EP2931326A1 - Substitut osseux et procédé de fabrication dudit substitut osseux - Google Patents

Substitut osseux et procédé de fabrication dudit substitut osseux

Info

Publication number
EP2931326A1
EP2931326A1 EP12812816.2A EP12812816A EP2931326A1 EP 2931326 A1 EP2931326 A1 EP 2931326A1 EP 12812816 A EP12812816 A EP 12812816A EP 2931326 A1 EP2931326 A1 EP 2931326A1
Authority
EP
European Patent Office
Prior art keywords
bone substitute
substitute according
container
jacket
bone
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Withdrawn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
EP12812816.2A
Other languages
German (de)
English (en)
Inventor
Andre BUTSCHER
Marc Bohner
Nicola DÖBELIN
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.)
Dr HC Robert Mathys Stiftung
Original Assignee
Dr HC Robert Mathys Stiftung
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 Dr HC Robert Mathys Stiftung filed Critical Dr HC Robert Mathys Stiftung
Publication of EP2931326A1 publication Critical patent/EP2931326A1/fr
Withdrawn legal-status Critical Current

Links

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
    • A61F2/28—Bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/12—Phosphorus-containing materials, e.g. apatite
    • 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
    • B29C64/10—Processes of additive manufacturing
    • B29C64/165—Processes of additive manufacturing using a combination of solid and fluid materials, e.g. a powder selectively bound by a liquid binder, catalyst, inhibitor or energy absorber
    • 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
    • B33Y70/00—Materials specially adapted for additive 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
    • A61F2/3094—Designing or manufacturing processes
    • 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
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
    • 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
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • 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
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30224—Three-dimensional shapes cylindrical
    • 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
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
    • A61F2002/30588—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid filled with solid particles
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • A61F2002/30784—Plurality of holes
    • 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
    • A61F2002/30968—Sintering
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • 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
    • A61F2310/00179—Ceramics or ceramic-like structures
    • A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
    • 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
    • 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
    • B33Y80/00—Products made by additive manufacturing

Definitions

  • the invention relates to a bone substitute according to the preamble of claim 1 and to a method for its production according to the preamble of claim 29.
  • the pore density or distribution within the bone substitute material is difficult to control. It would therefore be desirable to obtain a bone substitute in which the porosity, especially in the inner core of the scaffold or Scaffolds has a greater porosity than in the edge region.
  • the porosity especially in the inner core of the scaffold or Scaffolds has a greater porosity than in the edge region.
  • it is typically the other way round in the conventional methods, with the result that cell / scaffolding interactions concentrate on the periphery.
  • the invention aims to remedy this situation.
  • the invention has for its object to provide a bone substitute, which:
  • a) also has a complex geometry with high porosity inside
  • B) allows the migration of cells; c) has an optimal surface-to-volume ratio, with as large a volume as possible accessible to the bone cells being available per volume; d) has a strength which enables the typically necessary manipulation of the bone substitute without damage; e) requires very little or no polymer components;
  • the invention solves this problem with a bone substitute, which has the features according to claim 1, and a method for its production, which has the features of claim 29.
  • the container has one or more windows penetrating the jacket.
  • the loose particles can thus be removed by depowdering through the window or windows from the cavity of the container.
  • the dimensions of the individual packing are defined by their longest enveloping circular cylinder with the diameter D z .
  • the average diameter Dp of the particles is between 1 pm and 250 pm.
  • the mean diameter D M of the pores or channels is less than Dz.
  • each of the windows has a smallest dimension DF that obeys the relationship D z >DF> Dp.
  • the diameter Dz is greater than 200 pm, preferably greater than 500 pm.
  • the diameter DF is greater than 50 pm.
  • the filler body and the jacket are produced in one operation by means of a three-dimensional printing process 3DP or a selective laser sintering process SLS.
  • the inventive bone substitute may also be made by making a hollow cylinder, filling the cylinder with small particles, and closing the ends of the cylinder with a hydraulic cement.
  • the filler bodies are spaced apart, wherein preferably the minimum distance between the packing is greater than 50 pm. If the fillers are placed too close together, they may stick together.
  • the jacket in addition to the openings and the windows, contains a number of passages whose diameter D D is at least equal to Dp and at least 30 ⁇ m. In a further embodiment, the jacket has interparticle and intercrystalline spaces with an average diameter which is in the range of 0.1 D P to 0.5 Dp and 1 to 50 ⁇ .
  • the jacket of the container and the packing are the reaction product of the solidification of a loose powder of the particles, preferably produced by means of 3DP or SLS.
  • solidification by crystal formation or polymerization e.g., sugar or salt powder + water from the printhead or, alternatively, any powder + salt / sugar / polymer solution from the printhead.
  • the sugar crystals form a matrix which the CaP particles
  • Sugar crystals include.
  • Example Polymer solution printed on powder bed with any material.
  • the jacket of the container and the packing are different reaction products of the solidification of a loose powder of the particles, preferably generated by means of 3DP or SLS.
  • the 3DP process allows for different solutions (eg with two printheads) which potentially lead to different reaction products.
  • CDHA calcium-deficient hydroxyapatite
  • DPD dicalcium-phosphate
  • the jacket of the container and the packing are the reaction product of a hydraulic cement after its curing, preferably generated by 3DP.
  • the shell of the container and the packing are the melt product of the composite of a ceramic powder in a SLS process.
  • the solidification is based on the reaction of one or more calcium phosphates or calcium sulphates with an aqueous solution.
  • the calcium phosphate is alpha-TCP, beta-TCP, hydroxyapatite, TetCP or a mixture thereof.
  • the final product contains DCPD, DCP or a mixture thereof.
  • the solidification takes place on the reaction
  • beta-TCP Ca 3 (PO 4 ) 2
  • alpha-TCP Ca 3 (PO 4 ) 2
  • hydroxyapatite Ca 5 (PO 4 ) 30H
  • calcium-deficient hydroxyapatite Caio-x (HPO 4 ) x (P0 4 ) 6-x (OH) 2-x , with 0 ⁇ x 1) or tetracalcium phosphate (Ca 4 (PO 4 ) 2 0) and
  • Additives to the aqueous liquid that are sprayed onto the powder bed by the printhead are acids, hydrogels, alcohols, fats, and surfactants.
  • the advantage is achieved that the necessary for the solidification reaction acid is made possible by the MCPM cement reaction by pure water.
  • much higher mechanical properties are achieved since it is not the capillary forces that determine the local cement reaction, but rather a more homogeneous one through the powder layer Reaction is enabled and thereby a better connection between the individual powder layers can be achieved.
  • the porosity of the filling of the container defined by the filling bodies is in the range from 1 to 70%, preferably from 20 to 30%. This provides the advantage that the porosity between the packing aids the formation of cells and blood vessels.
  • the fillers have pores with an average diameter of 1 pm to 50 pm.
  • the sheath has any shape which is not rotationally symmetrical, but the sheath is preferably rotationally symmetrical.
  • the jacket has a thickness d> Dz.
  • the bone substitute comprises a plurality of interconnected containers, which are arranged side by side or one above the other.
  • the bone substitute has, in addition to the plurality of unconnected packing, a number of interconnected packing.
  • the jacket has one or more columnar protrusions projecting inside the container.
  • the container has on the inside one or more transverse bars, which are connected at both ends with the jacket.
  • the layers produced by the 3DP or SLS method have a thickness of from 10 pm to 250 pm, preferably from 30 pm to 100 pm.
  • the particles of the hydraulic cement which form the powder consist of MCP and MCPM and TCP and are cured solely by means of water or aqueous solution.
  • the loose particles remaining inside the container by the 3DP or SLS method are removed from the container by at least one window using one of the following techniques:
  • the advantage is achieved that the remaining non-interconnected particles of the powder in the 3DP and SLS process form a kind of support function for overhanging and nested geometries of the container and the packing.
  • This is a decisive advantage over other rapid prototyping methods.
  • the disadvantage that the remaining particles must be removed again is overcome according to the invention.
  • the small movements of the filling bodies and the time-dependent deflection and swirling of the injected air allow the depowdering even of complex geometries in the interior of the shell.
  • a preferred use of the bone substitute is the in vivo colonization with body cells or in vitro culture of cell tissues.
  • Another preferred use of bone replacement is the in vitro colonization of bone or cartilage cells.
  • the bone substitute is used to fill or bridge defects or voids in the bone.
  • the invention and further developments of the invention are explained in more detail below with reference to the partially schematic representations of several embodiments.
  • Fig. 1 is a perspective view of an embodiment of the inventive bone replacement
  • FIG. 2 shows a plan view of the embodiment of the bone replacement according to the invention shown in FIG. 1;
  • FIG. 3 shows a longitudinal section through the embodiment of the inventive bone replacement shown in FIG. 1;
  • FIG. 4 shows a cross section through the embodiment of the inventive bone replacement shown in FIG. 1;
  • FIG. 5 shows a side view of the embodiment of the bone replacement according to the invention shown in FIG. 1;
  • FIG. 6 shows a perspective view of a further embodiment of the bone substitute according to the invention.
  • FIG. 7 shows a plan view of the embodiments of the bone replacement according to the invention shown in FIG. 6;
  • FIG. 8 shows a longitudinal section through the embodiments of the inventive bone replacement shown in FIG. 6;
  • FIG. 9 shows a cross section through the embodiment of the inventive bone replacement shown in FIG. 6; FIG. and
  • FIG. 10 is a side view of the embodiment of the inventive bone replacement shown in FIG. 6.
  • FIGS. 1 to 5 show an embodiment of the bone substitute 1 according to the invention, which essentially comprises a container 2 and a plurality of random packings 5 enclosed in the container 2.
  • the dimensions of the individual packing 5 are defined by their longest enveloping circular cylinder with the diameter D z .
  • the packing 5 consist of interconnected particles with a mean diameter Dp of at least 1 pm.
  • the diameter D z of the longest wrapping body 5 enveloping Circular cylinder is greater than 200 ⁇ .
  • the bone substitute 1 may comprise a plurality of interconnected container 2, which are arranged side by side or one above the other.
  • the bone substitute 1 may comprise, in addition to the plurality of unconnected packing 5, a number of interconnected packing 5.
  • the container 2 comprises a porous jacket 4 which is at least partially provided with openings (not shown) and which may have any desired shape, but is preferably rotationally symmetrical (eg hollow cylindrical).
  • the container 2 further comprises a container bottom 7 and a container cover 8, wherein the container bottom 7 and the container cover 8 may also be porous and at least partially with openings (not shown) may be formed.
  • the openings of the shell 4, the container bottom 7 and the container cover 8 are interconnected pores or channels with an average diameter of DM which is smaller than Dz.
  • the container 2 comprises a plurality of the jacket 4 penetrating windows 6, which are dimensioned so that no filler 5 passes through one of the windows 6.
  • the windows 6 have a smallest dimension D F , which obeys the relationship D z > D F > Dp.
  • the diameter Dp of the window 6 is greater than about 50 ⁇ .
  • the shell 4 may comprise a plurality of passages 3 (FIGS. 6 and 8 to 10) whose diameter DD corresponds at least to the mean diameter D P of the particles forming the packing 5, in order to remove the loose powder allow, but ideally greater than 30 ⁇ (angiogenesis) is.
  • the jacket 4 may have interparticle and intergranular spaces, which have a mean diameter in the range of 0.1 Dp to 0.5 Dp, wherein this average diameter is between 1 and 50 ⁇ .
  • the thickness d of the shell 4 may be smaller than the diameter Dz of the longest wrapping body 5 enveloping circular cylinder.
  • the jacket 4 may have one or more columnar projections projecting inside the container 2.
  • the container 2 inside one or more cross bars identify that are connected to both ends of the jacket 4.
  • the porosity of the filling defined by the filling body 5 of the container 2 is in the range of 1 to 70%.
  • SFF Solid Free Form Fabrication
  • the present invention primarily relates to an application with the powder-based 3DP method (three-dimensional printing) but is also applicable to other powder-based SFF methods, such as e.g. SLS (Selective Laser Sintering) directly applicable.
  • SFF Selective Laser Sintering
  • 3D printers which include machines that build three-dimensional workpieces.
  • the construction of the workpiece is usually computer-controlled from one or more liquid or powdery materials according to predetermined dimensions and shapes, which can be defined by CAD methods.
  • the 3DP process is an additive process wherein a workpiece is made by sequentially forming layers of material.
  • physical or chemical hardening processes take place.
  • the dimensions and the shape are read in by the machine and then the individual layers of liquid, powder or plate-like material are deposited in succession, so that a workpiece is formed from a series of cross-sectional layers. These layers are automatically connected or fused together to make the workpiece.
  • the SLS process is also an additive process whereby spatial structures are produced by sintering from a powdery starting material.
  • the workpiece is also built up layer by layer, with small particles of plastic, metal or ceramic being melted by high-energy lasers (carbon dioxide lasers).
  • the material is selectively melted on the surface of a powder bed to form a solid cross-sectional layer of the workpiece upon curing of the molten material.
  • the powder bed is lowered by one layer thickness and a new layer of material is applied to the surface of the lowered powder bed. The process is repeated until the workpiece is completed.
  • the jacket 4 of the container 2 and the plurality of random packings 5 are produced in layers at the same time by means of 3DP or SLS methods.
  • the layers produced by the 3DP or SLS method may have a thickness of 10 pm to 250 pm, preferably of 30 pm -10 pm.
  • the particles of the hydraulic cement constituting the powder may consist of MCPM (Ca (H 2 PO 4 ) 2 H 2 O) or MCP (Ca (H 2 PO 4 ) 2) and TCP and cured alone by means of an aqueous solution or water ,
  • the uncured particles remaining inside the container by the 3DP or SLS method can be removed from the container 2 by at least one of the windows 6 using one of the following techniques: vacuum, rinsing with a medium in an ultrasonic bath, or vibration.
  • Another innovation according to the invention relates to the composition of the powder.
  • the prior art in 3DP for bone replacement is as follows: An acid is applied to the powder bed by means of a printhead, whereby the ceramic powder particles are locally bonded by means of a precipitation reaction.
  • a novel method of blending the ceramic particles e.g., CaP calcium phosphates
  • particles that form acid upon contact with water e.g., MCP monocalcium phosphate
  • the bone substitute produced according to the invention is reinforced, for example, by immersion in an acid bath, by thermal aftertreatment, for example sintering or by aftertreatment (infiltration)
  • post-hardening ie the bone substitute produced according to the invention is reinforced, for example, by immersion in an acid bath, by thermal aftertreatment, for example sintering or by aftertreatment (infiltration)
  • a new and completely unproblematic "post-hardening” is possible by replacing the bone at a controlled or saturated humidity or by direct contact with water (with capillary Absorption, immersion or spraying) by subsequent crystal formation is solidified.
  • the jacket 4 of the container 2 and the packing 5 may be the reaction product of the solidification of a loose powder of the particles and are produced by means of 3DP or SLS.
  • Examples are a) solidification by crystal formation or polymerization (eg sugar or salt powder + water from the printhead or as another alternative any powder + salt / sugar / polymer solution from printhead (eg sugar / CaP powder bed locally with water droplets (from the printhead via 3DP The serrations of the sugar crystals form a matrix which holds the CaP particles together, and subsequent steps may involve further bonding of the CaP or washing out of the sugar crystals.)
  • b) solidification by capillary forces: drying and dicing of the surface of a powder; c) solidification by gelation (eg alginate + Ca 2+ ions gel); d) solidification by cooling (eg a liquid medium is printed on a powder and solidifies on cooling); or e) solidification by sintering or melting and cooling (SLS or SLM (Selective
  • the jacket 4 of the container 2 and the packing 5 may be the reaction product of a hydraulic cement after it has hardened, preferably produced by 3DP or else the reaction product of the composite of e.g. Be ceramic and polymer powder mixture in a SLS process.
  • solidification may be based on the reaction of one or more calcium phosphates or calcium sulphates with an aqueous solution.
  • the calcium phosphate may be alpha-TCP, beta-TCP, hydroxyapatite, TetCP or a mixture thereof.
  • the solidification may also be based on the reaction a) of a powder mixture of MCP (Ca (H 2 PO 4 ) 2) or MCPM (Ca (H 2 PO 4 ) 2 H 2 O) or a mixture thereof with b) one or more several of the following substances: beta-TCP (Ca 3 (PO 4 ) 2) or, alpha-TCP (Ca 3 (PO 4 ) 2 ) or hydroxyapatite (Ca 5 (PO 4 ) 3 OH) or calcium-deficient hydroxyapatite (Caio -x (HPO 4 ) x (PO 4 ) 6-x (OH) 2-x , with 0 ⁇ x ⁇ 1) or tetracaicium phosphate (Ca 4 (PO 4 ) 2 0) and c) an aqueous solution or pure water respectively.
  • beta-TCP Ca 3 (PO 4 ) 2
  • alpha-TCP Ca 3 (PO 4 ) 2
  • hydroxyapatite Ca 5
  • the embodiment of the inventive bone replacement 1 shown in FIGS. 6 to 10 differs from the embodiment described in FIGS. 1 to 5 only in that the filling bodies 5 are T-shaped or mushroom-shaped.
  • the filling bodies 5 may comprise two substantially circular-cylindrical sections, of which each a first section has a larger diameter than the second section adjoining thereto.
  • Also differently configured embodiments of the packing 5 are conceivable and arbitrarily combinable.

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  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Materials Engineering (AREA)
  • Manufacturing & Machinery (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Inorganic Chemistry (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un substitut osseux (1) comprenant A) un contenant (2) constitué d'une enveloppe (4) poreuse et au moins en partie munie d'ouvertures et B) une pluralité de corps de remplissage (5) logés dans le contenant (2) et non liés les uns aux autres, C) les corps de remplissage (5) étant composés de particules liées les unes aux autres d'un diamètre moyen Dp et D) les ouvertures de l'enveloppe (4) étant des pores ou des canaux reliés les uns aux autres d'un diamètre moyen DM.
EP12812816.2A 2012-12-11 2012-12-11 Substitut osseux et procédé de fabrication dudit substitut osseux Withdrawn EP2931326A1 (fr)

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PCT/CH2012/000270 WO2014089711A1 (fr) 2012-12-11 2012-12-11 Substitut osseux et procédé de fabrication dudit substitut osseux

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CN105411725B (zh) * 2015-12-14 2018-04-20 宋占涛 一种具有多维通道结构的骨修复材料制备方法
CN112842636A (zh) 2015-12-16 2021-05-28 纽文思公司 多孔脊柱融合植入物
US11638645B2 (en) 2016-05-19 2023-05-02 University of Pittsburgh—of the Commonwealth System of Higher Education Biomimetic plywood motifs for bone tissue engineering
WO2017201371A1 (fr) * 2016-05-19 2017-11-23 University Of Pittsburgh-Of The Commonwealth System Of Higher Education Motifs en contre-plaqué biomimétique destinés à l'ingénierie des tissus osseux

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US20150297349A1 (en) 2015-10-22
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