Apparatus, system, and method for generating patient-specific implants and / or instruments for osteotomy

Abstract

An apparatus, system, and method for correcting a condition existing in a patient are disclosed. In some aspects, the apparatus can include an excision guide having excision features that define a trajectory at least partially determined based on a bone model of at least a portion of the patient's foot and a body. The bone model can be based on a medical image of the patient's foot. The apparatus includes a first bone attachment feature and a second bone attachment feature configured to secure the excision guide to the bone. Additionally, the apparatus can include at least one complementary component selected from the group having an alignment guide, a rotation guide, a compression guide, a correction guide, a positioning guide, a pin guide, and a fixation guide.

Description

Technical Field

[0001] The present disclosure relates to surgical devices, systems, instruments, and methods. More specifically, the present disclosure relates to patient-specific cutting guides and implants, and methods of designing and using them.

Background Art

[0002] Various bone conditions can be corrected using surgical procedures in which one or more tendons, ligaments, and / or bones can be cut, replaced, repositioned, reoriented, reattached, fixed, and / or fused. These surgical procedures may require a surgeon to appropriately locate, position, and / or orient one or more osteotomy cut sites, fixation guides, fixtures, bone tunnels, grafts, or attachment points for the ends of soft tissues. Given the prior art and instruments, it can be difficult to determine and locate the optimal position and trajectory for one or more steps of a surgical procedure, and / or to provide an instrument that can guide or assist in steps of a surgical procedure such as performing an osteotomy, deploying a fixture, etc. One of the problems with the prior art is the way in which a model of a patient's anatomy and / or a virtual instrument is translated, mapped, or transformed into the real physical world in order to perform a surgical procedure. Additionally, surgical procedures can be more difficult when dealing with anatomical structures such as the bones of a patient's foot or hand, which have much smaller bones that require a higher degree of accuracy compared to larger bones such as the femur. What is needed is one or more devices or instruments to facilitate the localization, alignment, orientation, planning, mapping, preparation, initiation, execution, and / or completion of such surgical procedures from a virtual model to the body's anatomical structure. Additionally, what is needed is a method, apparatus, device, implant, and / or instrument that can be customized to a particular patient so that precise and accurate adjustments and / or corrections can be made to meet the needs of each particular patient.

[0003] In certain surgical procedures, wedge osteotomy can be difficult for the surgeon because the surgeon may wish to preserve the cortical bone on the opposite side of the osteotomy site. Performing such an osteotomy freehand can be very difficult to achieve the desired angle and trajectory in one or more planes while still preserving the cortical bone on the opposite side of the osteotomy site. Existing solutions for guiding such orthopedic procedures are inadequate and prone to errors.

Summary of the Invention

[0004] Various devices, apparatuses, systems, and / or methods of the present disclosure have been developed in response to current state-of-the-art technology, and in particular, in response to problems and needs in the art that are not yet fully solved by currently available technology.

[0005] One general aspect of the present disclosure may include an osteotomy system, the osteotomy system may include a resection guide, the resection guide may include a body having a front side, a rear side, an inner side, an outer side, a dorsal side, and a bottom side, and a rear resection feature configured to guide a cutting tool to form a first osteotomy in the bone, the rear resection feature extending from the outer side to the inner side through the resection guide along a first trajectory at least partially determined based on a bone model of at least a portion of the patient's foot, the bone model being based on a medical image of the patient's foot and configured to be similar to the anatomical structure of the patient's foot, the rear resection feature; and a front resection feature configured to guide a cutting tool to form a second osteotomy in the bone, the front resection feature extending from the outer side to the inner side through the resection guide along a second trajectory at least partially determined based on the bone model; and a bone attachment feature configured to secure the resection guide to the bone.

[0006] The osteotomy system may also include at least one complementary component selected from the group consisting of an alignment guide, a rotation guide, a compression guide, a correction guide, a positioning guide, a pin guide, and a fixation guide.

[0007] The embodiment may also include one or more of the following features. The first trajectory converges with the second trajectory at a vertex having a wedge angle such that the posterior resection feature and the anterior resection feature form a wedge-shaped osteotomy that includes a wedge-shaped bone fragment after formation of the first osteotomy and the second osteotomy, the wedge angle being determined based at least in part on the bone model. A system, wherein the bone attachment feature is configured to secure the resection guide to a portion of the bone that forms the wedge-shaped bone fragment after formation of the wedge-shaped osteotomy.

[0008] A system, wherein when the resection guide is designed for a patient's foot, the vertex is pre-positioned such that it is between the medial cortex of the bone and the resection guide. The system includes a bone engagement surface configured to align the inner side of the resection guide with the outer surface of the bone, the bone engagement surface being defined based on the outer surface of the bone model and the planned position of the resection guide on the outer surface of the bone.

[0009] The posterior resection feature may include a posterior dorsal slot having an open dorsal end and a closed bottom end, a posterior bottom slot having an open bottom end and a closed dorsal end, and a posterior bridge positioned between the posterior dorsal slot and the posterior bottom slot, the posterior bridge forming the closed bottom end of the posterior dorsal slot and the closed dorsal end of the posterior bottom slot. The anterior resection feature may include an anterior dorsal slot having an open dorsal end and a closed bottom end, an anterior bottom slot having an open bottom end and a closed dorsal end, and an anterior bridge positioned between the anterior dorsal slot and the anterior bottom slot, the anterior bridge forming the closed bottom end of the anterior dorsal slot and the closed dorsal end of the anterior bottom slot.

[0010] The system may include the pin guide having an arm configured to engage at least one of the posterior resection feature and the anterior resection feature, the arm being connected to a bone engagement feature configured to receive a fastener. The system may include an opening in the arm configured to receive a bridge of at least one of the posterior resection feature and the anterior resection feature.

[0011] The system may include at least one of the arm and the bone engagement feature including a patient-specific feature defined based on the bone model. The resection guide may include a bottom-side landmark alignment feature extending from the bottom side of the resection guide, the bottom-side landmark alignment feature being configured to engage a landmark of the bone. The bottom-side landmark alignment feature may include a bone engagement surface fabricated based on the bone model, and the landmark of the bone may include the bottom-side surface of the bone.

[0012] The system may include the positioning guide, the positioning guide including a body having a front side, a rear side, an inner side, an outer side, a dorsal side, and a bottom side, a front alignment feature, a rear alignment feature, and an offset feature on the inner side of the body, the offset feature being configured to translate the posterior bone fragment relative to the anterior bone fragment, the posterior bone fragment and the anterior bone fragment being formed by one of the first osteotomy and the second osteotomy. The positioning guide may include the bone engagement surface on the inner side, the bone engagement surface being configured to align with the outer surfaces of the posterior bone fragment and the anterior bone fragment, the bone engagement surface being defined based on the outer surface of the bone model and the planned reduced positions of the posterior bone fragment and the anterior bone fragment.

[0013] One general aspect of the present disclosure can include an apparatus that can include a body having a front side, a rear side, an inner side, an outer side, a dorsal side, and a bottom side. A rear resection feature extending from the outer side to the inner side at a rear angle, wherein the rear angle is at least partially determined based on a calcaneus model derived from a medical image of a patient's foot calcaneus, and the calcaneus model is configured to be significantly similar to the anatomical structure of the patient's foot. The apparatus may also include the rear resection feature.

[0014] A front resection feature extending from the outer side to the inner side at a front angle, wherein the front angle is determined based on the calcaneus model, and the osteotomy formed by the rear resection feature and the front resection feature is determined to form a wedge osteotomy including a wedge fragment determined based on the calcaneus model. The apparatus may further include the front resection feature.

[0015] The apparatus may additionally include a bone attachment feature configured to engage the wedge fragment after formation of the wedge osteotomy. The apparatus may further include a bottom side alignment feature extending from the bottom side of the body and configured to contact the bottom side surface of the calcaneus. The apparatus may also include a handle extending from the dorsal side of the body. The apparatus may further include a bone engagement surface on the inner side of the body, wherein the bone engagement surface is configured to conform to the contour of the calcaneus when the body is positioned for use on the calcaneus.

[0016] Embodiments may also include one or more of the following features: an apparatus, wherein the posterior resection feature is configured to receive an arm of a posterior pin guide having an arm connecting a planar fin to a bone engaging feature having an opening and a posterior pin, the anterior resection feature is configured to receive an arm of an anterior pin guide having an arm connecting a planar fin to a bone engaging feature having an opening and an anterior pin, the posterior pin guide is configured to guide the posterior pin into the posterior bone fragment parallel to the osteotomy made using the posterior resection feature, and the anterior pin guide is configured to guide the anterior pin into the anterior bone fragment substantially parallel to the osteotomy made using the anterior resection feature.

[0017] The device is configured to receive a positioning guide, the positioning guide comprising: a body having an anterior side, a posterior side, a medial side, a lateral side, a dorsal side, and a bottom side, an anterior alignment feature, a posterior alignment feature, an offset feature on the medial side of the body, the offset feature configured to translate the posterior bone fragment relative to the anterior bone fragment, and a bone engaging surface on the medial side, the bone engaging surface configured to align with an outer surface of the posterior bone fragment and the anterior bone fragment, the bone engaging surface being defined based on an outer surface of the calcaneus model and a planned reduced position of the posterior bone fragment and the anterior bone fragment.

[0018] The posterior alignment feature may include a slot configured to receive the posterior pin, the slot including a dorsal end, a bottom end, and a length between the dorsal end and the bottom end that includes a predetermined length based on the calcaneus model to allow a user to rotate the posterior bone fragment relative to the anterior bone fragment.

[0019] One general aspect of the present disclosure may include a method that may include accessing an outer surface of the calcaneus. The method may also include positioning a resection guide on the outer surface, the resection guide having a body with anterior, posterior, medial, lateral, dorsal, and bottom sides, and a posterior resection feature configured to guide a cutting tool to form a first osteotomy within the calcaneus, the posterior resection feature extending from the outside to the inside through the resection guide along a first trajectory determined based on a calcaneal model of the calcaneus based on a medical image of the patient's foot, the calcaneal model being configured to match the anatomical structure of the patient's foot; a front resection feature configured to guide a cutting tool to form a second osteotomy connecting to the first osteotomy to form a cuneiform fragment from the calcaneus, the front resection feature extending from the outside to the inside through the resection guide along a second trajectory determined based on the calcaneal model; a first bone attachment feature configured to engage the cuneiform fragment after formation of the cuneiform fragment; a second bone attachment feature configured to engage the cuneiform fragment after formation of the cuneiform fragment; a bottom alignment feature extending from the bottom side of the body and configured to contact the bottom surface of the calcaneus; and a bone engagement surface on the medial side of the body, the bone engagement surface being configured to match the contour of the calcaneus when the body is positioned on the calcaneus.

[0020] The method may further include disposing a first fastener within the first bone attachment feature and a second fastener within the second bone attachment feature, such that the first fastener and the second fastener are parallel to each other and enter a portion of the calcaneus that will form the cuneiform fragment.

[0021] The method may additionally include inserting the cutting tool into the posterior resection feature to a depth pre-specified in a pre-operative plan designed based on the calcaneal model to form the first osteotomy.

[0022] Inserting the cutting tool into the anterior resection feature to a depth pre-defined in a pre-operative plan designed based on the calcaneus model to form the second osteotomy, which may further include forming the second osteotomy to form a posterior bone fragment and an anterior bone fragment.

[0023] The method may also include engaging a posterior pin guide with the posterior resection feature, disposing a posterior pin within a bone attachment feature of the posterior pin guide, engaging an anterior pin guide with the anterior resection feature, and disposing an anterior pin within a bone attachment feature of the anterior pin guide.

[0024] The method may further include removing the posterior pin guide, the anterior pin guide, and the resection guide.

[0025] The method may additionally include removing the wedge-shaped bone fragment with the first fastener and the second fastener.

[0026] The method may further include sliding a positioning guide over the posterior pin and the anterior pin by passing the posterior pin through a posterior alignment feature and the anterior pin through an anterior alignment feature.

[0027] The method may also include sliding the positioning guide along the posterior pin and the anterior pin until the positioning guide contacts the posterior bone fragment and the anterior bone fragment.

[0028] The method may further include disposing a fixture across the osteotomy between the posterior bone fragment and the anterior bone fragment.

[0029] Embodiments may also include one or more of the following features. The method may include disrupting the medial cortex of the calcaneus on the opposite side of the wedge-shaped bone fragment and translating the posterior pin within the posterior alignment feature to rotate the posterior bone fragment to a position determined by the surgeon to restore the condition of the patient's foot.

[0030] One general aspect of the present disclosure may include an osteotomy system that may include at least one fastener configured to engage a phalanx of a patient's foot. An excision guide having a body with a front side, a rear side, an inner side, an outer side, a dorsal side, and a bottom side, and a rear excision feature configured to guide a cutting tool to form a first osteotomy in the phalanx, wherein a first track for the first osteotomy is determined based on a bone model of the phalanx based on a medical image of the patient's foot, and the bone model is configured to be substantially similar to the anatomical structure of the patient's foot, the rear excision feature; and a front excision feature configured to guide a cutting tool to form a second osteotomy in the phalanx, wherein a second track for the second osteotomy is determined based on the bone model, the front excision feature; a first bone attachment feature configured to secure the excision guide to the phalanx; and a second bone attachment feature configured to secure the excision guide to the phalanx, and the excision guide may also be included, the osteotomy system.

[0031] Embodiments may also include one or more of the following features. At least one of the first bone attachment feature and the second bone attachment feature is configured to form a guide hole for a fastener in the phalanx when at least one of the first bone attachment feature and the second bone attachment feature is disengaged from the phalanx. The system. The first bone attachment feature is configured to form a first guide hole, the second bone attachment feature is configured to form a second guide hole, the first guide hole is configured for a first leg of a bone staple, and the second guide hole is configured for a second leg of the bone staple. The system.

[0032] The advantages, properties, and additional features of the exemplary embodiments of the present disclosure will become more fully apparent from the following description and the appended claims, in conjunction with the accompanying drawings. It is to be understood that these drawings depict only exemplary embodiments and are not to be considered as limiting the scope of the present disclosure, and that the exemplary embodiments of the present disclosure will be described with additional specificity and detail by the use of the accompanying drawings.

Brief Description of the Drawings

[0033]

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[0034] Exemplary embodiments of the present disclosure are best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. As generally described and illustrated in the figures of this specification, it will be readily understood that the components can be arranged and designed in a wide variety of different configurations. Accordingly, the following more detailed description of the embodiments of the apparatus, system, and method is not intended to limit the scope of the present disclosure, but is merely representative of exemplary embodiments.

[0035] 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, fluidic, and thermal interactions. Two components may be functionally coupled to each other even if they are not in direct contact with each other. The term “abutting” refers to those that are in direct physical contact with each other, but they do not necessarily have to be attached together. The phrase “in fluid communication” refers to two features that are connected such that fluid within one feature can pass into the other feature.

[0036] The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” should not necessarily be construed as preferred or advantageous over other embodiments. Although various aspects of the embodiments are presented in the drawings, the drawings are not necessarily drawn to scale unless otherwise specifically indicated.

[0037] In this disclosure, standard medical reference planes and descriptive terms are used. These terms are generally used to refer to the human body, although certain terms are generally applicable to physical objects. A standard system of three mutually perpendicular reference planes is used. The sagittal plane divides the body into a right and a left part. The coronal plane divides the body into a front and a rear part. The transverse plane divides the body into an upper and a lower part. The median sagittal plane, median coronal plane, or median transverse plane divides the body into equal parts that can be bilaterally symmetric. The intersection of the sagittal and coronal planes defines the superior-inferior or cephalocaudal 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 cephalocaudal axis, anterior-posterior axis, and medial-lateral axis are mutually perpendicular.

[0038] Anterior means toward the front of the body. Posterior means toward the rear of the body. Superior or cranial means toward the head. Inferior or caudal means toward the feet or tail. Medial means toward the midline of the body, particularly toward the plane of bilateral symmetry of the body. Lateral means away from the midline of the body or away from the plane of bilateral symmetry of the body. Axial means toward the central axis of the body. Abaxial means away from the central axis of the body. Ipsilateral means on the same side of the body. Contralateral means on the opposite side of the body from the side having a particular condition or structure. Proximal means toward the torso of the body. Proximal may also mean toward the user, observer, or operator. Distal means away from the torso. Distal may also mean away from the user, observer, 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 the body structure.

[0039] Antegrade means moving forward from a proximal location / position to a distal location / position, or moving in the forward direction. Retrograde means moving backward from a distal location / position to a proximal location / position, or moving in the backward direction. The sagittal plane refers to the midline of the patient's anatomical structure that divides the body into the left or right half. The sagittal plane is at the center of the body and can divide it into two halves. The prone position means the body of a person lying horizontally with the face down. The supine position means the body of a person lying horizontally with the face up.

[0040] "Patient-specific cutting guide" refers to a cutting guide designed, operated, and / or fabricated for use with a specific patient. In one aspect, a patient-specific cutting guide is unique to a single patient and may include features specific to the patient, such as surface contours or other characteristics.

[0041] "Patient-specific" refers to features, attributes, characteristics, structures, functions, constructs, devices, guides, tools, instruments, apparatuses, members, components, systems, assemblies, modules, or subsystems that are adjusted, adapted, modified, tailored, configured, designed, positioned, operated, and / or fabricated to specifically address the anatomical structure, physiology, condition, abnormality, needs, or desires of a specific patient or the surgeon serving that specific patient. In one aspect, patient-specific attributes or features are unique to a single patient and may include features specific to the patient, such as the number of cutting channels, the number of bone attachment features, the number of bone engagement surfaces, the number of resection features, the depth of one or more cutting channels, the angle with respect to one or more resection channels, surface contours, component positions, component orientations, the trajectory of the patient's instrument, implant, or anatomical site, outer offsets, and / or other characteristics.

[0042] As used herein, "condition" refers to any state with respect to its appearance, quality, or operating state. In certain aspects, the condition may refer to the health state or physical condition of a patient, or the health state or physical condition of an organ or anatomical part of a patient. In certain embodiments, the condition may refer to a disease, defect, disorder, or deformity of a patient or an organ or anatomical part of a patient. (Search for "condition" at wordhippo.com. WordHippo, 2021. Web. Accessed December 8, 2021. Modified.)

[0043] "Bone condition" refers to any one of the various conditions of a patient's bones. Generally, bone condition refers to the orientation, position, and / or alignment of one or more of a patient's bones relative to other anatomical structures of the patient's body. Bone condition can be caused by, or be the result of, deformities, displacements, rotational abnormalities, fractures, joint dysfunctions, etc. Bone condition includes, but is not limited to, any angular deformations (e.g., tibial deformity, calcaneal deformity, femoral deformity, and radial deformity) of one or more bone segments in either the lower or upper extremities. Alternatively, or additionally, "bone condition" may refer to the structural composition and constitution of one or more of a patient's bones. Thus, bone condition may refer to the temporary or permanent state of a region of a bone, or a bone site such as a head, base, shaft, prominence, process, lamina, foramen, etc., along the metaphysis region, epiphysis region, and / or diaphysis region, the thickness of the cortex, bone density, the thickness and / or porosity of the internal region (e.g., whether it is a calcaneus or cancellous bone).

[0044] As used herein, "implant" refers to a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. In many cases, a medical implant is an artificial device, but an implant may also be a naturally-derived structure. The surface of an implant that contacts the body may be made of or include biocompatible materials such as titanium, cobalt chrome, stainless steel, carbon fiber, another metal alloy, silicone, polymer, synthetic polyvinyl alcohol (PVA) hydrogel, biomaterial, polyetheretherketone (PEEK) or polylactide polymer (e.g., PLLA), and / or any combination of these depending on functionality and / or economics, or apatite, or any combination thereof. An implant may have various configurations, may be integral, partial, and / or may include some components that are flexible, semi-flexible, compliant, elastic, pliable, semi-rigid, or rigid. In some cases, an implant includes electronic devices, such as artificial pacemakers and cochlear implants. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or drug-eluting stents. Orthopedic implants can be used to relieve problems with the bones and / or joints of 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, full suture implants, ball full suture implants, self-locking suture implants, cross-thread suture implants, plates used to anchor fractured bones while the bones heal or fuse together. (Searched "implant (medicine)" on Wikipedia.com on May 26, 2021. CC-BY-SA 3.0 licensed. Accessed June 30, 2021.)

[0045] "Topographical" refers to the physical distribution of organs or other anatomical structures, or sites, structures, or features on or within the surface of an organism. (Search "define topographical" on google.com. Oxford Languages, Copyright 2022. Oxford University Press. Web, modified. Accessed February 15, 2022.)

[0046] As used herein, "pre-operative plan" refers to a plan for performing a surgical procedure. Depending on the complexity of the surgery, the pre-operative plan can be very simple and general, or very detailed and specific to a particular surgical procedure. In one aspect, the pre-operative plan can include very detailed and specific step-by-step instructions for the surgical procedure. The instructions can be ordered according to a particular sequence to achieve the desired outcome. In certain embodiments, the pre-operative plan can indicate the instruments, machines, systems, tests, and / or personnel to be used in the surgical procedure. The pre-operative plan can take many forms and formats based on the needs and desires of the user of the pre-operative plan. In one embodiment, the pre-operative plan is a report that can be displayed on a screen or printed on paper. In another embodiment, the pre-operative plan can include instructions for operating plan software. In another embodiment, the pre-operative plan can include instructions for a surgical rehearsal tool that includes software. In another embodiment, the pre-operative plan can include commands for surgical planning using virtual reality or augmented reality software.

[0047] "Vertex" refers to the point at which lines, structures, trajectories, or paths intersect. (Search "vertex" on wordhippo.com. WordHippo, 2023. Web, modified. Accessed June 13, 2023.)

[0048] As used herein, "pin" refers to an elongated structure. In certain embodiments, the pin can be used to connect two structures or function as a bearing between two structures. In certain embodiments, the pin can be configured to support a load (including tensile, compressive, shear, torsional, and / or bending loads). In certain embodiments, the pin may be a cylindrical structure thinner than the connected structures. The pin can perform various functions and may include modifiers that identify specific functions. For example, certain solutions may use alignment pins, attachment pins, fixing pins, etc. The pin can serve temporary or permanent structural purposes. The pin can be used in various devices, components, apparatuses, and systems, including but not limited to fixed plates, measuring instruments, pin guides, cutting guides, surgical instruments, etc. The pin can function temporarily or permanently as a fastener. An example of a pin is a Kirschner wire ("K-wire"). The pin can have various geometric cross-sectional shapes, including but not limited to circles, ellipses, ovals, or other circular or semi-circular shapes, and rectangles, squares, or other polygonal shapes. The pin has two ends, one end may be blunt and the other end may be pointed. The pin can be made from various materials, including metals, plastics, ceramics, wood, glass fibers, etc. The pin can also be formed from any biocompatible material, including but not limited to shape memory alloys such as titanium, titanium alloys, stainless steel alloys, cobalt-chromium steel alloys, nickel-titanium alloys, nitinol, biocompatible ceramics, and biocompatible polymers such as polyetheretherketone (PEEK) or polylactide polymers (e.g., PLLA), and / or others.

[0049] "Align" or "alignment" refers to the act of aligning, fitting, contacting, engaging, or coupling 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 depressions that are the reverse or mirror image configuration of protrusions and / or depressions of one or more portions and / or surfaces of the other object.

[0050] "Position" refers to an arrangement or location. (Search "position" on wordhippo.com. WordHippo, 2022. Web. Accessed August 9, 2022.) As used herein, "slot" refers to a narrow opening or groove. (Search "slot" on Merriam-Webster.com. Merriam-Webster, 2021. Web. August 4, 2021. Accessed.) As used herein, "end" refers to a part or structure of an area or span that is at a boundary or edge. An end can also refer to a point that indicates some range and / or a point where something ceases to exist. An end can also refer to the extreme or last part in the longitudinal direction of a structure or surface. (Search "end" on Merriam-Webster.com. Merriam-Webster, 2021. Web. August 4, 2021. Accessed.)

[0051] "Bone fragment" or "fragment" typically refers to a part of a bone that is part of another bone of a patient. A bone fragment can be partially or completely separated from another bone of the patient due to deformation, osteotomy, resection, and / or trauma. In one aspect, the bone to which the bone fragment is normally part of, connected to, or joined to is referred to as the parent bone.

[0052] "Cortex" refers to an area of bone that extends from the outer surface of the bone towards the central part of the bone. The cortex is typically composed of cortical bone.

[0053] As used herein, "stop" refers to a device, instrument, structure, member, device, component, system, or assembly that is structured, organized, configured, designed, arranged, or operated to prevent, limit, obstruct, stop, or restrict the movement or motion and / or operation of another object, member, structure, component, part, device, system, or assembly.

[0054] As used herein, "fastener", "fixing device", or "fastening system" refers to any structure configured, designed, or operated to join two structures. Fasteners can be made of a variety of materials including metal, plastic, composite materials, metal alloys, plastic composites, and the like. Examples of fasteners include, but are not limited to, screws, rivets, bolts, nails, snaps, surface fasteners, set screws, bone screws, nuts, posts, pins, thumb screws, and the like. Other examples of fasteners include 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.

[0055] As used herein, "fixation" or "fixing device" refers to an apparatus, instrument, structure, device, component, member, system, assembly, step, process, or module structured, organized, configured, designed, arranged, or operated to connect two structures either permanently or temporarily. The two structures may be one or the other, or both, of artificial and / or biological tissue, hard tissue such as bone, teeth, soft tissue such as ligaments, cartilage, tendons, and the like. In certain embodiments, fixation is used as an adjective to describe a device or component or step that secures two structures so that the structures remain connected to each other in a desired position and / or orientation. A fixing device may also function to maintain a desired level of tension, compression experienced by the two structures, or redistribute loads and stresses, and may function to reduce relative movement of one part with respect to another part. Examples of fixing devices are numerous and include both those for external fixation and those for internal fixation and include, but are 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.

[0056] In certain embodiments, the term fastener may refer to a fastener system that includes two or more structures configured to be combined to function as a fastener. An example of a fastener system is a rod or shaft having an opening or hole within another structure having a corresponding internal thread configured to engage the external thread of the rod or shaft and the external thread.

[0057] In certain embodiments, the term fastener may be used with an adjective that identifies an object or structure that the fastener is particularly configured, designed, or operated to engage, connect, join, contact, or couple with one or more other structures of the same or different types. For example, a "bone fastener" may refer to a device for joining or connecting one or more bones, one or more bone portions, soft tissue to bone or a bone portion, hard tissue to bone or a bone portion, a device to a bone or a portion of a bone, and the like.

[0058] In certain embodiments, the fastener may be a temporary fastener. A temporary fastener engages and functions as a fastening function for a relatively short period of time. Typically, a temporary fastener is configured to be used until another procedure or operation is completed and / or until a particular event occurs. In certain embodiments, the user may remove or disengage the temporary fastener. Alternatively, or additionally, another structure, event, or machine may disengage the temporary fastener.

[0059] As used herein, "osteotomy" or "osteotomy procedure" or "surgical osteotomy" refers to a surgical procedure in which one or more bones are cut to shorten or lengthen them or to change their alignment. The procedure may include removing one or more portions of the bone and / or adding one or more portions of bone or bone substitute. (Searched "osteotomy" on Wikipedia.com on February 3, 2021 and February 22. CC-BY-SA 3.0 licensed. Accessed on February 15, 2022.) As used herein, "patient-specific osteotomy procedure" refers to an osteotomy procedure that is adjusted, customized, modified, or configured to specifically address the anatomical structure, physiology, condition, abnormality, needs, or desires of a particular patient. In certain aspects, one patient-specific osteotomy procedure may be usable only in relation to one patient. In other aspects, one patient-specific osteotomy may be usable in several patients having certain classes 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 instruments. In another aspect, 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 instruments.

[0060] "Trajectory" refers to the path along which a body moves, or a path configured for a body to move through space. (Searched "trajectory" on wordhippo.com. WordHippo, 2023. Web. Modified. Accessed on June 13, 2023.)

[0061] "Wedge osteotomy" refers to an osteotomy procedure in which one or more wedges are used as part of the procedure. Generally, wedge osteotomy can be one of two types: open wedge and closing wedge. The type of osteotomy refers to how the procedure changes the relationship between two parts of the bone involved in the osteotomy. In open wedge osteotomy, a wedge of bone or graft or other material is inserted between two parts of the bone. Thus, the wedge shape is "open" in the bone. In closed / closing wedge osteotomy or closing wedge osteotomy, a wedge of bone is removed from the bone. Thus, the wedge shape formed in the bone is "closed".

[0062] As used herein, "anatomical data" refers to data that is identified, used, collected, gathered, and / or generated in relation to the anatomical structures of a human or animal. Examples of anatomical data can include location data for both independent structures and structures connected to other structures within a coordinate system. Anatomical data can also include data that labels or identifies one or more anatomical structures. Anatomical data can include volume data, material composition data, etc. Anatomical data can be generated based on medical image data or measurements using various instruments including monitors and / or sensors. Anatomical data can be collected from, measured, or gathered from anatomical models and / or used to generate, manipulate, or modify anatomical models.

[0063] A bone model or anatomical model of a patient's body or body part(s) can be generated by a computing device that analyzes images of medical images. The structure of the patient's body can be determined using a process called segmentation.

[0064] As used herein, "segmentation" or "image segmentation" refers to the process of partitioning an image into distinct meaningful segments. These segments can correspond to different tissue classes, organs, pathologies, bones, or other biologically relevant structures. Medical image segmentation addresses imaging ambiguities such as low contrast, noise, and other imaging artifacts.

[0065] Certain computer vision techniques can be used or adapted for image segmentation. For example, techniques and / or algorithms for segmentation can include, but are not limited to, the following. Atlas-based segmentation: For many applications, clinical experts can manually label several images, and segmenting an unknown image is a matter of extrapolating from these manually labeled training images. This form of method is typically referred to as an atlas-based segmentation method. Parametric atlas methods typically combine these training images into a single atlas image, while non-parametric atlas methods typically use all of the training images separately. Atlas-based methods usually require the use of image registration to align the atlas image to a new unknown image.

[0066] Image registration is the process of correctly aligning images. Shape-based segmentation: Many methods often parameterize the template shape of a given structure, depending on control points along the boundary. The shape is then deformed so that the whole shape matches the new image. Two of the most common shape-based techniques are active shape models and active appearance models. Image-based segmentation: Some methods start with a template, such as the active contour model and its variations, and refine its shape according to the image data while minimizing an integral error measure. Interactive segmentation: An interactive method can be useful if the clinician can provide some information, such as a seed region for segmentation or a rough outline of the region. The algorithm can then iteratively refine such segmentation with or without guidance from the clinician. Manual segmentation, which explicitly defines the tissue class of each pixel using tools such as a paint brush, remains the gold standard for many imaging applications. Recently, the principles of feedback control theory have been incorporated into segmentation, giving the user much greater flexibility and enabling automatic error correction. Subjective surface segmentation: This method is based on the idea of the evolution of a segmentation function governed by an advection-diffusion model. To segment an object, a segmentation seed is required (a starting point that determines the approximate position of the object within the image). As a result, an initial segmentation function is constructed. In the subjective surface method, the position of the seed is the main factor determining the form of this segmentation function. Hybrid segmentation based on a combination of methods. (Search for "medical image computing" on Wikipedia.com on June 24, 2021. CC-BY-SA 3.0 license. Accessed on June 24, 2021.)

[0067] As used herein, "medical image" refers to the technologies and processes for imaging the interior of the body for clinical analysis and medical intervention, as well as the visual representation of the function (physiology) of several organs or tissues. Medical images are intended to reveal internal structures hidden by the skin and bones and to diagnose and treat diseases. Medical images can be used to establish a database of normal anatomical structures and physiology in order to enable the identification of abnormalities. Medical images in the broadest sense are part of biological images and incorporate radiology using imaging techniques such as X-ray imaging, magnetic resonance imaging, ultrasound, endoscopy, elastography, tactile imaging, thermography, medical photography, positron emission tomography (PET), and single-photon emission computed tomography (SPECT) nuclear medicine functional imaging techniques. Another form of X-ray imaging includes computed tomography (CT) scans, where the computer controls the positions of the X-ray source and detectors. Magnetic resonance imaging (MRI) is another medical imaging technique. Measurement and recording techniques not primarily designed to generate images such as electroencephalogram (EEG), magnetoencephalogram (MEG), electrocardiogram (ECG), and others represent other techniques that generate data that is easily represented as maps containing parameter graphs versus time or data regarding the measurement location. These techniques may be considered a form of medical image in certain fields. (Searched "medical imaging" on Wikipedia.com on June 16, 2021. CC-BY-SA 3.0 licensed. Accessed on June 23, 2021.) Data containing images, text, and other data associated with medical images are referred to as patient image data. As used herein, "patient image data" refers to data that is identified, used, collected, gathered, and / or generated in relation to medical imaging and / or medical imaging data. Patient image data can be shared among users, systems, patients, and specialists 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.

[0068] As used herein, "medical image computing" or "medical image processing" includes the fields of computer science, information engineering, electrical engineering, physics, mathematics, and medicine, and refers to systems, software, hardware, components, and / or devices that combine them. Medical image computing deals with medical images and develops computational and mathematical methods for 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. The methods can be grouped into several broad categories, such as image segmentation, image registration, and image-based physiological modeling. (Search "medical image computing" on Wikipedia.com on June 24, 2021. CC-BY-SA 3.0 licensed. Accessed June 24, 2021.) Medical image computing may include 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 images 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 a computational model to represent a particular subject / patient, thus opening the way to a personalized computational model. The individuation of a general computational model through images can be achieved in three complementary directions: the definition of subject-specific computational domains (anatomical structures) and related subdomains (tissue types), the definition of boundaries and initial conditions from images (dynamic and / or functional), and the characterization of structural and functional tissue properties. Medical images and medical image computing enable the translation of the model into a clinical environment using both diagnostic and therapeutic applications.(Same as above) In certain embodiments, medical image computing can be used to generate bone models, patient-specific models, and / or device-specific instruments from medical images and / or medical image data.

[0069] As used herein, "model" refers to a useful representation of an object, person, or system. Representation models can be broadly divided into the concrete (e.g., physical form) and the abstract (e.g., behavioral patterns represented in a mathematical form in particular). In the abstract form, a particular model can be based on data used in a computer system or software program to represent the model. Such a model can be referred to as a computer model. A computer model can be used to display a model, modify a model, and print a model (on a 2D medium or using a 3D printer or additive manufacturing technology). A computer model can also be used in an environment with models of other objects, people, or systems. A computer model can also be used for generating simulations, displays in virtual environment systems, displays in augmented reality systems, etc. A computer model can be used in computer-aided design (CAD) and / or computer-aided manufacturing (CAM) systems. A particular model can be identified by an adjective that identifies 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. (Searched for "model" on Wikipedia.com on June 13, 2021. CC-BY-SA 3.0 licensed. Accessed on June 23, 2021.) Of course, a model can model an entire object or a complete object, or a model can model or represent a part of an object. For example, a bone model can model an entire bone or a part of a bone. As used herein, "additive manufacturing" refers to a manufacturing process in which materials are joined together in a process of repeatedly building one layer on top of another to produce 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, biochemcials, and the like. Additive manufacturing can offer unique advantages such that implants can be manufactured directly with pores and / or latticework (without the need to generate molds, tool paths, and perform any milling and / or other manufacturing steps).

[0070] As used herein, "excision" refers to a method, procedure, or step of removing tissue from another anatomical structure or body. Excision is typically performed by a surgeon on a part of a patient's body. (Searched "surgery" on Wikipedia.com on May 26, 2021. CC-BY-SA 3.0 licensed. Accessed May 26, 2021.) Excision can be used as a noun or a verb. In verb form, the term is "excise" and refers to the act of performing or carrying out an excision. The past tense of the verb "excise" is "excised".

[0071] As used herein, "guide" refers to a part, component, member, or structure that is designed, adapted, configured, or operated to guide or direct one or more other parts, components, or structures. A guide may be part of, integrated with, connected to, attachable to, or coupled 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 a guide include, but are not limited to, "pin guide" that guides or directs one or more pins, "cutting guide" that guides or directs the making or one or more cuts, "placement, deployment, or insertion guide" that guides or directs the placement, positioning, orientation, deployment, installation, or insertion of a fastener and / or an implant, "cross-fixation guide" that induces the deployment of a fastener or a fixing member, "alignment guide" that guides the alignment of two or more objects or structures, "navigation guide" that guides a user when navigating a path or process or procedure such as a surgical procedure, "resection guide" that functions to guide the resection of soft or hard tissue in osteotomy or the like, "reduction guide" that guides the reduction of one or more bone segments or fragments, "placement guide" that functions to identify how an object can be placed relative to another object or structure, and the like. Further, a guide may include a modifier applied due to a procedure or location within a patient where the guide is used. For example, if a guide is used in a joint, the guide may be referred to herein as a "joint fixation guide". As used herein, "feature" refers to any characteristic attribute or aspect. (Search "feature" on google.com. Oxford Languages, 2021. Web. April 20, 2021.) 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 the feature part include, but are not limited to, "attachment feature part", "bone attachment feature part", "fixed feature part", "protruding feature part", "engagement feature part", "offset feature part", "alignment feature part", "patient-specific feature", "disengagement feature part", "resection feature part", "guide feature part", etc.

[0072] "Fin" refers to an appendage to another structure. A fin can also refer to a thin, rigid component or structure used to stabilize, direct, and / or orient a connected structure. (Search "fin" on wordhippo.com. WordHippo, 2023. Web. Modified. Accessed June 13, 2023.)

[0073] "Cutting tool" refers to any tool that can be used to cut or excise another object. In particular, a cutting tool can refer to a manual or power tool for cutting or excising a patient's tissue. Examples of cutting tools include, but are not limited to, bars, oscillating saws, reciprocating saws, coping saws, drills, mills, side cutters, pivot bars, pivot resection guides, pivot drill bits, etc.

[0074] As used herein, "handle" or knob refers to a structure used to hold, control, or operate a device, apparatus, component, tool, etc. A "handle" can be designed to be gripped and / or held using one or two hands of a user. In certain embodiments, the handle or knob can be an elongated structure. In one embodiment, the knob can be a shorter and thicker structure.

[0075] "Contour" refers to an outer shape that represents the shape or form of an object or indicates a boundary. A contour can also refer to the outer limit of an object, an area of an object, or the surface of an object. (Search "contour" on wordhippo.com. WordHippo, 2023. Web. Modified. Accessed June 13, 2023.)

[0076] One of ordinary skill in the art will understand that the excised feature(s) can take various forms and can include a single feature or one or more features that together form the excised feature(s). In certain embodiments, the excised feature(s) can take the form of one or more slots. Alternatively, or in addition, the excised feature(s) can be referred to using other terms including, but not limited to, channels, cut channels, etc.

[0077] As used herein, "side" refers to a structure or part of a structure, including, but not limited to, a longer bounding surface or line of an object, particularly as contrasted with an end; a line or surface that forms a boundary or face of an object; any surface of a thin object; a boundary line or structure of a geometric figure or shape, etc. (Search "side" at Merriam-Webster.com. Merriam-Webster, 2021. Web. August 3, 2021. Revised.) A side can also refer to a geometric edge of a polygon (two-dimensional shape) and / or a face or surface of a polyhedron (three-dimensional shape). (Search "side" at Wikipedia.com on July 21, 2021. CC-BY-SA 3.0. Revised. Accessed August 3, 2021.) A side can also refer to a structural location. For example, a side can be a structural location that is at or near the position furthest from the central axis of a structure.

[0078] As used herein, the term "side" may include one or more modifiers that define and / or orient and / or distinguish the side of an object based on the location and / or manner in which the object is disposed within or in relation to a second object. For example, in the context of an implant for a patient, when the implant is disposed, the side of the implant may be labeled based on where the side is relative to the patient. As an example, the "front side" of an implant or instrument refers to the side that is in front of the other side of the implant or instrument relative to the patient when the implant or instrument is disposed within the patient. Similarly, as an example, the "inner side" of an implant or instrument refers to the side that is inner relative to the other side of the implant or instrument or faces the inside of the patient when the implant or instrument is disposed within the patient. As another example, in the context of an instrument used by a patient, the side of the instrument may be labeled based on where the side is when the instrument is being used for its intended purpose. As an example, the "front side" of an instrument refers to the side that faces the user of the instrument when the instrument is being used. As another example, the "rear side" is the side that faces or is on top of the rear side of the implant or instrument when the device is disposed on or within the patient.

[0079] "Bridge" refers to a structure, device, system, and / or construct that spans a division or opening and / or connects one side of a division or opening to the other side. (Search "bridge" at wordhippo.com. WordHippo, 2023. Web. Revised. Accessed June 13, 2023.)

[0080] As used herein, "arm" refers to an elongated structure extending from another structure such as a base or body. In certain embodiments, the arm can be configured to support loads (including tensile, compressive, shear, torsional, and / or bending loads). In certain embodiments, the arm can generally include a planar structure. The arm can be a separate structure connected to or integrated with another structure. Based on how the arm is connected to or extends from another structure such as a base or body, the arm can be similar to a human or animal arm in that the arm can be an appendage to another structure. The arm can be two-dimensional or three-dimensional and can have various geometric and / or cross-sectional shapes including, but not limited to, rectangles, squares, or other polygons, as well as circles, ellipses, ovals, or other circular or semi-circular shapes. The arm can be made from a variety of materials including metals, plastics, ceramics, wood, fiberglass, and the like. One arm can be distinguished from another arm based on where the arm is positioned within a structure, component, or device.

[0081] As used herein, "aperture" refers to a gap, hole, opening, port, portal, slit, space or recess within a structure, void within a structure, etc. In certain embodiments, an aperture can refer to a specifically configured structure for receiving something and / or enabling access. In certain embodiments, an aperture can pass through a structure. In such embodiments, the aperture can be referred to as a window. In other embodiments, an aperture can be present within a structure but not pass through the structure. In other embodiments, an aperture can begin on the surface or edge or side of a structure and extend into the structure a certain distance but not pass through or extend to another side or edge of the structure. In other embodiments, an aperture begins on the surface or edge or side of a structure and extends into the structure until the aperture either extends through or to another side or edge of the structure. An aperture can be two-dimensional or three-dimensional and can have various geometric and / or cross-sectional shapes including, but not limited to, rectangles, squares, or other polygons, as well as circles, ellipses, ovals, or other circular or semi-circular shapes. As used herein, the term "aperture" can include one or more modifiers that define a particular type of "aperture" based on the purpose, function, operation, location, or place of the "aperture". By way of example, a "fastener aperture" refers to an "aperture" that is adapted, configured, designed, or operated to receive or accommodate a "fastener".

[0082] The present disclosure discloses a surgical system and method by which a condition of a bone, such as a deformity, can be corrected. Known methods of correcting a condition of a bone are often limited to a discrete range of instrument sizes. Patients with abnormal conditions or anatomical structures that fall between instrument sizes may not be easily treated with such systems.

[0083] Furthermore, patient-specific cutting guides can be used for a variety of other procedures on the foot or other bones of the musculoskeletal system. Patient-specific cutting guides can be used for a variety of procedures involving osteotomy, including, but not limited to, arthroplasty, fusion, and deformity correction procedures. According to one example, a patient-specific cutting guide similar to cutting guide 300 can be used on the metatarsophalangeal (''MTP'') joint. A method similar to method 100 can be used.

[0084] In some embodiments, one or more joint surfaces of a joint can be replaced and / or resurfaced. For example, for the MTP joint, a patient-specific cutting guide can be used to determine the cutting angle of the distal midfoot bone or proximal phalanx for preparation of replacement or resurfacing of the midfoot head and / or proximal phalanx base. Implants for either the midfoot bone or phalanx can be customized to match the patient's original anatomical structure, such as the curvature of the MTP joint. In other embodiments, the MTP joint can be fused through the use of a patient-specific cutting guide. A patient-specific cutting guide can be used to treat any joint in the body (e.g., through fusion, resurfacing, and / or arthroplasty) using a method similar to method 100.

[0085] According to another example, a patient-specific cutting guide can be used to perform an Evans calcaneal osteotomy and / or a medial displacement calcaneal osteotomy. Patient-specific instruments will be shown and described in connection with the Evans calcaneal osteotomy and the medial displacement calcaneal osteotomy.

[0086] Figure 1A is a flowchart diagram illustrating a method 100 for correcting a bone condition according to one embodiment. Method 100 can be used for any of a wide variety of bone conditions including, but not limited to, deformities, fractures, joint dysfunctions, etc. Furthermore, method 100 can provide correction by a wide variety of treatments including, but not limited to, arthroplasty, arthrodesis, fracture repair, etc.

[0087] As shown, method 100 can begin at step 102 where a CT scan (or another three-dimensional image, also referred to as a medical image) of a patient's anatomical structure is obtained. Step 102 can involve capturing a scan of only the specific bone(s) to be treated or can involve capturing additional anatomical information such as surrounding tissue. Additionally or alternatively, step 102 can involve receiving a pre-captured image, for example, at a design and / or manufacturing facility. Performing step 102 can result in the acquisition of a three-dimensional model of the patient's anatomical structure or three-dimensional surface points that can be used to construct such a three-dimensional model.

[0088] After step 102 is executed, method 100 can proceed to step 104 where a CAD model of the patient's anatomical structure (including one or more bones) is generated. The CAD model can be an example of a bone model. The CAD model can be in any known format including, but not limited to, SolidWorks, Catia, AutoCAD, or DXF. In some embodiments, customized software can be used to generate the CAD model from the CT scan. The CAD model can include only the bone(s) to be treated and / or can include surrounding tissue. In an alternative embodiment, step 104 may be omitted since the CT scan can capture data that can be used directly in future steps without the need for conversion.

[0089] In one embodiment, the generated CAD model and / or a plan for performing a patient-specific instrument, implant, and / or surgical procedure can be enhanced by the use of advanced computer analysis systems, machine learning, and / or automation / artificial intelligence. For example, these techniques can be used to revise a series of steps for the procedure so that a more desirable outcome is achieved.

[0090] In step 106, the CAD model and / or CT scan data can be used to model patient-specific instruments that can be used to correct the state so that they exist in the patient's anatomical structure. In some embodiments, any known CAD program can be used to view and / or manipulate the CAD model and / or CT scan and generate one or more instruments that specifically match the size and / or shape of the patient's bone(s). In some embodiments, such instruments can include cutting guides that are attachable to one or more bones and have one or more resection features that facilitate resection of one or more bones according to a procedure such as arthroplasty or arthrodesis. In some embodiments, performing step 106 can include modeling an instrument having a bone augmentation surface that is shaped to match the contour of the bone surface so that the bone augmentation surface can be positioned directly on the corresponding contour.

[0091] In step 108, the model(s) can be used to manufacture patient-specific instruments and / or implants. This can be done via any known manufacturing method, including casting, forging, milling, additive manufacturing, etc. Additive manufacturing can offer unique advantages because the model can be used directly to manufacture the instrument and / or implant (without the need to generate molds, tool paths, etc. beforehand). Such instruments can optionally include a cutting guide having a bone augmentation surface and one or more of the resection features described above.

[0092] In addition to, or as an alternative to, step 108, a model(s) can be selected from available sized implants and / or instruments and used to advise the surgeon accordingly. For example, if a range of cutting guides are available for a given procedure, analysis of the CAD data can facilitate preoperative selection of the optimal cutting guide and / or optimal placement of the cutting guide on the bone. Similarly, if a range of implants can be used for a given procedure, analysis of the CAD data can facilitate preoperative selection of the optimal implant(s). More specifically, appropriate sized spacers, screws, bone plates, and / or other hardware can be selected preoperatively.

[0093] Accordingly, the result of step 108 can be one or more of the following preparations for the surgeon: (1) one or more patient-specific instruments, (2) one or more patient-specific implants, (3) an instrument selected from one or more available instrument sizes and / or configurations, (4) an implant selected from one or more available implant sizes and / or configurations, (5) instructions on which instrument(s) to select from available instrument sizes and / or configurations, (6) instructions on which implant(s) to select from available implant sizes and / or configurations, (7) instructions for proper positioning or anchoring of one or more instruments used in the procedure, and (8) instructions for proper positioning or anchoring of one or more implants used in the procedure. These can be provided directly to the surgeon or to a medical device company or representative for subsequent delivery to the surgeon.

[0094] In step 110, the manufactured instrument can be used in surgery to facilitate treatment of the condition. In some embodiments, this may involve placing a bone augmentation surface modeled to the corresponding contour of the bone used to obtain its shape and then using resection feature(s) to guide one or more bone resections. The bone(s) can 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 arthroplasty or fracture repair). Prior to completion of step 110, the instrument can be removed from the patient and the surgical wound can be closed.

[0095] As described above, method 100 can be used to correct a wide variety of bone conditions. An example of method 100 is shown and described in relation to FIG. 1B with respect to correction of hallux valgus deformity of the foot.

[0096] In certain embodiments, one or more of the disclosed methods, devices, and / or systems can be used to train a surgeon to perform patient-specific procedures or techniques. In one embodiment, the generated CAD model, and / or patient-specific instruments, implants, and / or plans for performing a surgical procedure can be used to train a surgeon to perform patient-specific procedures or techniques.

[0097] In one embodiment, a surgeon may submit a CT scan of a patient's foot to a device or system implementing the disclosed solution. Next, a manual or automated process may be used to generate a CAD model and perform the desired measurements and corrections on the patient. In the automated process, advanced computer analysis systems, machine learning, and automation / artificial intelligence may be used to generate a CAD model and / or one or more patient-specific instruments and / or a surgical plan. For example, a patient-specific cutting guide may be fabricated using computer-aided manufacturing (CAM) tools that are aligned to the patient's anatomical structure. Additionally, CAM tools may be used to fabricate a 3D structure representing the patient's anatomical structure, referred to herein as a patient-specific cadaver. (such as one or more bones of the patient's foot). Next, the patient-specific cutting guide and the patient-specific cadaver may be provided to the surgeon, who can fully rehearse the surgical procedure before entering the operating room with the patient.

[0098] In certain embodiments, the patient-specific cutting guide may be used to pre-position and pre-drill a plate system for fixation purposes. Such a plate system may be optimally positioned for each CT scan after a corrective procedure for optimal fixation outcome. In another embodiment, CAD models and / or automated processes such as advanced computer analysis systems, machine learning, and automation / artificial intelligence may be used to measure the depth of each cut through a patient-specific cutting guide for use in a robotic device and / or system that controls the depth of each cut within the guide to protect important structures under or adjacent to the bone being cut. In another embodiment, CAD models and / or automated processes such as advanced computer analysis systems, machine learning, and automation / artificial intelligence may be used to define the length and / or trajectory of a desired fastener (e.g., a bone screw) through a patient-specific cutting guide and / or implant. Such lengths, trajectories, and component details may be detailed in a report provided to the surgeon preparing to perform the procedure.

[0099] Figure 1B is a flowchart diagram illustrating a method 120 for correcting hallux valgus deformity of a human foot according to one embodiment. The method 120 can be used to perform an arthrodesis in which the first midtarsal cuneiform joint is removed and the first cuneiform bone and the first midtarsal bone are fixed together in a manner that properly aligns the first midtarsal bone to provide correction of the deformity.

[0100] As shown, method 120 can begin at step 122 where a CT scan (or other three-dimensional image) of the patient's foot is obtained. Step 122 can involve capturing a scan of only the first cuneiform bone and the first midtarsal bone, or can involve capturing additional anatomical information such as the entire foot. Additionally or alternatively, step 122 can involve receiving pre-captured image data. Capturing the entire foot at step 122 can facilitate proper alignment of the first midtarsal bone with the rest of the foot (e.g., with the second midtarsal bone). Performing step 122 can result in a three-dimensional model of the patient's foot, or the generation of three-dimensional surface points that can be used to construct such a three-dimensional model.

[0101] After step 122 is executed, method 120 can proceed to step 124 where a CAD model of the relevant portion of the patient's anatomical structure is generated. The CAD model can optionally include the bones of the entire foot, such as the CT scan obtained at step 122. In an alternative embodiment, step 124 can be selected and omitted by directly utilizing the CT scan data as described in connection with step 104.

[0102] In step 126, the CAD model and / or CT scan data can be used to model a patient-specific instrument that can be used to correct hallux valgus deformity. Such an instrument can include a cutting guide that is attachable to the first cuneiform and the first midfoot bone and has two resection features that facilitate resection of the cuneiform and midfoot bones in preparation for arthrodesis. In some embodiments, the implementation of step 126 can include modeling the cutting guide using a bone augmentation surface that is shaped to conform to the contours of the surfaces of the cuneiform and midfoot bones such that the bone augmentation surface can be positioned directly on the corresponding contours of the first cuneiform and the first midfoot bone.

[0103] In step 128, the model(s) can be used to manufacture the patient-specific instrument and / or instruments. This can include manufacturing a cutting guide having a bone augmentation surface and resection features as described above. Similar to step 108, step 128 can additionally or alternatively involve preparing one or more instruments and / or implants from among a plurality of predetermined configurations or sizes. Further, step 128 can additionally or alternatively involve preparing instructions for the placement and / or anchoring of one or more instruments and / or instruments for performing the procedure.

[0104] In step 130, the manufactured cutting guide can be used surgically to facilitate treatment of the condition. Specifically, the bone addition surface of the cutting guide can be positioned against the corresponding contours of the first cuneiform bone and the first midfoot bone. The resection features (e.g., slots) can then be positioned on either side of the joint between the first cuneiform bone and the first midfoot bone to guide the resection of the first midfoot bone and the first cuneiform bone and remove the intervening joint. The cutting guide can then be removed, and the remaining portions of the first cuneiform bone and the first midfoot bone can be positioned to abut against each other. The cutting guide can be shaped such that the cuts made to the first cuneiform bone and the first midfoot bone are properly oriented to return the first midfoot bone to its proper orientation relative to the rest of the foot. The first cuneiform bone and the first midfoot bone can be secured together using a bone plate or the like. The surgical wound can be closed to allow the foot to heal and to allow the first cuneiform bone and the first midfoot bone to fuse together.

[0105] Methods 100 and 120 are merely exemplary. Those skilled in the art will recognize that the various steps of methods 100 and 120 can be rearranged, omitted, and / or supplemented with additional steps not specifically shown or described herein.

[0106] As described above, method 120 is a type of method 100, and the present disclosure encompasses many different procedures that are 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 FIGS. 2-7D. Those skilled in the art will recognize that method 120 can be used in connection with different instruments, and similarly, the instruments of FIGS. 2-7D can be used in connection with methods different from methods 100 and 120.

[0107] FIG. 2A is a perspective dorsal view of the foot 200. The foot 200 may have, inter alia, a medial cuneiform 202, an intermediate cuneiform 204, a lateral cuneiform 206, a first midfoot bone 208, a second midfoot bone 210, a third midfoot bone 212, a fourth midfoot bone 214, a fifth midfoot bone 216, a navicular bone 218, a cuboid bone 220, a talus bone 222, and a calcaneus bone 224. The medial cuneiform 202 and the intermediate cuneiform 204 may be joined together at the first midfoot bone cuneiform joint, and the first midfoot bone 208 and the second midfoot bone 210 may be joined together at the second midfoot bone cuneiform joint. The foot 200 includes a set of first to fifth numbered proximal phalanges (230, 232, 234, 236, 238), a set of first to fifth numbered distal phalanges (240, 242, 244, 246, 248), and a set of second to fifth numbered middle phalanges (250, 252, 254, 256).

[0108] FIG. 2B is a perspective lateral view of the foot 200 with the bones of the foot labeled.

[0109] FIG. 2C is a perspective medial view of the foot illustrating a dorsal side 280 and a bottom side 282. As illustrated, the foot 200 may have, inter alia, a tibia 226 and a fibula 228. The dorsal side refers to the top of the foot. The bottom side refers to the bottom of the foot. The proximal 284 is defined as "near the primary attachment point". The distal 286 is defined as "far from the attachment point". Plantarflex (or plantarflexion) 288 means movement towards the bottom side 282 of the foot or hand, towards the sole or palm of the foot or hand. Dorsiflex (or dorsiflexion) means movement towards the dorsal side 278 of the foot or hand, towards the top. FIG. 2D is a perspective dorsal view of the foot 200. The cross-section is a plane showing the top of the foot. The lateral 292 means the side that is farthest from the midline of the body or farthest from the plane of bilateral symmetry of the body. The medial 294 means the side that is closest to the midline of the body or towards the plane of bilateral symmetry of the body. In the case of a Lapidus procedure, the intermetatarsal (IM) angle 296 is the angle that is corrected to remove a bunion deformity.

[0110] FIG. 2E is a view of a foot illustrating a common reference plane 260 for a human foot. FIG. 2E illustrates a sagittal plane 262 that divides the foot into right and left halves. The sagittal plane 262 is perpendicular to the frontal or coronal plane 264 and the transverse plane 266. In the foot, the frontal plane 264 generally runs vertically through the ankle, and the transverse plane 266 generally runs horizontally through the midfoot and toes of the foot.

[0111] FIG. 2F is a perspective view of a portion of a foot 200 having a hallux valgus deformity that is treated through the use of the method 100 (more specifically, method 120) described above. The foot 200 may have a medial cuneiform 202, an intermediate cuneiform 202, a first midfoot bone 208, and a second midfoot bone 210. The medial cuneiform 202 and the first cuneiform 208 may be joined together at the first midfoot bone cuneiform joint, and the intermediate cuneiform 202 and the second midfoot bone 210 may be joined together at the second midfoot bone cuneiform joint.

[0112] The first midfoot bone 208 is overly angled in the medial direction 270 (i.e., toward the lower left corner of the page), causing a painful protrusion at the distal end 272 of the first midfoot bone 208, and further, may overly angle a phalanx (not shown) attached to the distal end 272 in the lateral direction 274 (i.e., pointing toward the other phalanges of the foot rather than straight ahead). The excessive medial angulation of the first midfoot bone 208 may also result in an excessive gap between the first midfoot bone 208 and the second midfoot bone 210.

[0113] The first midfoot bone 208 may be further offset in the bottom side direction 276 or the dorsal direction 290 with respect to the rest of the foot 200. Thus, the orientation of the first midfoot bone 208 may need to be adjusted to move the distal end 272 in the lateral direction 274, the bottom side direction 276, and / or the dorsal direction 278.

[0114] All deformities are different, and thus the degree of angular adjustment required in each direction can vary from patient to patient. The use of a patient-specific cutting guide can assist the surgeon in obtaining optimal realignment in the lateral direction 274 and the bottom direction 276 or the dorsal direction 278. Conversely, since the surgeon may not have a guide that precisely matches the correction required for the foot 200, the use of one of several different sized cutting guides can provide only approximate correction, and thus the surgeon must select the cutting guide that most closely provides the desired correction. Such differently sized cutting guides are not contoured to fit the medial cuneiform 202 or the first midfoot bone 208, and thus introduce an additional potential for error since the surgeon must properly align the selected cutting guide.

[0115] Accordingly, providing a patient-specific cutting guide can provide unique advantages. Specifically, a patient-specific cutting guide can provide precise correction of the deformities present in the foot 200 and can reduce the likelihood of improper correction due to misalignment of the cutting guide on the foot 200. The optimal cut provided by such a cutting guide can further reduce the likelihood that additional procedures, such as the attachment of the first midfoot bone 208 to the second midfoot bone 210 using screws or the like, are required to provide the desired correction. Any such additional procedures carry their own additional surgical burden and risk of failure. Thus, the use of a patient-specific instrument can shorten the surgery, accelerate recovery, and reduce the risk of complications.

[0116] Figures 3A - 19H are, respectively, top perspective views, top perspective views, bottom views, front views, rear views, right views, left views, and alternative top perspective views of a patient-specific cutting guide, or cutting guide 300, according to one alternative embodiment.

[0117] The cutting guide 300 can be designed to facilitate resection of the first cuneiform near the distal end and the first midfoot bone near the proximal end to provide dual-plane correction of the orientation of the first midfoot bone relative to the first cuneiform, thereby providing correction in the lateral direction, the bottom direction, and / or the dorsal direction.

[0118] As shown, the cutting guide 300 may have a monolithic construction and have a body 310 with a generally rectangular prism shape. As used herein, "body" refers to the main or central part of a structure. The body may function as a structural component for connecting, interconnecting, surrounding, and / or protecting one or more other structural components. The body may be made of various materials including, but not limited to, metal, plastic, ceramic, wood, fiberglass, acrylic, carbon, biocompatible materials, biodegradable materials, etc. The body may be formed from any biocompatible material including, but not limited to, titanium, titanium alloys, stainless steel alloys, cobalt-chromium steel alloys, nickel-titanium alloys, shape memory alloys such as nitinol, biocompatible ceramics, and biocompatible polymers such as polyetheretherketone (PEEK) or polylactide polymers (e.g., PLLA), and / or others. In one embodiment, the body may include a housing or frame or framework for a larger system, component, structure, or device. The body may include modifiers that identify a particular function, location, orientation, operation, and / or particular structure associated with the body. Examples of such modifiers applied to the body include, but are not limited to, "lower body", "upper body", "outer body", "inner body", etc.

[0119] The body 310 includes a proximal side 312, a distal side 314, an inner side 316, an outer side 318, an upper side 320, and a lower side 322. In the illustrated embodiment, the body 310 may also include a proximal arm 330 extending from the body 310 and a distal arm 340 extending from the body 310. The proximal side 312 is the side closest to the patient's torso when the cutting guide 300 is being used. The distal side 314 is the side farthest from the patient's torso when the cutting guide 300 is being used. The inner side 316 is the side that faces inward when the cutting guide 300 is being used. The outer side 318 is the side that faces outward when the cutting guide 300 is being used. The upper side 320 is the side that faces upward and away from the bone(s) when the cutting guide 300 is being used. The lower side 322 is the side that faces downward, faces, and / or contacts (e.g., contacts the surface of one or more bones) the bone(s) when the cutting guide 300 is being used.

[0120] The lower side 322 may be custom contoured to conform to the shape of one or more of the surfaces of the first cuneiform bone and / or the first midfoot bone. In one embodiment, the lower side 322 may include a bone engagement surface 324. The bone engagement surface 324 may be shaped to match the first surface of the first bone of the joint with the second surface of the second bone.

[0121] "Bone-engaging surface" refers to the surface or other feature of an object, instrument, or device, such as an implant, that is oriented toward, faces, or contacts one or more bones of a patient. In one aspect, the bone-engaging surface can abut, touch, or contact the surface of a bone. In another aspect, the bone-engaging surface, or a portion of the bone-engaging surface, can be close to but not abut, touch, or contact the surface of a bone. In certain aspects, the bone-engaging surface can be configured to engage the surface of one or more bones. Such a bone-engaging surface can correspond to and include protrusions and recesses that match the protrusions and recesses of the one or more bone surfaces. As used herein, matching protrusions and recesses means that the protrusions on one structure are substantially the same size and shape as the corresponding recesses of the other structure such that when the two structures are in contact or close proximity, each protrusion of one structure seats / locates / fits within the recess of the other structure. The bone-engaging surface can include flat portions of the side or surface, contoured portions of the side or surface, protrusions and / or recesses of the side or surface, or any combination thereof. Such variations in the fabrication and configuration of the bone-engaging surface can exist within a single embodiment or in separate embodiments. Put another way, the bone-engaging surface is a surface that is a mirror image of the surface of the bone on the opposite side where the bone-engaging surface abuts, touches, and / or contacts.

[0122] "Joint" or "articulation" refers to the connection that occurs between bones within the body of a human or animal that connects the skeletal system to form a functional whole. Joints can be biomechanically classified as simple joints, compound joints, or complex joints. Joints can be anatomically classified into groups such as hand joints, elbow joints, wrist joints, axillary joints, sternoclavicular joints, vertebral joints, temporomandibular joints, sacroiliac joints, hip joints, knee joints, foot joints, etc. (Searched "joint" on Wikipedia.com on December 19, 2021. CC-BY-SA 3.0 licensed. Accessed on January 20, 2022.)

[0123] In one example, the bone engagement surface 324 can be shaped such that the bone engagement surface 324 conforms to the surface of the cuneiform bone and the surface of the intermediate cuneiform bone of the tarsometatarsal (「TMT」) joint. Since the bone engagement surface 324 is fabricated from a bone model of the patient's bone, it can be shaped in such a way. The body 310 is configured, designed, and / or fabricated to seat across a joint (e.g., the TMT joint) where the bone engagement surface 324 engages the first surface of the first bone and the second surface of the second bone.

[0124] In one embodiment, the body 310 is configured to be present on the dorsal surfaces of the first cuneiform bone and the first intermediate cuneiform bone to provide proper alignment of the body 310 with the intermediate cuneiform bone joint (e.g., the joint between the first intermediate cuneiform bone and the medial cuneiform bone, also known as the TMT joint). In another embodiment, the body 310 is configured to be present between, or on, the medial and dorsal surfaces of the first cuneiform bone and the first intermediate cuneiform bone to provide proper alignment of the body 310 with the intermediate cuneiform bone joint (e.g., the joint between the first intermediate cuneiform bone and the medial cuneiform bone).

[0125] In certain embodiments, the bone engagement surface 324 can include a cuneiform bone addendum 326 and an intermediate cuneiform bone addendum 328. As shown, the cuneiform bone addendum 326 can be contoured to match the contour of the surface of the first cuneiform bone on which it is placed, and the intermediate cuneiform bone addendum 328 can similarly be contoured to match the contour of the surface of the first intermediate cuneiform bone on which it is placed. (See FIG. 3C.) Thus, the body 310 can have only one stable position and orientation with respect to the first cuneiform bone and the first intermediate cuneiform bone during a surgical osteotomy to correct the condition.

[0126] Advantageously, the fidelity of the patient image data enables the bone model, the pre-cut guide model, and the patient-specific instrument (e.g., the patient-specific cutting guide, the patient-specific pin guide, the patient-specific alignment guide, etc.) to uniquely match a particular patient. Thus, the bone engagement surface 324 can engage the bone surfaces of the joint in a single configuration. Such a closely matching fit facilitates the surgical osteotomy.

[0127] FIG. 3D illustrates the cutting guide 300 from a perspective facing the inner side 316. FIG. 3E illustrates the cutting guide 300 from a perspective facing the outer side 318. In certain embodiments, the cutting guide 300 may include one or more features that facilitate the use of the cutting guide 300 while avoiding certain soft tissues near the joint. For example, the inner side 316 may include an inner upper surface 332 and an inner lower surface 334 that intersect at an inner edge 336. Advantageously, the inner lower surface 334 may extend from the lower side 322 to the inner edge 336 at an angle such that the inner lower surface 334 does not impinge on soft tissue near the joint (e.g., near the inner end of the joint). In certain embodiments, the angle may range from about 80 degrees to about 170 degrees. In another example, the outer side 318 may include an outer upper surface 342 and an outer lower surface 344 that intersect at an outer edge 346. Of course, the inner upper surface 332 may extend from the upper side 320 to the inner edge 336 at an angle. The angle of the inner upper surface 332 may enable the use of the cutting guide 300 in a more compact opening and thus may minimize the size of the incision used in the procedure.

[0128] Advantageously, the outer lower surface 344 may extend from the lower side 322 to the outer edge 346 at an angle such that the outer lower surface 344 does not impinge on soft tissue near the joint (e.g., near the inner end of the joint). In certain embodiments, the angle may range from about 80 degrees to about 170 degrees. Of course, the outer upper surface 342 may extend from the upper side 320 to the outer edge 346 at an angle. The angle of the outer upper surface 342 may enable the use of the cutting guide 300 in a more compact opening and thus may minimize the size of the incision used in the procedure.

[0129] The body 310 may further include a resection feature that guides a cutter to resect the first cuneiform bone and the first midfoot bone in a manner necessary to effect the desired correction. For example, the resection feature may be used to guide a flat cutting blade, an arcuate cutting blade, a drill or mill, a bar, or the like.

[0130] In the embodiments of FIGS. 3A-3H, the resection feature may guide a reciprocating planar blade, such as a surgical bone saw, that forms a planar cut in the first cuneiform bone and the first midfoot bone. A variety of manual or power tools may be used to form the planar cut. In one embodiment, a sagittal saw may be used. In one example, the resection feature may take the form of a first slot 360 and a second slot 370. The first slot 360 may include an outer end 362 and an inner end 364. The second slot 370 may include an outer end 372 and an inner end 374.

[0131] In one embodiment, the first slot 360 and the second slot 370 extend from an upper side 320 to a lower side 322. In certain embodiments, the first slot 360 may extend from near the outer side 318 to near the inner side 316. In other embodiments, one or both of the first slot 360 and the second slot 370 may extend from one of the inner side 316 or the outer side 318 of the body 310. In certain embodiments, the first slot 360 intersects the second slot 370. In other embodiments, the first slot 360 and the second slot 370 do not intersect.

[0132] Thus, when the cutting guide 300 is positioned as desired, the second slot 370 may be positioned over at least a portion of the first cuneiform bone to facilitate resection of the first cuneiform bone, while the first slot 360 may be positioned over at least a portion of the first midfoot bone to facilitate resection of the first midfoot bone. In one embodiment, the second slot 370 is positioned near the distal end of the first cuneiform bone and the first slot 360 is positioned near the proximal end of the first midfoot bone. The first slot 360 and the second slot 370 are positioned together with the bone engagement surface 324 overlapping the first cuneiform bone and the first midfoot bone to guide resection of the first cuneiform bone and the first midfoot bone during a surgical osteotomy to correct the condition.

[0133] In an alternative embodiment, the resection feature may be designed to guide different types of cutters such as drills, mills, or side cutters. In such an embodiment, the resection feature may not be a slot, but instead may be a translatable or rotatable cutter retainer that guides the translation and / or rotation of the cutter relative to the bone. In certain embodiments, two or more resection features may be replaced by a single resection feature sized to enable a surgeon to resect both the first cuneiform bone and the first metatarsal bone using the cutting guide 300.

[0134] In one embodiment, the first resection feature is configured to define a first cutting surface that may be formed by resecting a first bone. The second resection feature is configured to define a second cutting surface that may be formed by resecting a second bone. In such an embodiment, one or both of the first cutting surface and the second cutting surface may be oriented at one or more angles relative to landmarks on the bone or other anatomical structures.

[0135] Alternatively, or additionally, in certain embodiments, one or both of the first resection feature and the second resection feature may be positioned on or within the body 310 and / or may have an orientation based on patient image data. The patient image data may be used to position and orient one or both of the first resection feature and the second resection feature such that formation of one or both of the first cutting surface and the second cutting surface, and fixation of the two cutting surfaces relative to each other, mitigate the patient's condition. For example, as described in the present disclosure, the patient image data may be used to generate a bone model of the patient's bone. The bone model may be used to determine and / or define the contour of the bone engagement surface 324, the position of the first slot 360, the orientation of the first slot 360, the position of the second slot 370, the orientation of the second slot 370, and other features and attributes of one or more patient-specific instruments that may be used in the procedure.

[0136] "Cut surface" refers to the surface of an object created or formed by the removal of one or more portions of an object including the original surface. The cut surface can be created using various methods, tools, or apparatuses, and can be formed using various removal actions including, but not limited to, windowing, drilling, polishing, cutting, sawing, planing, excavation, shaving, etc. The tools and / or methods used to form the cut surface can include manual, mechanical, electric, hydraulic, automated, robotic, etc. In certain embodiments, the cut surface(s) is / are planar.

[0137] "Orientation" refers to the direction, angle, position, state, temporary state, 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.

[0138] FIG. 4 illustrates an embodiment of a cutting guide 300 secured to the first intermediate cuneiform 208 and the medial cuneiform 202. In the illustrated embodiment, the first resection feature may take the form of a first slot 360, and the second resection feature may take the form of a second slot 370. Referring now to FIGS. 4 and 3D, the position and / or angle (e.g., orientation) of one or both of the resection features based on the patient image data is illustrated. In the illustrated embodiment, the first slot 360 is positioned between the distal side 314 and the second slot 370. The first slot 360 is oriented based on a desired angle to ease the patient's condition. In one example, the first slot 360 is angled perpendicular to the longitudinal axis of the first intermediate cuneiform 208. This orientation of the first slot 360 allows the first cutting surface to extend from the body 310 toward the bone to form a cutting surface that is also perpendicular to the longitudinal axis 376 of one of the bones of the joint. "Longitudinal axis" refers to the axis of a structure, device, object, apparatus, or a portion thereof that extends from one end of the longest dimension to the opposite end. Typically, the longitudinal axis passes through the center of the structure, device, object, apparatus, or a portion thereof along the longitudinal axis. The center point used for the longitudinal axis may be a geometric center point and / or a center of mass point. In the illustrated embodiment, the longitudinal axis 376 is the longitudinal axis of the first intermediate cuneiform 208.

[0139] In the illustrated embodiment, the second slot 370 is positioned between the proximal side 312 and the first slot 360. In addition to the illustrated embodiment, the second slot 370 is oriented based on a desired angle for alleviating the patient's condition. In the illustrated embodiment, the orientation of the second slot 370 can be described with reference to a first angle A and a second angle B. FIG. 3D illustrates the first angle A. In one embodiment, the second cut surface formed by resection using the second slot 370 extends downward from the first cut surface formed by resection using the first slot 360. Stated another way, the angle A is the angle between a first plane 378 that includes the first slot 360 and the first cut surface formed by resection using the first slot 360, and a second plane that includes the second slot 370 and the second cut surface formed by resection using the second slot 370, and the second plane extends from the first plane toward the proximal side 312 of the body 310. In a particular embodiment, the angle A can range from about 4 degrees to about 18 degrees. In a particular embodiment, the angle A can start at 0 degrees and then increase to a positive degree or decrease to a negative degree as illustrated, depending on how the surgeon may prescribe an adjustment for correction.

[0140] FIG. 3H illustrates a second angle B. In one embodiment, a second cut surface formed by resection using the second slot 370 extends posteriorly from a first cut surface formed by resection using the first slot 360. Stated another way, in the illustrated embodiment, the angle B is an angle between a first plane 378 that includes the first slot 360 and the first cut surface formed by resection using the first slot 360, and a third plane 381 that includes the second slot 370 and the second cut surface formed by resection using the second slot 370, and the third plane 381 extends from the first plane toward the proximal side 312 of the body 310. In a particular embodiment, the angle B can be in the range of about 0 degrees to about 35 degrees. In a particular embodiment, the angle B starts at 0 degrees and then can increase to a positive degree or decrease to a negative degree as illustrated, depending on how the surgeon may prescribe adjustments for correction.

[0141] One of ordinary skill in the art will understand that the positions and orientations of the first slot 360 and the second slot 370, and the corresponding cut surfaces that a surgeon may form using these resection features, can vary depending on the patient's anatomy, the osteotomy procedure being performed, the surgeon's preference, the nature of the condition, and the like. For example, in the illustrated embodiment, the inner end 364 of the first slot 360 is closer to the inner end 374 of the second slot 370 than the outer end 362 is to the outer end 372. In another embodiment, the outer end 362 of the first slot 360 may be closer to the outer end 372 of the second slot 370 than the inner end 364 is to the inner end 374. Of course, in another embodiment, the first slot 360 and the second slot 370 can be configured such that a first distance between the outer end 362 and the outer end 372 and a second distance between the inner end 364 and the inner end 374 are substantially the same.

[0142] Referring to FIG. 3D, in one embodiment, anatomical data regarding a patient may be used to define the cutting guide 300 or other structures of other patient-specific instruments. For example, anatomical data regarding a patient that may be incorporated into patient image data may be used to define how deep the first resection feature and / or the second resection feature is (e.g., due to the fidelity of the technology providing the patient image data). Controlling the depth of the first resection feature and / or the second resection feature may be used to manage how deep the surgeon's cutting instrument can reach within the first resection feature and / or the second resection feature. Managing the depth of one or more resection features may be referred to as defining the patient-specific height relative to the cutting guide 300.

[0143] For example, in one embodiment, patient image data may be used to define the distance between the first upper edge 366 (e.g., the first slot 360) of the first resection feature and the first surface (e.g., the surface of the first bone such as the first intermediate cuneiform 208). Alternatively, or additionally, patient image data may be used to define the distance between the second upper edge 368 (e.g., the second slot 370) of the second resection feature and the second surface (e.g., the surface of the second bone such as the medial cuneiform 202). Managing the distance between the first upper edge 366 and / or the second upper edge 368 and the bone surface is one way to provide a stop within the cutting guide 300. The stop may function to limit the depth to which the surgeon excises hard / soft tissue when using the cutting guide 300 for the procedure. If the surgeon excises until the cutting instrument engages the stop, the surgeon can be confident that the excision extends to the desired depth (not too far and not too short).

[0144] As used herein, a "stop" refers to a device, instrument, structure, member, device, component, system, or assembly that is structured, organized, configured, designed, arranged, or operated to prevent, limit, impede, stop, or restrict the movement and / or operation of another object, member, structure, component, part, device, system, or assembly.

[0145] Referring to FIGS. 3H and 4, in one embodiment, the body 310, or one or more arms, may include one or more bone attachment features that facilitate attachment of the body 310 to the medial cuneiform 202 and / or the first intermediate cuneiform 208. Such bone attachment features may include any of a variety of fasteners, including but not limited to holes, spikes, fastening devices, and the like.

[0146] Effective connection of the cutting guide 300 to one or more bones across the joint can ensure that the cutting surface is formed at the desired location and orientation, and can reduce removal of hard and / or soft tissue outside of the desired location.

[0147] Accordingly, the cutting guide 300 includes one or more bone attachment features. As embodied in FIGS. 3A - 3H, the bone attachment features may take the form of one or more holes 350 extending from the lower surface 322 to the upper surface 320 and / or one or more fixing devices. The holes 350 may be shaped to receive pins, K - wires, and / or other elongate bone fixation elements that may be fixed to the medial cuneiform 202 and / or the first intermediate cuneiform 208 to hold the cutting guide 300 in a predetermined position.

[0148] Figure 4 illustrates an example of a cutting guide 300 coupled to bone using proximal bone attachment features 352 and distal bone attachment features 354. In the illustrated embodiment, proximal bone attachment feature 352 includes at least holes 350 and fasteners, and distal bone attachment feature 354 includes at least holes 350 and fasteners. In Figure 4, the fasteners are K-wires. Advantageously, proximal bone attachment feature 352 and distal bone attachment feature 354 each include at least two holes 350, each having a K-wire passing therethrough and entering the bone facing the underside 322. Using two holes 350 and two fasteners ensures a stable connection between cutting guide 300 and the bone(s). Advantageously, in certain embodiments, the two holes 350 of proximal bone attachment feature 352 and distal bone attachment feature 354 are aligned such that the inserted K-wires are parallel to each other. Among other advantages, the parallel K-wires of each of proximal bone attachment feature 352 and distal bone attachment feature 354 prevent cutting guide 300 from pivoting around one of the K-wires of proximal bone attachment feature 352 or distal bone attachment feature 354.

[0149] In the illustrated embodiment, proximal arm 330 includes proximal bone attachment feature 352 and distal arm 340 includes distal bone attachment feature 354. In one embodiment, the holes 350 of proximal bone attachment feature 352 are aligned with each other and perpendicular to an excision feature such as second slot 370. The holes 350 of distal bone attachment feature 354 may also be aligned with each other and perpendicular to another excision feature such as first slot 360. This means that the aligned holes 350 (and the K-wires fixed therein) of distal bone attachment feature 354 will also be perpendicular to the cut surface formed using first slot 360. This also means that the aligned holes 350 (and the K-wires fixed therein) of proximal bone attachment feature 352 will also be perpendicular to the cut surface formed using second slot 370. As a result, at least one of proximal bone attachment feature 352 and distal bone attachment feature 354 can be used to position and orient the cut surface of first intermediate phalanx 208 and the cut surface of medial cuneiform 202.

[0150] Returning to FIGS. 3A-4, the body 310 may further have features that facilitate the desired translation and orientation of the first intermediate phalanx 208 and / or the medial cuneiform 202 to fuse or join the two bones to complete the procedure. For example, in the illustrated embodiment, the cutting guide 300 may include at least one alignment feature. The second alignment feature may be integrated with the cutting guide 300, or the second alignment feature may be a separate feature from the cutting guide 300.

[0151] In the illustrated embodiment, the proximal bone attachment feature 352 functions as both a bone attachment feature and an alignment feature, such as a proximal alignment feature 380. In this way, the proximal bone attachment feature 352 may provide both a bone attachment feature and an alignment feature with a single feature. In situations where the second bone of the joint, such as the first intermediate phalanx 208, does not need to be rotated, translated, and / or reoriented to relieve the patient's condition, the distal bone attachment feature 354 may also function as both a bone attachment feature and an alignment feature, such as a distal alignment feature 390.

[0152] Typically, in osteotomy for conditions such as hallux valgus, it is desirable to rotate the first intermediate phalanx 208 to address the condition. The first intermediate phalanx 208 can be rotated, for example, to reposition the distal sesamoid bone from a lateral orientation to a more plantar direction. Studies have shown that performing such reorientation alleviates the recurrence of hallux valgus conditions. In such situations, the distal bone attachment feature 354 can function as a bone attachment feature and as a reference for positioning the distal alignment feature 390, which is separated from the cutting guide 300.

[0153] For example, in such cases, the distal bone attachment feature 354 can function as a reference for the placement of a distal alignment feature 390 (see FIG. 4A) that is parallel to the distal bone attachment feature 354 as measured along the longitudinal axis 376 of the first midfoot bone 208. Following the formation of the cut surface on the first midfoot bone 208, the distal alignment feature 390 can be coupled to the first midfoot bone 208 parallel to the distal bone attachment feature 354 (e.g., via a pin guide). In certain embodiments, the distal alignment feature 390 can include two or more aligned holes and / or a pair of K-wires that enter the bone parallel to each other. Additionally, in such situations, the proximal alignment feature 380 and the distal alignment feature 390 may not need to be aligned initially. Instead, the proximal alignment feature 380 and the distal alignment feature 390 can be configured to align as the bone coupled to the distal alignment feature 390 rotates. The fastener 356 of the distal bone attachment feature 354 can be aligned with the longitudinal axis 376 and perpendicular to the first slot 360 through the hole 350. The fastener 356 of the proximal bone attachment feature 352 can be aligned with the reference line 392 and perpendicular to the second slot 370 through the hole 350. The reference line 392 may not be aligned with the long axis 376.

[0154] FIG. 4 illustrates an exemplary cutting guide 300 seated across the talo-metatarsal (「TMT」) joint 400. The TMT joint 400 includes an outer end 402 and an inner end 404. In certain embodiments, such as the illustrated embodiment, the body 310 is configured to extend between the outer end 402 and the inner end 404. Additionally, the proximal arm 330 and the distal arm 340 can be aligned with each other.

[0155] Further, in certain embodiments, the proximal arm 330 and the distal arm 340 can extend and be positioned from the body 310 near the outer end 402 (see FIG. 6). In other words, the proximal arm 330 and the distal arm 340 can extend and be positioned from the body 310 such that the arms extend over the dorsal surfaces of the medial cuneiform bone 202 and the first midfoot bone 208. In another embodiment, the proximal arm 330 and the distal arm 340 can extend and be positioned from the body 310 near the inner end 404.

[0156] Figure 4 illustrates an exemplary cutting guide 300 at a particular stage of an osteotomy procedure. In one embodiment, a surgeon is creating an incision that transects the TMT joint 400 via a dorsal approach. In the illustrated embodiment, the cutting guide 300 may be configured to seat between the dorsal and medial surfaces of both the medial cuneiform 202 and the first metatarsal 208 (e.g., the bone engagement surface 324). The surgeon has also created an incision down to the cortical bone surfaces of the medial cuneiform 202 and the first metatarsal 208. Further, the surgeon cuts or retracts the soft tissue covering the cortical bone surfaces of the medial cuneiform 202 and the first metatarsal 208, or moves it laterally, sufficient to seat the bone engagement surface 324 on the cortical bone surfaces of the medial cuneiform 202 and the first metatarsal 208.

[0157] The surgeon deploys two or more fasteners 356 (e.g., K-wires) through the holes 350 of the proximal bone attachment feature 352 and the distal bone attachment feature 354. In certain embodiments, the distal bone attachment feature 354 and / or the proximal bone attachment feature 352 may include additional holes 358 for another fastener 356. The additional holes 358 and fasteners 356 may help maintain the cutting guide 300 in a predetermined position during the resection and alignment operations. In certain embodiments, the additional holes 358 are aligned with the two holes 350 of the distal arm 340, but need not be aligned.

[0158] Next, the surgeon may resect the distal articular surface of the medial cuneiform 202 and the proximal articular surface of the first metatarsal 208 via the second slot 370 and the first slot 360. After resection, the distal end of the medial cuneiform 202 includes a planar cut surface, and the proximal end of the first metatarsal 208 includes a planar cut surface. Figure 4 illustrates the bone engagement surface 324 conforming to the surfaces of the two bones (e.g., the medial cuneiform 202 and the first metatarsal 208).

[0159] FIG. 5A and FIG. 5B illustrate perspective views of the first cuneiform bone and the first midfoot bone according to one embodiment of a patient-specific cutting guide. Before resection is completed at the illustrated stage of FIG. 4, the surgeon may desire to check or confirm that the desired cutting guide is being used and that the selected cutting guide will provide the desired alignment between the bones of the foot after the resection and fixation steps.

[0160] Thus, in the illustrated embodiment, the cutting guide 300 may include one member of the coupler 410 configured to engage a corresponding member of the coupler coupled to the alignment guide 420. Those skilled in the art will understand that various designs of the coupler may be used. In the illustrated embodiment, the coupler 410 includes an opening 412 (see FIG. 20) that may extend within the body 310 from the upper side 320 to the lower side 322, and a support 414. In one embodiment, the opening 412 may include one of the slots such as the second slot 370. The support 414 may include an engagement member 416.

[0161] In one embodiment, the opening 412 and the support 414 engage each other by a friction fit. For example, the support 414 may slide within the second slot 370, and the engagement member 416 may slide within the opening 412. In one embodiment, the engagement member 416 may include a tab that is biased outwardly to engage the opening 412 when inserted and to release the opening when the tabs are pushed together, and the tab may be larger than the diameter of the opening 412.

[0162] The alignment guide 420 includes a body 422, a lower end 424, and an upper end 426, and one or more openings 428 near the upper end 426. The openings 428 can be aligned. A surgeon can use the alignment guide 420 by engaging a coupler 410 to couple the alignment guide 420 to the cutting guide 300. The surgeon can then insert one or more K-wires through the openings. The openings 428 and the alignment guide 420 can be configured such that the K-wires within the openings extend along the anteroposterior axis and, when the osteotomy is complete, indicate the orientation and alignment of the medial cuneiform 202 and the first metatarsal 208. The surgeon can compare this alignment to the orientation and alignment of other bones of the patient. In this way, the surgeon can confirm that the desired outcome is achieved when the osteotomy procedure is complete.

[0163] 6A-6C are, respectively, a top perspective view, a top view, and a bottom view of a patient-specific cutting guide 600 according to one embodiment. The cutting guide 600 can be designed to facilitate resection of the first cuneiform near the distal end and the first metatarsal near the proximal end to provide dual-plane correction of the orientation of the first metatarsal relative to the first cuneiform, thereby providing correction in the lateral, plantar, and / or dorsal directions.

[0164] As shown, the cutting guide 600 can have a monolithic construction and a body 610 having a generally rectangular shape. The body 610 includes a proximal side 612, a distal side 614, an inner side 616, an outer side 618, an upper side 620, and a lower side 622. In the illustrated embodiment, the body 610 can also include a proximal arm 630 extending from the body 610 and a distal arm 640 extending from the body 610. The proximal side 612 is the side closest to the patient's torso when the cutting guide 600 is in use. The distal side 614 is the side farthest from the patient's torso when the cutting guide 600 is in use. The inner side 616 is the side that faces inward when the cutting guide 600 is in use. The outer side 618 is the side that faces outward when the cutting guide 600 is in use. The upper side 620 is the side that faces upward away from the bone(s) when the cutting guide 600 is in use. The lower side 622 is the side that faces downward, faces, and / or contacts the bone(s) (e.g., contacts the surface of one or more bones) when the cutting guide 600 is in use.

[0165] The lower side 622 can be custom contoured to conform to the shape of one or more of the surfaces of the first cuneiform bone and / or the first midfoot bone. In one embodiment, the lower side 622 can include a bone engagement surface 624. The bone engagement surface 624 can be shaped to match the first surface of the first bone of the joint and the second surface of the second bone.

[0166] In one example, the bone engagement surface 624 can be shaped to match the surface of the cuneiform bone and the surface of the midfoot bone of the tarsometatarsal ("TMT") joint. The bone engagement surface 624 can be so shaped because it is fabricated from a bone model of the patient's bone. The body 610 is configured, designed, and / or fabricated to seat across a joint (e.g., the TMT joint) where the bone engagement surface 624 engages the first surface of the first bone and the second surface of the second bone.

[0167] Figures 6A-6C include the same components, parts, devices, apparatuses, features, and aspects as those disclosed and described in relation to Figures 3A-19H, but the difference in Figures 6A-6C is that the body 610, the bone engagement surface 624, and / or one or more arms (e.g., the proximal arm 630 and / or the distal arm 640) are configured to be coupled to the bone and extend at least partially across the joint, if not completely, on the dorsal side of the bone. Thus, the cutting guide 600 may be referred to as a dorsal cutting guide.

[0168] In addition, the cutting guide 600 may be configured to avoid contact with soft tissues such as nerves, tendons, blood vessels, etc., that may run along the inner and / or outer sides of the first intermediate cuneiform 208. Thus, the cutting guide 600 may be fabricated to seat transversely with respect to the TMT joint such that the bone engagement surface contacts the dorsal surface of the first bone (e.g., the medial cuneiform 202) and / or the second bone (e.g., the first intermediate cuneiform 208). For example, the proximal arm 630 and / or the distal arm 640 may be positioned more laterally than in other embodiments.

[0169] In the illustrated embodiment, the body 610 is configured to be present on the dorsal surfaces of the first cuneiform and the first intermediate cuneiform to provide proper alignment of the body 610 with the midfoot cuneiform joint (e.g., the joint between the first intermediate cuneiform and the medial cuneiform, also known as the TMT joint). In another embodiment, the body 610 is configured to be present or seat between the inner surface and the dorsal surface for osteotomy.

[0170] In certain embodiments, the bone engagement surface 624 may include a cuneiform addendum 626 and an intermediate cuneiform addendum 628. As shown, the cuneiform addendum 626 may be contoured to match the contour of the surface of the first cuneiform on which it is placed, and the intermediate cuneiform addendum 628 may likewise be contoured to match the contour of the surface of the first intermediate cuneiform on which it is placed. (See Figure 6C.) Thus, the body 610 may have only one stable position and orientation with respect to the first cuneiform and the first intermediate cuneiform during a surgical osteotomy to correct the condition.

[0171] Advantageously, the fidelity of the patient image data enables the bone model, the pre-cut guide model, and patient-specific instruments (e.g., patient-specific cutting guides, patient-specific pin guides, patient-specific alignment guides, etc.) to uniquely match a particular patient. Thus, the bone engagement surface 624 can engage the surface of the bone of the joint in a single configuration. Such closely matching conformations facilitate surgical osteotomy.

[0172] FIG. 6D illustrates the cutting guide 600 from a perspective facing the inner side 616. FIG. 6E illustrates the cutting guide 600 from a perspective facing the outer side 618. In certain embodiments, the cutting guide 600 may include one or more features that facilitate the use of the cutting guide 600 while avoiding particular soft tissue near the joint. For example, the inner side 616 may include an upper inner surface 632 and a lower inner surface 634 that intersect at an inner edge 636. Advantageously, the lower inner surface 634 may extend from the lower side 622 to the inner edge 636 at an angle such that the lower inner surface 634 does not impinge on soft tissue near the joint (e.g., near the inner end of the joint). In certain embodiments, the angle may range from about 80 degrees to 170 degrees. In another example, the outer side 618 may include an upper outer surface 642 and a lower outer surface 644 that intersect at an outer edge 646 (see FIG. 6E). Of course, the upper inner surface 632 may extend from the upper side 620 to the inner edge 636 at an angle. The angle of the upper inner surface 632 enables the use of the cutting guide 600 in a more compact opening and thus may minimize the size of the incision used for the procedure.

[0173] Advantageously, the lower outer surface 644 may extend from the lower side 622 to the outer edge 646 at an angle such that the lower outer surface 644 does not impinge on soft tissue near the joint (e.g., near the inner end of the joint). In certain embodiments, the angle may range from about 80 degrees to 170 degrees. Of course, the upper outer surface 642 may extend from the upper side 620 to the outer edge 646 at an angle. The angle of the upper outer surface 642 enables the use of the cutting guide 600 in a more compact opening and thus may minimize the size of the incision used for the procedure.

[0174] The body 610 may further include a resection feature that guides a cutter to resect the first cuneiform bone and the first midfoot bone in a manner necessary to perform a desired correction. For example, the resection feature may be used to guide a flat cutting blade, an arcuate cutting blade, a drill or mill, a bar, etc.

[0175] In the embodiment of FIGS. 6A-6C, the resection feature may guide a reciprocating flat blade, such as a surgical bone saw, that forms a flat cut in the first cuneiform bone and the first midfoot bone. Various manual or power tools may be used to form the flat cut. In one embodiment, a sagittal bone saw may be used. In one example, the resection feature may take the form of a first slot 660 and a second slot 670. The first slot 660 may include an outer end 662 and an inner end 664. The second slot 670 may include an outer end 672 and an inner end 674.

[0176] In one embodiment, the first slot 660 and the second slot 670 extend from the upper side 620 to the lower side 622. In a particular embodiment, the first slot 660 may extend from near the outer side 618 to near the inner side 616. In other embodiments, one or both of the first slot 660 and the second slot 670 may extend from one of the inner side 616 or the outer side 618 of the body 610. In a particular embodiment, the first slot 660 intersects the second slot 670. In other embodiments, the first slot 660 and the second slot 670 do not intersect.

[0177] Thus, when the cutting guide 600 is in the desired position, the second slot 670 can be positioned above at least a portion of the first cuneiform bone to facilitate resection of the first cuneiform bone, while the first slot 660 can be positioned above at least a portion of the first intermediate cuneiform bone to facilitate resection of the first intermediate cuneiform bone. In one embodiment, the second slot 670 is positioned near the distal end of the first cuneiform bone and the first slot 660 is positioned near the proximal end of the first intermediate cuneiform bone. The first slot 660 and the second slot 670 are positioned together with the bone engagement surface 624 overlapping the first cuneiform bone and the first intermediate cuneiform bone to guide the resection of the first cuneiform bone and the first intermediate cuneiform bone during a surgical osteotomy to correct the condition.

[0178] In an alternative embodiment, the resection feature can be designed to guide different types of cutters such as drills, mills, or side cutters. In such an embodiment, the resection feature may not be a slot, but instead may be a translatable or rotatable cutter retainer that guides the translation and / or rotation of the cutter relative to the bone. In certain embodiments, two or more resection features may be replaced by a single resection feature sized to enable a surgeon to resect both the first cuneiform bone and the first intermediate cuneiform bone using a single cutting guide 600.

[0179] In one embodiment, the first resection feature is configured to define a first cutting surface that can be formed by resection of the first bone. The second resection feature is configured to define a second cutting surface that can be formed by resection of the second bone. In such an embodiment, one or both of the first cutting surface and the second cutting surface can be oriented at one or more angles relative to landmarks on the bone or other anatomical structures.

[0180] Alternatively, or in addition, in certain embodiments, one or both of the first resection feature and the second resection feature may be positioned on or within the body 610 and / or may have an orientation based on patient image data. The patient image data may be used to position and orient one or both of the first resection feature and the second resection feature such that formation of one or both of the first cut surface and the second cut surface, and fixation of the two cut surfaces relative to each other, alleviates the patient's condition. For example, as described in the present disclosure, the patient image data may be used to generate a bone model of the patient's bone. The bone model may be used to determine and / or define the contour of the bone engagement surface 624, the position of the first slot 660, the orientation of the first slot 660, the position of the second slot 670, the orientation of the second slot 670, and other features and attributes of one or more patient-specific instruments that may be used in the procedure.

[0181] FIG. 6 illustrates a perspective view of a first cuneiform bone and a first midfoot bone, including an embodiment of a patient-specific cutting guide positioned above the TMT joint. In the illustrated embodiment, the first resection feature may take the form of the first slot 660, and the second resection feature may take the form of the second slot 670. Similar to the embodiments of FIGS. 3A-19H and FIG. 20, the position and / or angle (e.g., orientation) of one or both of the resection features based on patient image data is illustrated. The first slot 660 is oriented based on a desired angle to alleviate the patient's condition. In one example, the first slot 660 is angled perpendicular to the longitudinal axis 676 of the first midfoot bone 208. This orientation of the first slot 660 allows the first cut surface to extend from the body 610 toward the bone and form a cut surface that is also perpendicular to the longitudinal axis 676 of one of the bones of the joint.

[0182] In the illustrated embodiment, the second slot 670 is positioned and oriented based on a desired angle for patient comfort. In the illustrated embodiment, the orientation of the second slot 670 may be described with reference to a first angle A and a second angle B as described above in connection with FIGS. 3D and 3H.

[0183] One of ordinary skill in the art will understand that the positions and orientations of the first slot 660 and the second slot 670, as well as the corresponding cutting surfaces that a surgeon may form using these resection features, may vary depending on the patient's anatomy, the osteotomy procedure being performed, the surgeon's preferences, the nature of the condition, and the like.

[0184] Referring to FIGS. 6C and 23, in one embodiment, the body 610, or one or more arms, may include one or more bone attachment features that facilitate attachment of the body 610 to the medial cuneiform 202 and / or the first intermediate cuneiform 208. Such bone attachment features may include any of a variety of fasteners, including, but not limited to, holes, spikes, fastening devices, and the like. Effective connection of the cutting guide 600 to one or more bones across the joint can ensure that the cutting surfaces are formed in the desired locations and orientations and can reduce removal of hard and / or soft tissue outside of the desired locations.

[0185] Accordingly, the cutting guide 600 includes one or more bone attachment features. As embodied in FIGS. 6A - 6C, the bone attachment features may take the form of one or more holes 650 and / or one or more fixation devices extending from a lower side 622 to an upper side 620. The holes 650 may be shaped to receive pins, K-wires, and / or other elongate bone fixation elements that may be anchored to the medial cuneiform 202 and / or the first intermediate cuneiform 208 to hold the cutting guide 600 in a predetermined position.

[0186] FIG. 6 illustrates an example of a cutting guide 600 coupled to bone using a proximal bone attachment feature 652 and a distal bone attachment feature 654. In the illustrated embodiment, the proximal bone attachment feature 652 includes at least a hole 650 and a fastener, and the distal bone attachment feature 654 includes at least a hole 650 and a fastener. In FIG. 6, the fastener is a K-wire. Advantageously, the proximal bone attachment feature 652 and the distal bone attachment feature 654 each include at least a hole 650 and each has a K-wire that passes through the hole 650 and enters the bone facing the underside 622. Using the hole 650 and two fasteners ensures a stable connection between the cutting guide 600 and the bone(s). Advantageously, in certain embodiments, the holes 650 of the proximal bone attachment feature 652 and the distal bone attachment feature 654 are aligned such that the inserted K-wires are parallel to each other. Among other advantages, the parallel K-wires of each of the proximal bone attachment feature 652 and the distal bone attachment feature 654 prevent the cutting guide 600 from pivoting about one of the K-wires of the proximal bone attachment feature 652 or the distal bone attachment feature 654.

[0187] In the illustrated embodiment, the proximal arm 630 includes a proximal bone attachment feature 652 and the distal arm 640 includes a distal bone attachment feature 654. In one embodiment, the holes 650 of the proximal bone attachment feature 652 are aligned with each other and are aligned perpendicular to a resection feature such as the second slot 670 (see reference line 392). The holes 650 of the distal bone attachment feature 654 may also be aligned with each other and may be aligned perpendicular to another resection feature such as the first slot 660 (see reference line 394). This means that the aligned holes 650 of the distal bone attachment feature 654 (and the K-wires fixed therein) will also be perpendicular to the cut surface formed using the first slot 660. This also means that the aligned holes 650 of the proximal bone attachment feature 652 (and the K-wires fixed therein) will also be perpendicular to the cut surface formed using the second slot 670. As a result, at least one of the proximal bone attachment feature 652 and the distal bone attachment feature 654 can be used to position and orient the cut surface of the first metatarsal 208 and the cut surface of the medial cuneiform 202. In certain embodiments, the proximal bone attachment feature 652 and the distal bone attachment feature 654 may not be aligned with each other, and the alignment offset may be a change in the orientation of the bones of the joint desired to address the condition. Note that the distal bone attachment feature 654 may be parallel to the longitudinal axis 676. In this way, the distal bone attachment feature 654 can be used as a reference for positioning the distal alignment feature 690 on the first metatarsal 208.

[0188] Returning to FIGS. 3A-4, the body 610 may further have features that facilitate the desired translation and orientation of the first metatarsal 208 and / or the medial cuneiform 202 to complete the procedure by fusing or joining the two bones. For example, in the illustrated embodiment, the cutting guide 600 may include at least one alignment feature. The second alignment feature may be integrated with the cutting guide 600 or the second alignment feature may be a separate feature from the cutting guide 600.

[0189] In the illustrated embodiment, the proximal bone attachment feature 652 functions as both a bone attachment feature and an alignment feature, e.g., a proximal alignment feature 680. In this way, the proximal bone attachment feature 652 can provide both a bone attachment feature and an alignment feature with a single feature. In situations where the second bone of a joint, such as the first metatarsal bone 208, does not need to be rotated, translated, and / or reoriented to alleviate the patient's condition, the distal bone attachment feature 654 can also function as both a bone attachment feature and an alignment feature, e.g., a distal alignment feature 690.

[0190] Typically, in an osteotomy for a condition such as hallux valgus, it is desirable to rotate the first metatarsal bone 208 to address the condition. The first metatarsal bone 208 can be rotated, for example, to reposition the distal sesamoid bone from a lateral orientation to a more plantar direction. Studies have shown that performing such reorientation alleviates the recurrence of hallux valgus conditions. In such situations, the distal bone attachment feature 654 can function as a bone attachment feature and as a reference for positioning the distal alignment feature 690 that is separated from the cutting guide 600.

[0191] For example, in such cases, the distal bone attachment feature 654 can function as a reference for the placement of the distal alignment feature 690 that is parallel to the distal bone attachment feature 654 as measured along the longitudinal axis 676 of the first metatarsal bone 208. Following the formation of the cutting surface on the first metatarsal bone 208, the distal alignment feature 690 can be coupled to the first metatarsal bone 208 parallel to the distal bone attachment feature 654 (e.g., via a pin guide). In certain embodiments, the distal alignment feature 690 can include two or more aligned holes and / or a pair of K-wires that enter the bone parallel to each other. Additionally, in such situations, the proximal alignment feature 680 and the distal alignment feature 690 do not need to be aligned initially. Instead, the proximal alignment feature 680 and the distal alignment feature 690 can be configured to align when the bone coupled to the distal alignment feature 690 rotates.

[0192] FIG. 7 illustrates an exemplary cutting guide 600 seated across the talo-metatarsal (「TMT」) joint 400. The TMT joint 400 includes a lateral end 402 and a medial end 404. In certain embodiments, such as the illustrated embodiment, the body 610 is configured to extend between the lateral end 402 and the medial end 404. In this way, the first slot 660 and the second slot 670 extend in a lateral-medial direction along the TMT joint 400 and are long enough so that a surgeon can easily excise the respective ends of the respective bones of the joint. Additionally, the proximal arm 630 and the distal arm 640 can be aligned with each other. In one embodiment, the proximal arm 630 and the distal arm 640 can extend proximal to the lateral 618 of the joint (e.g., TMT joint 400) and / or proximal to the lateral end 402.

[0193] Advantageously, the cutting guide 600 can be used in patients with smaller bones and joints, such as pediatric or female patients. The cutting guide 600 conforms directly to the dorsal surface of the bones of the joint. This arrangement can avoid contact with soft tissue that may run along the medial and / or lateral surfaces of the bones of the joint.

[0194] FIG. 7 illustrates that the cutting guide 600 can be secured to bone using the proximal bone attachment feature 652 and / or the distal bone attachment feature 654, each of the bone attachment features can include two or more fasteners 356. In certain embodiments, the fasteners 356 of the proximal bone attachment feature 652 are aligned with each other and perpendicular to the second slot 670. The fasteners 356 of the distal bone attachment feature 654 are aligned with each other and perpendicular to the first slot 660. The conformity of the bone engagement surface 624 to the surface of the bone (dorsal in this embodiment) helps to secure the cutting guide 600 in place and ensure that resection of the bone using the first slot 660 and the second slot 670 forms the desired cut surface for the procedure.

[0195] One of ordinary skill in the art will understand that in various embodiments, certain aspects may contact one or more dorsal sides of each or both of the bones of the joint. The illustrated embodiments provide at least one example. In other embodiments, at least one of the cutting guide body, proximal arm, distal arm, and bone engagement surface on the lower surface of the body is configured to engage one or more dorsal surfaces of the first bone and the second bone.

[0196] Note that the cutting guide 300 and / or the cutting guide 600 may be configured to engage the dorsal side of one bone (e.g., the medial cuneiform bone 202) and the outer surface of the second bone of the joint (e.g., the first metatarsal bone 208 of the TMT joint 400). For example, if the patient has a hallux valgus condition, the first metatarsal bone 208 may be rotated about its longitudinal axis 376 / 676 such that the outer surface of the first metatarsal bone 208 faces dorsally. Advantageously, the present disclosure describes that the cutting guide 300 / 600 is configured to contact the dorsal surface on one bone and the outer surface of the second bone (or the proximal surface if the bone is rotated in another direction). Further, the proximal alignment feature 380 / 680 may engage the dorsal surface of the proximal bone, and the distal alignment feature 390 / 690 may engage the dorsal surface of the distal bone even if the distal bone is rotated.

[0197] Referring to FIGS. 4 and 7, in the illustrated embodiments, the proximal alignment feature 380 / 680 and the distal alignment feature 390 / 690 may be in separate devices rather than combined in a single device. FIGS. 4 and 7 show the proximal alignment feature 380 / 680 as part of the cutting guide 300 / 600.

[0198] Figure 8A is a perspective view of the foot after resection of the first cuneiform bone 202 and the first intermediate cuneiform bone 208, removal of the cutting guide 300, and placement of the first intermediate cuneiform bone 208 adjacent to the first cuneiform bone 202. As shown, here the distal end 272 of the first intermediate cuneiform bone 208 can be positioned much closer to the second intermediate cuneiform bone 210 in a more natural position. Further, Figure 8A illustrates the first proximal phalanx 230, which can be properly oriented substantially parallel to the other phalanges (not shown) rather than pointing in the lateral direction 274. If necessary, further steps can be performed to place them in the appropriate relative orientation with respect to the joint between the first intermediate cuneiform bone 208 and the first proximal phalanx 230. The distal end 272 may also be shifted in the plantar direction 276 or the dorsal direction 278 from the position in Figure 2. Thus, the desired dual-plane correction of the orientation of the first intermediate cuneiform bone 208 can be completed.

[0199] The first intermediate cuneiform bone 208 can be fixed to the medial cuneiform bone 202 at least until appropriate bone ingrowth occurs between the medial cuneiform bone 202 and the first intermediate cuneiform bone 208. In some embodiments, a bone plate (not shown) or other fasteners (not shown) can be used to fix the medial cuneiform bone 202 and the first intermediate cuneiform bone 208 together. If necessary, additional hardware (not shown) can be used to stabilize the position and / or orientation of the first proximal phalanx 230 with respect to the first intermediate cuneiform bone 208. The surgical wound can be closed, and the foot 200 can be allowed to heal with the hallux valgus deformity corrected.

[0200] Figures 8B and 8C are dorsal views of the foot 200 before and after correction, respectively. Figures 8B and 8C illustrate correction of the angle of the first intermediate cuneiform bone 208 in which the distal end 272 of the first intermediate cuneiform bone 208 moves in the lateral direction 274. In some embodiments, the implant 810 can be inserted into the space between the first intermediate cuneiform bone 208 and the medial cuneiform bone 202 to hold the first intermediate cuneiform bone 208 and the medial cuneiform bone 202 together and / or to facilitate bone fusion between the first intermediate cuneiform bone 208 and the medial cuneiform bone 202.

[0201] In some embodiments, implant 810 can be patient-specific. For example, implant 810 can have a side surface 820 facing the cuneiform bone shaped and / or sized to be fixed to the adjacent resected surface of the medial cuneiform bone 202, and a side surface 830 facing the midfoot bone shaped and / or sized to be fixed to the adjacent resected surface of the first midfoot bone 208. Since the resections performed on the first midfoot bone 208 and the medial cuneiform bone 202 can both be planar, the side surface 820 facing the cuneiform bone and / or the side surface 830 facing the midfoot bone can also be planar. However, the side 820 facing the cuneiform bone and / or the side 830 facing the midfoot bone can advantageously be shaped to respectively match the profile of the resected surfaces of the medial cuneiform bone 202 and the first midfoot bone 208.

[0202] This shaping can be achieved by custom designing implant 810 for the patient using the same models (e.g., from a CT scan) of the first midfoot bone 208 and the medial cuneiform bone 202 that were used to generate the cutting guide 300. Thus, implant 810 can have a shape that provides secure attachment and / or fusion between the first midfoot bone 208 and the medial cuneiform bone 202, while avoiding protruding edges or other protruding features that could otherwise interfere with surrounding tissue.

[0203] Figures 9A, 9B, and 9C are, respectively, a preoperative dorsal view, a postoperative dorsal view, and a postoperative lateral view of a foot treated with an Evans calcaneal osteotomy, according to one embodiment. In patients with flat feet, external rotation of the foot can occur. An Evans or lateral column lengthening procedure may be performed on these patients. An incision is made on the outside of the foot and the front half of the calcaneus is cut. A bone wedge (typically either a titanium or bone-based graft) is then placed in the cut area of the calcaneus. This wedge helps to "lengthen" the calcaneus and rotate the foot into its correct position. The wedge is usually held in place using screws or surgical staples.

[0204] Figure 10 illustrates an exemplary embodiment of a compressor / distractor 1000 that may be used with a particular embodiment. The compressor / distractor 1000 may be used for one or both of extension and compression. For example, the compressor / distractor 1000 may be used to extend the first metatarsal 208 relative to the medial cuneiform 202.

[0205] The user may slide holes 1002a, b above the pins of one or both bones. This may cause the desired rotation and translation of the first metatarsal 208 relative to the medial cuneiform 202. When the user positions the parallel compressor / distractor 1000 above the pins, this may force the cut surfaces of the two bones to be parallel. Advantageously, when the cutting guide 600 is fabricated, the position, orientation, and angle of the holes of the alignment feature(s) may be pre-defined and customized for each patient, such that the cut surfaces of the two bones may be forced to be parallel.

[0206] This alignment enables parallel compression of the two bones together using the parallel compressor / distractor 1000. Parallel compression enables the two bones to be compressed together more effectively. Next, the space between the resected surface of the medial cuneiform 202 and the first metatarsal 208 is prepared for fusion. Then, the parallel compressor / distractor 1000 may be actuated such that the medial cuneiform 202 and the first metatarsal 208 are fused together. The parallel compressor / distractor 1000 may include a first leg 1004 and a second leg 1006. At one end of each leg 1004 / 1006, the leg may include a tip 1008 / 1010 at its distal end. In one embodiment, the tips 1008 / 1010 are angled towards each other. The angled configuration of the legs 1004 / 1006 via the tips 1008 / 1010 may apply a torque force to the tips 1008 / 1010, which may further assist in pushing the two bones connected to the parallel compressor / distractor 1000 together.

[0207] The present disclosure is not limited to cutting guides or limb procedures. In some embodiments, patient-specific instruments can be used to correct a wide variety of bone conditions. Such conditions include, but are not limited to, any angular deformities (e.g., tibial deformity, calcaneal deformity, femoral deformity, and radial deformity) from within one bone segment in either the lower or upper extremities. The present disclosure can also be used to treat the interface between two bone segments (e.g., ankle joint, midfoot cuneiform joint, Lisfranc joint, complex Charcot deformity, wrist joint, knee joint, etc.). As an example, angular deformities or segmental malalignment of the forefoot can be treated as seen at the midfoot level such as the cuneiform level, the naviculocuneiform junction, the calcaneocuboid or subtalar joint, or the hindfoot at the ankle between the tibia and the talus joint. Additionally, patient-specific instruments can be used in the upper extremities as seen at the proximal leg between two bone segments, or at the wrist or midcarpal level.

[0208] Artificial neural network Artificial intelligence can utilize, for example, neural networks. An artificial neural network (ANN) can learn tasks based on examples, for example, without task-specific programming. An ANN can be based on a group of connected units or nodes, that is, artificial neurons. Each connection between artificial neurons can generate a signal to be sent to another artificial neuron. One or more artificial neurons can receive the signal, process it, and, for example, use it to initiate a task. The signals in the connections between artificial neurons can be numerical values, and the output can be calculated by various functions or algorithms, for example, non-linear functions. Artificial neurons can have weights assigned to them, which can amplify or attenuate their signals. Artificial neurons can be organized into layers, and different layers perform different types of transformations. An artificial neural network can utilize various techniques, processes, and / or algorithms, for example, backpropagation, parallel distributed processing, max pooling, Hebbian learning, long-term potentiation, support vector machines, and linear classifiers. An ANN can include recurrent neural networks and deep feedforward neural networks. An ANN can perform functions such as pattern recognition and machine learning. The components of an ANN can include neurons, connections and weights, propagation functions, and learning rules. Neurons can include activation components, threshold components, activation functions, and output functions. An ANN can define mathematical functions and other functions. An ANN can use pre-defined functions, for example, hyperbolic tangent function, sigmoid function, softmax function, or rectifier function.

[0209] ANN can be used for learning. Learning can involve using a number of observations to find a function that solves a given or desired task, e.g., an optimal outcome, in an optimal sense. Learning can be supervised learning, unsupervised learning, or reinforcement learning. Supervised learning can use one or more sets of example pairs, and the goal can be to find a function in a class of admissible functions that, e.g., matches the examples. Pattern recognition, classification, and regression can be part of supervised learning. Supervised learning can use information fuzzy networks, random forests, neighborhood algorithms, logistic model trees, and other algorithms. Supervised learning can use statistical classification, e.g., decision trees, Bayesian networks, and / or linear classifiers.

[0210] In unsupervised learning, a set of data can be provided, e.g., with a cost function to be minimized, which can be a function of the data and the network output. The cost function can depend on the task, the characteristics of the parameters, the observed variables or data. Unsupervised learning can be applied to, e.g., pattern recognition, classification, and regression, general estimation problems, clustering, estimation of statistical distributions, compression, and filtering. Unsupervised learning can use one or more ANNs, the expectation maximization algorithm, data clustering, etc. In association rule learning, e.g., the Apriori algorithm, ECLAT algorithm, FP-growth algorithm, hierarchical clustering (e.g., single-link clustering and conceptual clustering), partitioning clustering (e.g., K-means algorithm, fuzzy clustering), reinforcement learning (e.g., Monte Carlo method, Q-learning, temporal difference learning, and combinations thereof can be used.

[0211] In reinforcement learning, data can be generated by the interaction of an agent with one or more objects, for example, a surgeon interacting with a patient. The agent, for example, the surgeon, can perform actions, and the environment, for example, the target tissue or surgical site, can generate one or more observations and, for example, some dynamics or parameters, for example, the cost associated with tissue removal or risk of infection. The goal can be to find a treatment, treatment algorithm, treatment modification that can reduce or minimize a measure of cost, for example, risk of infection, an outcome measurement reported by the patient, a functional outcome. The parameters and dynamics of the environment, for example, the surgical site, can be unknown but can be estimated. The environment, for example, the target tissue or surgical site, can be modeled as a Markov decision process with possible probability distributions, for example, a cost distribution, an observation distribution, and one or more transitions, and a policy or algorithm or solution can be defined as a conditional distribution for actions given one or more observations. Dynamic programming can be combined with an ANN and applied to multi-dimensional non-linear problems.

[0212] Learning can utilize one or more cost functions. For example, the cost can be a good or bad clinical outcome. A cost function can provide information on how far a particular solution, such as a clinical treatment, treatment sequence, treatment algorithm, or surgical technique, is from an optimal outcome, such as a good score on an outcome measure reported by a patient. An ANN can find a solution, such as a clinical treatment, treatment sequence, treatment algorithm, or surgical technique, that results in a minimum cost, such as the distance or amount from an optimal outcome or a good score on an outcome reported by a patient. The cost can be a function of observed values. The cost can be described statistically. The cost can be the mean squared error, which can attempt to minimize the mean squared error between the output of the network and one or more target values over exemplary pair(s). The cost function can be selected or predetermined for a particular problem set, such as a clinical problem set or clinical observation data, such as preoperative, intraoperative, or postoperative data. AI can be developed to find one or more optimal cost functions for a set of observational data, and AI can refine the cost function as the size of the observational data set increases. (See U.S. Patent No. 11,278,413, paragraphs 58-63).

[0213] Machine learning Machine learning may include supervised learning, semi-supervised learning, active learning, reinforcement learning, or unsupervised learning. In supervised learning, a computer may receive exemplary inputs and desired outputs that may be provided from a database or using a learning tool, and the goal is to learn one or more rules that map the inputs to the outputs. Semi-supervised learning may differ in that a computer may optionally be given inputs of incomplete training examples with some of the desired outputs missing. In active learning, a computer can only obtain training inputs for a limited set of examples, and the computer can optimize the selection of inputs for which to obtain labels. In reinforcement learning, training data such as inputs and desired outputs can only be given as feedback to the actions of a program in a dynamic environment such as a surgical guide. In unsupervised learning, training input and / or output data are not provided, and the computer and computer processor will have to find structure on their own from among the inputs.

[0214] Machine learning can use processes such as, for example, classification, regression, clustering, density estimation, dimensionality reduction, and topic modeling. By classification, the input can be split into two or more classes. For example, a learning system can generate a model that assigns unknown inputs to one or more of these classes. Data can be classified, for example, into "excellent", "good", "acceptable", or "bad" outcomes, such as clinical outcomes. Numerical values or ranges of numerical values can be assigned to different classes, such as numerical values or ranges of numerical values from outcome measurements reported by patients, clinical reporting systems, and / or one or more electronic measurements. In regression, the output can be continuous rather than discrete. Regression can be used, for example, when a patient's outcome is continuous. According to clustering, the input can be split into groups. The groups cannot be known in advance, and thus, clustering learning can be unsupervised. According to density estimation, the distribution of inputs in a given space or sample can be determined. According to dimensionality reduction, the inputs can be simplified by mapping them into a low-dimensional space. According to topic modeling, a machine learning system can be given a list of human language documents and tasked with examining which documents cover similar topics.

[0215] Developmental learning can include, for example, autonomous self-exploration and robotic learning, which can create unique learning situations for acquiring new skills, for example, through interaction with a human teacher.

[0216] The goal of machine learning or deep learning can be to generalize from experience. Generalization can be the ability of a learning machine or system to perform accurately on new, unknown inputs after being trained on a training dataset. The training examples can come from an unknown probability distribution, and the learning machine or system can be given the task of constructing an input and output model that enables it to generate sufficiently accurate predictions on new inputs. Bounds or limits regarding the performance, accuracy, and reproducibility of machine learning, such as probabilistic bounds, can be determined. When machine learning is used to solve clinical problems, such as outcome prediction or treatment planning or modification, the bounds or limits on the performance, accuracy, and / or reproducibility of the machine learning system or learning machine can affect and / or determine the performance, accuracy, and / or reproducibility of the clinical application, such as outcome prediction or treatment planning or modification. Examples of accuracy can include the evaluation of true positives, true negatives, false positives, and false negatives. Reproducibility can be precision. The performance of the machine learning system and / or learning machine can include other statistical measures known in the art for evaluating the performance of clinical systems.

[0217] Learning systems including machine learning can use decision tree learning, association rule learning, artificial neural networks (ANNs), deep learning, inductive logic programming, support vector machines, clustering, Bayesian networks, reinforcement learning, representation learning, similarity and distance learning, sparse dictionary learning, biological or genetic algorithms, rule-based machine learning, and learning classifier systems.

[0218] In decision tree learning, a decision tree can be used as a predictive model, which can map observations regarding one or more parameters to conclusions regarding the target values of the parameters. According to association learning, relationships between variables or parameters can be identified in large databases. According to ANN, calculations can be structured through interconnected groups of artificial neurons, and information is processed using a connected approach. ANN can be non-linear data modeling used with various statistical methods and approaches known in the art. Deep learning can employ multiple layers in an artificial neural network. Inductive logic programming (ILP) can utilize, for example, logic programming for rule learning that uses a uniform representation for input examples, background knowledge, and hypotheses. Support vector machine (SVM) can be a set of supervised learning methods used for classification and / or regression. A given set of training examples can be marked as belonging to a first category or a second category, and an SVM training machine can build a model to predict whether a new input falls within the first category or the second category.

[0219] Clustering can be the assignment of a set of observations to subsets, where the data within each subset has similarity with respect to one or more parameters, while the data in different subsets can be different with respect to one or more parameters. Clustering techniques can provide information regarding similarity or dissimilarity, for example, reflected in a similarity metric, a measure of internal compactness, or the separation between different clusters. A Bayesian network can be, for example, a graphical model representing random variables and their conditional independences. This can be shown in a directed acyclic graph. A Bayesian network can represent the probabilistic relationship between diseases and symptoms. A Bayesian network can be used to calculate the probability (ies) of the presence of one or more diseases.

[0220] According to reinforcement learning, input and output pairs can never be presented, and reinforcement learning can map states such as a patient's clinical condition and develop predictions, actions, or treatments that the system can perform. According to representation learning algorithms, input information is stored but can be transformed to make it more useful, for example, enabling the reconstruction of inputs coming from an unknown data generation distribution as a preprocessing step before performing classification or prediction.

[0221] Deep learning can utilize multiple levels of representation, for example, in an ANN. Higher-level, more abstract parameters or data can be defined as generating lower-level parameters or data. According to similarity learning, a learning system or machine can be given pairs of data considered similar and pairs of data less similar. Then, a similarity function or distance metric function can be learned to predict whether new objects are similar.

[0222] A rule-based machine can be the identification and utilization of a series of relational rules that can represent the knowledge captured by a learning system. A learning classifier system (LCS) can be a family of rule-based machine learning algorithms or systems that can combine discovery components with learning components.

[0223] The accuracy of a classification machine learning model can be evaluated using accuracy estimation techniques and statistical techniques and methods for testing accuracy, sensitivity, specificity, false positives, and false negative rates. Other statistical methods such as receiver operating characteristic (ROC) and the associated area under the curve (AUC) and total operating characteristic (TOC) can be used. (See U.S. Patent No. 11,278,413, paragraphs 64 - 75).

[0224] Deep learning Deep learning may include machine learning algorithms that can use multiple layers of non-linear processing units or elements. Each layer may use the output from a higher layer as input. A deep learning system may operate in a supervised setting, for example, using one or more classification systems. A deep learning system may also operate in an unsupervised setting, for example, in the context of texture analysis or pattern recognition. A deep learning system may learn multiple levels of representation corresponding to different levels of abstraction. The different levels may form an order or hierarchy of concepts. The different layers of a deep learning system may be present in different layers of an artificial neural network, i.e., a deep neural network. They may include hidden layers in the ANN. A deep learning system and a deep ANN may utilize a Boltzmann machine. According to a deep learning system, a layer may correspond to a layer of abstraction, for example, across a deep neural network. Different numbers of layers and layer sizes may provide different degrees of abstraction. Higher and more complex concepts may be learned from lower layers.

[0225] A deep neural network (DNN) may be one or more ANNs having multiple hidden layers between an input layer and an output layer. A DNN may model complex non-linear relationships. A DNN may generate a model in which an object is represented as a hierarchical composition. A DNN may be a feed-forward network in which data flows from the input layer to the output layer without looping back, and a DNN may be a recurrent neural network or a convolutional deep neural network.

[0226] Deep learning algorithms may be applied to unsupervised learning tasks. This is an important advantage because unlabeled data may be more abundant than labeled data. For example, in a clinical setting, a deep learning system with a multi-layer ANN may first be trained using outcome classification in a supervised format. As the data grows, the system may optionally learn in an unsupervised manner by utilizing pattern recognition across a large clinical dataset that may include, for example, pre-operative, intra-operative, and post-operative data. (See U.S. Patent No. 11,278,413, paragraphs 76-79).

[0227] Classification Classification can be a process of creating categories into which data or objects can be recognized, distinguished, or understood. A classification system can be an approach to achieve classification. Classification can be implemented using mathematical classification, statistical classification, classification theorems, for example, in mathematics, and attribute-value systems. Classification can be alphanumeric. Classification can be one-dimensional or multi-dimensional. Classification can be single-layer or multi-layer. Classification can be color-coded. An ANN can use a single classification system, for example, supervised learning. An ANN can use multiple classification systems. When multiple classification systems are used, they can exist in different layers of a DNN or deep learning system.

[0228] Classification can be a problem of identifying to which category or subpopulation a new observation belongs, which can be determined, for example, using a training dataset with observations whose category membership is known. For example, a diagnosis can be assigned to a patient as a category that can be characterized by measured data or characteristics such as heart rate, blood pressure, presence or absence of symptoms, or a combination of symptoms. Classification can also be pattern recognition.

[0229] Individual observations or data can be divided into a set of quantifiable characteristics. These characteristics can be categorical, for example, "a", "b", "c", "d", etc., or ordinal, for example, "excellent", "very good", "good", "acceptable", "average", or "bad". They can be integer-valued or real-valued. Observations or data can also be classified using a similarity function or a distance function, for example, based on previous observations or data. The algorithm implementing classification can be a classifier, and a classifier can also be a mathematical function implemented by, for example, a classification algorithm that can map input data to categories.

[0230] Data can be classified, for example, into “excellent,” “good,” “acceptable,” or “bad” outcomes, such as one or more clinical outcomes or clinical outcome variables. Numerical values or ranges of numerical values can be assigned to different classes, such as numerical values or ranges of numerical values from outcome measurements reported by patients, clinical reporting systems, and / or one or more electronic measurements.

[0231] Discriminative vs. Generative Models and Networks In machine learning, discriminative models can be distinguished from generative models.

[0232] 1. Discriminative models are trained to learn the boundaries between classes. They model the conditional probability of the target variable Y (class) given an observation x: P(Y|X = x) (“the probability of Y given X = x”). A discriminative model describes the probability of classifying a given example x into class Y. Discriminative models include, for example, logistic regression, conditional random fields, support vector machines, neural networks, random forests, or perceptrons.

[0233] Generative models model the distribution of individual classes. They can provide a statistical model of the joint probability distribution for observable variables X and target variable Y, generating data for X × Y, P(X, Y) = P(X|Y)*P(Y). Generative models include, for example, naive Bayes models and Bayesian networks, hidden Markov models, Boltzmann machines, variational autoencoders, or generative adversarial networks (GANs).

[0234] In some embodiments, a computer system can determine a treatment plan using a trained artificial neural network (ANN). The ANN can implement a discriminative model. The discriminative model can be trained to classify input data, i.e., pre-operative and / or intra-operative data and / or post-operative data, into different classes, where each class can represent a different treatment plan.

[0235] In some embodiments, the ANN may implement a generative model. Instead of assigning preoperative and / or intraoperative input data and / or postoperative data to existing classes, the generative model is trained to generate treatment plan steps based on the input data.

[0236] In some embodiments, generative and discriminative network models can be combined into a generative adversarial network (GAN) to generate a treatment plan. Using a training dataset of existing recorded treatment plans for some preoperative and / or intraoperative input data and / or postoperative datasets, in this context, the generative network can be trained to generate a preferred treatment plan from the preoperative and / or intraoperative input data. The discriminative network can be trained to evaluate the generated treatment plan and distinguish the generated treatment plan from the actual treatment plans of the training cases. Thus, the discriminative network can cause the generative network to improve its results. (See U.S. Patent No. 11,278,413, paragraphs 80-91).

[0237] FIG. 11 illustrates a flowchart diagram illustrating a method 1100 for generating one or more patient-specific instruments configured to correct the condition of a bone, according to one embodiment. Prior to the steps of method 1100, a bone model (also referred to as the above CAD model) is generated. The bone model can be generated using medical images of the patient's foot and can also be referred to as an anatomical model. The medical imaging image(s) can be used by a computing device to generate the patient's image data. The patient image data can be used to measure and describe the orientation of one or more structures of the patient's anatomical structure. In certain embodiments, the patient image data can serve as or be part of the patient's anatomical data.

[0238] In one embodiment, method 1100 begins after a bone model of the patient's body or body part(s) has been generated. In a first step 1102, method 1100 can review the bone model and the data associated with the bone model to determine the anatomical data of the patient's foot.

[0239] After step 1102, method 1100 determines the deformation of the patient's anatomical structure using anatomical data (1104). In certain embodiments, the detection and / or identification of the deformation can utilize advanced computer analysis systems, expert systems, machine learning, and / or automation / artificial intelligence. As used herein, "artificial intelligence" refers to intelligence demonstrated by machines, as opposed to natural intelligence exhibited by humans and animals, which involves consciousness and emotions. The categorical distinction between artificial intelligence and natural intelligence is often elucidated by the chosen acronyms. "Strong" AI is typically labeled as artificial general intelligence (AGI), while attempts to emulate "natural" intelligence are referred to as artificial biological intelligence (ABI). Major AI textbooks define this field as the study of "intelligent agents," which are any devices that recognize their environment and take actions to maximize their opportunities to achieve their goals. The term "artificial intelligence" can also be used to describe machines that mimic "cognitive" functions such as "learning" and "problem-solving" that humans associate with the human mind. (Search "artificial intelligence" on Wikipedia.com on June 25, 2021. CC-BY-SA 3.0 licensed. Accessed on June 25, 2021.) Various types of deformations such as hallux valgus can be identified. The determined deformations can include congenital deformations and deformations caused by injury or trauma.

[0240] Next, method 1100 proceeds and a preliminary cutting guide model is provided from a repository of template cutting guide models (1106). The preliminary cutting guide model is a model of a preliminary cutting guide.

[0241] As used herein, a “pre-cut guide” refers to a guide configured, designed, and / or operated to function as a template, prototype, archetype, or starting point for creating, generating, or fabricating a patient-specific cutting guide. In one aspect, the pre-cut guide can be used as is without any further modification, correction, or adjustment, and thus becomes a patient-specific cutting guide. In another aspect, the pre-cut guide can be modified, adjusted, or configured to more specifically address the goals, objectives, or needs of the patient or surgeon, and the modification results in a patient-specific cutting guide. The patient-specific cutting 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 bone, for a procedure. Thus, a pre-cut guide model can be used to generate a patient-specific cutting guide model. The patient-specific cutting guide model can be used in a surgical procedure to address, correct, or mitigate the effects of an identified deformation, and can be used to generate a patient-specific cutting guide for use in a surgical procedure for the patient.

[0242] In certain embodiments, the pre-cut guide model can be generated based on anatomical data and / or a bone model, or a combination thereof, and a model, or a pre-designed structure, template, or prototype need not be generated. Alternatively, or additionally, the pre-cut guide model can be, or be derived from, a template cutting guide model selected from a set of template cutting guide models. Each model within the set of template cutting guide models can include one or more cutting resection features positioned and / or sized and / or configured to fit an average patient's foot. The template cutting guide model can then be modified or revised by an automated process or a manual process to generate the pre-cut guide model used in the present disclosure.

[0243] As used herein, "template cutting guide" refers to a guide configured, designed, and / or operated to function as a template for creating, generating, or fabricating a patient-specific cutting guide. In one aspect, the template cutting guide can be used as is without any further modification, correction, or adjustment, and thus becomes a patient-specific cutting guide. In another aspect, the template cutting guide can be modified, adjusted, or configured to more specifically address the goals, objectives, or needs of the patient or surgeon, and the modification results in a patient-specific cutting guide. The patient-specific cutting 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 bone for a procedure. Thus, a template cutting guide model can be used to generate a patient-specific cutting guide model. The patient-specific cutting guide model can be used in a surgical procedure to address, correct, or mitigate the effects of identified deformities, and can be used to generate a patient-specific cutting guide for use in a surgical procedure for the patient.

[0244] "Repository" refers to any data source or dataset that includes data or content. In one embodiment, the repository exists on a computing device. In another embodiment, the repository exists on a remote computing device or a remote storage device. The repository can include files, folders, directories, sets of files, sets of folders, sets of directories, databases, applications, software applications, text content, email content, calendar entry content, etc. In one embodiment, the repository includes unstructured data. In one embodiment, the repository includes structured data such as tables, arrays, queues, lookup tables, hash tables, heaps, stacks, etc. The repository can store data in any format, including binary, text, encrypted, unencrypted, its own format, etc.

[0245] Next, method 1100 can align a preliminary cutting guide model with one or more bones of the bone model (1108). This step 1108 facilitates the customization and modification of the preliminary cutting guide model to generate a patient-specific cutting guide model from which a patient-specific cutting guide can be generated. The alignment step 1108 combines the two models and / or patient image data and positions both models for use within one system and / or one model (e.g., model alignment).

[0246] As used herein, "model alignment" or "image alignment" refers to a method, process, module, component, device, and / or system that attempts to achieve accuracy in the alignment of two images. As used herein, "image" can refer to an image of a structure or object and / or either or both of 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 alignment, two images are aligned. One image can function as a target image and the other as a source image, and the source image is transformed, positioned, re-aligned, and / or modified to match the target image. Optimization procedures can be applied to update the transformation of the source image based on a similarity value that evaluates the current quality of the alignment. The iterative procedure of optimization can be repeated until an (local) optimum is found. An example is the alignment of CT and PET images to combine structural and metabolic information. Image alignment can be used in various medical applications: studying changes over time. Longitudinal studies can acquire images over months or years to study long-term processes such as the progression of a disease. A time series corresponds to images acquired within the same session (seconds or minutes). Time series images can be used to study cognitive processes, cardiac deformation, and respiration. Combining complementary information from different image modalities. An example can be the fusion of anatomical and functional information.

[0247] Since the size and shape of the structures vary depending on the modality, it can be more difficult to evaluate the alignment quality. Therefore, similarity measures such as mutual information can be used to characterize the population of interest. In contrast to the alignment within a subject, there may not be a one-to-one mapping between subjects depending on the structural variations of the organs of interest. Alignment between subjects can be used in atlas construction in computational anatomical structures. Here, the goal can be to statistically model the anatomical structure of the organs across subjects. Computer-assisted surgery: Preoperative images in computer-assisted surgery, such as CT or MRI, can be aligned to intraoperative images or tracking systems to facilitate image guidance or navigation. When performing image alignment, several considerations can exist. Transformation models. Common options are rigid transformation, affine transformation, and deformable transformation models. B-spline and thin-plate spline models are commonly used for parameterized transformation fields. Non-parametric or dense deformation fields carry displacement vectors at all grid locations, which can use additional regularization constraints. A particular class of deformation fields is the diffeomorphism, which is a reversible transformation with a smooth inverse function. Similarity metric. A distance function or similarity function is used to quantify the alignment quality. This similarity can be calculated either from the original image or from features extracted from the image. Common similarity measures are the sum of squared distances (SSD), the correlation coefficient, and the mutual information. The choice of similarity measure depends on whether the images are from the same modality, and the acquisition noise can also play a role in this decision. For example, SSD can be the optimal similarity measure for images of the same modality with Gaussian noise. However, the image statistics in ultrasound can be significantly different from Gaussian noise, leading to the introduction of ultrasound-specific similarity measures.

[0248] Multimodal alignment may use more sophisticated similarity measures or, alternatively, different image representations such as alignment of structural representations or adjacent anatomical structures may be used. Optimization procedures. Either continuous optimization or discrete optimization is performed. For continuous optimization, gradient-based optimization techniques are applied to improve the convergence rate. (Search "medical image computing" on Wikipedia.com on June 24, 2021. CC-BY-SA 3.0 licensed. Accessed on June 25, 2021.)

[0249] Next, method 1100 may design a patient-specific cutting guide model based on a preliminary cutting guide model (1110). Design step 1110 may be fully automated or, optionally, may allow a user to modify the preliminary cutting guide model or a partially completed patient-specific cutting guide model before the patient-specific cutting guide model is complete. The preliminary cutting guide model and the patient-specific cutting guide model are two examples of instrument models. As used herein, "instrument model" refers to any physical or digital model that represents an instrument, tool, device, or apparatus. Examples of instrument models may include cutting guide models, patient-specific cutting guide models, and the like. In one embodiment, the patient-specific cutting guide and the patient-specific cutting guide model may be specific to a particular patient and that patient's anatomical structure and / or condition.

[0250] Method 1100 may end with step 1112 where a patient-specific cutting guide can be manufactured based on a patient-specific cutting guide model. Various manufacturing tools, devices, systems, and / or techniques can be used to manufacture the patient-specific cutting guide. As used herein, "manufacturing tool" or "fabrication tool" refers to a manufacturing or fabrication process, tool, system, or apparatus that creates an object, device, apparatus, feature, or component using one or more source materials. Manufacturing tools or fabrication tools can use various manufacturing processes, including but not limited to additive manufacturing, subtractive manufacturing, forging, casting, etc. Manufacturing tools can use various materials, including polymers, thermoplastics, metals, biocompatible materials, biodegradable materials, ceramics, biochemicals, etc. Manufacturing tools can be operated manually by an operator, automatically using a computer numerical controller (CNC), or a combination of these techniques.

[0251] FIG. 12 illustrates an exemplary system 1200 configured to generate one or more patient-specific instruments configured to correct a bone condition, according to one embodiment. "Bone condition" refers to any of various conditions of a patient's bone. The bone condition can be caused by or be a result of deformities, displacements, rotational abnormalities, fractures, joint dysfunctions, etc. The bone condition can include, but is not limited to, any angular deformation of one or more bone segments in either the lower or upper extremities (e.g., tibial deformity, calcaneal deformity, femoral deformity, and radial deformity). "Rotational abnormality" refers to a condition where a part, typically a part of a patient's body, has rotated from its normal position to an abnormal or non-normal position. System 1200 can include a device 1202 configured to receive, review, receive, or reference a bone model 1204 and provide a patient-specific cutting guide 1206. In one embodiment, device 1202 is a computing device. In another embodiment, device 1202 can be a combination of a computing device and / or software components, or a single software component such as a software application.

[0252] The device 1202 may include a determination module 1210, a deformation module 1220, a preparation module 1230, an alignment module 1240, a design module 1250, and a manufacturing module 1260. Each of them may be implemented by one or more of software, hardware, or a combination of hardware and software.

[0253] The determination module 1210 determines anatomical data 1212 from the bone model 1204. In certain embodiments, if the anatomical data is directly available from the bone model 1204, the system 1200 may not include the determination module 1210. In certain embodiments, the anatomical data of the bone model 1204 may include data identifying each anatomical structure within the bone model 1204 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. Further, the anatomical data may include position information identifying where each structure, such as a bone, is within the bone model 1204 relative to other structures that include the bone. The anatomical data may be in any suitable format and may be stored separately or together with the data defining the bone model 1204.

[0254] In one embodiment, the determination module 1210 may use an advanced computer analysis system, such as image segmentation, to determine anatomical data. Alternatively, or in addition, the determination module 1210 may use software and / or a system that implements one or more artificial intelligence methods (e.g., machine learning and / or neural networks) to derive, determine, or extrapolate anatomical data from the bone model. In one embodiment, the determination module 1210 may perform an anatomical mapping of the bone model 1204 to determine each unique aspect of the intended osteotomy procedure and / or bone resection and / or bone translation. The anatomical mapping may be used to determine coordinates for the osteotomy procedure, manually or automatically, or the location and pattern of resection performed using robotic surgical assistance, the width for bone cutting, the angle for bone cutting, a predetermined depth for bone cutting, the dimensions and configuration of a resection instrument such as a saw blade, the milling bit size and / or speed, depth markers for the saw blade, and / or instructions for an automated or robotic resection operation.

[0255] The deformation module 1220 determines or identifies one or more deformations or other abnormalities based on the anatomical data 1212. The deformations may include deformations between two bones of the patient's foot, as represented in the bone model 1204. In one embodiment, the deformation module 1220 may compare the anatomical data 1212 to a general model that represents the anatomical structure of most patients and has no deformations or abnormalities. In one embodiment, if the anatomical data 1212 does not match the general model, a deformation is determined. Various deformations may be detected, including deformations with well-known names of conditions and deformations without names.

[0256] The preparation module 1230 is configured to provide a pre-cutting guide model 1238. The preparation module 1230 can use various methods to provide the pre-cutting guide model. In one embodiment, the preparation module 1230 can generate the pre-cutting guide model. In the same or alternative embodiments, the preparation module 1230 can select a template cutting guide model for an osteotomy procedure configured to correct the deformations identified by the deformation module 1220. In one embodiment, the preparation module 1230 can select the template cutting guide model from a set of template cutting guide models (e.g., a library, set, or repository of template cutting guide models).

[0257] The alignment module 1240 aligns the pre-cutting guide model with one or more bones or other anatomical structures of the bone model 1204. As described above, alignment is the process of combining medical image data, patient image data, and / or one or more models such that the pre-cutting guide model can be used with the bone model 1204.

[0258] The design module 1250 designs a patient-specific cutting guide (or patient-specific cutting guide model) based on the pre-cutting guide model. The design operations of the design module 1250 can be fully automated, partially automated, or fully manual. The user can control the degree to which the design of the patient-specific cutting guide (or patient-specific cutting guide model) is automated or manual.

[0259] Manufacturing module 1260 can manufacture a patient-specific cutting guide 1206 using a preliminary cutting guide model. Manufacturing module 1260 can use a patient-specific cutting guide model generated from the preliminary cutting guide model. Manufacturing module 1260 can provide the patient-specific cutting guide model to one or more manufacturing tools and / or fabrication tools. The patient-specific cutting guide model can 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, the user can adjust default parameters of the patient-specific cutting guide, such as the type and / or thickness of the material, dimensions, etc., before manufacturing module 1260 provides the patient-specific cutting guide model to the manufacturing tools.

[0260] Effective connection of the cutting guide to one or more bones across the joint can ensure that the cutting surface is formed at the desired location and orientation and can reduce removal of hard and / or soft tissue outside of the desired location.

[0261] FIG. 13 illustrates an exemplary deformation module 1220 configured to determine deformations, according to one embodiment. Deformation module 1220 can detect one or more deformations and / or abnormalities of a patient's anatomical structure by analyzing anatomical data 1212 and other inputs, such as a particular type or class of deformation to search for.

[0262] Deformation module 1220 may be fully automated, partially automated, or fully manual. The user can control the degree to which deformation detection is automated or manual. The user can provide instructions to deformation module 1220 to facilitate automatic or partially automated detection or determination of one or more deformations.

[0263] The deformation module 1220 may include a deformation detection module 1222. The deformation detection module 1222 may be configured for automatic determination of deformation. For example, in one embodiment, the deformation detection module 1222 includes an artificial intelligence or machine learning module 1224. The artificial intelligence or machine learning module 1224 is configured to implement one or more of various artificial intelligence modules that may be trained to detect anomalies or deformations based on anatomical data 1212. In another embodiment, the deformation module 1220 may receive patient image data, bone models, CAD models, etc., and use these inputs to determine the deformation of the patient's bone.

[0264] In one embodiment, the artificial intelligence or machine learning module 1224 may be trained using a large dataset of anatomical data 1212 for healthy, non-deformed bones and a large dataset of anatomical data 1212 for deformed bones where the deformations have been pre-identified and labeled within the dataset. The artificial intelligence or machine learning module 1224 may implement or use a neural network configured according to the training such that when the artificial intelligence or machine learning module 1224 receives the anatomical data 1212 of a particular patient, the artificial intelligence or machine learning module 1224 can determine what deformations 1226, if any, exist in the patient's bone.

[0265] Figures 14A and 14B illustrate an example of a method for determining deformation and correction of deformation according to one embodiment. The deformation module 1220 may use a particular method to determine whether two or more bones have a deformation 1226. The deformation module 1220 may use one or more advanced computing techniques to determine the deformation 1226.

[0266] Referring now to FIG. 14A, in one embodiment, the deformation module 1220 begins by identifying the central longitudinal axes 1228a, 1228b (FIG. 14A shows two of the plurality of axes for clarity) for each bone within the bone model 1204. For example, the deformation module 1220 may identify the central longitudinal axis 1228a for the first midfoot bone and the central longitudinal axis 1228b for the second midfoot bone.

[0267] Next, the deformation module 1220 may identify a reference axis 1229 that is perpendicular to one of the central longitudinal axes 1228a, b, such as the central longitudinal axis 1228b. The reference axis 1229 may be at or near a joint between the bones of the bone model 1204. The deformation module 1220 may determine that a deformation 1226 exists when the central longitudinal axes 1228a, b are not parallel or are not parallel when measured with a pre-defined margin for error. FIG. 13A illustrates a bone model 1204 having a deformation 1226. The deformation 1226 is at the joint between the first midfoot bone and the medial cuneiform bone, where the first midfoot bone is not parallel or not sufficiently parallel to the second midfoot bone. Once the deformation 1226 is determined, the deformation module 1220 or the device 1202 may determine which steps, procedures, or instruments may be used to correct the deformation 1226. The deformation module 1220 may use a name, label, tag, or other identifier for a particular deformation 1226.

[0268] FIG. 14B illustrates the bone model 1204 of FIG. 14A after a corrective procedure and / or application of a corrective implant may have been performed. The central longitudinal axes 1228a, b are parallel or sufficiently parallel such that the deformation 1226 is not a problem for the patient.

[0269] FIG. 15 illustrates an exemplary preparation module 1230 configured to provide a preliminary cutting guide model. The preparation module 1230 can receive anatomical data 1212 and a designation, identifier, label, or name of the deformation 1226. In the illustrated embodiment, the preparation module 1230 can generate a preliminary cutting guide model 1238 (e.g., generate from a “scratch”), or the preparation module 1230 can automatically select a template cutting guide model 1236 from a set of template cutting guide models 1236 stored in the repository 1502. The preparation module 1230 can incorporate various parameters to prepare, generate, determine, or select the template cutting guide model 1236. For example, in addition to the anatomical data 1212, the preparation module 1230 can include patient image data, deformation parameters of various angular deformations (in all three planes) of the midfoot or hindfoot and ankle where osteotomy can be used, patient preferences, and / or surgeon input parameters.

[0270] In one embodiment, the preparation module 1230 can include a generator 1232 and / or a selection module 1234. In one embodiment, the generator 1232 is configured to generate a preliminary cutting guide model 1238. In certain embodiments, the generator 1232 can generate or create a preliminary cutting guide model based on anatomical data and / or a bone model, or a combination thereof, and without other inputs. (E.g., without a model or pre-designed structure, template, or prototype). Alternatively, or additionally, the generator 1232 can generate or create a preliminary cutting guide model using a standard set of features or components that can be combined to form the preliminary cutting guide model. The generated preliminary cutting guide model can then be modified or revised by an automated process and / or a manual process to generate the preliminary cutting guide model used in the present disclosure.

[0271] The selection module 1234 can be configured to select a template cutting guide model 1236 for an osteotomy procedure configured to correct the deformities identified by the deformation module 1220. In one embodiment, the preparation module 1230 can select the template cutting guide model 1236 from a set of template cutting guide models (e.g., a library, set, or repository of template cutting guide models 1236). In one embodiment, the template cutting guide model 1236 can include a digital model. In another embodiment, the template cutting guide model 1236 can include a physical model. In such an embodiment, the repository 1502 can be a warehouse or other inventory repository. If the template cutting guide model 1236 is a physical model, the systems, modules, and methods of the present disclosure can be used and the physical model can be milled or machined (e.g., with a CNC machine) to form a patient-specific cutting guide that conforms to the patient's bone surface.

[0272] The selection of a suitable template cutting guide model 1236 can be fully automated and / or partially automated and / or can depend on user confirmation before the generated preliminary cutting guide model or the proposed template cutting guide model 1236 becomes the preliminary cutting guide model 1238. In another embodiment, the selection module 1234 can facilitate manual selection by the user of the template cutting guide model 1236 that will become the preliminary cutting guide model 1238. The selection module 1234 can use the anatomical data 1212 or the bone model 1204, or a combination thereof, to select a suitable template cutting guide model that will become the preliminary cutting guide model 1238.

[0273] In another embodiment, the generator 1232 may facilitate revision or editing by the user of the generated cutting guide model to become the preliminary cutting guide model 1238. The selection module 1234 may use the anatomical data 1212 or the bone model 1204, or a combination thereof, to select a suitable template cutting guide model to become the preliminary cutting guide model 1238.

[0274] The repository 1502 may include any number and / or variety of template cutting guide models 1236. The template cutting guide models 1236 may be distinguished based on, for example, the gender or age of the patient, which joints of the midfoot, hindfoot, or ankle are to be cut, what material is to be used for the template cutting guide, and the like. The template cutting guide models 1236 may differ from each other in the degree of deformity correction designed to be provided by the template cutting guide models 1236. Additionally, the template cutting guide models 1236 may be distinguished based on how one or more features of the template cutting guide models 1236 are positioned, arranged, and / or configured relative to each other. For example, in a particular template cutting guide model 1236, the number, location, and / or configuration of alignment features and / or bone attachment features (e.g., holes) may vary based on the needs or preferences of the patient, the nature of the deformity, and / or the preferences of the surgeon.

[0275] In certain embodiments, the template cutting guide model 1236 can vary in how the slots for cutting (e.g., resection features, see FIG. 6) are positioned, angled, and oriented relative to each other and / or relative to the longitudinal axis of each bone at the joint for use with the template cutting guide model 1236. For example, in one template cutting guide model 1236, the slot 1352 for resection of the middle foot bone can be perpendicular to the longitudinal axis of the middle foot bone, and the slot 1350 can be angled relative to the longitudinal axis of the cuneiform or cuboid bone such that when the two bones come together, the deformity is corrected. Alternatively, in another template cutting guide model 1236, the slot for resection of the middle foot bone can be angled relative to the longitudinal axis of the middle foot bone, and the slot 1350 can be perpendicular to the longitudinal axis of the cuneiform or cuboid bone such that when the two bones come together, the deformity is corrected.

[0276] The selection module 1234 may be configured to automatically select the template cutting guide model 1236 and / or to provide recommendations for an automatically generated template cutting guide model 1236 that can be modified by a user such as a surgeon. For example, in one embodiment, the preparation module 1230 and / or the selection module 1234 includes an artificial intelligence or machine learning module. The artificial intelligence or machine learning module may be configured to implement one or more of various artificial intelligence modules that may be trained to select the template cutting guide model 1236 based on the anatomical data 1212 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 1212 for a suitable template cutting guide model 1236 that has been identified and labeled within the dataset by an expert for use in treating a particular deformity 1226. 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 a suitable template cutting guide model 1236. The template cutting guide model 1236 selected by the selection module 1234 may become the preliminary cutting guide model 1238.

[0277] FIG. 16 illustrates an exemplary design module 1250 configured to design a patient-specific cutting guide model according to one embodiment. The design module 1250 may receive the preliminary cutting guide model 1238 and generate a patient-specific cutting guide model 1602. In one embodiment, the design module 1250 includes a contour module 1604, an application module 1606, and / or an optional modification module 1608.

[0278] Referring now to FIG. 16, the design module 1250 may modify the preliminary cutting guide model 1238 such that the surface of the preliminary cutting guide model 1238 facing the bone and / or the surface contacting the bone coincides with the surface of the joint and / or the contour of the joint of the bone to be resected using the preliminary cutting guide model 1238.

[0279] The contour module 1604 can determine the contour of the bone that will contact the preliminary cutting guide model 1238. The contour module 1604 can use the bone model 1204 and / or the anatomical data 1212 to determine the contour. For example, the contour module 1604 can determine the shape of the medial cuneiform bone 202 and / or the first midfoot bone 208.

[0280] The application module 1606 can apply the contour to the provided preliminary cutting guide model 1238 to custom contour the bone addition surface of the preliminary cutting guide model 1238 to match the shape of the medial cuneiform bone 202 and / or the first midfoot bone 208. Applying the contour to the preliminary cutting guide model 1238 can convert the preliminary cutting guide model 1238 into a patient-specific cutting guide model 1602.

[0281] The generation of the contours of the cuneiform addition portion 326 and the midfoot addition portion 328 of the preliminary cutting guide model 1238 can be relatively easily implemented in various CAD programs. In some embodiments, the shape of the corresponding surfaces of the medial cuneiform bone 202 and the first midfoot bone 208 can be directly obtained from the bone model 1204, the anatomical data 1212, the CAD model, and / or the CT scan data and simply copied to the preliminary cutting guide model 1238. Various operations can be used to copy the surface from one object to another. Additionally, or alternatively, various Boolean operations, such as Boolean subtraction operations, can be used to remove material from the model for the body 310 of the preliminary cutting guide model 1238 that has a shape that matches the surfaces of the medial cuneiform bone 202 and the first midfoot bone 208.

[0282] In certain embodiments, design module 1250 may include any module such as modification module 1608. Modification module 1608 may enable a user, such as an engineer or surgeon, to make additional modifications to the design and configuration of the pre-cut guide model 1238. In one embodiment, the user may change any of the features, angles, configurations, or parameters of the pre-cut guide model 1238. For example, a surgeon may recognize other concerns or anatomical deformities of a patient in relation to the hip joint or other orthopedic joints that motivate the surgeon to adjust, for example, the angle of the opposite leg or one of the resection features of the pre-cut guide model 1238.

[0283] Alternatively, or in addition, the user may use modification module 1608 to modify a pre-defined osteotomy procedure. The user may add, remove, or modify the steps and instruments used in the osteotomy procedure to create a patient-specific osteotomy procedure. In this way, the user may configure the pre-cut guide model 1238 or a modified pre-cut guide model and / or the features of the osteotomy procedure specific to the patient-specific osteotomy that the surgeon has planned for the patient. As used herein, "patient-specific osteotomy procedure" refers to an osteotomy procedure that has been adjusted, tailored, modified, or configured to specifically address the needs or desires or specificities of a particular patient. In certain aspects, one patient-specific osteotomy procedure may be usable in relation to only one patient. In other aspects, one patient-specific osteotomy may be usable in several patients having certain classes of characteristics.

[0284] The user may review the pre-cut guide model 1238, may adjust or revise it, or may not adjust or revise it. The output of modification module 1608 and / or application module 1606 is the patient-specific cutting guide model 1602.

[0285] FIG. 17 illustrates an exemplary system 1700 configured to generate one or more patient-specific instruments configured to correct the condition of a bone, according to one embodiment. System 1700 may include components or modules similar to those described in connection with FIG. 12. Additionally, system 1700 may include a fixture selector 1702 and / or an export module 1704.

[0286] The fixture selector 1702 enables a user to determine the fixture(s) to be used for an osteotomy procedure planned for a patient. In one embodiment, the fixture selector 1702 may recommend one or more fixtures based on the bone model 1204, the deformity 1226, or input from the user, or the history of previous osteotomy procedures performed to correct a particular deformity 1226. In one embodiment, the fixator selector 1702 selects a bone plate for the fixation of two bones of a patient during an osteotomy procedure. The fixture selector 1702 may select a fixture model from a set of pre-defined fixture models or select a physical fixture from a set of fixtures. The fixture may include a plate and associated accessories such as screws, anchors, etc.

[0287] As used herein, a "fixture" refers to an apparatus, instrument, structure, device, component, member, system, assembly, or module structured, organized, configured, designed, arranged, or operated to connect two bones or bone fragments, or a single bone or bone fragment and another fixture, to position and hold the bone or bone fragment in a desired position and / or orientation. Examples of fixtures include both those for external fixation and those for internal fixation 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, intervertebral cages, fusion cages, etc.

[0288] In one embodiment, the fixture selector 1702 includes 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 can be trained to select the fixture(s) based on the anatomical data 1212 and / or other input parameters. In one embodiment, the artificial intelligence or machine learning module can be trained using a large dataset of anatomical data 1212 for suitable fixture(s) identified and labeled within the dataset by experts for use in treating a particular deformation 1226. The artificial intelligence or machine learning module can implement or use a neural network configured according to the training so that the artificial intelligence or machine learning module can select or recommend suitable fixture(s).

[0289] The export module 1704 is configured to enable the export of the patient-specific cutting guide model 1602 for various purposes including, but not limited to, the fabrication / manufacture of the patient-specific cutting guide 1206 and / or fixture(s), the generation of a preoperative plan, the generation of a physical bone model that matches the bone model 1204, etc. In one embodiment, the export module 1704 is configured to export the bone model 1204, the anatomical data 1212, the patient-specific cutting guide model 1602, the preoperative plan 1706, the fixture model 1708, etc. In this way, custom instruments and / or treatment steps for the osteotomy procedure can be used with other tools. The preoperative plan 1706 can include a series of step-by-step instructions and / or recommendations for the surgeon or other staff when performing an osteotomy procedure such as a patient-specific osteotomy procedure. The preoperative plan 1706 can include image and text instructions and can include the identification of the instruments used in different steps of the osteotomy procedure. The instruments can include the patient-specific cutting guide 1206 and / or one or more fixtures. In one embodiment, the export module 1704 can provide a fixture model that can be used to fabricate a fixture for the osteotomy procedure.

[0290] Exports (1204, 1212, 1602, 1706, and 1708) can be inputs to various third - party tools 1710, including manufacturing tools, simulation tools, virtual reality tools, augmented reality tools, surgical procedure simulation tools, robotic assistance tools, etc. The surgeon can then use these tools when performing an osteotomy procedure or for rehearsal and preparation of an osteotomy procedure. For example, a physical model of the bone, a patient - specific cutting guide 1206, and / or a fixture can be fabricated and used for a rehearsal surgical procedure. Alternatively, the surgeon can perform a simulated osteotomy procedure using a surgical procedure simulation tool with a bone model 1204, a pre - cutting guide model 1238, and / or a fixture model.

[0291] FIG. 18 is a rear perspective view of a foot 1800 after performing an Evans calcaneal osteotomy and a medial displacement calcaneal osteotomy with patient - specific instruments and / or implants, according to one embodiment. The foot 1800 can have a calcaneus 1806 and a talus 1810 in addition to a midfoot 1820 and cuneiforms 1830. According to the Evans calcaneal osteotomy, the front portion of the calcaneus 1806 can be cut along the medial - lateral direction to separate a first bone segment 1840 of the calcaneus 1806 from a second bone segment 1842 of the calcaneus 1806. The second bone segment 1842 can be re - oriented medially with respect to the first bone segment 1840 such that the heel 1850 of the calcaneus 1806 moves medially and simulates a natural and healthy arch within the foot 200.

[0292] The cut between the first bone segment 1840 and the second bone segment 1842 can be performed virtually (e.g., in CAD) on a model of the calcaneus 1806 obtained from a CT scan or other image of the patient's foot. Thus, an optimal realignment of the posterior end of the calcaneus 1806 can be obtained. If desired, a patient - specific cutting guide, or cutting guide 1843, can be generated to facilitate resection of the calcaneus 1806.

[0293] As shown, the cutting guide 1843 can have a first end 1844 and a second end 1845, each of which can have a bone attachment feature 1846. The bone attachment feature 1846 can be used to secure the first end 1844 and the second end 1845 to the first bone segment 1840 and the second bone segment 1842, respectively. The first end 1844 can have a first bone engagement surface 1847 shaped to conform to a corresponding contour on the first bone segment 1840, and the second end 1845 can have a second bone engagement surface 1848 shaped to conform to a corresponding contour on the second bone segment 1842. Thus, the cutting guide 1843 lies flush with the surface of the calcaneus 1806 at an optimal location on the calcaneus 1806 to facilitate resection of the calcaneus 1806 and to divide the first bone segment 1840 from the second bone segment 1842. The cutting guide 1843 can have a resection feature 1849, such as a slot, that can be used to guide a cutter to form a single cut between the first bone segment 1840 and the second bone segment 1842.

[0294] After the cut is made to divide the calcaneus 1806 into a first bone segment 1840 and a second bone segment 1842, the surgeon can angle the second bone segment 1842 relative to the first bone segment 1840 in a predetermined (pre-modeled) relative orientation. This reorientation between the first bone segment 1840 and the second bone segment 1842 can leave a wedge-shaped gap between the first bone segment 1840 and the second bone segment 1842. To maintain the desired relative orientation, an implant 1860 having a wedge shape can be inserted into the gap and secured to the first bone segment 1840 and the second bone segment 1842. Since the precise angling and positioning of the realignment can also be patient-specific, the implant 1860 can be specially fabricated for the patient. As shown, the implant 1860 can have an outer surface that is contoured to match the contours of adjacent portions of the first bone segment 1840 and the second bone segment 1842. Thus, the implant 1860 can provide secure fixation without protruding beyond the adjacent surfaces of the first bone segment 1840 and the second bone segment 1842. Thus, the implant 1860 may not have a protruding edge or other protrusions, as otherwise it could interfere with the movement between the calcaneus 1806 and the talus 1810, or with the surrounding soft tissue, and thus potentially impede the patient's postoperative walking. "Soft tissue" refers to the tissues of a patient (i.e., a human or animal). Examples of soft tissue include, but are not limited to, skin, ligaments, tendons, fascia, adipose muscle, fibrous tissue, blood vessels, lymphatic vessels, brain tissue, and / or nerves.

[0295] The implant 1860 can be made of any biocompatible material including, but not limited to, titanium and its alloys, stainless steel, PEEK, etc. The implant 1860 can be formed by any method known in the art including, but not limited to, forging, casting, milling, additive manufacturing, etc. In some embodiments, the implant 1860 can have internal voids that can be filled with a bone graft or other material designed to promote ingrowth of bone between the cut surfaces of the first bone segment 1840 and the second bone segment 1842. In alternative embodiments, the implant 1860 can have a mesh and / or lattice structure that facilitates such ingrowth of bone, and the structure can be formed via additive manufacturing.

[0296] As described above, the medial displacement calcaneal osteotomy can be optionally performed in addition to or in place of the Evans calcaneal osteotomy. As shown, the heel 1850 can be cut from the remainder of the second bone segment 1842 and displaced medially. This displacement can also help to restore normal walking and tendon function of the foot 200, particularly when combined with the Evans calcaneal osteotomy. The appropriate displacement of the heel 1850 relative to the remainder of the second bone segment 1842 can be determined based on an analysis of the CAD model from a scan of the foot 200. If desired, a model of the calcaneus 1806 can be segmented and manipulated in CAD to simulate repositioning of the heel 1850 according to the medial displacement calcaneal osteotomy. Thus, the alignment of the heel 1850 relative to the remainder of the foot 200 can be easily evaluated and optimized prior to surgery.

[0297] Such preoperative alignment and planning can be particularly useful when multiple procedures, such as an Evans calcaneal osteotomy and a medial displacement calcaneal osteotomy, are combined for a single patient. Without such planning, it can be difficult to appropriately evaluate the effect of the combined procedures on the patient's anatomical structure. For example, the effect of an Evans calcaneal osteotomy, and the effect of a medial displacement calcaneal osteotomy, is to shift the heel 1850 medially. The combined shift can be difficult to evaluate in the operating room, but can be measured much more easily and accurately via manipulation of the modeled anatomical structure.

[0298] In some embodiments, in addition to, or instead of, the procedure of FIG. 9, one or more additional procedures may be performed. For example, in addition to, or instead of, an Evans calcaneal osteotomy and a medial displacement calcaneal osteotomy, a navicular osteotomy (medial cuneiform opening wedge osteotomy) and / or a first midfoot metatarsal midfoot osteotomy may be performed. A patient-specific cutting guide can be designed, fabricated, and surgically used to facilitate any of these procedures through the presence of a bone-engaging surface shaped to be placed on a particular bone surface adjacent to the osteotomy.

[0299] Similar to the case of an Evans calcaneal osteotomy, a custom cutting guide, or cutting guide 1853, can be generated to assist the surgeon in obtaining a pre-modeled and / or planned correction using a computer model of the patient's foot. The cutting guide 1853 can have a structure and function similar to the structure and function of the cutting guide 1843 used for an Evans calcaneal osteotomy. Such a cutting guide can have a contoured surface that matches the contour of the adjacent bone surface of the second bone segment 1842 and / or the remaining portion of the heel 1850.

[0300] More specifically, the cutting guide 1853 can have a first end 1854 and a second end 1855, each of which has a bone attachment feature 1856. The bone attachment feature 1856 can be used to fixedly attach the first end 1854 and the second end 1855 to the second bone segment 1842 and the heel 1850, respectively. The first end 1854 can have a first bone engagement surface 1857 shaped to conform to a corresponding contour on the second bone segment 1842, and the second end 1855 can have a second bone engagement surface 1858 shaped to conform to a corresponding contour on the heel 1850. Thus, the cutting guide 1853 naturally lies flush with the surface of the calcaneus 1806 at an optimal position on the calcaneus 1806 to facilitate resection of the calcaneus 1806 and to divide the second bone segment 1842 from the heel 1850. The cutting guide 1853 can have a resection feature 1859, such as a slot, that can be used to guide a cutter to form a single cut between the second bone segment 1842 and the heel 1850.

[0301] To maintain the heel 1850 in an appropriate position relative to the remaining portion of the second bone segment 1842, a bone plate 1870 can be fixedly attached to the heel 1850 and the remaining portion of the second bone segment 1842. The bone plate 1870 can include a first end 1880 fixedly attached to the remaining portion of the second bone segment 1842, a second end 1882 fixedly attached to the heel 1850, and an intermediate portion 1884 extending from the first end 1880 to the second end 1882 and providing a desired medial shift between the first end 1880 and the second end 1882. The first end 1880 and the second end 1882 can be fixedly attached to the remaining portion of the second bone segment 1842 and the heel 1850, respectively, through the use of screws 1890.

[0302] Similar to the implant 1860, the bone plate 1870 can be made of any known biocompatible material through the use of any manufacturing process known in the art. In some embodiments, the bone plate 1870 may also be specially fabricated for the foot and may enable the bone plate 1870 to precisely maintain the desired level of correction. When specially fabricated for the foot in combination with each other, the implant 1860 and the bone plate 1870 can provide a very predictable, precise, and customizable level of correction of flatfoot deformity.

[0303] Advantageously in certain embodiments, the present disclosure can be used to prepare a pre-operative plan, one or more instruments, implants, or guides, including patient-specific implants and / or guides, and / or to perform one or more osteotomies on any body part of a patient.

[0304] FIG. 18 illustrates some examples of osteotomies that can be performed. In particular, the present disclosure can be used to perform a wedge osteotomy.

[0305] FIG. 19 illustrates an exemplary osteotomy system 1900 according to one embodiment. The osteotomy system 1900 can include one or more fasteners 1910, one or more resection guides 1920, and one or more complementary components 1930. The osteotomy system 1900 can be used for any osteotomy procedure, but one or more features, components, and / or aspects of the osteotomy system 1900 may be particularly suitable for wedge osteotomy, Evans osteotomy, Kouts osteotomy, etc.

[0306] In certain embodiments, the one or more fasteners 1910 can include both one or more permanent fasteners and one or more temporary fasteners. Typically, the fasteners 1910 can be used during various different treatment steps. Temporary fasteners are often used because they can securely hold the bone or a part of the bone. A common temporary fastener that can be used in the osteotomy system 1900 is a K-wire, also referred to as a pin.

[0307] One or more resection guides 1920 assist a surgeon in performing different resection steps for an osteotomy procedure. In certain embodiments, the resection guide 1920 includes one or more resection features 1922 and one or more bone attachment features 1924. The resection features 1922 can take various forms and / or embodiments. Similarly, the bone attachment features 1924 can take various forms and / or embodiments. The resection features 1922 provide a guide for a surgeon to excise a patient's bone, one or more bones, or other tissue using a cutting tool. The bone attachment features 1924 function to secure the resection guide 1920 to one or more bones and / or one or more other structures. Often, the bone attachment features 1924 can include holes within the resection guide 1920 for use with temporary fasteners such as K-wires or pins.

[0308] In certain embodiments, the resection guide 1920 can include one or more bone engagement surfaces 1926 and / or one or more landmark alignment features 1928. A "landmark alignment feature" refers to a structure configured to engage with 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. Various structures can function as landmark alignment features. For example, the landmark alignment features can include protrusions, bumps, ridges, cavities, voids, depressions, tabs, extensions, hooks, curves, and the like. Similarly, various structures can function as landmarks that engage with the landmark alignment features. For example, in the context of bone, landmarks can include heads, necks, condyles, maxillae, tuberosities, tubercles, crests, spines, ridges, trochanters, lines, fossae, foramina, notches, grooves or sulci, protrusions, bumps, nodules, cavities, voids, depressions, tabs, extensions, hooks, curves, surfaces of the bone, such as inner surfaces, outer surfaces, anterior surfaces, posterior surfaces, bottom surfaces, and the like.

[0309] In certain embodiments, the bone engagement surface 1926 is patient-specific and contoured to match the surface of one or more bones that the resection guide 1920 contacts during the osteotomy procedure. Alternatively, or additionally, the bone engagement surface 1926 may not be patient-specific and may or may not contact the bone surface during use of the resection guide 1920. One of ordinary skill in the art will understand that one or more sides of any of the members of the osteotomy system 1900 may include one or more bone engagement surfaces 1926. Thus, one or more sides of the fastener 1910, resection guide(s) 1920, complementary component 1930, one or more pin guides 1994, and / or implant 1996 may include one or more bone engagement surfaces 1926.

[0310] The complementary component 1930 functions to assist the surgeon during one or more steps of the osteotomy procedure. One of ordinary skill in the art will understand that several components may function as the complementary component 1930. Examples of the complementary component 1930 include, but are not limited to, the alignment guide 1940, rotation guide 1950, correction guide 1960, compression guide 1970, positioning guide 1980, fixation guide 1990, one or more pin guides 1994, and one or more implants 1996. Generally, the complementary component 1930 functions to assist the surgeon in performing the function included in the name of the complementary component 1930. Thus, the alignment guide 1940 may help the surgeon align the patient's bone, bone site, or other site as part of the osteotomy procedure. The rotation guide 1950 may help the surgeon rotate one or more of the patient's bones, bone sites, or other sites as part of the osteotomy procedure.

[0311] The correction guide 1960 can assist a surgeon in positioning and / or orienting one or more bones, bone sites, or other sites of a patient as part of an osteotomy procedure to reduce a bone, multiple bones, a bone site, or other site and / or to correct the position and / or orientation of a bone, multiple bones, a bone site, or other site. The compression guide 1970 can assist a surgeon in compressing one or more bones, bone sites, or other sites of a patient together with or against an implant as part of an osteotomy procedure. The positioning guide 1980 can assist a surgeon in positioning one or more bones, bone sites, or other sites of a patient as part of an osteotomy procedure. In certain embodiments, the positioning guide 1980 can be designed and fabricated to be patient-specific. Patient-specific aspects can include patient-specific bone engagement surfaces, pre-defined angles for reorienting one or more bones or bone sites in one or more planes, pre-defined positions for bone attachment features 1924 or fasteners 1910, and the like. Alternatively, or additionally, the positioning guide 1980 can be selected from a kit, collection, or repository of positioning guides 1980, each having a different configuration for one or more aspects / attributes of the positioning guide 1980. For example, each member of the repository / kit can include different positioning angles (repositioning or correction angles), which can differ, for example, by only two degrees. In such embodiments, each positioning guide 1980 may not be patient-specific for a particular patient but can provide the desired amount of positioning to meet the surgeon's goals. In certain embodiments, a pre-operative plan generated based on the present disclosure can include a recommendation for the positioning guide 1980 to be used even if the recommended positioning guide 1980 is not patient-specific for a particular patient.

[0312] The fixed guide 1990 can assist a surgeon in completing one or more temporary or permanent fixation steps on one or more bones, bone sites, or other sites of a patient as part of an osteotomy procedure. One or more pin guides 1994 function to guide a surgeon in the deployment of one or more pins (e.g., K-wires) for use in a surgical procedure. In one embodiment, one or more pin guides 1994 can engage and / or serve as a reference for a position and / or trajectory that is offset from any of the one or more resection guides 1920 and / or complementary components 1930. In one embodiment, one or more pin guides 1994 can be configured to enable (or facilitate) the deployment of one or more pins at a pre-defined distance, offset, and / or trajectory with respect to another component of the osteotomy system 1900 and / or one or more osteotomy cuts formed during a surgical procedure. In another embodiment, one or more pin guides 1994 can be configured to enable (or facilitate) the deployment of one or more pins at a patient-specific distance, offset, and / or trajectory with respect to another component of the osteotomy system 1900 and / or one or more osteotomy cuts formed during a surgical procedure. The patient-specific distance, offset, and / or trajectory can be predetermined to meet the needs of the patient and / or the surgeon.

[0313] An example of the complementary component 1930 can include a compressor / distractor 1000. The compressor / distractor 1000 can be used to compress or extend a bone or bone site involved in an osteotomy procedure.

[0314] Advantageously, the osteotomy system 1900 can assist a surgeon in overcoming one or more of the challenges encountered when performing an osteotomy procedure, particularly on the bones of a patient's foot, such as the forefoot, midfoot, or hindfoot. One challenge during an osteotomy procedure can be to maintain the control and / or position and / or orientation of the bone, one or more bones, and / or bone fragments / fragments, particularly when a resection is performed. Advantageously, the fasteners 1910, resection guides 1920, and / or complementary components 1930 can be configured to assist in overcoming this challenge.

[0315] Advantageously, the osteotomy system 1900 can assist the surgeon in accurately positioning, placing, and / or orienting the resection guide. Modern techniques can include preoperative planning, simulation, or practice using computer models, virtual reality systems, augmented reality systems, and the like. However, simulations and models still differ from positioning a resection guide on a patient's bone, joint, or body part during a procedure. The osteotomy system 1900 can include several features to assist the surgeon in positioning. In one embodiment, the resection guide 1920 can include one or more landmark alignment features 1928.

[0316] Advantageously, the osteotomy system 1900 can assist in easily removing a guide (e.g., a resection guide) without preventing the surgeon from securing a guide of the osteotomy system 1900, such as a resection guide, and reducing, shifting, reorienting, or repositioning one or more bones or bone sites while removing the guide. In certain embodiments, the osteotomy system 1900 is configured to allow removal of the guide while keeping a temporary fastener in place for use in subsequent steps of the osteotomy procedure. Alternatively, or additionally, the osteotomy system 1900 facilitates positioning of a temporary fastener between one step of a wedge osteotomy procedure for use in subsequent steps of the wedge osteotomy procedure. Removal of the guide during an osteotomy procedure can be particularly difficult if translation and / or rotation of the bones involved in the wedge osteotomy procedure are required for the success of the wedge osteotomy procedure. Advantageously, the osteotomy system 1900 accommodates translation and / or rotation of the bones during a wedge osteotomy procedure while facilitating a favorable outcome of the wedge osteotomy procedure.

[0317] Advantageously, the components of the osteotomy system 1900 can be specifically designed for a particular patient. Alternatively, or additionally, the components of the osteotomy system 1900 can be specifically designed for a class of patients. Each component of the osteotomy system 1900 can be designed, adapted, operated, and / or manufactured such that each feature, attribute, or aspect of the component is specifically designed to address one or more particular indications present in the patient. Advantageously, the cuts made for an osteotomy procedure can be of a size, location, orientation, and / or angle provided by an optimal osteotomy with a minimal risk of unwanted resection. In one embodiment, the components of the osteotomy system 1900 can be configured such that an osteotomy is performed that enables correction in two or more planes with respect to a part of the patient's body. For example, the cutting channels within the resection guide 1920 can be oriented and configured such that when the bone is fused / fixed, correction results from the translation, rotation, and / or movement of the bone or part of the bone in two or more planes (e.g., the sagittal plane and the transverse plane).

[0318] In certain embodiments, the components of the osteotomy system 1900 can be made as small as possible to minimize the amount of soft tissue opened in the patient for the osteotomy procedure. Alternatively, or additionally, the walls and / or sides of the components can be angled and / or beveled to avoid contact with other hard or soft tissue in the surgical field for the osteotomy procedure.

[0319] One of ordinary skill in the art will understand that for certain wedge osteotomy procedures, a complementary component 1930 may not be required, or a given complementary component 1930 may be optional for use in a wedge osteotomy procedure. Similarly, one of ordinary skill in the art will understand that certain features of the fasteners 1910, resection guide 1920, and / or complementary components 1930 can be combined into one or more of the devices or apparatuses, or can be provided using a plurality of separate devices.

[0320] Dwyer osteotomy FIG. 20 illustrates an exemplary osteotomy system 200 for Dwyer osteotomy according to one embodiment. In one embodiment, the osteotomy system 2000 can include an excision guide 2020 (two embodiments 2020a, 2020b) and at least one complementary component 1930. In such an embodiment, the excision guide 2020 and / or at least one complementary component 1930 can include patient-specific features. In one embodiment, the osteotomy system 2000 includes at least one complementary component 1930 selected from the group of complementary components 1930. Examples of members of the group include, but are not limited to, alignment guides, rotation guides, compression guides, correction guides, positioning guides, pin guides, fixation guides, etc. One or more of the guides included in at least one complementary component 1930 can include patient-specific features including, but not limited to, bone engagement surfaces, bone attachment features, excision features, landmark alignment features, handles, etc.

[0321] In certain embodiments, a single complementary component 1930 can be configured to perform the functions of two or more other components within the group of at least one complementary component 1930. The other components can be combined due to aspects identified in one or more bone models of one or more bones of the patient and can be combined to form patient-specific components. Alternatively, or additionally, the other components can be combined to reduce the number of instruments used or required in the surgical procedure and / or to reduce the number of steps in the surgical procedure. Further, in certain embodiments, the osteotomy system 2000 can be initially configured and designed in a virtual environment, along with a surgical technique that minimizes the number of complementary components 1930 used or required and / or the number of steps in the surgical technique. For example, the excision guide 2020 and / or at least one fastener 2010 and / or complementary component 1930 can cooperate with each other to provide an instrument (which may or may not include patient-specific aspects) and a surgical technique that provides a favorable outcome for the patient and minimizes the burden on the surgeon.

[0322] In the illustrated embodiment, the osteotomy system 2000 includes at least one fastener 2010, a resection guide 2020 (two embodiments 2020a, 2020b), one or more pin guides 2200, and a positioning guide 2300.

[0323] Figures 21A-21J illustrate views of the resection guide 2020 of the osteotomy system of FIG. 20 according to one embodiment. In one embodiment, the resection guide 2020a includes one or more resection features 2022 (e.g., a posterior resection feature 2022a, an anterior resection feature 2022b), one or more bone attachment features 2024 (e.g., a first bone attachment feature 2024a, a second bone attachment feature 2024b), one or more handles 2026 (e.g., handles 2026a, b), a body 2028, and a bone engagement surface 2033.

[0324] Figure 21A illustrates a perspective bottom side rear view of one embodiment of the resection guide 2020a including a posterior resection feature 2022a and an anterior resection feature 2022b. The illustrated embodiment includes two resection features 2022 and two bone attachment features 2024.

[0325] The body 2028 includes an outer side 2030, an inner side 2032, a front side 2034, a rear side 2036, a dorsal side 2038, and a bottom side 2040. See FIGS. 21A-21I. Generally, the sides of the body 2028 refer to the directions in which the sides face when the resection guide 2020 is in use. The inner side 2032 faces the patient's bone and faces in an inner direction with respect to the patient. The outer side 2030 faces away from the patient and faces in an outer direction. The front side 2034 faces in the anterior direction, and the rear side 2036 faces in a posterior direction with respect to the patient.

[0326] The resection feature 2022 facilitates performing an osteotomy on the patient's bone. The resection feature 2022 can function as a template or guide for operating a cutting tool to create an osteotomy site. In one embodiment, the resection feature 222 guides a cutting tool along a predetermined trajectory to cut within and / or through the bone.

[0327] FIG. 21B illustrates an embodiment of a resection guide 2020a that includes a posterior resection feature 2022a and an anterior resection feature 2022b. FIG. 21B illustrates a perspective dorsal posterior view of an embodiment of the resection guide 2020a. In certain embodiments, the posterior resection feature 2022a and the anterior resection feature 2022b may be parallel to each other on the outer 2030 surface of the body 2028. Alternatively, or additionally, the posterior resection feature 2022a and the anterior resection feature 2022b may be non-parallel to each other on the outer 2030 surface of the body 2028.

[0328] FIG. 21C illustrates a posterior perspective view of the resection guide 2020a.

[0329] FIG. 21D illustrates an anterior perspective view of the resection guide 2020a.

[0330] Referring to FIGS. 21C and 21D, the resection guide 2020a may include one or more bone attachment features 2024. The one or more bone attachment features 2024 secure the resection guide 2020a to bone for one or more osteotomies. In one embodiment, a single bone attachment feature 2024 may be sufficient to secure the resection guide 2020a for a surgical procedure.

[0331] In the illustrated embodiment, the bone attachment feature 2024 is embodied in the form of an opening that extends from the outside 2030 to the inside 2032. The opening is sized to receive and securely engage (e.g., by friction fit) a fastener 2010 disposed within the bone through the opening. In one embodiment, there is a single bone attachment feature 2024. In another embodiment, the bone attachment feature 2024 may be composed of two or more bone attachment features (e.g., bone attachment feature 2024a and bone attachment feature 2024b). In the illustrated embodiment, the bone attachment feature 2024 includes a first bone attachment feature 2024a and a second bone attachment feature 2024b. Using two bone attachment features 2024 can be advantageous because the two bone attachment features 2024 fixed to the bone can prevent the resection guide 2020a from rotating about a single bone attachment feature 2024.

[0332] One challenge when performing osteotomy can be how to control the bone fragments formed by the osteotomy. Considerable effort is made to perform surgical procedures with minimal incisions in order to reduce tissue destruction and promote healing and recovery. However, such efforts can increase the challenge of controlling the bone fragments formed by the osteotomy. For example, assume that the resection guide 2020a is used for a wedge osteotomy. When the osteotomy is successfully completed, a wedge-shaped bone fragment may be created under the resection guide 2020a. In the illustrated embodiment, advantageously, at least one bone attachment feature 2024 is positioned between the posterior resection feature 2022a and the anterior resection feature 2022b. Thus, when the osteotomy using both the posterior resection feature 2022a and the anterior resection feature 2022b is completed, the resulting wedge-shaped bone fragment remains fixed to at least one bone attachment feature 2024. Of course, the fastener 2010 for at least one bone attachment feature 2024 may extend to a depth within the bone such that the fastener 2010 does not interfere with the completion of the wedge osteotomy. After the wedge osteotomy, the surgeon can use the fastener 2010 to remove the wedge-shaped bone fragment, if desired.

[0333] In the illustrated embodiment, the bone attachment features 2024 are aligned with each other. In another embodiment, the bone attachment features 2024 may not be aligned with each other. In certain embodiments, the bone attachment features 2024 are configured such that the fasteners 2010 used with the bone attachment features 2024 are parallel to each other. In this way, the resection guide 2020a can slide off the fasteners 2010 easily, while the fasteners 2010 remain in the bone. Advantageously, the remaining fasteners 2010 can be reused in subsequent steps of the surgical procedure.

[0334] One of ordinary skill in the art will understand that one or more bone attachment features 2024 can be implemented in various ways and / or with various structures. For example, in one embodiment, the bone attachment features 2024 can be embodied as one or more prongs, pins, or spikes extending from the inner side 2032 of the resection guide 2020a. The pins, prongs, or spikes can be driven into the bone by a mallet. Of course, other embodiments of the bone attachment features 2024 can have different configurations and still fall within the scope of the present disclosure.

[0335] In certain embodiments, the resection guide 2020a can include one or more handles 2026. The handles 2026 can facilitate positioning and / or placement of the resection guide 2020a. In certain embodiments, the resection guide 2020a may not include the handles 2026. Instead, the user can grip the body 2028 for positioning. Alternatively, or additionally, the handles 2026 can be relatively straight and aligned with the longitudinal axis of the resection guide 2020a such that the handles 2026 can be used as a visual guide for the surgeon to confirm the positioning, placement, and / or orientation of the resection guide 2020a on the patient's bone. Of course, other aspects of the resection guide 2020a can perform the same or similar functions as the handles 2026 such that a dedicated handle 2026 may not be required.

[0336] Furthermore, the handle 2026 may serve two or more functions or purposes. In certain embodiments, one or more of the handles 2026 may function both as a handle for use by the user to position / orient the resection guide 2020a and / or as a landmark alignment feature.

[0337] The landmark alignment feature functions to assist the surgeon in mapping or transforming one of the models of one or more bones of the patient in the virtual environment and / or preoperative plan from the position of the model of the resection guide 2020 to the actual physical position on one or more bones of the patient during the procedure. In the illustrated embodiment, the resection guide 2020a includes at least one landmark alignment feature.

[0338] In particular, the resection guide 2020 may include an underside landmark alignment feature 2041a. In another embodiment, the resection guide 2020 may include a dorsal landmark alignment feature 2041b. See, e.g., FIG. 21E. Alternatively, or additionally, the resection guide 2020 may include a landmark alignment feature 2041 extending from either side of the resection guide 2020.

[0339] The landmark alignment feature 2041 is configured to engage a landmark on the patient's bone. Advantageously, the landmark alignment feature 2041 provides the surgeon with confidence and certainty in the placement and positioning of the resection guide 2020a on the bone because the landmark alignment feature 2041 engages one or more specific landmarks (e.g., protrusions or recesses or cavities) on the bone. The landmark alignment feature 2041 is one feature that assists the surgeon in transferring the position of the instrument model relative to the patient's bone model to the instrument positioned on the patient's actual bone during the surgical procedure.

[0340] Alternatively, or additionally, the landmark alignment feature 2041 may include a bone engagement surface 2043 that may further facilitate alignment of the landmark alignment feature 2041 and / or the resection guide 2020a with bone. In this way, the surgeon can be confident during the surgery that the resection guide 2020a is positioned according to the preoperative plan. In one embodiment, the bone engagement surface 2043 is fabricated based on a bone model of the bone with which the bone engagement surface 2043 will engage. In a particular embodiment, the bone engagement surface 2043 is shaped to receive the surface of the bone disposed in contact with the resection guide 2020a. Alternatively, or additionally, the bone engagement surface 2043 of the landmark alignment feature 2041 may be shaped to include a contour that is similar to, substantially similar to, and / or matches the surface of a bone model of the bone (e.g., the patient's bone) with which the resection guide 2020a will be used for the surgical procedure. The bone engagement surface 2043 may be formed, in part, and / or similarly, with the bone engagement surface 2033 of the resection guide 2020a.

[0341] In a particular embodiment, the landmark alignment feature 2041 may be shaped like a hook for engaging the bottom / lower surface or the dorsal / upper surface of the bone. Alternatively, or additionally, the resection guide 2020a may include landmark alignment features 2041 (lower / bottom landmark alignment feature 2041a and upper / dorsal landmark alignment feature 2041b) at each end, and the landmark alignment features 2041 may engage one or more landmarks on the surface of the bone such that together they allow the surgeon to accurately position and align the resection guide 2020a with the bone. Of course, the resection guide 2020a may include multiple landmark alignment features 2041. In one embodiment, one or more landmark alignment features 2041 may engage the bottom side and / or the dorsal side of the calcaneus 224.

[0342] In the illustrated embodiment, the bottom alignment feature 2041a extends from the bottom side 2040. Advantageously, the alignment feature 2041 is configured to engage one or more markers for the patient's bone. Advantageously, since the resection guide 2020a is defined in relation to one or more bones of the patient using one or more bone models and a model of the resection guide 2020a, the size, shape, length, and width of the alignment feature 2041 can be defined to facilitate engagement between the alignment feature 2041 and a marker such as the dorsal surface of the bone. Further, whether the resection guide 2020a includes the alignment feature 2041 can be a patient-specific feature.

[0343] Similar to the body 2028, the bottom alignment feature 2041a and the handle 2026a may also include an inner side 2032, and the body 2028 and the bottom alignment feature 2041a may both have the same inner side 2032. In one embodiment, the bone engagement surface 2033 may include a bone engagement surface 2043 (see FIGS. 21E and 21F). In other words, the bone engagement surface 2033 may extend beyond the inner side 2032 of the body 2028 to include the inner sides of the bottom alignment feature 2041a and the handle 2026a.

[0344] In certain embodiments, the posterior resection feature 2022a and the anterior resection feature 2022b may extend from the outer side 2030 to the inner side 2032. Advantageously, the depth of the posterior resection feature 2022a and / or the anterior resection feature 2022b through the body 2028 is long enough to guide the cutting tool and continue to orient the cutting tool along a trajectory defined by the opening of the resection feature 2022. Advantageously, the present disclosure enables an osteotomy system 2000 that assists a surgeon in managing the depth of osteotomy in bone.

[0345] FIG. 21E illustrates a perspective view of the inner 2032 of resection guide 2020a. In the illustrated embodiment, the inner 2032 includes a bone-engaging surface 2033. In one embodiment, the bone-engaging surface 2033 is configured to contact and / or engage the surface of a patient's bone. In one embodiment, the periosteum on the bone is lifted and / or dissected around the area of the bone where the resection guide 2020a is to be positioned. Lifting the periosteum exposes the bone surface for engagement by the bone-engaging surface 2033. Advantageously, the bone-engaging surface 2033 is configured to substantially conform to the surface of the bone. Alternatively, or additionally, the bone-engaging surface 2033 is configured to partially conform to the surface of the bone.

[0346] Alternatively, or additionally, the bone-engaging surface 2033 is configured to receive the surface of the bone on which the resection guide 2020a is to be placed. Specifically, a user may determine the planned position of the resection guide 2020a on the outer surface of the patient's bone based on a prescription and / or in consultation with a surgeon. The user may then use a model of the patient's bone and a model of the resection guide 2020a to reflect this planned position. Since the model of the patient's bone is a very accurate representation, the bone-engaging surface 2033 defined on the inner 2032 of the model of the resection guide 2020a accurately includes the features and aspects of the surface of the patient's bone. Examples of features and aspects of the bone-engaging surface 2033 include, but are not limited to, the surface of the bone model, but nodules, tubercles, ridges, spines, elevations, trochanters, lines, fossae, foramina, notches, grooves or sulci, protrusions, convexities, nodules, cavities, voids, depressions, tabs, extensions, hooks, curves, etc. in an inverted or reverse configuration. For example, if a cavity is on the surface of the bone model (and the patient's bone), a protrusion that conforms to the cavity is present on the bone-engaging surface 2033.

[0347] In one embodiment, the bone engagement surface 2033 is configured to align with the outer surface of the patient's bone. In certain embodiments, the bone engagement surface 2033 is defined at least in part based on the outer surface of a bone model of the patient's foot bone. Advantageously, the bone engagement surface 2033 is a negatively contoured surface that is similar, substantially similar, and / or coincident with the surface of the bone model that contacts the model of the resection guide 2020a when the model of the resection guide 2020a is positioned on the bone model as desired. In one embodiment, aligning the bone engagement surface 2033 means that each feature or aspect of the bone engagement surface 2033 engages, fits, and / or conforms within the corresponding feature or aspect of the surface of the patient's bone. For example, if the bone surface includes a protrusion, the bone engagement surface 2033 includes a recess configured to receive and engage that protrusion.

[0348] As described herein, the bone model used to determine or at least partially determine the shape, size, and / or configuration of the bone engagement surface 2033 is based on a medical image of at least a portion of the patient's foot and is configured to be similar, significantly similar, and / or coincident with the anatomical structure of the patient's foot.

[0349] FIG. 21F is a medial side view of the resection guide 2020a.

[0350] FIG. 21G is a lateral side view of the resection guide 2020a.

[0351] FIG. 21H is a dorsal side view of the resection guide 2020a.

[0352] FIG. 21I is a bottom side view of the resection guide 2020a.

[0353] FIG. 21J illustrates a cross-sectional view of the resection guide 2020a positioned on a patient's bone (e.g., the calcaneus). The surgeon created a first bone cut using the posterior resection feature 2022a and a second bone cut using the anterior resection feature 2022b.

[0354] Referring now to FIGS. 21J, 21A, and 21B, in the illustrated embodiment, the posterior resection feature 2022a includes an opening that begins at the outer side 2030 and extends to the inner side 2032. The opening of the posterior resection feature 2022a extends through the body 2028 along the first track 2042. In the illustrated embodiment, the anterior resection feature 2022b includes an opening that begins at the outer side 2030 and extends to the inner side 2032. The opening of the anterior resection feature 2022b extends through the body 2028 along the second track 2044.

[0355] The opening of the posterior resection feature 2022a and / or the opening of the anterior resection feature 2022b have a width and / or length that is large enough to accommodate or receive the cutting element of a cutting tool. In one embodiment, the opening of the posterior resection feature 2022a is configured to guide a cutting tool and / or to enable a cutting tool to form a first osteotomy 2046 within and / or through the bone along the first track 2042. Advantageously, the first osteotomy 2046 tracks, follows, and / or is aligned with the first track 2042. In one embodiment, the opening of the anterior resection feature 2022b is configured to guide a cutting tool and / or to enable a cutting tool to form a second osteotomy 2048 within and / or through the bone along the second track 2044. Advantageously, the second osteotomy 2048 tracks, follows, and / or is aligned with the second track 2044. Thus, a surgeon operating a cutting tool within the openings of the posterior resection feature 2022a and the anterior resection feature 2022b can easily form a first osteotomy 2046 and a second osteotomy 2048 that conform to a design that may be set in a model of the resection guide 2020a and / or a model of the patient's bone(s).

[0356] In one embodiment, the first trajectory 2042 can be determined and / or defined as a patient-specific feature. Similarly, the second trajectory 2044 can be determined and / or defined as a patient-specific feature. Advantageously, using the devices, methods, and / or systems of the present disclosure, a user can determine and / or at least partially determine the first trajectory 2042 and / or the second trajectory 2044 based on a bone model of at least a portion of the bone of a patient who is to undergo one or more osteotomies. The bone model of at least a portion of the bone can be derived from and / or based on a medical image of the patient's foot. In certain embodiments, the bone model used to determine or at least partially determine the first trajectory 2042 and / or the second trajectory 2044 is configured to be similar, substantially similar, or identical to the anatomical structure of the patient's foot.

[0357] As used herein, in certain embodiments, the partial determination of the first trajectory 2042 and / or the second trajectory 2044 based on a bone model can mean that the bone model of the bone of the patient who is to undergo an osteotomy is used together with other image data, anatomical data, patient image data, patient data, information from a physician's prescription, information regarding a surgeon's preference, measurement data obtained from the bone model or medical image, etc., and can also be used to determine the first trajectory 2041 and / or the second trajectory 2044.

[0358] In one embodiment, the posterior resection feature 2022a extends along a first trajectory 2042 through the resection guide 2020 from the outside 2030 to the inside 2032. The first trajectory 2042 is at least partially determined based on a bone model of at least a portion of the bones of the patient's foot. The bone model is based on a medical image of the patient's foot and is configured to be similar, significantly similar, and / or identical to the anatomical structure of the patient's foot. Alternatively, or additionally, the anterior resection feature 2022b extends along a second trajectory 2044 through the resection guide 2020 from the outside 2030 to the inside 2032. The second trajectory 2044 is at least partially determined based on a bone model of at least a portion of the bones of the patient's foot. The bone model is based on a medical image of the patient's foot and is configured to be similar, significantly similar, and / or identical to the anatomical structure of the patient's foot.

[0359] One of ordinary skill in the art will understand that the first trajectory 2042 and the second trajectory 2044 may define the path of the bone cut formed using the posterior resection feature 2022a and / or the anterior resection feature 2022b. Alternatively, or additionally, if the surgical procedure is planned to perform a wedge osteotomy, the first trajectory 2042 and the second trajectory 2044 may predefine the size, shape, and configuration of the wedge fragment formed by the osteotomy.

[0360] In one embodiment, a surgeon may desire to perform a cuneotomy. In this embodiment, the resection guide 2020a is designed such that the posterior resection feature 2022a and the anterior resection feature 2022b form a cuneotomy portion having a cuneiform bone fragment after the formation of the first osteotomy portion 2046 and the second osteotomy portion 2048, and the first trajectory 2042 converges with the second trajectory 2044 at the apex 2102 having a wedge angle 2104, and the wedge angle 2104 is determined based at least in part on the bone model 1204. Advantageously, various aspects of the design of the resection guide 2020a and / or the surgical techniques and / or complementary components 1930 associated therewith can be performed prior to the fabrication of one or more components of the osteotomy system 2000. Thus, the surgeon can define or adjust the position of the apex 2102, the degree of the wedge angle 2104, the height 2106 of the body 2028, and the like. Of course, certain of these aspects may be pre-defined for the surgeon and / or may be recommendations made to the surgeon. Alternatively, or in addition, certain of these aspects may be patient-specific, while other aspects may be standard based on experience and / or established practice for a particular procedure.

[0361] In certain embodiments, the surgeon and / or the technician working with the surgeon can determine the size, shape, and / or configuration of the cuneiform bone fragment 2050 removed from the bone. Further, the surgeon and / or the technician can determine whether to perform an osteotomy that forms the cuneiform bone fragment 2050, or an osteotomy that enables an opening cuneotomy, or an osteotomy that does not include a wedge (closing or opening). The type of osteotomy performed can determine whether the first trajectory 2042 and / or the second trajectory 2044 converge, and / or the size of the posterior angle 2052 and / or the anterior angle 2056.

[0362] In one embodiment, the surgeon can also determine preoperatively whether the apex 2102 is on the inside or outside of the bone. For example, the surgeon can determine that the apex 2102 on the outside of the bone is at a distance from the inner surface 2108 of the bone (e.g., the calcaneus 224). The position of the apex 2102 can depend on the surgical procedure, the surgeon's preference, the planned correction by the surgeon, etc. In such an embodiment, the first trajectory 2042 can converge with the second trajectory 2044 at the apex 2102 on the outside of the bone and can be spaced from the inner cortex 2110 of the bone.

[0363] In another case, the surgeon can determine that the apex 2102 is between the inner cortex 2110 of the bone and the resection guide 2020a when the resection guide 2020a is being used for a surgical procedure. Alternatively, or additionally, the surgeon can determine that the apex 2102 is between the inner cortex 2110 of the bone and the resection guide 2020a when the resection guide 2020a is designed for the patient's foot. In a particular osteotomy, the surgeon may desire that the apex 2102 be positioned within the bone and offset from the inner cortex 2110 by a predetermined offset 2112. Advantageously, using embodiments of the present disclosure, the surgeon can determine and / or adjust the size of the predetermined offset 2112.

[0364] When the surgeon uses the resection guide 2020a for a surgical procedure such that the first osteotomy 2046 and the second osteotomy 2048 leave the bone intact between the apex 2102 and the medial cortex 2110, it may be desirable to position the apex 2102 between the medial cortex 2110 of the bone and the resection guide 2020a. This intact bone can function to keep the posterior bone fragment 2114 connected to the anterior bone fragment 2116. Depending on the planned surgical procedure, the surgeon may wish to keep this bone intact and function as a "living hinge" that can be used to close a wedge osteotomy. Of course, different surgeons may have different sizes that they desire for a given offset 2112. Alternatively, or additionally, the size of the given offset 2112 may be based at least in part on how the patient presents for the procedure or for the preparation and planning of the procedure.

[0365] Advantageously, the present disclosure enables the thickness / size of the given offset 2112 to be predetermined, patient specific, and a determination of whether to have the given offset 2112. As described, the surgeon can pre-position the apex 2102 such that it is within or outside of the bone.

[0366] In certain embodiments, the position of the apex 2102 can be customized for a particular patient. The position of the apex 2102 may be patient specific. Alternatively, or additionally, the position of the apex 2102 may be set to a default given offset 2112, such as 1 millimeter. In another embodiment, the position of the apex 2102 may be predetermined, for example, due to the type of osteotomy being performed.

[0367] In one embodiment, the position of vertex 2102 can be fixed due to the type of osteotomy to be performed. One of ordinary skill in the art will understand that at the fixed position of vertex 2102, based on the thickness of the bone at the location for the osteotomy, the size of wedge angle 2104 can directly affect the width of body 2028. One of ordinary skill in the art will understand that the size of wedge angle 2104 can vary according to the needs of the patient, the preference of the surgeon, anatomical data, and the like. In one embodiment, wedge angle 2104 can be in the range of about 5.0 degrees to about 45.0 degrees. In one embodiment, wedge angle 2104 is about 13.4 degrees. In another embodiment, wedge angle 2104 is about 18.3 degrees. Advantageously, the user or surgeon can define and / or adjust wedge angle 2104 within a tool for viewing and / or editing the parameters of the bone model and / or the model of resection guide 2020. In one embodiment, wedge angle 2104 is determined based on the bone model.

[0368] FIG. 21J also illustrates one fastener 2010 secured within first bone attachment feature 2024a. First bone attachment feature 2024a secures resection guide 2020 to a portion of bone during the osteotomy. Bone attachment feature 2024 secures resection guide 2020a to the portion of bone that will form wedge-shaped bone fragment 2050 after the formation of the wedge osteotomy. As described herein, osteotomy system 2000 can include a second bone attachment feature 2024b that can be used to secure resection guide 2020a to bone. In one embodiment, first bone attachment feature 2024a and second bone attachment feature 2024b include fasteners 2010 that enter the bone parallel to each other, facilitating removal of resection guide 2020a while leaving fasteners 2010 in the bone. In the illustrated embodiment, the fasteners 2010 of first bone attachment feature 2024a and second bone attachment feature 2024b both enter the portion of bone that will become wedge-shaped bone fragment 2050. Using fasteners 2010 within wedge-shaped bone fragment 2050, wedge bone fragment 2050 can be easily manipulated and / or removed during the surgical procedure.

[0369] Advantageously, embodiments of the present disclosure enable a user (e.g., an engineer and / or a surgeon) to visualize and manipulate a bone model and a model of the resection guide 2020 before the resection guide 2020 is fabricated. Thus, the user can identify and measure the effects of one or more osteotomies formed using the resection guide 2020 along the first trajectory 2042 and / or the second trajectory 2044. Additionally, the user can change the positions of the first trajectory 2042, the second trajectory 2044, the posterior resection feature 2022a and / or the anterior resection feature 2022b relative to each other (in one, two, or three planes), as well as various other aspects of the resection guide 2020 and / or the osteotomy system 2000, before the instrument is fabricated and used on a patient. Thus, the user can design and / or revise the resection guide 2020 and its properties and features to achieve a customized surgical procedure and / or outcome for the patient.

[0370] Referring back to FIGS. 11, 12, and / or 17, embodiments of the present disclosure may use one or more bone models (e.g., bone model 1204) as factors in determining, sub-determining, and / or identifying, positioning, selecting, orienting, and / or defining components of an osteotomy system. One of ordinary skill in the art will understand that the accuracy and / or fidelity of the bone model may vary depending on the techniques and / or equipment used to capture and / or process medical images. Thus, in one embodiment, the accuracy, fidelity, and / or quality of the medical images and / or processing for generating a three-dimensional bone model may result in a bone model having each of the same characteristics as the corresponding bone of the patient such that the bone model 1204 may match or substantially match the anatomical structure of the patient's foot. In another embodiment, the accuracy, fidelity, and / or quality of the medical images and / or processing for generating a three-dimensional bone model may be such that the accuracy, fidelity, and / or quality may be lower than optimal. In such cases, the bone model 1204 may be similar or significantly similar to the anatomical structure of the patient's foot. This may mean that certain features and / or aspects are exactly the same, while on the one hand, other features and / or aspects are similar to, but not actually the same as, the corresponding features of the patient's bone(s).

[0371] Furthermore, one of ordinary skill in the art will understand that the bone model 1204 may model a portion of a single bone of the patient. Alternatively, or in addition, the bone model 1204 may model all or substantially all of a single bone of the patient. Alternatively, or in addition, the bone model 1204 may model multiple bones of the patient.

[0372] Referring now to FIG. 21J, the resection guide 2020a may be used for a surgical procedure on the patient's calcaneus 224 or another bone. The resection guide 2020a may include at least one bone attachment feature. In one embodiment, the user may secure the resection guide 2020a to the calcaneus 224 by deploying at least one fastener 2010 through at least one bone attachment feature and into the calcaneus 224.

[0373] In the illustrated embodiment, the resection guide 2020a includes a posterior resection feature 2022a and an anterior resection feature 2022b. The posterior resection feature 2022a is configured to guide a cutting tool to form a first osteotomy 2046. The anterior resection feature 2022b is configured to guide a cutting tool (which may be the same cutting tool) to form a second osteotomy 2048.

[0374] The posterior resection feature 2022a extends along a first trajectory 2042 through the resection guide 2020a from the outer side 2030 to the inner side 2032. The first trajectory 2042 is at least partially determined based on a calcaneus model of at least a portion of the patient's calcaneus bone of the foot. The calcaneus model is based on a medical image of the patient's foot and is configured to be similar, significantly similar, and / or match the anatomical structure of the patient's foot. Alternatively, or additionally, the anterior resection feature 2022b extends along a second trajectory 2044 through the resection guide 2020 from the outer side 2030 to the inner side 2032. The second trajectory 2044 is at least partially determined based on a calcaneus model of at least a portion of the patient's calcaneus bone 224 of the foot.

[0375] In the illustrated embodiment, the second osteotomy 2048 connects with the first osteotomy 2046 to form a cuneiform fragment 2050. Advantageously, the cuneiform fragment 2050 is connected to at least one fastener 2010. This connection enables the surgeon to easily remove and / or manipulate the cuneiform fragment 2050 as needed.

[0376] In a particular embodiment, the posterior resection feature 2022a may extend from the outer side 2030 to the inner side 2032 at a posterior angle 2052, and the posterior angle 2052 may be an angle measured in degrees from an axis 2054 parallel to the outer side 2030 of the body 2028 to the first trajectory 2042. The anterior resection feature 2022b may extend from the outer side 2030 to the inner side 2032 at an anterior angle 2056, and the anterior angle 2056 may be an angle measured in degrees from the axis 2054 to the second trajectory 2044.

[0377] The posterior angle 2052 can be determined based at least in part on a calcaneal model derived from a medical image of the patient's calcaneus bone of the foot. In one embodiment, the calcaneal model is configured to closely resemble the anatomical structure of the patient's foot. The anterior angle 2056 can be determined based on the calcaneal model. Further, the anterior angle 2056 can be determined such that the osteotomy formed by the posterior resection feature 2022a and the anterior resection feature 2022b forms a wedge osteotomy. The wedge osteotomy includes a wedge fragment 2050. In certain embodiments, the wedge fragment 2050 can be determined based at least in part on the calcaneal model.

[0378] Still referring to FIG. 21J, in one embodiment, the resection guide 2020a includes at least one bone attachment feature configured to receive at least one fastener 2010. The fastener 2010 can engage a portion of the calcaneus bone prior to formation of the wedge osteotomy. Advantageously, the fastener 2010 can extend into the calcaneus bone such that the fastener 2010 does not interfere with the wedge osteotomy, but the fastener 2010 also engages the wedge fragment 2050 after formation of the wedge osteotomy.

[0379] Those skilled in the art will understand that the posterior resection feature 2022a and / or the anterior resection feature 2022b can have a variety of different designs, can be similar to each other, or can be different from each other. In the illustrated embodiment, the resection feature 2022 has a similar mirror image configuration for the posterior resection feature 2022a and for the anterior resection feature 2022b. Generally, the resection feature 2022 includes an opening that can also be referred to as a slot, a channel, etc. Similarly, the posterior resection feature 2022a and / or the anterior resection feature 2022b can have the same, similar, or different opening configurations.

[0380] In the illustrated embodiment, the rear resection feature 2022a includes a rear dorsal slot 2058, a rear bottom slot 2060, and a rear bridge 2062. In a particular embodiment, the rear dorsal slot 2058 and the rear bottom slot 2060 have similar height, width, and depth. The front resection feature 2022b includes a front dorsal slot 2064, a front bottom slot 2066, and a front bridge 2068. In a particular embodiment, the front dorsal slot 2064 and the front bottom slot 2066 have similar height, width, and depth.

[0381] The rear dorsal slot 2058 may include an open dorsal end 2070 and a closed bottom end 2072. The rear bottom slot 2060 may include an open bottom end 2074 and a closed dorsal end 2076. The front dorsal slot 2064 may include an open dorsal end 2078 and a closed bottom end 2080. The front bottom slot 2066 may include an open foot side end 2082 and a closed dorsal end 2084. In the illustrated embodiment, the rear bridge 2062 is positioned between the rear dorsal slot 2058 and the rear bottom slot 2060. In one embodiment, the rear bridge 2062 may form the closed bottom end 2070 of the rear dorsal slot 2058 and the closed dorsal end 2074 of the rear bottom slot 2060. In one embodiment, the front bridge 2068 is positioned between the front dorsal slot 2064 and the front bottom slot 2066. The front bridge 2068 may form the closed bottom end 2080 of the front dorsal slot 2064 and the closed dorsal end 2084 of the front bottom slot 2066.

[0382] Advantageously, the resection feature 2022 can be positioned, sized, and / or oriented to enable a surgeon to resect any particular shape within the bone for an osteotomy procedure. In the illustrated embodiment, the resection feature 2022 is configured to direct a cutting tool at an angle into the bone such that a wedge is resected. Advantageously, the size, shape, and angle of the wedge can be pre-defined, determined pre-operatively, and patient-specific. In this way, the resection guide 2020a functions to provide a patient-specific osteotomy procedure. Alternatively, or additionally, the resection feature 2022 can be configured to enable a surgeon to easily resect in an inferior direction and / or a dorsal direction. In the illustrated embodiment, the resection feature 2022 includes an opening at one end to enable a surgeon to position a cutting tool to make a desired cut that can extend to the dorsal and / or inferior surface of the bone.

[0383] Advantageously, in the illustrated embodiments, the resection feature 2022 includes open ends (e.g., open dorsal end 2070, open bottom end 2074, open dorsal end 2078, and open bottom end 2082). The open ends allow the surgeon to manipulate or tilt the cutting tool from its normal orientation relative to the slot to an angled position that moves the cutting tool beyond the perimeter of the resection guide 2020a. For example, the surgeon can insert the cutting tool into the posterior dorsal slot 2058 and cut bone below the posterior dorsal slot 2058. Additionally, the surgeon can angle the cutting tool in a bottomward direction, and the posterior dorsal slot 2058 guides the cutting tool to cut outside the perimeter of the resection guide 2020a. In particular, moving the cutting tool in a bottomward direction enables the cutting edge of the cutting tool to cut bone dorsally relative to the posterior dorsal slot 2058 while still aligning with the posterior dorsal slot 2058. In this way, the surgeon can create an osteotomy that extends dorsally beyond the dorsal cortex of the bone. Similarly and in a similar manner, the open bottom end 2074, open dorsal end 2078, and / or open bottom end 2082 allow the surgeon to form osteotomies that reach other dorsal and / or bottom surfaces of the bone. These open ends allow the resection guide 2020 to be smaller (not in terms of its length along its longitudinal axis) such that a smaller incision is required for use.

[0384] In the illustrated embodiments, the posterior bridge 2062 is horizontally aligned with the anterior bridge 2068. However, one of ordinary skill in the art will understand that the posterior bridge 2062 and the anterior bridge 2068 may not be aligned in other embodiments. Further, one of ordinary skill in the art will understand that the posterior resection feature 2022a and / or the anterior resection feature 2022b can have various configurations, including a single slot having a closed bottom end and an opposite open dorsal end, a single slot having an open bottom end and an opposite closed dorsal end, a single slot having a closed bottom end and a closed opposite dorsal end, and the like.

[0385] Still referring to FIG. 21J, the resection guide 2020a may include a bottom-side landmark alignment feature 2041a and a handle 2026 (not shown in cross-section, see FIGS. 22A-22I), and the bottom-side landmark alignment feature 2041a extends from the bottom side 2040 of the body 2028 and is configured to contact the bottom surface of the calcaneus 224. Alternatively, or additionally, the resection guide 2020a may include a bone-engaging surface 2033 on the inner side 2032 of the body 2028. The bone-engaging surface 2033 is configured to be similar, substantially similar, or conform to the contour of the calcaneus when the body 2028 is positioned on the calcaneus 224. In one embodiment, the resection guide 2020a may include a handle 2026 extending from the dorsal side 2038 of the body 2028.

[0386] FIGS. 22A-22G illustrate diagrams of a pin guide of an osteotomy system, such as the osteotomy system 2000, according to one embodiment. In one embodiment, the osteotomy system 2000 may include at least one complementary component 1930. The complementary component 1930 may include one or more pin guides 2200. In a particular embodiment, the complementary component 1930 may include a rear pin guide 2202 and a front pin guide 2204. In one embodiment, a single pin guide 2200 may be used as both the rear pin guide 2202 and the front pin guide 2204. Using a single pin guide 2200 may facilitate reuse and / or ease the manufacture of the pin guide 2200. Alternatively, or additionally, the rear pin guide 2202 may be configured differently from the front pin guide 2204.

[0387] The pin guide 2200 functions to position and / or orient one or more pins for deployment within a patient's bone. Advantageously, the pin guide 2200 can be designed using a model of the bone and / or a model of other components of the osteotomy system 2000. In particular, the pin guide 2200 can enable fasteners 2010 of another component, such as the resection guide 2020, to be parallel to each other and one or more fasteners 2010 to be deployed within the bone at non-parallel angles to each other. Pins within the bone at non-parallel angles can be used for reduction and / or compression and / or fixation during steps of a surgical procedure.

[0388] In the illu...

Claims

1. An osteotomy system for repairing the condition of bones present in a patient's foot, the system comprising: An excision guide, A body having a front side, a rear side, an inner side, an outer side, a dorsal side, and a bottom side, A rear excision feature configured to guide a cutting tool to form a first osteotomy portion within the bone, the rear excision feature extending from the outer side to the inner side through the excision guide along a first trajectory at least partially determined based on a bone model of at least a portion of the patient's foot, the bone model being based on a medical image of the patient's foot and configured to be similar to the anatomical structure of the patient's foot; the rear excision feature; A front excision feature configured to guide a cutting tool to form a second osteotomy portion within the bone, the front excision feature extending from the outer side to the inner side through the excision guide along a second trajectory at least partially determined based on the bone model; the front excision feature; The excision guide, comprising a bone attachment feature configured to fix the excision guide to the bone; An alignment guide, A rotation guide, A compression guide, A correction guide, A positioning guide, A pin guide, and At least one complementary component selected from the group consisting of a fixation guide; the system.

2. The system according to claim 1, wherein the first trajectory converges with the second trajectory at a vertex having a wedge angle such that the rear excision feature and the front excision feature form a wedge osteotomy portion including a wedge bone fragment after formation of the first osteotomy portion and the second osteotomy portion, and the wedge angle is determined based at least in part on the bone model.

3. The system according to claim 2, wherein the bone attachment feature is configured to fix the excision guide to a portion of the bone that forms the wedge bone fragment after formation of the wedge osteotomy portion.

4. The system according to claim 2, wherein when the excision guide is designed for the patient's foot, the vertex is pre-positioned such that it is between the inner cortex of the bone and the excision guide.

5. The system according to claim 1, wherein the inner side of the excision guide includes a bone engagement surface configured to align with the outer surface of the bone, the bone engagement surface being defined based on the outer surface of the bone model and the planned position of the excision guide on the outer surface of the bone.

6. wherein the posterior resection feature comprises a posterior dorsal slot having an open dorsal end and a closed bottom end, a posterior bottom slot having an open bottom end and a closed dorsal end, and a posterior bridge positioned between the posterior dorsal slot and the posterior bottom slot, the posterior bridge forming the closed bottom end of the posterior dorsal slot and the closed dorsal end of the posterior bottom slot; and wherein the anterior resection feature comprises an anterior dorsal slot having an open dorsal end and a closed bottom end, an anterior bottom slot having an open bottom end and a closed dorsal end, and an anterior bridge positioned between the anterior dorsal slot and the anterior bottom slot, the anterior bridge forming the closed bottom end of the anterior dorsal slot and the closed dorsal end of the anterior bottom slot; the system of claim 1.

7. the pin guide, wherein the at least one complementary component comprises an arm configured to engage at least one of the posterior resection feature and the anterior resection feature, the arm being connected to a bone engagement feature configured to receive a fastener; the system of claim 1.

8. the system of claim 7, wherein the arm comprises an opening configured to receive a bridge of at least one of the posterior resection feature and the anterior resection feature.

9. the system of claim 7, wherein at least one of the arm and the bone engagement feature comprises a patient-specific feature defined based on the bone model.

10. wherein the resection guide comprises a bottom alignment feature extending from the bottom side of the resection guide, and the bottom alignment feature is configured to engage a mark on the bone; the system of claim 1.

11. the system of claim 10, wherein the bottom alignment feature comprises a bone engagement surface fabricated based on the bone model, and the mark on the bone comprises the bottom surface of the bone.

12. wherein the at least one complementary component comprises an alignment guide, the alignment guide comprising a body having a front side, a rear side, an inner side, an outer side, a dorsal side, and a bottom side, an anterior alignment feature, and a posterior alignment feature. The offset feature on the inside of the body, wherein the offset feature is configured to translate the posterior bone fragment relative to the anterior bone fragment, and the posterior bone fragment and the anterior bone fragment are formed by one of the first bone cut and the second bone cut, the system of claim 1 comprising the offset feature.

13. The positioning guide is The bone engagement surface on the inside, the bone engagement surface including the bone engagement surface configured to align with the outer surfaces of the posterior bone fragment and the anterior bone fragment, The system of claim 12, wherein the bone engagement surface is defined based on the outer surface of the bone model and the planned reduced positions of the posterior bone fragment and the anterior bone fragment.

14. An apparatus for repairing the condition of a patient's foot bone, the apparatus comprising A body having a front side, a rear side, an inner side, an outer side, a dorsal side, and a bottom side, A posterior resection feature extending from the outer side to the inner side at a posterior angle, the posterior angle being at least partially determined based on a calcaneus model derived from a medical image of the patient's foot's calcaneus, the calcaneus model being configured to be substantially similar to the anatomical structure of the patient's foot, the posterior resection feature, An anterior resection feature extending from the outer side to the inner side at an anterior angle, the anterior angle being determined based on the calcaneus model, and the bone cut formed by the posterior resection feature and the anterior resection feature being determined to form a wedge-shaped bone cut including a wedge-shaped bone fragment determined based on the calcaneus model, the anterior resection feature, A bone attachment feature configured to engage the wedge-shaped bone fragment after formation of the wedge-shaped bone cut, A bottom alignment feature extending from the bottom side of the body and configured to contact the bottom surface of the calcaneus, A bone engagement surface on the inner side of the body, the bone engagement surface being configured to conform to the contour of the calcaneus when the body is positioned for use on the calcaneus, the apparatus comprising the bone engagement surface.

15. The posterior resection feature is configured to receive an arm of a posterior pin guide that includes an arm connecting a planar fin to a bone engagement feature including an opening and a posterior pin. The anterior resection feature portion is configured to receive an arm of an anterior pin guide having an arm that connects a planar fin to a bone engagement feature portion having an opening and an anterior pin, The posterior pin guide is configured to guide the posterior pin into the posterior bone fragment parallel to a bone cut formed using the posterior resection feature portion, The apparatus according to claim 14, wherein the anterior pin guide is configured to guide the anterior pin into the anterior bone fragment substantially parallel to a bone cut formed using the anterior resection feature portion.

16. The posterior pin deployed by the posterior pin guide and the anterior pin deployed by the anterior pin guide, A body having a front side, a rear side, an inner side, an outer side, a dorsal side, and a bottom side, An anterior alignment feature, A posterior alignment feature, An offset feature on the inner side of the body, the offset feature being configured to translate the posterior bone fragment relative to the anterior bone fragment, the offset feature, A bone engagement surface on the inner side, the bone engagement surface being configured to align with the outer surfaces of the posterior bone fragment and the anterior bone fragment, the bone engagement surface being defined based on the outer surface of the calcaneus model and the planned reduced positions of the posterior bone fragment and the anterior bone fragment, the bone engagement surface, and is configured to receive a positioning guide. The apparatus according to claim 15.

17. The posterior alignment feature includes a slot configured to receive the posterior pin, the slot, A dorsal end, A bottom end, The length between the dorsal end and the bottom end including a predetermined length based on the calcaneus model to enable a user to rotate the posterior bone fragment relative to the anterior bone fragment. The apparatus according to claim 16.

18. The apparatus according to claim 14, wherein the bone engagement surface extends inside the bottom side landmark alignment feature.

19. A method for repairing the condition of a bone present in a patient's foot, the method comprising, Accessing the outer surface of the calcaneus, Positioning a resection guide on the outer surface, the resection guide, A body having a front side, a rear side, an inner side, an outer side, a dorsal side, and a bottom side, A posterior resection feature configured to guide a cutting tool to form a first osteotomy within the calcaneus, the posterior resection feature extending from the outside to the inside through the resection guide along a first trajectory determined based on a calcaneal model of the calcaneus based on a medical image of the patient's foot, the calcaneal model being configured to match the anatomical structure of the patient's foot, the posterior resection feature; An anterior resection feature configured to guide a cutting tool to form a second osteotomy connecting to the first osteotomy and to form a cuneiform fragment from the calcaneus, the anterior resection feature extending from the outside to the inside through the resection guide along a second trajectory determined based on the calcaneal model, the anterior resection feature; A first bone attachment feature configured to engage the cuneiform fragment after formation of the cuneiform fragment; A second bone attachment feature configured to engage the cuneiform fragment after formation of the cuneiform fragment; A bottom alignment feature extending from the bottom side of the body and configured to contact the bottom surface of the calcaneus; A bone engagement surface on the inside of the body, the bone engagement surface being configured to match the contour of the calcaneus when the body is positioned on the calcaneus, the bone engagement surface; and positioning; Deploying a first fastener within the first bone attachment feature and a second fastener within the second bone attachment feature, whereby the first fastener and the second fastener are parallel to each other and enter a portion of the calcaneus that will form the cuneiform fragment, the deploying; Inserting the cutting tool into the posterior resection feature to a depth pre-defined in a pre-operative plan designed based on the calcaneal model to form the first osteotomy; Inserting the cutting tool into the anterior resection feature to a depth pre-defined in a pre-operative plan designed based on the calcaneal model to form the second osteotomy, the second osteotomy forming a posterior fragment and an anterior fragment, the forming; Engage the rear pin guide with the rear resection feature, deploy the rear pin within the bone attachment feature of the rear pin guide, engage the front pin guide with the front resection feature, and deploy the front pin within the bone attachment feature of the front pin guide, Remove the rear pin guide, the front pin guide, and the resection guide, Remove the wedge-shaped bone fragment with the first fastener and the second fastener, Slide the positioning guide over the rear pin and the front pin by passing the rear pin through the rear alignment feature and the front pin through the front alignment feature, Slide the positioning guide along the rear pin and the front pin until the positioning guide contacts the rear bone fragment and the front bone fragment, A method comprising deploying a fixture across the osteotomy between the rear bone fragment and the front bone fragment.

20. Destroy the medial cortex of the calcaneus on the opposite side of the wedge-shaped bone fragment, The method according to claim 19, further comprising translating the rear pin within the rear alignment feature and rotating the rear bone fragment to a position determined by a surgeon to repair the condition of the patient's foot.

21. An osteotomy system for repairing the condition of a bone in a patient's foot, the system comprising, At least one fastener configured to engage a phalanx of the patient's foot, A resection guide, A body having a front side, a rear side, an inner side, an outer side, a dorsal side, and a bottom side, A rear resection feature configured to guide a cutting tool to form a first osteotomy within the phalanx, wherein a first track for the first osteotomy is determined based on a bone model of the phalanx based on a medical image of the patient's foot, and the bone model is configured to be substantially similar to the anatomical structure of the patient's foot, the rear resection feature; A front resection feature configured to guide a cutting tool to form a second osteotomy within the phalanx, wherein a second track for the second osteotomy is determined based on the bone model, the front resection feature; A first bone attachment feature configured to secure the resection guide to the phalanx, A second bone attachment feature configured to secure the resection guide to the phalanx, and the resection guide comprising the resection guide.

22. The system of claim 21, wherein at least one of the first bone attachment feature and the second bone attachment feature is configured to form a guide hole for a fastener within the phalanx when at least one of the first bone attachment feature and the second bone attachment feature is disengaged from the phalanx.

23. The system of claim 21, wherein the first bone attachment feature is configured to form a first guide hole, the second bone attachment feature is configured to form a second guide hole, the first guide hole is configured for a first leg of a bone staple, and the second guide hole is configured for a second leg of the bone staple.

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