EP2413816A1 - Schnittschablone aus keramik - Google Patents

Schnittschablone aus keramik

Info

Publication number
EP2413816A1
EP2413816A1 EP10713617A EP10713617A EP2413816A1 EP 2413816 A1 EP2413816 A1 EP 2413816A1 EP 10713617 A EP10713617 A EP 10713617A EP 10713617 A EP10713617 A EP 10713617A EP 2413816 A1 EP2413816 A1 EP 2413816A1
Authority
EP
European Patent Office
Prior art keywords
cutting template
zirconia
oxides
volume
matrix 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.)
Withdrawn
Application number
EP10713617A
Other languages
German (de)
English (en)
French (fr)
Inventor
Roman Preuss
Heinrich Wecker
Matthias Eschle
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 EP2413816A1 publication Critical patent/EP2413816A1/de
Withdrawn legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/14—Surgical saws ; Accessories therefor
    • A61B17/15—Guides therefor
    • A61B17/154—Guides therefor for preparing bone for knee prosthesis
    • A61B17/155—Cutting femur
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1764—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the knee
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L31/121—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix
    • A61L31/124—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix of other specific inorganic materials not covered by A61L31/122 or A61L31/123
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Definitions

  • the present invention is a cutting template or a saw block, preferably a cutting template or a saw block for use in medical technology.
  • a so-called incision template or saw block is fixed on the femur.
  • This cutting template three cuts are normally made to adapt the femoral surface to the geometry of the femoral component.
  • a guide in the cutting template (3 or 4 cuts in 1 template).
  • the cut is performed with an oscillating saw blade.
  • the saw blades and the cutting templates are today basically made of biocompatible metal alloys.
  • the guide rails in the saw block have a width of 1, 2 - 1, 5 mm. Due to the oscillation of the saw blade and the friction occurring between saw blade and guide rail, high metal abrasion occurs on the side of the guide rail. This abrasion does not or can only be removed from the wound inadequately intraoperatively. Thus, this abrasion can turn into the cause of infections and, above all, lead to allergic reactions of the patient. For this reason, it is essential to reduce this abrasion in principle, but in particular if an implant reaction is to be avoided by the use of a ceramic femoral component in the potential allergic person.
  • the object underlying the present invention was to eliminate the disadvantages of the cutting templates / saw blocks of the prior art, and in particular:
  • the inventive task was surprisingly by a
  • Cutting template / a saw block ceramic hereinafter, the terms sintered body or sintered body are used for the inventive cutting template / saw block according to the invention
  • the features of the independent claims Preferred embodiments can be found in the subclaims. It was surprisingly found that the
  • the invention provides as matrix a mixed crystal of aluminum oxide / chromium oxide.
  • the invention provides that the zirconium matrix embedded in the matrix dioxide and the mixed oxide forming the mixed crystal together with the aluminum oxide in a certain molar ratio to one another. This measure makes it possible to achieve the required hardness values even with higher zirconium dioxide contents, which may be required to obtain a particularly good fracture toughness. On the other hand, at low
  • the zirconia and chromium oxide containing the stabilizing oxides should be present in a certain molar ratio, inevitably results in certain ratios for the other components, since e.g. with decreasing proportion of zirconium dioxide, the proportions of the stabilizing oxides, based on the sintered molded body decrease, while on the other hand, the proportion of alumina increases. Based on the aluminum oxide of the sintered body, the chromium oxide is in a weight of 0.004 to
  • chromium oxide and the stabilizing oxides containing zirconia are in the indicated molar ratio.
  • the cerium oxide has been found to be most preferred.
  • the proportion of the matrix material on Sinterform body is at least 70 vol .-% - and is made of an aluminum oxide / chromium oxide mixed crystal with a chromium oxide content of 0.01 to 2.32 wt .-%, based on alumina, with from 2 to 30% by volume of zirconia incorporated into the matrix, and the zirconia contains from 0.27 to 2.85 mole percent yttria, based on the mixture of zirconia and yttria, and the zirconia does not exceed 2 micrometers average grain size predominantly in the tetragonal modification.
  • An amount of 0.27 to 2.85 mol% of yttria, based on the mixture of zirconia and yttrium oxide, corresponds to 0.5 to 5.4 wt%.
  • yttria-containing zirconia and chromium oxide is a molar ratio of 370: 1 to 34: 1 before.
  • the matrix material consisting of an aluminum oxide / chromium oxide mixed crystal and a further mixed crystal of the formula Cr x -x SrAli2 Oi9, wherein x has a value from 0.0007 to 0.045.
  • the toughening effect of the zirconia incorporated in the mixed-crystal matrix is increased, while the addition of chromium can counteract a decrease in the hardness values caused by the zirconium dioxide content.
  • strontium oxide platelets form in the structure, which he general formula SrAli 2- ⁇ Cr x Oi 9 correspond.
  • the additionally formed by the addition of strontium oxide mixed crystal of the formula SrAli 2- ⁇ Cr x Oi9 has the additional effect that it gives the sintered body even at a higher temperature, a further improved toughness.
  • the wear resistance of these sintered bodies under the influence of elevated temperature is therefore also improved.
  • the cerium oxide has been found to be particularly suitable. Platelets also form if the matrix does not contain Cr 2 ⁇ 3 .
  • the wear resistance of the sintered shaped bodies can still by the incorporation of 2 to 25 VoI .-% of one or more carbides, nitrides or carbonitrides of the metals of the 4th and 5th subgroup of the Periodic Table of the Elements (PSE) - based on the Matrix material - to be improved in these.
  • the proportion of these hard materials is 6 to 15 vol .-%.
  • titanium nitride, titanium carbide and titanium carbonitride are suitable.
  • the molar ratio of the zirconium containing the stabilizing oxides is umdioxids to chromium oxide as a function of the zirconia present in the sintered shaped bodies according to the invention are adjusted so that at low zirconia shares also small quantities of chromium oxide are present.
  • an adjustment of the molar ratio zirconium dioxide: chromium oxide has proven to be in the range of
  • the adjustment of a particle size of the zirconium dioxide not exceeding 2 ⁇ m is required.
  • a maximum amount of max. 5% by volume are preferably less than 2% by volume, very particularly preferably less than 1% by volume, so that preferably more than 90% by volume are present in the tetragonal modification.
  • the sintered molded body contains only in an unavoidable manner entrained impurities other than the components specified in the claims, which according to a further preferred embodiment of the invention is not more than 0.5 vol .-%
  • the sintered molded body consists only of the alumina-chromium oxide mixed crystal or containing the stabilizing oxides in the presence of strontium oxide and chromium oxide, in this solid solution and the mixed crystal of the formula SrAli 2- ⁇ Cr x Oi9 and from and embedded in the matrix of said mixed crystals zirconium koniumdioxid. Other phases, such.
  • the zirconia is present in an amount of not more than 30% by volume. Preferably, the zirconia is also not present in an amount of less than 15% by volume. If there are between 15 and 30% by volume of zirconium dioxide, the molar ratio between the zirconium dioxide and chromium oxide containing the stabilizing oxides is very particularly preferably between 40: 1 and 25: 1.
  • the proportion of zirconium dioxide present in tetragonal modification is more than 95% by volume, with only up to 5% by volume being present in total in the cubic and / or monoclinic modification.
  • Very particular preference is given to maintaining a particle size of the incorporated zirconium dioxide in the range of 0.2 to 1, 5 microns.
  • an average grain size of the alumina / chromium oxide mixed crystal in the range of 0.8 to 1, 5 microns has been found to be particularly suitable. If, in addition, carbides, nitrides and carbonitrides of the metals of the 4th and 5th subgroups of the PSE are used, they are used in a particle size of 0.8 to 3 ⁇ m.
  • the grains of the mixed crystal of the formula SrAli 2- ⁇ Cr x Oi 9 have a length / thickness ratio in the range from 5: 1 to 15: 1. Its maximum length is 12 ⁇ m, its maximum thickness 1.5 ⁇ m. It has surprisingly been found that corresponding platelets can be produced in the microstructure not only with strontium oxide but also with certain other oxides. The prerequisite for platelet formation is the formation of a hexagonal crystal structure of the "in situ" platelets to be formed. If the material system Al 2 ⁇ 3-Cr 2 ⁇ 3 -ZrO 2 -Y 2 ⁇ 3 (CeO 2 ) is used as the matrix, the following platelets can be formed "in situ" using a wide variety of oxides.
  • the corresponding Al kal-Aln-x Cr x 0i 7 form - in alloying of alkaline earth metal oxides
  • the corresponding ErdalkaliAli 2-x Cr x Oi9 -Platelets form, on alloying of CdO, PbO, HgO the corresponding (Cd, Pb or HgAli 2-x Cr x Oi9) -Platelets and alloying of the corresponding rare earth oxides, rare Erdaln -x Cr x Oi8 -Platelets.
  • La 2 ⁇ 3 may also form the compound La 0 , 9Aln, 7 6- ⁇ Cr x Oi9. Platelets also form when the matrix does not contain Cr 2 ⁇ 3 .
  • the platelets forming then, without the presence of strontium oxide, correspond to the general ones
  • the matrix material in a preferred Ausgestal- contains tung an aluminum oxide / chromium oxide mixed crystal and an additional mixed crystal according to one of the general formulas Me 1 AI n -x Cr x 0i 7, Me 2 AI i 2-x Cr x 0 1 9, Me 2 Ali 2-x Cr x Oi 9 or Me 3 Al n -x Cr x 0i8 where Me 1 is an alkali metal, Me 2 is an alkaline earth metal, Me 2 is cadmium, lead or mercury and Me 3 is a rare earth metal.
  • added to the matrix material can be mixed crystal La 0 , 9Aln, 7 6- ⁇ Cr x Oi9. x can assume values of 0.0007 to 0.045.
  • the inventively provided "in situ" Plateletverstärkung also occurs when the matrix does not contain Cr 2 ⁇ 3. This is provided according to the invention in particular when a drop in the hardness values does not disturb.
  • Cr 2 ⁇ 3 forming platelets then correspond to the general formulas Me 1 Ah 1O17, Me 2 Ali 2 Oi 9 , Me 2 Ali 2 Oi 9 or Me 3 Ali 2 Oi 8 .
  • the same preferred embodiments can be provided, as with the sintered shaped bodies containing Cr 2 Os in the matrix material.
  • the sintered molded body with Cr 2 ⁇ 3 in the matrix material further above statements in an analogous manner to the sintered body without
  • the Vickers hardness of the sintered shaped bodies according to the invention is greater than 1750 [HVo. ⁇ ], but is preferably more than 1,800 [HVo.s].
  • the microstructure of the sintered body according to the invention is free of microcracks and has a degree of porosity of not more than 1.0%.
  • the sintered body may further include whiskers, but not silicon carbide.
  • the sintered shaped body preferably contains none of the substances frequently used as grain growth inhibitors, such as. B. magnesium oxide.
  • mixed crystal used in the claims and in the description is not to be understood as meaning a single crystal, rather it means a solid solution of chromium oxide in aluminum oxide or strontium aluminate.
  • the stabilizer oxides dissolve in the ZrO 2 lattice and stabilize its tetragonal modification.
  • high-purity raw materials ie alumina and zirconium dioxide with a purity of more than 99%.
  • the degree of impurities is still much lower.
  • SiO 2 contents of more than 0.5% by volume, based on the finished sintered body are undesirable. Excluded from this rule is the inevitable presence of hafnium oxide in a small amount of up to 2% by weight within the zirconium dioxide.
  • the sintered shaped body according to the invention is produced by pressure-free sintering or hot pressing of a mixture of aluminum oxide / zirconium dioxide / chromium oxide and stabilizing oxides or a mixture of these components is used which additionally contains strontium oxide or alternatively an alkali oxide instead of strontium oxide.
  • an alkaline earth oxide, CdO, PbO, HgO, a rare earth oxide or La2 ⁇ 3 and / or one or more nitrides, carbides and carbonitrides of the 4th and 5th subgroup of the PSE are added.
  • yttrium oxide and chromium oxide can also be in the form of yttrium chromium oxide (YCrOs), while the addition of strontium oxide can preferably be carried out in the form of strontium salts, in particular as strontium carbonate (SrCOs).
  • strontium salts in particular as strontium carbonate (SrCOs).
  • Mercury, rare earth oxides or the lanthanum oxide may preferably be added in the form of their salts, in particular as carbonates. But also the addition of ternary compounds that decompose and rearrange during sintering is possible.
  • Various ceramic mixtures were prepared by mixed grinding. To the milled mixtures was added a temporary binder and the mixtures were then spray dried. Subsequently, green bodies were pressed from the spray-dried mixtures and these were sintered under standard conditions, for example either sintered or presintered without pressure and subjected to a gas pressure sintering process under argon.
  • pressureless sintering includes both sintering under atmospheric conditions, as well as under inert gas or in a vacuum.
  • the molded body is first pre-sintered without pressure to 90 to 95% theoretical density and then by hot isostatic pressing or gas recompressed inside the pressure. The theoretical density can thereby be increased to a value of more than 99.5%.
  • the dispersion and grinding can have a special influence on the properties of the ceramic according to the invention.
  • the grinding process and the grinding unit itself can affect the result.
  • the solids content of the millbase used may additionally contribute to the dispersion.
  • the metal abrasion is reduced by up to 90% compared to the previous cutting templates or saw blocks made of metal.
  • the service life of the cutting template or the saw block according to the invention in use is significantly prolonged, since only slight wear of the cutting template occurs. This reduces the costs.
  • the risk of allergies or the allergic reactions of patients and the risk of infections are reduced.
  • the cutting template is used in medical technology, in particular in operations for processing a bone, preferably in a knee-TEP implantation.
  • the advantages of the ceramic cutting template according to the invention or of the ceramic from which it is made are: >
  • the cutting template has an extremely low abrasion.
  • the material is biocompatible.
  • the cutting template according to the invention is labeled with a laser, it is very clearly visible and readable and can thus reduce incorrect handling when using the cutting template.
  • the cutting template has good tribological properties.
  • FIG. 1 to 4 show a cutting template 1 of ceramic according to the invention in different views.
  • FIG. 5 shows images of the shape and intraoperative use of a conventional metal cutting template.
  • a cutting template 1 according to the invention is shown, which is also referred to as a saw block.
  • Such a cutting template 1 serves to guide a surgical saw blade during the implantation of an artificial knee joint.
  • the cutting template consists of a base body 2, which is provided with slot-like recesses 3 for the implementation and precise guidance of a plate-shaped saw blade, wherein the slot-like recesses 3 has opposing guide surfaces 4. At these guide surfaces 4, the saw blade (see Figure 5) is applied during the sawing process. In the base body 2 through holes 5 are introduced, which serve for screwing the cutting template 1 on the femur.
  • sintered body / sintered body denote a ceramic in the form of or for use as a cutting template or saw block.

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  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Ceramic Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Manufacturing & Machinery (AREA)
  • Materials Engineering (AREA)
  • Structural Engineering (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Dentistry (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Transplantation (AREA)
  • Composite Materials (AREA)
  • Compositions Of Oxide Ceramics (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Surgical Instruments (AREA)
EP10713617A 2009-04-01 2010-04-01 Schnittschablone aus keramik Withdrawn EP2413816A1 (de)

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DE102009002085 2009-04-01
DE102009002088 2009-04-01
PCT/EP2010/054423 WO2010112588A1 (de) 2009-04-01 2010-04-01 Schnittschablone aus keramik

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WO2011000390A1 (en) * 2009-06-30 2011-01-06 Aktiebolaget Skf Zirconia-alumina ceramic materials
CN103260529A (zh) * 2010-10-06 2013-08-21 陶瓷技术有限责任公司 陶瓷切割模板
WO2013078206A1 (en) * 2011-11-21 2013-05-30 Smith & Nephew, Inc. Methods of designing molds for machining cost reduction
US20160022879A1 (en) * 2014-07-24 2016-01-28 Jared Ruben Hillel FORAN Hypoallergenic orthopedic surgical instruments and methods
CN107427306A (zh) * 2015-03-06 2017-12-01 陶瓷技术有限责任公司 由塑料构成的、带有由陶瓷构成的锯切片引导部的锯切块
EP3361959A4 (en) * 2015-10-14 2019-06-19 Mighty Oak Medical, Inc. APPARATUS FOR MATCHING PATIENTS AND METHODS FOR EXECUTING SURGICAL PROCEDURES
JP7555121B2 (ja) 2021-06-11 2024-09-24 明央 有海 骨切り用ガイド

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US6069103A (en) * 1996-07-11 2000-05-30 Saint-Gobain/Norton Industrial Ceramics Corporation LTD resistant, high strength zirconia ceramic

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2010112588A1 *

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DE102010003605A1 (de) 2010-12-02
JP2012522711A (ja) 2012-09-27
JP5762397B2 (ja) 2015-08-12
CN102448385A (zh) 2012-05-09
WO2010112588A1 (de) 2010-10-07
KR20120022853A (ko) 2012-03-12
US20120123421A1 (en) 2012-05-17

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