WO2019052622A1 - Modèle électronique spécifique au patient destiné à être utilisé dans des ostéotomies correctives pour le traitement de déformations osseuses et articulaires - Google Patents

Modèle électronique spécifique au patient destiné à être utilisé dans des ostéotomies correctives pour le traitement de déformations osseuses et articulaires Download PDF

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Publication number
WO2019052622A1
WO2019052622A1 PCT/EG2018/000013 EG2018000013W WO2019052622A1 WO 2019052622 A1 WO2019052622 A1 WO 2019052622A1 EG 2018000013 W EG2018000013 W EG 2018000013W WO 2019052622 A1 WO2019052622 A1 WO 2019052622A1
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WO
WIPO (PCT)
Prior art keywords
template
bone
leg bone
leg
osteotomy
Prior art date
Application number
PCT/EG2018/000013
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English (en)
Other versions
WO2019052622A4 (fr
Inventor
Mahmoud Alm EL Din HAFEZ
Original Assignee
Hafez Mahmoud Alm El Din
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 Hafez Mahmoud Alm El Din filed Critical Hafez Mahmoud Alm El Din
Publication of WO2019052622A1 publication Critical patent/WO2019052622A1/fr
Publication of WO2019052622A4 publication Critical patent/WO2019052622A4/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/14Surgical saws ; Accessories therefor
    • A61B17/15Guides therefor
    • A61B17/151Guides therefor for corrective osteotomy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/14Surgical saws ; Accessories therefor
    • A61B17/15Guides therefor
    • A61B17/151Guides therefor for corrective osteotomy
    • A61B17/152Guides therefor for corrective osteotomy for removing a wedge-shaped piece of bone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8095Wedge osteotomy devices

Definitions

  • the present invention is related to a patient-specific electronic template for usage in corrective osteotomies for the leg, whether the upper or axial part of the leg bone.
  • the template preoperatively determines the exact direction of the bone cuts to be made, the degree of deformity, and the amount of bones to be cut in a correct way by means of software-assisted preoperative planning.
  • Corrective osteotomy as a surgical operation for the upper or axial part of the leg bone, is a serious procedure that requires a high degree of expertise and considerable surgical skills.
  • the surgeon has to determine the location, angle and degree of the cut to be made to the leg bone, whether in upper or axial osteotomies.
  • the incision made in conventional surgical operations is significantly long, thus requiring extensive recovery and prolonged rehabilitation at home.
  • Total dependence on the 2D X-ray for planning for the surgery limits the possibilities of total success, such as the correct alignment and placement of the metal strip on the bone, the inclination degrees, and the amounts of bones to be cut. It does not also provide the surgeon with the ability to predetermine the size and shape of the metal strip and the dimensions and position of the wedge used for separating between the two parts of the leg bone after undergoing osteotomy.
  • corrective osteotomies for the leg represent an alternative for total knee replacement, they still need to be performed by surgeons with great expertise and skills to be able to determine the exact location and angle of inclination of the cut, and the dimensions of the wedge or bone graft to be placed subsequent to osteotomy.
  • the present invention is related to a patient-specific electronic template for usage in corrective osteotomies for the leg, whether the upper or axial part of the leg bone.
  • the template according to the present invention, is an ideal solution for surgeons that may help achieve the required exactness and correctness for positioning the metal strip on the bone and also for determining the location, level and angle of the cut to be made in the bone, and the dimensions of the wedge used for correcting the bone deformity.
  • the present invention is related to a patient-specific electronic template for usage in corrective osteotomies for the leg, whether the upper or axial part of the leg bone.
  • the template preoperatively determines the exact direction of the bone cut to be made, the degree of deformity, and the amount of bones to be cut in a correct way by means of software-assisted preoperative planning. (See figures 1, 3, 8, and 10)
  • the template, according to the present invention is a single-use device.
  • the design and placement of this patient-specific template is based on the preoperative CT scan made to the patient before undergoing corrective osteotomy for the leg, whether the upper or axial part of the leg bone.
  • a CT scan of one patient cannot be similar to that of any other individual.
  • the surgeon may perform the surgical cut for the leg bone through the paths arranged in the template, which are designed to match the same inclination degree of the required cut and the level and location of the cut.
  • the template also provides the surgeon with the ability to determine the size of the metal strip and wedge used after performing osteotomy. (See figures 1, 3, 6, and 7)
  • the said template is designed according to software-assisted preoperative planning.
  • the 2D CT scan is first inputted into the computer program then converted into a 3D model for the bone.
  • the said 3D model shows all the details and anatomic features of the surface of the thigh bone, such as the anterior tibial projection of the leg bone, and the upper surface and conical shape thereof. (See figures 1, 2, 3, 4, and 5)
  • the hypothetical preoperative planning is made by using a computer program for determining the level and inclination degree of the bone cut, the dimensions of the wedge to be used, and the amounts of the bone graft required. (See figure 6)
  • the features of the template inner surface are produced.
  • the said features match those of the outer surface of the leg bone in the same location where the template shall be fixed to perform osteotomy, whether upper osteotomy on the top of the leg bone or axial osteotomy on the surface of the leg bone.
  • the features of the inner surface represent one of the advantages of the template, according to the present invention, since they enable the surgeon to place the template on the leg bone in the only one correct location. These features do not match the surface of the leg bone except in the just one location already predetermined on the computer program; wherein the said location matches the location of the cut to be made. (See figures 2 and 9)
  • Software-assisted preoperative planning for corrective osteotomy is based on the mechanical and anatomic axes of the bone as well as its degree of inclination and deformity. It also depends on the dimensions of the bone as inputted into the computer program by means of the images of the CT scans.
  • the surgeon may select the appropriate size of the metal strip and wedge and design their placement location, their alignment, and their inclination angle on the bone.
  • the surgeon may also determine the location, level, and inclination angle of the cut to be made in order to correct the bone deformity.
  • the computer program begins producing an electronic form for the template according to the size, location and alignment already determined by the surgeon.
  • the features of the inner surface of the template match those of the outer surface of the leg bone in the location where the template is to be fixed to perform osteotomy, whether upper osteotomy on the top of the leg bone or axial osteotomy on the surface of the leg bone. (See figures 3, 4, 5, and 10)
  • This electronic form or file of the template is sent to a 3D printer to produce a real model that may be used in surgical operations.
  • the model may be printed using different techniques, selected by the surgeon, according to the desired quality and final price.
  • the said electronic template may be easily sterilized. It is also easy to carry because of its light weight and small size, unlike prior art large and heavy tools.
  • the surface of the electronic template contains printed data about the size of the metal strip and wedge, the direction of the template that suits the right or left leg, and the name of the patient to prevent any confusion or loss between templates. (See figure 5)
  • the electronic template comprises fixation openings or fixation holes through which fixation pins and fixation screws pass to attach the template on the bone surface.
  • the said openings have different locations and inclination angles on the bone surface as well as diverse diameters according to the type of the template, whether it is used for corrective osteotomy for the upper or axial part of the leg bone.
  • upper openings are arranged on the template for fixation thereof on the top of the bone surface
  • other fixation openings are arranged with a certain inclination angle on the surface of the anterior leg bone
  • orthogonal openings are arranged on the surface of the anterior leg bone.
  • fixation openings completely restrict the movement of the template to ensure its best fit on the leg bone in the exact location already plotted on the computer program to achieve correct and safe cut for the leg bone.
  • fixation openings are arranged with a certain inclination angle on the surface of the anterior leg bone and orthogonal openings are arranged for fixation on the surface of the anterior leg bone for the same above-mentioned reasons.
  • Such openings enable the surgeon to perform osteotomy easily without fear of the possibility of the template being displaced from its predetermined location as mapped out on the computer program used in the preoperative planning. (See figures 1 and 8)
  • the surgical operation of osteotomy is made by means of paths comprised in the template and designed for enabling the surgeon to make the proper bone cut while ensuring that the cut angle matches that already mapped out on the computer program.
  • the template comprises two paths; a main path used for corrective osteotomy for the upper or axial part of the leg to perform the main cut in the leg bone and a secondary path for performing additional cuts, if necessary.
  • the two paths i.e. the main one and the secondary one
  • comprised in the electronic template for corrective osteotomy extend to the opposite direction of the surgeon to ensure that the saw does not deviate from its inclination angle and that the template correctly fits into the leg bone. This helps achieve accuracy and correctness of the location of the cut to be made. (See figures 1, 6, and 8)
  • Figure (1) Shows a two-dimensional elevation for the template used in corrective osteotomy for the upper part of the leg bone. As shown in the figure, an upper opening (4) is arranged for template fixation on the bone and two inclined openings are arranged for fixation on the bone surface (3). The figure also shows the main path (1) used by the surgeon to perform osteotomy and also the two orthogonal openings arranged for fixing the template on the bone surface (2).
  • Figure (2) Shows a three-dimensional perspective view for the template used in corrective osteotomy for the upper part of the leg bone. The surface features are shown on the inner surface (5) and these features exactly match the leg bone surface in the location where the template is to be fixed.
  • Figure (3) Shows a two-dimensional elevation for the template (7) used in corrective osteotomy for the upper part of the leg bone.
  • the template is fixed in its right location on the leg bone (8).
  • the figure also shows the contact surface (6) between the template and the bone.
  • Figure (4) is a two-dimensional horizontal elevation for the template used in corrective osteotomy for the upper part of the leg bone.
  • the template is fixed in its right location on the leg bone.
  • Figure (5) Shows a two-dimensional side elevation for the template used in corrective osteotomy for the upper part of the leg bone.
  • the template is fixed in its right location on the leg bone.
  • Figure (6) is a two-dimensional elevation for the template used in corrective osteotomy for the upper part of the leg bone.
  • the template is fixed in its right location on the leg bone.
  • the figure also shows the cut paths (9) to be made on the leg bone.
  • Figure (7) Shows a two-dimensional elevation for the metal strip (10) with the wedge comprised therein. The metal strip and the wedge are fixed in their right locations on the leg bone subsequent to osteotomy.
  • Figure (8) Shows a two-dimensional elevation for the template used in corrective osteotomy for the axial part of the leg bone. The figure shows an upper opening (13) for fixation of the template on the bone and two lower openings for fixation on the bone surface (14). The figure also shows the main cut path (11) used by the surgeon to perform osteotomy and also the secondary cut path (12) used for making additional cuts, if necessary, and for determining the thickness of the wedge to be fixed.
  • Figure (9) Shows a three-dimensional perspective view for the template used in corrective osteotomy for the axial part of the leg bone.
  • the surface features are shown on the inner surface (15) and these features exactly match the leg bone surface in the location where the template is to be fixed.
  • Figure (10) Shows a three-dimensional perspective view for the template used in corrective osteotomy for the axial part of the leg bone.
  • the template is fixed in its right location on the leg bone.
  • the figure also shows the contact surfaces (16) between the template and the bone.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dentistry (AREA)
  • Engineering & Computer Science (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne des modèles spécifiques à un patient pour une ostéotomie afin de prédéterminer la direction exacte et le degré de déformation avant chirurgie et d'estimer un alignement post-opératoire de membre qui doit imiter le chargement physiologique pour garantir un résultat clinique favorable. L'ostéotomie de correction à l'aide de techniques classiques peut conduire à une sous-correction ou une surcorrection. Nous avons conçu une technique de modélisation spécifique à un patient pour une ostéotomie tibiale haute ainsi que pour une ostéotomie corrective de difformités d'arbre. La technique a été appliquée à une ostéotomie tibiale haute unilatérale et bilatérale et une déformation d'arbre tibial. Les modèles spécifiques au patient sont basés sur des images de balayage CT qui sont transférées à un logiciel spécifique pour construire un modèle 3D d'os. Une planification virtuelle de la chirurgie est effectuée pour concevoir les modèles qui sont utilisés pour effectuer la chirurgie. La machine d'impression 3D est utilisée pour produire le modèle spécifique au patient.
PCT/EG2018/000013 2017-09-14 2018-09-12 Modèle électronique spécifique au patient destiné à être utilisé dans des ostéotomies correctives pour le traitement de déformations osseuses et articulaires WO2019052622A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EG2017090024 2017-09-14
EG2017090024 2017-09-14
EG2018030447 2018-03-13
EG2018030447 2018-03-13

Publications (2)

Publication Number Publication Date
WO2019052622A1 true WO2019052622A1 (fr) 2019-03-21
WO2019052622A4 WO2019052622A4 (fr) 2019-05-02

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11931106B2 (en) 2019-09-13 2024-03-19 Treace Medical Concepts, Inc. Patient-specific surgical methods and instrumentation
US11986251B2 (en) 2019-09-13 2024-05-21 Treace Medical Concepts, Inc. Patient-specific osteotomy instrumentation

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007127994A2 (fr) * 2006-04-28 2007-11-08 Acumed Llc Systèmes d'ostéotomie
US20110213376A1 (en) * 2010-02-26 2011-09-01 Biomet Sports Medicine, Llc Patient-Specific Osteotomy Devices and Methods
US20160242791A1 (en) * 2015-02-19 2016-08-25 First Ray, LLC Indexed tri-planar osteotomy guide and method
WO2017070318A1 (fr) * 2015-10-22 2017-04-27 Materialise N.V. Guide chirurgical en deux parties
WO2017085479A1 (fr) * 2015-11-16 2017-05-26 Oxford University Innovation Ltd. Système d'ostéotomie tibiale proximale

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007127994A2 (fr) * 2006-04-28 2007-11-08 Acumed Llc Systèmes d'ostéotomie
US20110213376A1 (en) * 2010-02-26 2011-09-01 Biomet Sports Medicine, Llc Patient-Specific Osteotomy Devices and Methods
US20160242791A1 (en) * 2015-02-19 2016-08-25 First Ray, LLC Indexed tri-planar osteotomy guide and method
WO2017070318A1 (fr) * 2015-10-22 2017-04-27 Materialise N.V. Guide chirurgical en deux parties
WO2017085479A1 (fr) * 2015-11-16 2017-05-26 Oxford University Innovation Ltd. Système d'ostéotomie tibiale proximale

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11931106B2 (en) 2019-09-13 2024-03-19 Treace Medical Concepts, Inc. Patient-specific surgical methods and instrumentation
US11986251B2 (en) 2019-09-13 2024-05-21 Treace Medical Concepts, Inc. Patient-specific osteotomy instrumentation

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