RU93264U1 - IMPLANT FOR OSTEOPLASTY (OPTIONS) - Google Patents

Abstract

 1. An implant for osteoplasty, comprising a material, characterized in that the implant is made of a material containing synthetic calcium phosphates, including synthetic composite materials based on them, and carrageenan. ! 2. An implant for osteoplasty, comprising a material, characterized in that the implant is made of nanoscale material containing synthetic calcium phosphates, including synthetic composite materials based on them, and carrageenan. ! 3. An implant for osteoplasty, comprising a material, characterized in that the implant is made of a material containing synthetic calcium phosphates, including synthetic composite materials based on them, and carrageenan with the partial use of nanosized particles in the material. ! 4. An implant for osteoplasty, comprising a material, characterized in that the implant is made of a gel-like material containing synthetic calcium phosphates, including synthetic composite materials based on them, and carrageenan.

Description

The utility model relates primarily to medicine, the medical industry. More specifically, it relates to implants for bone grafting and can be used for the manufacture of implants when replacing any kind of destruction of bone tissue that occurs when cysts and tumors are removed from bone tissue, etc., when restoring the volume of an organ or tissue, and also as a carrier biologically active substances, drugs and cells.

Known implants for osteoplasty, including materials based on biological raw materials - native bone after appropriate processing. [RU 2278655 C1, publ. 06/27/2006].

A known implant for osteoplasty, including material based on biological raw materials - native bone, obtained by cleaning, sawing bone tissue, degreasing, processing with a solution of urea, washing, drying, packaging and sterilization, (patent RU 2104703, 02.20.98)

A disadvantage of the known technical solution is that the implant material contains mainly animal raw materials, a large proportion of animal collagen, which, as you know, is a carrier of genetic memory of diseases. When using such an implant, one cannot exclude the possibility of manifestation of immune dependence, other types of negative effects on health.

An implant for osteoplasty is also known, including material based on biological raw materials - native bone, obtained by cleaning bone tissue, sawing it into plates with a thickness of 0.1-2.0 cm, processing with a 20% alkali solution (24 hours), degreasing in a mixture of ethanol : chloroform in a ratio of 1: 2 (24 hours), treatment with a mixture of a solution of 1% ammonia: 1% ethanol in a ratio of 1: 1 (10-16 hours), washing with deionized water and saturation of sGAG from 800 to 1500 μg / cm ³ washing buffer, drying, packaging and sterilization by radiation exposure. (Patent RU 2278679, publ. 06/27/2006)

A disadvantage of the known technical solution is that the implant material obtained by chemical treatment of native bone leads to partial collagen destruction, as well as partial demineralization and destruction of the mineral skeleton of bone tissue and, as a result, to a decrease in the mechanical strength of the material. The resulting final product was a porous-fibrous structure in which the mineral component is located above the surface of collagen fibers in the form of spherical formations along their length, had the composition: non-demineralized collagen from bone tissue - 97-99 wt.%, Sulfated glycosaminoglycans - 0.08 -1.5 wt.%, Deionized water - the rest. The disadvantages of the obtained material are also: a high collagen content, which does not exclude immune dependence, the location of the mineral component and collagen fibers is such that they do not form a single structure, the mechanical properties in this case cannot be high, and the mineral component can not be washed out when using it in vivo. In addition, the technology is complex (obtaining sGAG, saturation sGAG), its use for the manufacture of material in large quantities is impractical, the mineral component in the final product is large-sized, which cannot provide a uniform structure, and therefore high mechanical properties.

Implants for osteoplasty are known, including materials based on synthetic HA mixed with processed bone material - a source of collagen (e.g., US Pat. No. 5,425,770 dated June 20, 1995. Known implants are also not free of the effect of antigenicity.

Known implant, including material for the replacement of defects in bone tissue (Patent RU 2274461 C2, publ. 04/20/2006 - prototype)., Representing a plate consisting of artificially synthesized fluorohydroxyapatite (PHA) in collagen, while the content of PHA is 40-90% by weight. The method for its preparation is characterized in that the porous collagen matrix is placed between solutions containing 0.2-1 mol of calcium chloride and a solution containing 0.1-1 mol / l of sodium phosphate or ammonium phosphate and 0.01-0.1 mol / l of fluoride ammonia, as well as a solution of ammonia or sodium hydroxide. The process of synthesis of PHA on collagen is carried out using electrophoresis with a current density of 7-20 mA / cm for 10-24 hours. As a result, the interaction occurs: 10 Ca ²⁺ + 6PO ₄ ^3- + xF ^- + (2-x) OH ^- Ca ₁₀ (OH) _{2 x} H (P) _x (PO ₄ ) ₆ and fluorohydroxyapatite is obtained, which is deposited on protein fibers. In this case, the material is formed in the form of porous plates with a thickness of 3-10 mm.

A disadvantage of the known implant is the presence in its material of a large amount of collagen, since the deposition of PHA occurs on the porous collagen matrix, as well as the large size of the crystals of PHA, which cannot provide high strength characteristics of the material. Since the porous collagen matrix is obtained from the bone of an animal, it is not clear what volume in the bone should be pores to ensure the strength of the material (from which bone and what age the donor should be) to obtain a material of satisfactory strength. A large amount of collagen in the resulting product increases its antigenicity and reduces biocompatibility.

Thus, a common drawback of known implants for osteoplasty, including materials obtained from biological raw materials, or containing biological raw materials as a component, are the antigenicity inherent to one degree or another. It should be noted that the extraction of non-collagenic proteins with urea is carried out after removal of fat and partial demineralization of bone tissue, which leads to partial destruction of collagen and destruction of the mineral skeleton of bone tissue. Partial loss of the mineral component of bone tissue after demineralization significantly reduces its mechanical and strength characteristics. At the same time, with this treatment, part of the fat and non-collagen proteins remains, thereby increasing the antigenicity of the implant and reducing its biocompatibility.

It should also be noted that the process of engraftment of such an implant for osteoplasty, its adaptation to the surrounding tissues of the bone defect, proliferation and migration of cells into the stroma of the material is quite long, since the level of sGAG responsible for the adaptation of the implant is significantly reduced in diseases and injuries of the connective tissue, cell adhesion. A disadvantage is also psychological considerations, and sometimes ethical ones, associated with the use of native objects for the manufacture of implants, even if properly processed, as well as the lack of antiseptic properties in all of the materials listed. In addition, the materials thus obtained and used for implants have a large-sized structure, which does not ensure their single structure, and therefore, the sufficient mechanical strength of the implants.

The technical task of the utility model is to obtain an implant for osteoplasty that meets the requirements of the absence of antigenicity effect, increase biocompatibility and mechanical strength, as well as having high antiseptic properties.

This goal is achieved by the fact that in the implant for osteoplasty, including the material, the implant is made of a material containing synthetic calcium phosphates, including synthetic composite materials based on them and carrageenan; the implant for osteoplasty can be made of a nanoscale material containing synthetic calcium phosphates, including synthetic composite materials based on them, and carrageenan; the implant for osteoplasty can be made of a material containing synthetic calcium phosphates, including synthetic composite materials based on them, and carrageenan with partial use of nanosized particles in the material; and also - the implant can be made of a gel-like material containing synthetic calcium phosphates, including synthetic composite materials based on them, and carrageenan.

The utility model has the following differences from the prototype:

- the implant is made of a material containing synthetic calcium phosphates, including synthetic composite materials based on them and carrageenan (option 1);

- the implant can be made of nanoscale material containing synthetic calcium phosphates, including synthetic composite materials based on them and carrageenan (option 2);

- the implant can be made of a material containing synthetic calcium phosphates, including synthetic composite materials based on them, and carrageenan with partial use of nanosized particles in the material (option 3);

- the implant can be made of a gel-like material containing synthetic calcium phosphates, including synthetic composite materials based on them, and carrageenan. (option 4).

This will allow you to get an implant for osteoplasty that meets the requirements of the lack of antigenicity effect, increase biocompatibility and mechanical strength, and also has high antiseptic properties.

In the patent information fund we reviewed, no similar technical solutions were found, as well as technical solutions containing a combination of these distinctive features.

The utility model is applicable and will be used in the industry in 2008-2009.

The implant is made as follows.

OPTION 1.

The implant is made from a material containing biocompatible calcium phosphates (FC) [may contain, for example, calcium hydroxyapatite (HA) Ca ₁₀ (PO ₄ ) ₆ (OH) ₂ , calcium carbonate hydroxyapatite (KHA) Ca ₁₀ (PO ₄ ) ₆ (OH ) _2-2x (СО ₃ ) _x at 0≤х≤1 or Ca _{10-х + y} (PO ₄ ) _6-х (СО ₃ ) _х (ОН) _{2-х + y} at 0 х≤2,0 < y≤1 / 2, tricalcium phosphate (TKF) Ca ₃ PO ₄ , and also synthetic inorganic composite materials based on them (GA / TKF, KGA / TKF)] and carrageenan (CAR). Carrageenan (C ₆ H ₁₁ NO ₄ ) _n , (TU 8411-008-00472012-93); Carrageenan is a seaweed processing product.

The specified material, in contrast to analogues and prototype, is small with a particle size of 1-5 mm, which ensured its composition.

The material for the implant was used in the form of particles (grains) of a white paste-like mass, gaining strength after drying in air, comparable to the strength of ceramics and native bone.

The material for the implant was used in the form of crystalline particles.

EXAMPLE 1

An implant is made by placing a moist paste-like mass in a matrix, which is preliminarily made in accordance with the shape and geometrical dimensions of the native object, in which it is dried in fresh air. Drying time depends on the shape and geometric dimensions of the native object, as well as on the ambient temperature. After removing the implant from the matrix, additional processing is carried out (polishing, grinding, etc.), then sterilized and installed in the patient’s body during surgery.

The resulting implant may take the form of: a volumetric object, a section of bone, a joint, a dental object, devices for attaching bone fragments (screws, plates of various shapes, granules, etc.).

EXAMPLE 2

The implant is made of crystalline material. Such an implant is performed by filling, for example, during the operation, bone defects and damaged areas, while the process of engraftment of such an implant occurs; its adaptation to the surrounding tissues of the bone defect, proliferation and migration of cells into the stroma of the material.

The utility model according to OPTION 1 will make it possible to obtain an implant for osteoplasty that meets the requirements of the absence of antigenicity effect (since the implant is obtained from a material consisting of synthetic components), to increase biocompatibility and mechanical strength (since the implant material consists of biocompatible components forming polymer chains and containing active hydroxyl and carboxyl groups capable of actively interacting with the inorganic fraction of the resulting organic-mineral OGM composite during nteza) as well as possessing high antiseptic properties (their provides carrageenan).

The possibility of obtaining (in contrast to analogues and prototype) a small-sized material containing the above components provides a large surface for the interaction of the implant particles with body tissues, and therefore their uniform structure and their active engraftment and high mechanical strength of the implant.

OPTION 2.

The implant is made of a nanosized material containing synthetic calcium phosphates (FC) [may contain, for example, calcium hydroxyapatite (HA) Ca ₁₀ (PO ₄ ) ₆ (OH) ₂ , calcium carbonate hydroxyapatite (KGA) Ca ₁₀ (PO ₄ ) ₆ ( OH) _2-2x (СО ₃ ) _x at 0≤х≤1 or Ca _{10-х + y} (PO ₄ ) _6-x (СО ₃ ) _х (ОН) _{2-х + y} at 0≤х≤2, 0≤y≤1 / 2, tricalcium phosphate (TCF) Ca ₃ PO ₄ , and also synthetic inorganic composite materials based on them (GA / TCF, KGA / TKF)] and carrageenan (CAR).

The specified material contains particles with sizes from 1 nm to 100 nm.

EXAMPLE 3

EXAMPLE is carried out according to EXAMPLE 1 when using a paste-like material consisting of nanosized particles containing synthetic calcium phosphates (FC), including synthetic composite materials based on them and carrageenan (CAR).

EXAMPLE 4

EXAMPLE is performed according to EXAMPLE 2 using a crystalline material consisting of nanosized particles containing synthetic calcium phosphates (FC), including synthetic composite materials based on them, and carrageenan (CAR).

The utility model according to OPTION 2 will make it possible to obtain an implant for osteoplasty that meets the requirements of the absence of antigenicity effect (since the implant is obtained from a material consisting of synthetic components), to increase biocompatibility and mechanical strength (since the implant material consists of biocompatible components forming polymer chains and containing active hydroxyl and carboxyl groups capable of actively interacting with the inorganic fraction of the resulting organic-mineral OGM composite during nteza) as well as possessing high antiseptic properties (their provides carrageenan).

The use of a material consisting of nanosized particles for the implant ensures a homogeneous material structure, an increase of 100 and 1000 times the surface of interaction of the material with body tissues, and therefore significantly intensifies (compared to OPTION 1) the healing process of such an implant; its adaptation to the surrounding tissues of the bone defect, proliferation and migration of cells into the stroma of the material is very active.

OPTION 3.

The implant is made of a material containing synthetic calcium phosphates (FC) [may contain, for example, calcium hydroxyapatite (HA) Ca ₁₀ (PO ₄ ) ₆ (OH) ₂ , calcium carbonate hydroxyapatite (KHA) Ca ₁₀ (PO ₄ ) ₆ (OH ) _2-2x (СО ₃ ) _x at 0≤x≤1 or Ca _{10-х + y} (PO ₄ ) _6-х (СО ₃ ) _х (ОН) _{2-х + y} at 0 x≤2,0≤ y≤1 / 2, tricalcium phosphate (TKF) Ca ₃ PO ₄ , and also synthetic inorganic composite materials based on them (GA / TKF, KGA / TKF)] and carrageenan (KAR) with partial use of nanosized particles in the material.

EXAMPLE 5

EXAMPLE is carried out according to EXAMPLE 1 when using a paste-like material containing synthetic calcium phosphates (FC), including synthetic composite materials based on them, and carrageenan (CAR) with partial use of nanosized particles in the material.

EXAMPLE 6

EXAMPLE was carried out according to EXAMPLE 2 using a crystalline material consisting of particles containing synthetic calcium phosphates (FC), including synthetic composite materials based on them, and carrageenan (CAR) with partial use of nanosized particles in the material.

The utility model according to OPTION 3 will make it possible to obtain an implant for osteoplasty that meets the requirements of the absence of antigenicity effect (since the implant is obtained from a material consisting of synthetic components), to increase biocompatibility and mechanical strength (since the implant material consists of biocompatible components forming polymer chains and containing active hydroxyl and carboxyl groups capable of actively interacting with the inorganic fraction of the resulting organic-mineral OGM composite during nteza) as well as possessing high antiseptic properties (their provides carrageenan).

The use of a material for the implant, partially consisting of nanosized particles, provides a homogeneous material structure, an increase in the surface of interaction of the material with body tissues, and therefore significantly intensifies the healing process of such an implant; its adaptation to the surrounding tissues of the bone defect, proliferation and migration of cells into the stroma of the material is very active, but the useful model according to OPTION 3 allows you to carry out a targeted effect on the properties of the implant in accordance with the objectives of medical practice (regulation of mechanical characteristics, control of the nature and characteristics of metabolism , imparting certain properties to the implant depending on the application, size and amount of nanoscale particles used in the implant material and it depends on many factors, particularly the nature of the injury, of the volume of the damaged organ, etc.).

OPTION 4.

The implant is made of a gel-like material containing synthetic calcium phosphates (FC) [may contain, for example, calcium hydroxyapatite (HA) Ca ₁₀ (PO ₄ ) ₆ (OH) ₂ , calcium carbonate hydroxyapatite (KGA) Ca ₁₀ (PO ₄ ) ₆ ( OH) _2-2x (CO ₃ ) _x at 0≤x≤1 or Ca _{10-x + y} (PO ₄ ) _6-x (CO ₃ ) _x (OH) _{2-x + y} at 0≤x≤2, 0≤y≤1 / 2, tricalcium phosphate (TCF) Ca ₃ PO ₄ , and also synthetic inorganic composite materials based on them (GA / TCF, KGA / TKF)] and carrageenan (CAR).

EXAMPLE 7

The gel-like material is introduced into hard-to-reach cavities, for example, with a syringe or injected.

EXAMPLE 8

The gel-like material is applied by spreading on the damaged area.

EXAMPLE 9

The gel-like material is applied by dipping into it, for example, a titanium prosthesis, etc.

The utility model according to OPTION 4 will make it possible to obtain an implant for osteoplasty that meets the requirements of the absence of antigenicity effect (since the implant is obtained from a material consisting of synthetic components), to increase biocompatibility and mechanical strength (since the implant material consists of biocompatible components forming polymer chains and containing active hydroxyl and carboxyl groups capable of actively interacting with the inorganic fraction of the resulting organic-mineral OGM composite during nteza) as well as possessing high antiseptic properties (their provides carrageenan).

The advantage of OPTION 4 is that the implant material can be inserted into hard-to-reach cavities (for example, into cracks ...).

Table 1 shows the phase composition of the products of the synthesis of OMK GA / CAR.

In FIG. X-ray data are presented (OMK GA / CAR research results) obtained using a Dron-4 diffractometer.

Table 1. The phase composition of the synthesis products of OMK GA / CAR before (A) and after (B) heat treatment. Sample Heat treatment Inorganic phase Mass fraction (%) a, a s, A D; nm D; Nm BUT No Ca ₁₀ (PO ₄ ) ₆ (OH) ₂ one hundred 9,442 6,878 56.8 13.6 AT 900 ° C, 1 h Ca ₃ (PO ₄ ) ₂ one hundred 10,430 37,396 255.8

Table 1. The phase composition of the products of the synthesis of OMK GA / CAR before (A) and after (B) heat treatment. Sample Heat treatment Inorganic phase Mass fraction (%) a, a s, A D ||; nm D⊥; Nm BUT No Ca ₁₀ (PO ₄ ) ₆ (OH) ₂ one hundred 9,442 6,878 56.8 13.6 AT 900 ° C, 1 h Ca ₃ (PO ₄ ) ₂ one hundred 10,430 37,396 255.8

Thus, the use of a utility model makes it possible to obtain an implant for osteoplasty, which meets the requirements of the absence of antigenicity effect, increase biocompatibility and mechanical strength, and also has high antiseptic properties.

Claims (4)

1. An implant for osteoplasty, comprising a material, characterized in that the implant is made of a material containing synthetic calcium phosphates, including synthetic composite materials based on them, and carrageenan. 2. An implant for osteoplasty, comprising a material, characterized in that the implant is made of nanoscale material containing synthetic calcium phosphates, including synthetic composite materials based on them, and carrageenan. 3. An implant for osteoplasty, comprising a material, characterized in that the implant is made of a material containing synthetic calcium phosphates, including synthetic composite materials based on them, and carrageenan with the partial use of nanosized particles in the material. 4. An implant for osteoplasty, comprising a material, characterized in that the implant is made of a gel-like material containing synthetic calcium phosphates, including synthetic composite materials based on them, and carrageenan.