Calcium-phosphate biologically active coating of implant and method of deposition

FIELD: medicine.

SUBSTANCE: invention refers to medical equipment. What is described is a calcium-phosphate biologically active coating of an implant which refers to medical equipment, namely, to biologically compatible coatings exhibiting the osteointegration properties, and can be used in dentistry, traumatology and orthopaedics for manufacturing of high-loaded bone implants of various structural materials, e.g. stainless steel. The coating is double-layer. A base made of a structural material is coated with an intermediate layer of the thickness 5-50 mcm made of a valve metal, e.g. titanium. The next layer of calcium-phosphate compounds is generated by an electrochemical method of titanium anodising in a phosphoric acid solution with added calcium compounds to over-saturation in a spark or arc discharge mode. An intermediate titanium layer is formed in continuous vacuum-arc discharge plasma.

EFFECT: method of calcium-phosphate biologically active coating deposition on the implants made of metal structural materials is simple, fast and efficient.

3 cl, 3 ex

 

The invention relates to the field of medical equipment, namely to biocompatible calcium phosphate coatings having properties of osseointegration, and can be used in dentistry, traumatology and orthopedics in the manufacture of high-loaded bone implants from structural materials such as stainless steel.

Currently, widespread implants made of titanium or its alloys with the surface of the oxide film and coated with the surface layer of bioactive calcium-phosphate compounds, in particular hydroxyapatite. Such a coating can be formed by the method of thermal [plasma or flame spraying (SU 1743024)]. This method gives a low adhesion coating with titanium base due to the large differences in thermal and biomechanical characteristics of the metal substrate and the coating material.

A known method of manufacturing implants with plasmolen multilayer coating (EN 2146535). The method of manufacture is carried out by plasma spraying titanium based implant coatings with different dispersion and thickness, consisting of five layers: the first two of a titanium powder or titanium hydride different dispersion, the next two layers of a mixture of titanium or titanium hydride with hydroxyapatite calcium, distinguish the s content of components in layers, and outside, the fifth layer of calcium hydroxylapatite. The compositions of the layers provide maximum adhesion to adjacent layers. The coating layers are in different modes, providing a smooth transition from the compact structure of the titanium bases of the implant through a multi-layer system of the transition of the coating to thin the biologically active surface of the porous layer. Multilayer coating on the implant surface also serves as a shock absorber (damper)that's the closest artificial system implant with porous bioactive coating to the natural biological system and increases its mechanical strength. However, the proposed method is very time consuming, requires sophisticated equipment. In addition, coupling of biologically active layer applied by plasma spraying, the basis is not sufficiently mechanically strong, and layer easily crack and peel if the loads on the implant. Recently spread coatings electrochemical methods in conditions of a spark or arc discharges. Such methods are quite technologically advanced, high productivity and low unit material and energy costs. In the patent RU 2194536 described method of microarc oxidation of the implant surface is the presence of bioactive substances - hydroxyapatite or other calcium phosphate compounds. The implant is made of metal selected from the group consisting of titanium, aluminum, zirconium, and the oxidation was carried out in a pulsed mode at a voltage of 150-500, in the range of operating currents of 0.1 to 5.0 And with a current density of 0.05 a/m2the oxidation time was varied from 2 to 60 minutes the microarc oxidation Process is as follows. In the electrolyte for anodizing injected mixture of substances containing calcium and phosphorus, and/or hydroxyapatite. When voltage is applied at the beginning of the anode voltage increases rapidly due to gate the properties of the oxide film thickness of several angstroms, which is always present on the surface of the titanium sample. In the oxidation of the sample surface covered with an oxide film thickness of 15 μm, in appearance resembling a film received conventional anodizing. However, in certain locations, the film breaks with the formation of microdog, and there are small point - germ formation of a new layer with inclusions of hydroxyapatite. For this reason, this method is called by microarc oxidation. In the subsequent coating becomes uneven distribution of hydroxyapatite on the surface of the sample at a coating thickness of 50 microns.

This method can be applied calcium-phosphate p the closure on the valve metals group (for example, Zr, TA, Nb, Al), who, like titanium, are always on the surface of the oxide conductive film. Steel, alloys with the addition of cobalt, chromium and Nickel are not on the surface of this film. Solid calcium phosphate layer on their surface in such a method it is not possible to create. In the patent it is mentioned that the method is suitable for coating metals of the transition groups, such as Fe and Cu, and their alloys, for example H, H, which are widely used in medical practice. However, according to the conventional electrochemical provisions for initiating the process of microarc oxidation on the metal or alloy should be thin non-conductive layer, which in normal conditions is present only on valve metals. Our research has shown that this process is not suitable for alloys of iron.

In the patent RU 2154463 applies essentially the same electrochemical method, but in terms of spark discharge. The process is conducted in a saturated solution of hydroxyapatite in phosphoric acid with a concentration of 5-20% or 3-5% suspension of hydroxyapatite particle size less than 100 microns in a saturated solution. The process differs from the previous form (type) of the discharge occurring on the surface of titanium oxide. The method allows to obtain a titanium-based bioactive coating containing titanium oxide, oxides of calcium and FOS is ora, having good adhesion to the base and having osteoconductive properties and enhanced biological fixation to the tissue. Bioimplants with this coating does not cause suppuration, inflammation and allergic reactions of bone tissue, and also have good adhesion to the surrounding tissue.

The known method EN 2221904 coating on an implant made of titanium and its alloys, including anodizing implant pulsed or direct current in terms of the spark discharge repetition rate 0.5 to 10.0 Hz in a solution of phosphoric acid for 10-30 min with constant stirring, and the anodizing is carried out at a voltage of 90-200 In and 20-35°C in a solution of phosphoric acid with a concentration of 5-25%, containing powder of Cao to a supersaturated state, or in solution of phosphoric acid with a concentration of 5-25%, containing powder of Cao to the supersaturated state and an additional 5-10% suspension of hydroxyapatite particle size less than 70 microns to create suspension. This method allows to reduce the cost of obtaining a bioactive coating for savings on expensive and scarce hydroxyapatite.

The described processes are promising for applications as simple enough, give coatings with good biological characteristics and have a high speed coating; the required thickness of the coating can be especen during several minutes.

All of the above electrochemical methods of coating in terms of micro-arc or spark discharge is applicable for coating only on valve metals group (titanium, tantalum, niobium, zirconium), which are always on the surface of the oxide conductive film. Of this group, only titanium is widely used as the basis for implants, other metals are quite expensive. However, titanium is ill-suited for endoprosthetics of big joints, bearing a large load, for example, for a prosthetic knee or hip joints. This requires a more durable structural material, such as stainless steel.

The coating produced by the method of anodizing in the conditions of the spark or arc discharges selected for the prototype.

Thus, the object of the invention is to develop a simple, rapid and economical method of applying the calcium phosphate bioactive coatings on implants of any metallic structural materials.

The technical result of the invention is to widen the range of materials for the base of the implant, which can cause calcium phosphate bioactive coatings by electrochemical method in the conditions of the spark or arc discharges.

To achieve the technical result development is but the coating on the implant, the basis of which is made of any metal material, in particular stainless steel. The coating contains applied on the basis of the intermediate layer metal gate group (titanium, tantalum, niobium or zirconium) with a thickness of 5-50 μm and a subsequent layer of calcium-phosphate compounds formed by electrochemical anodization of the layer of titanium in terms of the spark or arc discharges.

The method of applying a bioactive coating includes two stages. In the first stage, a layer of a valve metal such as titanium, of a thickness of 5-50 μm on the base material is applied in the continuous plasma vacuum arc discharge. This method is chosen because it is well understood and the settings for it are widespread. Coating in plasma continuous vacuum-arc discharge can be applied to all structural metallic materials. The process has a sufficiently high speed coating, the required thickness of the coating can be provided over time to 90 minutes. The resultant film of a valve metal has a high adhesion.

In the second stage, a layer of calcium phosphate compounds formed on the surface of the titanium film. This process does not differ from the prototype, as the surface for its application serves as a valve metal, in particular titanium. The application of the coating is lead by a method of anodizing titanium pulsed or constant current under conditions of a spark or arc discharges. Anodizing is carried out in a solution of phosphoric acid concentration 5-33% with the addition of calcium compounds to surpressing state, i.e. the state when the solution has a significant amount of not dissolved compounds. The thickness of the intermediate layer of a valve metal, for example titanium, is selected from the following considerations. When the thickness of the intermediate layer is less than 5 μm in the second stage of the oxidation process occurs at a depth greater thickness of the layer of valve metal, which is unacceptable. When the thickness of the intermediate layer of a valve metal is more than 50 μm, the total cohesion of the coating on the substrate surface of the implant decreases, decreases the strength of the coating as a whole. Furthermore, increasing the thickness of the intermediate layer more than necessary for the second stage of formation of the coating leads to unnecessary energy and time.

The concentration of the solution of phosphoric acid for the second stage of the process is an essential characteristic. At low concentration of phosphoric acid in solution decreases the conductivity, which requires improving the operating voltage for the occurrence of the spark or arc discharge. At high concentration of phosphoric acid in the electrolyte increases the viscosity of the solution, and the process of coating deposition is slowed down. In a solution with a concentration of the FOSFA the nuclear biological chemical (NBC acid of about 33% dissolved the maximum amount of calcium. The optimal concentration of the solution are in the range 5-33%.

As in the known methods, for cheaper ways as calcium compounds can be used Cao. To increase the content of calcium and phosphorus in the coating in a solution of phosphoric acid, it is expedient to introduce the powder of hydroxyapatite particle size of 70 μm in the amount of 5-10%. The use of hydroxyapatite in the form of a dispersed phase leads to the balance of calcium and phosphorus in the floor, close to the mineral composition of bone tissue.

In General, the method is as follows. Before coating the sample - based implant stainless steel is subjected to ion cleaning in the plasma of argon. The pressure of the reaction gas in the vacuum volume varied from 0.8 to 1.5 PA. For the formation of ion flux on the sample was applied constant bias voltage of 900 C. the ion current Density on the sample was changed in the range from 1 to 10 mA/cm2. The temperature of the sample in the ion cleaning mode was changed from 250 to 450°C.

The formation of the intermediate titanium coating was carried out in the continuous plasma vacuum arc discharge. The cathode was used titanium brand VT1-0. The samples were submitted to a constant bias voltage, variable in the range from 90 to 500 C. the ion current Density on the samples in the mode of NAS is the basis of the coating was 30 mA/cm 2. The pressure in the vacuum volume was maintained at the level of 1·10-3PA. The formation of the coating was carried out at a temperature of 350-400°C. for 120 minutes on the sample surface was formed a coating of titanium with a thickness of 40 μm.

The second stage coating can be performed in several different modes.

Because in the second stage, the calcium-phosphate coating is deposited on the titanium layer, you can use any of the known electrochemical methods of deposition of calcium-phosphate coatings on titanium. In particular, there can be used a method of microarc oxidation, as in the patent RU 2194536. In the desired process regulations electrolyte used for anodizing titanium, introducing a bioactive substance (hydroxyapatite) or mixture of substances containing calcium and phosphorus. The implant is made of stainless steel with an intermediate layer of titanium with a thickness of 5-50 μm is placed in a bath of electrolyte between the two electrodes (e.g., molybdenum). The oxidation is carried out in a pulsed mode with a simultaneous flow of the reverse current or without him. Operating current is 0.1 to 5.0 A, voltage 120-500 In the current density of 0.05 a/m2the oxidation time was varied from 2 to 60 min. Thickness formed by the calcium-phosphate coatings will be 30-50 microns, with sufficient casinitaliano layer of titanium.

You can also use the methods of anodizing titanium pulsed or constant current under conditions of spark discharge, which are described in the patents 2154463 and 2221904.

Show them with specific examples.

Example 1. A 5% solution of phosphoric acid add a powder of Cao to a supersaturated state. The implant coated with a film of titanium is placed in the prepared solution. After the solution is passed pulse current voltage of 200 V At a pulse frequency of 0.5 Hz. For these modes, the oxide film on the surface of the intermediate titanium layer breaks, forming a spark discharge. Categories serve as initiators for the synthesis of calcium phosphate compounds, due to which there is a growth of biologically active coating. The process is conducted with constant stirring and the temperature of 20-35°C for 30 minutes. The resulting thickness of the calcium phosphate coating is 5-10 microns.

Example 2. To 25%of the resultant solution of phosphoric acid add a powder of Cao in excess of the supersaturated state. Then add 10% of a powder of hydroxyapatite particle size of 70 microns to obtain a suspension. The implant coated with a film of titanium is placed in the prepared solution. Through a solution of miss DC voltage of 120 C. the Process is conducted with constant stirring and the temperature of 20-35°C for 20 minutes the resulting thickness of ocrite 35-40 microns.

Example 3. To 20%aqueous solution of phosphoric acid add powder of hydroxyapatite to saturation. Then add another 4% of hydroxyapatite powder to obtain a slurry. Available to cover the implant stainless steel with an intermediate layer of titanium is placed in a bath prepared electrolyte. Pass through the electrolyte DC voltage of 150 V for 15 minutes. The process is conducted with constant stirring. The resulting coating thickness is 15-20 microns.

The process has a sufficiently high speed coating, the desired coating thickness can be provided at the time in a few minutes. Thus obtained coatings have high adhesivo to the metal base. Microtarget composite coating after the formation of calcium-phosphate coating is about 3 HPa and the surface roughness of the order of Rz=1 μm. The strength of the coating after heat treatment at 900°C increases: the microhardness increases to 7 GPA and Rz to 3 microns.

Biological properties of the coatings does not differ from the properties of the prototype. Biological compatibility of calcium-phosphate coatings was investigated by determining their toxicity and osteoconductivity in tissue culture in vitro.

Studies have shown that

- test calcium phosphate (CP) coating on the metallic base is not vyzyvae is a direct toxic effect on target cells;

- calcium-phosphate coating on a metal implant, it is not toxic to the body, supports the growth of bone tissue of the bone marrow cells, has good biocompatibility, ability to osseointegration, shows costaposada (osteoconductive) properties.

The above examples of the method using as the material of the intermediate layer of titanium. The titanium in the experiments was chosen because it is the cheapest and most available metal of the valve group that is allowed for medical use, and is most widely used in medicine.

However, the claimed technical result is achieved with the use of other valve metals group. In fact, to achieve the specified result, an intermediate metal layer on the base material must have certain properties. Namely, it should in normal circumstances to have on its surface a thin oxide film. As shown above, only such a metal may be coated by a method of anodizing a pulsed or constant current under conditions of a spark or arc discharge. This requirement responds to all of the valve metals of the group: titanium, zirconium, tantalum, niobium, aluminum, of which the first four are allowed for medical use.

In addition, the literature known to the opportunity to apply bipartite metal Zirconia electrochemical method in particular microarc anodic oxidation (oxidation) (see design No. 14579 in the database "Atlas technologies" http://www.tech-atlas.net/atlas/17/an14579/). The possibility of application of calcium-phosphate coatings on zirconium oxide microarc anodizing also described in the report: Kuleshova HP, Wurkin PV Calcium-phosphate coatings on zirconium alloy. // Proceedings of the VI International conference of students and young scientists "prospects for the development of fundamental Sciences, Russia, Tomsk, 26-29 may 2009 - p.143-145.

Thus, a composition of multilayer coatings with good osteoconductive properties and allow you to create such coatings on any structural material.

1. Calcium phosphate bioactive coating on the implant, which is made of a structural material, in particular stainless steel, containing drawn on the basis of the intermediate layer metal gate group, in particular titanium, the thickness of 5-50 μm and a subsequent layer of calcium-phosphate compounds deposited by electrochemical method of anodizing, in particular, titanium mode spark or arc discharges.

2. The method of coating according to claim 1 on the implant, in which an intermediate layer of metal gate group, in particular titanium, the thickness of 5-50 μm is applied on the base material, in particular from stainless steel, eUSA steel in the continuous plasma vacuum arc discharge, and subsequent layer of calcium-phosphate compounds formed by electrochemical method of anodizing, in particular, titanium, pulsed or constant current under conditions of a spark or arc discharge in solution of phosphoric acid concentration 5-33% with the addition of calcium compounds to surpressing state.

3. The method of coating according to claim 2, characterized in that compounds of calcium CaO choose and additionally add in a solution of 5-10% of a powder of hydroxyapatite dispersion of not more than 70 μm.



 

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