EP2872188A1 - Élément en céramique pour fusionner des corps vertébraux - Google Patents

Élément en céramique pour fusionner des corps vertébraux

Info

Publication number
EP2872188A1
EP2872188A1 EP13736538.3A EP13736538A EP2872188A1 EP 2872188 A1 EP2872188 A1 EP 2872188A1 EP 13736538 A EP13736538 A EP 13736538A EP 2872188 A1 EP2872188 A1 EP 2872188A1
Authority
EP
European Patent Office
Prior art keywords
ceramic
component
inner part
porous
ceramic component
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
EP13736538.3A
Other languages
German (de)
English (en)
Inventor
Alfons Kelnberger
Fiona NEUMANN
Heinrich Wecker
Frank Ziermann
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 EP2872188A1 publication Critical patent/EP2872188A1/fr
Ceased legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B35/00—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
    • C04B35/01—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics
    • C04B35/10—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics based on aluminium oxide
    • 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
    • A61L27/10—Ceramics or glasses
    • 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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/02—Surgical adhesives or cements; Adhesives for colostomy devices containing inorganic materials
    • 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
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
    • A61L27/32—Phosphorus-containing materials, 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B35/00—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
    • C04B35/622—Forming processes; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
    • C04B35/64—Burning or sintering processes
    • 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
    • A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs

Definitions

  • the invention relates to ceramic components, in particular implants, for the fusion of vertebral bodies and to processes for producing these ceramic components.
  • plastics based on plastics such. highly cross-linked PE materials or PEEK are known. Disadvantages of the plastics are, for example: The mechanical properties may be insufficient, e.g. can lead to breaking off prongs or other parts of the component, for example during installation.
  • Ceramic components based on silicon nitride are also known.
  • this material class was developed with a view to achieving excellent high-temperature properties - such as mechanical machining of metallic components for the automotive industry - and tends to rank higher in terms of strength, hardness and long-term stability required for this application than other high performance ceramic materials based on oxide systems in the midfield.
  • it is a relatively complicated material with acicular silicon nitride, which is in a glass matrix is embedded. Therefore, the sintering of the material is expensive.
  • mechanical processing such as grinding or polishing is very demanding and difficult.
  • components made of silicon nitride have a rather dark coloration - gray to black - which, even for optical reasons, meets rather low acceptance in the medical field. All of these disadvantages lead to increased costs in the manufacture of the components, which represents a further disadvantage.
  • the object of the invention is therefore to provide a method for producing a component for the fusion of vertebral bodies and to provide a component for the fusion of vertebral bodies, which avoids the disadvantages mentioned and in particular has sufficient strength, hardness and long-term stability.
  • a further object of the invention is to provide a method which places as little special demands on the processing process as possible.
  • the object is achieved by a component for fusing vertebral bodies according to claim 1 and a method for producing this component according to claim 8.
  • the component according to the invention for the fusion of vertebral bodies accordingly consists of an oxidic ceramic.
  • the products produced have the advantages of oxide ceramics.
  • Oxide ceramics are characterized in particular by a high resistance to and good compatibility with body media.
  • Oxidic ceramics have good biocompatibilities and do not cause allergic reactions.
  • the invention comprises a ceramic component for fusion of vertebrae, in particular in the field of human spine.
  • the component is based on oxide ceramic material systems, comprising: Zirconia-reinforced aluminum oxide (ZTA) and all ZTA systems developed on this basis.
  • ZTA Zirconia-reinforced aluminum oxide
  • Zirconia ceramics in particular yttrium-stabilized zirconia (3Y-TZP).
  • Cerium-stabilized zirconium oxide Cerium-stabilized zirconium oxide (Ce-TZP), in which the stabilization of the tetragonal phase of zirconium oxide by cerium oxide takes place.
  • dispersoid composite component can be based on aluminates and also other stabilizers from the group of rare earths can be used, such. Gd and Sm.
  • ZTA The base material forms the alumina. Its strength and fracture toughness are doubled by adding oxides and ceramic platelets compared to standard ZTAs. This made it possible to realize components in additional sizes and for new applications.
  • the ZTA can be prepared, for example, from materials of the following composition: 72 to 82% by weight Al 2 O 3 , 28 to 18% by weight ZrO 2 , 0 to 1% by weight Cr 2 O 3 , 0 to 6% by weight. -% Y 2 O 3 based on the ZrO 2 content, 0 to 2 wt .-% SrO, 0 to 0.5 wt .-% TiO 2 and 0 to 0.5 wt .-% MgO.
  • a preferred embodiment of the invention comprises a material having the following composition: 72.65 to 74.54% by weight Al 2 O 3 , 24.0 to 25.5% by weight ZrO 2 , 0.5 to 0.65% by weight .-% Y 2 O 3 based on the Al 2 O 3 content, 0.26 to 0.35 Cr 2 O 3 and 0.70 to 0.85 wt .-% SrO.
  • the component has the following composition: 70 to 90 wt .-% Al 2 O 3 : Cr (aluminum oxide with chromium doping, 12 to 22 wt .-% ZrO 2 : Y (zirconium oxide with yttrium stabilization) and 1 to 5% by weight of SrAli 2-x Cr x Oi 9 (strontium nunnin, with variable chromium doping, where x is preferably between 0.0007 and 0.045).
  • 3Y zirconia, 3Y-TZP zirconia (ZrO 2 ) has the highest fracture toughness among ceramic materials.
  • stabilizers such as yttrium oxide are required, with which a strength of more than 1600 MPa is achieved. Similar to the ZTA, the crack propagation is blocked by the so-called conversion gain.
  • Zirconia also makes it possible to produce sharp edges, which predestines the material for the production of components with self-tapping threads, which is already being used, for example, in dentistry.
  • Ce zirconium oxide Ce-TZP: Cerium oxide (Ce 2 Os) can also be used as a stabilizer for zirconium oxide.
  • this material achieves an even higher fracture toughness than 3Y-TZP. It even allows plastic deformation to a limited extent, much like metal. In contrast, strength and hardness are lower than for 3YZirkonoxid. With its also significantly increased elasticity of this material is a particularly preferred choice for the production of a component according to the invention.
  • the component is adapted in its geometry to the anatomy of the human vertebral body. It sits between two vertebrae and replaces the disc completely or partially.
  • the component holds in a first phase of whereabouts in the human body only by its mechanical properties, the vertebral bodies at a distance and in an anatomically correct position. In a second phase it promotes the Fusion and thus the ingrowth of the two vertebral bodies between which it is introduced.
  • the so-called primary stability immediately after surgery and before osseointegration is important.
  • This can be achieved, for example, by providing on the top and the bottom of the component, which are in contact with the cover plates of the adjacent vertebra, morphological formations are provided which ensure a slip-resistant connection to the adjacent vertebrae.
  • Such morphological formations can be, for example, serrated, pyramidal or knobbed structures. With the help of these structures, the components can get caught with the vertebral bodies or the component is fixed in the position in which it was used.
  • the component is ring-shaped or banana-shaped, with geometry and size adapted to the various regions of the spine (e.g., cervical or lumbar).
  • the shape of the component plays an important role in the introduction or implantation in the human body. For different implantation methods different component shapes are required, which are known per se to those skilled in the art.
  • the component has an outer, solid or all-ceramic part, which satisfies the mechanical, biological and chemical requirements during implantation and also during the whereabouts in the human body in an excellent manner.
  • the component also preferably has an inner part which is designed so that human bone cells (eg osteoblasts) or cells, which are necessary in the formation of human bone tissue (ossification), optimal conditions find.
  • human bone cells eg osteoblasts
  • osteoblasts or cells, which are necessary in the formation of human bone tissue (ossification), optimal conditions find.
  • the goal here is the complete bony insertion into the human spine, the so-called osseointegration.
  • this inner part may be hollow, so only an empty, ceramic-free area, which can be used to bring the body's own or autologous bone material, preferably together with known osshuis swipenden substances.
  • this inner part may also be porous, so be designed as a porous, preferably ceramic structure.
  • This porous structure can be particularly preferably realized on the basis of the same ceramic material as the outer part. It has been found that the following properties of an implant positively influence the ossification:
  • Interconnectivity i. the individual pores are at least partially interconnected
  • the structure of the inner part can be produced by various methods, in particular directly during the production process of the ceramic component or separately by subsequent introduction of the inner part in the outer part.
  • the direct manufacturing processes include e.g. a two-component injection molding process, in which preferably only the outer part is poured into a tool and then, in particular by suitable modification of the tool, the inner part is poured. This is followed by a co-sintering of the two parts and the finishing.
  • the inner part can also be produced as a foam-like structure, for example by direct frozen foaming.
  • organic materials are added to a ceramic slip and then burned out leaving pores behind.
  • outer and inner part formed independently of each other and sintered and only in the second step, preferably mechanically, brought together.
  • this inner part e.g. recourse to direct impression processes.
  • Polyurethane foams are suitable here, which are impregnated with ceramic slip after appropriate pretreatment to produce a suitable structure and then burnt out.
  • direct impression biomimetic methods may also be used, which per se have a trabecular bone structure or similar structure.
  • organic materials such as bamboo are suitable.
  • the structures of the inner and / or the outer part can be coated with conventional functional coatings such as, for example, hydroxyapatite or tricalcium phosphate or other calcium phosphates which, for example, promote osseointegration. Also fillings based on bioglaskeramischen materials with high proportions of S1O2, CaO, P2O 5 and / or K 2 O suitable for this purpose. Also with this material, the component or only the inner or the outer part may be coated.
  • Figure 1 shows a possible embodiment of a ceramic component according to the invention for the fusion of vortex bodies.
  • the implant has a stable solid outer area with pyramidal structures on the top and bottom for fixation against displacement on the adjacent vertebral bodies.
  • the inner part is designed as a cavity that can be filled, for example, with autologous bone to promote osseointegration.
  • the component consists of a zirconia-reinforced alumina ceramic.

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Ceramic Engineering (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Medicinal Chemistry (AREA)
  • Manufacturing & Machinery (AREA)
  • Materials Engineering (AREA)
  • Structural Engineering (AREA)
  • Organic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Surgery (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne des éléments en céramique pour fusionner des corps vertébraux, et des procédés de fabrication de ces éléments en céramique.
EP13736538.3A 2012-07-11 2013-07-09 Élément en céramique pour fusionner des corps vertébraux Ceased EP2872188A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102012212138 2012-07-11
PCT/EP2013/064440 WO2014009340A1 (fr) 2012-07-11 2013-07-09 Élément en céramique pour fusionner des corps vertébraux

Publications (1)

Publication Number Publication Date
EP2872188A1 true EP2872188A1 (fr) 2015-05-20

Family

ID=48783225

Family Applications (1)

Application Number Title Priority Date Filing Date
EP13736538.3A Ceased EP2872188A1 (fr) 2012-07-11 2013-07-09 Élément en céramique pour fusionner des corps vertébraux

Country Status (5)

Country Link
US (1) US20150191396A1 (fr)
EP (1) EP2872188A1 (fr)
CA (1) CA2878791A1 (fr)
DE (1) DE102013213395A1 (fr)
WO (1) WO2014009340A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017529297A (ja) * 2014-07-22 2017-10-05 セラムテック ゲゼルシャフト ミット ベシュレンクテル ハフツングＣｅｒａｍＴｅｃ ＧｍｂＨ 椎体を融合するための部材
CN115872728A (zh) * 2023-02-02 2023-03-31 北京安颂科技有限公司 一种高强SrO-Cr2O3-ZTA陶瓷及其制备方法

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1492475B1 (fr) * 2001-04-16 2011-12-21 Wright Medical Technology, Inc. Structures denses/poreuses utilisees comme substituts osseux
ES2424614T3 (es) * 2001-05-01 2013-10-07 Amedica Corporation Injerto óseo radiolúcido
US20040193270A1 (en) * 2003-03-31 2004-09-30 Depuyacromed, Inc. Implantable bone graft
DE102007020471A1 (de) * 2007-04-27 2008-11-06 Ceramtec Ag Innovative Ceramic Engineering Sinterformkörper
CN101254315B (zh) * 2008-03-21 2012-08-08 中国科学院上海硅酸盐研究所 CaO-ZrO2-SiO2涂层和钛合金的骨替换材料及制备方法

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
None *
See also references of WO2014009340A1 *

Also Published As

Publication number Publication date
WO2014009340A1 (fr) 2014-01-16
US20150191396A1 (en) 2015-07-09
DE102013213395A1 (de) 2014-01-16
CA2878791A1 (fr) 2014-01-16

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