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, e.g. tourniquets
  • A61B17/14—Surgical saws ; Accessories therefor
  • A61B17/15—Guides therefor
  • A61B17/151—Guides therefor for corrective osteotomy
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
  • A61B17/17—Guides or aligning means for drills, mills, pins or wires
  • A61B17/1728—Guides or aligning means for drills, mills, pins or wires for holes for bone plates or plate screws
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • 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, setting implements or the like
  • 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
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
  • A61B17/17—Guides or aligning means for drills, mills, pins or wires
  • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
  • A61B17/1764—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the knee
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B2017/564—Methods for bone or joint treatment
  • A61B2017/565—Methods for bone or joint treatment for surgical correction of axial deviation, e.g. hallux valgus or genu valgus
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B2017/568—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor produced with shape and dimensions specific for an individual patient
• • 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

Definitions

• Invention relates to cutting measuring navigation system processing web based radiological screen displays used for detecting bone curve for High Tibal Osteotomy (HTO) in Varus and Valgus deformities occurring in knee joint and customised cut and Screwing obtained by means of modelling the values measured by the navigation and transmission thereof to three-dimensioned printer for use in orthopaedics surgery in medicine sector.
• HTO High Tibal Osteotomy
• Chinese patent model application numbered CN111481259 A is found.
• Said application discloses a method of preparing osteotomy guide plate. According to the model magnetic resonance imaging data of bone tissue of the patient are obtained, magnetic resonance imaging data are transmitted to three-dimensioned simulation software and three-dimensioned model of bone tissue is re-generated.
• said system does not disclose a customized process.
• Present invention relates to cutting measuring navigation system processing web based radiological screen displays used for detecting bone curve and customised cut and screw guide obtained by means of modelling the values measured by the navigation meeting the needs mentioned above, eliminating all disadvantages and providing some additional advantages.
• Primary purpose of the invention is to develop a technology providing measurement of bone angular deformities of a patient from radiological images, processing the data therefrom and capable to print out customised bone cut and screw guide in three-dimensioned printer.
• a separate planning and measurement system is provided for each patient and customised design is provided from the system and thus it will be possible to obtain 3 dimensioned printed bone cut guide and external plate screw guide system modelled by patient’s data in order to correct the angular deformity.
• the invention has the novelty to provide fault free cases without use of conventional surgery guide but with better and customized corrections and cuts.
• Another purpose of the invention is to disclose a system to carry standard deformity measurement techniques into digital environment, measure anatomic axis of femur and tibia, define varus or valgus deformity, and automatically calculate angle needed for correction. According to the calculated angle 3-dimensioned cut guide and external implant screw guide is provided.
• anatomic and mechanical axis are processed in open source coded software such as open CV, Phyton on radiological image pictures installed into software and after automatic calculation by use of marking and symbols, bone angular deformity of patient is defined as varus or valgus deformity in the software and then it is possible to record the data. In line with the data cut angle to provide correction is discovered and accordingly cut guide design is conducted.
• the data obtained via software are preferably modelled in SolidWorks program and processed according to personal measurement data and then transmitted to 3-dimensioned printer; customized three-dimensioned cut and screw guide to enable physician to screw implant of desired brand in desired angle and size.
• cut guides are convenient for open surgical method.
• stage of plating implant application mentioned in the invention
• skin is completely opened, and screw holes are provided and then plating is made.
• the distal part of the guide (the part in the lower part) enables fixing implanted plate to patient as external guide with minimally incision on patient’s skin.
• the invention is a method to detect curve in the bone for correction cut in the bone and produce person customized cut and screw guide in the plating method of High Tibial Osteotomy operations in Varus and Valgus deformities occurring in knee joint and comprises process steps of
• Figure 1 shows process of finding femur head centre by help of tangents drawn for femur in Figures 1 A and 1 B.
• Figure 2 shows process of finding femur head centre by help of square and diagonals drawn for femur in Figures 2A and 2B.
• Figure 3 shows process of finding femur distal joint face centre in Figures 3A and 3B.
• Figure 4 shows process of finding femur anatomic and mechanical axis in Figures 4A and 4B.
• Figure 5 shows process of finding tibia proximal joint face mid-point in Figures 5A and 5B.
• Figure 6 shows process of finding tibia distal joint face mid-point in Figures 6A and 6B.
• Figure 7 shows process of finding tibia distal joint face mid-point in Figures 7A and 7B.
• Figure 8 shows finding tibia axis and their relations in Figures 8A, 8B and 8C.
• Figure 9 shows view of proximal guide section from various angles.
• Figure 10 shows view of distal guide section from various angles.
• Figure 11 is a general view of guide screw.
• Figure 12 shows general view of cut on tibia bone and screw guide.
• Figure 13 is a detailed view of guide screw.
• Figure 14 shows anatomic and mechanical axis of femur in frontal plan.
• Figure 15 shows drawing of tibia distal joint orientation line in frontal plan in figure 15A, drawing of tibia proximal joint orientation line in frontal plan in Figure 15B.
• Figure 16 shows femur distal joint orientation line in frontal plan.
• Figure 17 shows line combining femur head centre and big trocanter head in Figure 17A, femur head centre to mid-point of femur neck in Figure 17B.
• Figure 18 shows relationship between femur proximal joint orientation line in frontal plan to femur mechanical axis in Figure 18A and femur anatomic axis in Figure 18B.
• Figure 19 shows relationship between femur proximal joint orientation line in frontal plan and femur anatomic axis.
• Figure 20 shows relationship between femur distal joint orientation line in frontal plan to femur mechanical axis in Figure 20A and femur anatomic axis in Figure 20B.
• Figure 21 shows relationship between tibia proximal joint orientation line and tibia anatomic and mechanic axis.
• Figure 22 shows relationship between tibia distal joint orientation line in frontal plan and tibia anatomic and mechanic axis.
• Figure 23 shows view of marking and calculation of mechanical axis of lower extremity in frontal plan.
• Figure 24 shows view of marking and calculation of mechanical axis of lower extremity in frontal plan.
• Figure 25 shows view of marking and calculation of mechanical axis of lower extremity in frontal plan.
• Figure 26 shows view of drawing mLDFA angle to detect whether or not deformity occurs in femur in frontal plan.
• Figure 27 shows drawing of occurrence of varus or valgus deformities in femur in frontal plan.
• Figure 28 shows drawing of MPTA angle to detect whether or not deformity occurs in tibia in frontal plan.
• Figure 29 shows varus deformity in tibia if angle in MPTA in figure 29A is smaller than 85 degrees and valgus deformity in tibia if MPTA in figure 29B is bigger than 90 degrees regarding deformity in tibia in frontal plan.
• Figure 30 shows drawing of JLCA angle to detect whether or not deformity occurs in knee joint in frontal plan.
• Figure 32 shows position of placed plant (implant).
• Invention relates to software based cutting measuring navigation system processing radiological screen displays used for detecting bone curve for High Tibial Osteotomy (HTO) in Varus and Valgus deformities occurring in knee joint and customised angle adjustable cut and screw guide (7) obtained by means of modelling the values measured by the navigation and transmission thereof to three-dimensioned printer for use in orthopaedics surgery in medicine sector.
• HTO High Tibial Osteotomy
• HTO-High Tibial Osteotomy operations for treatment of Varus and Valgus deformities occurring in kneed joint x-ray or tomography film of the patient is transmitted to navigation system having its own software and detecting curve in bone by surgeon in order to detect curve in the bone for recovery osteotomy to be conducted to bone. Then marking directed by navigation system having said software is conducted on x-ray or tomography film added to system.
• a cut and screw guide (7) printed out from bio-compatible material from 3- dimensioned printer by use of obtained data.
• femur and tibia mechanical and anatomic axis are calculated based on radiological images in the software. It is needed to find out proximal and distal joints centres of femur to draw femur mechanical axis. For these two tangents parallel to each other are drawn from top and bottom for femur ( Figure 1 A and Figure 1 B). Points of contacts of tangents with femur head (points a and b) are combined. Thus, diameter of circle is found out. Then a tangent is drawn from medial, the point where the line from contact point of the tangent with femur head (point c in Figure 1 B) cuts diameter is detected as femur head centre (M). Two tangents are added vertically from medial and lateral to two tangents drawn in figure 1 and thus figure is made square (Figure 2A). Diagonals of square are drawn, and centre is found ( Figure 2B).
• Centre of femur distal joint face can be found in two ways.
• Top point of femoral dent can be taken (Figure 3A). Femoral dent matches centre of femur distal joint face.
• Femur anatomic axis for femur anatomic axis is drawn by combining mid points of lines drawn vertically from two or three points to femur diaphysis ( Figure 4B).
• Processes mentioned hereunder are processed in software and are calculated by help of software by providing reference signs and symbols on x-ray images.
• Tibia proximal joint face centre is found in two ways.
• tibial plate can be taken (Figure 5B). For this a line is drawn to joint face from the point where internal tibial plate finishes. Similarly, a second line is drawn from the point where external tibial plate finishes. Distance between these lines is combined vertically and mid-point centre is shown. Tibia distal joint face centre is found in four ways.
• Figure 8 shows the relationship between mechanic axis in Figure 8A, anatomic axis in Figure 8B), tibia anatomic (dark arrow) and mechanic axis (light arrow) in Figure 8C.
• Mechanic axis is a smooth line. Since anatomic axis is the line combining mid points of diaphysis, anatomic axis can be curve (like anatomic axis of femur in sagital plan). Anatomic and mechanic axis of tibia are parallel to each other in frontal plan and there is only a few mm between them. The angle between two axis is 0 degree. For that reason, in practice anatomic and mechanic axis are deemed as the same (Figure 8C). Anatomic and mechanic axis of femur are different in frontal plan. The angle between two axis is 7 degrees on average. Normally 2 degrees deviation may occur ( Figure 14).
• distal tibia subcontral line is taken as basis ( Figure 15A).
• distal tibia proximal joint orientation line in frontal plan concave points of two tibial plate subconoral line are combined in software (Figure 15B).
• Figure 15A shows drawing of tibia distal joint orientation line in frontal plan.
• Figure 15B shows drawing of tibia proximal joint orientation line in frontal plan.
• distal femur subcondral line is taken as basis and drawn in software ( Figure 16). Two lines are used for femur proximal joint orientation in frontal plan.
• First letter defines direction of angle. If angle is in frontal plan, angle direction is either lateral or medial. If in sagital plan, it is either anterior or posterior. For that reason, first letters is one of L, M, A or P which are initial letters of direction words. Second letter indicates if angle is in proximal or distal of the bone. Second letter is P if in proximal and D if in distal. Third letter indicates where the angle belong to (tibia, femur). If angle is tibia third letter is T and if femur, it is F.
• Fourth letter is the same in all of them and is initial letter of term angle, which is A: Different from them, a or m in small letter is written before 4-capital letter angle term and a indicates that angle is drawn according to anatomic axis, m to mechanical axis.
• mLPFA Line combining femur head centre and trocanter top makes an angle of 90 degrees on average with femur mechanic axis in lateral (minimum 85 and maximum 90 degrees). This angle is called Lateral Proksimal Femoral Agi (mLPFA) ( Figure 18A). it is displayed on monitor in software based system.
• aMPFA This line combining femur head centre and trocanter top makes an angle of 84 degrees on average with anatomic axis (minimum 80 and maximum 89 degrees). This angle is called Medial Proksimal Femoral Angle aMPFA ( Figure 18B).
• aMNSA This line combining femur head centre and femur neck mid point makes an angle of 130 degrees on average with anatomic axis (minimum 124 and maximum 136 degrees). This angle is called Medial Neck-Shaft Angle aMNSA ( Figure 19).
• Distal femur joint orientation line makes an angle of 87 degrees on average with femur mechanic axis in lateral (minimum 85 and maximum 90 degrees) ( Figure 20A. This angle is called
• mLDFA Lateral Distal Femoral Angle
• aLDFA atomic Lateral Distal Femoral Angle
• mMPTA Proximal tibia joint orientation line makes an angle of 87 degrees on average with tibia mechanic axis in medial (minimum 85 and maximum 90 degrees) ( Figure 21.
• mMPTA Medial Proksimal Tibial Angle
• mLDTA Distal tibia joint orientation line makes an angle of 89 degrees on average with tibia anatomic and mechanic axis in medial (minimum 86 and maximum 92 degrees) in lateral ( Figure 22). This angle is called Lateral Distal Tibial Angle (mLDTA).
• JLCA Joint line convergence angle
• Femoral condils lowest subcondral points are combined and distal femur orientation line is drawn.
• tibial plates lowest subcondral points are combined and proximal tibia orientation line is drawn, these two lines are parallel to each other. There can be an angle up to 2 degrees between them. Angle bigger than 2 degrees indicates deformity in knee joint ( Figure 30). If this angle is bigger than 2 degrees and in medial, knee joint has valgus deformity ( Figure 31 A). If JLCA angle is bigger than 2 degrees and in lateral, knee joint has varus deformity ( Figure 31 B). It is marked and computed in software based system.
• Tibia support flaps (4) are support structures in flap form to provide holding of cut and screw guide (7) onto tibia bone or skin during operation.
• kishner wire guide holes (3) are the holes used to fix cut and screw guide (7) onto said bone.
• tibia support flaps (4) and kishner wire guide holes (3) by help of preferably wire or pin.
• proximal guide section (10) which is upper part of cut and screw guide (7) is fixed to bone through guide holes (1 ).
• Cut area (6) adjustable tailored to person is the area where saw goes into cut and screw guide (7) for cutting bone (osteotomy). This area is in the angled form according to angle measured in software based system. Saw printed out in person tailored angle conducts osteotomy at the angle specified from bone cut channel. Flere physician decides on open and close mixed osteotomy by marking in the software. Thus cuts in angles planned in software based system are conducted.
• Proximal guide section (10) and distal guide section (11) are connected to each other through locking hole (5) by means of 3-dimensioned guide screw (12).
• Said locking hole (5) is the screw hole connecting cut and screw guide (7) proximal guide section (10) and distal guide section (11).
• Cut and screw guide (7) proximal guide section (10) is removed from where it is fixe.
• Plate (13) (implant) designed according to desired brand and model is placed into plate housing (2) in proximal guide section (10) of cut and screw guide (7) and fixed to bone.
• tibia support flaps (4) and kishner wire guide holes (3) are used.
• implant housing (2) is the structure where into implant will seat after osteotomy.
• the cut and screw guide (7) designed tailored for person at 3-dimensioned printer are used as external screw guide.
• proximal guide section (10) and distal guide section (11) comprise a plate (implant) housing (2) convenient for placement of implant thereinto.
• implant (13) Since guide holes (1) located on cut and screw guide (7) are in the same place as implant (13) holes, implant (13) is firstly screwed on upper part by help of proximal guide section (10). It is brought to bone at desired angle by means of angling apparatus based on recovery angle degree measured in software based system and placed in a manner distal guide section (11) remains on in cut and screw guide (7). As stated, distal section of implant is fixed onto bone by help of guide holes (1) and operation is completed with minimally cuts (Minimally Invasive Operation) skin.
• data obtained from said software based system used for bone measurement and cut are preferably processed in web based software, received data are modelled person tailored in preferably solid works program and transferred to 3-dimensioned printer.
• Cut and screw guide (7) which is designed person tailored at 3-dimensioned printer comprises two basic parts, namely proximal guide section (10) and distal guide section (11).
• Proximal guide section (10) is fixed to bone and bone is cut in cut and screw guide (7) produced with a person tailored angle.
• YTO plate implant
• proximal guide section (10) and distal guide section (11) fix the plate externally (with minimally invasive on to skin) by help of screwing holes on cut and screw guide (7).

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Citations (3)

• 2021
  • 2021-04-26 TR TR2021/007090A patent/TR202107090A2/tr unknown
• 2022
  • 2022-04-11 EP EP22796292.5A patent/EP4329640A1/en active Pending
  • 2022-04-11 WO PCT/TR2022/050316 patent/WO2022231548A1/en active Application Filing

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