Silicon-doped calcium phosphate bioceramics (sbc)

FIELD: medicine.

SUBSTANCE: invention relates to medicine, particularly to formulation of porous bioglassceramics containing fine soluble potassium, synthetic mineral granules - calcium phosphates that are parts of native bone tissue, wollastonite formed by crystallisation of soluble potassium, as well as addition of carbonate and carbon pore-former. The invention also refers to a method for making medical implant materials and devices of the presented formulation suitable for replacement of bone defects and deformities in maxillofacial surgery, dental surgery, neurosurgery, traumatology and orthopaedics.

EFFECT: bioceramics is gradually replaced by bone tissue and consists of the ingredients having no toxic, allergic, carcinogenic and mutagenic effects on human body.

3 cl, 2 tbl, 4 ex

 

The invention relates to medicine, namely to the composition of biocomposite material, method of manufacture, and can be used for the manufacture of implant materials and articles intended to replace and eliminate defects and deformities in reconstructive bone and plastic surgery.

Recently for the clinical application of the proposed bioactive composite materials that compete with metals and alloys, oxide ceramics, polymers and materials based on carbon. Of particular interest porous osteoconductive materials, including calcium phosphate biomechatronics materials that promote attachment, proliferation and differentiation of bone cells into osteoblasts, followed appositional the new bone formation on their surface. A characteristic feature of these materials is that they are not susceptible to capsulerebel side of the body. In this case, the bone tissue growing into the implant, capable of forming with him biochemical communication. This reaction of the body to the implantation of bioactive inorganic calcium phosphate materials is explained by the closeness of their mineral composition and pore structure to the native bone [Nikitin A.A., Sapova O., Titov, NV, Shapovalov A.B., the Holder of the ova E.B., Popov L.A. the Use of biocompatible calcium phosphate ceramics "BCS" in the surgical treatment of cysts of the jaws // Glass and ceramics. - 2007. No. 10. - P.37-38].

Clinically proven the possibility of using calcium phosphate materials in substitution defects and eliminating deformations of different bone tissues [Solonin V.L., Shapovalov A.B., Vlasova E.B., Topilin L.A., Nikitin A.A., Nikitin D.A., Cedars AV New domestic implant materials and their application in clinical practice // Glass and ceramics. - 2010. No. 12. - P.27-30].

Lack of calcium phosphate biomechatronic is a significant amount (more than 50 wt.%) glass rim, which leads to low resorbable and the fragility of the implant material. The fragility of the material makes it difficult mechanical turning during fitting to the bone bed, and also causes difficulties securing the implant to the bone [Shoals MARINA. Clinical and experimental rationale for the use opticoelectonic implants for replacing defects and deformities of the bones of the facial skull: dis. candlenut. - M., 2002, 121 S.].

Closest to the proposed invention is a material for bone implants based on medical glass and hydroxyapatite and a method of manufacturing this material (patent RU 2053737 - prototype).

Numerous clinical observations which I was enabled to ascertain the shortcomings of this prototype, which are that the bone can grow into the pores of the implant only a small depth, forming surface is not strong enough bond with the implant. In addition, even after prolonged contact with the internal environment of the body, the implant does not undergo resorption and replacement by bone.

The aim of the invention is the creation of osteoconductive bioceramics silicochloroform ("BCS"), is gradually replaced by bone tissue, and method of manufacture on the basis of implant materials and products for defects and deformations in reconstructive bone and plastic surgery.

The goal is solved by the fact that the composite material comprises a biocompatible bioresistance and bioresorbable components that do not have a General toxic, allergic, carcinogenic and mutagenic effects on the human body and well-developed homogeneous pore structure, also ensure the effectiveness of the clinical application of this development in these areas of medicine.

The composition of the biocomposite material "BCS" includes the following components:

- bioretention vitreous nutritionally matrix, providing uniform distribution of mineral phases (bioactive and hardening), pore-and then asnago size and shape;

- bioresorbable bioactive phase consisting of phosphate of calcium hydroxyapatite (HA) CA10(PO4)6(OH)2and more resorbable beta-tricalcium phosphate (β-TCP), β-CA3(PO4)2providing a prolonged course of the process of osteogenesis at the implant material;

- strengthening mineral phase (wollastonite CaSiO3)formed during crystallization of the vitreous matrix as a result of its heat treatment;

the pore of organic and inorganic origin, which is administered separately, namely: pre-dissolved in distilled water starch, which is mixed with powder of HA or β-TCP to obtain porous granules, at the same time as calcium carbonate, caso3mixed with powder of vitreous matrices for the formation of porous structure of biocomposite material;

- interpenetrating pores with a bimodal distribution in size and shape, namely a spherical diameter of less than 50 to 100 microns to ensure the adsorption of proteins and adhesion of osteogenic cells, and channel diameter from 100 to 200 μm and more for vascularization of blood vessels and colonization of bone cells throughout the volume of the implant.

A method of manufacturing an implant material "BCS" with a predominantly open-cellular to the national pore structure allows it to be included among osteoporotic, osteoconductive, providing optimal conditions for attachment, proliferation and differentiation of cells into osteoblasts, followed appositional the formation of bone on the surface and in the volume of the implant.

Time-temperature regime sintering bioceramics "BCS" provides obtaining mineral composition and bimodal pore distribution in which the structure of the material is within the following limits:

spherical pores with a diameter less than 50 microns and 50 to 100 μm are 45-55% and 20-25%, respectively;

channel pore diameter of from 100 to 200 μm and 200 μm are 10-5% and 8-10%, respectively.

The change of the pore structure and properties of the material is governed by the relationships between mineral phases and glassy matrix, the content of which varies within the following limits:

- Mineral phasesnot less than 65 wt.%
- Vitreous matrixnot more than 35 wt.%
- Open porosityfrom 60 to 70%
Water absorptionnot less than 65%
- PHfrom 6 to 9

the quality vitreous nutricionales matrix in the present invention applied medical glass. In particular, can be used medical container glass brand ito containing oxides (wt.%): 73,0±0,50 SiO2, 2,5±0,20 Al2O3, 2,0±0,30 MgO, 8,0±0,30 Cao, 14,5±0,25 Na2O. the Use of glass ito provides education porous skeleton on the surface and inside walls of which are minerals, phosphates and silicates of calcium. Experimentally proved, that the silanol groups (≡Si-OH)present in the matrix, increase the tendency of the material to the bone remineralization HA after implantation.

The hydrophilic characteristic of nutritionally glasses, promotes rapid wetting and impregnation of the total implant tissue fluid, and, if necessary, drugs (antibiotics, antiseptics and other drugs).

Introduction to the material composition of the pore in an amount of from 0.1 to 10 wt.% provides reception of implant material with a well-developed homogeneous, predominantly open-pore structure, which favors the process of osteogenesis.

The change of the pore structure and material properties can also be achieved by selection of fractional composition of bioactive phase and a glassy matrix, based on the conditions that their volumetric content varies from 1:1 to 4:1 depending on the case of clinical application is possible.

The manufacturing process bioceramics "BCS" includes the following stages :

Grinding nutricionales glass to obtain a glass powder with a specific surface area of from 1.2 to 2.4 m2/, the particle Size of the vitreous matrix is 2 to 1 μm. Add the carbonate-bearing pore-forming with a specific surface area of 2.5 to 3.0 m2/g, which corresponds to a particle size of from 0.9 to 0.7 μm, and both components are thoroughly mixed until a homogeneous mixture.

Granulation bioactive phase carried out by adding a binder, which may be polyvinyl alcohol, collagen, or starch. The presence of one of these components allows to obtain granules with a specific surface area of from 0.01 to 0.2 m2/g, and their size varies from 1000 to 100 microns.

Calculated in accordance with the specified part number bioactive phase and a glassy matrix is stirred mill with corundum glasses, the speed of which is 50-100 rpm, within 3-10 minutes.

The prepared mixture is placed in a sectional metal molds, which are placed in a laboratory electric furnace. The furnace shall be in accordance with the temperature-time regime sintering according to a given program. The speed of lifting and lowering the temperature regulated zones, to ensure achiwa education mainly open pore structure. The sintering process implant materials includes the following areas:

- heating for 60 minutes at temperatures up to 600°C at the rate of 8-10°C/min;

- baking for 40 minutes at temperatures from 600 to 800°C at the rate of 4-6°C/min;

- foaming for 10 minutes at temperatures from 800 to 850°C at the rate of 4-6°C/min;

- lowering the temperature within 45 minutes up to 560°C with a speed of 6°C/min;

- reduction of temperature within 30 minutes from 560 to 480°C with a speed of 2°C/min;

- slow cooling to 20°C at 1°C/min

Sintered billet bioceramics "BCS" are removed from the molds and cut into blocks and plate, whose dimensions are listed in table 1. Billet having cracks or cavities with a diameter of more than 2 mm, crushed in a jaw crusher to obtain granules and powders. The size of the resulting granules and powders are presented in table 2.

Received implant material is washed in an ultrasonic washing using distilled water, dried, bagged, and labeled.

Example 1. The composition of the mixture to obtain granules and powders of different dispersion of bioceramics silicochloroform "BCS" for maxillofacial surgery, dentistry and traumatology.

Bioactive phase and a glassy matrix are taken in a volumetric ratio of 4:1. The ratio of fractions (0,9-0,7 mm), (0,7-0,4) mm is (0,4-0,2) mm bioactive phase is respectively 1:2:2.

Example 2. The composition of the mixture bioceramics for porous blocks and plates of bioceramics silicochloroform "BCS" for maxillo-facial surgery, neurosurgery and traumatology.

Bioactive phase and a glassy matrix are taken in a volume ratio of 1:1. The ratio of fractions (2,0-1,0) mm and (1,0-0,9) mm bioactive phase is 2:1.

Example 3. A method of producing granules and powders of different dispersion of example 1.

Obtained in example 1, the mixture is poured into the form, compacted using hand pre and is sintered in an electric laboratory furnace at the specified mode. Sintered samples, which are used for granulation, sawn into blocks of cubic shape with the size of the ribs 25 mm, fall asleep in a jaw crusher, slit width which, depending on the desired size of granules and powders varies from 0.1 to 10 mm Sieving of the granules and powders into fractions is carried out within 5-10 minutes on a shaker with an amplitude of sifting 1,5-3,0 mm, While the actual output is:

3,00-4,008%
2,00-3,0010%
1,00-2,0012%
1,00-0,673%
0,67-0,3913%
0,39-0,2019%
0,20-0,0925%

Example 4. A method of manufacturing blocks and plates according to example 2.

Obtained according to example 2, the mixture is poured into a ball mill and mixed with the speed of rotation of the Cup 60 rpm for 5 minutes. The mixture is placed in a mold, compacted in a hydraulic press under a load of 50 kN and is sintered in an electric laboratory furnace. Feature temperature-time regime of sintering is to increase the rate of 5°C/min while heating up to 850°C and decreased in 2 times the time of sintering, which gives a material with more developed pore structure.

Next, the resulting billet is sawn into blocks, plates and milled with the frequency of rotation of the cutters up to 20,000 rpm After machining the implant is washed with distilled water using ultrasound with a frequency 42000 Hz at 50°C for 10 minutes Drying implant occurs at a temperature of 120°-150°C for 3-4 hours.

Table 1
Characteristics of rectangular blocks and the plastic is of bioceramics "BCS"
Form bioceramics "BCS"Volume (area*) fill the cavity, cm3Size mm
1. Plate
100,0*±5,0100×100×7
25,0*±3,050×50×5
4,0*±1,020×20×5
2. Blocks
19,0±1,045×20×20
12,5±0,530×20×20
10,5±0,535×17×17
7,0±0,530×15×15
4,0±0,217×15×15

Tolerances on linear sizes of products from bioceramics "BCS" is ±2 mm

Table 2
Characteristics of granules and powders of bioceramics "BCS"
No.The shape, size of granules and powders, mmFilling the cavity without seals, cm3Mass, g
1234
13-40,50,2±0,1
1,00,3±0,1
2,00,8±0,1
3,01,3±0,1
5,02,2±0,2
10,04,7±0,2
22-3 0,50,2±0,1
1,00,3±0,1
2,00,8±0,1
3,01,3±0,1
5,022±02
10,04,7±0,2
31-20,50,2±0,1
1,00,3±0,1
2,00,8±0,1
3,01,3±0,1
5,02,2±0,2
10,04,7±0,3
41-0,670,50,2±0,1
1,00,3±0,1
2,00,8±0,1
3,01,3±0,1
5,02,2±0,2
10,04,7±0,3
1234
50,67-0,390,50,3±0,1
1,00,4±0,1
2,01,0±0,1
3,01,5±0,1
5,02,5±0,2
10,05,0±0,3
60,39-0,20,50,3±0,1
1,00,5±0,1
2,01,2±0,1
3,01,8±0,1
5,03,0±0,2
10,0/td> 5,5±0,3
70,2-0,090,50,3±0,1
1,00,6±0,1
2,01,3±0,1
3,02,2±0,1
5,03,6±0,2
10,07,0±0,3

The composition of bioceramics silicochloroform "BCS" and the method of its manufacture ensures obtaining biocompatible and astarabadi implant materials with open porosity of 70%, a water absorption of not less than 65% and the change in pH in the physiological solution from 6 to 9 units, which facilitates the process of regeneration of bone tissue in the replacement of defects and deformities of the bones.

Clinically proven the feasibility of application of bioceramics "BCS" in the form of porous blocks, wafers, granules and powders of different granularity in oral and maxillofacial surgery, dentistry, neurosurgery and traumatology to fix:

large defects and deformities of congenital and acquired character to whom these skeleton after removal of benign tumors in various bones, as well as gunshot wounds and osteomyelitis;

- small and medium postoperative defects of the bones of the facial skull and brain and the alveolar processes of the upper and lower jaws of different etiology and sinus lift;

- large, medium and small periodontal bone defects of the jaws.

1. Bio silicochloroform "BCS", containing hydroxyapatite, nutritionally matrix and the pore of organic and inorganic origin, characterized in that it further contains wollastonite and β-tricalcium phosphate, which hydroxyapatite bioactive forms the phase and fractional composition of the bioactive phase and matrix changes within their volumetric content of from 1:1 to 4:1.

2. Bio according to claim 1, characterized in that nutricionista matrix made with a specific surface area of 2.4 m2/g and its content does not exceed 35 wt.%, and as pore-forming substance is a carbonate having a specific surface of up to 3.0 m2/g in an amount up to 10 wt.%.

3. A method of manufacturing bioceramics according to claim 1 based on the heat treatment of mechanical mixtures of bioresorbable and bioreactive components, characterized in that the heat treatment is carried out by heating the mixture to a temperature of 600°C for 60 min, sintering at temperatures from 600 to 800°C for 40 min, VSP is niania at temperatures from 800 to 850°C for 10 min, then reduce the temperature to 560°C for 45 min, the decrease in temperature from 560 to 480°C for 30 min, a further reduction in temperature to 20°C takes place by the inertial mode of cooling of the furnace.



 

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2 cl, 8 ex

FIELD: medicine.

SUBSTANCE: group of inventions relate to medicine. In accordance with first version set contains prosthesis or part of prosthesis, which have, at least, one contact surface; metal granules, which possess internal porosity; bone cement. Said granules are made on the basis of titanium. Said granules preferably possess osteoconductivity, and preferably have coating from group of osteoconductive or osteoinductive coatings, or coatings, containing bioceramics, bioglass or osteoconductive or osteoinductive molecules or liquids or cells. Titanium granules for application in said set of articles have porosity from 40 to 90% and diameter from 1 to 10 mm. Said granules preferably possess osteoconductivity. Said granules preferably have coating from group of osteoconductive or osteoinductive coatings, or coatings, containing bioceramics, bioglass or osteoconductive or osteoinductive molecules or liquids or cells. Method of fixation of prosthgesis or its part, in organism or out of organism, in bone or in artificial bone, contains the following stages: preparation of hole in bone fort reception of, at least, one contact surface of prosthesis; filling of said hole and (or) detected bone defect, at least, partially with metal granules, made on the basis of titanium, possessing internal porosity, and osteoconductivity, and preferably having coating from group of osteoconductive or osteoinductive coatings, or coatings, containing bioceramics, bioglass or osteoconductive or osteoinductive molecules or liquids or cells in such a way that, at least, part, but preferably practically entire internal wall of said hole is covered by the layer of said granules; introduction of compacting instrument into said granules into aperture in said layer and compacting said layer of granules on said internal wall in such a way that after extraction of said compacting instrument from said aperture, said aperture has shape and dimensions of, at least, one contact surface of said prosthesis; introduction of bone cement and at least one said contact surface of prosthesis into said aperture in such a way that bone cement is pressed into the layer of said granules; thus, that when said, at least, one contact surface is in required for fixation position, space between said, at least, one contact surface and internal wall is filled with said layer of granules, and bone cement is pressed into said layer. Application of titan-based metal, porous granules and bone cement in preparation of set of articles for fixation of prosthesis in bone. Application of titan-based metal, porous granules in preparation of elements for filling in bone defects. In accordance with the second version set contains porous metal granules, made on the basis of titanium, bone cement and compacting instrument for preparation of elements for filling in bone defects and (or) fixation of prosthesis or its part in bone. Set in accordance with the first or the second version, in which said compacting instrument has longitudinal direction and is provided with surface of impaction influence on longitudinal end with the aim to influence said compacting instrument in said longitudinal direction, and, at least, slightly narrowing part, preferably terminal part, narrowing in direction, opposite to said surface of impaction influence. Method of coating titanium granules, used in set of articles for fixation of prosthesis or its part and/or filling in bone defects with said titanium granules with porosity from 40 to 90% and diameter from 1 to 10 mm, which includes, at least, one of the following operations: biomimetic covering, covering in supersaturated solution; covering by plasma spraying; or electrochemical precipitation, preferably with application of salt solution bath, or electric jet spraying.

EFFECT: inventions ensure improvement of bone cement cohesion with bone and increase depth of its penetration.

35 cl, 25 dwg

FIELD: medicine.

SUBSTANCE: invention refers to a bioactive microcellular material for orthopaedic surgery, which contains certain proportions of isle-, chain-, ring- and layer-pattern powdered strongly alkaline glass of certain composition, powdered calcium phosphate excipient, hydroxyapatite specified in calcium-deficient hydroxyapatite with the Ca/P ratio = 1.5-1.65 or β-tricalcium phosphate, and a cellulating agent representing starch or gelatine. Besides, the invention refers to a method for making said material applied for the purpose of orthopaedic surgery which involves the stages of material granulation, moulding and heat treatment. At the stage of granulation, glass of dispersity 40-120 mcm is introduced into the powdered material, while the heat treatment is three-staged: at first the material is heated up to 600-750°C and kept for 30-50 minutes, then tempered to 520-550°C and kept for 5-10 minutes and cooled slowly to 450-470°C and kept for 5-10 minutes.

EFFECT: making the materials characterised by adjustable solubility, high hydrophilic properties, biomodal pore structure and high mechanical properties.

2 cl, 4 ex

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