The way contouring, repair, correction, removal or replacement of defect, damage or deformation of bone or cartilage tissue and the implant for its implementation

 

The invention relates to medicine and medical technology, maxillo-facial, cranial or aesthetic surgery, dentistry, oncologically, traumatology. The invention provides the possibility of directly during the operation to make final adjustments and modeling of the implant with the exception of thermal damage to the bone tissue. For contouring, repair, correction, replacement or removal of defects, damage or deformation of bone or cartilage tissue using composite implant, which contains a porous matrix and a dense structure in which a porous matrix made of a porous ceramic material, and dense composition contains bone cement or bone glue, or injection, or dense ceramic material, or other dense biocompatible material, filling or covering the pores of the one or more surface layers of the porous matrix. In the implant for contouring, repair, correction, replacement or removal of defects, damage or deformation of bone or cartilage tissue containing a porous matrix and a dense structure, the porous matrix of the implant is made of a porous ceramic is the cue material, or other dense biocompatible material, filling or covering the pores of the one or more surface layers of the porous matrix, and dense composition is one or more surface layers of a porous ceramic matrix material by contact of the implant after implantation of the soft tissues and pores of the ceramic matrix material is made open in the direction of contact of the implant after implantation with bone or cartilage tissue. 2 C. and 8 C.p. f-crystals, 1 Il.

Technical FIELD the Invention relates to medicine and medical equipment, namely, maxillo-facial, cranial or aesthetic surgery, dentistry, oncologically, trauma, and can be used for treatment, contouring, repair, correction, replacement or removal of defects, deformities or defects of the facial bones, craniofacial bones or cerebral cranium bones or cartilages, with traumatic or other defects or destruction of tumor or degenerative-dystrophic processes, and also to change the shape and dimensions of the various departments of the front or cerebral cranium or cartilaginous tissues of the head of rantarou 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 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 the size of the bone fragments 0.5-2.5 mm in volume, filling the bone defect [2].

A method of obtaining and applying 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 to remove the PR>oWith the passage of time from 4 hours to 7 days [3].

The General disadvantages of using obtained according to the methods of the implants are 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 a great weight and lead to acute hypothermia (sometimes freezing) implanted region at low (sub-zero) temperatures 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 a perforated mesh tite implants is very difficult 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 of 40-60%, water absorption (pharmacological capacity) 35-50%, a compressive strength of not less than 10 MPa [6].

The technical disadvantages of implants based on hydroxyapatite are 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, the village is an urn plastic implants from self-hardening plastic. However, this method of contouring the use of self-hardening plastic material has the disadvantage that when applied in the stage of polymerization on the bone surface due to flowing exothermic reaction, possible thermal damage to bone structures. In the simulation of the implant in the wound do not exclude the possibility of penetration of the monomer into the wound. In addition, there is no osseointegration of the implant, which may be the cause of his removal and inflammatory complications.

One of the ways contouring is the use of translateto-Alloplant. The use of these grafts is very promising, but not without some drawbacks. Alloplasty in engrafting partially or totally dissolve and do not have sufficient strength for reimbursement of bone defects. Sometimes there are also inflammatory and allergic reactions to the introduction of Alloplant.

The known method of eliminating defects and deformations of the frontal bone and the bones of the human cerebral cranium [7], the method of forming a curl of the ear [8], a method to restore chewing ability in patients with large defects of the lower jaw with osteoplastic operations [9], the method eliminated Amici.

However, these sources of information are not disclosed properties and metrics used ortopediska implants, qualitative and quantitative composition, properties, manufacturing techniques and design features of corundum ceramics, which indicates a General formulation of inventive problems, but does not disclose data in the sources of information about new specific technical solutions. It is known, in particular that of ceramics, containing in its composition more than 95% of aluminum oxide, called corundum, qualities and characteristics which are determined by a number of factors, including the type of raw materials and additives, their quantitative ratio, mode and conditions of the technological process of its production [11].

Known monolithic implants for surgery-ceramic materials based on alumina (aluminum oxide) approved in 1981 the international standard ISO 6474-81 [12] having the chemical composition: Al2About3not 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. This ceramic material and made of him the implants have the properties of douliana 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 known technological methods of manufacturing the monolithic ceramic implants the way it is molded from a 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 1994, the international standard ISO 6474-81 (1981) was cancelled and the International Organization for Standardization approved a new edition of the international standard ISO 6474 1994-02-01 [13], where it was recommended to produce ceramic implant materials of aluminum oxide of high purity 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 oaks is%, 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). Implants made of this material is usually obtained by preparing a ceramic composition of a mixture of ultra-fine powder of high-purity aluminum oxide powder and magnesium oxide, molding by pressing and sintering of the material. Ultra-fine alumina powder of high purity usually get plasmochemical methods and it is very expensive, and forming implants compaction method allows you to get only the thick-solid products simple geometric, often spherical or cylindrical shape. Therefore, manufactured from high-purity alumina implants roads that are inaccessible to a broad spectrum of patients and is currently used only as substitutes joints and tol is poison with their advantages have a number of technical drawbacks, due to the design features of monolithic ceramics. First, after implantation does not occur integrating monolithic ceramic implants with bone or cartilage tissue, so monolithic ceramic implants are present in the body of the recipient as abnormal body surrounded by a connective tissue capsule. Secondly, in view of the high density and strength of monolithic ceramics implants of monolithic ceramics are heavy and almost not amenable to correction during the operation, which is often necessary to account for the individual characteristics of damaged, replaced or restored bone or cartilaginous tissue of the recipient. These problems usually try to solve it by drawing on a monolithic ceramic implants porous ceramic layer or surface layer of porous, but, as practice shows, the use of such implants, it is not enough to effectively address the aforementioned technical drawbacks.

The closest in technical essence and the achieved when using the result (the prototype for the method and implant) is a method for preparing a composite material intended for implant is t, at least one block of biocompatible porous solid matrix, consisting mainly of at least one calcium salt selected from calcium phosphates, sulphates of calcium and carbonates of calcium, regardless of the solid matrix, prepare of curing a liquid solution capable of after curing to form a cured biocompatible solid composition of hydraulic cement consisting mainly of at least one calcium salt selected from calcium phosphates, sulphates of calcium and carbonates of calcium, and is able to completely dissolve in the environment of the implant, the unit matrix is immersed in a liquid solution prior to its curing a period of time sufficient to ensure that the solution has infiltrated and filled porous volume of the unit matrix to the core, and then produce drying and curing the liquid solution to the solid composition, and then carry out the forming of each block of the composite material obtained in this way. Composite material intended for implantation in a biological environment of the animal or human, which can be obtained as described above, consists of (a) a biocompatible porous solid matrix, the chemical composition of which is largely biocompatible inseparable solid composition cured hydraulic cement, consisting mainly of at least one calcium salt selected from calcium phosphates, sulphates of calcium and carbonates of calcium, and this solid composition fills the porous volume matrix and is able to completely dissolve in a specified environment [14] (prototype). Technical deficiencies in the application of these composite implants is their integrity that prevents osseointegration and requires additional traumatic mechanical means of fixation of implants to bone or cartilage.

OBJECTIVES of the INVENTION Objectives of the invention and the required technical result achievable with the use of the invention are the creation and application in craniofacial, brain or aesthetic surgery, dentistry, oncologically, traumatology new effective way of filling bone cavities after removal of tumors and contouring that allows directly during the operation, the final fit and modeling of the geometric dimensions of the implant size and shape of the wounds, damaged or recovered bone or cartilage tissue, which excluded the possibility of thermal damage to the bone and obespechivayuschikh or cartilage structures having a traumatic or other defects in, or affected tumor or degenerative-dystrophic processes, as well as providing the possibility of changing the shape and dimensions of the various departments of the front or cerebral cranium or cartilaginous tissue, increase efficiency and manufacturability of ceramic implants while reducing weight, simplify resizing, enhancing the reliability of fixation of the implant and increase the efficiency of the use of implants with complex anatomical shape of the surface and the required strength.

Summary of the INVENTION the task is solved and the required technical result from the use of the invention is achieved in that according to the method of contouring, repair, correction, replacement or removal of defects, damage or deformation of bone or cartilage tissue according to the invention using a composite implant, which contains a porous matrix and a dense structure in which a porous matrix made of a porous ceramic material, and dense composition contains bone cement or bone glue or Alloplant or dense ceramic material or other dense biocompatible eat dense composition is one or more surface layers of a porous ceramic matrix material by contact of the implant after implantation of the soft tissues, as the pores of the ceramic matrix material is made open in the direction of contact of the implant after implantation with bone or cartilage tissue.

In this use, the implant is performed with anatomical shape and/or anatomical surface profile that is identical or similar to the anatomical shape and/or anatomical surface profile being restored, corregirutuyu or replaced craniofacial, brain, or other bone or cartilage or joint or damaged, restored, korregiruet or replaced parts.

Using the implant, one or more surfaces of which are made with a dense structure with anatomical shape and/or anatomical surface profile that is identical or similar to the anatomical shape and/or anatomical surface profile being restored, corregirutuyu or replaced bone or cartilage or damaged, korregiruet or replaced parts.

In addition, use of the implant, the porous matrix which further comprises a drug and/or antibacterial and/or stimulating osteosynthesis, osteocephalus and/or implantation of the implant and/or segeplan the same, in the implant for contouring, repair, correction, replacement or removal of defects, damage or deformation of bone or cartilage tissue containing a porous matrix and a dense composition according to the invention the porous matrix of the implant is made of a porous ceramic material, and dense composition contains bone cement or bone glue or Alloplant or dense ceramic material or other dense biocompatible material, filling or covering the pores of the one or more surface layers of the porous matrix, and dense composition is one or more surface layers of a porous ceramic matrix material by contact of the implant after implantation of the soft tissues, as the pores of the ceramic matrix material is made open in the direction of contact of the implant after implantation with bone or cartilage tissue.

When this implant is performed with anatomical shape and/or anatomical surface profile that is identical or similar to the anatomical shape and/or anatomical surface profile being restored, corregirutuyu or replaced craniofacial, brain, or other bone or cartilage or su the several surfaces of the implant is made with a dense structure with anatomical shape and/or anatomical surface profile, identical or similar anatomical shape and/or anatomical surface profile being restored, corregirutuyu or replaced bone or cartilage or damaged, korregiruet or replaced parts and a porous matrix of the implant contains the medicinal product and/or antibacterial and/or stimulating osteosynthesis, osteocephalus and/or implantation of the implant and/or healing of damaged tissues.

Thus, the main content of the invention is that use composite implant comprising a porous ceramic matrix and bone cement or injection or other similar solid biologically compatible material, and for reimbursement of bone defects may use the combined implant consisting of porous and monolithic ceramics. While implants are oriented in space in such a way that the surface of the bone adjoined porous ceramics, making the newly formed bone tissue grows into the pores of the ceramic implant, providing a reliable osseointegration and implant fixation. To prevent ingrowth into the pores of the ceramic implant soft tissues, melirovanie implant outside of the porous ceramic matrix of the implant is covered by a dense layer of bone cement or injection or other thick biologically compatible material.

LIST of DRAWINGS disclosure of the invention illustrated by the drawing, which shows a sectional structure of a composite implant according to the invention after implantation to replace the bone.

This drawing shows a section of bone 1 with a partial defect of bone tissue, which is replaced by a composite implant comprising a porous ceramic matrix 2 open pores in places of contact of the implant with the restored area of bone tissue and monolithic surface layer 3 formed by the layer of bone cement or bone glue or Alloplant or dense ceramic material or other thick biocompatible material, filling or covering the pores of the one or more surface layers of a porous ceramic matrix with the formation of the anatomical shape of the surface of the restored section of bone.

The INDUSTRIAL APPLICABILITY of the Disclosure the invention is illustrated on the example of the disclosure of the structural design of the combined implant and examples of experimental and clinical studies of the effectiveness of the combined use of an implant with a porous ceramic matrix.

Were experimental image, toxicologi hygienic and clinical trials.

Porous ceramic matrix implants were made of alumina by cooking the slurry, forming organic foam and sintering.

The results of extensive testing of the ceramic material of the implant in the all-Russian scientific-research and testing Institute of medical technology of the Ministry of health of the Russian Federation showed that the ceramic material and the implant out of the Toxicological-hygienic and sanitary-chemical indicators meet all the requirements of the medical devices of similar purpose.

Clinical trials used ceramic material and ceramic implants were conducted in the prescribed manner at the St. Petersburg state medical University named after academician I. P. Pavlov. 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, among others bol is 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 surgeries. In 5 cases a surgical procedure, the introduction of ceramic 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.

As a result of clinical trials, had the warrior 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 combined implants of porous ceramics was preceded by experimental studies on laboratory animals, the purpose of which was to study the processes of integration with the bone tissue and soft tissue structures adjacent to the implant surface.

The first series of experiments was carried out on white rats Vistor weighing 150-180 grams. Have used three types of implants: 1 - implant made of porous ceramics of cubic or cylindrical, 2 - implant made of porous ceramics, the outer surface of which was covered with a layer of bone cement for fixation of implants, 3 - implant made of porous ceramics, the surface of which was covered by the Alloplant.

The progress of experiment: under ether anesthesia of the median incision in the occipital region was detached periosteum in the parieto-occipital area and formed in the tunnel entered the implant. The wound was usuals.

In rats withdrawn from experience after 3 months, it was found that the implants are quite well-fixed to p and method of the chip. Under electron microscopy revealed that in the area of contact of the implant with the bone surface, there are lots ingrowth of bone tissue into the pores of the implant.

The second part of the experiment was conducted on rabbits. The plan of the experiment was similar.

When analyzing the results of the experiment revealed that the implants made of porous ceramics with open porosity was smaller than the original, despite the strong fixation to the bone surface, i.e., does not retain its shape, or were surrounded by connective capsule, separating them from the bone surface.

Otherwise behaved combined implants. They were tightly coupled with the underlying bone tissue and has retained its original shape.

Thus, experimental studies proved the advantage of the combined implants.

The use of ceramic implants with open porosity did not meet the objectives of the experiment or did not provide the necessary osseointegration. This can be explained by the fact that they do not have sufficient strength and are easily damaged under any load, and also that the rate of proliferation of connective tissue exceeds the speed pret growing them in the bone tissue, i.e. osseointegration.

In those cases, when the porous implant is covered on the outside with a layer of cement or Alloplant preventing ingrowth into him connective tissue, newly formed bone tissue has time to grow into the open pores of the implant. And the body more resistant to mechanical stress.

In addition, experiments conducted on dogs weighing 25 kg 2 years of age and weighing 12 kg 6 months of age.

Under intravenous anesthesia was produced skin incision in the iliac region of length 8 cm, skeletonema comb Powszechny bone, in which is formed bone defect size with a ceramic implant 2,5 see In the region of the defect entered cylindrical implant, the outer surface of which is solid, and the cavity is made of porous ceramics dimensions 2.5 x 1.0 cm without primary fixation. Joints in layers with catgut, skin sutures silk.

In the iliac crest region of the other limb is formed of the same defect, which introduced the porous ceramic implant 2.5 x 1.0 cm, the outer surface of the closed injection, fixed catgut to surrounding tissues.

In the submandibular region made the skin incision length 5 see Skeletonema the outer surface of the lower th is m, which introduced the porous ceramic implant, outside it was closed by allplant, which is fixed to the lower jaw two standard screws.

On the other hand also exposed outer surface of the lower jaw and subperiosteal entered porous ceramic implant 1.0 x 1.0 x 0.5 cm, outer surface covered with Alloplant, which is fixed to the jaw standard screws.

After 2 and 2.5 months the animals were removed from the experiment. The study found that all ceramic implants are firmly fixed to the bone in the iliac crest region and in the lower jaw. This is confirmed by clinical and radiographically. The exterior of the implant is covered with a fibrous capsule.

Thus, it was experimentally proved that the composite implants with a porous ceramic matrix can be used to repair bone defects, for contouring the maxillofacial region, for filling bone cavities formed after removal of the various formations.

The results of preliminary experimental studies have served as the basis for testing the combined implants in clinics is on 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.

This proves the possibility of realization of the invention industrially, the possibility of solving problems and achieving the required technical result, which further confirmed by the following examples of clinical observations.

EXAMPLE 1. Patient N., 22 years after childhood osteomyelitis of the mandible on the left formed a combined asymmetric deformation of the lower and upper jaw with pronounced asymmetry of the lower third of the face. The bite of the patient is adapted, opening the mouth and chewing is not difficult. In this regard, the patient and his parents expressed a desire to be limited to the removal of the asymmetry of the lower third of the face by contouring.

Surgical treatment was carried out in two stages. The first was to correct the shape of the lower jaw to the right by podatkowego the introduction of combined implants of Paris is to defended porous implants from germination connective tissue, but and held in a predetermined position of the individual fragments of porous implant.

In addition, the use of bone cement allowed to make the final modeling of the implant during the operation.

For operative intervention was made a block of porous ceramics. Surgical intervention was carried out external access with excision of the scar in the left submandibular region. After exposure of the outer surface of the branch and body of the mandible was the final modeling of porous ceramic implant. It should be emphasized that the porous ceramic implant does not possess great strength that requires careful attitude both during surgery and in the postoperative period, before germination him tissues. However, due to this property, one can easily simulate the implant during surgery.

After formation of the implant was placed in the region of the defect angle and body of the mandible. Outside the implant was fixed two ligatures of chromic catgut. The patient is satisfied with the result.

EXAMPLE 2. Patient 36 years, was previously operated on for malocclusion. After normalization bite is connected with microgenia. At the explicit request of the patient he made genioplasty porous implant. The implants of the individual pieces were laid on the chin surface of the lower jaw and to prevent ingrowth of connective tissue and displacement of the implant was covered on the outside by the Alloplant standard which is fixed with titanium screws. Results patient happy.

EXAMPLE 3. Patient M., aged 20, was admitted to the hospital with a diagnosis of combined subcluster-facial anomaly. Micrognathia left, micro - and retrogene. Deformation was formed due to scald one year old. Surgical treatment carried out by the method of contouring a combined implant, covered on the outside by injection. The results of the use of the combined porous ceramic implant showed that they can be used in plastic surgery for sculpting and shaping your face.

EXAMPLE 4. Patient N., 22 years old, was admitted to the hospital with a diagnosis of deformation of the lower jaw to the left, asymmetrical microgenia. Was conducted contour of the lower jaw on the left of combined implants of porous ceramics and Alloplant, genioplasty Noah area on the left, layers dissected tissue and skeletonema the front surface of the lower jaw to the left. In the field additional cleat fixed chromed catgut. Formed and todeliver implant made of porous ceramics in the form of the defect, laid on the surface of the bone, covered with the Alloplant and fixed chromed catgut. In the anterior Alloplant is fixed to the soft tissues with catgut. Chin area using the drill was removed protruding mound for the symmetry of the face. Layers with catgut sutures. Skin sutures vein, put the glove drainage. On the right, the projection angle of the mandible produced by the mucosal incision and soft tissue introduced Alloplant for the symmetry of the face. The seams on the mucous vein.

The postoperative period was uneventful. The drainage was removed on the second day. Sutures were removed on the 10th day.

Inspection a year later showed that the ceramic implant sufficiently firmly fixed to the lower jaw, deformed, does not cause any discomfort. Cosmetic result, the patient is happy.

EXAMPLE 5. The patient was admitted with a diagnosis of post-traumatic deformity of the midface in a car accident, traumatic brain injury, fracture NATO held craniotomy, rhinoplasty, correction of the bridge of the nose, contour, replacement of the defect with prosthesis, the restoration of the medial corner of the eye.

During the operation executed contour forehead and superciliary region on the left of combined implants of porous ceramics and Alloplant.

Under ATN produced excision of the scar in the eyebrow area to the left. The formed tunnel in the area of deformation, be cut scars. Medial bottom of the wound is made of cartilage tissue, bone tissue in the superciliary region is absent. Above defect has preserved bone. Formed in the tunnel at the bottom of the wound entered porous ceramic implant small fragments from 5 to 10 mm, which from the outside was covered with injection of the sole of the foot. Produced hemostasis. Joints in layers with vicryl. Skin sutures polyamide 4/0.

The postoperative period was uneventful. Sutures were removed on the 7th day. Inspection a year later showed that the implant remains in the same place, with good filling cosmetic defect in the forehead and superciliary region.

EXAMPLE 6. The diagnosis of the patient M: SSCL, micrognathia left, micro - and retrogene. 'an. morbi: In 1981, scald head and upper half of the body II-III senior 3-year-old appeared deformation h is kombinirovannym implants made of porous ceramics and Alloplant in the lower jaw on the right.

Under ATN with intubation using a bronchoscope due to contracture of the lower jaw made a skin incision in the right submandibular region with a length of about 9 cm from the angle of the lower jaw to the chin. Layers dissected tissue, skeletonema the front surface of the mandible from the corner to the chin. Released n.mentalis dex. A simulation of a porous ceramic implant according to the form of the defect, avoiding the area of the mental foramen. The formed implant is introduced into the deformation area on the surface of the bone and covered by injection. Fixation combined implant performed by the layer suturing of wounds with catgut without additional fixation. In the wound entered the drainage. The seams on the skin vein.

The postoperative period was uneventful. Inspection a year later showed that the implant is well fixed to the lower jaw, fixed, fixes and cosmetic deformity.

COMPLIANCE with the ELIGIBILITY CRITERIA Outlined above detailed description of the features of the method of application of the combined ceramic implants and structural features of the used implants do not leave any doubt as to their feasibility - all the elements of technical production techniques is the service of ceramic materials and medical practice.

Detailed analysis of the existing prior art shows a lack of open and accessible sources of information unique set of features which would be identical with the totality of the essential features of the invention. Therefore, the claimed technical solution meets the criteria of "novelty."

Combined ceramic implants according to the invention can be produced industrially, and their production does not require expensive materials or special equipment. When using inventions in medicine they achieve the desired technical result. Therefore, the proposed technical solution meets the criterion of "industrial applicability".

The task is solved by the original simple, but previously unknown way, the invention enables to solve tasks and to provide a new previously unknown positive result.

As shown by the examples of experimental and clinical trials on the implementation of the invention, the proposed technical solutions allow to get easy to manufacture, but effective design combined Finance, to increase the reliability of their fixation, significantly reduce the invasiveness of bone tissue during implantation and improve the biocompatibility and accelerate the healing process of damaged tissues. So there is every reason to believe that the group of inventions meet the criterion of "inventive step".

In General, given the novelty and pacificnet of the invention, the materiality of all the General and specific features of the invention (shown in the section "summary of the invention"), and also shows the industrial feasibility of the invention, a solid solution of the tasks and achieving the desired technical result of the claimed technical solution of the urgent tasks meets all requirements for eligibility requirements for 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 the invention of the group and for the combined ceramic implant directly for use according to the method of contouring, repair, correction, us is thread two inventions in one application.

SOURCES OF INFORMATION 1. RF application 93040884, A61F2/28, publ. 1996.07.27.

2. RF application 99117208, A61F2/28, publ. 2001.06.10.

3. RF application 97108964, A61L27/00, publ. 1999.06.20.

4. The application of Germany 3224265, A61L27/00, RF patent 2035192, publ. 1995.05.20.

5. RF patent 2157245, A61L27/00, publ. 2000.10.10.

6. RF patent 2074672 A61L27/00, publ. 1997.03.10.

7. RF application 99104861, A61F2/28, publ. 2001.01.10.

8. RF application 99104875, A61F2/28, publ. 2001.01.10.

9. RF application 991111043, A61F2/28, publ. 2001.03.27.

10. RF application 99104860, A61F2/28, publ. 2001.01.10.

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

12. ISO 6474-81, 1981, page 5

13. ISO 6474, 1994-02-01, 1994, 6 pages

14. RF application 98104066/14, A61L27/00, AC/033, A61L31/00, publ. 2000.01.10 (prototype).

Claims

1. The way contouring, repair, correction, replacement or removal of defects, damage or deformation of bone or cartilage, characterized in that use composite implant, which contains a porous matrix and a dense structure in which a porous matrix made of a porous ceramic material, and dense composition contains bone cement or bone glue, or injection, or dense ceramic material, or other dense biocompatible material that fills or pokryvailo use the implant, where dense composition is one or more surface layers of a porous ceramic matrix material by contact of the implant after implantation of the soft tissues and pores of the ceramic matrix material is made open in the direction of contact of the implant after implantation with bone or cartilage tissue.

3. The method according to any of paragraphs.1 and 2, characterized in that use, the implant is performed with anatomical shape and/or anatomical surface profile that is identical or similar to the anatomical shape and/or anatomical surface profile being restored, corregirutuyu or replaced craniofacial, brain, or other bone or cartilage, or joint, or damaged, restored, korregiruet or replaced parts.

4. The method according to p. 3, characterized in that the use of the implant, one or more surfaces of which are made with a dense structure with anatomical shape and/or anatomical surface profile that is identical or similar to the anatomical shape and/or anatomical surface profile being restored, corregirutuyu or replaced bone, or cartilage or damaged, korregiruet or the Itza which further comprises a drug and/or antibacterial and/or funds, stimulating osteosynthesis, osteocephalus, and/or implantation of the implant, and/or healing of damaged tissues.

6. Implant for contouring, repair, correction, replacement or removal of defects, damage or deformation of bone or cartilage tissue containing a porous matrix and a dense composition, characterized in that the porous matrix of the implant is made of a porous ceramic material, and dense composition contains bone cement or bone glue, or injection, or dense ceramic material, or other dense biocompatible material, filling or covering the pores of the one or more surface layers of the porous matrix.

7. The implant according to p. 6, characterized in that a dense composition is one or more surface layers of a porous ceramic matrix material by contact of the implant after implantation of the soft tissues and pores of the ceramic matrix material is made open in the direction of contact of the implant after implantation with bone or cartilage tissue.

8. The implant according to any of paragraphs.6 and 7, characterized in that the implant is performed with anatomical shape and/or anatomical surface profile that is identical or as is whether the substituted maxillofacial, cranial, or other bone or cartilage, or joint, or damaged, restored, korregiruet or replaced parts.

9. The implant according to p. 8, characterized in that one or more surfaces of the implant is made with a dense structure with anatomical shape and/or anatomical surface profile that is identical or similar to the anatomical shape and/or anatomical surface profile being restored, corregirutuyu or replaced bone, or cartilage, or slain, korregiruet or replaced parts.

10. The implant according to any of paragraphs.6 to 9, characterized in that the porous matrix of the implant contains drugs, and/or an antibacterial agent, and/or an agent stimulating osteosynthesis, osteocephalus, and/or implantation of the implant, and/or healing of damaged tissues.

 

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