EP3171901A1 - Bauteile zur fusionierung von wirbelkörpern - Google Patents

Bauteile zur fusionierung von wirbelkörpern

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Publication number
EP3171901A1
EP3171901A1 EP15749739.7A EP15749739A EP3171901A1 EP 3171901 A1 EP3171901 A1 EP 3171901A1 EP 15749739 A EP15749739 A EP 15749739A EP 3171901 A1 EP3171901 A1 EP 3171901A1
Authority
EP
European Patent Office
Prior art keywords
component according
porous
ceramic
component
region
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Withdrawn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
EP15749739.7A
Other languages
German (de)
English (en)
French (fr)
Inventor
Heinrich Wecker
Alfons Kelnberger
Mateusz Juszczyk
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.)
Ceramtec GmbH
Original Assignee
Ceramtec GmbH
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 Ceramtec GmbH filed Critical Ceramtec GmbH
Publication of EP3171901A1 publication Critical patent/EP3171901A1/de
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/447Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02Inorganic materials
    • A61L27/10Ceramics or glasses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3092Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/30971Laminates, i.e. layered products
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2002/4629Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof connected to the endoprosthesis or implant via a threaded connection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2240/00Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001Designing or manufacturing processes
    • A61F2240/005Templates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00179Ceramics or ceramic-like structures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00179Ceramics or ceramic-like structures
    • A61F2310/00185Ceramics or ceramic-like structures based on metal oxides
    • A61F2310/00203Ceramics or ceramic-like structures based on metal oxides containing alumina or aluminium oxide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00179Ceramics or ceramic-like structures
    • A61F2310/00185Ceramics or ceramic-like structures based on metal oxides
    • A61F2310/00221Ceramics or ceramic-like structures based on metal oxides containing calcia or calcium oxide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00179Ceramics or ceramic-like structures
    • A61F2310/00185Ceramics or ceramic-like structures based on metal oxides
    • A61F2310/00239Ceramics or ceramic-like structures based on metal oxides containing zirconia or zirconium oxide ZrO2
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00179Ceramics or ceramic-like structures
    • A61F2310/00293Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/38Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs

Definitions

  • the present invention relates to components for the fusion of vertebral bodies, processes for their preparation and their use.
  • Endoprosthetic components for fusion of vertebral bodies are well known. They are adapted in geometry to the anatomy of the human vertebral body, are located between two vertebral bodies and replace the intervertebral disc completely or partially.
  • PE polyethylene
  • PEEK polyetheretherketone
  • Ceramic components based on oxide or non-oxide ceramics for example of silicon nitride or aluminum oxide-based materials.
  • a decisive further disadvantage of ceramic components for the fusion of vertebral bodies is generally the high rigidity, which is substantially higher than that of the human vertebral bodies.
  • the mechanical stimulus necessary for bone formation and bone remodeling is missing in the spine and the fusion of the vertebral bodies only insufficient or long-term absence.
  • This phenomenon is also known as "stress shielding". It can lead to the breakdown of bone material and prevent the buildup of new bone material.
  • porous ceramic structures are already known which can be produced by various processes, for example via template techniques / molding techniques, direct foaming methods or freeze-foaming methods.
  • ceramic components can be produced for the fusion of vertebral bodies, and the bone cells find optimal structures for the construction of new bone material, which may possibly be rendered osseo-inductive by additional functionalizing layers.
  • porous ceramic structures can be designed to produce these mechanical and bone growth conducive conditions.
  • a major disadvantage is that in these porous structures based on ceramic materials during handling during implantation - for example, by the use of an instrument or during healing in the human body - due to biomechanical stresses to point loads on the individual webs of the porous ceramic implant can come and then this fails at least locally.
  • Either the ceramic component is made so massive that it can withstand the mechanical requirements as an implant, then this can suppress the formation of bone and it is only conditionally suitable as a ceramic fusion implant, or one can design if it is bone-porous, then it can happen that it does not meet the mechanical requirements.
  • the object of the present invention is to ensure in a ceramic component for the fusion of vertebral bodies a sufficiently high elongation to promote the formation of new bone and bone regeneration and at the same time a high mechanical and sufficient stability.
  • the invention relates to a ceramic component for fusing vertebral bodies in the region of the human spine (cages), which on the one hand supports bone regeneration and bone remodeling on the one hand solely because of its mechanical properties and on the other hand a sufficiently high mechanical stability and high protection against the occurring forces and effects during implantation and remaining in the human body.
  • the ceramic implant should ensure the fusion of two vertebral bodies quickly and sustainably and thus ensure an optimal result for the patient.
  • the object according to the invention is achieved by the following features of the invention: Component for fusing vertebral bodies, wherein the component consists of a porous, multi-surface body (second area) which has an edge with a compacted area (first area) on at least one surface.
  • the material used for the ceramic of the first region is preferably aluminum oxide, zirconium oxide or mixed ceramics based on previously mentioned materials.
  • Zirconia-reinforced materials are among the mixed ceramics in the context of this invention.
  • zirconium oxides fall all kinds of tetragonal-stabilized zirconia such.
  • the zirconia-based materials with an E-modulus of> 100 GPa and thus on the order of steel are suitable for the invention. Since these materials have high strengths, it is ensured that the component as a whole has sufficient and high strength according to the invention.
  • the standard measured 4-point bending strengths of these materials are in the range between 500 and 2000 MPa, preferably 700 to 1500 MPa.
  • the second inner region according to the invention consists of a porous ceramic, wherein the ceramic may in principle comprise the same material as that of the first region, but may be bioactivated by additional additions of bioactive substances.
  • hydroxyapatite or tricalcium phosphate (TCP) or glass-like substances such as.
  • TCP tricalcium phosphate
  • B. Bioglasses In the case of the hydroxylapatite variants, in particular nanoparticle-based coatings have been found to be particularly favorable according to the invention.
  • Bioglas has the designation 45S5 with the main components S1O2 (silicon dioxide), CaO (calcium oxide), Na2O (sodium hyperoxide) and P2O5 (phosphorus pentoxide).
  • S1O2 silicon dioxide
  • CaO calcium oxide
  • Na2O sodium hyperoxide
  • P2O5 phosphorus pentoxide
  • bioglass compositions which, for example, also have antibacterial properties, which in turn drastically reduces the risk of infection.
  • phosphating layers which are covalently bound to the ceramic surface and, because of their high hydrophilicity, are extremely attractive to bone cells.
  • This bioactivation ensures according to the invention that the process of bone regeneration is excited efficiently and leads to a permanent fusion of the two vertebral bodies.
  • the internal structure of this second inner region has a decisive influence on the osseoconductivity of the component and consequently on the ability to build up new bone material.
  • So-called trabecular structures have proven to be particularly suitable. These structures are very similar to the morphology of cancellous bone and provide optimal conditions for the growth of cells involved in bone formation.
  • trabecular structures can be produced by known impression technologies, wherein polyurethane support structures are used as templates, which are immersed in appropriately prepared ceramic slurry and then burned out.
  • Direct foaming methods are also conceivable in which the foam-forming substances are part of the ceramic slip and the porous, interconnecting structures can be spontaneously generated in a targeted manner.
  • the mechanical properties of the second inner region in the final sintered state depend strongly on the composition of the material and on the structure, but can also be adjusted specifically and adapted to the biological environment. According to the invention, however, the second region of the component is less firm and less rigid than the first, outer region of the component, so that the deformations necessary for the stimulation of the bone can take place.
  • zirconium xid-based materials such as As cerium-stabilized zirconia or multiphase zirconia-based materials such.
  • B. strontium hexaaluminate-containing, yttrium-stabilized zirconia are suitable because of their relatively low modulus of elasticity for the invention.
  • the modulus of elasticity of the porous inner region is in the range of ⁇ 100 GPa, preferably ⁇ 50 GPa, particularly preferably ⁇ 25 GPa, very particularly preferably between 1 and 10 GPa.
  • the modulus of elasticity of the inner region is thereby understood the effective, macroscopic modulus of elasticity of the porous structure.
  • the corresponding compressive strengths are in the range of a few 10 MPa.
  • the compressive strength of the material of the compacted region (first region) is at least a factor of 10 higher than the compressive strength of the porous region (second region).
  • Decisive for the component according to the invention is the combination of these two areas or the design of the component resulting from the combination.
  • the first region is formed in two parts, with each part of the first region surrounding the mechanically sensitive edge regions of the end faces of the second region according to FIGS. 1 and 2.
  • the two peripheral parts of the first region are fixedly connected to the porous second region, for example sintered together.
  • the two parts of the first area but have no connection with each other.
  • the mechanical flexibility of the component is predetermined by the porous second region, the mechanically sensitive edge regions being protected by monolithic, solid and circumferential second ceramics.
  • the second porous region is offset inwardly overall and is thus protected by the two parts of the first region in the manner of a protector.
  • the two parts of the first region can also have structures, for example recesses, holes with / without threads or grooves, which make it possible to engage an instrument for safe handling, in particular during implantation.
  • the interface with the instrument according to the invention therefore extends primarily over the stable first region.
  • the first region of the component according to the invention represents the primary interface with the two end plates of the adjacent vertebral bodies, which are formed by suitable structures, such as, for example, As peaks, edges or pyramidal elevations ensures optimal primary stability.
  • connection of the two areas can be made according to the invention by joining in the green state and by subsequent cosintering, so that a cohesive connection is formed.
  • any type of shaping in the green according to the prior art is suitable for ensuring a connection of the two areas.
  • the porous second region can be foamed directly into the two monolithic partial regions, which are arranged in a special shape.
  • such an implant may be made of other materials suitable for implantation, such as titanium metals and metal wires, rather than ceramic.
  • materials suitable for implantation such as titanium metals and metal wires, rather than ceramic.
  • various of the above such as lower artifacts in imaging, general non-toxicity and others. The same applies to the next variant too.
  • the sensitive edge regions of the porous ceramic of the second region are green-infiltrated with a ceramic slip. Infiltration densifies these areas. Subsequent sintering forms a cohesive bond in which the mechanically sensitive regions of the fusion component are protected.
  • specific gradients in the porosity or other porous structures can also be set or produced according to the invention in order to specifically adapt the elastic properties of the ceramic component to the mechanical requirements of bone growth.
  • the invention comprises a component for fusing vertebral bodies, wherein the component consists of a porous, multi-surface body which has an edge with a compressed area on at least one surface.
  • the component consisting of the porous, multi-surface body, in each case on at least one surface on two opposite edges on a compacted region.
  • the component consisting of the porous, multi-surface body, on at least one surface on an edge with a circumferential, compacted area.
  • the component, consisting of the porous multi-surface body has edges with compressed regions on two surfaces lying opposite one another.
  • the component consisting of the porous, multi-surface body, on two opposite surfaces each edge with a circumferential, compacted area.
  • the component consisting of the porous, multi-surface body, made of porous ceramic.
  • the component consisting of the porous, multi-surface body, made of porous ceramic and allows large elastic strains to.
  • the compacted region consists of densely sintered ceramic.
  • the compacted region consists of densely sintered ceramic with high mechanical stability.
  • the material for the ceramic is selected from the group consisting of aluminum oxide, zirconium oxide or mixed ceramics based on the aforementioned.
  • the material for the ceramic is selected from zirconia-reinforced materials (ZTA, zirconia toughened alumina).
  • the component consisting of the porous, multi-surface elegantst the material for the ceramic tetragonal-stabilized zirconium oxide.
  • the component consisting of the porous, multi-surface elegantst the material for the ceramic yttrium-, cerium- or gadolinium-stabilized zirconium oxide.
  • the material for the porous ceramic is selected from the group consisting of aluminum oxides, zirconium oxides or mixed ceramics based on previously mentioned, wherein the material additionally contains a bioactive substance by the the ceramic is bioactivated.
  • porous, multi-surface body is carried out by a bioactive substance based on calcium phosphate, by a glass-like substance or by a phosphating.
  • the bioactive substance is based on calcium phosphate. Hydroxylapatite or tricalcium phosphate (TCP).
  • the glass-like substance is a bioglass with the designation 45S5, which contains as main constituents SiO 2 (silicon dioxide), CaO (calcium oxide), Na 2 O (sodium hyperoxide) and P 2 O 5 (phosphorus pentoxide) ,
  • the effective, markoscopic modulus of elasticity of the porous inner region (second region) is ⁇ 100 GPa.
  • the compacted region has a 4-point bending strength in the range of about 500 to 2000 MPa, preferably 700 to 1500 MPa.
  • the material for the porous ceramic of a zirconia-based material with a compressive strength of> 10 MPa is selected from the group consisting of the porous, multi-surface body.
  • the material of the compacted region has an at least a factor of 10 higher compressive strength than the porous region.
  • the porous ceramic has the following parameters: a pore size between 100 and 1000 ⁇ ,
  • the geometry of the component of the anatomy of the human vertebral body is adapted.
  • the process for producing the component according to the invention comprises the use of template techniques / molding techniques, direct foaming methods or freeze-foaming methods.
  • the edge regions (edges) of the porous ceramic are compacted in a second step by infiltration with a ceramic slurry.

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  • Health & Medical Sciences (AREA)
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  • Oral & Maxillofacial Surgery (AREA)
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  • Prostheses (AREA)
  • Porous Artificial Stone Or Porous Ceramic Products (AREA)
EP15749739.7A 2014-07-22 2015-07-22 Bauteile zur fusionierung von wirbelkörpern Withdrawn EP3171901A1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102014214286 2014-07-22
PCT/EP2015/066776 WO2016012506A1 (de) 2014-07-22 2015-07-22 Bauteile zur fusionierung von wirbelkörpern

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EP3171901A1 true EP3171901A1 (de) 2017-05-31

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US (1) US20170348464A1 (zh)
EP (1) EP3171901A1 (zh)
JP (1) JP2017529297A (zh)
CN (1) CN107072795A (zh)
BR (1) BR112017001391A2 (zh)
DE (1) DE102015213846A1 (zh)
RU (1) RU2017105757A (zh)
WO (1) WO2016012506A1 (zh)

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US10687962B2 (en) 2013-03-14 2020-06-23 Raed M. Ali, M.D., Inc. Interbody fusion devices, systems and methods
US9861495B2 (en) 2013-03-14 2018-01-09 Raed M. Ali, M.D., Inc. Lateral interbody fusion devices, systems and methods
CN111227994A (zh) * 2018-11-28 2020-06-05 财团法人金属工业研究发展中心 多孔质生医植入物及其制造方法
JP7557264B2 (ja) * 2018-12-06 2024-09-27 キヤノン株式会社 セラミックス物品の製造方法、及びセラミックス物品
WO2020116568A1 (ja) * 2018-12-06 2020-06-11 キヤノン株式会社 セラミックス物品の製造方法、及びセラミックス物品
US12080533B2 (en) 2019-05-31 2024-09-03 Dh Technologies Development Pte. Ltd. Method for real time encoding of scanning SWATH data and probabilistic framework for precursor inference

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US20120330420A1 (en) * 2001-05-01 2012-12-27 Amedica Corporation Spinal fusion implants
JP2004089326A (ja) * 2002-08-30 2004-03-25 Akira Nai 人工椎弓用部材および人工椎体用部材
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JP2008541851A (ja) * 2005-05-27 2008-11-27 アメディカ コーポレイション セラミックの脛骨部品を有する人工膝関節
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US20090317278A1 (en) * 2006-08-31 2009-12-24 Japan Science And Technology Agency Composite artificial bone
WO2008122595A2 (en) * 2007-04-05 2008-10-16 Cinvention Ag Biodegradable therapeutic implant for bone or cartilage repair
DE102009014184A1 (de) * 2008-11-07 2010-05-20 Advanced Medical Technologies Ag Implantat zur Fusion von Wirbelsäulensegmenten
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CN102397588B (zh) * 2011-11-15 2014-02-12 东南大学 多孔镁合金三维增强可吸收医用复合材料及其制备方法
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Also Published As

Publication number Publication date
JP2017529297A (ja) 2017-10-05
RU2017105757A (ru) 2018-08-22
BR112017001391A2 (pt) 2017-11-21
CN107072795A (zh) 2017-08-18
DE102015213846A1 (de) 2016-01-28
US20170348464A1 (en) 2017-12-07
RU2017105757A3 (zh) 2019-03-05
WO2016012506A1 (de) 2016-01-28

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