Method of forming nanostructured biocompatible coating on implants

FIELD: medicine.

SUBSTANCE: invention relates to field of medicine. Described is method of biocompatible coating on implant surface which lies in precipitation on implant surface of polysilicon film in reactor. Obtained polysilicon film is subjected to chemical etching to form nanostructured superficial layer of porous polysilicon. Etching of polysilicon film nis carried out submerging implant into mixture which contains 50-55% water solution of tetrafluoroboric acid (HBF4), 70-90% water solution of nitric acid (HNO3) and anionic surface active substance on the basis of ammonium salt of perfluorsulfonic acid RfSO3NH4 in amount 5·10-3-10-2 (wt %), where Rf - C8F17 or C2F5OC3F6OC2F4, or C6F13CH2CH2. Used are water solution of acids with ratio of their volume parts: HBF4:HNC3, as (100-800):(1:1.1), with further washing of implant with deionised water and drying.

EFFECT: extension of technological possibilities of the method irrespective of materials used and constructive abilities of implants.

2 cl, 1 dwg, 2 ex

 

The technical field

The invention relates to the field of medicine and medical equipment, and in particular to methods of forming a biocompatible coating on the surfaces of implants used for reconstructive operations with replacement of bone implants.

Such operations are typical for traumatology, orthopedics, dentistry.

Development and production of implants in the world are dozens of companies.

For reliability of osseointegration, i.e. biological integration of the implant into the bone without inflammatory reactions, to reduce exclusion implant contact surface of the implant modify by applying elements of the macro retention-notches, recesses for connecting the implant with the bone tissue and form a special biocompatible coatings for germination of bone on the implant surface.

Prior art

There are known various processes for the formation of biocompatible coatings on implant surfaces.

The most common biocompatible coatings for implants are coatings based on calcium phosphate compounds - hydroxiapatite, which is similar to the composition of bone tissue.

For example, in the technical solution (see patent RU №2291918, publ. 2007; No. 2221904, publ. 2004; No. 2154463, publ. 2000) proceedings fo the formation of biocracy, containing calcium phosphate compounds is carried out at the premises of the implant, made of titanium or its alloys in an aqueous solution of the acid of the electrolyte on the basis of phosphoric acid and hydroxyapatite powder and at excitation microarc discharges carry out the formation of the coating.

A common disadvantage of these methods is that as the basis for the electrolyte used is phosphoric acid, which is corrosive environment.

In the technical solution according to the patent RU No. 2206642 the formation of biocracy containing calcium phosphate compounds is carried out at the placement of the product (implant) in the aqueous electrolyte solution and carry out the excitation microarc discharges on the surface of the product applying pulses of current at a voltage of up to 1000 C. the pulse Duration of 30-400 ISS and the pause between them is not less than 100 μs. In the variant described in example 12 of the patent, the coating on titanium W 1-00 carried out for 10 minutes in an aqueous electrolyte solution with a pH of 12-14 containing KOH, hydroxyapatite and Al3About3when the ratio of anodic and cathodic currents are equal to the magnitude of 6.7. According to data given thickness of the coating is approximately 41 μm, a porosity of 24%. However, the considerable thickness of the coating reduces the strength that can lead to the East is the porous and other complications.

Technologically limited the use of this solution to obtain microparti miniature implants that do not allow significant thickness of the coating on the surface.

From the above prior art, it follows that the required physical and mechanical properties of calcium-phosphate coatings on titanium implants (thickness, microhardness, porosity, roughness) in traumatology, orthopedics and dentistry vary widely and depend on many conditions, such as:

the purpose of the implant for implantation in the body or in the role of the prosthetic replacement of missing bodies);

- the duration of stay in the body, needs to be extracted after a certain time in the restoration of natural bodies or replacement is necessary, the expected loads, etc.

The disadvantages of the known technical solutions on formation on implant surfaces biocompatible calcium-phosphate coatings are:

- the inability to control their physical and mechanical properties, mainly strength;

low fracture toughness and low fatigue strength under physiological conditions;

- porous surface coating has an irregular structure, cell pores of various sizes, can be fully monolithic area on the floor that reduces the effect of what you want to make germination, in particular, the bone tissue on the material and leads to osteoporosis and other complications;

a weak stimulating effect on the growth of new bone tissue.

- a significant amount of phosphorus in connection Ca10-x(NRA4)x(RHO4)6-x(OH)2-x(0<x<1) does not reproduce the morphology of the bone (see "journal of Nanotechnology Ecology Production", №1 (8), January 2011, p.102-103).

Currently, the most promising implants with modified surfaces based coatings polycrystalline silicon porous surface layer.

Biocompatibility of porous polysilicon was described in 1995 (author Canham and others, "Bioactive Silicon Structure Through Nanoetching Techniques)), log ((Advanced Materials), 1995, Vol 7, No. 12, pp.1033 - 1037).

In the patent GB No. 2317885, publ. 08.04.1998 was proposed technical solution using porous polysilicon as a material compatible with the tissues of a living organism. The US patent No. 7186267, publ. 03.06.2007, (application US No. 2004/000313, publ. 15.01.2004,) confirmed the possibility of using polycrystalline silicon nanostructured porous layer of polysilicon as a coating on the surfaces of the implants, made mainly of titanium or steel. According to this technical solution, it was confirmed that the presence on the surface is the surface of the implant coating polysilicon nanostructured porous layer of polysilicon promotes the formation on its surface of the bone tissue.

The technical solution according to US patent No. 7186267 selected as the closest analogue of the present invention.

In the above technical solution, the formation of biocompatible coatings on implant surfaces is performed by deposition on the surface of the implant the polysilicon film in the reactor, in the subsequent etching with the formation of a layer of nanostructured surface layer of the porous polysilicon.

As follows from this technical solution, the formation on implant surfaces biocompatible coatings on the basis of porous polysilicon carried out using known techniques, in which on a substrate by pyrolysis of monosilane (SiH4in reactors operating at reduced pressure, the precipitated film of polysilicon and is carried out by electrochemical etching using an electrolyte containing hydrofluoric acid (HF) (see US patent No. 5348618, publ. 20.09. 1994).

Method of etching used for nanostructuring the surface layer of polysilicon film deposited on the surface of the implants, made of electrochemically active materials that include titanium, steel, widely used in implantology.

Among the metals that are used for implantation, the proportion of titanium and it is alloys, best for implantology of biocompatibility and the specific strength is about 5%. This is due to the low technology of Titan.

Currently, considerable attention is paid to the creation of implants of dielectrics, in particular ceramics. The use of implants made of these materials ensures the reliability of their fixation, accelerates the process of healing and reduces the risk of postoperative complications, eliminates tapping into the bone, thereby facilitating preparation for implantation. The main technological process of production of these implants is relatively cheap casting, which significantly reduces the cost of prosthetics.

However, the dielectric properties of ceramic materials preclude implementation of a process for nanostructuring pripoverhnostnogo film layer of polycrystalline silicon by electrochemical etching method.

Technologically limited the possibility of using known technical solutions for US patent No. 7186267 in the case of etching the polysilicon film on the relief surface of the implant in order to obtain uniform thickness of the nanostructured porous layer of polysilicon that is due to heterogeneity current density in different areas of the relief surface of impla the Tata.

The invention

The technical result of the present invention consisted in expanding the technological capabilities of the method of forming a biocompatible coating for obtaining nanostructured porous layer of polysilicon on the surface of implants, regardless of their fabrication materials and design features of the implants.

To solve this technical result, a method for forming nanostructured biocompatible coatings for implants, which consists in depositing on the surface of the implant the polysilicon film in the reactor, in the subsequent etching with the formation of nanostructured surface layer of the porous polysilicon, the etching of the polysilicon film is carried out at the immersion of the implant in a mixture containing 50-55% aqueous solution tetrafluoroboric acid (HBF4), 70-90% aqueous solution of nitric acid (HNO3) and anionic surface-active agent based on ammonium salts perftoralkil RfSO3NH45·10-3-10-2(wt.%), where Rf- C8F17or C2F5OC3F6OC2F4or C6F13CH2CH2when using aqueous solutions of the acid in the ratio of their parts by volume: HBF4:HNO3

In the present invention on the implant surface to form a coating in the form of a film of polysilicon thickness equal to 0.4-0.6 μm, and with the formation of nanostructured surface layer of the porous polysilicon with a thickness not more than 200 nm.

When implementing the present invention are expanding technological possibilities of the method for the formation on implant surfaces biocompatible coatings with obtaining nanostructured porous layer of polysilicon:

regardless of the materials used implants with formed on their surfaces with a film of polycrystalline silicon in the processing of their aqueous solution of concentrated tetrafluoroborate (HBF4) and nitric (HNO3) acids in the process of chemical etching of the polycrystalline silicon film. The process of oxidation of polycrystalline films in the presence of an aqueous solution of nitric acid is accompanied by formation of nitrous acid ions and microzone (NO+), which is the active oxidizing agent, point impact which the local zone of the crystal structure of polysilicon implements the process of selective etching in these zones with the formation of porous silicon. The use of chemical p is the target of concentrated nitric acid in the presence of tetrafluoroboric acid (HBF 4) increases the concentration of ions in solution microzone that stabilium the process of forming a nanoporous structure of the near-surface layer of polysilicon;

- the specified acids solution provides a process of forming a uniform thickness nanoporous surface layer of polysilicon on the surface of the implant difficult terrain, which is associated with in an aqueous solution of the acid anionic surfactants based on ammonium salts perftoralkil;

- use composition of the concentrated terraforming acid (HBF4enables the chemical process of forming a nanostructured porous layer of polysilicon on implant surfaces modified with a film of polycrystalline silicon, regardless of the materials used for implants (metal, ceramic).

In the analysis of the prior art are not identified technical solutions with a set of features of the present invention described above and provides the result.

The analysis of the prior art demonstrates compliance with the proposed technical solution criteria invention of "novelty", "inventive step".

The present invention can be industrially realized by using known what's technological processes, equipment and materials, including those intended for the manufacture of implants made of titanium, its alloys, steel and dielectric materials, for example, on the basis of ceramics.

The implementation of the invention

The invention is illustrated by figure 1, which shows a fragment of the cross-section of the polysilicon film with nanostructurally layer of porous polysilicon, obtained by chemical etching of the polycrystalline silicon film formed on a metal (titanium) surface.

To implement the invention using known industry equipment and materials.

1. Reactor for gas-phase deposition of a film of polycrystalline silicon on the surface of the products used, for example, in the electronics industry in the manufacture of semiconductor devices. The process of deposition of the film of polysilicon on the surface of the product in the reactor is carried out in a known manner and, preferably, in the pyrolysis of monosilane (SiH4) at a temperature of 600-650°C and under reduced pressure (25-130 PA). Proceeding with the chemical reaction is as follows: SiH4→Si+2H2. When you process film is formed of polycrystalline silicon.

For this process can be used implants with different embossed on top of the spine and made of metal (titanium, titanium alloys, steel), as well as cermets and ceramics.

2. An aqueous solution of 50-55% tetrafluoroboric acid (HBF4).

For the implementation of the present invention, preferably, the use of concentrated 50% solution tetrafluoroboric acid (HBF4), with the ratio of mass fraction of fluorine and boron for this acid 3,85-4,05, according to THE 301-14-92, Russia.

3. 70-90% aqueous solution of nitric acid (HNO3- see Handbook "Aldrich", 2006, str, [7697-37-2].

For the implementation of the present invention, preferably, the use of concentrated 70% aqueous solution of nitric acid.

4. Anionic surface - active agent based on ammonium salts perftoralkil RfSO3-NH4+where Rf- C8F17or C2F5OC3F6OC2F4or C6F13CH2CH2. Anionic fluorine-organic surfactant manufactured by DuPont (US), 3M company (US). Anionic fluorine-containing surfactant 3M company (US) have the trademark Novec 4300.

Selected for the implementation of the present invention the anionic fluorine-organic surface-active substance (SAS) has a high resistance to aggressive environments, increases the wetting of surfaces and stabilizes the diffusion processes of oxidation in the formation nanostrukturirovannoi what about the porous layer of polysilicon.

Specified by the present invention, the concentration of the specified anionic fluorine-organic surfactants in aqueous solution these acids the most optimal in terms of wetting surfaces, impact on the processes of oxidation and cost when it is used.

For the implementation of the present invention is selected anionic fluoride surfactant brand FS-62, the formula C6F13CH2CH2SO3-NH4+the drug company "DuPont" (see http://www.dupont.com/).

The process of formation of biocompatible coatings on implant surfaces was carried out by implementing the following steps.

stage 1.

To implement the present invention as samples used disks of steel - 3 piece titanium - 3 STI glass-ceramic plate - 1 piece disk Diameter 10 cm, thickness 4 mm, plate size is 2×3 cm, thickness - 4 mm

On the disks and the plate by the method of vapor deposition were formed film of polycrystalline silicon. The process of formation of a film of polycrystalline silicon on the disks of steel was carried out to obtain a film thickness of 0.5 μm on disks made of titanium and plate film thickness of 0.4 μm.

Specified according to the invention the minimum value (0.4 µm) film thickness of polycrystalline silicon is most optimal for the formation of biocompatible coatings on surfaces the threads of the implant and, preferably, miniature implants used in dentistry. The possibility of obtaining a film of polycrystalline silicon on the surfaces of implants is less than 0.4 μm, using known methods of obtaining them technologically complicated.

stage 2.

To implement the present invention was prepared in a concentrated aqueous solution of the acid. To prepare the solution used:

an aqueous solution of 50% tetrafluoroboric acid (HBF4), with the ratio of mass fraction of fluorine and boron for this acid 3,85-4,05, and 70% aqueous solution of nitric acid (HNO3).

Specified in the present invention, the ratio of parts by volume of the used acids optimally.

With increase in the composition ratio of parts by volume of nitric acid (HNO3and tetrafluoroboric acid (HBF4) has a polishing effect of the solution on the polysilicon crystals, and the surface, reducing the efficiency of the process of selective etching of local zones films of polycrystalline silicon. In General, the change in the ratio of parts by volume of nitric acid (HNO3and tetrafluoroboric acid (HBF4in the solution affects the process of nanostructuring film polysilicon.

For the implementation of the invention were prepared aqueous solutions of acids by the following examples.

PR is measures 1.

100 ml [700 (OBC)] - 50% solution tetrafluoroboric acids;

0.15 ml [~1 OBC] - 70% solution of nitric acid. The mixture was stirred with addition of 0.008 mg anionic fluorine-containing surfactant brand FS-62.

Example 2 (control).

100 ml [700 (OBC)] - 50% solution tetrafluoroboric acids;

0.15 ml [~1 OBC] - 70% solution of nitric acid. The mixture was stirred.

stage 3.

In obtained in example 1 an aqueous solution was lowered steel and titanium discs. Only been used on 2 disks of each material and the plate of glass ceramics.

In obtained in example 2 aqueous solution was lowered steel and titanium discs. Used one disk of each material.

When liquid etching disk processing time was determined by visual evaluation of color change of the modified surfaces of the disks from the color characteristic of the film polikristallicheskogo silicon, to bluish-purple when wet etching.

In liquid-provide the Etchant according to example 1, the surface of the samples with deposited on them by the polycrystalline silicon film had a uniform bluish-purple color after 0.5 minutes

Time processing of implants in the aqueous solution used in the invention composition depends mainly on the thickness of the film of polycrystalline silicon on its surface.

During the same period the om processing time of the disc surface (deposited on them with a film of polycrystalline silicon) when processing in liquid provide the Etchant according to example 2 was obtained irregular bluish-purple color of the surface, that shows the inadequacy of this solution to obtain a uniform thickness of the nanostructured surface layer of polysilicon.

The resulting liquid etching the samples of porous polysilicon was filtered deionized water and subjected to drying.

In the washing process samples the surface of the porous polysilicon was subjected to oxidation with predominant formation of surface relations of the type Si-HE needed to improve the biocompatibility of the material.

Made of titanium disk is processed by wet etching in an aqueous solution of the acid of example 1, was investigated using atomic force microscope Solver P-47 (the manufacturer of NT - MDT, Moscow, Russia) for the detection and evaluation of nanostructured surface layer of the porous polysilicon, obtained on the film of polycrystalline silicon.

In the accompanying figure 1 shows the AFM image of (X, Y, Z) of the polysilicon film (1) with nanostructurally surface layer of the porous polysilicon (2), obtained by chemical etching of the film according to the invention.

From the figure it follows that on film polycrystalline silicon (1) the invention provides the formation of a uniform structure and thickness nanostrukturirovannogo the near-surface layer of the porous polysilicon (2).

The thickness of the obtained nanostructured surface layer of the porous polysilicon does not exceed 200 nm.

Biological compatibility of porous polysilicon, the presence of adhesion of bone tissue and the formation of calcium-phosphate compounds on its surface, the absence of cytotoxicity is confirmed by a number of research works, including the following:

- S.C. Bayliss, Harris, P.J. and other. Phosphate and cell growth on nanostructured semiconductors. Jornal of Materials Science Letters. 1997:16:737-740;

- Yangyang Lu, Fan Yang, Linto Cai. Osteoblast adhesion on porous silicon. Bulleten of Advanced Technology Research. 2009, Jan., Vol.3, No.l, 25-28.

In particular, the influence of porous polysilicon on the viability and proliferation of the cells was investigated in vitro on cultures of cells - osteoblasts, fibroblasts. Pre cells (culture medium) for their track marked indicator (probe) CellTracker™ green CMFDA, molecular probes). Probes CellTracker™ is a fluorescent derivative of chlormethyl. Labeled cells were investigated by means of vertical Leica microscope designed for high contrast of epifluorescence and include a program for fixing (capture) image.

The research results show that nanostructured porous layer of polysilicon promotes cell adhesion structures on the surface of the material. Studies show that porous the polysilicon capable of supporting the growth of osteoblasts and fibroblasts, is non-toxic and biocompatible material.

1. The method of forming nanostructured biocompatible coatings on implant surfaces, which consists in depositing on the surface of the implant the polysilicon film in the reactor, in the subsequent etching with the formation of nanostructured surface layer of the porous polysilicon, the etching of the polysilicon film is carried out at the immersion of the implant in a mixture containing 50-55%aqueous solution tetrafluoroboric acid (HBF4), 70-90%aqueous solution of nitric acid (HNO3) and anionic surface-active agent based on ammonium salts perftoralkil RfSO3NH45·10-3-10-2(wt.%), where Rf-C8F17or C2F5OC3F6OC2F4or C6F13CH2CH2when using aqueous solutions of the acid in the ratio of their volume parts of HBF4:HNO3as (100-800):(1:1,1), followed by rinsing the implant deionized water and drying.

2. The method according to claim 1, characterized in that the implant surface to form a coating in the form of a film of polysilicon thickness equal to 0.4-0.6 μm, and with the formation of nanostructured surface layer of the porous polysilicon with a thickness not more than 200 nm.



 

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2 cl, 2 ex, 7 dwg

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

FIELD: medicine.

SUBSTANCE: invention concerns biology and medicine, and can be used for making plasters, bandages, prostheses and implants. A medical coating contains a monocrystalline carbon layer with chains of carbon and silver atoms.

EFFECT: medical coating is deposited on a base (a substrate) and has an entactic homeotropic structure.

8 cl, 6 dwg, 2 ex

FIELD: medicine.

SUBSTANCE: invention concerns medicine area. The covering on osteal implants for traumatology and orthopedy is described. The covering on the titan and its alloys contains titan oxide and copper oxide in a certain quantitative parity. Covering formation is carried out by electrochemical oxidising of preliminary sand jet processed titan and its alloys (BT1-0, BT1-00, BT-6, BT-16, etc.) using direct current consistently in two electrolytes, thus at first the layer of titan oxides is formed in electrolyte with concentration of 200 g/l of sulfuric acid in the distilled water, then a solution with concentration of 50 g/l of copper sulphate in the distilled water is added in it, and the subsequent oxidising with formation of the second layer of an admixture of titan oxides and copper oxide. The way allows receiving the superficially porous biocompatible covering possessing antiseptic properties.

EFFECT: reception of the superficially porous biocompatible covering possessing antiseptic properties.

2 cl, 2 tbl, 3 dwg, 1 ex

FIELD: chemistry.

SUBSTANCE: method of the polymer surface modification includes processing the polymer surface by a pulsed plasma spraying of graphite target. Spraying is effected with a 0.9-0.9 Hz pulse frequency. In spraying, the surface is subjected to etching by independent ion-beam source in an oxygen-containing mix with inert gas, the oxygen concentration making 10-30 parts by volume.

EFFECT: hydrophilic-hydrophobic nanostructures are obtained on the polymer surfaces, they sizes being comparable to those of biologically-active molecules.

3 tbl, 1 ex

FIELD: medical engineering.

SUBSTANCE: method involves using titanium alloy casing coated with alumina. First, the casing is etched with hydrofluoric acid, washed with distilled water, covered with calcium ions over external casing surface. Then, alumina layer is sprayed by atomizing sapphire target with argon ions in vacuum. Alumina layer thickness is equal to 0.11-0.2 mcm. Next, calcium ions are introduced into alumina layer.

EFFECT: high quality of implant.

1 dwg

FIELD: medicine.

SUBSTANCE: invention refers to medicine. What is described is a method for making an endosseous implant with a biocompatible coating that involves applying a biologically active coating on a metal titanium substrate of the implant in which the coating is applied in layers with the fourth layer applied at the distance of 70 mm, of the thickness of 20÷30 mcm. The fourth layer is made by mixing aluminium oxide or hydroxyapatite powders of particle size 40÷90 mcm and hydroxyapatite powder of particle size less than 40 mcm and aluminium oxide powder of particle size 1÷3 mcm in amount 70÷95 wt % and 5÷30 wt % respectively; the mixture is stirred, baked for 1.5÷3 h and milled.

EFFECT: endosseous implant possesses high osseointegration properties and shows higher strength.

4 cl, 3 tbl, 4 dwg

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