WO2013055203A1 - Procédé permettant de réaliser un dispositif spécifique au patient destiné à être utilisé pour une correction osseuse, kit de traitement, procédé permettant de faire fonctionner un système de traitement de données, programme informatique, et dispositif de correction et de fixation et dispositif d'aide à la coupe pour la correction osseuse - Google Patents

Procédé permettant de réaliser un dispositif spécifique au patient destiné à être utilisé pour une correction osseuse, kit de traitement, procédé permettant de faire fonctionner un système de traitement de données, programme informatique, et dispositif de correction et de fixation et dispositif d'aide à la coupe pour la correction osseuse Download PDF

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Publication number
WO2013055203A1
WO2013055203A1 PCT/NL2011/050702 NL2011050702W WO2013055203A1 WO 2013055203 A1 WO2013055203 A1 WO 2013055203A1 NL 2011050702 W NL2011050702 W NL 2011050702W WO 2013055203 A1 WO2013055203 A1 WO 2013055203A1
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WO
WIPO (PCT)
Prior art keywords
bone
correction
fixation
fitting surface
bone portion
Prior art date
Application number
PCT/NL2011/050702
Other languages
English (en)
Inventor
Johannes Gijsbertus Gerardus DOBBE
Original Assignee
Academisch Medisch Centrum Bij De Universiteit Van Amsterdam
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 Academisch Medisch Centrum Bij De Universiteit Van Amsterdam filed Critical Academisch Medisch Centrum Bij De Universiteit Van Amsterdam
Priority to PCT/NL2011/050702 priority Critical patent/WO2013055203A1/fr
Priority to PCT/EP2012/069374 priority patent/WO2013053614A1/fr
Publication of WO2013055203A1 publication Critical patent/WO2013055203A1/fr

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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
    • A61B2017/00526—Methods of manufacturing
    • 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
    • A61B2034/101—Computer-aided simulation of surgical operations
    • A61B2034/102—Modelling of surgical devices, implants or prosthesis
    • 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
    • A61B2034/101—Computer-aided simulation of surgical operations
    • A61B2034/105—Modelling of the patient, e.g. for ligaments or bones

Definitions

  • Method to provide at least one patient specific device to be used for bone correction a treatment kit, a method of operating a data-processing system, a computer program, and a correction and fixation device and a cutting assisting device for bone correction.
  • the present invention relates to a method for providing at least one patient specific device to be used for bone correction, in particular osteotomy.
  • the invention further relates to a treatment kit, a method of operating a data-processing system, a computer program, and a correction and fixation device and a cutting assisting device for bone correction.
  • WO 2004/071309 discloses a method for treating malunited bones by osteotomy, the contents of which are herein incorporated by reference in its entirety.
  • the method of WO 2004/071309 comprises the steps of: (A) obtaining a bone model representing a bone which is a subject of treatment; (B) obtaining a target bone model to which treatment aims; (C) determining a treatment process which is to be performed on the bone based on the bone model and the target bone model ; and (D) performing a surgical operation using the determined treatment process.
  • the osteotomy assisting member includes a fitting surface as a positioning element for indicating a position of the osteotomy assisting member which is to be attached to the bone; a slit as a cutting section indicating element for indicating a cutting section along which the bone is to be cut and divided; and guide holes each as an attachment position indicating element for indicating an attachment position of rods.
  • the fitting surface is formed to fit on a surface portion of the bone.
  • the slit is provided so as to correspond to the cutting section of the bone.
  • the cutting section is defined so as to be such a position that a post-correction bone shape and the shape of a normal bone are closest to each other.
  • the post-correction bone shape is obtained by dividing the bone along the cutting section into a proximal portion and a distal portion and moving and/or rotating the distal portion.
  • the fitting surface of the osteotomy assisting member and the surface feature portion of the bone to be treated are made to fit each other, so as to fix the osteotomy assisting member in a closely fit manner.
  • the osteotomy assisting member is uniquely positioned and attached to the bone.
  • Rods are inserted into the guide holes, and the bone is pierced with the end of each rod so as to attach the rods to the bone.
  • the bone is cut by moving a cutting jig such as a saw or the like along the slit, and the osteotomy assisting member is removed while leaving the rods in place.
  • the distal bone portion and the accompanying tissues are moved to a position at which the other end of each rod is insertable into a respective insertion hole of a correction block, and then the rod is inserted thereinto. This step puts the bone portions into the desired positional relationship.
  • a drawback of the known method is that the final fixation of the two bone portions with a standard fixation plate may result in the introduction of stress into the assembly of the rods and the correction block and/or in the assembly of fixation plate and the bone portions. This stress may result in change of the relative position between the first bone portion and the second bone portion after the removal of the correction block and consequently in sub- optimal positioning of the bone portions with respect to each other.
  • this method requires many steps, which makes it a time consuming procedure. This is a burden on the patients as well as on the healthcare team and makes it costly.
  • the aim of the present invention is to provide a device which may improve the results of osteotomy surgery.
  • the present invention provides a method to provide at least one patient specific device to be used in a bone correction method, the method comprising the steps of:
  • step of determining a treatment process at least comprising the steps of:
  • step of designing comprising:
  • a correction and fixation device having a first positioning part having a first positioning surface tightly fitting to the first fitting surface, a second positioning part having a second positioning surface tightly fitting to the second fitting surface, and a connection part connecting the first positioning part and the second positioning part, wherein the connection part is shaped to arrange the first bone portion and the second bone portion in the relative target position when the correction and fixation device is fixed with the first positioning surface on the first fitting surface and with the second positioning surface on the second fitting surface.
  • the method of the invention provides a method to provide at least a correction and fixation device to be used in bone correction surgery, in particular in osteotomy.
  • the correction and fixation device which results of the method of the invention may be in the form of a three dimensional computer model, or in the form of a correction and fixation device manufactured on the basis of a computer model.
  • the correction and fixation device resulting from the method of the invention comprises a first positioning part having a first positioning surface tightly fitting to the first fitting surface and a second positioning part having a second positioning surface tightly fitting to the second fitting surface.
  • the first fitting surface and the second fitting surface are based on three dimensional bone models and preferably selected such that the first and second positioning surface can only be placed in one unique position on the first fitting surface and the second fitting surface, respectively.
  • first and second positioning surfaces are arranged, via the connection part, in a fixed relationship with respect to each other in six degrees of freedom, fixation of the correction and fixation device on the first and second fitting surface will result in a reliable positional relationship between the first bone portion and the second bone portion.
  • first and second positioning surface fit tightly to the first and second fitting surfaces stress free mounting of the correction and fixation device on the first and second bone portion is possible.
  • Designing the correction and fixation device comprises the following steps.
  • a three dimensional bone model of the bone to be treated and a three dimensional target bone model to which treatment aims are obtained.
  • the three-dimensional bone model of the bone to be treated and the target bone model can be obtained by any suitable method, for example by any method disclosed in WO 2004/071309, such as a model calculated on the basis of x-ray, CT or MRI images.
  • the three-dimensional model of the bone to be treated and/or the target bone model may be calculated as a step of the method of the invention on the basis of image data obtained from imaging the bone to be treated.
  • the three dimensional bone model may also directly be obtained from another system for instance a 3D scanning system capable of directly calculating a three dimensional model that can be used in the method of the invention.
  • the three dimensional model of the target bone model may be based on calculations of the bone model of the bone to be treated or another bone model, but is preferably based on the healthy contralateral limb of the patient's body.
  • corrections are included to compensate for bilateral differences, as data about contralateral differences in populations are acquired along this and other processes.
  • a treatment process can be determined.
  • the treatment process comprises cutting the bone at a cutting section into a first and a second bone portion and repositioning the first and the second bone portions to optimally resemble the target bone model.
  • the treatment process may include bone rotation, bone excision, insertion of a graft, and bone distraction or any combination thereof.
  • the determination of the relative position of the first and second bone portion after correction can be based on any suitable technique, such as a screw displacement method.
  • the correction of the relative position of the first bone portion and the second bone portion may comprise translations and/or rotations to reposition the first bone portion and second bone portion in six degrees of freedom with respect to each other.
  • a cutting section is determined for cutting the bone to be treated in a first bone portion and the second bone portion.
  • a correction and fixation device may be designed.
  • a first fitting surface and a second fitting surface are determined on the bone.
  • the first fitting surface is located on the first bone portion and the second fitting surface is located on the second bone portion.
  • This first and second fitting surface are three dimensional surfaces selected such that any surface complementary to the first or second fitting surface can only be tightly arranged in one unique position with respect to the first and second fitting surface, respectively.
  • the relative target position of the first fitting surface and the second fitting surface after bone correction are also known.
  • the selection of the locations of the first fitting surface and the second fitting surface may also be based on further criteria.
  • the relative target positions of the first bone portion and the second bone portion may be based on the target bone model or another bone model and may also be based on further criteria, such as bilateral difference compensation.
  • the locations of the first fitting surface and the second fitting surface have to be suitable for fixation of the correction and fixation device.
  • the bone material at these locations should be capable of holding fixation means such as screws or wires, and the presence of the fixation and correction device preferably has no or little negative effect on the functioning of soft tissues, such as tendons and muscles, surrounding the bone or on the kinematics of a joint.
  • the relative target position of the first and second fitting surface are used to design a correction and fixation device to be used in the actual bone correction surgery.
  • connection part is shaped to arrange the first fitting surface and the second fitting surface in the relative target position when, after cutting the bone into the first bone portion and the second bone portion, the first positioning surface is arranged on the first fitting surface and the second positioning surface is arranged on the second fitting surface.
  • the method of claim 1 may be implemented as a method of operating a data processing system.
  • the correction and fixation device is configured to be implanted into a human body
  • the correction and fixation device is preferably a plate-shaped device made of implantable material.
  • the correction and fixation device is further preferably designed to have high stiffness and low volume.
  • the correction and fixation device comprises fixation locations to fix the correction and fixation device on the first bone portion and the second bone portion.
  • fixation locations may be in the form of one or more fixation holes each configured to receive a fixation means, such as a fixation screw, fixation wire or other fixation tool suitable to fix the correction and fixation tool on the respective bone portion.
  • the fixation locations in the first positioning part are arranged in a first pattern with respect to the first fitting surface, and the fixation locations in the second positioning part are arranged in a second pattern with respect to the second fitting surface.
  • This first pattern and second pattern can be selected to properly anchor the correction and fixation device on the first and second bone portion.
  • the first and second pattern can for example be based on the locations where the bone is most suitable for anchoring the correction and fixation device.
  • fixation locations may be planned dependent on the shape and state of the specific bone to be treated.
  • the first fitting surface and the second fitting surface are adjacent to the cutting section.
  • the distance between the first and second fitting surface after bone correction can be kept relatively low.
  • less material and/or less stiff material is required to provide the correction and fixation device.
  • the method further comprises the step of designing in the data processing system a graft model to be arranged between the first and second bone portion. In osteotomy procedures often use is made of grafts that are to be placed between the first and second bone portion. The graft is used for promoting the healing of the first and second bone portions to each other, and/or to support the bone.
  • the material with which the graft is made may be bone material obtained from the patient or from a donor.
  • the graft material may also be made of other suitable biocompatible and/or biodegradable material, such as artificial bone material.
  • the shape of the graft will depend on the space between the first and second bone portion after correction, and may for instance be substantially cylindrical or substantially wedge shaped.
  • the method of the invention comprises the step of designing in the data processing system a cutting assisting device comprising a surface tightly fitting to the first fitting surface and to the second fitting surface and a cutting assisting element.
  • a cutting assisting device can be used to assist in the cutting of the bone to be treated in a first and second bone portion.
  • the cutting assisting element may be an element which assists in the cutting of the bone, such as an indicator indicating the location and/or orientation where the cut should be made.
  • the cutting assisting device comprises a slit in the cutting assisting device designed to receive a cutting device, for instance a cutting saw.
  • the slit may act as a guide for the cutting device, therewith assuring cutting at the desired cutting section.
  • the cutting assisting element of the cutting assisting member for example a cutting slit may be designed and manufactured as "the template assisting member" disclosed in
  • the cutting assisting device can only be arranged in a single position with respect to the bone, and the cutting assisting element will reliably be positioned with respect to the desired cutting location. It is remarked that the surface of the cutting assisting device tightly fitting to the first fitting surface and the second fitting may be composed of two separate surface areas with for instance a cutting slit there between.
  • the step of designing the cutting assisting device comprises the step of providing temporarily fixation locations in the cutting assisting device to temporarily fix the cutting assisting device to the bone to be treated. It is desirable to fix the cutting assisting device during cutting of the bone. Fixation locations may be provided for this reason. These fixation locations may be in the form of one or more fixation holes each configured to receive a fixation means, such as a fixation screw, fixation wire or other fixation tool suitable to fix the correction and fixation tool on the respective bone portion.
  • a fixation means such as a fixation screw, fixation wire or other fixation tool suitable to fix the correction and fixation tool on the respective bone portion.
  • the step of providing the cutting assisting device comprises the step of providing one or more holes in the cutting assisting device configured to assist in preparing the first bone portion and/or the second bone portion for fixation of the correction and fixation device on the first bone portion and/or the second bone portion. Since both the correction and fixation device and the cutting assisting device comprise surfaces tightly fitting to the first and second fitting surface, the correction and fixation device and the cutting assisting device can each only be placed in one unique fitting position on the first and/or second fitting surfaces.
  • the cutting assisting device may be used to prepare the first bone portion and the second bone portion for the fixation of the correction and fixation device.
  • holes may be provided in the cutting assisting device to prepare the first and second bone portion.
  • the holes may be holes configured to receive a drilling or tapping element to drill and/or tap a hole in the first bone portion and/or second bone portion.
  • the resulting pre-drilled and/or tapped holes in the first and/or second bone portion can be used to receive fixation means to fix the correction and fixation device on the first and/or second bone portion, respectively.
  • holes also other means to assist in the preparation of the bone for fixation of the correction and fixation device may be provided.
  • the holes may be configured to also receive a fixation means to temporarily fix the cutting assisting device to the bone to be treated.
  • the holes are also fixation locations for the cutting assisting device, and the holes may be used both for temporarily fixing the cutting assisting element and for preparing the fixation of the correction and fixation device to the first and/or second bone portion.
  • the locations of fixation in the bone portions resulting from the fixation locations of the cutting assisting device are also used as the locations for fixation of the correction and fixation device, as such bypassing the need of creating new, extra locations for fixation in the first and second bone portions.
  • fixation locations for example fixation holes
  • the cutting assisting device can first be fixed to the bone using the fixation holes.
  • the holes configured to assist in preparing the bone for fixation of the correction and fixation device can be used to preparing the bone, for example for pre-d rilling and/or tapping.
  • the holes in the cutting assisting device configured to assist in preparing the first bone portion and/or the second bone portion for fixation of the correction and fixation are provided in a pattern corresponding with the first pattern with respect to the first fitting surface and with the second pattern with respect to the second fitting surface.
  • the cutting assisting device can be used as a template for creating fixation locations in the first and second bone portions for fixing the correction and fixation device to the first and second bone portion. It is remarked that the pattern and the first and second pattern of fixation locations should be determined on the surface of the cutting assisting device and the first and second positioning surface, respectively.
  • the thickness of the cutting assisting device can be relatively large so that the fixation locations in the cutting assisting device provide a proper guidance of surgical saw and/or surgical drill or any other device to be used together with the cutting assisting device.
  • this guidance is less important when the correction and fixation device is fixed on the bone after removal of the cutting assisting device, since the locations for fixation in the bone are already prepared.
  • the method further comprises the step of manufacturing the correction and fixation device and/or the step of manufacturing the cutting assisting device.
  • Manufacturing of the patient specific correction and fixation device and/or the cutting assisting device may be performed by any suitable method, but is preferably carried out by a computer aided 3D manufacturing method such as 3D CAD/CAM or 3D printing.
  • the correction and fixation device and the cutting assisting device can be made out of any suitable material.
  • the material of the correction and fixation device is made of implantable material which is preferably stiff, and may be biodegradable.
  • the correction and fixation device may for example be made of Titanium or Stainless Steel.
  • the cutting assisting device can be made of biocompatible material.
  • the invention further provides a patient specific correction and fixation device to be used in a bone correction method, wherein the correction and fixation device comprises a first positioning part having a first positioning surface, a second positioning part having a second positioning surface, and a connection part connecting the first and the second positioning part, wherein the first positioning surface is configured to tightly fit on a first fitting surface defined on the bone to be treated and the second positioning surface is configured to tightly fit on a second fitting surface defined on the bone to be treated, and wherein the connection part is shaped to arrange the first fitting surface and the second fitting surface in a relative target position when the correction and fixation device is fixed on the first fitting surface and the second fitting surface.
  • the correction and fixation device may be part of a bone treatment kit.
  • the bone treatment kit may further include a cutting assisting device and/or a graft.
  • the bone treatment kit may also comprise fixation tools to fix the correction and fixation device and/or the cutting assisting device to the bone. Any other device or tool may also be part of the treatment kit.
  • the invention may also be applied as a method of operating a data-processing system comprising the steps of:
  • step of determining a treatment process at least comprising the steps of:
  • step of designing comprising:
  • a correction and fixation device model having a first positioning part having a first positioning surface tightly fitting to the first fitting surface, a second positioning part having a second positioning surface tightly fitting to the second fitting surface, and a connection part connecting the first positioning part and the second positioning part, wherein the connection part is shaped to arrange the first bone portion and the second bone portion in the relative target position when the correction and fixation device is fixed with the first positioning surface on the first fitting surface and with the second positioning surface on the second fitting surface.
  • the method is further adapted to perform the step of controlling a 3D manufacturing device, for example a 3D printer to form a correction and fixation device on the basis of the correction and fixation device model.
  • a 3D manufacturing device for example a 3D printer to form a correction and fixation device on the basis of the correction and fixation device model.
  • the method comprises the step of designing a cutting assisting device comprising a surface tightly fitting to the first fitting surface and to the second fitting surface and a cutting assisting element.
  • the method of operating a data-processing system may further comprise any of the method steps of claims 2-14.
  • the invention may provide a computer program comprising software code adapted to perform the steps of the method of any of the claims 16-18.
  • the invention may also provide a correction and fixation device obtained by the method of any of the claims 1 -14 and a cutting assisting device obtained by the method of any of the claims 7-14. Further, the invention may provide a bone correction method, comprising the steps of:
  • step of determining a treatment process at least comprising the steps of:
  • step of designing comprising:
  • a correction and fixation device having a first positioning part having a first positioning surface tightly fitting to the first fitting surface, a second positioning part having a second positioning surface tightly fitting to the second fitting surface, and a connection part connecting the first positioning part and the second positioning part, wherein the connection part is shaped to arrange the first bone portion and the second bone portion in the relative target position when the correction and fixation device is fixed with the first positioning surface on the first fitting surface and with the second positioning surface on the second fitting surface,
  • the bone correction method may comprise the step of designing a cutting assisting device comprising a surface tightly fitting to the first fitting surface and to the second fitting surface and a cutting assisting element, and, during the treatment process, the step of temporarily fixing the cutting assisting device on the bone to be treated and using the cutting assisting element to cut the bone to be treated at the cutting location.
  • the bone correction method may further comprise the step of using locations of fixation in the bone portions resulting from fixation locations of the cutting assisting device, e.g. holes drilled through the cutting assisting device into the bone portions, as locations for fixation of the correction and fixation device on the bone portions.
  • Figure 1 shows a bone model of a bone to be treated
  • Figure 2 shows a target bone model to which treatment aims
  • Figure 3 shows a relative target position of the first bone portion and the second bone portion of the bone model of Figure 1 after dividing the bone in a first and second bone portion;
  • Figure 4 shows a cutting assisting device arranged on the bone to be treated
  • Figure 5 shows the cutting assisting device in perspective view
  • Figure 6 shows the correction and fixation device arranged on the first and the second bone portion
  • Figure 7 shows the correction and fixation device in perspective view.
  • Osteotomy is a surgical operation whereby a bone is cut to shorten, lengthen, and/or change its alignment.
  • the method of the invention proposes pre-operative planning of the treatment process for bone correction and design of a patient specific cutting assisting device and a preferably patient-specific correction and fixation device.
  • the correction and fixation device is designed to be implanted into the patient temporarily or permanently. By fixating the correction and fixation device in the planned position on both the first bone portion and the second bone portion, the correction and fixation device automatically arranges the first and second bone portions in the desired target position.
  • Figure 1 shows a three-dimensional bone model of a deformed bone.
  • the bone model is indicated by reference sign 1 . It is desirable to correct the bone to position the ends of the bones in a normal position with respect to each other.
  • a target bone model is configured to define the desired positions of the ends of the bone after bone correction.
  • Figure 2 shows such three-dimensional target bone model 2.
  • the target bone model shows the model to which treatment aims.
  • the target bone model may be calculated on the basis of patient specific data, and for example be based on the corresponding bone of the contra lateral limb of the patient.
  • the target bone model may also be based on any other suitable data, for example data obtained from a group of persons having similar build. It is also possible that the target bone model is completely calculated on the basis of the bone to be treated and physical structure of the patient.
  • the bone model and target bone model are provided as three dimensional computer models. These computer models are for example obtained by obtaining images on the basis of imaging techniques, such as x-ray, CT or MRI, and calculating a three-dimensional computer model on the basis of these images and possibly other data.
  • imaging techniques such as x-ray, CT or MRI
  • the computer models are preferably 3D CAD compatible models that can be used in 3D CAD software, such as "Solid works” or “Surgicase Connect", available from Materialise N.V., Leuven, Belgium.
  • the computer models are preferably high resolution computer models that provide detailed information on the surfaces of the bone structure, at least at the relevant location, such as the first and second fitting surface to be discussed hereinafter.
  • the treatment involves cutting the bone in a first bone portion and a second bone portion and repositioning the first and second bone portion to arrange the bone ends in a relative position optimally resembling the target bone model. It is remarked that in some treatments the bone may also be cut in more than two bone portions. For example, when the osteotomy involves shortening of the bone, the bone may be cut in three bone portions, whereby the central bone portion is taken out of the bone, and the two outer bone portions are fixed to each other to form a new bone structure.
  • Determining a treatment process comprises determining a cutting section where the bone is to be cut in a first bone portion and a second bone portion. After cutting the bone into a first and second bone portion, the first bone portion and the second bone portion can be positioned in the desired relative position by translation and/or rotation of the first bone portion and the second bone portion with respect to each other.
  • Figure 3 shows a three dimensional computer model of the deformed bone 1 of Figure 1 divided in a first bone portion 3 and a second bone portion 4, whereby the first bone portion 3 and the second bone portion 4 are arranged in their relative target position to resemble the target bone model of Figure 2.
  • Any suitable method may be used to determine the translation and/or rotation of the first and second bone portion required to position the first and second bone portion in the relative target position.
  • the relative position may be determined in six degrees of freedom.
  • the step of selecting a cutting section may be a start point to subsequently determine how the first and second bone portion should be positioned with respect to each other.
  • the cutting section may be a result of the determination of the desired movement.
  • the cutting selection may be selected such that only rotation and/or translation in one or two directions is required to relocate the respective bone portion to the desired position. It is also possible that the determination of the cutting section comprises a number of iterative steps.
  • a cutting assisting device 10 and a correction and fixation device 20 are designed
  • the cutting assisting device 10 is shown in Figure 4 arranged on the bone 1 to be treated.
  • Figure 5 shows a perspective view of the cutting assisting device 10.
  • the correction and fixation device 20 is shown in Figure 6 arranged on the first bone portion 3 and the second bone portion 4.
  • Figure 7 shows a perspective view of the correction and fixation device.
  • the cutting assisting device 10 is designed to assist the surgeon in cutting the bone 1 to be treated at the cutting section 7 to obtain the first bone portion 3 and the second bone portion 4.
  • a first fitting surface 5 and a second fitting surface 6 are selected on the bone 1 .
  • the first fitting surface 5 is located on the first bone portion 3 and the second fitting surface 6 is located on the second bone portion 4, as shown in Figure 3.
  • the cutting assisting device 10 comprises a surface 1 1 which tightly fits to the first fitting surface 5 and the second fitting surface 6 before the bone is cut into the first bone portion 3 and the second bone portion 4.
  • the cutting assisting device 10 further comprises a slit 12 which is configured as a cutting assisting element.
  • the first fitting surface 5 and the second fitting surface 6 are selected such that the surface 1 1 can only be arranged in one fitting position with respect to the bone 1 , in which fitting position the surface 1 1 is in close contact with the first fitting surface 5 and the second fitting surface 6.
  • the cutting assisting element 10 can only be arranged in one unique position on the bone 1 to be cut.
  • the slit 12 is configured to guide a cutting saw or such during cutting of the bone such that the bone will be cut at the cutting section 7.
  • the cutting assisting device 10 comprises a number of fixation holes 13a, 13b for receiving fixation means such as fixation screws or fixation wires with which the cutting assisting device 10 can be fixed on the bone.
  • the fixation holes 13a are arranged in a first pattern with respect to a first part of the surface 1 1 to be placed on the first fitting surface 5.
  • fixation holes 13b are arranged in a second pattern with respect to a second part of the surface 1 1 to be placed on the second fitting surface 6.
  • the fixation holes 13a, 13b may be designed to receive any fixation means, such as fixation screws or wires to fix the cutting assisting device to the bone to facilitate cutting of the bone at the desired location.
  • the cutting assisting device has a relative large thickness so that, during the operation, the resulting relative long fixation holes 13a, 13b provide a good guidance during cutting or drilling or such into the bone.
  • the correction and fixation device 20 is designed to assist the surgeon in
  • first bone portion 3 and the second bone portion 4 repositioning the first bone portion 3 and the second bone portion 4 with respect to each other, and to fix the first bone portion 3 and the second bone portion 4 to each other in this relative position so that the bone may heal with the first bone portion 3 and the second bone portion 4 in the desired relative position.
  • the correction and fixation device 20 comprises a first positioning part 21 having a first positioning surface 22 tightly fitting to the first fitting surface 5 and a second positioning part 23 having a second positioning surface 24 tightly fitting to the second fitting surface 6.
  • the first positioning part 21 and the second positioning part 23 are connected to each other with a connection part 25.
  • the connection part 25 is shaped to position the first bone portion 3 and the second bone portion 4 in the desired relative position, when the first positioning surface 21 is arranged on the first fitting surface 5 and the second positioning surface 23 is positioned on the second fitting surface 6.
  • the patient specific correction and fixation device 20 has the advantage that no complex positioning system has to be provided to arrange the first bone portion 3 and the second bone portion 4 in their relative target location after cutting the bone. Also, since the correction and fixation device is used to fix the first and second bone portions 3, 4 to each other, there is no stress introduced by the correction and fixation device itself during the fixation of the first bone portion 3 and the second bone portion 4, and the bone portions will remain in the desired relative target position.
  • a number of fixation holes 26 are provided to fix the correction and fixation device 20 on the first bone portion 3
  • a number of fixation holes 27 are provided to fix the correction and fixation device 20 on the second bone portion 4.
  • the fixation holes 26 are provided in the same first pattern as the fixation holes 13a on the cutting assisting device 10.
  • the fixation holes 27 are provided in the same second pattern as the fixation holes 13b of the cutting assisting device 10.
  • the cutting assisting device may comprise further fixation locations, for example fixation holes, to temporarily fix the cutting assisting device on the bone to be treated, and the holes in a pattern corresponding to the patterns of the fixation holes of the correction and fixation device are used for assistance in preparing the bone for fixation of the correction and fixation device.
  • fixation locations for example fixation holes
  • different hole diameters can be used for either fixation of the cutting assisting device and/or for creating predrill holes for fixation of bone portions using the correction and fixation device model using fixation means, for example (bicortical) screws.
  • the design of the cutting assisting device 10 and the correction and fixation device 20 can be used to create a cutting assisting device and a correction and fixation device in accordance with these models.
  • the cutting assisting device and the correction and fixation device can be created by any suitable method, for example a 3D printing method or 3D CAD/CAM and with any suitable material.
  • the cutting assisting device and the correction and fixation device may be part of a patient specific treatment kit for bone correction.
  • the treatment kit may further comprise a graft computer model or a graft, which graft is to be arranged between the first bone portion 3 and the second bone portion 4, to fill the space between the first bone portion 3 and the second bone portion 4.
  • the graft model can be used to directly manufacture a graft, for example by a 3D manufacturing method such as 3D printing or 3D CAD/CAM.
  • the graft may be manufactured from any implantable material, such as artificial bone material.
  • the graft model may also be used as a guidance in adapting the shape of a bone part, for instance a bone part taken from the iliac crest of the patient to the desired shape for implantation.
  • the graft may have any suitable shape such as a cylindrical or a wedge shape.
  • Figure 6 shows a graft model 30 which is designed to be arranged between the first bone portion 3 and the second bone portion 4.
  • Preoperative planning for a radius osteotomy is based on a CT scan of the affected bone and the healthy contralateral bone.
  • the contralateral bone is used as reference for restoring the affected bone.
  • the affected bone is first segmented to create a 3-D polygon using "Surgicase Connect", available from Materialise N.V., Leuven, Belgium.
  • a distal and a proximal segment are subsequently clipped, hereby excluding the fracture site.
  • the clipped segments are aligned with the mirrored image of the healthy contralateral bone. This yields two matrices: Md, which aligns the distal segment with the reference bone, and Mp which aligns the proximal segment with the reference bone.
  • intensity-based point-to-image registration may be used.
  • the affected bone is first segmented to find the polygon vertices describing the bone surface. These are used to resample the gray-level image 1 -mm towards the inside (bright voxels) and outside (dark voxels) of the bone. Using this double-contour polygon renders gray-level registration of the affected bone with the reference image very discriminative and accurate.
  • the affected bone is segmented using threshold-connected region growing followed by a binary closing algorithm to fill residual holes inside the object and at its surface.
  • This intermediate segmentation result is used to initialize a Laplacian level-set segmentation growth algorithm which slightly adjusts the edges towards the highest intensity gradient of the bone image.
  • a polygon is finally extracted from the segmented image, which is used to visualize the bone in 3-D. The vertices of this polygon are also used to determine the double- contour polygon for image registration, as described above.
  • This cutting section is defined by the vector normal to the cutting section ( n ° ) and the distance (dc) of the plane to the origin of the coordinate system.
  • a piece of the affected bone polygon is clipped by interactively positioning a box and extracting the fitting surface inside that box.
  • This fitting surface which is patient specific and especially marked by the fracture, is used to create 1 ) a patient specific cutting assisting device for setting the actual osteotomy and for predrilling holes, and 2) a patient-specific correction and fixation plate for bone positioning and fixation.
  • the patient-specific cutting assisting device is created by extruding the clipped bone fitting surface towards the average surface normal vector, to create a 3-D mold that snugly fits to the bone surface.
  • the extrusion length is set by the user, e.g. 30 mm.
  • a slit with a user-defined width, e.g. a cutting blade thickness, is added at the position and orientation of the cutting section defined above.
  • the surgeon is enabled to add holes to the guide for fixation of the cutting assisting device itself using, e.g., Kirschner wires, and for predrilling the bone for subsequent fixation using the patient-specific correction and fixation plate with bicortical screws. Different hole positions, orientations and diameters can be chosen during this virtual planning step.
  • the cutting assisting device may be shaped by virtually cutting undesired pieces from the mold until it is conveniently shaped for surgical utilization.
  • the actual cutting assisting device is created from a medical grade polyamide powder by stereolithography printing Materialise, Leuven, Belgium.
  • the patient-specific correction and fixation plate is created in a similar way as for the cutting assisting device although less user interaction is required.
  • First the clipped bone fitting surface obtained above is again extruded towards the average surface normal vector, to create a template that snugly fits to the bone surface.
  • the extrusion length is set by the user and corresponds to the desired plate thickness, e.g. 2 mm.
  • Screw holes are added at the same predrill positions and orientations as defined for the cutting and drilling guide, although the hole diameters are adjusted to be in agreement with the required screw diameters.
  • the affected bone polygon and the template polygon are cut using the defined cutting section and the distal bone and template segments are repositioned in 3-D space as planned using the correction matrix Mc.
  • the missing piece between the two template segments, i.e. positioning parts is created by linear or Bezier interpolation between corresponding points. Bezier interpolation results in a smooth connection part between the two positioning parts, altogether comprising the patient-specific correction and fixation plate.
  • the actual patient-specific correction and fixation plate is created from e.g. a medical grade titanium powder by stereolithography printing (Materialise, Leuven, Belgium).
  • the cutting assisting device is positioned at the first and second fitting surface and is fixated with Kirschner wires using the predefined holes.
  • the cutting assisting device is subsequently used to insert predrill holes which are used for plate fixation using bicortical screws after osteotomy.
  • the same cutting assisting device is subsequently used to position and orient the oscillating surgical saw for osteotomy through the slit.
  • the cutting assisting device is removed and the patient-specific correction and fixation plate is first connected to the distal bone portion. It tightly fits to the fitting surface on the distal bone portion while the predrilled holes serve to further guide fixation of the plate to the distal bone portion using screws.
  • the bone portions are distracted in order to align the proximal holes of the plate with the predrilled holes in the proximal bone portion. Fixation is then achieved by mounting the plate to the fitting surface of the proximal bone using bicortical screws.

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

Abstract

L'invention concerne un procédé permettant de réaliser un dispositif spécifique à au moins un patient, destiné à être utilisé dans un procédé de correction osseuse, le procédé selon l'invention comprenant les étapes suivantes : acquisition d'un modèle osseux et d'un modèle osseux théorique ; détermination d'un processus de traitement comprenant une partie coupe consistant à couper l'os en une première partie d'os et une seconde partie d'os, et d'une position relative cible de la première et de la seconde partie d'os ; et conception dans le système de traitement de données d'un dispositif de correction et de fixation présentant un premier élément de positionnement comportant une première surface de positionnement étroitement ajustée à la première partie d'os, un second élément de positionnement comportant une seconde surface de positionnement étroitement ajustée à la seconde surface d'ajustement, et un élément de liaison reliant le premier élément de positionnement et le second élément de positionnement, l'élément de liaison présentant une forme permettant de disposer la première partie d'os et la seconde partie d'os dans la position relative théorique.
PCT/NL2011/050702 2011-10-14 2011-10-14 Procédé permettant de réaliser un dispositif spécifique au patient destiné à être utilisé pour une correction osseuse, kit de traitement, procédé permettant de faire fonctionner un système de traitement de données, programme informatique, et dispositif de correction et de fixation et dispositif d'aide à la coupe pour la correction osseuse WO2013055203A1 (fr)

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Application Number Priority Date Filing Date Title
PCT/NL2011/050702 WO2013055203A1 (fr) 2011-10-14 2011-10-14 Procédé permettant de réaliser un dispositif spécifique au patient destiné à être utilisé pour une correction osseuse, kit de traitement, procédé permettant de faire fonctionner un système de traitement de données, programme informatique, et dispositif de correction et de fixation et dispositif d'aide à la coupe pour la correction osseuse
PCT/EP2012/069374 WO2013053614A1 (fr) 2011-10-14 2012-10-01 Procédé pour obtenir au moins un dispositif spécifique d'un patient à utiliser pour la correction osseuse, trousse de traitement, procédé pour la mise en œuvre d'un système de traitement de données, programme informatique, ainsi que dispositif de correction et de fixation et dispositif d'aide à la découpe pour correction osseuse

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PCT/NL2011/050702 WO2013055203A1 (fr) 2011-10-14 2011-10-14 Procédé permettant de réaliser un dispositif spécifique au patient destiné à être utilisé pour une correction osseuse, kit de traitement, procédé permettant de faire fonctionner un système de traitement de données, programme informatique, et dispositif de correction et de fixation et dispositif d'aide à la coupe pour la correction osseuse

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PCT/EP2012/069374 WO2013053614A1 (fr) 2011-10-14 2012-10-01 Procédé pour obtenir au moins un dispositif spécifique d'un patient à utiliser pour la correction osseuse, trousse de traitement, procédé pour la mise en œuvre d'un système de traitement de données, programme informatique, ainsi que dispositif de correction et de fixation et dispositif d'aide à la découpe pour correction osseuse

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WO2013156545A1 (fr) * 2012-04-18 2013-10-24 Materialise N.V. Systèmes et procédés de fixation d'os orthopédiques
EP3069671B1 (fr) * 2013-11-12 2020-02-26 Makoto Goto Procédé de fabrication d'un élément d'aide à la découpe d'os, programme de fabrication d'un élément d'aide à la découpe d'os, et élément d'aide à la découpe d'os
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US11096753B1 (en) 2020-06-26 2021-08-24 Procept Biorobotics Corporation Systems and methods for defining and modifying range of motion of probe used in patient treatment
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JP2020115976A (ja) * 2019-01-21 2020-08-06 国立大学法人京都大学 矯正骨切り術用ガイド
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CN112862975A (zh) * 2021-03-17 2021-05-28 武汉联影智融医疗科技有限公司 骨骼数据处理方法、系统、可读存储介质和设备
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