Biocoating for titanium and alloy implant and method for making thereof

FIELD: medicine.

SUBSTANCE: invention refers to medical equipment and can be applied for making a biocompatible coating of medical intraosseous and transosseous implant of high engraftment level. The titanium and alloy coating contains titanium and copper oxides in a certain quantitative ratio, and lanthanum. The coating is formed on titanium and titanium alloys (BT 1-0, BT 1-00, BT-6, BT-16 etc.) by the electrochemical method sequentially in two electrolytes; at first, anodic oxidation is used to make a layer of mixed titanium and copper oxides in electrolyte of concentration 200 g/l of sulphuric acid with added 50 g/l of copper sulphate in distilled water with direct anode current; then cathodic incorporation enables generation of a lanthanum layer in the form of fragments in electrolyte of concentration 0.5 M of lanthanum salicylate in dimethyl formamide with direct cathode voltage 3 V.

EFFECT: method allows making the osteointegration oxide biocoating exhibiting bactericidal and anticoagulant properties.

2 cl, 1 ex

 

The invention relates to the field of medical equipment and can be used to create biocompatible coatings for medical intraosseous and transosseous implants with a high level of engraftment in the body.

High statistical frequency of operational failures during the implantation of bone implants is largely determined by an allergic reaction to a foreign body and intense thrombus formation on the border of the implant-tissue in the initial postoperative period. These phenomena lead to irritation, inflammation, suppuration adjacent bone, reducing the effectiveness of osseointegration and the subsequent rejection of the implant. The unsatisfactory nature of these results contributed to the search for new solutions to this problem, to ensure a proper osseointegration, minimizing postoperative complications and reduce the frequency of operational failures.

Known oxide coating containing titanium oxide (A.S. 534525, USSR). This coating has high hardness, wear resistance, but does not possess antibacterial and anticoagulant properties.

Known bioactive coating on implants made of titanium-based hydroxyapatite, optionally containing oxides of Nickel, titanium, manganese, iron, chromium, vanadium, magnesium, silicon (Patent RF №1743024). However, this pok the eve ENT does not create antibacterial and anticoagulant effect on the biological media.

The closest analogue, according to the authors, is the technical solution according to the patent of Russian Federation №2154463, in which the coating of the implant contains titanium oxide and calcium phosphate compounds of the type hydroxyapatite providing osteoinductive properties and do not cause suppuration and allergic reactions of bone tissue. The disadvantage of this coating is that it has no anticoagulant properties, which increases the terms of osseointegration and the process of engraftment of the implant. This hinders the widespread use of implants in traumatology and orthopedics, where they in a short time have become anchored in the bone tissue for the perception of functional loads.

The objective of the invention is the creation of osteointegration bipartite, with antibacterial and anticoagulant properties.

This object is achieved in that the coating containing titanium oxide, consists of two layers, the first layer thickness of 40-50 μm from a mixture of titanium oxide and copper oxide in the following ratio, wt.%: 70-80 20-30 accordingly, the second layer consists of lanthanum in the form of fragments of a thickness of 1-3 μm. The inventive coating has antibacterial and anticoagulant properties.

A known method of manufacturing a dental implant with a multilayer bioactive coating, the floor is Chemin plasma sputtering (RF Patent No. 2146535). This method allows you to get layered coating system, consisting of titanium and hydroxyapatite calcium with bioactivity, but does not allow to obtain a coating with antibacterial and anticoagulant properties.

There is a method of applying a coating on an implant made of titanium and its alloys (taken as a prototype), in which the coating is carried out by anodic oxidation of titanium and its alloys constant or pulsed current conditions of the spark discharge (RF Patent No. 2159094). This method allows you to get coverage with osteoinductive and osteoconductive properties, but such coverage does not possess the functions of antiseptic and anticoagulant.

The objective of the invention is to provide a method that allows to obtain biomatrica, with antibacterial and anticoagulant properties.

To obtain this technical result in the proposed method, including anodizing titanium and its alloys by direct current, the process is conducted in an electrolyte, the concentration of 200 g/l of sulfuric acid with a solution of 50 g/l of copper sulphate in distilled water, while receiving the first coating layer, and when the second coating layer is conducted cathode implementation in the electrolyte of 0.5 M musk lanthanum in dimethyl-formamide.

Example. The proposed method is as fo the om:

take pre-prepared, the implant is made of titanium and its alloys and immersed in an electrolytic bath of the cell with electrolyte 200 g/l of sulfuric acid with the addition of 50 g/l of copper sulphate in distilled water and having a temperature of 40-50°C. pass Through the electrolyte DC voltage 30-100, the anode current density 1-3 A/DM2. The process of oxidation are within 30-50 min with constant stirring of the electrolyte. The ratio of the obtained components in the first layer covering the following, wt%: the titanium oxide - 70-80, copper oxide - 20-30, and thickness of the resulting layer of a mixture of oxides of titanium and copper is 40-50 microns. After anodizing, the implant is then removed from the bath of the electrolysis with sulfuric acid electrolyte, washed in distilled water and dried. Then oxidized implant is placed in a bath prepared with electrolyte, representing a 0.5 M solution of salicylate lanthanum in dimethylformamide and having a temperature of 25-30°C. the cathode implementation of lanthanum carried out in potentiostatic conditions at a constant cathode voltage of 3 V, the duration of 15-30 minutes In the thickness of the sections of the layer of lanthanum is 1-3 μm. The formation of a layer of lanthanum in the form of fragments is due to the introduction of lanthanum in the portions of the first oxide layer, where its thickness is minimal and who meet the lowest electrical resistance. Therefore, the cathode implementation is carried out on a bottom surface of the pores of the layer of a mixture of oxides of titanium and copper, thereby creating fragments of the layer of lanthanum.

The ratio of the components in the first coating layer, comprising: a titanium oxide - 70-80 wt.%, the copper oxide - 20-30 wt.%, is optimal, since less than 20% of the content of copper oxide does not provide effective bactericidal coatings, more than 30% of causes of inflammatory processes in tissues.

Positive effect (antibacterial and anticoagulant properties) is achieved by forming a two-layer coating consisting of a mixture of titanium oxide, copper oxide and lanthanum, providing the implant surface run antibacterial and anticoagulant functions. The oxides of titanium and copper are created when the anodizing of the implant in the electrolyte 200 g/l of sulfuric acid with the addition of 50 g/l of copper sulphate in distilled water, which characterizes the bactericidal effect of copper in the coating composition, the lanthanum is formed in the cathode implementation of a 0.5 M solution of salicylate lanthanum in dimethylformamide and provides anticoagulant properties of the coating. This is achieved by minimizing the inflammatory response, sepsis, thrombosis course of normal wound healing process with effective osseointegration and fixing impl ntata in the body.

Implants made of titanium and its alloys with lipocream, the composition of which is obtained by the claimed method have been tested on laboratory animals (rabbits breed "Black giant"). The results of clinical experiments showed a complete lack of suppurative and inflammatory reactions, reduction of implant integration period up to 1.5-2 times.

1. Biomatrica on an implant made of titanium and its alloys containing titanium oxide, characterized in that it consists of two layers, the first layer thickness of 40-50 μm from a mixture of titanium oxide and copper oxide in the following ratio, wt.%: 70-80 20-30, respectively, and the second layer consists of lanthanum in the form of fragments of a thickness of 1-3 μm.

2. A method of producing a coating according to claim 1, comprising anodizing titanium and its alloys by direct current in an electrolyte, characterized in that when the first layer of the coating process is carried out in the electrolyte concentration of 200 g/l of sulfuric acid with the addition of 50 g/l of copper sulphate in distilled water, and the second coating layer is generated by the cathode implementation in the electrolyte of 0.5 M musk lanthanum in dimethylformamide.



 

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