Method of implant material production on basis of pored polytetrafluorethylene and material produced by this method

FIELD: medicine.

SUBSTANCE: described method of implant material production on basis of pored polytetrafluorethylene includes processing of base surface which serves as a substrate, deposition of surface layer modified with alloying elements onto processed substrate by magnetron deposition of one of targets selected from the following metals: titanium, zirconium, hafnium, niobium, tantalum, mainly titanium, carbides of mentioned metals, mainly titanium carbide of TiC0.5; compound ceramic materials from the following group: TiC0.5+10 mass.% CaO; TiC0.5+10 mass.% CaO+2 mass.% KMnO4; TiC0.5+10 mass.% ZrO2; TiC0.5+10 mass.% hydroxyapatite (Ca10(PO4)6(OH)2, deposition of one of mention targets at that is carried out at pressure 1-2x10-1 Pa, at substrate temperature between 150-170°C, in argon or argon and nitrogen medium at nitrogen partial pressure 14%. Implant material includes base of polytetrafluorethylene of porosity 3.0-40.0%, and surface layer of thickness not less than 50 nm modified with alloying elements composing mentioned targets. Surface layer at deposition of metal target in argon medium contains mentioned metal as alloying element mainly titanium. Surface layer at deposition of metal carbide in argon and nitrogen medium contains Ti-C-N as alloying elements. Surface layer at deposition of ceramic target TiC0.5+10 mass.% CaO in argon and nitrogen medium contains Ti-Ca-C-O-N as alloying elements. Surface layer at deposition of ceramic target TiC0.5+10 mass.% CaO+2 mass.% KMpO4 in argon and nitrogen medium contains Ti-Ca-Mn-K-C-0-N as alloying elements. Surface layer at deposition of ceramic target TiC0.5+10 mass.% ZrO2 in argon and nitrogen medium contains Ti-Zr-C-O-N as alloying elements. Surface layer at deposition of ceramic target TiC0.5+10 mass.% (Ca10(PO4)6(OH)2, in argon and nitrogen medium contains Ti-Ca-P-C-O-N as alloying elements.

EFFECT: method of implant materials production as a substrate for hybrid implants characterized by improved physicochemical, biomechanical properties and enhanced biological activity to biotissues.

10 cl, 1 dwg

 

The invention relates to medicine, in particular to methods for new implants (implants) based on porous polytetrafluoroethylene (PTFE), mainly with such a coating, which can be used for the base hybrid implants in implant dentistry and osteoplastic surgery.

The use of implant materials (IM) has a long tradition in the development of medicine and is a means of replacement of damaged organs and tissues, and, therefore, restore or compensate for lost functions. In case of success is the integration of the implant in the tissue environment, and he begins to function as part of a living system, which is the human body.

With great visibility regularities of the process of integration can be traced in the study of THEM, innoculating in bone that occurs in osteoplastic surgery.

There are three types histomorphologically deterministic integration of the implants into the bone.

1. Fibrointimal - the formation of a fibrous capsule around the implant.

2. Osteoporosisrelated - areas of education in the interface implant - associated connective tissue layer interspersed with areas where the implant directly adjoins the bone.

3. Osseointegration - to the implant directly adjoins the bone.

The most appropriate assignment is osseointegration, in which close to the implant is formed complete in structural and functional (support function) bone.

In this regard, the most important task is to obtain THEM for medicine. One of the most promising materials is a porous polytetrafluoroethylene (PTFE).

Known material based on polytetrafluoroethylene brand f-4 (porous) metal coating of copper (EN 2020777 C1, C23C 14/24, 30.09.1994). The method of obtaining such material includes cleaning a substrate of polytetrafluoroethylene in an organic solvent, its treatment in a glow discharge and subsequent application to the substrate the adhesion of the copper coating by decomposition of ORGANOMETALLIC compounds of copper in plasma of RF discharge.

Known material used in the manufacturing of integrated circuits RF and microwave microelectronics, but cannot be used in medicine as THEM as has no biological compatibility with living tissues.

Known material based on polytetrafluoroethylene brand f-4 coated Nickel-boron ((EN 2213812 C1, C25D 15/00, 10.10.2003). The coating is applied to the substrate by electrochemical method. The resulting material is intended for use in machinery and may not be used in medicine as THEM as has no biological joint is shown with living tissues and because of the toxicity of Nickel and boron.

Known implant material based on porous polytetrafluoroethylene, which is used for the manufacture of implants in reconstructive endovascular surgery (EN 2203685 C2, A61L 27/14; A61F 2/02, 10.05.2003). The implant is a multilayer structure with a porosity 67-80%formed by layering multiple biaxially oriented microporous PTFE films, previously heat-treated at 320-340°C. the Implant can be formed by layering 2-96 layers of PTFE film, depending on its purpose, but its use in osteoplastic surgery is not known.

Known PTFE membrane for directed regeneration of periodontal tissues, which is used in the treatment of periodontal diseases (EN 2257232 C1, A61L 27/56; A61L 27/40; A61F 2/02, 27.07.2005). The membrane includes at least two layers of porous PTFE: layer adjacent to the periodontal tissues, has a volume fraction of the space of voids 78-94%, the outer layer has a volume fraction of the space of voids 30-60%. The membrane has a high regenerative activity and easy to use.

Purposeful use of known membrane for the treatment of periodontal disease limits its use in dental and bone surgery. The main disadvantage is its high porosity, which can be the t to facilitate the penetration of microbial colonies in living tissue.

The disadvantages of the known medical Institute, made of PTFE, are first of all their not high enough biomechanical characteristics and low biological inertness.

The closest analogue to the claimed technical solution in terms of material can be chosen based on porous polytetrafluoroethylene according to EN 2207825 C1.

Objective of the claimed invention is the development of new implant materials for fundamentals of hybrid implants are promising for application in medicine, with optimal integration potential, physico-chemical and biomechanical characteristics, adequate to the requirements of their application in implantology and osteoplastic surgery.

The technical result is to obtain implant materials as the basis for hybrid implant with a metal or ceramic coating with high physical-chemical, biomechanical characteristics and high biological activity to living tissue.

The technical result is achieved in that a method of obtaining an implant material based on porous polytetrafluoroethylene includes preparation of the substrate surface serving as a substrate, the coating on the prepared surface of the substrate surface of the coating layer of the modified legious the mi elements by magnetron sputtering of a target, selected from a number of metals, including titanium, zirconium, hafnium, niobium, tantalum; carbides of these metals, or a composite of ceramic materials selected from the group comprising: titanium carbide containing 10 wt.% of calcium oxide (TiC0.5+10 wt.% CaO); titanium carbide containing 10 wt.% of calcium oxide and 2 wt.% potassium permanganate (TiC0.5+10 wt.% CaO+2 wt.% KMnO4); titanium carbide containing 10 wt.% zirconium oxide (TiC0.5+10 wt.% ZrO2), titanium carbide containing 10 wt.% hydroxyapatite (TiC0.5+10 wt.% (CA10(PO4)6(OH)2while spraying one of these targets is performed at a pressure of 1-2×10-1PA, at a temperature of the substrate in the range of 150-170°With, in the atmosphere of argon or mixtures of argon with nitrogen at a partial pressure of nitrogen is 14%.

From the specified number of metal target is used mainly titanium and metal sputtering is carried out in an argon atmosphere.

From carbides of these metals to the target is used mainly titanium carbide composition TiC0.5.

Implant material based on porous polytetrafluoroethylene obtained by the described method, includes a base PTFE porosity from 3.0 to 40.0%, and the surface coating layer thickness of not less than 50 nm, modified alloying elements that are part mentioned is isana. The surface layer coating by sputtering of a metallic target in argon contains as an alloying element is referred to metal, preferably titanium. The surface layer of the coating when sprayed carbide metal in a mixture of argon and contains nitrogen as alloying elements mentioned metal, preferably titanium, carbon and nitrogen (Ti-C-N). The surface layer coating by sputtering a ceramic target composition (TiC0.5+10 wt.% CaO) in a mixture of argon and contains nitrogen as alloying elements titanium, calcium, carbon, oxygen and nitrogen (Ti-Ca-C-O-N). The surface layer coating by sputtering a ceramic target composition (TiC0.5+10 wt.% CaO+2 wt.% KMnO4) in a mixture of argon and nitrogen, contains as alloying elements titanium, calcium, manganese, potassium, carbon, oxygen and nitrogen (Ti-Ca-Mn-K-C-O-N).

The surface layer coating by sputtering a ceramic target composition (TiC0.5+10 wt.% ZrO2) in a mixture of argon and contains nitrogen as alloying elements titanium, zirconium, carbon, oxygen and nitrogen (Ti-Zr-C-O-N). The surface layer coating by sputtering a ceramic target composition (TiC0.5+10 wt.%(CA10(PO4)6(OH)2in a mixture of argon and nitrogen, contains as alloying elements titanium, calcium, phosphorus, carbon, oxygen and nitrogen (Ti-Ca-P-O N).

The choice of elements for them is santali titanium, zirconium, hafnium, niobium, tantalum, tungsten or ceramic composite materials as a target is determined by the fact that these elements in the coating is easily passivated by formation of oxides, which are biocompatible with the human body. These metal targets for use with a purity not less than 99,999, which is obtained by the known methods, for example by melting in a vacuum induction furnace.

Used these in the formula ceramic target: TiC0.5, TiC0.5+10 wt.% CaO, TiC0.5+10 wt.% CaO+2 wt.% KMnO4, TiC0.5+10 wt.% ZrO2, TiC0.5+10 wt.% (CA10(PO4)6(OH)2) received well-known method of power SHS (self-propagating high-temperature synthesis) compaction with subsequent hot isostatic pressing (HIP) (Iaglevichi, Astrogate, Viehweg, Iporanga // Physico-chemical and technological bases of self-propagating high temperature synthesis, Moscow, JSC "Publishing BINOM, 1999) on the basis of the pilot section of the self-propagating high temperature synthesis (SHS) of Scientific-educational center of SHS Misa-ISMAN (www.shs.misis.ru).

As substrates for the deposition of coatings used PTFE samples with a porosity of from 3.0 to 40% of closed joint stock company concern "Ecoflon" in the form of plates size 10×10×5. Preparation of surface the STI PTFE includes cleaning it in ethyl alcohol. Coating deposition is carried out for 60 minutes by magnetron sputtering target in a gas mixture of argon and mix it with nitrogen at a partial pressure of nitrogen is 14%. The total pressure in the vacuum chamber was 1-2×10-1PA, and the temperature of the substrate was maintained in the range 150-170°C.

The stated conditions of the coating allow you to get on the surface of the PTFE almost amorphous coating thickness not less than 50 nm. In the atmosphere of argon and nitrogen in the surface layer porous PTFE when the sputtering of the target material creates a zone with a high content of metal carbonitride or carbonitride and calcium atoms and oxygen, or carbonitride, atoms, phosphorus, manganese, potassium, oxygen, decomposition products HA with high adhesive properties with respect to the basis of PTFE. During thermal Cycling or after deformation isothermal reversible formation and disappearance of martensite plates does not lead to the destruction of the density metal layer, and this causes high corrosion resistance and good adhesion of this material under conditions of cyclic loading.

As criteria for a conclusion about the possible use of the materials tested as the basis for hybrid implants served as the evaluation of the adhesion and rasplastyvanija embryonic fibral the ists person on the surface of the samples.

Fibroblasts were isolated from skin and muscle tissue of embryos age 6 weeks. Cells were cultured in the medium of DMEM/199 (1:1) supplemented with 10% fetal calf serum (ETS) and 100 U/ml penicillin/streptomycin in an atmosphere of 5% CO2. Culture cells at passage 11 (CD133-, Cd117-, CD45-, CD90+, CD54-, CD62L-, CD62P-, CD9+, CD34-, CD31-, CD71-, CD20-That CD157-, D106+, CD62E+) was used to test materials. Cells were sown on the surface of samples with a density of 35 thousand/cm2and were cultured for 72 hours.

Four sample after cultivation on the surface of fibroblasts was investigated using fluorescence microscopy: 1. Metal (Ti) with a sputtering target TiC0.5+10% CaO. 2. PTFE coated TiC0.5+10% CaO. 3. Metal (Ti) coated TiC0.5+10% Cao+2% KMnO4. 4. PTFE coated TiC0.5+10% CaO+2% KMnO4.

Evaluation of the morphology and viability of cells was performed on a microscope LUMAM AND-2 using the method of staining cells 0.0002% solution of acridine orange in phosphate buffer. This dye selectively interacts with DNA and RNA by intercalation or electrostatic attraction, respectively. When this is associated with a dye DNA fluorescent in the green light (525 nm), and electrostatic damage to the module is automatic associated with RNA acridine orange fluorescent in the red range (> 630 nm). This allows for an overall assessment of cell activity, proliferate, peace, apoptosis).

As shown by studies using fluorescent microscopy on the surface of all 4 samples were located a large number gathered in clusters or scattered in many parts of the surface intersecting elongated cells. They were characterized by large oblong core, shining in the pale-green spectrum, in the cytoplasm of cells often had areas of orange and red glow. In individual cells in the nucleus was detected bright green on (Ti sputtered TiC0.5+10% CaO+2% KMnO4).

Using the method of scanning electron microscopy (SEM) study of the surface structure of the samples and morphology of adherent thereto embryonic fibroblasts on the following materials: 1. Ti uncoated; with coatings. 2. Ti-Ca-C-O-N. 3. Ti-Ca-Mn-C-O-N. 4. PTFE without coating. 5. PTFE + Ti. 6. PTFE + Ti-Ca-C-O-N. 7. PTFE + Ti-Ca-Mn-C-O-N.

As shown by the SEM study, embryonic fibroblasts were attached to the surface of samples of Ti in small quantities and was practically sprawled on her, testified that, from our point of view, weak integration potential of this material (Fig. a).

Embryonic fibroblasts were adhesively and prostrate themselves who and the sample surface Ti coated Ti-Ca-C-O-N and Ti-Ca-Mn-C-O-N.

On the PTFE samples without coating fixation of the cells was observed (Fig. b). In contrast, samples of PTFE coated Ti, Ti-Ca-C-O-N, Ti-Ca-Mn-C-O-N (Fig. and d) were observed attaching a large number of cells and their raspletanie. The most pronounced this effect was on the PTFE samples with CA-containing coatings.

Thus, the research results obtained materials with SAM installed:

1. All study materials support the adhesion and raspletanie human fibroblasts greatest flatness and the characteristic elongated shape of the cells is observed with the sputtering target TiC0.5+10% Cao+2% KMnO4.

2. Cells cultivated on the surface all materials are in the active state (the presence of RNA speaks of protein synthesis). On the surface of materials by sputtering a target of TiC0.5+10% CaO+2% KMnO4there's a lot of cell proliferation.

3. All requested materials are not toxic to cells.

4. Criterion rasplastyvanija cells gave the opportunity to compare and evaluate in vitro integration potential of the test samples, because their "engraftment" - integration in the tissue of the recipient organism begins with the migration of cells from the tissue environment and their attachment and rasplastyvanija on the surface of the implants.

5. Samples with calcium-containing and coatings possess high the integration potential. Cells on their surface well desirous and rasplachivayutsya.

6. Received new implant materials can be recommended as a carrier of stem cells and precursor cells in a hybrid implants.

7. Created effective way of obtaining implant materials based on porous polytetrafluoroethylene having osteoconductive properties, enhanced biological fixation to the tissue, with high corrosion resistance and their low solubility in aggressive environments.

1. The method of obtaining implant material based on porous polytetrafluoroethylene, including the preparation of the substrate surface serving as a substrate, the coating on the prepared surface of the substrate surface of the coating layer of the modified alloying elements, by magnetron sputtering of a target selected from a number of metals, including titanium, zirconium, hafnium, niobium, tantalum; carbides of these metals, or a composite of ceramic materials selected from the group comprising: titanium carbide containing 10 wt.% of calcium oxide; titanium carbide containing 10 wt.% of calcium oxide and 2 wt.% potassium permanganate; titanium carbide containing 10 wt.% zirconium oxide; titanium carbide containing 10 wt.% hydroxyapatite, while spraying one pointed to by the x targets is performed at a pressure of 1-2· 10-1PA, at a temperature of the substrate in the range of 150-170°With, in the atmosphere of argon or mixtures of argon with nitrogen at a partial pressure of nitrogen is 14%.

2. The method according to claim 1, characterized in that the specified number of metal target is used mainly titanium.

3. The method according to claim 1, wherein the carbide of these metals to the target is used mainly titanium carbide composition TiC0,5.

4. Implant material based on porous polytetrafluoroethylene obtained according to claims 1-3, including the basis of polytetrafluoroethylene porosity from 3.0 to 40.0%, and the surface coating layer thickness of not less than 50 nm, modified alloying elements that are part of the mentioned targets.

5. Implant material according to claim 4, characterized in that the surface coating layer contains as an alloying element is referred to metal, preferably titanium.

6. Implant material according to claim 4, characterized in that the surface coating layer contains as alloying elements mentioned metal, preferably titanium, carbon and nitrogen.

7. Implant material according to claim 4, characterized in that the surface coating layer contains as alloying elements titanium, calcium, carbon, oxygen and nitrogen.

8. Implant material according to claim 4, characterized in that the surface layer of the p the closure contains as alloying elements titanium, calcium, manganese, potassium, carbon, oxygen and nitrogen.

9. Implant material according to claim 4, characterized in that the surface coating layer contains as alloying elements titanium, zirconium, carbon, oxygen and nitrogen.

10. Implant material according to claim 4, characterized in that the surface coating layer contains as alloying elements titanium, calcium, phosphorus, carbon, oxygen and nitrogen.



 

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