WO2025212925A1

WO2025212925A1 - Osteotomy plate

Info

Publication number: WO2025212925A1
Application number: PCT/US2025/023009
Authority: WO
Inventors: Turlough O'DONNELL; Alan LAING; Annunziato Amendola
Original assignee: Arc Techionics, Inc
Current assignee: Arc Techionics, Inc
Priority date: 2024-04-03
Filing date: 2025-04-03
Publication date: 2025-10-09
Anticipated expiration: 2026-10-03

Abstract

An osteotomy plate includes a rotating hinge, a first leaf having a flat portion lying in the plane and extending outward from a side of the flat barrel, a second leaf having a flat portion lying in the plane and extending outward from an opposite side of the flat barrel, and a surgical wedge window defined on one side by a length at the first distal distance where the first bent portion begins, wherein the osteotomy plate is configured as a surgical implant for use by a surgeon in a surgical procedure by attaching the first leaf and second leaf to the bone, cutting the bone through the wedge window, and correcting the non-normal axis by moving the hinge along the arc to the normal alignment of the bone.

Description

OSTEOTOMY PLATE

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit from U.S. Provisional Patent Application Serial No. 63/574,210, filed April 3, 2024, which is incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

[0002] The present invention relates generally to osteotomy, and more particularly to an osteotomy plate.

[0003] In general, osteotomy is a surgical procedure that involves cutting bone (and sometimes adding bone tissue) to reshape or realign your bones. The surgery can include the surgeon re- breaking the malaligned bone and realigning it to the anatomically correct position. The healing process is usually difficult and lengthy, similar to that of a broken bone. [0004] There are different types and levels of severity for realignments which helps determine the treatment. Screws, rods, wires, or pins can be used to secure the new alignment, and possibly a new cast around a limb. The bone may be trimmed, and it is also possible that a bone graft could be used to help with healing. During the process, a surgeon may need to implant rods, wires, pins, or screws by re-breaking the bone, aligning the limb by eyesight and X-ray, and securing with the fasteners.

[0005] What is needed are intelligently planned implants that help guide the exact bone placement during precision osteotomies and other bone malalignment surgeries from beginning to end.

BRIEF SUMMARY OF THE INVENTION

[0006] The following presents a simplified summary of the innovation in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the invention. It is intended to neither identify key or critical elements of the invention nor delineate the scope of the invention. Its sole purpose is to present some concepts of the invention in a simplified form as a prelude to the more detailed description that is presented later.

[0007] In an aspect, the invention features an osteotomy plate including a rotating hinge including a substantially flat barrel which, when disposed at a bone position of the malalignment defines a plane on which an arc of the malalignment lies when a non-normal axis of the malalignment is restored to a normal alignment of the bone, a first leaf having a flat portion lying in the plane and extending outward from a side of the flat barrel, and having a first bent portion beginning a first distance distal from the barrel, with the bent portion disposed about perpendicular to the plane, a second leaf having a flat portion lying in the plane and extending outward from an opposite side of the flat barrel, and having a second bent portion beginning a second distance distal from the barrel and disposed about perpendicular to the plane, and a surgical wedge window defined on one side by a length at the first distal distance where the first bent portion begins, defined on another side by a length at the second distal distance where the second bent portion begins, defined at a top side by an edge of the hinge barrel, and defined at a bottom side by a bottom edge of the bone, the surgical wedge window lying about perpendicular to the plane, wherein the osteotomy plate is configured as a surgical implant for use by a surgeon in a surgical procedure by attaching the first leaf and second leaf to the bone, cutting the bone through the wedge window, and correcting the non-normal axis by moving the hinge along the arc to the normal alignment of the bone.

[0008] In another aspect, the invention features a method including providing a computer system having at least a processor, software, and memory, receiving data representing a surgical assessment of a subject, including data for a bone with a malunion, superimposing a targeted bone shape with a normal alignment over the data for the bone with the malunion, overlaying an osteotomy plate image with a wedge window over the superimposition, and adjusting the osteotomy plate’s size, shape, and/or a wedge window of the plate to plan an osteotomy for re- aligning the bone with the malunion to the targeted bone shape, outside of the computer system, outputting data for the adjusted plate and/or window suitable for either manufacturing an osteotomy plate and window and manufacturing such, or suitable for obtaining a pre- manufactured plate and window, providing the plate with the window for a surgery for the subject, whereby the surgery, the plate, and the wedge window provide a planned surgical outcome and will correct the malunion in the subject.

[0009] In still another aspect, the invention features a method including performing and/or obtaining a surgical assessment of the subject, whereby data from the subject’s bone with the malalignment and/or surrounding tissues is acquired, superimposing a normal alignment of the bone over the data from the bone with the malalignment, and determining an osteotomy wedge that, if removed from the bone with the malalignment, will enable an axis of the malalignment to be rotated along an arc to the normal alignment, obtaining an osteotomy plate with a wedge window for use in removing bone during an osteotomy of a bone with the malalignment in the subject in need thereof, the plate including a rotating hinge including a substantially flat barrel which, when disposed at a bone position of the malalignment, defines a plane on which an arc of the malalignment lies when a non-normal axis of the malalignment is restored to a normal alignment of the bone, and a first and second leaf extending outwards from the hinge, an edge of the hinge and the first and second leaf defining a wedge window through-which the wedge can be removed, and fastening the plate to the bone of the subject, removing the wedge, and rotating a leaf of the plate around the hinge to align the bone to the normal alignment.

[0010] These and other features and advantages will be apparent from a reading of the following detailed description and a review of the associated drawings. It is to be understood that both the foregoing general description and the following detailed description are explanatory only and are not restrictive of aspects as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] These and other features, aspects, and advantages of the present invention will become better understood with reference to the following description, appended claims, and accompanying drawings where:

[0012] FIG. 1 shows an example process 10 of treating a subject in need of a bone defect surgery including steps (1), (2), (3), (4), (5), and (6). It should be understood that each step is optional and can be intermingled with other methods and figures discussed herein.

[0013] FIG. 2A shows a view of a bone 20 with a first end, head, or first epiphysis 25, a second end, second epiphysis 30 or trochlea, a shaft or diaphysis 35, and a normal alignment 40 or a normal axis of the bone.

[0014] FIG. 2B shows a fractured bone 21 with a fracture, break, or transverse fracture 22.

[0015] FIG. 2C shows a fractured bone 21 with an oblique fracture 24.

[0016] FIG. 2D shows a fractured bone 21 with a spiral fracture 26.

[0017] FIG. 2E shows a fractured bone 21 with a comminuted fracture 32.

[0018] FIG. 2F shows a fractured bone 21 with a segmental fracture 34.

[0019] FIG. 2G shows a bone 36 with a non-union 38.

[0020] FIG. 2H shows a bone 50 with a malunion 55 that has caused a non-normal bone alignment 60 or non-normal axis of the bone.

[0021 ] FIG. 21 shows a comparison of the non-fractured bone 20 from FIG. 2 A (at left) and a bone 50 with a malunion 56 and a non-normal alignment 60 to illustrate how the non- normal alignment 60 must be moved (along an arc when the bone is positioned) to obtain the normal alignment 40. The invention described herein can be utilized on any bone, and the various defect illustrated in FIGs. 2B-2H are non-limiting examples.

[0022] FIG. 3 A shows an example of a bone 66 with a bone malalignment location at 68 (or a malunion location) after fastening an osteotomy plate of the present invention 65 (screws/fasteners not shown) to the bone. A rotating hinge, which can be precision calibrated, 67 is shown with a line at 68 orthogonal to the non-normal axis of the bone. The osteotomy site 75 is indicated in a wedge window 70 provided by the implant 65, which includes a fastening leaf 69 (or plates) which can include, for example, a 2.2 mm arc tech plate.

[0023] FIG. 3B shows an example of the configuration in FIG. 3A with a line orthogonal to the normal bone axis 78 compared to the line orthogonal to the malunion (or non-normal) axis 68 and an enlarged view in

[0024] FIG. 3C showing optional one or more springs or polymers 80 inside the hinge 67 providing optional forces 82 and 84 (which can be planned in either of the directions) along with an osteotomy site 75 indicated wherein bone removal will enable a correction of the bone by thereafter rotating the hinge (or guide hinge).

[0025] The precision guided surgical effect after rotating to correct alignment is shown in FIG. 3D, which shows the now aligned bone 86 after the cutting of bone at the osteotomy site 75 (in FIG. 3C) and after rotating of the hinge 67 along an arc 61 to move the non-normal alignment 60 to the normal bone alignment or normal axis 40, and the osteotomy is now closed at 85. Thus, FIG. 3D shows a precision surgery, and FIG. 3E shows a side-view of the precision surgery after the hinge 67 has been rotated (in a plane including arc 61 in FIG. 3D) to close the osteotomy site 85 within the wedge window 70. Optional forces 82 and 84 are illustrated in FIG. 3D.

[0026] FIG. 3F shows how, in some embodiments, the fastener holes 206 can be configured as ovals or ‘screw adjusting’ holes 205.

[0027] FIG. 3G shows, according to some aspects, how oval or ‘screw adjusting’ holes 205 can be configured for a longitudinal screw adjustment at 207. In some embodiments, the addition of the long oval slot (FIG. 3F, FIG. 3G) placed closest to the wedge window also offers the ability to adjust in another plane.

[0028] FIG. 3H shows how, in some embodiments, the hinge, which can be precision calibrated, 67 defines a central axis 97 that lies perpendicular or orthogonal to a plane 95 wherein lies parallel to an arc 61 spanning between the non-normal bone axis 60 and the normal bone alignment 40.

[0029] FIG. 31 shows the plane 95 that the hinge 67 lies parallel to, the axis 97 defined by the hinge, wherein the axis 97 is orthogonal to the plane 95, and wherein the arc 61 lies parallel to the plane 95. As such, a precision guided surgery is provided, according to some aspects, by moving the bone along the arc 61 after cutting bone during the osteotomy and correcting alignment at 85; the bone is precision aligned and can be held in alignment for long-term healing of the patient. According to some aspects, the holes exemplified at 205 and at 207 provide a DSSH (perpendicular de-rotation sliding screw hole) that will provide rotation of a bone, alignment of a bone, and/or movement of a bone after affixing a perpendicular fastener through the hole because the underlying bone can still be moved. Next, the fastener in DSSH hole 205 or 207 can be tightened to hold the bone in the correct rotation, correct alignment, or correct position to provide a ‘locked down’ position of the bone. Along with the hinge 67, the DSSH provided at 205 and 207 provides unprecedented bone rotation and adjustments after the osteotomy plate is attached.

[0030] FIG. 4 shows a bone 100 with a normal alignment 40 after a precision alignment (or malunion) surgery described herein and the optional step 90 of removing the osteotomy plate 110 from the healed bone.

[0031] FIG. 5 A illustrates an exemplary osteotomy plate in an example, bone aligned position 200, which can be the same as osteotomy plate 65 in FIG. 3A. The implant 200 includes fastener holes 206, which can be optionally omitted, or can optionally be oval or ‘screw adjusting’ holes, and optional alignment markings 220, along with optional osteotomy site markings 210 or etchings. A wedge window 270 is defined by an edge of the hinge, which can be precision calibrated, 267, and edge of a leaf 204, an edge of leaf 208, and optionally by a lower portion of the bone that the implant is attached to (not shown). The osteotomy site 275 is within the window 270. A central axis of the hinge, which can be precision calibrated, is at 268.

[0032] FIG. 5B shows an illustration of how the osteotomy plate 200 can be rotated along arc 61 (FIG. 31) to fit an abnormal bone alignment and how the alignment markers 220 will indicate the non-normal alignment. An initial position of leaf 208 can be at line “Init” and the arc 61 can be up to about 180° all the way to final line “Final”, where in this example, the bone has been moved to a normal position or normal axis.

[0033] FIG. 5C illustrates how at 201, in any of the embodiments disclosed herein, a leaf 204 at one side of a hinge 67 can be separated (at the hinge) from another leaf 208 by using a fastener placed through the hinge 67 at 68. In some embodiments, the hinge 67 has male and female interlocking portions (not shown), such that the hinge can be pushed together on a bone, or the hinge can be pulled apart, as illustrated in FIG. 5C.

[0034] FIG. 6 shows another exemplary osteotomy plate 300 with optional fastener holes 306 and optional osteotomy site markings 310. In this example, the leaf 304 and the leaf 308 each have a different shape compared to the leaf 204 and leaf 208 in FIG. 5B. The hinge 367 and the axis 368, along with the wedge window 370 and osteotomy site 375 are illustrated to demonstrate that the osteotomy plates of the invention can have any shape or configuration but still provide the precision aligned surgeries described herein.

[0035] FIG. 7 shows a flow diagram of a method 700 to make an osteotomy plate of the invention provided herein.

[0036] FIG. 8 shows an example method 800 of treating a subject in need of a malalignment surgery.

[0037] FIG. 9 shows another example method 900 of treating a subject in need of a malunion surgery according to the invention disclosed herein.

[0038] FIG. 10 illustrates an AP DFO plate post application pre-osteotomy.

[0039] FIG. 11 illustrates a lateral DFO plate pre-osteotomy.

[0040] FIG. 12 illustrates an AP DFO plate osteotomy through an osteotomy window.

[0041] FIG. 13 illustrates an AP DFO plate correction alignment with hinge unlocked.

[0042] FIG. 14 illustrates a lateral DFO plate post osteotomy.

[0043] FIG. 15 illustrates an AP DFO plate post graft implantation and correction and hinge locked.

DETAILED DESCRIPTION OF THE INVENTION

[0044] The subj ect innovation is now described with reference to the drawings, wherein like reference numerals are used to refer to like elements throughout. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It may be evident, however, that the present invention may be practiced without these specific details. In other instances, well- known structures and devices are shown in block diagram form in order to facilitate describing the present invention.

[0045] For convenience, the meaning of some terms and phrases used in the specification, examples, and appended claims, are provided below. Unless stated otherwise, or implicit from context, the following terms and phrases include the meanings provided below. The definitions are provided to aid in describing particular embodiments, and are not intended to limit the claimed invention, because the scope of the invention is limited only by the claims. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. If there is an apparent discrepancy between the usage of a term in the art and its definition provided herein, the definition provided within the specification shall prevail. In general, typical chemical terminology is found in the International Union of Pure and Applied Chemistry GoldBook. This disclosure is purposefully presented in commonly understood words, known to a person of skill in the art, but Merriam-Webster’s Online Dictionary is used, when appropriate, for terms not specifically demonstrated herein or not known in the art.

[0046] As used herein, the term "approximately" or "about" in reference to a value or parameter are generally taken to include numbers that fall within a range of 5%, 10%, 15%, or 20% in either direction (greater than or less than) of the number unless otherwise stated or otherwise evident from the context (except where such number would be less than 0% or exceed 100% of a possible value). As used herein, reference to "approximately" or "about" a value or parameter includes (and describes) embodiments that are directed to that value or parameter. For example, description referring to "about X" includes description of "X".

[0047] As used herein, the term “or” means “and/or.” The term "and/or" as used in a phrase such as "A and/or B" herein is intended to include both A and B; A or B; A (alone); and B (alone). Likewise, the term "and/or" as used in a phrase such as "A, B, and/or C" is intended to encompass each of the following embodiments: A, B, and C; A, B, or C; A or C; A or B; B or C; A and C; A and B; B and C; A (alone); B (alone); and C (alone).

[0048] As used herein, the term “implant” can be used interchangeably with “osteotomy plate”.

[0049] The term "statistically significant" or "significantly" refers to statistical significance and generally means a two-standard deviation (2SD) or greater difference.

[0050] As used herein, the term "subject" refers to a mammal, including but not limited to a dog, cat, horse, cow, pig, sheep, goat, rodent, or primate. Subjects can be house pets (e.g., dogs, cats), agricultural stock animals (e.g., cows, horses, pigs, chickens, etc.), laboratory animals (e.g., mice, rats, rabbits, etc.), but are not so limited. Subjects particularly include human subjects in urgent treatment as described herein. The human subject may be a pediatric, adult, or a geriatric subject. The human subject may be of any sex.

[0051] The term “treating” includes prophylactic and/or therapeutic treatments. The term “prophylactic or therapeutic” treatment is art-recognized and includes administration to the host of one or more of the subject compositions and/or application of one or more therapies or surgeries. If this is done prior to clinical manifestation of the unwanted condition (e.g., disease or other unwanted state of the host animal) then the treatment is prophylactic (i.e., it protects the host against developing the unwanted condition), whereas if it is administered after manifestation of the unwanted condition, the treatment is therapeutic, (i.e., it is intended to diminish, ameliorate, or stabilize the existing unwanted condition or side effects thereof).

[0052] As used herein, the terms “treat,” “treatment,” “treating,” or “amelioration” when used in reference to a disease, disorder, or medical condition, refer to therapeutic treatments for a condition, wherein the object is to reverse, alleviate, ameliorate, inhibit, slow down or stop the progression or severity of a symptom or condition. The term “treating” includes reducing or alleviating at least one adverse effect or symptom of a condition. Treatment is generally “effective” if one or more symptoms or clinical markers are reduced. Alternatively, treatment is “effective” if the progression of a condition is reduced or halted. That is, “treatment” includes not just the improvement of symptoms or markers, but also a cessation or at least slowing of progress or worsening of symptoms that would be expected in the absence of treatment. Beneficial or desired clinical results include, but are not limited to, alleviation of one or more symptom(s), sign(s), diminishment of extent of the deficit, stabilized (i.e., not worsening) state of a symptom or condition, delay or slowing of onset of symptoms or indications, and an increased lifespan as compared to that expected in the absence of treatment.

[0053] The terms: “decrease”, “reduced”, “reduction”, or “inhibit” are all used herein to mean a decrease by a statistically significant amount. In some embodiments, “reduce,” “reduction" or “decrease" or “inhibit” typically means a decrease by at least 10% as compared to a reference level (e.g., the absence of a given treatment or agent) and can include, for example, a decrease by at least about 10%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, at least about 98%, at least about 99% , or more. As used herein, “reduction” or “inhibition” does not encompass a complete inhibition or reduction as compared to a reference level. “Complete inhibition” is a 100% inhibition as compared to a reference level. A decrease can be preferably down to a level accepted as within the range of normal for an individual without a given disorder.

[0054] In some embodiments, the decrease in the one or more signs or symptoms is evaluated according to a specialized healthcare provider. In some embodiments, signs are observed or measured by a health care provider. Symptoms can be reported by the subject. In some embodiments, the decrease of signs or symptoms occurs in less than about 120 minutes, 90 minutes, less than about 60 minutes, less than about 30 minutes, less than about 15 minutes, less than about 10 minutes, or less than about 5 minutes, or less than about 3 minutes, or less than about 1 minute. In some embodiments, the decrease of signs or symptoms occurs in less than 1 day, less than 1 week, less than 1 month, or in less than 1 year.

[0055] The terms “increased”, “increase”, “enhance”, or “activate” are all used herein to mean an increase by a statically significant amount. In some embodiments, the terms “increased”, “increase”, “enhance”, or “activate” can mean an increase of at least 10% as compared to a reference level, for example an increase of at least about 20%, or at least about 30%, or at least about 40%, or at least about 50%, or at least about 60%, or at least about 70%, or at least about 80%, or at least about 90% or up to and including a 100% increase or any increase between 10-100% as compared to a reference level, or at least about a 2-fold, or at least about a 3-fold, or at least about a 4-fold, or at least about a 5-fold or at least about a 10-fold increase, or any increase between 2-fold and 10-fold or greater as compared to a reference level. In the context of a marker or symptom, a “increase” is a statistically significant increase in such level.

[0056] As used herein, an agent or a therapeutic agent provided to a subject and suspected to be or involved in a treatment can be a small molecule less than 1000 MW or a large molecule not less than 1000 MW including biologies, oligonucleotides, peptides, oligosaccharides, and larger molecules. Any of the therapeutic agents disclosed herein can be used as or in combination with small molecules and/or large molecules as discussed herein.

[0057] A subject can be one who has been previously diagnosed with or identified as suffering from or having a condition in need of treatment (e.g., a malunion, a non-union, or a malaligned bone, joint or a related disorder) or one or more complications related to such a condition, and optionally, but need not have already undergone treatment for a condition or the one or more complications related to the condition. Alternatively, a subject can also be one who has not been previously diagnosed as having a condition in need of treatment or one or more complications related to such a condition. For example, a subject can be one who exhibits one or more risk factors for a condition, or one or more complications related to a condition or a subject who does not exhibit risk factors. A “subject in need” of treatment for a particular condition can be a subject having that condition, diagnosed as having that condition, suspected as having, or at risk of developing that condition. In another example, the subject has been brought into a treatment situation entirely without the subject’s knowledge and/or intent. For example, a subject can obviously be in need of treatment but not be responsive to a previous surgery, and as described herein the present methods and implants may save the subject’s life.

[0058] A huge problem in malalignment surgeries and in malunion surgeries is that the conventional wires, screws, rods, and fasteners (human-bent or currently manufactured worldwide) do not meticulously follow the normal alignment or normal axis of a healthy bone. These older technologies do not guide a precision surgery to an optimum outcome, and instead, place a huge burden on the surgeon to make critical decisions during the surgery. During an alignment correction surgery of the past, a surgeon does not have an implant, ready prepared, to properly line up the bone and must re-align the bone after either rebreaking the bone or after removing some of the bone (i.e., osteotomy) to place the bone accurately where it should be for healing. In a broad embodiment, the invention herein provides an implant that is intelligently manufactured to provide a planned, precise surgical outcome. The invention disclosed herein can be applied to any set of bones, either as a primary surgery or a revision surgery, whether that be a non-union, malunion, refracture or revision surgery due to infection for example. The osteotomy device of the present invention disclosed herein is universal in its applications to bones, while malunion is discussed in examples to illustrate. Another primary indication for the invention herein is re-rotation osteotomy of the distal or proximal femur related to congenital deformities. The bone with the defect will be precision guided by the implant, after the osteotomy, to be positioned accurately where it should be for healing.

[0059] In some embodiments, the implants disclosed herein can include markings (or etchings) on the implant. According to some aspects, the markings guide the surgeon to the exact osteotomy site, where to remove bone. In this example, other markings can guide the surgeon to indicate when the implant has been moved (along with the fastened bone) to precision guide the bone in exactly the correct, normal alignment or axis for long-term healing.

[0060] In some embodiments, the invention disclosed herein changes the order of execution of steps in an osteotomy surgery. For example, now the osteotomy plate (disclosed herein) can be affixed to a bone, the osteotomy can be done after the affixing, then the bone is moved to a precision surgical position, then the osteotomy plate is tightened to hold the desired bone position. As an example, a possible solution to the problem discussed above, the invention herein provides, in some embodiments, an osteotomy plate with a wedge window for use in removing bone during an osteotomy of a bone with a malalignment in a subject in need thereof, the plate including: A) a rotating hinge, optionally calibrated, including a substantially flat barrel which, when disposed at a bone position of the malalignment, defines a plane on which an arc of the malalignment lies when a non-normal axis of the malalignment is restored to a normal alignment of the bone; B) a first leaf having a flat portion lying in the plane and extending outward from a side of the flat barrel, and having a first bent portion beginning a first distance distal from the barrel, and the bent portion disposed about perpendicular to the plane; C) a second leaf having a flat portion lying in the plane and extending outward from an opposite side of the flat barrel, and having a second bent portion beginning a second distance distal from the barrel and disposed about perpendicular to the plane; D) a wedge window defined on one side by a length at the first distal distance where the first bent portion begins, defined on another side by a length at the second distal distance where the second bent portion begins, defined at a top side by an edge of the hinge barrel, and defined at a bottom side by a bottom edge of the bone, the wedge window lying perpendicular to the plane.

[0061] The parameters A-D above are wherein the osteotomy plate is configured as a surgical implant for use by a surgeon in a surgical procedure by attaching the first leaf and second leaf to the bone, removing a portion of the bone through the wedge window, and correcting the non-normal axis by moving the hinge along the arc to the normal alignment of the bone. Thus, A-D above provide precision surgery, as is described in increasing detail below.

[0062] In any of the embodiments described herein the fastener holes for fastening an osteotomy plate to a bone of a subject can be configured as perpendicular sliding screw hole, a perpendicular de-rotation sliding screw hole (DSSH), or “de-rotation holes”, ovals, or ‘screw adjusting’ holes. With the DSSH feature a fastener can be placed into a fastening hole and into bone, and the bone can still be rotated, aligned, and moved back and forth for adjustment purposes. Then, the screw (or fastener) in the DSSH can be tightened, locking down the aligned or tuned position. In combination with the alignment hinge used in the osteotomy plates herein, the DSSH enables unprecedented bone alignment after the osteotomy plate is fastened to a bone of the subject. According to some aspects, the DSSH can change the order of execution of osteotomy surgeries because alignment can be accomplished after fastening the plate.

[0063] According to some aspects, a method of treating a subject with a bone defect or a malaligned bone is disclosed herein, the method including the steps of (1) obtaining preoperative data representing a surgical assessment of a subject in need or with a malalignment; (2) superimposing the data with a targeted surgical outcome plan/data that represents an ideal recovered state of the subject after surgery; (3) designing a shape, size, and/or configuration of an osteotomy plate and wedge window (and/or fasteners); to fit the pre-operative data and/or the targeted surgical outcome data; to provide at least one osteotomy plate for a surgery to implant in the subject; (4) obtaining the at least one osteotomy plate either by manufacturing or from a pre- manufactured selection of one or more osteotomy plates; (5) implanting the one or more osteotomy plates during a surgery on the subject; and (6) optionally re-assessing the subject and/or removing the implant after a recovery time.

[0064] In some embodiments, various methods of making implants for correcting bone malalignments in subjects are disclosed herein. An example method includes the following steps done with a computer, software, and computer memory: obtaining a historical patient database (from ideal surgical outcomes and non-ideal) for an algorithm training (i.e., large dataset); input one patient’s data for anatomical landmarks/malalignment, e.g., bone positions, non-normal bone axis, predicted normal bone axis, bone incidence/angles, and any additional landmarks; outputting planned implant shapes, sizes, fastener positions, wedge window, and tension specifications in digital format; optionally output measurements/depth for osteotomy site in digital format.

[0065] In this example of a method of making an osteotomy plate, a surgeon can check the design or prototype output and, if needed provide adjustments to wedge window(s), positions (i.e., human guided training). The adjustments can either be fed back into the historical database for added machine learning and/or can be used to manufacture or select the correct or unique implants for the subject, then progress to surgery.

[0066] Thus, the presently disclosed invention provides machine learning in various layers of convolutional neural networks to provide pre-engineered implants, pre-planned shapes, wedge windows, curvatures, and surgical guides (and associated hardware) that enable a surgeon to plan an accurate and desired surgical outcome for the patient. This brings great relief to patients, especially over a long-term of 2 or more years, and continues for a lifetime of enjoyment with properly aligned bones.

[0067] The present invention is discussed in terms of correcting bone defects. While an open wedge osteotomy surgery is described, it is important to note the osteotomy plates disclosed herein can be used for a closing wedge osteotomy as well. In one example, a surgeon would put the plate on with a bend at the hinge, then perform the osteotomy, and open up the plate to be straight, after which the surgeon would insert a bone wedge in through the wedge window of the device. In another example, the osteotomy plate will go onto the bone straight, then a surgeon will cut the bone and then bend the osteotomy at the hinge in order to achieve the desired outcome of a straight bone. In some embodiments, the invention can be utilized for a medial open wedge osteotomy, which is used for osteoarthritis in a varus deformity knee to offload the medial compartment. Osteoarthritis is another indication where the osteotomy plate disclosed herein is used to correct malalignment because it is a way to treat osteoarthritis by offloading a portion or a certain part of the knee joint.

[0068] Typically, during an osteotomy surgery, a bone is cut to shorten or lengthen it or to change its alignment. A portion of the bone can be removed, and the bone closed, a so- called “closing wedge osteotomy.” In addition, the bone can be opened, creating a wedge of “space’, a so-called “opening wedge osteotomy.” Osteotomy is performed to correct a malalignment or rotational deformity, or to straighten a bone that has a malunion following healing from a fracture. In some cases, the wedge of bone is removed, and the remaining bone is moved in an attempt to align the bone to a normal alignment. An osteotomy can also be utilized to correct a coxa vara, genu valgum, and genu varum. An osteotomy is typically done under a general anesthetic due to the depth of the surgery involved.

[0069] In an example, for adolescents and adults, femoral de-rotational osteotomies are performed to correct residual symptomatic increased femoral torsion in adolescents and adults. Some indications are anterior knee pain caused by patellar mal-tracking and patellofemoral instability. While there is not a consensus as to what the correct indication is, there is a need for improved surgical techniques that lead to the best outcomes in performing a femoral de- rotational osteotomy 15. The invention provided herein includes one or more perpendicular de- rotation sliding screw hole (DSSH) in the osteotomy plate, which dramatically improves de- rotation surgeries because the DSSH can enable a perpendicular fastener to be placed through the osteotomy plate and into the bone, then the bone can be derotated and/or aligned for the best surgical outcome, and the fastener can be tightened to hold the bone in the correct rotation/position.

[0070] The osteotomy procedure is usually a serious surgery, and recovery for the subject may be extensive. The location of the removed wedge or portion of bone depends on where the center of deformity is, whether or not an associated osteoarthritis has caused damage, and how many misalignments must be corrected. Osteotomy can be one method to relieve a pain of arthritis, especially of the hip and knee. It can also be used to correct deformity around a joint, especially in younger patients, to alleviate symptoms and prevent future degenerative arthritis from occurring.

[0071] The surgery usually begins after regional or general anesthesia is administered. The surgical team sterilizes the area with antibacterial solution. The surgeon maps out the exact size of the bone wedge or portion to be removed, using an X-ray, CT scan, or 3D computer modeling. Guide wires can be drilled into the bone to aid in general alignments. An oscillating saw can be run along the guide wires, removing most of the bone wedge from the bone, or allowing an opening wedge of bone. As can be seen in this example, a major problem is planning the optimum surgical outcome, planning exactly where to remove bone, and then aligning the bone (after removing bone) to the accurate placement. These decisions place large technical demands upon the surgeon during key points during the surgery. The present invention can solve these large problems.

[0072] In a broad embodiment, a problem encountered in osteotomy surgeries is that the conventional wires or rods (human-bent or currently manufactured worldwide) do not meticulously follow the proper alignment needed for the best surgical outcome. At critical times during the surgery, the surgeon must make estimates of movements that can affect a patient for years to come.

[0073] In some embodiments, the invention disclosed herein changes the order of execution of steps in an osteotomy surgery. For example, now the osteotomy plate (disclosed herein) can be affixed to a bone; at this step the screw is placed in the de-rotation sliding screw hole (DSSH) in the distal part of the plate, the osteotomy can be done after the affixing, then the bone is moved to a precision surgical position. Optionally, a bone graft or further adjustment can be done before moving, and additional surgeries can be performed through the wedge window. Then, the osteotomy plate is tightened to hold the desired bone position. To further introduce solutions to the problems discussed above, in some embodiments, FIG. 1 of the present invention provides an example method 10 of treating a subject in need of a malalignment surgery including steps of: (1) obtaining pre-operative data representing a surgical assessment of a subject in need or with a malalignment; (2) superimposing the data with a targeted surgical outcome plan/data that represents an ideal recovered state of the subject after surgery; (3) designing a shape, size, and/or configuration of an osteotomy plate and wedge window (and/or fasteners); to fit the pre- operative data and/or the targeted surgical outcome data; to provide at least one osteotomy plate for a surgery to implant in the subject; (4) obtaining the at least one osteotomy plate either by manufacturing or from a premanufactured selection of one or more osteotomy plates; (5) implanting the one or more osteotomy plates during a surgery on the subject; and (6) optionally re-assessing the subject and/or removing the implant after a recovery time.

[0074] It is important to note that the implants, principles, and the methods disclosed herein can be utilized for a deformity correction of a bone that has never been traumatized. Any realignment procedure can include the presently disclosed implants, devices, techniques, methods, and principles, whether the procedure be a rotational procedure, opening wedge, closing wedge, or combined biplanar or multiplanar correction. In some embodiments, the hinge (e.g., 67 at FIGs. 3D-3G) can be calibrated, thereby allowing for very precise and accurate correction of alignment. The implants disclosed herein allow for an osteotomy to be formed after affixing the osteotomy plate to any bone. In some embodiments, the implants disclosed herein can be affixed to a bone after an osteotomy is performed. In examples herein, the implant is affixed to a bone before the osteotomy is performed (or before an osteotomy bone wedge is removed). Then, the bone can be guided to a precision location by the implant. The implant can be fixed in position, providing a highly desirable surgical outcome for the long-term.

[0075] The invention is not limited to any size or type of bone. Examples are discussed using arm bones or leg bones, but the invention can be applied to any bone in the body. The invention be used with any bone with any type of fracture, or deformity, whether congenital or acquired, or with any type of bone defect. The implants and methods disclosed herein can be used for any malalignments (e.g., congenital or environmentally caused), non-unions, broken bones in general, and for any bone known. In various examples, FIG. 2A shows a view of a bone 20 with a first end, head, or first epiphysis 25, a second end, second epiphysis 30 or trochlea, a shaft or diaphysis 35, and a normal alignment 40 or a normal axis of the bone. FIG. 2B shows a fractured bone 21 with a fracture, break, or transverse fracture 22. FIG. 2C shows a fractured bone 21 with an oblique fracture 24. FIG. 2D shows a fractured bone 21 with a spiral fracture 26. FIG. 2E shows a fractured bone 21 with a comminuted fracture 32. FIG. 2F shows a fractured bone 21 with a segmental fracture 34. FIG. 2G shows a bone 36 with a non-union 38. FIG. 2H shows a bone 50 with a malunion 55 that has caused a non-normal bone alignment 60 or non-normal axis of the bone. FIG. 21 shows a comparison of the non-fractured bone 20 from FIG. 2A (at left) and a bone 50 with a malunion 56 and a non-normal alignment 60 to illustrate how the non-normal alignment 60 must be moved (along an arc when the bone is positioned) to obtain the normal alignment 40. The invention can also be utilized on joints.

[0076] In another focused solution to the problems discussed above, in some embodiments, the invention herein provides an osteotomy plate with a wedge window for use in removing bone during an osteotomy of a bone with a malalignment in a subject in need thereof, the plate including: A) a rotating hinge, which can be precision calibrated, including a substantially flat barrel which, when disposed at a bone position of the malunion, defines a plane on which an arc of the malalignment lies when a non-normal axis of the malalignment is restored to a normal alignment of the bone; B) a first leaf having a flat portion lying in the plane and extending outward from a side of the flat barrel, and having a first bent portion beginning a first distance distal from the barrel, and the bent portion disposed about perpendicular to the plane; C) a second leaf having a flat portion lying in the plane and extending outward from an opposite side of the flat barrel, and having a second bent portion beginning a second distance distal from the barrel and disposed about perpendicular to the plane; D) a surgical wedge window defined on one side by a length at the first distal distance where the first bent portion begins, defined on another side by a length at the second distal distance where the second bent portion begins, defined at a top side by an edge of the hinge barrel, and defined at a bottom side by a bottom edge of the bone, the surgical wedge window lying about perpendicular to the plane.

[0077] The wedge window can be of any size depending on a size of the bone that is the focus of the surgery and depending on the amount of rotation or movement needed to correct the alignment of the bone. For example, when the osteotomy plate is first installed on a malaligned bone, the window can be about 10 cm wide by about 4 cm tall (e.g., the word “tall” meaning in height), optionally about 5 cm wide by about 2 cm tall, optionally about 3 cm wide by about 1.5 cm tall, optionally about 2 cm wide by about 1 cm tall, optionally about 1 cm wide by about 5 mm tall, and any of these example endpoint can be exchanged within and/or inter-combined to provide new example ranges.

[0078] In FIG. 3A, the osteotomy site 75 is indicated within a wedge window 70 provided by the implant 65, which includes a fastening leaf 69 (or plates) which can include, for example, a 2.2 mm arc tech plate. FIG. 3A shows an example of a bone 66 with a malalignment or defect at 68 after fastening an osteotomy plate of the present invention 65 (screws/fasteners not shown) to the bone. A rotating hinge, which can be precision calibrated, 67 is shown with a line at 68 orthogonal to the non-normal axis of the mal-aligned bone. In some embodiments, the line at 68 can include a fastener or screw making the hinge capable of locking in its position. In this example, the fastener is loosened, and the hinge can be rotated; when the fastener is tightened, the hinge is fixed in position. In some embodiments, one leaf of the implant 65 is affixed to the bone, then the other leaf is separately affixed to the bone and attached to interlocking components at the hinge. According to some aspects, a screw or fastener can be disposed at 68 that will enable the hinge to be undone. In this example, a portion of the implant can be affixed to bone, then the other portion attached by the hinge at 68. The osteotomy site 75 is indicated in a wedge window 70 provided by the implant 65, which includes a fastening leaf 69 (or plates) which can include, for example, a 2.2 mm arc tech plate. FIG. 3B shows an example of the configuration in FIG. 3 A with a line orthogonal to the normal bone axis 78 compared to the line orthogonal to the malunion (or non-normal) axis 68 and an enlarged view in FIG. 3C showing optional one or more springs or polymers 80 inside the hinge 67 providing optional forces 82 and 84 along with an osteotomy site 75 indicated wherein bone removal can enable a correction of the bone by thereafter rotating the hinge (or guide hinge). The precision effect after rotating to correct alignment is shown in FIG. 3D, which shows the now aligned bone 86 after the removal of bone from osteotomy site 75 (in FIG. 3C) and after rotating of the hinge 67 along an arc 61 to move the non-normal alignment 60 to the normal bone alignment or normal axis 40, and the osteotomy is now closed at 85. In other example, the osteotomy plate 65, (FIG. 3 A) is affixed to the bone, the osteotomy is performed, and then the wedge window 70 of the osteotomy plate is opened wider by opening up at the hinge. A bone graft or grafting implant can then be applied through the wedge window 70, and the bone can be affixed in the (now aligned) position for long-term healing.

[0079] Thus, FIG. 3D shows an outcome of the precision surgery, and FIG. 3E shows a side- view of the precision surgery after the hinge 67 has been rotated (in a plane including arc 61 in FIG. 3D) to close the osteotomy site 85 within the wedge window 70. It is important to note that the hinge can be rotated in any direction to achieve the desired bone alignment. Optional forces 82 and 84 are illustrated in FIG. 3D. The invention can be used in adjustable configurations. For example, FIG. 3F shows how, in some embodiments, the fastener holes 206 can be configured as ovals or ‘screw adjusting’ holes 205. With these oval holes, a fastener can be placed into hole 205 and into bone, and the leaf or implant can still be moved back and forth for adjustment purposes. Then, the screw (or fastener) in hole 205 can be tightened, locking down the tuned position.

[0080] FIG. 3G shows, according to some aspects, how oval or ‘screw adjusting’ holes 205 can be configured for a longitudinal screw adjustment at 207. In the examples depicted in FIG. 3F and FIG. 3G, the addition of a long oval slot placed closest to the wedge window also offers the ability to adjust in another plane. In some embodiments, the adjustments allow for an orthogonal screw insertion into a bone; for example, by adjusting the osteotomy plate with the ‘screw adjusting’ holes, any screw can be inserted with the shaft of the screw orthogonal to the surface of the bone. In any of the embodiments disclosed herein, any of the fastener holes 206 can be configured as oval holes 205 or 207 (FIG. 3G), allowing the implants to be fastened to bone, then adjusted in position using the oval or ‘screw adjusting’ holes, then affixed tightly to the desired position on the bone. FIG. 3H shows how, in some embodiments, the hinge, which can be precision calibrated, 67 defines a central axis 97 that lies perpendicular or orthogonal to a plane 95 wherein lies parallel to an arc 61 spanning between the non-normal bone axis 60 and the normal bone alignment 40. FIG. 31 shows the plane 95 that the hinge 67 lies parallel to, the axis 97 defined by the hinge, wherein the axis 97 is orthogonal to the plane 95, and wherein the arc 61 lies parallel to the plane 95. As such, a precision guided surgery is provided, according to some aspects, by moving the bone along the arc 61 after removing bone during the osteotomy and closing or opening the osteotomy site at 85; the bone is precision aligned and can be held in alignment for long-term healing of the patient. Returning to FIG. 3A, which shows an example of a bone with a malunion or a defect 66 after fastening an osteotomy plate of the present invention 65 (screws/fasteners not shown) to the bone, it should be understood that the osteotomy plate 65 can be substituted with any other embodiments of the osteotomy plates discussed herein.

[0081 ] According to some aspects, the osteotomy plate is configured as a surgical guide or a surgical implant for use by a surgeon in a surgical procedure by attaching the first leaf and second leaf to the bone, removing a portion of the bone through the wedge window, and correcting the non-normal axis by moving the hinge along the arc to the normal alignment of the bone. The hinge can be moved in any direction; the hinge may contain teeth or ratcheting, clicking gears to indicate degrees of movement. In another example, etchings or markings on the hinge can indicate to a surgeon where to lock down the hinge.

[0082] FIG. 4 shows a bone 100 with a normal alignment 40 after a precision malalignment surgery described herein and the optional step 90 of removing the osteotomy plate 110 from the healed bone.

[0083] According to some aspects, the osteotomy plate disclosed herein is configured so that the wedge window marks a location for a closing or opening wedge osteotomy to be performed during surgery inside the wedge window. As discussed above, if the osteotomy plate is used on very large bones, the wedge window can be quite large, even larger than the example ranges discussed above. In some embodiments, the osteotomy plate disclosed herein is configured so that the wedge window marks a location for an opening wedge osteotomy to be performed during surgery inside the wedge window. In this example, the bone can be opened up after the osteotomy by a rotation of the hinge.

[0084] In some embodiments, the hinge is operative to be rotated to close a wedge osteotomy site after a portion of bone has been removed therefrom, thereby restoring the bone to the normal alignment by the rotation of the hinge. After installing the hinge on a bone with a defect or a malunion and removing bone, the hinge may need to be rotated about 180° to restore the bone to a normal axis in an extreme example, the hinge may need to be rotated about 100°, optionally about 90°, optionally about 75°, optionally about 60°, optionally about 45°, optionally about 30°, optionally about 25°, optionally about 20°, optionally about 15°, optionally about 10°, optionally about 5°, or optionally any amount between about 0.1° and about 270°. As can be discerned, the invention is not limited by the diagrams and descriptions because the solutions presented by the inventive concepts are beginning to be in a detailed focus herein.

[0085] In some embodiments, the hinge is operative to be rotated to open a wedge osteotomy site after a portion of bone has been removed therefrom, thereby restoring the bone to the normal alignment by the rotation of the hinge. After installing the hinge on a bone with a defect or a malunion and removing bone, the hinge may need to be rotated about 180° to restore the bone to a normal axis in an extreme example, the hinge may need to be rotated about 100°, optionally about 90°, optionally about 75°, optionally about 60°, optionally about 45°, optionally about 30°, optionally about 25°, optionally about 20°, optionally about 15°, optionally about 10°, optionally about 5°, or optionally any amount between about 0.1° and about 270°. According to some aspects, the first leaf and the second leaf each comprise one or more screw holes operative to accept a bone screw through each hole and into the bone of the subject, thereby fastening the first leaf and the second leaf to the bone. In some embodiments, a central axis of rotation of the hinge defines an axis line that is about perpendicular to the plane. A locking fastener can be present at the central axis of the hinge, operative to lock the hinge in position or to unlock the hinge for rotation.

[0086] FIG. 5A illustrates an exemplary osteotomy plate in an example, bone aligned position 200, which can be, for example, the same as osteotomy plate 65 in FIG. 3A. The implant 200 includes optional fastener holes 206 and optional alignment markings or etchings 220, along with optional osteotomy site markings or etchings 210. Although not shown, any of the rotating hinges 67 or 267 herein can include degree markings so that the hinge can be rotated to a certain degree setting. In other example, the hinges 67 or 267 herein can include mechanical teeth within the hinge, making the hinge click or provide a clickable setting to various degrees’ setting of the hinges. According to some aspects, the mechanical teeth can provide a ratcheting effect on any of the hinges disclosed herein. In some examples, each click of a tooth can indicate a degree of hinge turn, a half a degree of hinge turn, or 2 to 5 degrees of hinge turn. A wedge window 270 can be defined by an edge of the hinge 267, and edge of a leaf 204, an edge of leaf 208, and optionally by a lower portion of the bone that the implant is attached to (not shown). The osteotomy site 275 is within the window 270. A central axis of the hinge is at 268. FIG. 5B shows an illustration of how the osteotomy plate 200 can be rotated along arc 61 (FIG. 31) to fit an abnormal bone alignment and how the alignment markers 220 will indicate the non-normal alignment. As discussed above, the hinge can be rotated in varying different amounts of rotation to restore a bone to normal, so the alignment markers can be placed in suitable locations to guide a surgeon during the surgery. In any of the embodiments disclosed herein, FIG. 5C illustrates how at 201, a leaf 204 at one side of a hinge 67 can be separated (at the hinge) from another leaf 208 by using a hinge fastener (not shown) placed through the hinge 67 at 68. For example, one leaf or side can be attached to a bone, then the other half, side, or leaf can be positioned over the hinge 67 and a fastener is placed through the hinge axis at 68. A portion of the hinge along axis 68 can have threads (e.g., to accept a screw fastener into the hinge), in some examples. The hinge can be rotated, then the fastener at axis 68 is tightened to lock the hinge into a desired position.

[0087] In some embodiments, the osteotomy plate disclosed herein can be wherein the first leaf and the second leaf each include a thickness in a range from about 0.1 mm to about 5 mm, optionally in a range from about 0.5 mm to about 4 mm, or optionally in a range from about 0.5 mm to about 3 mm. In this example, in some embodiments, the first leaf and the second leaf each can include a thickness of about 2.2 mm. As discussed above, it is contemplated that the invention herein could be used on very large bones for very large mammals, and in these cases the thicknesses could exceed 5 mm.

[0088] According to some aspects, the osteotomy plate is wherein the plate includes a biocompatible material including stainless steel, a cobalt base alloy, a bio-ceramic, a titanium alloy, a pure titanium, a composite material, a non-resorbable polymers, a bioresorbable polymer, or a combination thereof. Portions of the implants can be resorbable, and portions can be non-resorbable. Any materials known in the art can be used.

[0089] In some embodiments, the osteotomy plate is compatible with a bone adhesive, operative to adhere the plate to the bone of the subject. In this example, no holes may be required for bone screws.

[0090] In some embodiments, the osteotomy plate can be further including one or more markings operative to indicate to a surgeon where to remove bone or where an osteotomy sight is located during a surgery. According to some aspects, the osteotomy plate can be further including one or more markings on the barrel of the hinge operative to indicate to a surgeon when the hinge is rotated so as to align the first leaf and the second leaf along a normal alignment of the bone in the subject.

[0091] In some embodiments, a hole, screw hole, or protrusion of the osteotomy plates disclosed herein can be used for attachment of a ligament, a tendon, or a tissue.

[0092] FIG. 6 shows another exemplary osteotomy plate 300 with optional fastener holes 306 and optional osteotomy site markings 310. In this example, the leaf 304 and the leaf 308 each have a different shape compared to the leaf 204 and leaf 208 in FIG. 5B. The hinge 367 and the axis 368, along with the wedge window 370 and osteotomy site 375 are illustrated to demonstrate that the osteotomy plates of the invention can have any shape or configuration but still provide the precision aligned surgeries described herein. The shapes and illustrations in the drawings do not limit the spirit and purpose of the inventive concept disclosed herein. FIG. 6 shows, according to some aspects, how the optional shapes of the osteotomy plates also offer the ability to adjust the position of the hinge in another plane, or to adjust the position of the osteotomy plate to closely follow the surface of a bone. In some embodiments, the adjustments allow for an orthogonal screw insertion into a bone; for example, by adjusting the osteotomy plate to follow the surface of the bone, any screw can be inserted with the shaft of the screw orthogonal to the surface of the bone. Also, in any of the embodiments disclosed herein, any of the fastener holes 306 (FIG. 6) or 206 can be configured as oval holes 205 or 207 (FIG. 3G), allowing the implants to be fastened to bone, then adjusted in position using the oval or ‘screw adjusting’ holes, then affixed tightly to the desired position on the bone.

[0093] In some embodiments, the osteotomy plate can be configured further including the flat barrel of the hinge has a spring or polymer inside operative to provide a force on the first leaf, the second leaf, or both. It is contemplated that the hinge can be a living hinge. In this example, the entire implant could, conceptually, be made by a 3D printing process.

[0094] According to some aspects, the osteotomy plate can be configured further including a locking mechanism internal to the barrel that will hold the hinge, the first leaf, and the second leaf in a position establishing the normal alignment of the bone after a surgeon locks the barrel. The locking mechanism can be actuated by any invention known in the art. [0095] In some embodiments, the osteotomy plates disclosed herein can be further including an antimicrobial coating. The plates can be used to release a drug or a therapeutic agent. The release can be for less than 2 years, for less than 1 year, for less than 6 months, or for less than one month.

[0096] Any of the osteotomy plates disclosed herein can be wherein the plate is provided in a plurality of osteotomy plates, for example, in a kit, each of the plates in the plurality having a different size and/or shape suitable for subjects of different sizes, different bones, and/or different positions during a surgery.

[0097] The osteotomy plates disclosed herein can be, in some embodiments, wherein the plate is operative for a long-term implantation in the subject. According to some aspects, the osteotomy plate can be wherein the plate can be surgically removed after a healing period of time in the subject.

[0098] According to some aspects, the osteotomy plate described above can be configured as a central hinge with two oppositely opposed leaves.

[0099] In some embodiments, a method of making an osteotomy plate of any aspect herein is provided, the method including the steps of: (1) in a computer system having at least a processor, software, and memory, (A) receiving data representing a surgical assessment of a subject, including data for a bone with a defect or with a malunion; (B) superimposing a targeted bone shape with a normal alignment over the data for the bone with the defect or malunion; (C) overlaying an osteotomy plate image with a wedge window over a superimposition of step (2), and adjusting the osteotomy plate’s size, shape, and/or a wedge window of the plate to plan an osteotomy for re-aligning the bone with the defect or malunion to the targeted bone shape; (2) outside of the computer system, outputting data for the adjusted plate and/or window suitable for either manufacturing an osteotomy plate and window and manufacturing such, or suitable for obtaining a pre-manufactured plate and window; (3) providing the plate with the window for a surgery for the subject; whereby the surgery, the plate, and the wedge window provide a planned surgical outcome and will correct the malalignment in the subject. The method can be, according to some aspects, wherein the data representing a surgical assessment of the subject includes X- ray data of the bone with the malunion.

[0100] In some embodiments, the method discussed above can be executed, wherein after step (B), the following step is executed: (Bl) locating a non-normal axis of the defect or malalignment and defining a plane on which an arc of the defect or malalignment lies when a non-normal axis of the malalignment is restored to a normal alignment of the bone.

[0101] According to some aspects, the method can be executed wherein after step (B), the following step is executed: (B2) locating a portion of bone for a wedge osteotomy site, whereby if that portion of bone is removed during an osteotomy surgery, the non-normal axis of the malalignment can be moved to a normal alignment of the bone.

[0102] In some embodiments, the method above can be executed wherein step (C) includes the following step: (Cl) positioning a hinge of the osteotomy plate image over the wedge osteotomy site, whereby the hinge is positioned lying in a plane parallel to the arc of the malalignment defined when the non-normal axis is moved to the normal alignment of the bone.

[0103] According to some aspects, the method above can be further including adjusting a bend of at least one leaf included in the plate to define a boundary of the wedge window. [0104] In some embodiments, the method of making above can be executed wherein the method is further including placing one or more markings on the plate, and wherein the osteotomy plate includes one or more markings operative to indicate to a surgeon where an osteotomy site is planned during the surgery.

[0105] According to some aspects, the method can be executed wherein the adjusting of the plate’s size, shape, and/or wedge window is further computed using one or more artificial intelligence (Al) methods or machine learning algorithms.

[0106] In some embodiments, the method of making can be executed further including a planning of one or more positions and/or depths of one or more fasteners or adhesions for the plate to a bone of the subject; the one or more positions and/or depths configured to fit the bone of the subject. According to some aspects, the method of making is executed wherein one or more artificial intelligence (Al) methods or machine learning algorithms are utilized to determine fastener or adhesion positions on the plate. In some embodiments, the osteotomy plates disclosed herein enable screws or fasteners to have shafts that are orthogonal to the surface of the bone, or at about 45° to the surface, or at about 50° to the surface, or at about 55° to the bone surface, or at about 60° to the surface, or at about 65° to the bone surface, or at about 70° to the surface, or at about 75° to the surface, or at about 80° to the surface, or at about 85° to the surface, or at about 90° to the surface.

[0107] In some embodiments, the method of making can be further including generating a fastener trajectory and/or an adhesion scheme using a navigation, a robotic assistance, and/or an ultrasound input.

[0108] In some embodiments, the method of making can be further including placing markings at two or more spaced locations along a hinge of the osteotomy plate, the markings configured to enable a precise alignment of the normal alignment of the bone after an osteotomy is performed on a bone of a subject. In this example, the method of can be wherein each of the locations of the two or more markings is operative to match a unique subject’s bone alignment, because the osteotomy plate is made using data from the subject’s bone, surrounding tissue, and an algorithm.

[0109] The method of making can be further including an execution of the surgery on a subject, whereby the osteotomy plate is implanted into the subject.

[0110] The method of making can be, in some embodiments, further including executing a follow-up surgical assessment on the subject’s malalignment after a healing time, removing the implanted plate after a healing time, obtaining additional post-surgical data from the subject, or a combination thereof; and further including inputting a datum into the computer system so as to improve a future manufacturing of a future osteotomy plate.

[0111] In some embodiments, a method of treating a subject in need of a bone defect surgery or a malalignment bone surgery is provided herein, the method including the steps of: (1) performing and/or obtaining a surgical assessment of the subject, whereby data from the subj ecf s bone with the defect and/or malalignment and/or surrounding tissues is acquired; (2) superimposing a normal alignment of the bone over the data from the bone with the defect or malalignment , and determining an osteotomy wedge that, if removed from the bone with the defect malalignment, will enable an axis of the malalignment to be rotated along an arc to the normal alignment; (3) obtaining an osteotomy plate with a wedge window for use in removing bone during an osteotomy of a bone with the defect or malalignment in the subject in need thereof, the plate including: Al) a rotating hinge including a substantially flat barrel which, when disposed at a bone position of the malalignment, defines a plane on which an arc of the defect or malalignment lies when a non-normal axis of the defect or malalignment is restored to a normal alignment of the bone; and (A2) a first and second leaf extending outwards from the hinge, an edge of the hinge and the first and second leaf defining a wedge window through-which the wedge can be removed; and (4) fastening the plate to the bone of the subject, removing the wedge, and rotating a leaf of the plate around the hinge to align the bone to the normal alignment.

[0112] According to some aspects, the method of treating is further including one or more of the following steps of surgical planning methods are executed: one or more radiographs are loaded on a surgical planning software; an osteotomy plate contour is planned to match a unique bone contour of the subject; one or more positions of one or more fasteners are planned to fasten the osteotomy plate to the bone of the subject; a data-driven, artificialintelligence, and/or machine-learning process is utilized to determine leaf and/or hinge positions on the osteotomy plate to ensure perfect execution of the surgical plan following a data established bone contour of the subject; and a screw trajectory and/or an adhesive placement is planned using overlays of one or more prototype osteotomy plates, robotic assistance, and/or ultrasound guidance.

[0113] In some embodiments, the method of treating is further including an intraoperative verification of the osteotomy plate is performed including one or more of measurements of the subject’s bone and/or the plate during a surgery from one or more assigned targets using radiography, fluoroscopy, computerized tomography (CT), robotics, and/or ultrasound.

[0114] According to some aspects, the method of treating is further including a pre-operative surgical plan is assessed using one or more of a healthcare provider’s examination of the subject, an ultrasound, and/or a robotic assisted exam.

[0115] In some embodiments, the method of treating is further including a postoperative surgical assessment is executed using one or more of a healthcare provider’s examination of the subject, an ultrasound, and/or a robotic assisted exam.

[0116] In some embodiments, the method of treating is executed wherein the osteotomy plate is further including: B) the first leaf having a flat portion lying in the plane and extending outward from a side of the flat barrel, and having a first bent portion beginning a first distance distal from the barrel, and the bent portion disposed about perpendicular to the plane; C) the second leaf having a flat portion lying in the plane and extending outward from an opposite side of the flat barrel, and having a second bent portion beginning a second distance distal from the barrel and disposed about perpendicular to the plane; D) the surgical wedge window defined on one side by a length at the first distal distance where the first bent portion begins, defined on another side by a length at the second distal distance where the second bent portion begins, defined at a top side by an edge of the hinge barrel, and defined at a bottom side by a bottom edge of the bone, the surgical wedge window lying about perpendicular to the plane; and wherein the osteotomy plate is configured as a surgical implant for use by a surgeon in a surgical procedure by attaching the first leaf and second leaf to the bone, removing a portion of the bone through the wedge window, and correcting the non-normal axis by moving the hinge along the arc to the normal alignment of the bone.

[0117] According to some aspects, the method of treating is executed wherein a surgeon makes one or more anatomical measurements to determine how to rotate the bone with the malalignment to correct angulation of the bone to a normal bone alignment.

[0118] In some embodiments, the method of treating is executed wherein the hinge of the osteotomy plate is planned to lie parallel to an arc of the rotation, to allow the surgeon to rotate the bone after the osteotomy plate is fastened to the bone and an osteotomy wedge is removed.

[0119] According to some aspects, the method of treating is executed wherein one or more markings on the osteotomy plate are used to indicate if the hinge is rotated to a normal alignment of the bone.

[0120] In some embodiments, the method of treating is executed wherein an osteotomy plate for an implantation in the subject is selected be a human being, by a surgical planning software, or a combination thereof.

[0121] According to some aspects, any of the methods or implants discussed herein can be wherein an osteotomy plate is made by a method including a 3D-printing.

[0122] In some embodiments, any of the methods or implants disclosed herein can be further including making one or more iterative adjustments of the osteotomy plate.

[0123] The methods of making and the methods of treating discussed herein can be, according to some aspects, further including a step of the following: providing one or more markings on the osteotomy plate to indicate an osteotomy site in the wedge window.

[0124] The methods of treating or the methods of making herein can be executed wherein a screw placement is provided with a positioning designed with a specific angulation to tie to the osteotomy plate, a fluoroscopy image, a robot, a navigation plan through a plate’s projected position in the subject, an ultrasound, a planned driving of the malalignment of the bone, and/or wherein the plate at least partially requires or dictates a screw location and orientation.

[0125] In some embodiments, a kit suitable for a sale is provided herein, the kit including at least one osteotomy plate with a wedge window for use in removing bone during an osteotomy of a bone with a malalignment in a subject in need thereof, the plate including: A) a rotating hinge including a substantially flat barrel which, when disposed at a bone position of the malalignment , defines a plane on which an arc of the malalignment lies when a non-normal axis of the malalignment is restored to a normal alignment of the bone; B) a first leaf having a flat portion lying in the plane and extending outward from a side of the flat barrel, and having a first bent portion beginning a first distance distal from the barrel, and the bent portion disposed about perpendicular to the plane; C) a second leaf having a flat portion lying in the plane and extending outward from an opposite side of the flat barrel, and having a second bent portion beginning a second distance distal from the barrel and disposed about perpendicular to the plane; D) a surgical wedge window defined on one side by a length at the first distal distance where the first bent portion begins, defined on another side by a length at the second distal distance where the second bent portion begins, defined at a top side by an edge of the hinge barrel, and defined at a bottom side by a bottom edge of the bone, the surgical wedge window lying about perpendicular to the plane; wherein the osteotomy plate is configured as a surgical implant for use by a surgeon in a surgical procedure by attaching the first leaf and second leaf to the bone, removing a portion of the bone through the wedge window, and correcting the non-normal axis by moving the hinge along the arc to the normal alignment of the bone.

[0126] In this example, the kit can be further including instructions for use in a media format of a video, instructions with illustrations, written instructions, or a combination thereof.

[0127] In some embodiments, the methods and implants disclosed herein can change the order of steps of an osteotomy surgery, for example, after this invention the osteotomy plate is affixed first. According to some aspects, a method of performing an osteotomy can be including the steps of: (1) fastening at least a portion of an osteotomy plate to a bone of a subject in need of an osteotomy, the plate including: (A) a rotating hinge including a substantially flat barrel which, when disposed at a bone position of the malalignment , defines a plane on which an arc of the malalignment lies when a non-normal axis of the malalignment is restored to a normal alignment of the bone; (B) a first leaf having a flat portion lying in the plane and extending outward from a side of the flat barrel, and having a first bent portion beginning a first distance distal from the barrel, and the bent portion disposed about perpendicular to the plane; (C) a second leaf having a flat portion lying in the plane and extending outward from an opposite side of the flat barrel, and having a second bent portion beginning a second distance distal from the barrel and disposed about perpendicular to the plane; (D) a surgical wedge window defined on one side by a length at the first distal distance where the first bent portion begins, defined on another side by a length at the second distal distance where the second bent portion begins, defined at a top side by an edge of the hinge barrel, and defined at a bottom side by a bottom edge of the bone, the surgical wedge window lying about perpendicular to the plane; (E) optionally one or more DSSH (perpendicular derotation sliding screw hole); (IB) affixing a fastener through a DSSH; (2) performing the osteotomy on the bone, after the plate has been affixed to the bone, and optionally d-rotating the bone for a preferred surgical outcome and fastening the one or more fasteners tightly through the DSSH, to hold the bone in a de-rotated or aligned position; (3) moving the osteotomy plate along the hinge to a desired bone position; optionally the hinge can be precision calibrated, for a preferred surgical outcome; and (4) tightening the osteotomy plate at the hinge or other locations for a fixed bone position.

[0128] In some embodiments, the methods disclosed herein are further including the step of: scanning a shape of the implant and using a software program to compare the shape to an image of the subject to determine if the implant is in an optimum shape and/or size for the subject or a bone of the subject. For example, the image of the subject can include an X- ray.

EXAMPLES

[0129] The invention will be more readily understood by reference to the following examples which are included merely for purposes of illustration of certain aspects and embodiments of the present invention and are not intended to limit the invention. As can be discerned, the invention herein provides a great improvement in guiding surgical outcomes, and by helping quality of life, long-term, for patients, it is foreseen that the invention will grow.

EXAMPLE 1. INTERPRETATION OF PATIENT DATA, WITH PREFERRED SURGICAL OUTCOMES FOR MANUFACTURING OF IMPLANTS

[0130] In this prophetic example, data sources are gathered initially from three databases: 1) normal subjects (with no malalignment s) are analyzed to define ideal bone alignments for a variety of bones. Subjects with malalignment s in 2) population data are analyzed as well to define statistical variance of malalignment s. A third database will be included with 3) anatomical parameters. Using different levels of convolutional neural networks, ML/AI (machine learning/artificial intelligence) is used to superimpose the 3 sources of data to generate ideal osteotomy outcomes based on patient specific parameters. [0131] Various methods of manufacturing are tested, and multiple iterations are used to find the best surgical outcomes for patients (long-term). FIG. 7 shows a flow diagram of a method 700 to make an osteotomy plate of the invention provided herein. At 705, a historical patient database (from ideal surgical outcomes and non-ideal outcomes) is obtained for an algorithm training (i.e., large dataset). Step 710 is inputting of one patient’s data for anatomical landmarks/malalignment e.g., bone positions, non-normal bone axis, predicted normal bone axis, bone incidence/angles, and any additional landmarks. At 715, a computer will output planned implant shapes, sizes, fastener positions, wedge window, and tension specifications in digital format. At 720, optionally output measurements/depth for osteotomy site in digital format. At 725, a surgeon checks algorithm output; if needed provides adjustments to wedge windows, positions (human guided training). A decision is made at 726. A surgeon can make a decision to proceed to surgery with the plan at 725 or the Al algorithm can be retrained at 727. Next, there is a manufacturing or selection of the custom implant(s) at 735 and surgery at 740.

EXAMPLE 2. INTELLIGENTLY DESIGNED SURGICAL OUTCOMES FOR METHODS OF TREATING PATIENTS

[0132] Over time, using data from surgeries, a surgical planning software is encoded, tested, debugged, and implemented in multiple revisions and versions. The software can be a proprietary tool that allows for loading and automatic measurement of X-ray images to perform an in-depth analysis and projected alignment of a malalignment in a subject.

[0133] Various methods of treating patients are tried and then refined over time. It is found that the implants disclosed herein change the workflow done during surgery. For example, now the osteotomy plate can be attached to bone before the actual osteotomy is done FIG. 8 shows an example method 800 of treating a subject in need of a malalignment surgery. At 805 is placing the osteotomy plate on a bone of the subject. At step 810 is fastening a portion or one leaf (one half) of the osteotomy plate to bone. Step 815 illustrates fastening another leaf (or one half) of the osteotomy plate to the hinge of the other leaf or to bone. In some surgeries, both halves or leaves are attached at one time. According to some aspects, one or more fasteners are attached through the osteotomy plate through a perpendicular derotation sliding screw hole (DSSH); for example, a bone can be de-rotated or aligned after attaching a fastener through the DSSH. At step 820 is performing osteotomy at the wedge window which is defined by the implant; the bone can be de-rotated by using the fastener through the DSSH, and the fastener can be tightened at the DSSH or sliding screw hole to hold the bone in correct rotation or correct alignment. At 825 is optionally perform bone grafting or filling, which can be done through the wedge window in some cases. At step 830 is rotate the implant at the hinge to desired or planned position. The hinge can be rotated to open up the wedge window further or to close the window. At step 835 is lock down (or tighten) the hinge. At step 840 is X-Ray (or other) to check bone position. At step 845 is if needed loosen hinge and re-adjust, re-check bone position.

[0134] The invention grows in commercial demand, and the methods are refined. FIG. 9 shows an example method 900 of treating a subject in need of a malalignment surgery according to the invention disclosed herein. At step 905 is digitizing/scanning/denoting a plurality of osteo- landmarks and/or anatomical landmarks from the malalignment of a subject in need of surgery (automated, optionally on a computer display). Then applying a machine learning algorithm at 910 to determine optimum planned positions for the landmarks and/or bone(s) after surgery. At step 915 is utilizing the algorithm to form a shape of an osteotomy plate/implant to provide the wedge window in the optimum planned position during surgery. At 920 is outputting size/ shape of osteotomy plate/implant in digital format. At 925 a surgeon checks output; if needed provides adjustments to windows, positions (i.e., human guided training). The surgeon can make a decision to proceed with the plan at 926 and/or to retrain the Al algorithm at 928. The manufacture or selection of the custom implant(s) is at 930, and surgery is at 940.

[0135] FIG. 10 illustrates an AP DFO plate post application pre-osteotomy.

[0136] FIG. 11 illustrates a lateral DFO plate pre-osteotomy.

[0137] FIG. 12 illustrates an AP DFO plate osteotomy through an osteotomy window. [0138] FIG. 13 illustrates an AP DFO plate correction alignment with hinge unlocked. [0139] FIG. 14 illustrates a lateral DFO plate post osteotomy.

[0140] FIG. 15 illustrates an AP DFO plate post graft implantation and correction and hinge locked.

[0141] As seen in FIGs. 10-15, one embodiment provides a surgical plate for a femur. The plate is placed on the femur before the osteotomy, allowing for correction of both rotation and alignment through a sliding hole and a rotating hinge. The plate may have etchings to indicate the degree of correction made. In one embodiment, the use of a disposable saw capture for the osteotomy is employed. This new design aims to make the procedure more efficient and less expensive than current methods.

[0142] In another embodiment, an osteotomy plate with rotating hinge is provided. In one example, the use of a Triplanar plate with a horizontal hole and etchings for ease of use is included. In another example, using a hinge in the plate for both opening and closing wedge osteotomies is included. One mechanism of the hinge includes a series of arcs that provide a strong hinge.

[0143] In one example, the plate may include a measurement guide for accurate correction.

[0144] In another embodiment, a biplanar orthopedic device has a hinge that allows for correction in the coronal plane and a sliding hole that enables rotational correction. The device includes two parts that meet at the hinge, with the most distal hole being a sliding hole.

[0145] It would be appreciated by those skilled in the art that various changes and modifications can be made to the illustrated embodiments without departing from the spirit of the present invention. All such modifications and changes are intended to be within the scope of the present invention except as limited by the scope of the appended claims.

Claims

WHAT IS CLAIMED IS:

1. An osteotomy plate with a wedge window for use in cutting bone and correcting alignment during an osteotomy of a bone with a malalignment in a subject in need thereof, the osteotomy plate comprising: a rotating hinge including a substantially flat barrel which, when disposed at a bone position of the malalignment defines a plane on which an arc of the malalignment lies when a non-normal axis of the malalignment is restored to a normal alignment of the bone; a first leaf having a flat portion lying in the plane and extending outward from a side of the flat barrel, and having a first bent portion beginning a first distance distal from the barrel, with the bent portion disposed about perpendicular to the plane; a second leaf having a flat portion lying in the plane and extending outward from an opposite side of the flat barrel, and having a second bent portion beginning a second distance distal from the barrel and disposed about perpendicular to the plane; and a surgical wedge window defined on one side by a length at the first distal distance where the first bent portion begins, defined on another side by a length at the second distal distance where the second bent portion begins, defined at a top side by an edge of the hinge barrel, and defined at a bottom side by a bottom edge of the bone, the surgical wedge window lying about perpendicular to the plane, wherein the osteotomy plate is configured as a surgical implant for use by a surgeon in a surgical procedure by attaching the first leaf and second leaf to the bone, cutting the bone through the wedge window, and correcting the non-normal axis by moving the hinge along the arc to the normal alignment of the bone.

2. The osteotomy plate of claim 1, further comprising one or more markings operative to indicate to a surgeon where to cut bone or where an osteotomy site is located during a surgery.

3. The osteotomy plate of claim 1, further comprising one or more markings on the barrel of the hinge operative to indicate to a surgeon when the hinge is rotated so as to align the first leaf and the second leaf along a normal alignment of the bone in a subject.

4. The osteotomy plate of claim 1, further comprising the flat barrel of the hinge has a spring inside operative to provide a force on the first leaf, the second leaf, or both.

5. The osteotomy plate of claim 1, further comprising a locking mechanism internal to the barrel that will hold the hinge, the first leaf, and the second leaf in a position establishing the normal alignment of the bone after a surgeon locks the barrel.

6. The osteotomy plate of claim 1, further comprising an antimicrobial coating.

7. The osteotomy plate of claim 1, wherein the plate can be surgically removed after a healing period of time in a subject.

8. A method of making a osteotomy plate, the method comprising: providing a computer system having at least a processor, software, and memory; receiving data representing a surgical assessment of a subject, including data for a bone with a malunion; superimposing a targeted bone shape with a normal alignment over the data for the bone with the malunion; overlaying an osteotomy plate image with a wedge window over the superimposition, and adjusting the osteotomy plate’s size, shape, and/or a wedge window of the plate to plan an osteotomy for re-aligning the bone with the malunion to the targeted bone shape; outside of the computer system, outputting data for the adjusted plate and/or window suitable for either manufacturing an osteotomy plate and window and manufacturing such, or suitable for obtaining a pre-manufactured plate and window; providing the plate with the window for a surgery for the subject; whereby the surgery, the plate, and the wedge window provide a planned surgical outcome and will correct the malunion in the subject.

9. The method of claim 8, further comprising adjusting a bend of at least one leaf included in the plate to define a boundary of the wedge window.

10. The method of claim 8, further comprising placing one or more marking one the plate, and wherein the osteotomy plate includes one or more markings operative to indicate to a surgeon where an osteotomy site is planned during the surgery.

11. The method of claim 8, further comprising a planning of one or more positions and/or depths of one or more fasteners or adhesions for the plate to a bone of the subject; the one or more positions and/or depths configured to fit the bone of the subject.

12. The method of claim 11, further comprising generating a fastener trajectory and/or an adhesion scheme using a navigation, a robotic assistance, and/or an ultrasound input.

13. The method of claim 8, further comprising placing markings at two or more spaced locations along a hinge of the osteotomy plate, the markings configured to enable a precise alignment of the normal alignment of the bone after an osteotomy wedge is removed from a bone of the subject.

14. The method of claim 8, further comprising an execution of the surgery on the subject, whereby the osteotomy plate is implanted into the subject.

15. The method of claim 14, further comprising executing a follow-up surgical assessment on the subject’s malalignment after a healing time, removing the implanted plate after a healing time, obtaining additional post-surgical data from the subject, or a combination thereof; and further comprising inputting a datum into the computer system so as to improve a future manufacturing of a future osteotomy plate.

16. The osteotomy plate of claim 1, further comprising the plate is configured as a central hinge with two oppositely opposed leaves.

17. A method of treating a subject in need of a malalignment bone surgery, the method comprising: performing and/or obtaining a surgical assessment of the subject, whereby data from the subject’s bone with the malalignment and/or surrounding tissues is acquired; superimposing a normal alignment of the bone over the data from the bone with the malalignment, and determining an osteotomy wedge that, if removed from the bone with the malalignment, will enable an axis of the malalignment to be rotated along an arc to the normal alignment; obtaining an osteotomy plate with a wedge window for use in removing bone during an osteotomy of a bone with the malalignment in the subject in need thereof, the plate comprising: a rotating hinge including a substantially flat barrel which, when disposed at a bone position of the malalignment, defines a plane on which an arc of the malalignment lies when a non-normal axis of the malalignment is restored to a normal alignment of the bone; a first and second leaf extending outwards from the hinge, an edge of the hinge and the first and second leaf defining a wedge window through-which the wedge can be removed; and fastening the plate to the bone of the subject, removing the wedge, and rotating a leaf of the plate around the hinge to align the bone to the normal alignment.

18. The method of claim 17, further comprising one or more of the following steps of surgical planning methods are executed: one or more radiographs are loaded on a surgical planning software; an osteotomy plate contour is planned to match a unique bone contour of the subject; one or more positions of one or more fasteners are planned to fasten the osteotomy plate to the bone of the subject; a data-driven, artificial-intelligence, and/or machine-learning process is utilized to determine leaf and/or hinge positions on the osteotomy plate to ensure perfect execution of the surgical plan following a data established bone contour of the subject; and a screw trajectory and/or an adhesive placement is planned using overlays of one or more prototype osteotomy plates, robotic assistance, and/or ultrasound guidance.

19. The method of claim 17, further comprising an intraoperative verification of the osteotomy plate is performed including one or more of measurements of the subject’s bone and/or the plate during a surgery from one or more assigned targets using radiography, fluoroscopy, computerized tomography (CT), robotics, and/or ultrasound.

20. The method of claim 17, further comprising a pre-operative surgical plan is assessed using one or more of a healthcare provider’s examination of the subject, an ultrasound, and/or a robotic assisted exam.

21. The method of claim 17, further comprising a post-operative surgical assessment is executed using one or more of a healthcare provider’s examination of the subject, an ultrasound, and/or a robotic assisted exam.