Ceramic artificial joint

 

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 provides a simplified design and reduced weight of the endoprosthesis and the improving technology of its manufacture. Ceramic artificial joint contains attached to the bones and movably sochlenenie elements of the endoprosthesis of alumina ceramics. The elements of the endoprosthesis made of ceramics based on aluminum oxide with additives of magnesium oxide. The surface elements of the endoprosthesis in their area of rolling joints made with anatomical profile similar to the profile of the corresponding surface of the prosthetic joint. Attached to the bones of the elements of the endoprosthesis is made porous with decreasing density and increasing porosity from sochlenenii surface to attach to the bones parts of the elements of the endoprosthesis or porous surface shaped to be inserted into bone tissue elongated or shaped protrusions or in the form imposed on the surface of the bone plates or shaped plates with the tabs or in the I to medicine, namely, arthrology, and can be used for the treatment of degenerative and post-traumatic deforming arthritis and other crippling damage to the joints.

The prior art method 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.

Known ceramic materials based on alumina (aluminum oxide), and implants for surgery approved in 1981 the international standard ISO 6474-81 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 odkomentowaniu International Organization 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 their reduced 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, where it was recommended to produce ceramic implant materials aluminum oxide high clean the indicators and components of an orthopaedic joint prostheses.

The chemical composition of the material according to ISO 6474 1994-02-01: main material aluminum oxide, Al2About3high 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).

Products from the 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 and sintering.

Known endoprosthesis of the ankle joint (A. C. the USSR 1711868 A1) Barcelona Etc., consisting of legs with rasejcami with bold end of the hinge area, which is included in the Cup of the endoprosthesis, having under it a cavity and an outer threaded surface. The inner part of the Cup there is ratesa traumatic enough, as the long stem of the prosthesis is introduced into the tibial bone when the lead foot in the direction of the intact ligaments almost 90', which could lead to disruption of the blood supply of the tissues of the foot.

Known endoprosthesis of the ankle joint (A. C. the USSR 546349, M. class. And 61 F 2/42) containing the distal portion made in the form of a rod with a curly head, and the proximal part made in the form of a semicylinder with pins connected to each other by using a hinge, wherein, with the aim of prosthetic ankle joint, protecting the natural longitudinal arch of the foot and soften the shock when walking, it has a plate with the shank and a ledge mounted on the half, and connected with the pins, and one of the pins is located on the ledge, the other on the shank, and the third is at the center of the plate in a direction opposite to the previous two, except that the endoprosthesis has a long stem at the proximal fragment of the prosthesis and three long pin, located at the distal fragment of the prosthesis, designed for tighter fastening detail to the bone and to retain the natural longitudinal arch of the foot, as well as to soften the shock when walking. Pins (rods) are inserted into the scaphoid, to the e l e C passing through the joint, will interfere with his work, as well as cause destruction of the joint, the formation of deforming arthrosis and pain. To implant the proximal part of the endoprosthesis with a long stem, need greater access and abduction of the foot almost 90othat is very traumatic.

The closest in technical essence and the achieved when using the result (the prototype) is a prosthetic joint with slip made of biocompatible material with good sliding properties, in particular ceramic, consisting of covered and covering components. Each component has a pin for mounting in the respective bones and connected with the pin on the platform. Covered component has at least two spherical surfaces, coaxially with the healing joint. Covering element has a hemispherical recess in the same amount, with the same General radius in cross-section, and a spherical zone. Each recess is a saddle for the covered item (application France 2465470, MCI And 61 F 1/00, publ. 1981). The design provides for the conservation cruciate ligament.

The disadvantages of this known FR is which is characterized by the asymmetry of the medial and lateral condyles, therefore, a mismatch occurs between the trajectory of the articulated surfaces and uneven tension cruciate ligament, the result is a collision between the articular surfaces, the occurrence of different-sized loads, leading to the loosening of the components of the prosthesis. The interaction of the articular cartilage of the patella with the flange on the anterior surface of the femoral component leads to erosion of the cartilage.

The General disadvantages of the known designs of implants is that they are of considerable size and weight, require the implementation of a bone using a special tool for each component of the endoprosthesis, which greatly injures the articulated surface of the bone, require additional traumatic means of fixation elements of the implant on the bone surface.

OBJECTIVES of the INVENTION objectives of the invention and the required technical result achievable with the use of the invention is to simplify the design and reduce the weight of the implant, as well as improving the efficiency and adaptability of its manufacture and implantation with simultaneous increase of its efficiency, simplify and increase the reliability of its fixation, sudesha use as implants.

The NATURE AND DISCLOSURE of the INVENTION the task is solved and the required technical result is achieved in that in a ceramic artificial joint, containing attached to the bones and movably sochlenenie elements of the endoprosthesis of alumina ceramics according to the invention the elements of the endoprosthesis made of ceramics based on aluminum oxide with additives of magnesium oxide, the surface elements of the endoprosthesis in their area of rolling joints made with anatomical profile similar to the profile of the corresponding surface of the prosthetic joint with capability of performing the implant functions ankle or hip, or shoulder, or elbow, or metacarpophalangeal joint, or joints of the hand or foot or feet, and attached to the bones of the elements of the endoprosthesis is made porous with decreasing density and increasing porosity from sochlenenii surface to attach to the bones parts of the elements of the endoprosthesis or porous surface shaped to be inserted into bone tissue elongated or shaped protrusions or in the form imposed on the surface of the bone plates or shaped pads made the morning the volume elements of the endoprosthesis is made hollow or porous or similar in structure to the prosthetic part of the bone of the joint, attached to the bones of the elements of the endoprosthesis is made integral with the possibility of changing their linear dimensions or angles of their attachment to the bones and provide additional holes or protrusions or depressions for additional means of fixation elements of the endoprosthesis on prosthetic bones, and surface elements of the endoprosthesis in the area of articulation also include limiting movement of the elements of the endoprosthesis relative to each other and/or additionally contain means preventing dislocation or dismemberment of the elements of the endoprosthesis.

The tasks are solved and the required technical result is also achieved by the fact that epocrates joint implant and method of implantation is implemented as follows: resetinput diseased or damaged articular surface of the bone and attach to the bones or the bones of the element or elements of the endoprosthesis with equidistant (equidistant from each other) mobile sochlenenii surfaces with anatomical profile similar to the profile of the respective mating surfaces of the prosthetic joint with capability of performing the implant functions ankle or knee, or hip, or plemya to the bones of the elements of the prosthesis are attached to bones by being inserted in the bone porous or have a porous surface of elongated protrusions or imposed on the surface of the bone plates or shaped elongated plates or shaped protrusions or in the form imposed on the surface of the bone plates or shaped pads or pads with protrusions or depressions shaped cross-section, after fixing elements of the endoprosthesis on the bones check the endoprosthesis on the magnitude of the angles of flexion-extension, or rotation, perform hemostasis, drain the wound is sutured, apply a sterile dressing, followed by the conservative restorative treatment with the protection of a prosthetic implant from the loads to the germination of bone tissue into the porous surface elements of the endoprosthesis.

This klentrou implant above-described construction, in whole or implanted only one of the elements of the endoprosthesis to the affected part of the prosthetic joint with preservation of unaffected parts of the prosthetic joint.

LIST of FIGURES of the DRAWINGS, the Disclosure of inventions is illustrated is illustrated on the example of the ceramic endoprosthesis of the ankle joint of Fig. 1 and 2, which depict views from the front and side elements ceramic endoprosthesis ankle joint Assembly.

The INDUSTRIAL APPLICABILITY of the Disclosure the invention is illustrated on the example of the ceramic endoprosthesis of the ankle joint.

The endoprosthesis of the ankle joint is made of alumina ceramics with additions of magnesium oxide and comprises (Fig.1 and Fig.2) of the tibial element 1 and the talus item 2, soldierette in their rolling joints made with anatomical profile And, similar to the profile of the corresponding surface of the prosthetic ankle joint, while part of the talus and tibial elements of the endoprosthesis in the places of their attachment to the talus and tibia bones are made of porous or contain porous layer 6 and contain the ledge 6 with holes 5 for additional means of fixation elements of the endoprosthesis on the talus and tibia bones.

The above detailed description of the design features of the implant and method of implantation leave no doubt as to their feasibility - all elements of technological methods of production design and a separate surgical implantation techniques known in medical technology and a well-developed modern medicine.

The CRITERIA for ELIGIBILITY analysis of the existing state of the art shows that there is no unique set of features which would be similar to the set of essential features of the invention. Therefore, the claimed technical solution meets the criteria of "novelty."

Endoprosthesis according to the invention can be made known industrial methods. When it is used in medicine as it provides the described vyslednou applicability".

The problem is solved the original, not previously known method makes it possible to use the properties of the ceramic material of the ceramics based on aluminum oxide with additives of magnesium oxide with the manufacture of the surface elements of the endoprosthesis in their area of rolling joints with anatomical profile similar to the profile of the corresponding surface of the prosthetic joint, and other distinctive signs, therefore, the present invention meets the requirement of the criterion of "inventive step".

As shown by the examples of industrial application of the invention, the proposed solution allows to obtain a simple design and implantation of the endoprosthesis low-weight high performance and high reliability of its fixation and significantly reduce the invasiveness of bone tissue during implantation of the elements of the endoprosthesis and, accordingly, to accelerate the healing process of damaged tissues. Therefore, there is reason to believe that the group of inventions meets the criterion of inventive step.

In General, given the novelty and non-obviousness of inventions, somethinsometimes of the invention, a solid solution of these invention challenges and achieving the desired technical result, in our opinion, the claimed technical solution of the urgent problem satisfies all the requirements of the inventions.

In addition, analysis of the essential features of the invention group and the unity achieved when using the technical result shows the existence of a single General inventive concept, the close and indissoluble connection between inventions groups and exclusiveness of the method of implantation directly to use the claimed design of the endoprosthesis, which allows you to combine two inventions in one application.

Sources of information 1. USSR author's certificate 1711868 A1, M CL a 61 F 2/42.

2. USSR author's certificate 546349, M. class. And 61 F 2/42.

3. Application France 2465470, MCI And 61 F 1/00, publ. 1981 (prototype).


Claims

1. Ceramic artificial joint, containing attached to the bones and movably sochlenenie elements of the endoprosthesis of alumina ceramics, characterized in that the elements of the endoprosthesis made of ceramics based on aluminum oxide with additives of magnesium oxide, the surface of the Lu corresponding to the surface of the prosthetic joint, and attached to the bones of the elements of the endoprosthesis is made porous with decreasing density and increasing porosity from sochlenenii surface to attach to the bones parts of the elements of the endoprosthesis or porous surface shaped to be inserted into bone tissue elongated or shaped protrusions or in the form imposed on the surface of the bone plates or shaped plates with protrusions or depressions shaped cross-section.

2. Ceramic implant under item 1, characterized in that the elements of the endoprosthesis is made by providing the possibility of performing the implant functions ankle, or hip, or shoulder, or elbow, or metacarpal-phalangeal joint or the wrist, or foot, or leg.

3. Ceramic endoprosthesis according to any one of paragraphs. 1 and 2, characterized in that the elements of the endoprosthesis contain a sealed cavity or internal volume elements of the implant are hollow, or porous, or similar structure of the denture part of the bone joint.

4. Ceramic endoprosthesis according to any one of paragraphs. 1-3, characterized in that attached to the bones of the elements of the endoprosthesis is made integral with the ability to change their Lin is different, however, that attach to the bones of the elements of the endoprosthesis contain additional holes, or protrusions or depressions for additional means of fixation elements of the endoprosthesis on prosthetic bones.

6. Ceramic endoprosthesis according to any one of paragraphs. 1-5, characterized in that the surface elements of the endoprosthesis in the area of articulation also include limiting movement of the elements of the endoprosthesis relative to each other or additionally contain means preventing dislocation or dismemberment of the elements of the endoprosthesis.

 

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