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WO2017098039A1 - Procédé de fabrication d'un dispositif permettant de supporter un matériau de remplissage de défaut et dispositif correspondant - Google Patents

Procédé de fabrication d'un dispositif permettant de supporter un matériau de remplissage de défaut et dispositif correspondant Download PDF

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Publication number
WO2017098039A1
WO2017098039A1 PCT/EP2016/080593 EP2016080593W WO2017098039A1 WO 2017098039 A1 WO2017098039 A1 WO 2017098039A1 EP 2016080593 W EP2016080593 W EP 2016080593W WO 2017098039 A1 WO2017098039 A1 WO 2017098039A1
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WO
WIPO (PCT)
Prior art keywords
bone
defect
implant
volume
filling material
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.)
Ceased
Application number
PCT/EP2016/080593
Other languages
English (en)
Inventor
Peter VAN DEN BERGHE
Wim Wouters
Ben Geebelen
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.)
Materialise NV
Mobelife NV
Original Assignee
Materialise NV
Mobelife NV
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 Materialise NV, Mobelife NV filed Critical Materialise NV
Publication of WO2017098039A1 publication Critical patent/WO2017098039A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61F2/32—Joints for the hip
    • A61F2/34—Acetabular cups
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing
    • 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
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2/4601—Special tools for implanting artificial joints for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
    • 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
    • A61F2002/30672—Features concerning an interaction with the environment or a particular use of the prosthesis temporary
    • 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
    • A61F2/30721—Accessories
    • A61F2/30734—Modular inserts, sleeves or augments, e.g. placed on proximal part of stem for fixation purposes or wedges for bridging a bone defect
    • A61F2002/30736—Augments or augmentation pieces, e.g. wedges or blocks for bridging a bone defect
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/34—Acetabular cups
    • A61F2002/3429—Acetabular cups with an integral peripheral collar or flange, e.g. oriented away from the shell centre line
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00353—Bone cement, e.g. polymethylmethacrylate or PMMA

Definitions

  • Bone loss and poor bone quality are two major challenges of joint revision surgery.
  • the defect can be prepared for implant placement, e.g. by filling it with defect-filling material such as adjunctive morselized bone-graft material, donor materials, bone- marrow-scaffold mixtures, or micro tissue cultures.
  • the same defect-filling material can be applied for re-establishing viable bone stock.
  • defect-filling material It is important to achieve good contact between the defect-filling material and both the host bone and the implant, in order to stimulate bone remodelling, ingrowth and ongrowth.
  • the challenge is therefore to be able to form the layer of defect-filling material in such a way that it fills all the cavities and that its shape is appropriate for receiving an implant, in particular a cup implant.
  • One technique of preparing the defect is the impaction bone-grafting technique, in which morselized bone-graft material is impacted within the defect cavity. This ensures a mechanically stable base for supporting an implant, and allows for the formation and remodelling of bone tissue at the location of the former defect.
  • the graft containment is crafted in situ, such that there is little control over implant location and orientation. This renders the method less suitable for use in combination with a patient-specific implant or pre-operative planning.
  • An alternative for the meshes, particularly when treating very large defects, are large implants, for instance provided with a plurality of flanges, for instance triflanges. Larger implants however often give rise to stress shielding, thereby jeopardizing the chances of survival of bone grafts.
  • This goal is met by a method according to claim 1. More specifically, this goal, amongst other goals, is met by a method for manufacturing a device to be connected to a location associated with a defect on a bone of a patient, wherein the method comprises the steps of:
  • step of designing of the device comprises:
  • the correction volume i.e. the volume which is to be filled by the defect-filling material
  • a suitable device for supporting the defect-filling material can be designed.
  • the device is thereto provided with at least one volume-contacting surface which is formed in accordance with the pre-planned volume.
  • the volume-contacting surface is preferably shaped so as to form a volume of defect-filling material in the shape of the pre-planned correction volume in use.
  • the device, and in particular the volume-contacting surface thereof thereby functions to form a receptacle for the defect-filling material on the location of the bone.
  • the device thereby forms, in connected state, a mould, wherein the mould is arranged to receive the defect-filling material.
  • a typical device according to the invention for supporting defect-filling material in a defect in a bone of a patient therefore preferably comprises:
  • At least one volume-contacting surface for at least partially enclosing a correction volume of defect-filling material, wherein said correction volume is representative for a volume of defect-filling material which at least partially fills said defect;
  • the correction volume may be designed to prepare the bone for said implant such the implant has a stable and predetermined fit on the bone, despite the implant being generic.
  • a properly supported implant reduces the effects of stress shielding, thereby reducing further bone quality deterioration.
  • the shape of the correction volume, in particular the correction surface thereof need not to be formed to exactly match the surface of the implant. It is for instance possible that the correction volume is determined to be larger than the final volume of the defect-filling material between the bone and the implant. Placing the implant on said over-dimensioned correction volume will then result in compression or additional compaction of the defect-filling material upon fixation of the implant, which may be beneficial. It is then preferred if the correction volume, in particular the correction surface thereof, is formed to be geometrically similar to the implant, in particular the surface to contact the defect-filling material. It may further be possible to design the correction volume to be smaller than the actual volume between the implant and the bone in connected state. Under-dimensioning the correction volume allows for cement to be inserted between defect-filling material and the implant.
  • the correction volume is preferably determined so that in use, that is when the device is connected to the bone and defect-filling material is introduced in said volume, the defect is at least partially filled by said material.
  • the defected bone is then at least partially filled or reconstructed, such that also the defected part of the bone can support the implant. This provides a more homogeneous support of the implant on the bone, also on the defected bone.
  • the correction volume is determined to ensure sufficient loading on the defect bone in connected state of the implant to prevent bone resorption.
  • the defect is hereto substantially filled.
  • the correction volume is determined to be substantially congruent to the defect of the bone.
  • the lower surface of the correction volume hereby preferably matches the surface of the bone. Correctly defining the lower surface of the correction volume allows an accurate determination of the correction volume and thereby also of the amount of defect-filling material to be used as will be explained in greater detail below.
  • a correction volume may also be determined to be located on healthy bone surfaces to customize the surface thereof. It is for instance possible that the correction volume is designed on the basis of the implant, wherein the correction volume is designed to fill a volume between the bone and the implant. This for instance allows a custom fit of a generic implant on the bone, wherein the implant is at least partially supported by the defect-filling material in the correction volume. Instead of, or at least in addition to, reaming, i.e. removing bone to allow a fit between an implant and the bone, the bone surface may be customized to the implant using defect-filling material. It is further possible to provide a plurality of correction volumes.
  • a further preferred embodiment of the method according to the invention further comprises the step of planning fixation of said device, for instance using a screw, pin or wire, on the basis of the patient model, wherein the step of designing the device further comprises designing fixation means in accordance with the planned fixation. It is for instance possible to pre-operatively plan the trajectories and lengths of a plurality of screws or pins for connecting said device the bone to ensure that the device is reliably connected to said bone.
  • the planning may for instance include determining the bone quality of the bone surrounding the device in connected state to ensure that for instance the screws or pins engage healthy bone.
  • the device according to the invention therefore further comprises fixation means for connecting the device to the bone, for instance using a screw, pin or wire, wherein the fixation means are designed on the basis of a pre-planned fixation of said device.
  • the fixation means may for instance be formed as holes in said device, wherein the holes have an orientation in accordance with the planned trajectories.
  • the step of designing the bone-contacting surface comprises identifying a healthy bone surface and forming said bone- contacting surface substantially congruent to said identified bone surface.
  • the bone surface is preferably identified to be remote from the defect such that the device does not rest on said defect to be corrected.
  • the fixation means as mentioned above are then preferably arranged in said bone-contacting surface such that the device is connected to the healthy bone.
  • the device according to the invention preferably comprises an annular body arranged to surround the defect in the bone.
  • a device is in particular suitable to correct an acetabular defect.
  • the annular body is then designed to surround the acetabular region, which is typically defected.
  • the annular body is then arranged to receive the defect-filling material to correct the defect or to allow fixation of an implant, such as a cup. It is then preferred if a volume-contacting surface is arranged on a radially inwardly surface of the annular body.
  • the device is designed to substantially cover the defect, such that the correction volume is substantially enclosed by the volume-contacting surface and the bone, and possibly the perforation-filling element as described above, wherein the device is designed with at least one through hole extending between the exterior and the correction volume for introducing defect-filling material.
  • the device is arranged to align an implant according to a pre-operative planning.
  • the method therefore preferably comprises the step of planning the position of an implant for correcting said defect on the basis of the patient model, wherein the step of designing the device further comprises designing implant connection means, wherein the implant connection means are arranged to align and connect the implant according to the planned position of the implant with respect to the device.
  • the connecting means may comprise alignment means which ensure a unique fit of the implant with respect to the device and thereby with the bone.
  • the implant-connection means be arranged to allow relative movement of the implant and the device along a predetermined direction.
  • the movement of the implant with respect to the device, and thus with respect to the bone, will result in extra loads being transferred from the implant, preferably via the defect-filling material, to the bone.
  • the direction is substantially parallel to the prevailing loading direction on the implant Joint loads are hereby transferred from the implant straight to the bone and defect-filling material, instead of to the device. This prevents stress shielding and promotes bone remodelling.
  • the implant-connection means may for instance comprise cooperating guiding surfaces on the device and the implant which limit relative movement along a predetermined direction.
  • the method preferably further comprises the step of providing a design of the implant, wherein the correction volume is determined on the basis of the design of the implant and the patient model, such that the implant is at least partially supported by the defect-filling material in the correction volume and preferably has a unique fit on the bone and/or defect-filling material.
  • the design of the implant may be based on the design of the device, in particular in terms of the bone-contacting surfaces and the volume-contacting surface. The latter further ensures a proper interconnection and fit of the implant and the defect-filling material.
  • the invention thus further relates to a combination, or a kit of parts, of a device according the invention and said implant, wherein the device is designed as a temporary device for providing the correction volume of defect-filling material on the bone to be replaced by the separate implant.
  • the device is designed as a temporary device for providing the correction volume of defect-filling material on the bone to be replaced by the separate implant.
  • a good fit between the applied defect-filling material and the implant is achieved when, according to a preferred embodiment, the implant and the device are provided with corresponding volume- contacting surfaces.
  • An efficient design method is obtained if the implant and the device are provided with
  • the bone surfaces identified for connecting the device to the bone are then also used for connecting the implant to the bone.
  • the device may further be provided with guiding means for guiding fixation means for fixing the implant to the bone, for instance in accordance with a pre -operative plan as mentioned above, wherein the implant is provided with corresponding fixation means.
  • the device may also function as drill guide which allows drilling screw holes in accordance with a pre- operatively determined plan.
  • the device may further be used to guide means for bone preparation.
  • the device is then preferably provided with tool-guiding means arranged to guide bone-preparing tools, such as saws, drills or the like.
  • the device may for instance be provided with cutting slots or guides for reamers which are designed to guide the tools for preparation of the bone, in particular the bone defect.
  • a further preferred embodiment of the method further comprises the step of determining an amount of defect-filling material for filling said correction volume and providing a container with said amount of defect- filling material. This ensures that the correct amount of material is available on site to fill the correction volume as planned.
  • a further preferred embodiment further comprises the step of providing an applicator device arranged for introducing defect-filling material in the correction volume, wherein the applicator device is provided with at least one engagement surface arranged for engaging said defect-filling material, wherein said engagement surface is designed in accordance with the determined correction volume.
  • the applicator device is arranged to form the material introduced in accordance with the shape of the correction volume, in particular the surfaces of the volume which are not in contact with the bone, the volume-contacting surfaces or other shape-defining surfaces.
  • the correction volume is then preferably enclosed by the engagement surface of the applicator device, the volume-contacting surface of the device, the bone and possibly the perforation-filling element as mentioned above.
  • the engagement surface is preferably shaped in accordance with the correction surface.
  • the invention thus further relates to the combination, or a kit of parts, of a device according to the invention and an applicator as described.
  • the invention then also relates to combination of a device according to the invention and an applicator device arranged for introducing defect-filling material in the correction volume, wherein the applicator device is provided with at least one engagement surface arranged for engaging said defect-filling material, wherein said engagement surface is designed in accordance with the determined correction volume such that in combined situation on the bone, the correction volume is enclosed by the engagement surface of the applicator device, the volume-contacting surface of the device, the bone and possibly the perforation-filling element as described above.
  • the applicator may be generic impacting device, wherein the device is shaped in accordance with said applicator, it is preferred if the applicator device is customized to the device, in particular to ensure a unique fit between the applicator device and the device to ensure that the defect-filling material is applied according to the pre -operative plan.
  • a further preferred embodiment therefore further comprises the steps of:
  • the applicator device comprises a plunger, wherein the plunger is movable between a first position such that the determined amount of defect-filling material can be contained in said applicator device and a second position such that the defect- filling material can be introduced in said determined correction volume. This ensures that the correct amount of material is introduced into the volume, while at the same time the material is correctly shaped in accordance with the correction volume as planned.
  • applicator device It is possible to use a single applicator device. It is however also possible to use a plurality of applicator devices, for instance one for each through hole provided in the device.
  • the applicator devices are then preferably shaped in accordance with the location of said through holes, for instance in terms of volumes of material to be held and/or shape of the engagement surface. For that case, it is preferred if an applicator device and the associated hole are provided with unique alignment means to ensure that the correct applicator device is used for the correct hole.
  • the applicator device is formed integrally with said device.
  • the device then functions as a defect-filling material shaping and introducing device.
  • the device may then for instance be provided with one or more movable members as mentioned above.
  • Rapid manufacturing includes all techniques whereby an object is built layer by layer or point per point by adding or hardening material (also called free-form manufacturing).
  • the best known techniques of this type are stereo lithography and related techniques, whereby for example a basin with liquid synthetic material is selectively cured layer by layer by means of a computer-controlled electromagnetic beam; selective laser sintering, whereby powder particles are sintered by means of an electromagnetic beam or are welded together according to a specific pattern; fused deposition modelling, whereby a synthetic material is fused and is stacked according to a line pattern;
  • SLS Selective Laser Sintering
  • FDM Fused Deposition Modeling
  • foil-based techniques etc.
  • SLS Selective Laser Sintering
  • FDM Fused Deposition Modeling
  • foil-based techniques etc.
  • SLS Selective Laser Sintering
  • a common feature of these techniques is that objects are typically built layer by layer.
  • the digital representation is sliced into a series of cross-sectional layers which can be overlaid to form the object as a whole.
  • the RP&M apparatus uses this data for building the object on a layer-by-layer basis.
  • the cross-sectional data representing the layer data of the 3-D object may be generated using a computer system and computer-aided design and manufacturing (CAD/CAM) software.
  • the invention further relates to a method for correcting a defect in a bone of a patient comprising the steps of:
  • FIGS. 2a-c show different ways of fixing the implant to a support device seen in cross section through the bone
  • FIGS. 3a-d show an alternative way of fixing an implant to a bone seen in cross section through the bone
  • figure 6a shows a top view of the applicator device of figures 5a-c;
  • figure 6b shows a top view of implant of figure 5d
  • FIG. 7 shows a device for filling a cavity in a defect seen in cross section through the bone
  • FIGS. 8a and 8b show top views of devices for filling a cavity in a bone.
  • a support device 2 which is arranged to support and delimit a volume of defect-filling material 34 in a defect 12 in a bone 1.
  • the support device 2 has a substantially annular shape having an annular body 23 which surrounds the defect 12, which is in this case an acetabular defect.
  • a three-dimensional patient model of the bone 1 is obtained, on the basis of which the design of the support device 2 is made. More specifically, on the basis of the patient model which contains the three-dimensional bone morphology of at least the part of the bone containing the defect, a planning is made how to correct the defect 12 in the bone 1. In this example, it is planned to place a cup implant 4 in the defect 12, see figure Id. On the basis of the design of the implant 4, in particular the lower surface 41 thereof, a volume 3 is determined (see figure la) which is to be filled with defect-filling material 34 (see figure lb).
  • the upper or correction surface 33 of the correction volume 3 is planned to correspond to the shape of the lower surface 41 of the implant 4. As will be explained in greater detail below, the shape of the correction surface 33 is not determined to be exactly as the shape of the lower surface 41 of the implant 4.
  • the lower surface 32 of the correction volume 3 is determined on the basis of the surface 13 of the defect 12 and the lower surface 32 is determined to be congruent to said surface 13 of the defect 12.
  • the support device 2 is provided with a volume-contacting surface 21 which is provided along the inner surface of the annular body 23 of the support device 2.
  • the bone surface 12 and the volume-contacting surface 21 thereby form a receptacle for the defect-filling material 34 to be inserted in a later step.
  • the correction volume 3 is enclosed on its lower surface 32 by the bone surface 12, on the upper surface 33 by a surface corresponding to the lower surface 41 of the implant 4 and at the sides 35 by the volume-contacting surface 21. It is however noted that determining the correction volume 3 is preferably based primarily on the lower surface 41 of the implant 4, or any other surface to be reconstructed.
  • the support device 2 is thereto provided with in this example three bone-contacting surfaces 22 which are formed on flanges 24 of the support device 2, wherein specific reference is again made to figure 2a.
  • the flanges 24 extend radially outwardly from the annular body 23.
  • the bone-contacting surfaces 22 of the flanges 24 are formed congruent to the bone surface 11 onto which the bone-contacting surfaces 22 are designed to engage.
  • the flanges 24 are furthermore provided with screw holes 25 arranged to receive bone screws to fixate the support device 2 to the bone 1.
  • the support device 2 is to be permanently fixed to the bone 1.
  • the screw holes 25 are positioned and aligned such that the screws to be inserted in the holes extend along pre-operatively planned screw trajectories.
  • the annular body 23 is provided with flanges 26a provided with screw holes 26 to receive screws.
  • the bone-contacting surfaces 22 are formed to closely match the bone surfaces 11 such that the device 2 rests stably on the bone 1.
  • the bone-contacting surfaces 22 on the other hand ensure that the support device 2 can only be placed on the bone 1 in a unique way, in this way ensuring the planned correction volume 3, which will also be defined by the volume-contacting surface 21, will be positioned on the bone 1 as planned.
  • defect-filling material 34 can be inserted into the correction volume 3 using a suitable applicator.
  • a suitable applicator In figure lb this situation is shown. It can be seen that the top surface of the applied defect-filling material 34 does not yet correspond to the pre- planned correction surface 33 of the correction volume 3.
  • an applicator 6 is used.
  • the applicator 6 is shown in inserted position.
  • the applicator 6 is provided with an engagement surface 61 which has a shape corresponding to the correction surface 33 and therefore with the lower surface 41 of the implant 4.
  • the applicator 6 is arranged to be received in the support device 2 in a predetermined way along a direction indicated with I such that the engagement surface 61 of the applicator 6 and the support device 2 are correctly aligned. This allows bringing the upper surface of the material 34 to conform to the pre-planned correction surface 33 of the correction volume 3.
  • the applicator 6 is provided with a flange 62 which is arranged to abut the upper surface of the support device 2, thereby limiting further movement of the applicator 4 with respect to the support device 2.
  • the close fit of the applicator 6 in the support device 2 ensures a unique fit between the applicator 6 and the support device 2, thereby ensuring that the resulting upper surface of the material 34 corresponds to the correction surface 33 as planned.
  • further alignment means for instance in the form of a protrusion engaging in a slit to ensure proper alignment between the applicator 6 and the support device 2.
  • implant-connection means are provided which are formed as a locking ring 27b which fits in an annular groove 27a of the support device 2 in this example, see again figure 2a.
  • discs 27d can be used which can be screwed in correspondingly shaped recesses 27c in the upper surface of the support device 2, see figure 2b.
  • Figure 2c shows a further alternative, wherein the washers 27f that can be fixed to the support device in correspondingly shaped recesses 27e are shown.
  • the device 2 serves to support the defect-filling material 34, in particular to shape the material upon insertion into the pre-planned correction volume 3.
  • the support device 2 however only limits movement of the implant 4 transversely or radially, see arrows ⁇ in figure Id and outwardly in the direction opposite to the direction indicated with I in figure lc.
  • Loads in the direction indicated with I in figure lc which are typical loads exerted on an acetabular cup implant 4, are directly transferred from the implant 4 to the defect-filling material 34 and then to the bone 1.
  • the correction volume 3, and thereby the design of the support device 2 is planned such that the exerted loads, or at least the majority thereof, are directly transferred from the implant to the defect-filling material.
  • the space defined in the housing 65 corresponds to a pre-determined volume corresponding to a pre-determined part of the correction volume 3.
  • the total combination of applicators 6a (in this example two) are then arranged to contain the amount of defect-filling material 34 which corresponds to the volume of the correction volume 3. This ensures filling the correction volume 3 as planned and ensures that sufficient, but also not too much, defect-filling material 34 is inserted into the correction volume 3.
  • this applicator 6a is designed to mate with the device 2 in a unique way.
  • the housing 65 of the applicator 6a is on the outside thereto provided with flanges 62 which are received on the surface of the device 2. Other suitable alignment means can be used as mentioned earlier.
  • the material is injected into the correction volume 3 and the applicator 6a is designed such that the engagement surface 61 of the plunger 64 is then flush with the correction surface 33.
  • each of the applicators 6a to be used is preferably provided with unique alignment means associated with its hole 28.
  • a predetermined amount of material 34 can be inserted into the cup of the device 2 to be subsequently pressed into the correction volume 3 using the applicator 6b.
  • the material 42 is preferably taken from a customized container shaped to contain the amount of the defect-filling material suitable for filling the predetermined correction volume 3.
  • inserts 29 are provided which are shaped to closely fit the holes 28 such that upon insertion of the inserts 29, a smooth surface 42 is formed.
  • the device 2 remains fixed to the bone 1.
  • the device acts as a support device for supporting an implant, whereas in the second example the device itself is formed as an implant.
  • the device 2 is only temporarily connected to the bone to be subsequently replaced by an implant. This allows the use of different materials for the device 2 and the implant 4.
  • the device 2 is again provided with through holes 28, three in this example, see the top view of figure 6a.
  • the device 2 is however provided with tubular guides 64a wherein plungers 64 are provided.
  • the guides 64a only allow a linear movement of the plungers 64 held therein.
  • the plungers 64 are again movable between a retracted position, wherein combined spaces 69 formed in the device 2 correspond to the correction volume 3 such that the amount of material 34 to be inserted into the correction volume 3 can be held in the device 2.
  • the held material Upon moving the plungers 64 to their extended position, see figure Sb, the held material will be injected into the space between the device 2 and the bone 1, thereby filling the correction volume 3.
  • the movement of the plungers is limited (not shown) such that in their extended positions, the end surfaces forming the engagement surfaces 61 are flush with the correction surface 33 as planned.
  • the device 2 can be removed, see figure Sc, to be replaced by an implant 4, see figures Sd and 6b.
  • the implant 4 is shaped similar to the device 2, with the difference that now an implant surface 42 is provided instead of the applicators in the form of plungers 64.
  • the implant 4 is for instance provided with flanges 44 which correspond to the flanges 24 of the device 2.
  • the implant 4 can be fixed to the bone 1 using the screw holes 45 and 26.
  • the acetabulum is shown to be defected but still more or less cup shaped.
  • the bone contains a perforation 14 as shown in figure 7.
  • a perforation-filling element 5 is designed on the basis of the patient model which is arranged to fill the perforation 14.
  • the correction volume 3 is thus enclosed by the perforation- filling element S, the bone surface 13 (see the top view in figure 8a) and the volume-contacting surface 21 of the device 2.
  • a connecting structure 51 is provided to connect the perforation- filling element to the device 2.
  • the present invention is not limited to the embodiments shown, but extends also to other embodiments falling within the scope of the appended claims.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Manufacturing & Machinery (AREA)
  • Physics & Mathematics (AREA)
  • Geometry (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un procédé de fabrication d'un dispositif (2) devant être raccordé à un emplacement associé à un défaut (12) sur un os (1) d'un patient, le procédé comprenant les étapes consistant : - à fournir un modèle de patient numérique tridimensionnel d'au moins une partie du patient comprenant l'emplacement sur l'os comportant ledit défaut; - à déterminer un volume de correction (3) dans le modèle de patient, ledit volume de correction étant représentatif d'un volume de matériau de remplissage de défaut (34); - à concevoir le dispositif sur la base du modèle de patient et du volume de correction déterminé; et - à fabriquer ledit dispositif, l'étape de conception du dispositif consistant : - à concevoir au moins une surface (21) de contact avec le volume sur la base du volume de correction déterminé de sorte que le volume de correction soit au moins partiellement renfermé dans l'os et ladite surface (21) de contact avec le volume; - à concevoir au moins une surface (22) de contact avec l'os conçue pour entrer en contact avec une surface de l'os, la surface (22) de contact avec l'os étant formée de manière à épouser sensiblement ladite surface de l'os pour assurer un emboîtement unique du dispositif sur ledit os. Le dispositif (2) comprend au moins une surface (21) de contact avec le volume pour remplir au moins partiellement un volume de correction de matériau de remplissage de défaut, le volume de correction étant représentatif d'un volume de matériau de remplissage défaut qui permet de remplir au moins partiellement le défaut, au moins une surface (22) de contact avec l'os étant conçue pour être en contact avec une surface de l'os, et ladite surface de contact avec l'os étant formée pour épouser sensiblement ladite surface de l'os pour assurer un emboîtement unique du dispositif sur ledit os.
PCT/EP2016/080593 2015-12-10 2016-12-12 Procédé de fabrication d'un dispositif permettant de supporter un matériau de remplissage de défaut et dispositif correspondant Ceased WO2017098039A1 (fr)

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NL2015935 2015-12-10
NL2015935A NL2015935B1 (en) 2015-12-10 2015-12-10 Method for manufacturing a device for supporting defect-filling material.

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WO2017098039A1 true WO2017098039A1 (fr) 2017-06-15

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CN110575289A (zh) * 2019-09-20 2019-12-17 重庆新索医药科技有限公司 一种骨缺损假体3d打印方法
WO2021050214A1 (fr) * 2019-09-11 2021-03-18 Cedars-Sinai Medical Center Appareil et procédé pour former un espaceur de hanche articulé sur ciment sur mesure
WO2021214601A1 (fr) * 2020-04-23 2021-10-28 DePuy Synthes Products, Inc. Augmentation personnalisée de positionnement imprimé 3d spécifique à un patient pour implant chirurgical orthopédique
US11369476B2 (en) 2018-07-11 2022-06-28 Smith & Nephew, Inc. Flexible acetabular implant
WO2022208410A1 (fr) * 2021-03-31 2022-10-06 DePuy Synthes Products, Inc. Implant chirurgical orthopédique monobloc imprimé en 3d à augmentation personnalisée spécifique au patient
WO2022208405A1 (fr) * 2021-03-31 2022-10-06 DePuy Synthes Products, Inc. Ensemble implant chirurgical acétabulaire modulaire

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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11369476B2 (en) 2018-07-11 2022-06-28 Smith & Nephew, Inc. Flexible acetabular implant
WO2021050214A1 (fr) * 2019-09-11 2021-03-18 Cedars-Sinai Medical Center Appareil et procédé pour former un espaceur de hanche articulé sur ciment sur mesure
CN110575289A (zh) * 2019-09-20 2019-12-17 重庆新索医药科技有限公司 一种骨缺损假体3d打印方法
CN110575289B (zh) * 2019-09-20 2021-10-22 中国人民解放军陆军军医大学第一附属医院 一种骨缺损假体3d打印方法
WO2021214601A1 (fr) * 2020-04-23 2021-10-28 DePuy Synthes Products, Inc. Augmentation personnalisée de positionnement imprimé 3d spécifique à un patient pour implant chirurgical orthopédique
US11730601B2 (en) 2020-04-23 2023-08-22 DePuy Synthes Products, Inc. Customized patient-specific 3D printed positioning augment for orthopaedic surgical implant
WO2022208410A1 (fr) * 2021-03-31 2022-10-06 DePuy Synthes Products, Inc. Implant chirurgical orthopédique monobloc imprimé en 3d à augmentation personnalisée spécifique au patient
WO2022208405A1 (fr) * 2021-03-31 2022-10-06 DePuy Synthes Products, Inc. Ensemble implant chirurgical acétabulaire modulaire
US11918475B2 (en) 2021-03-31 2024-03-05 DePuy Synthes Products, Inc. Modular acetabular surgical implant assembly
US11944549B2 (en) 2021-03-31 2024-04-02 DePuy Synthes Products, Inc. 3D printed monoblock orthopaedic surgical implant with customized patient-specific augment

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NL2015935A (en) 2017-06-22

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