to guide a first osteotomy of the donor bone; and a second resection feature configured to guide a second osteotomy of the donor bone, the first resection feature extending parallel to the second resection feature through the body, the first resection feature separated from the second resection feature by a distance determined based on a patient-specific graft bone insertion site; the harvesting guide, a guard configured to prevent cutting beyond a boundary into the donor bone; The system comprising:

14. The collection guide is a third cutting feature extending from the bone-facing side to the non-bone-facing side of the body; The system of claim 13 , wherein the third resection feature guides a third osteotomy connecting the first osteotomy and the second osteotomy.

15. The system of claim 14 , wherein the third ablation feature comprises an edge.

16. The system of any one of claims 13 to 15, further comprising a jig configured to guide the creation of a shape of a bone graft to be resected from the donor bone using the harvesting guide.

17. 1. A method for harvesting bone graft for a surgical procedure, comprising: performing an osteotomy on a patient using an instrument to create a retraction having a set of predetermined dimensions in one or more bones of the patient; deploying a harvest guide on the donor bone, said harvest guide comprising: Main body, Bone attachment features, a first resection feature configured to guide an osteotomy of the donor bone; a second resection feature configured to guide osteotomy of the donor bone; Including, deploying the first and second resection features relative to one another such that an osteotomy formed using the first and second resection features facilitates resection of a bone graft having at least one dimension that substantially matches one dimension of the set of predetermined dimensions; resecting the bone graft from the donor bone using the first resection feature and the second resection feature of the harvest guide; The method comprising:

18. preparing the bone graft for reduction within the retraction; reducing at least one bone fragment within the retraction with the bone graft; 20. The method of claim 17, further comprising:

19. 19. The method of claim 17 or 18, wherein the body includes bone engaging surfaces configured to engage at least two cortical surfaces of the donor bone.

20. 1. A method of providing a patient-specific collection guide, comprising: providing a set of predetermined dimensions for a retractor to receive a bone graft, the set of predetermined dimensions being patient-specific; Locating a bone graft harvest site on the donor bone; developing a patient-specific harvest guide model having a bone-engaging surface configured to engage a surface of the graft bone harvest site; fabricating a patient-specific collection guide based on the patient-specific collection guide model; providing said patient-specific harvesting guide for a surgical procedure; The method comprising:

Images