EP3758630A1 - Method for manufacturing a complex substitute object from a real object - Google Patents

Method for manufacturing a complex substitute object from a real object

Info

Publication number
EP3758630A1
EP3758630A1 EP19711993.6A EP19711993A EP3758630A1 EP 3758630 A1 EP3758630 A1 EP 3758630A1 EP 19711993 A EP19711993 A EP 19711993A EP 3758630 A1 EP3758630 A1 EP 3758630A1
Authority
EP
European Patent Office
Prior art keywords
real object
dimensional image
damaged
functional
reconstructed
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP19711993.6A
Other languages
German (de)
French (fr)
Inventor
Salima BOUVIER
Augustin LEREBOURS
Alain RASSINEUX
Frédéric MARIN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Centre National de la Recherche Scientifique CNRS
Universite de Technologie de Compiegne UTC
Original Assignee
Centre National de la Recherche Scientifique CNRS
Universite de Technologie de Compiegne UTC
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 Centre National de la Recherche Scientifique CNRS, Universite de Technologie de Compiegne UTC filed Critical Centre National de la Recherche Scientifique CNRS
Publication of EP3758630A1 publication Critical patent/EP3758630A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
    • B29C64/30—Auxiliary operations or equipment
    • B29C64/386—Data acquisition or data processing for additive manufacturing
    • 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
    • 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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • A61F2/4241—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for hands, e.g. fingers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • A61F2/4261—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for wrists
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y10/00—Processes of additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y50/00—Data acquisition or data processing for additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B19/00—Programme-control systems
    • G05B19/02—Programme-control systems electric
    • G05B19/18—Numerical control [NC], i.e. automatically operating machines, in particular machine tools, e.g. in a manufacturing environment, so as to execute positioning, movement or co-ordinated operations by means of programme data in numerical form
    • G05B19/4097—Numerical control [NC], i.e. automatically operating machines, in particular machine tools, e.g. in a manufacturing environment, so as to execute positioning, movement or co-ordinated operations by means of programme data in numerical form characterised by using design data to control NC machines, e.g. CAD/CAM
    • G05B19/4099—Surface or curve machining, making 3D objects, e.g. desktop manufacturing
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30688—Means for allowing passage or sliding of tendons or ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30948—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30952—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using CAD-CAM techniques or NC-techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30962—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using stereolithography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • A61F2/4241—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for hands, e.g. fingers
    • A61F2002/4256—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for hands, e.g. fingers for carpo-metacarpal joints, i.e. CMC joints
    • A61F2002/4258—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for hands, e.g. fingers for carpo-metacarpal joints, i.e. CMC joints for trapezo-metacarpal joints of thumbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • A61F2/4261—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for wrists
    • A61F2002/4271—Carpal bones
    • A61F2002/4274—Distal carpal row, i.e. bones adjacent the metacarpal bones
    • A61F2002/4276—Trapezium
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7532—Artificial members, protheses
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B2219/00—Program-control systems
    • G05B2219/30—Nc systems
    • G05B2219/49—Nc machine tool, till multiple
    • G05B2219/49007—Making, forming 3-D object, model, surface

Definitions

  • the present invention generally relates to the manufacture of a complex substitute object for replacing or replacing a real object in a given state, potentially damaged, in particular the manufacture of a trapezio-metacarpal prosthesis to replace the trapezoid bone of a human being subject to rhizarthrosis.
  • the applicant has developed a method of manufacturing a complex substitution object having at least one functional zone and intended to replace or replace a real object, said method comprising the following steps:
  • step A is performed on said real object being in a damaged state specific to a given deformation
  • said method comprises between steps A and B, the following substeps:
  • step B further comprises the following substeps:
  • step A adaptation of the template on said three-dimensional image defined in step A, to using a drawing or CAD software, to obtain a specific model (that is, a template adapted to the damaged state);
  • step b2) on the specific model, precise reconstruction of the damaged functional surfaces from the functional surfaces defined in step a'2), and approximate reconstruction, of the damaged filling surfaces from the functional surfaces defined in step a'2), to obtain a three-dimensional image reconstructed in the damaged state;
  • step b3) accurately reconstructing, on the three-dimensional image reconstructed in the damaged state, functional surfaces in the undamaged state, by modifying the values of the topological and morphological parameters sensitive to the deformation defined in step a '3) of so that they correspond to an absence of deformation, to obtain a three-dimensional image reconstructed in the undamaged state;
  • the first step of the method according to the invention is step A of acquiring a three-dimensional image of said real object which is digitized.
  • This step can be carried out in various ways, and in particular by three-dimensional scanning (or "3D scanning") using a 3D scanner. By this technique, three-dimensional synthetic images are obtained which do not need to be segmented later.
  • step A will be done in two steps, including the acquisition of three-dimensional images by techniques.
  • medical imaging systems such as Magnetic Resonance Imaging (generally known by the acronym "MRI"), which are then subjected to further segmentation processing.
  • MRI Magnetic Resonance Imaging
  • the images are obtained by 3D scan, they are directly in the form of a scatter plot (segmentation is not necessary)
  • step A of acquisition of the three-dimensional image of the object is carried out real, formatting the image into a neutral format (eg an STL file) compatible with a computer-aided drawing or design software.
  • a neutral format eg an STL file
  • the method according to the invention further comprises a substep a'1) of definition of invariant topological and morphological parameters of the real object, from which a template is defined.
  • invariant topological and morphological parameters of the real object is meant, in the sense of the present invention, parameters which are constantly present from one real object to another, whether or not it is damaged or not and belonging to to the same category or type of object, for example from one trapezoid oz to another.
  • template is understood to mean a generic model of an undamaged object (in the sense of being undeformed and undamaged by any use), which is defined by its invariant topological and morphological parameters.
  • Topological and morphological invariant parameters are preferably placed on functional areas.
  • Functional zones or surfaces of a given object within the meaning of the present invention, of the surfaces of the object having a given function, whether kinematic or otherwise.
  • the template can be defined with joined or non-joined surfaces.
  • adjoining surfaces is meant in the sense of the present invention, surfaces located side by side and defined by the same common curve. This implies that the two adjoining surfaces are dependent on each other.
  • the definition of the common side is similar to both surfaces, even if they have different functions. In addition, there is no free space between the two surfaces.
  • adjoining surfaces is meant, in the sense of the present invention, surfaces located side by side but which do not rest on the same curve. This implies that the two surfaces are independent of each other and there is a free space between the two surfaces. It is possible to put several surfaces facing one and the same surface.
  • the method according to the invention further comprises, after sub-step a '1), a sub-step a' 2) of determining the functional (or interest) surfaces and the surfaces filling (of minor importance, including areas other than areas of interest) from the actual object to the undamaged stage.
  • the method according to the invention comprises a sub-step a '3) of determining the topological and morphological parameters sensitive to the deformation of the real object (in the state damaged and identification of their variations, at the so-called functional surfaces.
  • This step can be performed from a statistical database of the actual geometry of known objects similar to said real object, in order to find an object at the same time. undamaged condition, especially at so-called functional surfaces.
  • Step B of the method according to the invention consists in reconstructing from the possibly segmented three-dimensional image, a three-dimensional model of the real object using a drawing software or computer-aided design.
  • Step B of the method according to the invention comprises in particular a first substep bl) of adapting the template on the digitized three-dimensional image obtained in step A, using a drawing or CAD software , to obtain a specific model, that is to say a template adapted to the damaged object.
  • the sub-step b4) of reconstructing the functional surfaces in the damaged state consists in modifying, on a three-dimensional image reconstructed in the undamaged state (obtained in the sub-step b3), the Morphological parameters sensitive to deformation, so that they correspond to an absence of deformation on the basis of the information obtained during the sub-step a '3).
  • step B may advantageously comprise, at the end of step b5), a step b6) of overall or localized smoothing of said closed volume model, which can be performed by a surface or volume method.
  • This step is optional but strongly recommended because of the few number of points defining the template (the possibility of having sharp edges that can be harmful for the patient in fine).
  • this step is strongly recommended if the creation of the closed volume model is done by voxels.
  • the method according to the invention is particularly suitable for producing complex objects salts of orthopedic insoles or dental prostheses, auditory, or bone for a human or animal body.
  • template in the sense of the present invention, is understood to mean the adimensional generic model of a part of a human body that one seeks to replace or supplement (by a prosthesis or a sole), which is the one a healthy subject (non-sick person) who has not been deformed or has suffered from degeneration or deformity.
  • the method according to the invention is particularly suitable for manufacturing a trapezometacarpal prosthesis as a complex object of substitution of a trapezoidal bone of a human being (real object).
  • a prosthesis is intended to be implanted in the hand of a patient at level of the trapeziometacarpal joint. This implantation is performed during a surgical procedure called prosthetic arthroplasty consisting in replacing, partially or totally, the diseased joint by a prosthesis. It is a therapeutic solution commonly used in the case of osteoarthritis which is a destruction or degeneration of the articular surfaces.
  • the areas of interest of the trapezoid bone will be the articular surfaces, that is to say the articulation surface with the second metacarpal, the articulating surface with the scaphoid, the articulation surface with the trapezoid, and optionally the surface defining a groove for the passage of flexor carpi radialis tendon.
  • the present invention also relates to a trapezio-metacarpal prosthesis obtained by the manufacturing method according to the invention as specifically defined for the manufacture of a trapezio-metacarpal prosthesis.
  • Figure 1 is a top view of a skeleton of a hand with a trapezio-metacarpal prosthesis according to the invention
  • Figure 2 is a detail and side view of the prosthesis of Figure 1;
  • Fig. 3 is a three-dimensional view of the implantation of the prosthesis of Fig. 1, in which only the first metacarpal and trapezoid of the skeleton of the hand are shown;
  • FIG. 4 shows where the trapezometacarpal joint is located in a patient's hand
  • Figure 5 includes two sets of 3D images obtained by MRI and segmentation of the trapezometacarpal joint in the hands of two patients with rhizarthrosis, one for the left hand of both patients ( Figure 5a) and the other for the right hand of these two patients ( Figure 5b);
  • Figure 6 shows the topological and morphological parameters constantly present from one trapezoid bone to another
  • Figures 7a to 7p show the variations of these topological and morphological parameters of a trapezoidal bone
  • Figures 8a to 8c show the evolution of the convex and concave curvatures of the contact surface with the 1st metacarpus according to the osteoarthritic state of the joint;
  • FIGS. 9a to 9g show steps A to B6 of digital reconstruction of a trapezoid bone that has not undergone rhizarthrosis-related deformation, according to the method according to the invention, in which step b5) of reconstruction of a closed volume model of the substitution object to be manufactured is produced by a surface method (called Poisson reconstruction: see FIG. 9f) or by a voluminal method, called a voxel filling method (that is to say cubes). digital: see Figure 9g);
  • FIG. 10 shows the template of a trapezoid bone and the set of points and curves defining it;
  • FIG. 11 shows the evolution of a smoothing of the closed volume model until the disappearance of the sharp angles while preserving the integrity of the parameters of a previously defined healthy trapezoidal bone;
  • FIG. 12 shows the various elements of the trapezio-metacarpal prosthesis to be added (1111) or extracted (1111);
  • FIG. 13 shows steps C and D of the process according to the invention in the context of the manufacture of a trapezio-metacarpal prosthesis, since obtaining the closed volumic model of the trapezoid bone to be reconstructed to additive manufacturing. and the final smoothing (respectively steps 13d and 13e) leading to the prosthesis of the trapezoid bone, which is finally implanted in the hand of a patient at the trapezio-metacarpal joint (13f);
  • FIG. 14 shows that the mobility properties of the hand are preserved after a prosthetic arthroplasty operation with the prosthesis of the trapezoid bone according to the invention.
  • Figure 15 shows the different steps A and B of rebuilding a cup from a deformed cup.
  • Image Segmentation Software OSIRIX, MATERIALIZE Segmented Image Segmentation Software: OSIRIX MATERIALIZE
  • trapezium-metacarpal prosthesis trapezium schematically shown in Figures 1 to 3 and shown in the photographs of Figures 13d and 13e (Example 1),
  • Trapezoid-metacarpal prosthesis trapezium bone schematically shown in Figures 1 to 3 and shown in the photographs of Figures 13d and 13e. material used for the additive manufacturing of the prosthesis: CrCoMo, TA6V.
  • FIGS. 1 to 3 relating to example 1
  • This trapezio-metacarpal prosthesis here comprises a prosthetic trapezium 111, a metacarpal pin 117 and an anchoring screw 113. It is intended to be placed between the first metacarpal 214 and the trapezoid 212 of a patient.
  • the prosthetic trapezium 111 is anchored to the trapezoid 212 with the anchoring screw 113.
  • the metacarpal peg 117 comprises two parts, here referred to one another: a base 115 and a head 116.
  • the patient's hand is scanned by MRI or tomography and then transformed into point clouds (STL format).
  • the technical characteristics of medical imaging and point cloud extraction are chosen so as to discretize the cortical part of the bones ( Figures 5a and 5b).
  • An STL digital file is extracted and the reference points defining the template are adapted to the patient model using a CAD software or mesh editing software.
  • MESHLAB software an open source software 3D mesh editing allows you to view STL files.
  • the template makes it possible to eliminate the protuberances and non-anatomical roughness very present in a bone with an advanced osteoarthritis state.
  • Figure 6 shows the topological and morphological parameters constantly present from one trapezoid bone to another.
  • SCP o Scaphoid
  • Figures 7a to 7p show all the measurements made on these landmarks in order to know their variability as a function of the osteoarthritis state.
  • the parameters relating to the area of contact with the first metacarpal are very sensitive to the osteoarthritis state (431).
  • FIGS. 8a to 8c show more specifically that the concave (441) and convex (442) curvatures of the surface of contact with the first metacarpal vary according to the osteoarthritis state of the joint.
  • the curvatures are concave and are very pronounced for a healthy subject (4411) and weakly pronounced in the osteoarthritic state (4412).
  • the convex curvatures are very pronounced in the osteoarthritic state (4422) and weakly pronounced for a healthy subject.
  • Healthy concave curvatures (4411) decrease along the radioulnar line but are stable for osteoarthritis (4412).
  • Healthy convex curvatures (4421) grow along the radioulnar line but decrease slightly for osteoarthritis (4412).
  • Figures 9a to 9f show the different steps of reconstruction of a three-dimensional model of a trapezoid bone that has not undergone rhizarthrosis-related deformation.
  • FIG. 14 shows that the mobility properties of the hand are preserved after a prosthetic arthroplasty operation with the prosthesis of the trapezoid bone according to the invention.
  • the whole of the movements relative to the trapezio-metacarpal joint were correctly realized, it is about the movements of retropulsion (91), antepulsion (92), abduction (93), adduction (94) and circumduction according to their respective extent .
  • EXAMPLE 2 Reconstruction using a drawing software, a three-dimensional model of a cup that has not been deformed from a deformed cup (steps A and B of the method according to the invention)
  • FIG. 15 shows the sequence of steps performed for this purpose from:

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Abstract

The present invention relates to a method for manufacturing a complex substitute object intended to supplement or replace a real object in a given state, potentially a damaged state, in particular a trapeziometacarpal prosthesis intended to replace the trapezoid bone of a human being suffering from rhizarthrosis. The present invention also relates to a trapeziometacarpal prosthesis that can be obtained by the manufacturing method according to the invention.

Description

PROCEDE DE FABRICATION D ' UN OBJET COMPLEXE DE SUBSTITUTION PROCESS FOR MANUFACTURING COMPLEX OBJECT OF SUBSTITUTION
À PARTIR D ' UN OBJET RÉEL FROM A REAL OBJECT
La présente invention concerne de manière générale la fabrication d'un objet complexe de substitution destiné à suppléer ou remplacer un objet réel dans un état donné, potentiellement endommagé, en particulier la fabrication d'une prothèse trapézo-métacarpienne pour remplacer l'os trapèze d'un être humain sujet à la rhizarthrose . The present invention generally relates to the manufacture of a complex substitute object for replacing or replacing a real object in a given state, potentially damaged, in particular the manufacture of a trapezio-metacarpal prosthesis to replace the trapezoid bone of a human being subject to rhizarthrosis.
Il est difficile de réaliser un objet de substitution tel qu'une prothèse à partir de l'objet abimé, surtout s'il s'agit d'une partie d'un corps humain tel qu'un os. Néanmoins, si l'on cherche à réaliser une prothèse en se basant sur des images tridimensionnelle d'un os qui n'est pas abimé, cela ne pourra pas être celui de la personne à laquelle la prothèse est destinée. Or, cela présente l'inconvénient majeur que cette prothèse risque de ne pas lui être parfaitement adaptée. Le risque de complications post-implantation se trouve accentué du fait d'une instabilité induit par une inadéquation avec l'environnement de la prothèse. Or, si l'os est très abimé, il est généralement difficile et long, voire impossible de se baser sur des images tridimensionnelles de cet os pour réaliser un modèle de programmation du pilotage d'une machine-outil à commande numérique pour l'impression tridimensionnelle de la prothèse ou tout autre moyen de fabrication tel que l'usinage.  It is difficult to make a substitute object such as a prosthesis from the damaged object, especially if it is a part of a human body such as a bone. Nevertheless, if one seeks to make a prosthesis based on three-dimensional images of a bone that is not damaged, it can not be that of the person to whom the prosthesis is intended. However, this has the major disadvantage that this prosthesis may not be perfectly suited. The risk of post-implantation complications is accentuated because of instability induced by an inadequacy with the environment of the prosthesis. However, if the bone is very damaged, it is generally difficult and long, if not impossible to rely on three-dimensional images of this bone to achieve a programming model of the control of a CNC machine tool for printing three-dimensional prosthesis or any other manufacturing means such as machining.
Afin de pallier les inconvénients précités, le demandeur a mis au point un procédé de fabrication d'un objet complexe de substitution présentant au moins une zone fonctionnelle et destiné à suppléer ou remplacer un objet réel, ledit procédé comprenant les étapes suivantes :  In order to overcome the aforementioned drawbacks, the applicant has developed a method of manufacturing a complex substitution object having at least one functional zone and intended to replace or replace a real object, said method comprising the following steps:
A. Acquisition d'une image tridimensionnelle dudit objet réel se présentant sous forme d'un nuage de points, ladite image tridimensionnelle étant ensuite numérisée ; A. Acquisition of a three-dimensional image of said real object in the form of a cloud of points, said three-dimensional image then being digitized;
B. A partir de ladite image tridimensionnelle numérisée, reconstruction à l'aide d'un logiciel de dessin ou de Conception Assistée par Ordinateur, d'un modèle tridimensionnel de l'objet réel ; B. From said digitized three-dimensional image, reconstruction using a drawing software or Computer Aided Design, a three-dimensional model of the real object;
C. A partir dudit modèle tridimensionnel, programmation du pilotage d'une machine-outil à commande numérique en vue de la fabrication dudit objet complexe de substitution ;  C. From said three-dimensional model, programming the control of a numerically controlled machine tool for the manufacture of said complex substitution object;
D. fabrication additive dudit objet complexe par la machine-outil à commande numérique ;  D. additive manufacturing of said complex object by the numerically controlled machine tool;
ledit procédé étant caractérisé en ce que l'étape A est réalisée sur ledit objet réel se trouvant dans un état endommagé spécifique à une déformation donnée, et  said method being characterized in that step A is performed on said real object being in a damaged state specific to a given deformation, and
en ce que ledit procédé comprend entre les étapes A et B, les sous-étapes suivantes :  in that said method comprises between steps A and B, the following substeps:
• a'1) définition de paramètres topologiques et morphologiques invariants de l'objet réel à partir de laquelle on définit un gabarit (à l'état non endommagé);  • a'1) definition of invariant topological and morphological parameters of the real object from which a template is defined (in the undamaged state);
• a' 2) détermination des surfaces fonctionnelles (ou d'intérêt) et des surfaces de remplissage de l'objet réel à l'état non endommagé;  • a '2) determination of the functional surfaces (or interest) and filling surfaces of the real object in the undamaged state;
• a' 3) définition des paramètres topologiques et morphologiques sensibles à la déformation de l'objet réel à l'état endommagé et identification de leurs variations au niveau de ses surfaces dites fonctionnelles ; et en ce que l'étape B comprend en outre les sous-étapes suivantes :  • a '3) definition of the topological and morphological parameters sensitive to the deformation of the real object in the damaged state and identification of their variations at its so-called functional surfaces; and in that step B further comprises the following substeps:
bl) adaptation du gabarit sur ladite image tridimensionnelle définies à l'étape A, à l'aide d'un logiciel de dessin ou de CAO, pour obtenir un modèle spécifique (c'est-à-dire un gabarit adapté à l'état endommagé) ; bl) adaptation of the template on said three-dimensional image defined in step A, to using a drawing or CAD software, to obtain a specific model (that is, a template adapted to the damaged state);
b2) sur le modèle spécifique, reconstruction précise des surfaces fonctionnelles à l'état endommagé à partir des surfaces fonctionnelles définies à l'étape a'2), et reconstruction approximative, des surfaces de remplissage à l'état endommagé à partir des surfaces fonctionnelles définies à l'étape a'2), pour obtenir une image tridimensionnelle reconstruite à l'état endommagé ; b2) on the specific model, precise reconstruction of the damaged functional surfaces from the functional surfaces defined in step a'2), and approximate reconstruction, of the damaged filling surfaces from the functional surfaces defined in step a'2), to obtain a three-dimensional image reconstructed in the damaged state;
b3) reconstruction précise, sur l'image tridimensionnelle reconstruite à l'état endommagé, des surfaces fonctionnelles à l'état non endommagé, par modification des valeurs des paramètres topologiques et morphologiques sensibles à la déformation définis à l'étape a' 3) de manière qu'ils correspondent à une absence de déformation, pour obtenir une image tridimensionnelle reconstruite à l'état non endommagé ; b3) accurately reconstructing, on the three-dimensional image reconstructed in the damaged state, functional surfaces in the undamaged state, by modifying the values of the topological and morphological parameters sensitive to the deformation defined in step a '3) of so that they correspond to an absence of deformation, to obtain a three-dimensional image reconstructed in the undamaged state;
b4) à partir de l'image tridimensionnelle reconstruite à l'état non endommagé, extraction d'un fichier numérique fonctionnel comprenant uniquement les zones d' intérêt et d'un fichier numérique de remplissage comprenant les zones autres que les zones d' intérêt ; b4) from the reconstructed three - dimensional image in the undamaged state, extracting a functional digital file comprising only the areas of interest and a digital fill file including the areas other than the areas of interest;
b5) Reconstruction à partir des fichiers fonctionnel et de remplissage d'un modèle volumique fermé dudit objet à reconstruire, qui est mis sous forme de fichier neutre adapté à la fabrication additive. La première étape du procédé selon l'invention est l'étape A consistant à acquérir une image tridimensionnelle dudit objet réel qui est numérisée. Cette étape peut être réalisée de diverses manières, et notamment par numérisation tridimensionnelle (ou « numérisation 3D ») à l'aide d'un scanner 3D. On obtient par cette technique des images de synthèse en trois dimensions qui n'ont pas besoin d'être ensuite segmentées. b5) Reconstruction from functional and filling files of a closed volume model of said object to be reconstructed, which is put in the form of a neutral file adapted to additive manufacturing. The first step of the method according to the invention is step A of acquiring a three-dimensional image of said real object which is digitized. This step can be carried out in various ways, and in particular by three-dimensional scanning (or "3D scanning") using a 3D scanner. By this technique, three-dimensional synthetic images are obtained which do not need to be segmented later.
Dans le cas où l'objet réel que l'on cherche à reconstruire ou suppléer est une partie d'un corps humain ou animal, l'étape A sera plutôt réalisée en deux étapes, comprenant notamment l'acquisition des images tridimensionnelles par des techniques d' imagerie médicales telle que l'Imagerie par Résonnance Magnétique (généralement connue sous l'acronyme « IRM ») , qui sont ensuite soumises à un traitement ultérieur de segmentation. Par contre, si les images sont obtenues par scan 3D, elles sont directement sous forme de nuage de points (la segmentation n'est donc pas nécessaire)  In the case where the real object that one seeks to reconstruct or supply is a part of a human or animal body, step A will be done in two steps, including the acquisition of three-dimensional images by techniques. medical imaging systems such as Magnetic Resonance Imaging (generally known by the acronym "MRI"), which are then subjected to further segmentation processing. On the other hand, if the images are obtained by 3D scan, they are directly in the form of a scatter plot (segmentation is not necessary)
Selon un mode de réalisation de l'invention, par exemple dans le cas d' images 3D par imagerie médicale et non par scanner 3D, on réalise, au cours de l'étape A d'acquisition de l'image tridimensionnelle de l'objet réel, un formatage de l'image en un format neutre (par exemple un fichier STL) compatible avec un logiciel de dessin ou de Conception Assistée par Ordinateur.  According to one embodiment of the invention, for example in the case of 3D images by medical imaging and not by 3D scanner, during step A of acquisition of the three-dimensional image of the object is carried out real, formatting the image into a neutral format (eg an STL file) compatible with a computer-aided drawing or design software.
Entre les étapes A et B, le procédé selon l'invention comprend en outre une sous-étape a'1) de définition de paramètres topologiques et morphologiques invariants de l'objet réel, à partir de laquelle on définit un gabarit.  Between steps A and B, the method according to the invention further comprises a substep a'1) of definition of invariant topological and morphological parameters of the real object, from which a template is defined.
Par paramètres topologiques et morphologiques invariants de l'objet réel, on entend, au sens de la présente invention, des paramètres qui sont constamment présents d'un objet réel à un autre, qu'il soit ou non endommagé ou non et appartenant à la même catégorie ou type d'objet, par exemple d'un oz trapèze à l'autre. By invariant topological and morphological parameters of the real object is meant, in the sense of the present invention, parameters which are constantly present from one real object to another, whether or not it is damaged or not and belonging to to the same category or type of object, for example from one trapezoid oz to another.
Par gabarit, on entend, au sens de la présente invention, un modèle générique adimensionnel d'un objet non endommagé (au sens de non déformé et non abimé par un quelconque usage) , qui est défini par ses paramètres topologiques et morphologiques invariants.  For the purposes of the present invention, template is understood to mean a generic model of an undamaged object (in the sense of being undeformed and undamaged by any use), which is defined by its invariant topological and morphological parameters.
Les paramètres topologiques et morphologiques invariants sont placés de façon préférable sur des zones fonctionnelles.  Topological and morphological invariant parameters are preferably placed on functional areas.
Par zones ou surfaces fonctionnelles d'un objet donné, au sens de la présente invention des surfaces de l'objet ayant une fonction donnée, qu'elle soit d'ordre cinématique ou autre.  Functional zones or surfaces of a given object, within the meaning of the present invention, of the surfaces of the object having a given function, whether kinematic or otherwise.
Le gabarit peut être défini avec des surfaces jointives ou non jointives.  The template can be defined with joined or non-joined surfaces.
Par surfaces jointives, on entend, au sens de la présente invention, des surfaces situées côte à côte et définies par une même courbe commune. Cela implique que les deux surfaces jointives sont dépendantes l'une de l'autre.  By adjoining surfaces is meant in the sense of the present invention, surfaces located side by side and defined by the same common curve. This implies that the two adjoining surfaces are dependent on each other.
La définition du côté commun est similaire aux deux surfaces, même si elles présentent des fonctions différentes. En outre, il n'y a pas d'espace libre entre les deux surfaces.  The definition of the common side is similar to both surfaces, even if they have different functions. In addition, there is no free space between the two surfaces.
A contrario, par surfaces jointives, on entend, au sens de la présente invention, des surfaces situées côte à côte mais qui ne s'appuient pas sur la même courbe. Cela implique que les deux surfaces sont indépendantes l'une de l'autre et il ' y a un espace libre entre les deux surfaces. Il est possible de mettre plusieurs surfaces en vis-à-vis d'une et même surface.  On the other hand, by adjoining surfaces is meant, in the sense of the present invention, surfaces located side by side but which do not rest on the same curve. This implies that the two surfaces are independent of each other and there is a free space between the two surfaces. It is possible to put several surfaces facing one and the same surface.
L'avantage de définir le gabarit par des surfaces non jointives est de permettre le raffinement des zone les plus fonctionnelles (c'est-à-dire l'augmentation du nombre de points) sans avoir la contrainte d'assurer la jonction des différentes surfaces adjacentes. Entre les étapes A et B, le procédé selon l'invention comprend en outre, postérieurement à la sous-étape a'1), une sous-étape a' 2) de détermination des surfaces fonctionnelles (ou d'intérêt) et des surfaces de remplissage (d'importance mineure, comprenant les zones autres que les zones d'intérêt) de l'objet réel à l'étape non endommagé. The advantage of defining the template by non-contiguous surfaces is to allow the refinement of the most functional zones (that is to say the increase in the number of points) without the constraint of ensuring the joining of the different surfaces. adjacent. Between steps A and B, the method according to the invention further comprises, after sub-step a '1), a sub-step a' 2) of determining the functional (or interest) surfaces and the surfaces filling (of minor importance, including areas other than areas of interest) from the actual object to the undamaged stage.
Par surface de remplissage, on entend, au sens de la présente invention, toute surface qui n'est pas fonctionnelle .  By filling surface is meant in the sense of the present invention, any surface that is not functional.
Outre les sous-étapes a' 1 et a' 2), le procédé selon l'invention comprend une sous-étape a' 3) de détermination des paramètres topologiques et morphologiques sensibles à la déformation de l'objet réel (à l'état endommagé et l'identification de leurs variations, au niveau des surfaces dites fonctionnelles. Cette étape peut être réalisée à partir d'une base de données statistiques de la géométrie réelle d'objets connus similaires audit objet réel, afin de retrouver un objet à l'état non-endommagé, particulièrement au niveau des surfaces dites fonctionnelles.  In addition to the substeps a '1 and a' 2), the method according to the invention comprises a sub-step a '3) of determining the topological and morphological parameters sensitive to the deformation of the real object (in the state damaged and identification of their variations, at the so-called functional surfaces.This step can be performed from a statistical database of the actual geometry of known objects similar to said real object, in order to find an object at the same time. undamaged condition, especially at so-called functional surfaces.
L'étape B du procédé selon l'invention consiste à reconstruire à partir de l'image tridimensionnelle éventuellement segmentée, un modèle tridimensionnel de l'objet réel à l'aide d'un logiciel de dessin ou de Conception Assistée par Ordinateur.  Step B of the method according to the invention consists in reconstructing from the possibly segmented three-dimensional image, a three-dimensional model of the real object using a drawing software or computer-aided design.
L'étape B du procédé selon l'invention comprend notamment une première sous-étape bl) d'adaptation du gabarit sur l'image tridimensionnelle numérisée obtenue à l'étape A, à l'aide d'un logiciel de dessin ou de CAO, pour obtenir un modèle spécifique, c'est-à-dire un gabarit adapté à l'objet endommagé .  Step B of the method according to the invention comprises in particular a first substep bl) of adapting the template on the digitized three-dimensional image obtained in step A, using a drawing or CAD software , to obtain a specific model, that is to say a template adapted to the damaged object.
Par ailleurs, la sous-étape b4) de reconstruction des surfaces fonctionnelles à l'état endommagé consiste à modifier, sur une image tridimensionnelle reconstruite à l'état non endommagé (obtenue à la sous-étape b3) , les paramètres morphologiques sensibles à la déformation, de manière à ce qu' ils correspondent à une absence de déformation sur la base des informations obtenues lors de la sous-étape a' 3) . Moreover, the sub-step b4) of reconstructing the functional surfaces in the damaged state consists in modifying, on a three-dimensional image reconstructed in the undamaged state (obtained in the sub-step b3), the Morphological parameters sensitive to deformation, so that they correspond to an absence of deformation on the basis of the information obtained during the sub-step a '3).
De manière avantageuse, l'étape B peut avantageusement comprendre, à l'issue de l'étape b5) , une étape b6) de lissage global ou localisé dudit modèle volumique fermé, pouvant être réalisée par une méthode surfacique ou volumique. Cette étape est facultative mais fortement conseillée du fait du peu de nombre de points définissant le gabarit (la possibilité d' avoir des arêtes vives pouvant être nocive pour le patient in fine) . Par ailleurs cette étape est fortement conseillée si la création du modèle volumique fermé est réalisée par voxels .  Advantageously, step B may advantageously comprise, at the end of step b5), a step b6) of overall or localized smoothing of said closed volume model, which can be performed by a surface or volume method. This step is optional but strongly recommended because of the few number of points defining the template (the possibility of having sharp edges that can be harmful for the patient in fine). In addition, this step is strongly recommended if the creation of the closed volume model is done by voxels.
Le procédé selon l'invention est particulièrement adapté pour réaliser des objets complexes sels des semelles orthopédiques ou des prothèses dentaires, auditives, ou osseuses pour un corps humain ou animal.  The method according to the invention is particularly suitable for producing complex objects salts of orthopedic insoles or dental prostheses, auditory, or bone for a human or animal body.
Dans le cas d'une réalisation de prothèse implantable, on pourra utiliser, pour l'étape D de fabrication additive, des poudres de matériaux biocompatibles tels que des poudres de TA6V, 316L, CrCoMo, ou encore de céramique ou encore de polymère .  In the case of an implantable prosthesis embodiment, it is possible to use, for the additive manufacturing step D, powders of biocompatible materials such as TA6V, 316L, CrCoMo powders, or even ceramic or polymer powders.
Dans ce cas, on entend par gabarit, au sens de la présente invention, le modèle générique adimensionnel d'une partie d'un corps humain que l'on cherche à remplacer ou suppléer (par une prothèse ou une semelle) , qui est celui d'un sujet sain (personne non malade), qui n'a pas été déformé ou subi une de dégénérescence ou déformation.  In this case, template, in the sense of the present invention, is understood to mean the adimensional generic model of a part of a human body that one seeks to replace or supplement (by a prosthesis or a sole), which is the one a healthy subject (non-sick person) who has not been deformed or has suffered from degeneration or deformity.
En particulier, le procédé selon l'invention est particulièrement adapté à fabriquer une prothèse trapézo- métacarpienne à titre d'objet complexe de substitution d'un os trapèze d'un être humain (objet réel) . Une telle prothèse est destinée à être implantée dans la main d'un patient au niveau de l' articulation trapézo-métacarpienne . Cette implantation est réalisée lors d'une intervention chirurgicale appelée arthroplastie prothétique consistant à remplacer, en partie ou totalement, l'articulation malade par une prothèse. Il s'agit d'une solution thérapeutique couramment utilisée dans le cas de l'arthrose qui est une destruction ou une dégénérescence des surfaces articulaires. In particular, the method according to the invention is particularly suitable for manufacturing a trapezometacarpal prosthesis as a complex object of substitution of a trapezoidal bone of a human being (real object). Such a prosthesis is intended to be implanted in the hand of a patient at level of the trapeziometacarpal joint. This implantation is performed during a surgical procedure called prosthetic arthroplasty consisting in replacing, partially or totally, the diseased joint by a prosthesis. It is a therapeutic solution commonly used in the case of osteoarthritis which is a destruction or degeneration of the articular surfaces.
Dans le cas de la fabrication d'une prothèse trapézo- métacarpienne à titre d'objet complexe de substitution, les zones d'intérêt de l'os trapèze seront les surfaces articulaires, c'est-à-dire la surface d'articulation avec le second métacarpe, la surface d'articulation avec le scaphoïde, la surface d'articulation avec le trapézoïde, et de façon optionnelle la surface définissant une rainure pour le passage du tendon flexor carpi radialis .  In the case of the manufacture of a trapezometacarpal prosthesis as a complex substitution object, the areas of interest of the trapezoid bone will be the articular surfaces, that is to say the articulation surface with the second metacarpal, the articulating surface with the scaphoid, the articulation surface with the trapezoid, and optionally the surface defining a groove for the passage of flexor carpi radialis tendon.
La présente invention a également pour objet une prothèse trapézo-métacarpienne obtenue par le procédé de fabrication selon l'invention tel que défini spécifiquement pour la fabrication d'une prothèse trapézo-métacarpienne.  The present invention also relates to a trapezio-metacarpal prosthesis obtained by the manufacturing method according to the invention as specifically defined for the manufacture of a trapezio-metacarpal prosthesis.
D' autres avantages et particularités de la présente invention résulteront de la description qui va suivre, donnée à titre d'exemple non limitatif et faite en référence aux figures annexées :  Other advantages and features of the present invention will result from the description which follows, given by way of nonlimiting example and with reference to the appended figures:
La figure 1 est une vue de dessus d'un squelette d'une main comportant une prothèse trapézo-métacarpienne selon l'invention ;  Figure 1 is a top view of a skeleton of a hand with a trapezio-metacarpal prosthesis according to the invention;
La figure 2 est une vue de détail et de côté de la prothèse de la figure 1 ;  Figure 2 is a detail and side view of the prosthesis of Figure 1;
La figue 3 est une vue tridimensionnelle de l'implantation de la prothèse de la figure 1, dans lequel seuls le premier métacarpe et le trapézoïde du squelette de la main étant représentés ;  Fig. 3 is a three-dimensional view of the implantation of the prosthesis of Fig. 1, in which only the first metacarpal and trapezoid of the skeleton of the hand are shown;
La figue 4 montre où se situe l'articulation trapézo- métacarpienne dans la main d'un patient ; La figure 5 comprend deux séries d' images 3D obtenues par IRM puis segmentation de l'articulation trapézo- métacarpienne des mains de deux patients souffrant de rhizarthrose, l'une pour la main gauche des deux patients (figure 5a) et l'autre pour la main droite de ces deux patients (figure 5b) ; Fig. 4 shows where the trapezometacarpal joint is located in a patient's hand; Figure 5 includes two sets of 3D images obtained by MRI and segmentation of the trapezometacarpal joint in the hands of two patients with rhizarthrosis, one for the left hand of both patients (Figure 5a) and the other for the right hand of these two patients (Figure 5b);
La figure 6 montre les paramètres topologiques et morphologiques constamment présent d'un os trapèze à un autre ;  Figure 6 shows the topological and morphological parameters constantly present from one trapezoid bone to another;
Les figures 7a à 7p montrent les variations de ces paramètres topologiques et morphologiques d'un os trapèze ;  Figures 7a to 7p show the variations of these topological and morphological parameters of a trapezoidal bone;
Les figures 8a à 8c montrent l'évolution des courbures convexes et concaves de la surface de contact avec le 1er métacarpe selon l'état arthrosique de l'articulation ; Figures 8a to 8c show the evolution of the convex and concave curvatures of the contact surface with the 1st metacarpus according to the osteoarthritic state of the joint;
Les figures 9a à 9g montrent les étapes A à b6 de reconstruction numérique d'un os trapèze n'ayant pas subi de déformation liée à la rhizarthrose, conformément au procédé selon l'invention, dans laquelle l'étape b5) de reconstruction d'un modèle volumique fermé de l'objet de substitution à fabriquer est réalisée par une méthode surfacique (dite de reconstruction de Poisson : voir figure 9f) ou par une méthode volumique, dite de remplissage par voxels (c'est-à-dire des cubes numériques : voir figure 9g) ;  FIGS. 9a to 9g show steps A to B6 of digital reconstruction of a trapezoid bone that has not undergone rhizarthrosis-related deformation, according to the method according to the invention, in which step b5) of reconstruction of a closed volume model of the substitution object to be manufactured is produced by a surface method (called Poisson reconstruction: see FIG. 9f) or by a voluminal method, called a voxel filling method (that is to say cubes). digital: see Figure 9g);
La figure 10 montre le gabarit d'un os trapèze et l'ensemble des points et des courbes le définissant ; La figure 11 montre l'évolution d'un lissage du modèle volumique fermé jusqu'à obtention de la disparition des angles vifs tout en conservant l'intégrité des paramètres d'un os trapèze sain préalablement définis ; La figure 12 montre les différents éléments de la prothèse trapézo-métacarpienne à ajouter (1111) ou à extraire (1111); Figure 10 shows the template of a trapezoid bone and the set of points and curves defining it; FIG. 11 shows the evolution of a smoothing of the closed volume model until the disappearance of the sharp angles while preserving the integrity of the parameters of a previously defined healthy trapezoidal bone; FIG. 12 shows the various elements of the trapezio-metacarpal prosthesis to be added (1111) or extracted (1111);
La figure 13 montre les étapes C et D du procédé selon l'invention dans le cadre de la fabrication d'une prothèse trapézo-métacarpienne, depuis l'obtention du modèle volumique fermé de l'os trapèze à reconstruire jusqu'à la fabrication additive et le lissage final (respectivement étapes 13d et 13e) aboutissant à la prothèse de l'os trapèze, qui est finalement être implantée dans la main d'un patient au niveau de l'articulation trapézo-métacarpienne (13f) ;  FIG. 13 shows steps C and D of the process according to the invention in the context of the manufacture of a trapezio-metacarpal prosthesis, since obtaining the closed volumic model of the trapezoid bone to be reconstructed to additive manufacturing. and the final smoothing (respectively steps 13d and 13e) leading to the prosthesis of the trapezoid bone, which is finally implanted in the hand of a patient at the trapezio-metacarpal joint (13f);
La figure 14 montre que les propriétés de mobilité de la main sont conservées après une opération d' arthroplastie prothétique avec la prothèse de l'os trapèze selon l'invention.  FIG. 14 shows that the mobility properties of the hand are preserved after a prosthetic arthroplasty operation with the prosthesis of the trapezoid bone according to the invention.
La figure 15 montre les différentes étapes A et B de reconstruction d'une tasse à partir d'une tasse déformée .  Figure 15 shows the different steps A and B of rebuilding a cup from a deformed cup.
Les figures 1 à 15 sont décrites plus en détail au niveau de l'exemple qui suit, donné à titre indicatif et qui illustre l'invention sans toutefois en limiter la portée.  Figures 1 to 15 are described in more detail in the following example, given by way of indication and which illustrates the invention without limiting its scope.
EXEMPLEEXAMPLE
DISPOSITIFS ET INSTRUMENTATION DEVICES AND INSTRUMENTATION
■ Comparateur (appareil de mesure) : (North and Rutledge, ■ Comparator (measuring device): (North and Rutledge,
1983)  1983)
■ Stéréophotogrammétrie (SPG) sur os de cadavres ■ Stereophotogrammetry (SPG) on cadaver bones
(résolution 25 ym) (Ateshian, 1992; Xu, 1998) ; (Resolution 25 ym) (Ateshian 1992, Xu 1998);
■ Segmentation of Ctscan (résolution 0,625 x 0,3 x 0,3mm) ■ Segmentation of Ctscan (resolution 0.625 x 0.3 x 0.3mm)
(Conconi, 2014 ; Halilaj, 2014b) ; ■ Scan laser 3D (LS) (Kovler, 2004; Markze, 2012) Système micro-CT sur os de cadavres (résolution 0,38ym) (Conconi, 2014, Halilaj, 2014b); ■ 3D laser scanning (LS) (Kovler, 2004; Markze, 2012) Micro-CT system on cadavers bone (resolution 0.38ym)
Logiciel de segmentation des images : OSIRIX, MATERIALIZE Logiciel de formatage des images segmentées en fichier STL : OSIRIX MATERIALIZE  Image Segmentation Software: OSIRIX, MATERIALIZE Segmented Image Segmentation Software: OSIRIX MATERIALIZE
Logiciel de visualisation des fichiers STL : MESCHLAB Logiciel de Conception Assistée par Ordinateur : CATIA V5 ;  STL File Visualization Software: MESCHLAB Computer Aided Design Software: CATIA V5;
MATÉRIAUX objets réels : MATERIALS real objects:
o os trapèzes de deux patients masculins souffrant de rhizarthrose, âgés respectivement de 61 ans (patient 1) et de 66 ans (patient 2), dont la main malade est montrée sur les figures 5a et 5b (exemple 1 ) ,  o trapezoids of two male patients suffering from rhizarthrosis, aged respectively 61 years (patient 1) and 66 years (patient 2), whose sick hand is shown in FIGS. 5a and 5b (example 1),
o tasse déformée (exemple 2) . objets à modéliser :  o deformed cup (example 2). objects to model:
o os trapèze de prothèses trapézo-métacarpiennes schématiquement représenté sur les figures 1 à 3 et montrées sur les photographies des figures 13d et 13e (exemple 1),  trapezium-metacarpal prosthesis trapezium schematically shown in Figures 1 to 3 and shown in the photographs of Figures 13d and 13e (Example 1),
o tasse non déformée (exemple 2) . objet à reconstruire :  undeformed cup (example 2). object to rebuild:
os trapèze de prothèses trapézo-métacarpiennes schématiquement représenté sur les figures 1 à 3 et montrées sur les photographies des figures 13d et 13e. matériau utilisé pour la fabrication additive de la prothèse : CrCoMo, TA6V. En référence aux figures 1 à 3 (relatives à l'exemple 1), nous allons décrire une prothèse trapézo-métacarpienne 1 susceptible d'être obtenue selon l'invention. Cette prothèse trapézo-métacarpienne comporte ici un trapèze prothétique 111, un pion métacarpien 117 et une vis d'ancrage 113. Elle est destinée à être mise en place entre le premier métacarpien 214 et le trapézoïde 212 d'un patient. Le trapèze prothétique 111 est ancré sur le trapézoïde 212 avec la vis d'ancrage 113. Dans le mode de réalisation illustré sur les figures 1 à 3, le pion métacarpien 117 comporte deux parties, ici rapportées l'une sur l'autre : une base 115 et une tête 116. Trapezoid-metacarpal prosthesis trapezium bone schematically shown in Figures 1 to 3 and shown in the photographs of Figures 13d and 13e. material used for the additive manufacturing of the prosthesis: CrCoMo, TA6V. With reference to FIGS. 1 to 3 (relating to example 1), we will describe a trapezio-metacarpal prosthesis 1 that can be obtained according to the invention. This trapezio-metacarpal prosthesis here comprises a prosthetic trapezium 111, a metacarpal pin 117 and an anchoring screw 113. It is intended to be placed between the first metacarpal 214 and the trapezoid 212 of a patient. The prosthetic trapezium 111 is anchored to the trapezoid 212 with the anchoring screw 113. In the embodiment illustrated in FIGS. 1 to 3, the metacarpal peg 117 comprises two parts, here referred to one another: a base 115 and a head 116.
L'autre objet à reconstruire, à savoir, la tasse, est décrit à l'exemple 2 et illustré sur la figure 15. The other object to be reconstructed, namely, the cup, is described in Example 2 and illustrated in FIG.
EXEMPLE 1 EXAMPLE 1
REALISATION D'UNE PROTHESE TRAPEZO-METACARPIENNE SELON LE PROCEDE DE L'INVENTION  REALIZATION OF A TRAPEZO-METACARPIAN PROSTHESIS ACCORDING TO THE PROCESS OF THE INVENTION
1.1 Acquisition d' images tridimensionnelles segmentées des os trapèzes (étape A du procédé selon l'invention) 1.1 Acquisition of Segmented Three-Dimensional Images of Trapezoid Bones (Step A of the Process According to the Invention)
La main du patient est scannée par IRM ou par tomographie puis transformée en nuages de points (format STL) . Les caractéristiques techniques de l'imagerie médicale et de l'extraction en nuage de points (séquences, pondération, contraste) sont choisies de telle sorte à discrétiser la partie corticale des os (figures 5a et 5b) . The patient's hand is scanned by MRI or tomography and then transformed into point clouds (STL format). The technical characteristics of medical imaging and point cloud extraction (sequences, weighting, contrast) are chosen so as to discretize the cortical part of the bones (Figures 5a and 5b).
Un fichier numérique STL est extrait puis les points de repères définissant le gabarit sont adaptés au modèle du patient sous un logiciel de CAO ou d'édition de maillage. Le logiciel MESHLAB, un logiciel de type « open source » d'édition de maillage 3D permet quant à lui de visualiser les fichiers STL. An STL digital file is extracted and the reference points defining the template are adapted to the patient model using a CAD software or mesh editing software. MESHLAB software, an open source software 3D mesh editing allows you to view STL files.
Lorsque le modèle est très arthrosique et abimé, et que le gabarit ne peut être entièrement adapté au patient, les points de repères non adaptés sont prédits par une base de données d'os sain. Par ailleurs le gabarit permet de supprimer les protubérances et rugosités non anatomiques très présentes dans un os avec un état arthrosique avancé.  When the model is very osteoarthritic and damaged, and the template can not be fully adapted to the patient, unsuitable landmarks are predicted by a healthy bone database. Moreover, the template makes it possible to eliminate the protuberances and non-anatomical roughness very present in a bone with an advanced osteoarthritis state.
1.2 Détermination des paramètres topologiques et morphologiques constamment présents d'un objet réel à un autre pour obtenir un gabarit (étape A' du procédé selon 1' invention) 1.2 Determination of the topological and morphological parameters constantly present from one real object to another to obtain a template (step A 'of the method according to the invention)
La figure 6 montre les paramètres topologiques et morphologiques constamment présents d'un os trapèze à un autre . Figure 6 shows the topological and morphological parameters constantly present from one trapezoid bone to another.
Sur le modèle biomécanique d'un os trapèze, on distingue trois types de points de repères :  On the biomechanical model of a trapezoid bone, there are three types of reference points:
• les points de repères anatomiques (411), définis par des experts et correspondants à des points ayant une signification biologique ;  • anatomical landmarks (411), defined by experts and corresponding to points of biological significance;
• les pseudo-points de repères (412), qui sont construits sur un objet, sur une ligne ou entre des points de repère.  • pseudo-landmarks (412), which are built on an object, on a line, or between landmarks.
Suite à la reconstruction, des caractéristiques communes sont ressorties (illustrées sur les figures 7a à 7p)  Following the reconstruction, common features emerged (illustrated in Figures 7a to 7p)
• présence de 4 surfaces d'articulation visibles : o Trapézoïde (TPZ) 421, • 4 visible articulation surfaces: o Trapezoid (TPZ) 421,
o Métacarpe 1 (Ml) 422,  o Metacarpus 1 (Ml) 422,
o Métacarpe 2 (M2)423,  o Metacarpus 2 (M2) 423,
o Scaphoïde (SCP) 424 dont 2 plans (SCP et M2), et o Scaphoid (SCP) 424 including 2 plans (SCP and M2), and
• L'articulation Ml (422) en forme de selle de cheval. Le choix s'est donc porté sur la mise en exergue de ces caractéristiques. • Ml (422) saddle-shaped articulation. The choice was therefore focused on the highlighting of these characteristics.
1.3 Détermination des paramètres topologiques et morphologiques variables sensibles à l'arthrose (étapes a' 1 à a' 3 du procédé selon l'invention) 1.3 Determination of variable topological and morphological parameters sensitive to osteoarthritis (steps a '1 to a' 3 of the process according to the invention)
Les figures 7a à 7p montrent l'ensemble des mesures effectuées sur ces points de repères afin de connaître leur variabilité en fonction de l'état arthrosique. Les paramètres relatifs à la surface de contact avec le premier métacarpe sont très sensibles à l'état arthrosique (431) . Figures 7a to 7p show all the measurements made on these landmarks in order to know their variability as a function of the osteoarthritis state. The parameters relating to the area of contact with the first metacarpal are very sensitive to the osteoarthritis state (431).
Par ailleurs, les figures 8a à 8c montrent plus spécifiquement, que les courbures concaves (441) et convexes (442) de la surface de contact avec le premier métacarpe varient en fonction de l'état arthrosique de l'articulation. Les courbures sont concaves sont très prononcées pour un sujet sain (4411) et faiblement prononcées à l'état arthrosique (4412). Inversement les courbures convexes sont très prononcées à l'état arthrosiques (4422) et faiblement prononcées pour un sujet sain. Les courbures concaves saines (4411) décroissent le long de la ligne radio-ulnaire mais sont stables pour un sujet arthrosique (4412) . Les courbures convexes saines (4421) croissent le long de la ligne radio- ulnaire mais décroissent légèrement pour un sujet arthrosique (4412) . Moreover, FIGS. 8a to 8c show more specifically that the concave (441) and convex (442) curvatures of the surface of contact with the first metacarpal vary according to the osteoarthritis state of the joint. The curvatures are concave and are very pronounced for a healthy subject (4411) and weakly pronounced in the osteoarthritic state (4412). Inversely, the convex curvatures are very pronounced in the osteoarthritic state (4422) and weakly pronounced for a healthy subject. Healthy concave curvatures (4411) decrease along the radioulnar line but are stable for osteoarthritis (4412). Healthy convex curvatures (4421) grow along the radioulnar line but decrease slightly for osteoarthritis (4412).
1.4 Reconstruction à l'aide d'un logiciel de dessin, d'un modèle tridimensionnel d'os trapèze n'ayant pas subi de déformation liée à la rhizarthrose correspondant aux os trapèze des patients malades (étape B du procédé selon 1' invention) 1.4 Reconstruction using a drawing software, of a three-dimensional trapezoid bone model that has not undergone rhizarthrosis-related deformity corresponding to the trapezoidal bones of the sick patients (stage B of the process according to the invention)
Les figures 9a à 9f montrent les différentes étapes de reconstruction d'un modèle tridimensionnel d'un os trapèze n'ayant pas subi de déformation liée à la rhizarthrose. Figures 9a to 9f show the different steps of reconstruction of a three-dimensional model of a trapezoid bone that has not undergone rhizarthrosis-related deformation.
Plus spécifiquement, ces figures montrent de manière détaillée :  More specifically, these figures show in detail:
• la mise en place (figure 9a3 : résultat de la mise en place) du gabarit (de la figure 9a2) sur le modèle numérique 3D de l'os trapèze du patient (figure 9al), • the placement (Figure 9a3: result of the placement) of the template (of Figure 9a2) on the 3D digital model of the trapezoid bone of the patient (Figure 9al),
• l'identification des valeurs des paramètres morphologiques ne concordant pas aux spécifications d'un os trapèze sain (figure 9b) , • the identification of morphological parameter values that do not match the specifications of a healthy trapezoid bone (Figure 9b),
• l'identification des zones d'intérêts et de remplissage (figure 9c) ,  • the identification of areas of interest and filling (Figure 9c),
• la modification des valeurs des paramètres afin qu'elles concordent aux spécifications d'un os trapèze sain (figure 9d) ,  • modifying the parameter values to match the specifications of a healthy trapezoid bone (Figure 9d),
• l'extraction des zones d'intérêt et de remplissage en modèle numérique maillé avec la précision suffisante par rapport aux tolérances exigées (figure 9e) ,  • the extraction of areas of interest and filling in a digital mesh model with sufficient accuracy compared to the required tolerances (figure 9e),
• la reconstruction d'un modèle 3D fermé par méthode surfacique (reconstruction de poisson : figure 9f) ou méthode volumique (remplissage par voxels : figure 9g) . 1.5 Obtention par impression 3D d'un os trapèze à partir du modèle tridimensionnel obtenu à l'exemple 4 (étapes C et D du procédé selon l'invention) • the reconstruction of a closed 3D model by surface method (fish reconstruction: figure 9f) or volume method (filling by voxels: figure 9g). 1.5 Obtaining by 3D Printing a Trapezoidal Bone from the Three-Dimensional Model Obtained in Example 4 (Steps C and D of the Process According to the Invention)
La figure 14 montre que les propriétés de mobilité de la main sont conservées après une opération d' arthroplastie prothétique avec la prothèse de l'os trapèze selon l'invention. L'ensemble des mouvements relatif à l'articulation trapézo-métacarpienne ont été correctement réalisé, il s'agit des mouvements de rétropulsion (91), antépulsion (92), abduction (93), adduction (94) et circumduction selon leur étendue respective. FIG. 14 shows that the mobility properties of the hand are preserved after a prosthetic arthroplasty operation with the prosthesis of the trapezoid bone according to the invention. The whole of the movements relative to the trapezio-metacarpal joint were correctly realized, it is about the movements of retropulsion (91), antepulsion (92), abduction (93), adduction (94) and circumduction according to their respective extent .
EXEMPLE 2 : Reconstruction à l'aide d'un logiciel de dessin, d'un modèle tridimensionnel d'une tasse n'ayant pas subi de déformation à partir d'une tasse déformée (étapes A et B du procédé selon l'invention) EXAMPLE 2: Reconstruction using a drawing software, a three-dimensional model of a cup that has not been deformed from a deformed cup (steps A and B of the method according to the invention)
La figure 15 montre la succession des étapes réalisées à cette fin à partir : Figure 15 shows the sequence of steps performed for this purpose from:
1. d'une tasse déformée ;  1. a deformed cup;
2. Obtention d'un nuage de points numériques acquis par bras robot laser ;  2. Obtaining a cloud of digital points acquired by laser robot arm;
3. Obtention d'un modèle maillé configurable (sous forme d'un fichier stl adapté à l'impression 3D) , avec zones non-connexes (non jointives) de la morphologie réelle,  3. Obtaining a configurable mesh model (in the form of a stl file suitable for 3D printing), with non-related zones (non-joined) of the actual morphology,
3.1 : par reconstruction de poisson, ou  3.1: by fish reconstruction, or
3.2 : par voxelisation et lissage ;  3.2: by voxelization and smoothing;
4. Obtention d'un modèle maillé configurable (sous forme d'un fichier stl adapté à l'impression 3D) avec zones non-connexes (non jointives) de la morphologie non- déformée  4. Obtaining a configurable mesh model (in the form of a stl file suitable for 3D printing) with non-related zones (non-joined) of the undistorted morphology
- 4.1 : par reconstruction de poisson, ou - 4.1: by fish reconstruction, or
- 4.2 : par voxelisation et lissage. - 4.2: by voxelization and smoothing.

Claims

REVENDICATIONS
1. Procédé de fabrication d'un objet complexe de substitution (1) présentant au moins une zone fonctionnelle et destiné à suppléer ou remplacer un objet réel (2), ledit procédé comprenant les étapes suivantes : A method of manufacturing a complex substitution object (1) having at least one functional area and for providing or replacing a real object (2), said method comprising the steps of:
A. acquisition d'une image tridimensionnelle (22) dudit objet réel (2) se présentant sous forme d'un nuage de points, ladite image tridimensionnelle (22) est ensuite numérisée (23) ;  A. acquiring a three-dimensional image (22) of said real object (2) in the form of a scatterplot, said three-dimensional image (22) is then digitized (23);
B. à partir de ladite image tridimensionnelle numérisée (23), reconstruction à l'aide d'un logiciel de dessin ou de Conception Assistée par Ordinateur, d'un modèle (3) tridimensionnel de l'objet réel (2) ;  B. from said digitized three-dimensional image (23), reconstruction using a computer-aided design or design software, of a three-dimensional model (3) of the real object (2);
C. à partir dudit modèle tridimensionnel (3), programmation du pilotage d'une machine-outil à commande numérique en vue de la fabrication dudit objet (1) complexe de substitution ;  C. from said three-dimensional model (3), programming the piloting of a numerically controlled machine tool for the manufacture of said object (1) substitution complex;
D. fabrication additive dudit objet complexe par la machine-outil à commande numérique ;  D. additive manufacturing of said complex object by the numerically controlled machine tool;
ledit procédé étant caractérisé en ce que l'étape A est réalisée sur ledit objet réel (2) se trouvant dans un état endommagé spécifique à une déformation donnée, et  said method being characterized in that step A is performed on said real object (2) being in a damaged state specific to a given deformation, and
en ce que ledit procédé comprend entre les étapes A et B, les sous-étapes suivantes :  in that said method comprises between steps A and B, the following substeps:
a'1) définition de paramètres topologiques et morphologiques invariants (4) de l'objet réel (2), à partir de laquelle on définit un gabarit (5) ; a' 2) détermination des surfaces fonctionnelles et des surfaces de remplissage de l'objet réel (2) à l'état non endommagé ;  a'1) definition of invariant topological and morphological parameters (4) of the real object (2), from which a template (5) is defined; 2) determining the functional surfaces and the filling surfaces of the real object (2) in the undamaged state;
a' 3) détermination des paramètres topologiques et morphologiques sensibles à la déformation (42) de l'objet réel (2) à l'état endommagé et identification de leurs variations, au niveau de ses surfaces dites fonctionnelles ; et 3) determination of topological and morphological parameters sensitive to deformation (42) of the real object (2) in the damaged state and identification of their variations, at its so-called functional surfaces; and
également caractérisé en ce que l'étape B comprend en outre les sous-étapes suivantes :  also characterized in that step B further comprises the following substeps:
bl) adaptation du gabarit (5) sur ladite image tridimensionnelle (22) définie à l'étape A, à l'aide d'un logiciel de dessin ou de CAO, pour obtenir un modèle spécifique (6) ;  bl) adapting the template (5) to said three-dimensional image (22) defined in step A, using a drawing or CAD software, to obtain a specific model (6);
b2) sur ledit modèle spécifique (6), reconstruction précise des surfaces fonctionnelles à l'état endommagé (61) à partir des surfaces fonctionnelles définies à l'étape a' 2) et reconstruction approximative des surfaces de remplissage à l'état endommagé (62) à partir des surfaces fonctionnelles définies à l'étape a' 2), pour obtenir une image tridimensionnelle reconstruite à l'état endommagé (7);  b2) on said specific model (6), precise reconstruction of the damaged functional surfaces (61) from the functional surfaces defined in step a '2) and approximate reconstruction of the damaged filling surfaces ( 62) from the functional surfaces defined in step a '2) to obtain a reconstructed three-dimensional image in the damaged state (7);
b3) reconstruction précise, sur ladite image tridimensionnelle reconstruite à l'état endommagé (7), des surfaces fonctionnelles à l'état non endommagé (71), par modification des valeurs des paramètres topologiques et morphologiques sensibles à la déformation définis à l'étape a' 3) de manière qu' ils correspondent à une absence de déformation, pour obtenir une image tridimensionnelle reconstruite à l'état non endommagé (8) ; b4) à partir de ladite image tridimensionnelle reconstruite à l'état non endommagé (8), définition précise des zones d'intérêt de l'objet complexe (1) à reconstruire, pour en extraire un fichier numérique fonctionnel (81) comprenant uniquement lesdites zones d' intérêt et un fichier numérique de remplissage (82) comprenant les zones autres que les zones d' intérêt ; b3) reconstructing, on said damaged three-dimensional reconstructed image (7), functional surfaces in the undamaged state (71) by modifying the values of the deformable topological and morphological parameters defined in step a '3) so that they correspond to an absence of deformation, to obtain a three-dimensional image reconstructed in the undamaged state (8); b4) from said three-dimensional image reconstructed in the undamaged state (8), precise definition of the areas of interest of the complex object (1) to be reconstructed, to extract a functional digital file (81) comprising only said areas of interest and a digital file of filling (82) including areas other than areas of interest;
b5) Reconstruction à partir des fichiers fonctionnel (81) et de remplissage (82) d'un modèle volumique fermé (9) dudit objet (1) à reconstruire, qui est mis sous forme de fichier neutre (10) adapté à la fabrication additive.  b5) Reconstruction from functional (81) and filling (82) files of a closed volume model (9) of said object (1) to be reconstructed, which is put in the form of a neutral file (10) adapted to additive manufacturing .
2. Procédé selon la revendication 1, selon lequel l'étape B comprend en outre, à l'issue de l'étape b5) , une étape b6) de lissage global ou localisé dudit modèle volumique fermé ( 9) . 2. Method according to claim 1, wherein step B further comprises, at the end of step b5), a step b6) of overall or localized smoothing of said closed volume model (9).
3. Procédé selon la revendication 2, selon lequel l'étape b6) est réalisée par une méthode surfacique ou volumique . 3. Method according to claim 2, wherein step b6) is carried out by a surface or volume method.
4. Procédé selon la revendication l'une quelconque des revendications 1 à 3, selon lequel on réalise, au cours de l'étape A, un formatage de ladite image tridimensionnelle (22) en un format neutre compatible avec un logiciel de dessin ou de Conception Assistée par Ordinateur. A method according to claim any one of claims 1 to 3, wherein in step A, a formatting of said three-dimensional image (22) in a neutral format compatible with a drawing or drawing software is performed. Computer Aided Design.
5. Procédé selon la revendication l'une quelconque des revendications 1 à 4, selon lequel l'objet complexe (1) à fabriquer est une semelle orthopédique ou une prothèse dentaire, auditive, ou osseuse, pour un corps humain ou animal . 5. Method according to claim any one of claims 1 to 4, wherein the complex object (1) to be manufactured is an orthopedic insole or a dental prosthesis, auditory, or bone, for a human or animal body.
6. Procédé selon la revendication 5, selon lequel l'objet réel est un os trapèze, pour une fabrication d'une prothèse trapézo-métacarpienne (11). 6. The method of claim 5, wherein the real object is a trapezoidal bone, for a manufacture of a trapeziometacarpal prosthesis (11).
7. Procédé selon la revendication 4, selon lequel les zones d'intérêt (26) de l'os trapèze sont les surfaces articulaires avec le scaphoïde, le trapézoïde, le premier métacarpe, et le second métacarpe. 7. The method of claim 4, wherein the areas of interest (26) of the trapezoid bone are the surfaces articular with the scaphoid, the trapezoid, the first metacarpal, and the second metacarpal.
8. Procédé selon l'une des revendications 6 et 7, selon lequel l'étape D de fabrication additive est réalisée à partir de poudre de matériaux biocompatibles. 8. Method according to one of claims 6 and 7, wherein the step D of additive manufacturing is carried out from powder of biocompatible materials.
9. Prothèse trapézo-métacarpienne obtenue par le procédé de fabrication tel que défini selon l'une quelconque des revendications 6 à 8. 9. Trapezo-metacarpal prosthesis obtained by the manufacturing method as defined in any one of claims 6 to 8.
EP19711993.6A 2018-02-26 2019-02-26 Method for manufacturing a complex substitute object from a real object Withdrawn EP3758630A1 (en)

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FR1851657A FR3078418B1 (en) 2018-02-26 2018-02-26 PROCESS FOR MANUFACTURING A COMPLEX SUBSTITUTION OBJECT FROM A REAL OBJECT
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US6126690A (en) * 1996-07-03 2000-10-03 The Trustees Of Columbia University In The City Of New York Anatomically correct prosthesis and method and apparatus for manufacturing prosthesis
US8545569B2 (en) * 2001-05-25 2013-10-01 Conformis, Inc. Patient selectable knee arthroplasty devices
US20110004317A1 (en) * 2007-12-18 2011-01-06 Hacking Adam S Orthopaedic implants
US7991599B2 (en) * 2008-04-09 2011-08-02 Active Implants Corporation Meniscus prosthetic device selection and implantation methods
WO2016102027A1 (en) * 2014-12-24 2016-06-30 Mobelife N.V. Method of using a computing device for providing a design of an implant
EP3277228B1 (en) * 2015-03-31 2020-01-15 Cartiva, Inc. Carpometacarpal (cmc) implants
US10231841B2 (en) * 2015-04-13 2019-03-19 Marco LANZETTA Prosthesis for the trapeze-metacarpal joint of the thumb
WO2017035506A1 (en) * 2015-08-27 2017-03-02 Institute of Orthopedic Research & Education Modification of the surface topography of cartilage grafts for joint reconstruction
EP3205311A1 (en) * 2016-02-10 2017-08-16 National University of Ireland, Galway An implant for a bone joint
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FR3066382A1 (en) * 2017-05-16 2018-11-23 Universite De Technologie De Compiegne METHOD FOR PRODUCING A TRAPEZO-METACARPIAN PROSTHESIS AND PROSTHESIS OBTAINED

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