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WO2025212925A1 - Plaque d'ostéotomie - Google Patents

Plaque d'ostéotomie

Info

Publication number
WO2025212925A1
WO2025212925A1 PCT/US2025/023009 US2025023009W WO2025212925A1 WO 2025212925 A1 WO2025212925 A1 WO 2025212925A1 US 2025023009 W US2025023009 W US 2025023009W WO 2025212925 A1 WO2025212925 A1 WO 2025212925A1
Authority
WO
WIPO (PCT)
Prior art keywords
bone
osteotomy
plate
subject
hinge
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/023009
Other languages
English (en)
Inventor
Turlough O'DONNELL
Alan LAING
Annunziato Amendola
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Arc Techionics, Inc
Original Assignee
Arc Techionics, Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Arc Techionics, Inc filed Critical Arc Techionics, Inc
Publication of WO2025212925A1 publication Critical patent/WO2025212925A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8095—Wedge osteotomy devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/108—Computer aided selection or customisation of medical implants or cutting guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/067—Measuring instruments not otherwise provided for for measuring angles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/376—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy
    • A61B2090/3762—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy using computed tomography systems [CT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound

Definitions

  • the present invention relates generally to osteotomy, and more particularly to an osteotomy plate.
  • 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.
  • 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
  • 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.
  • 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. 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. 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.
  • 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
  • FIG. 3D 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.
  • FIG. 3D shows a precision surgery
  • 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.
  • FIG. 3G shows, according to some aspects, how oval or ‘screw adjusting’ holes 205 can be configured for a longitudinal screw adjustment at 207.
  • 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.
  • 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.
  • 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.
  • 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.
  • the DSSH provided at 205 and 207 provides unprecedented bone rotation and adjustments after the osteotomy plate is attached.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • FIG. 6 shows another exemplary osteotomy plate 300 with optional fastener holes 306 and optional osteotomy site markings 310.
  • 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.
  • FIG. 7 shows a flow diagram of a method 700 to make an osteotomy plate of the invention provided herein.
  • FIG. 8 shows an example method 800 of treating a subject in need of a malalignment surgery.
  • FIG. 9 shows another example method 900 of treating a subject in need of a malunion surgery according to the invention disclosed herein.
  • FIG. 10 illustrates an AP DFO plate post application pre-osteotomy.
  • FIG. 11 illustrates a lateral DFO plate pre-osteotomy.
  • FIG. 12 illustrates an AP DFO plate osteotomy through an osteotomy window.
  • FIG. 14 illustrates a lateral DFO plate post osteotomy.
  • FIG. 15 illustrates an AP DFO plate post graft implantation and correction and hinge locked.
  • 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).
  • 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”.
  • 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).
  • 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).
  • statically significant or “significantly” refers to statistical significance and generally means a two-standard deviation (2SD) or greater difference.
  • 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.
  • the term “treating” includes prophylactic and/or therapeutic treatments.
  • 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).
  • 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.
  • 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.
  • “decrease”, “reduced”, “reduction”, or “inhibit” are all used herein to mean a decrease by a statistically significant amount.
  • “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.
  • “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.
  • the decrease in the one or more signs or symptoms is evaluated according to a specialized healthcare provider.
  • signs are observed or measured by a health care provider.
  • Symptoms can be reported by the subject.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the subject has been brought into a treatment situation entirely without the subject’s knowledge and/or intent.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • A-D above provide precision surgery, as is described in increasing detail below.
  • 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.
  • DSSH perpendicular de-rotation sliding screw hole
  • 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.
  • the DSSH 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.
  • a method of treating a subject with a bone defect or a malaligned bone 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.
  • 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.
  • a historical patient database from ideal surgical outcomes and non-ideal
  • 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
  • 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.
  • 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.
  • 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.
  • 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.”
  • 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.
  • 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.
  • 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.
  • DSSH perpendicular de- rotation sliding screw hole
  • 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.
  • 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.
  • 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.
  • 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.
  • the invention disclosed herein changes the order of execution of steps in an osteotomy surgery.
  • 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.
  • 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.
  • 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.
  • 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.
  • the hinge e.g., 67 at FIGs. 3D-3G
  • the implants disclosed herein allow for an osteotomy to be formed after affixing the osteotomy plate to any bone.
  • the implants disclosed herein can be affixed to a bone after an osteotomy is performed.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • FIG. 6 shows another exemplary osteotomy plate 300 with optional fastener holes 306 and optional osteotomy site markings 310.
  • 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.
  • any of the fastener holes 306 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.
  • 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.
  • the hinge can be a living hinge.
  • the entire implant could, conceptually, be made by a 3D printing process.
  • 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.
  • 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.
  • 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.
  • 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.
  • the osteotomy plate described above can be configured as a central hinge with two oppositely opposed leaves.
  • a method of making an osteotomy plate of any aspect herein 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;
  • step (B) 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Al artificial intelligence
  • 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.
  • 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.
  • Al artificial intelligence
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • FIG. 7 shows a flow diagram of a method 700 to make an osteotomy plate of the invention provided herein.
  • 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.
  • a computer will output planned implant shapes, sizes, fastener positions, wedge window, and tension specifications in digital format.
  • an osteotomy plate with rotating hinge is provided.
  • the use of a Triplanar plate with a horizontal hole and etchings for ease of use is included.
  • 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.

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Abstract

L'invention concerne une plaque d'ostéotomie comprenant : une charnière rotative ; une première feuille dotée d'une partie plate située dans le plan et s'étendant vers l'extérieur à partir d'un côté du cylindre plat ; une seconde feuille dotée d'une partie plate située dans le plan et s'étendant vers l'extérieur à partir d'un côté opposé du cylindre plat ; et une fenêtre de coin chirurgical définie sur un côté par une longueur à la première distance distale où la première partie courbée commence ; la plaque d'ostéotomie étant configurée sous la forme d'un implant chirurgical destiné à être utilisé par un chirurgien dans une intervention chirurgicale en fixant des première et seconde feuilles à l'os, en coupant de l'os à travers la fenêtre de coin, et en corrigeant l'axe non normal par déplacement de la charnière le long de l'arc vers l'alignement normal de l'os.
PCT/US2025/023009 2024-04-03 2025-04-03 Plaque d'ostéotomie Pending WO2025212925A1 (fr)

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US63/574,210 2024-04-03

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070173815A1 (en) * 2003-02-12 2007-07-26 Tsuyoshi Murase Method, members, system and program for bone correction
US8388690B2 (en) * 2003-10-03 2013-03-05 Linvatec Corporation Osteotomy system
US8496662B2 (en) * 2005-01-31 2013-07-30 Arthrex, Inc. Method and apparatus for forming a wedge-like opening in a bone for an open wedge osteotomy
US8888826B2 (en) * 2008-11-20 2014-11-18 Mbrace, Llc Surgical device, system and method of use thereof
WO2023060122A1 (fr) * 2021-10-05 2023-04-13 Aa Enterprises, Llc Plaque de fusion pour aider à la fusion d'un premier et d'un second os

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070173815A1 (en) * 2003-02-12 2007-07-26 Tsuyoshi Murase Method, members, system and program for bone correction
US8388690B2 (en) * 2003-10-03 2013-03-05 Linvatec Corporation Osteotomy system
US8496662B2 (en) * 2005-01-31 2013-07-30 Arthrex, Inc. Method and apparatus for forming a wedge-like opening in a bone for an open wedge osteotomy
US8888826B2 (en) * 2008-11-20 2014-11-18 Mbrace, Llc Surgical device, system and method of use thereof
WO2023060122A1 (fr) * 2021-10-05 2023-04-13 Aa Enterprises, Llc Plaque de fusion pour aider à la fusion d'un premier et d'un second os

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