The endoprosthesis from a ceramic material and a set of implants for the restoration, correction, removal or replacement of damaged or defective bone or cartilage

 

The invention relates to medicine and medical technology. The invention provides increased efficiency and manufacturability of implants available cheap raw materials while increasing quality indicators of durability, reliability fixation. The implant is made of based on the alumina ceramic material containing not less than 99,5% by weight of aluminum oxide, 0.15 to 0.4 wt.% magnesium oxide, not more than 0.1 wt.% silicon oxide and not more than 0.05 wt.% iron oxide, and LMEs has a monolithic structure without open porosity and water absorption, density of the ceramic material is of 3.80 3.98 g/cm3, bending strength is 150-750 MPa. The implants of the set is made of ceramic material containing not less than 99,5% by weight of aluminum oxide, 0.15 to 0.4 wt.% magnesium oxide, not more than 0.1 wt.% silicon oxide and not more than 0.05 wt.% iron oxide. 2 C. and 15 C.p. f-crystals, 21 ill.

THE TECHNICAL FIELD.

The invention relates to medicine and medical equipment, namely, oral and maxillofacial surgery, dentistry, oncologically, trauma, and can be used to treat, repair, correction, replacement or repair, the new skull or other bone or cartilage, having a traumatic or other defects in, or damage to, or destruction of tumor or degenerative-dystrophic processes of various etiologies, restore the function of the dentition, or change the shape or dimensions of the various departments of the face.

THE LEVEL OF TECHNOLOGY.

Known methods of manufacture and use of implants (implants) from autocost, usually from the rib of the patient. However, this technique is traumatic for the patient and is not suitable for replacing or restoring his thin flat or shaped surface of the bones or cartilages of the maxillo-facial or cranial region of the head. Therefore intensively developed new ways to replace damaged or deformed bone implants (implants) from alien bones or artificial materials.

A known method of preparation and use of bone retransplantation for replacement of bone defects, which use one-piece anatomical bone, past the saturation of the antibacterial composition [1].

The known method plasticity of the bone defect by filling crushed embryonic bone pigs or cattle with razmenena bone ceramics, depleted calcium oxide, which cut into pieces porous bones subjected to mineralization to remove all organic components with subsequent sintering mineralized bone matrix prior to the formation of ceramics, and removal of calcium oxide from the mineralized bone matrix, it is subjected to washing with demineralised water at 10-80oWith the passage of time from 4 hours to 7 days [3].

The General disadvantages of using obtained according to the methods of the implants (implants) is unsatisfactory compatibility abnormal tissue with the patient's tissue and the inability to replace or restore a relatively large area thin-walled flat or shaped surface of the bones or cartilages of the maxillo-facial or cranial region of the head.

It is known used in maxillo-facial, cranial or aesthetic surgery and dentistry of metal implants made of titanium, gold or other inert metals or alloys. However, they are not only expensive and not always compatible with soft and hard tissues of patients, but there are usually dark spots under the thin skin on the face or head, require rigid mechanical fixation, have bolinao) air temperature due to the high conductivity of the metal.

To resolve these technical shortcomings make and use the metal implant surface with open pores [4] or implants on the basis of perforated titanium mesh ribbon with a sprayed layer of bioceramics (hydroxyapatite, Biosite) with one or two sides [5]. However, these implants are very complicated to manufacture and are also not well compatible with hard and soft tissues of the patient and often they are rejected.

The well-known set of uniform blanks biocompatible osteoporotic cheeetah opticoelectonic implants for repair and replacement of bone defects in maxillofacial and dental surgery, including elements of the chin, the angle of the lower jaw left and right execution, the nose, the body of the lower jaw left and right execution, the left and right zygomatic bone, in which the content of synthetic hydroxyapatite or bone hydroxyapatite animal or hydroxyapatite mixed with other more soluble calcium phosphates 40-60 wt.%, temperature range for sintering and steam formation 800-1200oWith, the volume weight of 800-1200 kg/m3the average size of the cells (ERP) 300 μm, the total porosity nedostatki implants based on hydroxyapatite [CA5(RHO4)3HE] is not always satisfactory compatibility with the patient's tissue, the relatively low strength of the material and the impossibility of its use to replace the thin-walled flat or shaped surface of the bones or cartilages of the maxillo-facial or cranial region of the head, such as implants completely dissolve.

It is known, in particular that of ceramics, containing in its composition more than 95% of aluminum oxide, called corundum, properties and quality of which is determined by several factors, including the type of raw materials and additives, their quantitative ratio, mode and conditions of the technological process of its production [7].

Known ceramic materials based on alumina (aluminum oxide), and implants for surgery approved in 1981 the international standard ISO 6474-81 [8] having the chemical composition: Al2About3- not less than 99,5%, SiO2and alkali metal oxides is not more than 0.1%, a density of not less than 3,9 g/cm3, a bending strength of 400 MPa, the average grain size of not more than 7 μm. Data ceramic materials and made of him the implants have properties satisfactory biocollections is the situation for Standardization for the manufacture of joint and bone substitutes strips.

However, the physico-chemical properties of the ceramic material according to ISO 6474-81 and the known composition and technological ways of making a monolithic ceramic implants method of their formation from the natural powder of alumina (white clay) under hydrostatic pressure and subsequent firing made from this material only massive volumetric implants (joint replacements and bone strip) relatively simple geometric shapes to replace or correct defects or deformities of massive rounded joint or skeletal bones that did not meet the increasing quality requirements of implantable ceramic materials. In particular, one of the major drawbacks of ceramic of alumina obtained according to previously known technology, is the technical difficulty of obtaining thin-walled implants complex forms under hydrostatic pressure, decreased strength and increased shrinkage (more than 10-11%) while firing. In 1994, the international standard ISO 6474-81 (1981) was cancelled.

In 1994, the International Organization for Standardization approved the new edition of the international standard ISO 6474, 1994-02-01 [9], where the s with prikalivalsa the addition of magnesium oxide for use as a bone spacers, bone substitutes and components orthopaedic joint prostheses.

The chemical composition of the material according to ISO 6474 1994-02-01: main material aluminum oxide, Al2O3high purity is above 99.5%, prikalivalsa additive magnesium oxide Content of not higher than 0.3%, limits of impurities in a total amount of silicon oxide SiO2+ calcium oxide Cao + oxides of alkali metals not more than 0.1%. The grain size of the material according to ISO 6474, 1994-02-01 not more than 7.0 μm, the tensile strength Flexural strength not less than 150 MPa. This material is recommended ISO 6474 1994-02-01 for implants used at high loads (bearing surface, substitutes joints), and for implants used at low loads (implants top-maxillofacial and middle ear).

The implant material according to ISO 6474, 1994-02-01 usually obtained by preparing a ceramic composition of a mixture of ultrafine exactly fractionated powder of high-purity aluminium oxide and prikalivalsa supplements in powder form of magnesium oxide, molding by pressing and sintering.

Introduction prikalivalsa additives in ultrafine powder of high-purity aluminum oxide requires additional dispersion of magnesium oxide and prolonged stirring of the mixture and it is very expensive, and forming implants compaction method allows to obtain only thick massive product simple geometric, often spherical or cylindrical shape. It was found that the obtained similarly implants and implants because of their high hardness particles of the feedstock and the resulting ceramic material is almost impossible to machining and, therefore, cannot adjust their size according to the individual needs of the patient. Therefore, manufactured from high-purity alumina implants roads that are inaccessible to a broad spectrum of patients and is currently in practice are mainly used only as substitutes joints and thick massive implants and endoprostheses simple geometric shapes and standard sizes.

The closest in technical essence and the achieved when using the result (the prototype) is a ceramic implant, obtained by cooking the slurry (ceramic slurry) of a ceramic material, pouring the slip into a plaster mould and the firing of the endoprosthesis, characterized in that the implant is made from ceramic materical layer of PTFE, and conducting heat treatment [10] (prototype).

The technical disadvantages of these implants is their lack of biocompatibility and lack of strength, due to the high content of magnesium oxide that forms in intergranular areas aftentichna mixture with reduced strength, and the inability of manufacture of the ceramic material of the composition of thin-walled implants and implants with complex geometric shapes for surgery on the individual sizes of the patient.

TASKS AND TECHNICAL RESULT.

The objectives of the present invention and the required technical result achievable with the use of the invention is the creation and application in oral and maxillofacial surgery, dentistry, oncologically, trauma implants (implants) from the new biocompatible ceramic material, enhancing the efficiency and manufacturability of ceramic implants (implants) from the available cheap raw materials while increasing quality indicators and the strength of the ceramic material of the implants and reliability of fixation of implants (implants) with complex anatomical shape of the surface and the required strength and quality indicators ceramic m is Protasov complex geometric shapes.

THE ESSENCE OF THE INVENTION.

The tasks are solved and the required technical result from the use of the invention is achieved in that ACCORDING to the INVENTION the implant (implant) of the ceramic material for the repair, correction, replacement or removal of defects, damage or deformation of maxillo-facial or cranial bone or cartilage is made of a ceramic material containing alumina in the alpha phase of alumina containing not less than 99,5% by weight of aluminum oxide, 0.15 to 0.4 wt.% magnesium oxide, not more than 0.1 wt.% silicon oxide and not more than 0.05 wt.% iron oxide, while the ceramic material of the endoprosthesis has a monolithic structure without open porosity and water absorption.

Volume weight (density) of the ceramic material of the endoprosthesis is with 3.79 3.98 g/cm3the strength of the ceramic material of the endoprosthesis bending is 150-750 MPa, compressive strength is 1500 - 7500 MPa, Poisson's ratio is 0.22-0,23, the coefficient of thermal expansion (72-78)10-71/oC, the specific volume resistance of 1014Ohm/cm) dielectric constant at a frequency of 1010Hz and 9.4 and 9.8, the tangent of dielectric loss with frequency of the average grain size of the oxide ceramic material is 0.5 to 15.0 μm.

The material is white or white-yellowish or white-grayish color and it is obtained on the basis milled in water to an average particle size of 0.5-3.5 μm alumina containing not less than 99,5% by weight of aluminium oxide including at least 93 wt.% alumina in the alpha phase, through preparation of ceramic slurry density of 2.2-2.8 g/cm3, molding in plaster moulds or moulding on organic foam or molded with vigorem filler or molded by foaming ceramic slurry, drying, sintering-carbonization at a temperature of 1150-1250oWith and firing in an oxidizing atmosphere at a temperature of 1750-1790oC.

The implant is made with anatomic or anatomic surface profile that is identical or similar to the anatomical shape or anatomical surface profile being restored, corregirutuyu or replaced maxillo-facial, cranial bone or cartilage or damaged, korregiruet or replaced parts.

In particular, the implant is performed with anatomical form or anatomical surface profile that is identical or similar to the anatomical shape or anatomical surface profile of the lower jaw or mandibular angle is antalinos chin bone or the lower lateral edge of the eye socket or the lateral edge of the eye socket or the bottom of the socket or bone paranasales area or zygomatic bone or skolealderen ridge or bridge of the nose or tip of the nose or ear curl or damaged, korregiruet or replaced parts or other bone or cartilage.

In addition, the implant perforated and includes means for fixing its position on the bone or cartilage or soft tissue, made for example in the form of holes or protrusions or depressions or porous surface or in a layer of the ceramic foam material of identical chemical composition, which is located on the side of contact of the implant after implantation with bone or cartilage tissue and having an open porosity of 60-90%, macropores in the range of 0.1-10 mm and the micropores in the walls markapur of 0.0001 to 0.1 mm.

Panoramico made from containing alumina in the alpha-phase alumina, including not less than 99,5% by weight of aluminum oxide, 0,15-0,45 wt.% magnesium oxide, not more than 0.1 wt.% silicon oxide and not more than 0.05 wt.% iron oxide, by grinding of alumina in water to an average particle size of 0.5-3.5 μm, preparation of ceramic slurry density of 2.2-2.8 g/cm3, forming organic foam or molded with vigorem filler or molding foaming ceramic suspension lacanfora emulsion, sintering-carbonization at a temperature of 1150-1250oWith and firing in an oxidizing atmosphere at temperam, ACCORDING to the INVENTION in a set of ceramic implants (implants) for the restoration, correction, removal or replacement of defects of maxillo-facial or cranial bone or cartilage implants made of ceramic material containing not less than 99,5% by weight of aluminum oxide, 0.15 to 0.4 wt.% magnesium oxide, not more than 0.1 wt.% silicon oxide and not more than 0.05 wt.% iron oxide.

The ceramic material of the endoprosthesis has a monolithic structure without open porosity and water absorption, bulk density (density) of the ceramic material of the endoprosthesis is with 3.79 3.98 g/cm3the strength of the ceramic material of the endoprosthesis bending is 150-750 MPa, the strength of the ceramic material of the endoprosthesis compression is 1500-7500 MPa, and the grain size of the oxide ceramic material of the endoprosthesis is 0.5 to 15.0 μm, and the implants are made with anatomic or anatomic surface profile that is identical or similar to the anatomical shape or anatomical surface profile of the lower jaw, the angle of the mandible, articular process from the angle of mandible, alveolar ridge, or painting the zygomatic bones, mental chin bone, top-side is skolealderen ridge, the bridge of the nose, tip of nose, ear curl or other maxillo-facial or cranial bone or cartilage or its parts, or other bone or cartilage.

While implants are made of a ceramic material derived from milled in water to an average particle size of 0.5 - 3.5 μm alumina containing not less than 99,5% by weight of aluminium oxide including at least 93 wt.% alumina in the alpha phase, through preparation of the slurry (ceramic slurry) density of 2.2 - 2.8 g/cm3, molding in plaster moulds, sintering-carbonization at a temperature of 1150-1250oWith and firing in an oxidizing atmosphere at a temperature of 1750-1790oWith implants made perforated and have a white or white-yellowish or white-grayish color.

In addition, implants provide a means of fixing their position on the bone or cartilage or soft tissue, in the form of holes or protrusions or depressions or porous surface by contact with bone or cartilage tissue or layer of the ceramic foam material of identical chemical composition, which is located on the side of contact of the implant after implantation with bone or cartilage tissue and having Otkrytaya ceramic slurry of the milled alumina on lacanfora emulsion or by forming on the organic foam, drying, sintering-carbonization at a temperature of 1150-1250oWith and firing.

LIST OF FIGURES.

Disclosure of the invention illustrated by the drawings, which shows private versions of the endoprosthesis according to the invention.

In Fig.1 shows a side view of the endoprosthesis of the articular process to the angle of the lower jaw of the left execution, which contains attached to the bones of the wedge-shaped protrusion (item 1) with a surface (position 2) is made of porous or ceramic foam, and Fig 2 is a front view.

In Fig.3 shows a front view of the endoprosthesis of the alveolar ridge direct, and Fig.4 - its top view.

In Fig. 5 shows a side view of the endoprosthesis paranasales left execution, which contains attachable to a bone protrusion (item 1) with a surface (position 2) is made of porous or ceramic foam, and Fig.6 - its top view.

In Fig.7 depicts a side view of the implant bone paranasales left execution, and Fig.8 - its top view.

In Fig. 9 shows a front view of the endoprosthesis of the mental (chin) area, and Fig.10 - its top view.

In Fig.11 depicts a front view of the endoprosthesis painting (cheek) area left ispolneniya Fig.14 - its side view.

In Fig. 15 depicts a bottom view of the endoprosthesis of the bottom of the socket of the left execution, and Fig.16 is its side view.

In Fig.17 depicts a front view of the endoprosthesis of the back and tip of nose, and Fig.18 - its top view.

In Fig. 19 depicts a front view of the endoprosthesis of the alveolar ridge rounded, as in Fig.20 - its top view.

In Fig. 21 shows a photograph of a set of implants with anatomic or anatomic surface profile identical or similar anatomical shape or anatomical surface profile (in the right and left version, big and small forms) angle of the mandible, articular process from the angle of mandible, alveolar bone straight or rounded, painting Malar area, mental mental region of the bottom of the socket, paranasales region, skolealderen crest, back and nose, made perforated with holes (item 3).

All depicted in the figures of the drawings and pictures of some examples of execution of the implants can be made left or right version (mirror symmetry) for implantation, respectively on the right or left side of the patient, large or small standard cipora surface, identical or similar anatomical shape or anatomical profile, replaced, restored or corregirutuyu bone or cartilage or separate damaged or deformed parts.

Disclosure of the invention is illustrated on the example of the disclosure, examples of the manufacture of implants and examples of experimental and clinical studies of the effectiveness of the use of implants according to the invention, showing the industrial feasibility of the invention and the possibility of realization of the invention industrially.

Were experimental implants (implants) and they were all required for medical products, sanitary-chemical testing, Toxicological-hygienic and clinical trials.

Ceramic implants are made from alumina through preparation of the slurry (ceramic slurry), molding, drying and sintering.

Thus it is established experimentally that the ceramic material of the implants required according to the invention can be obtained only on the basis of containing not less than 93 wt.% alumina in the alpha phase of alumina in the presence of the original alumina and the resulting ceramic material is not less than 99,5 wt. % oxide and is not more than 0.1 wt.% iron oxide, preferably not more than 0.05 wt.% iron oxide, not more than 0.1 wt.% the sum of the oxides of sodium and potassium in terms of sodium oxide, for example, based on the alumina brand PMK on TU-48-5-200-79 production of JSC "Boksitogorsk Alumina Leningrad oblast or GOST 30559-98.

It was established experimentally that in order to obtain a monolithic ceramic material without open porosity and water absorption of the required quality and strength characteristics alumina appropriate composition to activate the surface of its particles and optimal shaping, you must first grind with getting ultradistance polyrational ceramic suspension on the basis of alumina containing not less than 99,5% by weight of aluminium oxide including at least 93 wt.% alumina in the alpha phase, and to prepare a slurry density of 2.2-2.8 g/cm3to produce billets implants in plaster moulds, drying, sintering at a temperature of 1150-1250oC and annealing in an oxidizing atmosphere at a temperature of 1750-1790oC.

It is found experimentally that for ceramic material of the required quality containing alumina in the alpha phase alumina appropriate composition to activate the surface of it is the R indices must be pre-grind in the aquatic environment to an average particle size of 0.5-3.5 μm, to mould implants in plaster moulds with obtaining a compacted surface layer, drying, annealing and sintering in the above process parameters.

Thus it is established experimentally that the preliminary sintering at a temperature of 1150-1250oWith allows to produce billets of implants that can be processed using mechanical methods to give them the desired shape and size, preliminary quality control of material structure and integrity of its surface, and the final calcination at a temperature of 1750-1790oWith lets get ready implants required quality and size.

It is found experimentally that as the source material for the manufacture of implants (implants) according to the invention it is expedient to use alumina brand PMK on TU-48-5-200-79 production of JSC "Boksitogorsk Alumina Leningrad oblast or alumina of similar quality or GOST 30559-98.

The results of extensive testing of implants (implants) from the new ceramic material based on alumina showed that the resulting ceramic material and implants (implantate) from Toxicological-hygienic and sanitary-Henichesk the>Studies have been conducted of bioinertness and biocompatibility of implants (implants) with a dense, porous and composite structure of this ceramic material. The object of the study was to ceramic implants made of ceramic by a method of slip casting in plaster moulds.

In experiments were used 72 animals, divided into two series. The number of animals at time of observation - 4. The timing of breeding animals from the experiment: 1, 2, 3, 4 weeks and 2, 3, 4, 5, 6 months. Electron microscopic examination was used for a detailed study of the contact of the ceramic incantatem with the bone tissue. The study was performed on a scanning electron microscope ISM - 840 A (Jeol, Japan). For elemental analysis and generation of distribution maps elements used energy dispersive analyzer'AN 10/85S (Link Analitical, England). When conducting the research were used the most informative and modern research methods with the volume of material sufficient to justify the following conclusions.

In the experiment on animals proved bioinert and biocompatibility with respect to bone implants made of ceramic material of the inventive composition and technologles formation of a connective tissue capsule around the implant, the absence of all periods of observation, both local and General inflammatory response to the implanted ceramic samples.

Defined reaction of bone tissue of laboratory animals transplanted them in ceramic implants and found that when an intramedullary implant ceramic monolithic rod in the femur of rats around it was observed the formation of bone capsules for 3 months. At follow-up bone tissue consistently transformed into the newly formed spongy bone, and then the plate tightly in contact with the implant. However at no time was found to education components of the connective tissue (fibroblasts, collagen fibers and cellular structures) between bone and ceramics.

When an intramedullary implant stem from a combination of ceramics in the femur of the rat-side thick part (as in the first series) was observed the formation of bone capsules to 3 months; bone tissue consistently transformed into the newly formed spongy bone and then into the plate with her tight contact with the implant. Side porous portion from the second week was observed ingrowth of newly formed the e as in the first series of experiment, on any of the observation period was not observed the formation of elements of connective tissue (fibroblasts, collagen fibers and cellular structures) between bone and ceramics.

The volume of studies and obtained positive results allowed to conclude about the feasibility of conducting a clinical trial implants of similar ceramics, ceramic implants made of the material of this composition is suitable for use in traumatology, orthopedics, reconstructive Oncology, maxillofacial surgery and can be used in clinical practice on the basis of compatibility with bone and soft tissues, bioinertness and biocompatibility, nontoxicity, and ease of sterilization in air at 180oC.

Clinical trials of this ceramic material and ceramic implants (implants) according to the invention were carried out in the prescribed manner. Ceramic implants have been used for defects and deformation of the bones of the facial skull and brain in 12 patients (3 women and 9 men) aged from 20 to 62 years. In 3 patients the defects of the mandible, the zygomatic bone was the result of surgical intervention regarding tumors,built in childhood osteomyelitis of the mandible, or was a congenital malformation.

Examination of patients before surgery included: an x-ray of the bones of the face and the neurocranium skull in special projections; computed tomography of the head; photography, General clinical research - clinical analysis of urine and blood tests, blood tests, ECG, chest x-ray, consultation of experts in the presence of concomitant pathology.

All surgical interventions were performed under General anesthesia. In 12 patients was performed 14 surgical intervention. In 5 cases a surgical procedure, the introduction of ceramic implant (implant) was carried out from the oral cavity, i.e. in terms of an infected receiving bed. In the postoperative period, all patients underwent prophylactic antibiotic therapy.

All operated patients were able to compensate for the defect and fully or partially eliminate the deformation, i.e. to get a good or satisfactory aesthetic effect from the treatment. Any reactions to the ceramic implant in the early postoperative period and in the long term after surgery (up to 1.5 years) was not observed.

In rasulo meet all the requirements for medical and technical requirements. They are recommended for production and use in clinical practice and is currently preparing their industrial production for wide use in medical practice.

Clinical trials of new ceramic implants in the clinic of maxillofacial surgery and dentistry in the prescribed manner to explore new used in dentistry materials when performing operations with the aim of defects, elimination of deformations of osseous structures, resulting from injury and inflammation, showed that the samples of ceramic implants and elements of the jaw bones and jaw all medical tests have passed and can be recommended for the organization of their production and application in medical practice. It was held on 31 surgical intervention in patients with injuries of the facial skeleton, including deformities and defects of all areas of the face, and complications in neither case was not identified. It is established that the endoprosthesis is stable, effective upon the replacement of defects and correcting deformities of the facial skeleton with good cosmetic and functional result and can be shown to DL the Ineke maxillofacial surgery and dentistry for 32 patients aged from 17 to 53 years with injuries of the facial skeleton, including deformities and defects of the middle and lower areas of the face showed that implants strain resistant, fully replace defects and eliminate deformations in the region of the facial skeleton, do not cause complications, is shown for use in reconstructive maxillofacial surgery and can be recommended for mass production and application in medical practice.

The results of extensive testing of the ceramic material of the implant showed that the used ceramic material and implants from the Toxicological-hygienic and sanitary-chemical indicators meet all the requirements of the medical devices of similar purpose.

Clinical studies have confirmed the use of implants and implant of a new ceramic material for a number of diseases, in particular if microgenia, secondary deformities of the lower jaw after childhood osteomyelitis and burn, deformation of the frontal region with the retraction in the compression fracture of the frontal bone. The postoperative period in all patients was uneventful and achieved good cosmetic result.

In PU meet all the requirements for medical and technical requirements. They are recommended for production and use in clinical practice and is currently preparing their industrial production for wide use in medical practice on the premises of the applicant's invention - LLC "Scientific-production center of medical ceramics (St. Petersburg).

This proves the possibility of realization of the invention industrially, the possibility of solving problems and achieving the required technical result.

The above detailed description of the manufacturing and application of new ceramic material based on alumina and design features of the endoprosthesis according to the invention does not leave any doubt as to their feasibility - all elements of some of the technical methods of production and use of implants known in medical technology, well-developed modern techniques of ceramic materials and medical practice.

In particular, the implementation process can be carried out by known experts and widely used in practice, the manufacture of ceramic products of the individual techniques described, for example, in the book Balk the second material can be applied known in the art and widely used in the practice of separate technological methods of manufacturing porous and foamed materials described, for example, in the book of O. G. Tarakanov, I. C. Shamov and C. D. Alpern "Filled foams", M.: Chemistry, 1989, 216 S.-depth look at techniques for the production of filled composites containing particulate fillers.

Ceramic implants according to the invention can be manufactured from readily available and cheap source of domestic alumina industrial way, and to make them not need expensive imported raw materials or special equipment.

Sources of information 1. RF application 93040884, A 61 F 2/28, publ. 1996.07.27.

2. RF application 99117208, A 61 F 2/28, publ. 2001.06.10.

3. RF application 97108964, A 61 L 27/00, publ. 1999.06.20.

4. The application of Germany 3224265, A 61 L 27/00, RF patent 2035192, publ. 1995.05.20.

5. RF patent 2157245, A 61 L 27/00, publ. 2000.10.10.

6. RF patent 2074672, A 61 L 27/00, publ. 1997.03.10.

7. Balcewicz C. L. Technical ceramics. M.: stroiizdat, 1984, S. 98-118.

8. International standard ISO 6474-81, 1981, page 5

9. International standard ISO 6474 1994-02-01, 1994, 6 pages

10. RF patent 2007971, A 61 F 2/28, publ. 1994.02.28. (prototype).

Claims

1. The endoprosthesis of the ceramic material for the repair, correction, replacement or removal of defects, damage or deformation to the on material, containing not less than 99,5 wt. % of aluminum oxide, 0.15 to 0.4. % of magnesium oxide, with this ceramic material has a monolithic structure without open porosity and water absorption.

2. Implant under item 1, characterized in that the density of the ceramic material is 3,79 3.98 g/cm3, bending strength 150-750 MPa, the strength of the ceramic material in compression is 1500-7500 MPa, coefficient of thermal expansion (72-78)10-71/oC, the specific volume resistance of 1014Ohm/cm) dielectric constant at a frequency of 1010Hz and 9.4 and 9.8, the tangent of dielectric loss with frequency of 1010Hz 310-4the melting point of the ceramic material 2040oC, and the average grain size of the oxide ceramic material is 0.5 to 15.0 μm.

3. Endoprosthesis according to any one of paragraphs. 1 and 2, characterized in that the implant is made of a ceramic material derived from milled in water to an average particle size of 0.5-3.5 μm alumina containing not less than 99,5 wt. % of aluminum oxide, including not less than 93 wt. % of alumina in the alpha phase, through preparation of ceramic slurry density of 2.2-2.8 g/cm3formulator 1750-1790oC.

4. Endoprosthesis according to any one of paragraphs. 1-3, characterized in that the implant is performed with anatomical form or anatomical surface profile that is identical or similar to the anatomical shape or anatomical surface profile being restored, correctable or replaced maxillo-facial, cranial bone or cartilage or damaged, correctable or replaced parts.

5. Endoprosthesis according to p. 4, characterized in that the implant is performed with anatomical form or anatomical surface profile that is identical or similar to the anatomical shape or anatomical surface profile of the lower jaw or mandibular angle, or articular process with the angle of the mandible, or the alveolar ridge, or painting (zygomatic) bone, or mental (chin) bone, or the lower lateral edge of the eye socket or the lateral edge of the eye socket or bone paranasales region, or the zygomatic bone or skolealderen crest, or the bridge of the nose, or nose, or ear curl, or damaged, correctable or replaced parts.

6. Endoprosthesis according to any one of paragraphs. 1-5, characterized in that the implant perforated.

7. Endoprosthesis according to any one of paragraphs. 1-6, Otley is some fabric, performed, for example, in the form of holes or ridges, or depressions, or porous surface by contact with bone or cartilage tissue.

8. Endoprosthesis according to any one of paragraphs. 1-6, characterized in that the device includes means for fixing its position on the bone or cartilage in a layer of the identical chemical composition of the ceramic foam material located on the side of contact of the implant after implantation with bone or cartilage tissue and having an open porosity of 60-90%, macropores in the range of 0.1-10 mm and micropores of 0.0001 to 0.1 mm.

9. Endoprosthesis according to any one of paragraphs. 1-8, characterized in that the ceramic material of the endoprosthesis has a white, or belogolovsky, or white-grayish color.

10. Set of implants for the restoration, correction, removal or replacement of bone defects or cartilage, characterized in that the implants are made of a ceramic material containing not less than 99,5 wt. % of aluminum oxide, 0.15 to 0.4. % of magnesium oxide, not more than 0.1 wt. % silica and not more than 0.005 wt. % iron oxide.

11. Set of implants under item 10, characterized in that the ceramic material of the endoprosthesis has a monolithic structure without open porosity and water absorption, bulk compression 1500-7500 MPa, the coefficient of thermal expansion (72-78)10-71/oC, the specific volume resistance of 1014Ohm/cm) dielectric constant at a frequency of 1010 HZ and 9.4 and 9.8, the tangent of dielectric loss with frequency of 10 Hz 310-4the melting point of the ceramic material 2040oC, and the average grain size of the oxide ceramic material is 0.5 to 15.0 μm.

12. Set endoprosthesis according to any one of paragraphs. 10 and 11, characterized in that the implants made of ceramic material derived from milled in water to an average particle size of 0.5-3.5 μm alumina containing not less than 99,5 wt. % of aluminum oxide, including not less than 93 wt. % of alumina in the alpha phase, through preparation of ceramic slurry density of 2.2-2.8 g/cm3, molding in plaster moulds, drying, sintering at a temperature of 1150-1250oWith and firing in an oxidizing atmosphere at a temperature of 1750-1790oC.

13. Set endoprosthesis according to any one of paragraphs. 10-12, characterized in that the implants made with anatomic or anatomic surface profile that is identical or similar to the anatomical shape or anatomical surface profile of the bottom is Noah zygomatic bone mental chin bone, and the lower lateral edge of the eye socket to the lateral edge of the eye socket to the bottom of the eye socket bone paranasales area, bone zygomatic bone, bone skolealderen ridge, nose, nose, ear curl or other bone or cartilage or portions thereof.

14. Set endoprosthesis according to any one of paragraphs. 10-13, characterized in that the implants made perforated.

15. Set endoprosthesis according to any one of paragraphs. 10-14, characterized in that the implants have a white, or white-yellowish or white-grayish color.

16. Set endoprosthesis according to any one of paragraphs. 10-15, characterized in that the implants provide a means of fixing their position on the bone or cartilage or soft tissue, in the form of holes or ridges, or depressions, or porous surface by contact with bone or cartilage tissue.

17. Set endoprosthesis according to any one of paragraphs. 10-16, characterized in that the implants provide a means of fixing their position on the bone or cartilage or soft tissue in a layer of the ceramic foam material located on the side of the contact implants after implantation with bone or cartilage tissue.

 

Same patents:

The invention relates to medicine, namely to arthrology, and can be used for the treatment of degenerative and post-traumatic deforming arthritis and other crippling damage to the joints

The invention relates to medicine, namely to the implants

The invention relates to medicine, namely to ophthalmology, and is intended to modify the surface region and improved method of manufacturing synthetic grafts used for scleroplasty

The invention relates to medicine, namely to arthrology, and can be used for the treatment of degenerative and post-traumatic deforming arthritis and other crippling damage to the joints

The invention relates to medicine, namely to orthopedics and traumatology, and can be used for bone grafting

The invention relates to medicine, in particular to the field of traumatology and orthopedics in the treatment of false joints and unjoining fractures of long bones
The invention relates to medicine, namely to traumatology in the treatment of hip fractures
The invention relates to medicine, namely to eteorology and orthopedics

The invention relates to medicine, namely to arthrology, and can be used for the treatment of degenerative and post-traumatic deforming arthritis and other crippling damage to the joints

The invention relates to the field of biological science sections of medicine: surgery, trauma, Orthopaedics and can be used in reconstruction-surgical interventions in different finishes skeleton in t

Ocular prosthesis // 2149649
The invention relates to the medical industry, in particular to the technology of manufacturing artificial eyes of glass, designed for the prosthetics of persons deprived of one or both eyes, and in the presence of Trofimovna eyeball or eye with a thorn, in medical and cosmetic purposes

The invention relates to medicine, namely to arthrology, and can be used for the treatment of degenerative and post-traumatic deforming arthritis and other crippling damage to the joints

The invention relates to medicine, namely to orthopedics and traumatology, and can be applied to bone-cement fixation of fractures of tubular bones in patients with osteoporosis

The invention relates to medicine, namely to spine surgery, and can be used in a complete replacement of the vertebral body

The invention relates to medicine, namely to the implant using a porous tetrafluoroethylene

The invention relates to medicine, namely to arthrology, and can be used for the treatment of degenerative and post-traumatic deforming arthritis and other crippling damage to the joints

The invention relates to medicine, namely to arthrology, and can be used for the treatment of degenerative and post-traumatic deforming arthritis and other crippling damage to the joints

The invention relates to medicine, namely to arthrology, and can be used for the treatment of degenerative and post-traumatic deforming arthritis and other crippling damage to the joints

The invention relates to medicine, namely to arthrology, and can be used for the treatment of degenerative and post-traumatic deforming arthritis and other crippling damage to the joints

The invention relates to medicine, namely to arthrology, and can be used for the treatment of degenerative and post-traumatic deforming arthritis and other crippling damage to the joints
The invention relates to medicine, namely to vascular neurosurgery, and can be used for intravascular operations for aneurysms and carotid-cavernous souljah, as well as to monitor patients in the postoperative period
Up!