Injectable composite applicable as bone filler

FIELD: medicine.

SUBSTANCE: composite contains a reactive ceramic phase of triple-substituted calcium phosphate and an organic phase containing polyvinyl alcohol hydrogel. The mechanical properties and injectability of said material can be adjusted by varying the concentration of two phases.

EFFECT: preparation of the new injectable composite applicable as a bone filler.

9 cl, 2 tbl

 

The present invention relates to a new injectable composite material suitable for use as bone substitutes. In particular, the present invention relates to an injectable composite material consisting of two phases: a ceramic phase and a liquid hydrogel.

In orthopedic surgery different biomaterials can be applied in a number of diseases of the skeleton, in which it becomes necessary to replace or additional formation area of the bone tissue, starting from the most common age-related diseases of the bones, such as osteoporosis, bone lesions in case of arthrosis and arthritis, to more serious pathologies, such as sarcoma and bone cysts.

For the development of bone tissue substitute, you must first explore the natural bone tissue. Natural bone is a solid fabric of complex composition consisting of an organic matrix (collagen fibers) and a ceramic frame, complexly organized in a single tertiary structure with anisotropic properties. First of all, the bone plays the role of a supportive and protective frame for soft tissues, and the second is involved in the metabolism of trace elements with blood and other surrounding fluids; examples of such a MIC is elements can serve as calcium and magnesium, the only tank which in the vertebrate is a bone.

To implement both of the above functions, the bone tissue is constantly replacing and remodeling. These processes are regulated by numerous and complex set of hormonal substances, some of which are actually produced by bone cells.

The mechanical properties of bone can be described using the values of modulus of elasticity, maximum compression and tensile strength. As a General rule for bone compressive strength exceeds the tensile strength and mechanical properties of bone superior to those of cancellous bone.

The literary value of the modulus of elasticity ranges from 50 MPa to 2 GPA for the spongy bone, and from 10 HPa to 22 GPA for bones. Values of compressive strength ranging from 1 MPa to 50 MPa for cancellous bone and from 100 MPa to 220 MPa for bones. These figures are reference values for evaluation of the mechanical properties of bone substitutes. To ensure interoperability mechanical properties of bone substitutes should be close (to the extent possible) to those of natural bone tissue.

The need to use substitutes for bone tissue occurs in fractures to the stay in the case, if natural recovery processes and bone growth does not occur during the physiological period of time or not happen at all or after surgical removal of the tumor or bone cysts for replacement of tissue removed surgically.

Thus, substitutes for bone tissue must be mechanically stable during a clinically acceptable period of time, and possess properties that are compatible with natural bone tissue, providing stimulation of formation of new tissue. One of the most important and necessary properties of bone substitutes is the ability to stay in contact with natural cloth for an unlimited period of time without requiring surgical removal.

In addition, due to the increasingly wide spread of arthroscopic techniques, there has been increased interest in injectable materials that can be easily introduced into the cavity of bone defects without prior assessment of their form and the linear dimensions or which will be able, if possible, eliminate the need for surgical intervention.

Currently, the most widely used injectable material in orthopedic surgery is polymethylmethacrylate (PMMA), the disadvantages of which are significant local Gibert RME hardening of the implant and the development of tissue necrosis, in contact with the latter.

Ceramic materials or cements based on phosphorus and calcium (ALS) is subject to significant interest in areas related to replacement/implantation of hard mineralized tissues. Such materials are non-toxic and neimenovani as their main components are calcium ions and phosphate ions, which are also natural components of the ceramic phase of bone tissue. One of the most useful properties of cements based on phosphorus and calcium (ALS) is the ability to buy liquid consistency when adding liquid aqueous phase during preparation of the implant. Another useful property of such cements is their ability to harden in the presence of water, used for receiving the implant.

Among all the CDS trehzameshchenny calcium phosphate able to communicate directly with the bone tissue, thus forming a very strong bond in the zone of contact between bone and implant material.

Trehzameshchenny calcium phosphate, as with all cement bone substitutes based on calcium phosphates (SRS), is a porous material, however, its mechanical properties are typical for brittle materials and, thus, significantly different from the mechanical properties of natural bone tissue.

N the past this according to numerous publications in early (from the point of view of solidification) the introduction of pasta, retrieved from translesanas calcium phosphate (TCP), there is a risk of fracture of the implant in contact with biological fluids, while the late introduction of pasta TCP, it hardens and poorly amenable to further manipulation. The introduction of such pastes with the help of a syringe is often spontaneous phase separation, in which the liquid phase passes through the syringe to fill the cavity, while the solid phase remains in the syringe.

In the patent application WO 02/070029 described the current sample mixture suitable for use as bone substitutes containing porous β-TCP, as well as linking agent selected from the group consisting of common amplificatory, suspendresume agents, thickeners and gelling, binding, dezintegriruetsja and stabilizing agents. Among the binding agents in the aforementioned application highlighted sodium alginate, hyaluronic acid, cellulose and its derivatives, collagen, peptides, mucin, chondroitin sulfate, etc.

Hydrogels are materials that are well knownper sethat over the last decade have been the focus of interest in the field of medical and scientific research, especially in applied biomedical research. Typical su the stations lattice structure, representing a cross-linked (physically or chemically) polymer fiber, allows the hydrogels to absorb and retain significant amounts of liquids, for example water or biological fluids, while not dissolving. Significant water content of the hydrogels leads to the fact that the surface tension at the phase boundary hydrogel-biological liquid is extremely small. This is an important property together with the permeability of hydrogels for small molecules such as metabolites and nutrients, making them particularly similar to biological tissues.

However, poor mechanical properties of hydrogels are the disadvantage of greatly limiting their potential use as materials for artificial implants.

The authors of the present invention have found that the combination of hydrogel of polyvinyl alcohol and translesanas calcium phosphate (TCP) as the ceramic phase may be used to obtain a composite material with an unexpectedly optimal mechanical properties similar to those of natural bone tissue. The obtained composite material is also characterized by improved ineterest compared to TCP as a single component.

Thus, one aspect of the present invention is injecion the first composite material, which among other things can be used as bone substitutes containing trehzameshchenny calcium phosphate as a ceramic phase and a hydrogel of polyvinyl alcohol as the liquid phase.

A composite material according to the present invention has mechanical properties very similar to those of natural bone tissue. This material is also characterized by improved ineterest and, consequently, greater ease of injection compared to the common cements based translesanas calcium phosphate.

Injectable composite material according to the present invention receive according to the following Protocol:

An aqueous solution of polyvinyl alcohol (PVA) of a given concentration of preferably from 2% to 30% by weight, more preferably from 10% to 20% by weight was mixed with powder translesanas calcium phosphate, preferably α-translesanas calcium phosphate, resulting in the obtained paste-like material, suitable for introduction into the cavity of bone defects, where the resulting material can harden in the presence of water in the material and the environment.

Preferably the mass ratio (weight/weight) of polyvinyl alcohol to trehzameshchenny the calcium phosphate in the injectable composite material is according the present invention is from 3/97 to 20/80.

Mechanical properties

To study the mechanical properties and ineterest composite material according to the present invention were obtained aqueous PVA solutions of different concentrations (10%, 17% and 20% by weight). These solutions were obtained by mixing the powdered polymer with water at 100°C for 20 minutes. After cooling to room temperature, the polymer solutions were mixed with a powder of α-TCP, resulting in received three different compositions with the mass ratio (weight/weight) of α-TCP/PVA 93/7, 88/12 and 86/14.

To study the mechanical properties of the compositions of the paste composite materials obtained by the above Protocol was introduced in a Teflon discs with a suitable geometry that during the next 4 days were passed in aqueous solution NaH2PO4(to 2.5% by weight) at 37°C to ensure curing of the compositions.

In table 1 the results of the tests in compression (ASTM D695) demonstrate that the mechanical properties of the composite material (α-TCP/PVA) can be adjusted by using different mass ratios of polymer and inorganic phases. In particular, some compositions exhibit mechanical properties that exceed those for calcium phosphate as the sole component. Indeed the maximum value of the compressive strength σmax for composite polymer phase which is up to 7% by weight (composite material 93/7), is 25±5 MPa compared to 21±3 MPa for α-TCP as a single component. Similarly, the value of the modulus of elasticity E for such a composite is 1.2 GPA, compared to 0.8 GPA α-TCP as a single component. It was also found a slight increase in the values of the maximum strain εmax, i.e. the values of the deformation corresponding to the maximum value of compressive strength (0,02±0,01 mm/mm for α-TCP as the sole component of 0.03±0.01 mm/mm for the composite according to the present invention), and a significant increase in the values of the ultimate strain εu, i.e. the values of the deformation corresponding to the break point (0,06±0.01 mm/mm for α-TCP as a single component, and 0.09±0.01 mm/mm for the composite according to the present invention). From a practical point of view, the results indicate greater (compared to cement) the ability of the composite material according to the present invention to deformation up to fracture. The data obtained can be interpreted in terms of durability, which can be calculated as the area under the mechanical curve, numerical maximum for which the composite material according to the present invention (2,1 MPa) three times okovoi α-TCP as a single component (0.7 MPa).

From the data shown in table 1, clearly shows that the composite materials containing more than 7% PVA by weight, illustrate the values of compressive strength and modulus of elasticity less than or equal to those for the original cement (α-TCP as a single component). Indeed the values of σmaxreduced to 17±1 MPa for the composite of α-TCP/PVA 88/12 and even up to 14±3 MPa for the composite of α-TCP/PVA 86/14, while the values of the modulus of elasticity is virtually unchanged. At the same time, the values of the maximum strain εmaxincrease to 0.04±0.01 mm/mm for the composite 88/12 and 0.05±0.01 mm/mm for the composite 86/14. The values of the ultimate strain εuamount of 0.08±0.01 mm/mm for the composite 88/12, which is only slightly different from the values for the composite 93/7, while εufor composite 86/14 increased very significantly and is to 0.11±0.01 mm/mm as a result of increasing values of two deformation indices values of strength for composites 88/12 (T = 1.1 MPa) and 86/14 (T = 1.0 MPa) greater than those for cement (α-TCP as a single component).

Based on comparison of values obtained in the above-described mechanical tests and previously published in respect of natural fabrics, it can be concluded that the mechanical properties of injectable bone substitutes according to the present invention correspond to the range of the Onam values, typical tissue spongy bone.

Ineterest

To study the applicability of the composite material according to the present invention and to compare it with the common cements based on calcium phosphate was introduced experimental setting ineterest", i.e. the mass percentage of material that can be extruded from a syringe.

Ineterest can be calculated according to the following formula: %I = We/Wi. To determine ineterest were used syringes filled with a specified number of the studied material (Wi), to the piston which was further applied compressive force using a torque device, in which the rate of descent of the cross struts was 15 mm/min and the applied force is about 100 N. After weighing the components were mixed with each other to achieve a composite paste-like consistency, then the obtained paste was filled in a syringe, which was then placed in a suitable tripod. The above procedure can be completed in 60-90 seconds. After filling the syringe started the countdown test. After completion of the experiment, the extruded material was weighed (We), and the target parameter was calculated using the above formula.

The data are shown in table 2, indicate that in the context of the practical application of the material, the addition of PVA hydrogel provides the obtained material advantages. The first significant positive effect is that the paste has the best consistency for extrusion through a syringe, and in the process of extrusion does not occur phase separation, as is sometimes the case when using α-TCP as a single component. The second important advantage is acceptable to the medical professional the length of time before solidification of the composite material, within which the material may be administered to the patient (1 hour). The increase in the time quite significantly (see table 2) compared to α-TCP as a single component, in which 91% is contained in the syringe material remains in the syringe and may not be introduced after 6 minutes.

From a more General point of view, the advantage of using a PVA hydrogel in the same composite with trehzameshchenny calcium phosphate is that contained in the hydrogel water slowly and fully released in the ceramic phase, which leads to uniform crystallization and, consequently, the final hardening of the composite even in the absence of exogenous water environment. In addition, during the solidification of the injectable composite material was not observed any significant increase in temperature.

Injectable composite material according to the present izaberete the Oia may also contain bioactive agent (i.e. the agent that has biological activity), for example, selected from the group consisting of drugs, cells, growth factors, etc. that may be contained in the form intended for controlled release during introduction of the material.

Table 1
Mechanical properties under compression
MaterialE (GPA)σmax(MPa)εmax(mm/mm)εu(mm/mm)T (MPa)
100%
α-TCP
0,8±0,221±30,02±0,010,06±0,010,7
PVA + 93%
α-TCP
1,2±0,125±50,03±0,010,09±0,012,1
PVA + 88%
α-TCP
0,7±0,317±10,04±0,010,08±0,021,1
PVA + 86%
α-TCP
0,9±0,1 14±30,05±0,010,11±0,021,0

Table 2
Ineterest
Solid phaseThe liquid phaseTimeout (min)%I
α-TCPWater + 2,5% by weight NaH2PO4244,2%
α-TCPWater + 2,5% by weight NaH2PO4330,9%
α-TCPWater + 2,5% by weight NaH2PO4518,8%
α-TCPWater + 2,5% by weight NaH2PO469%
α-TCPThe PVA solution (10 mass%)7100%
α-TCPThe PVA solution (10 mass%)20100%
α-TCPThe PVA solution (10 mass%)40100%
α-TCPThe PVA solution (10 mass%)6095.6%of

1. Injectable composite material suitable for use as bone substitutes consisting of translesanas calcium phosphate as a ceramic phase and a hydrogel of polyvinyl alcohol as the liquid phase.

2. Injectable composite material according to claim 1, in which the hydrogel of polyvinyl alcohol as the liquid phase is a 2-30% (by weight) aqueous solution of polyvinyl alcohol.

3. Injectable composite material according to any one of claims 1 to 2, in which the mass (weight/weight) ratio of the polymer of polyvinyl alcohol/trehzameshchenny calcium phosphate is from 3/97 to 20/80.

4. Injectable composite material according to claim 3, in which the mass (weight/weight) ratio of the polymer of polyvinyl alcohol/trehzameshchenny calcium phosphate is 7/93.

5. Injectable composite material according to claim 3, in which the mass (weight/weight) ratio of the polymer of polyvinyl alcohol/trehzameshchenny calcium phosphate is 12/88.

6. Injectable composite material according to claim 3, in which the mass (weight/weight) ratio of the polymer polyvinyl JV the mouth/trehzameshchenny calcium phosphate is 14/86.

7. Injectable composite material suitable for use as bone substitutes consisting of translesanas calcium phosphate as a ceramic phase and a hydrogel of polyvinyl alcohol as the liquid phase, optionally containing drug as a bioactive agent.

8. The use of injectable composite material according to any one of claims 1 to 7 to obtain the drug, suitable for use as bone substitutes.

9. The method of obtaining injectable composite material according to any one of claims 1 to 8, comprising preparing an aqueous solution of polyvinyl alcohol and then mixing the resulting solution with powder translesanas calcium phosphate.



 

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