Artificial dura mater and method of its production

FIELD: medicine.

SUBSTANCE: invention relates to chemical-pharmaceutical industry and represents artificial dura mater, produced from electrospinning layers by technology of electorspinning, with electrospinning layer, consisting of, at least, hydrophobic electrospining layer, which is produced from one or several hydrophobic polymers, selected from polylatic acid and polycaprolactone.

EFFECT: invention ensures creation of artificial dura mater, which has good tissue compatibility, anti-adhesiveness and possibility of introducing medications, preventing cerebrospinal fluid outflow during regeneration of person's own dura mater.

30 cl, 7 ex, 11 dwg

 

The technical field of the invention

The invention is directed to the study of artificial biofilms, namely artificial Dura membranes, and methods for their production.

The level of technology

Damage to the Dura mater is a common problem in neurosurgery. Open craniocerebral trauma (acquired at work, in a traffic accident or war), tumor invasion, congenital damage to the soft meninges or other diseases of the skull can cause damage to the Dura mater. Such damage to the Dura mater require prompt treatment to prevent the expiration of the cerebrospinal fluid, education hernia brain and loads from atmospheric pressure. Otherwise, it can be life-threatening.

Currently, despite the fact that there are a large number of substitutes Dura mater, the materials used in the substitutes can be divided into four types: autologous fascia, allograft, natural or artificial substance, and xenograft. However, the application of these materials in medical practice inevitably leads to problems such as high levels of infections. According to statistics, the level of infections in craniotomy is 4%; Dura mater, the manufacturer of the Lenna of the mucous membrane of porcine small intestine, gives the level of infection of 3.4%; and Dura, made of collagen - level infections of 3.8%. Because of the blood-brain barrier, as soon as there is intracranial infection, it is impossible to provide the desired concentration of anti-infective drugs in brain plasma, the infection will be difficult to control. Also, existing artificial substitutes Dura mater does not have the possibility of drug delivery in the Pia mater. Therefore, postoperative infection control is often not effective.

Moreover, one of the main reasons you need to restore the Dura using a graft of Dura mater is damage to the soft meninges due to invasion of the tumor. More than half of the cases of brain tumors cannot be completely removed by surgery and after surgery chemotherapy. Many chemotherapy drugs are toxic and cannot cross the blood brain barrier, so it is impossible to achieve an effective concentration of drug that reduces the results of chemotherapy.

Existing artificial substitutes Dura usually do not contain the interest of medicines. For example, due to the dense structure it is impossible to ensure the introduction of drugs in the autologous fascia in a natural way, it is also difficult to introduce drugs into the allograft or xenograft. However, substitutes for the Dura on the basis of synthetic material because of their good elasticity can be easily filled with drugs. On the other hand, due to the limitations of methods of drug is also not easy to introduce the drug into the artificial Dura, as well as to allow release of the drug after transplantation for therapeutic purposes. To date, the main route of administration of anti-infective drug in an artificial substitute Dura - soaking substitute drug. When using this method, a large part of the drug remains on the surface of the artificial Dura mater, while it is difficult to control, making it difficult to achieve controlled release.

In conclusion, it should be noted that the existing artificial substitutes Dura have such disadvantages as high level infections, low biocompatibility, incomplete absorption, the difficulty with the introduction of drugs and the control of its effective release.

Description of the invention

To solve at least one of the technical problems described above, according to the present izaberete the Oia provides an artificial Dura mater, which has an excellent tissue compatibility, ideal adhesiability, full absorption, good mechanical properties, low-level infections and the possibility of administering drugs.

In addition, a method of manufacturing an artificial Dura mater.

According to the invention, the artificial Dura mater consists of electroplating layers. The above electroprecizia layers comprise at least one hydrophobic electroplating layer, which is made of one or more hydrophobic polymers by the method of electroprecizia. The above-mentioned hydrophobic polymer is selected from the group consisting of hydrophobic aliphatic polyester, a polyester-ether copolymer, polyarteritis, polyurethane, polyanhydride, polyphosphazene, polyaminoamide, copolymers, and mixtures thereof.

Also, hydrophobic aliphatic polyester is at least one substance selected from the group consisting of polylactic acid, polyglycolide, polycaprolactone and polyhydroxybutyrate (PHB). The above-mentioned polyester-ether copolymer is at least one substance selected from the group consisting of polydioxanone (PDO), copolymer glycol-lactic acid and copolymer of polybutylene terephthalate/glycol. The above is UTY polyanhydride is at least one substance selected from the group consisting of polyanhydride policeacademy acid (PSPA)-cetane two-acid anhydride, polyanhydride type-I, polyanhydride type-II, polyanhydride type-III and polyanhydride type-IV.

The artificial Dura mater comprising a hydrophobic layer has a strength, similar strength Dura mater of humans. It can sealing brain damage and to prevent the expiration of the cerebrospinal fluid during regeneration own Dura mater of humans. The hydrophobic layer adverse to move and link cells, by means of what can be achieved the purpose of antiadhesive. In fact, you can use several hydrophobic layers in order to match different strength requirements.

In addition, according to the invention in an artificial Dura membrane, at least one hydrophilic electroplating layer can be placed on the above-mentioned hydrophobic elektroprijenos layer. The above-mentioned hydrophilic layer prepared by the method of electroprecizia, using one or more types of hydrophilic polymers selected from the group consisting of chondroitin sulfate, heparin, agar, glucan, algina, cellulose, modified cellulose, algina the sodium, starch, gelatin, fibrinogen, silk protein, polymer-peptide mimic of elastin, collagen, chitosan, modified chitosan, a hydrophilic polyurethane, polyethylene glycol, polymethylmethacrylate, polymethylmethacrylate, hydroxybutyrate co-hydroxyvalerate, Rwnh (polyhydroxybutyrate-with-hydroxyhexanoate), polyvinyl alcohol, polylactide, and mixtures thereof.

When transplants of Dura mater in the brain hydrophobic layer, which plays the role of an anti-adhesive substance, is placed close to the surface of the brain, while the hydrophilic layer, providing this nanofiber thin the us for adhesion, migration, proliferation, and differentiation of cells, is far from the brain. As the hydrophilic layer is made of hydrophilic materials with good biocompatibility, it can greatly enhance the processes of displacement and expansion of stem cells and fibroblasts, and, consequently, to contribute to the growth of autologous Dura mater. In fact, you can use several hydrophobic layers in order to match different requirements.

According to one embodiments of the invention with the features of the invention Dura may also have a transition layer between the hydrophobic and hydrophilic layers. Switched the hydrated layer is manufactured by the method of electroprecizia using one or more polymers, he has hydrophilicity, which gradually increases from the side closest to the above-mentioned hydrophobic electroprecizia layer to the side closest to the above-mentioned hydrophilic electroprecizia layer. The presence of the transition layer can improve the hydrophilicity between the hydrophobic and hydrophilic layers.

According to another variant embodiment of the invention, each of the hydrophobic, hydrophilic, and transition layers can be mixed with cytokine and/or medicine. Blending layers can provide the cytokine and/or drugs in the brain after transplantation, decorated with absorption scaffold polymer. Then the cytokine and/or medicine can achieve the goal of preventing local infection, adhesion and/or recurrence of the tumor or to facilitate the recovery of autologous Dura.

According to another variant of the invention, the adhesion of the hydrophobic and hydrophilic layers can be provided by use of cytokine and/or drugs.

Cytokine referred to in the invention is a factor that plays an important role in adhesion, movement, proliferation and differentiation of fibroblasts, which is selected from the group consisting of interleukin, colony stimulating factor, tumor necrosis factor, platelet the aqueous growth factor, basic fibroblast growth factor and combinations thereof. The cytokine can accelerate the recovery of damaged Dura.

Drug referred to in the invention is one or more substances selected from the group consisting of antibiotics, hemostatic means, antiadhesive agents and anticancer drugs. These medicines are placed on an artificial Dura membrane in accordance with the actual demand. After transplantation of the artificial Dura mater drug is gradually released so as to ensure that treatment goals during the decomposition of polymers and regeneration of damaged Dura mater. Thus, overcome the blood-brain barrier to the drug.

In addition, cytokine and/or medicine can be embedded in the hydrogel. Due to the effects of adhesion and fixation of the hydrogel in accordance with the regulations in place, the drug may be released in equal portions, or in a special way. The above-mentioned hydrogel consists of one or more substances selected from the group consisting of a polysaccharide polymer, polypeptide polymer and synthetic hydrophilic high-molecular polymer.

According to one and the variants of the invention, the hydrophobic electroplating layer above the artificial Dura mater consists of fibers with a diameter of 50-1000 nm. According to one embodiments of the invention the hydrophobic electroplating layer consists of pores that are smaller than 3 μm, while the hydrophilic electroplating layer consists of fibers with a diameter of 5-200 μm and a pore size of 20-200 μm. The pore size largely depends on the fiber diameter. If the fiber diameter decreases, the pore size decreases. Thus, the control of the fiber diameter can be controlled pore size electroplating layer. The average diameter of human cells is 10-50 μm. Pia mater is mainly composed of fibroblasts and collagen fibers secreted from fibroblasts. Most of the fibroblasts have a diameter of 20-30 μm. The pore size of the hydrophobic layer is less than 3 μm, which can prevent the penetration of cells and the adhesion between the Dura mater and brain tissue. The hydrophilic layer is comprised of pores whose size is equal to or larger than the average diameter of the cells, which may facilitate the penetration and movement of cells.

According to another aspect of the invention is a method of obtaining an artificial Dura mater also includes the following steps:

A) dissolving a hydrophobic polymer in a solvent in order to obtain a hydrophobic solution for electroprecizia, in which the above-mentioned hydrophobic polymer selects the I group, consisting of hydrophobic aliphatic polyester, a polyester-ether copolymer, polyarteritis, polyurethane, polyanhydride, polyphosphazene, polyaminoacid, copolymers, and mixtures thereof;

B) the manufacture by electroprecizia hydrophobic electroplating layer type film (or sheet) of the above-mentioned hydrophobic solution for electroprecizia, thereby making the above-mentioned artificial Dura.

In addition, the above-mentioned hydrophobic aliphatic polyester is at least one substance selected from the group consisting of polylactic acid, polyglycolide, polycaprolactone and polyhydroxybutyrate. The above-mentioned polyester-ether copolymer is at least one substance selected from the group consisting of polydioxanone (PDO), copolymer glycol/lactic acid, and copolymer of polybutylene terephthalate terephthalic acid/glycol. The above polyanhydride is at least one substance selected from the group consisting of polyanhydride policeacademy acid-cetane two-acid anhydride, polyanhydride type I, polyanhydride type II, polyanhydride type III and polyanhydride type IV.

The method is applicable to the principle of electroprecizia, creates an artificial Dura using the definition of the aqueous polymer. Dura can effectively prevent its adhesion to brain tissue.

To further prevent the adhesion of the artificial Dura mater with brain tissue is necessary to control the diameter of the fibers, and the result is also provided to control the pore size of scaffold. Thus it is possible to stop the movement of cells. The diameter of the fibers hydrophobic electroplating layer can be controlled in the range of 50-1000 nm. According to one embodiments of the invention the pore size hydrophobic electroplating layer is less than 3 microns.

In the method described above in paragraph B)above, electroprecizia performed using microfranchises pump performance 0.1-5.0 ml/h, and high voltage generator, operating with a voltage 5-40 kV and distance delivery 5,0-30,0 see

For best effect in clinical therapy the invention also provides a way similar to electroplating to create hydrophilic electroplating layer on the above-mentioned hydrophobic layer, which includes the following steps:

a') Dissolving the hydrophilic polymer in a solvent to obtain a hydrophilic solution for electroprecizia, in which the above-mentioned hydrophilic polymer is selected from the group consisting of chondroitin sulfate, is eparina, agar, glucan, algina, modified cellulose, sodium alginate, starch, cellulose, gelatin, fibrinogen, silk protein, polymer-peptide mimic of elastin, collagen, chitosan, modified chitosan, a hydrophilic polyurethane, polyethylene glycol, polymethylmethacrylate, polymethylmethacrylate, hydroxybutyrate co-hydroxyvalerate, Rwnh (polyhydroxybutyrate-with-hydroxyhexanoate), polyvinylalcohol of polylactide.

b') Placing the above-mentioned hydrophilic solution for electroprecizia by electroprecizia on the above-mentioned hydrophobic layer to create the above-mentioned hydrophilic electroplating layer.

Hydrophilic secretrary layer is set at a large distance from the surface of the brain to facilitate the movement of cells and regeneration of the Dura. To facilitate penetration of cells hydrophilic electroplating layer consists of fibers with a diameter of 5-200 μm and pores, the size of which is 20-200 μm.

In paragraph (b'), the creation of hydrophilic electroplating layer above electroprecizia performed using microfranchises pump performance 0.1 to 20.0 ml/h and the generator high voltage working voltage 10-40 kV, and the distance delivery 5,0-30,0 see

In the process of electroprecizia usually hidrovo is hydrated and hydrophilic polymer must be dissolved in appropriate solvents, respectively, to create electroprecizia solutions. Often, the above-mentioned solvents are volatile organic solvents, which include, inter alia, methanoic acid, acetic acid, ethanol, acetone, dimethylformamide, dimethylacetamide, dihydrofuran, dimethylsulfoxide, hexafluoroisopropyl alcohol, cryptonemiales alcohol, dichloromethane, trichloromethane, methyl alcohol, ethyl alcohol, chloroform, dioxane, trifluoroethane, cryptonemiales alcohol and mixtures thereof. Volatile organic solvents quickly evaporate during the process of creating electroplating layers, with the final electroprecizia layers will not contain or will contain a small degree of residual organic solvent which can be removed at a later stage. In some cases, the solvent may be used water, the very can then be removed by heating in a furnace or natural drying after creating electroplating layers.

In addition, a method of manufacturing an artificial Dura mater, provided in the present invention, includes, create, to manufacture the above-mentioned hydrophilic electroplating layer, the transition layer by electroprecizia between the above-mentioned hydrophilic and hydrophobic layers, with wisewoman the th transition layer has a hydrophilic, which gradually increases from the side closest to the above-mentioned hydrophobic electroprecizia layer to the side closest to the above-mentioned hydrophilic electroprecizia layer. Materials, solvents and settings electroprecizia for making the transition layer can be determined based on the actual situation and the need. The presence of the transition layer can improve the hydrophilicity between the hydrophilic and hydrophobic layers.

In one embodiment of the invention during the creation of each electroplating layer by electrostatic spinning in appropriate solutions for electroprecizia you can add a cytokine and/or medicine. When using the technique of mixing the mixed layers of polymers and cytokine and/or medicine are better suited for clinical use and have the best therapeutic effect.

A method of manufacturing an artificial Dura mater, presented in this invention also includes the distribution of cytokine and/or drugs on the above-mentioned hydrophobic elektroprijenos layer and/or the above-mentioned hydrophilic elektroprijenos layer by beobachte. Beobachte is the printing technology of the cytokine and/or drugs on biobodies consisting of scaffolds above hydrophobin the x electroplating layers and/or the above-mentioned hydrophilic electroplating layers.

In order to evenly distribute the above-mentioned cytokine and/or medicine and capture them at a certain point on the layers, it can be concluded cytokine and/or drug in the hydrogel.

In particular, the above beobachte consists of the following steps:

a) mixing a solution of the hydrogel with the cytokine and/or medicine to create a solution;

and

b) printing the above-mentioned solution of the above-mentioned hydrophobic electroplating layers and/or hydrophilic electroplating layers with the help of technology and beobachte.

The above solution of the hydrogel of the invention consists of aqueous solutions of polysaccharide polymer, polypeptide polymer, a synthetic hydrophilic polymer or mixtures thereof. While the above-mentioned polysaccharide polymer includes, without limitation, starch, cellulose, sodium alginate, hyaluronic acid and chitosan. The above-mentioned polypeptide polymer includes, without limitation, collagen, poly-L-lysine and a copolymer of lactic and glycolic acids (PLGA). The above-mentioned synthetic hydrophilic polymer includes, among others, acrylic acid, polymethacrylic acid, polyacrylamide and N-izopropilakrilamid.

Under normal conditions, the liquid hydrogel. At the corresponding temperature or under certain conditions, it may be the a short time to turn into a gel, he has good adhesion. According to the invention for participation in the reaction of some hydrogels require a cross-linking agent. Therefore, the method also includes processing the above-mentioned hydrophobic and/or hydrophilic layers with a solution containing a cross-linking agent prior to beobachte. When processing the above-mentioned solution containing cross-linking agent, cross-linking agent adheres to the layer or layers. After this cytokine and/or medicine will be added to the hydrogel solution and the mixed solution is placed in the printhead. During printing, when the solution of the hydrogel with the cytokine and/or medicine reaches electroplating layers, it hardens and adheres to the layers.

With a uniform and stable printing can provide uniform cytokine and/or drugs. While individual printing with different speeds and conditions in the private case, you can provide the cytokine and/or drug at a specific site. The choice of cross-linking agent depends on the type of hydrogel. For example, if the hydrogel is alginate sodium, cross-linking agent is a calcium chloride; if the hydrogel is fibrinogen cross-linking agent p is ecstasy a thrombin.

Compared with the prior art the invention has the following advantages:

(1) mechanical properties meet the requirement of tensile strength and elasticity, in addition, it is moisture-resistant and has anti-adhesive properties.

(2) Materials consisting of membranes, non-toxic and harmless to human body, have good compatibility, provide complete absorption after transplantation, which avoids the appearance of a tumor or cancer.

(3) In the manufacture of the shell are not used animal tissues, therefore you can avoid the risk of immune rejection, the spread of viruses and infections.

(4) Provided double layers can prevent adhesion, to promote growth of autologous cells, which, in turn, contribute to the timely recovery of the Dura.

(5) using technology beobachte therapeutic substances can be introduced into the shell and can be released after transplantation regulated method.

(6) the Material presented in large numbers in the document, inexpensive and convenient for transportation and storage.

(7) the Method of obtaining includes simple procedures, low cost and is simple to industrial implementation.

(8) a Simple application in honey is medical practice, it is also possible for individual application to the patient.

Additional aspects and advantages of the invention will be presented in the further description. After reading and applying it in practice, some issues become more apparent.

A brief description of the accompanying drawings

The above and/or additional aspects and advantages or additional aspects and advantages of the present invention will become more apparent and will be more easily understood upon reading the following description together with the drawings and options for implementation, which are:

Figure 1 - image process electroprecizia for producing an artificial Dura mater according to the present invention.

Figure 2 - image of the process of preparing the artificial Dura mater according to the present invention, which combines electroprecizia and beobachte.

Figure 3 - image of the artificial Dura mater according to the present invention comprising the above-mentioned hydrophobic electroplating layer (s).

Figure 4 - image of the artificial Dura mater according to the present invention comprising the above-mentioned hydrophobic electroplating layer and the above-mentioned hydrophilic electroplating layer.

Figure 5 - image is agenie artificial Dura mater according to the present invention, consisting of hydrophobic, hydrophilic and transition layers.

Figure 6A is an image of the above-mentioned mixed artificial Dura mater according to the present invention, consisting of a hydrophobic electroplating layer and hydrophilic electroplating layer.

Figure 6B is an enlarged image of type I in Figure 6A.

Figure 7A is an image of the above-mentioned mixed artificial Dura mater according to the present invention, consisting of a hydrophobic electroplating layer, hydrophilic electroplating layer and the transition layer.

Figure 7B shows an enlarged image type II in Figure 7A.

Figure 8A is an image of the above-mentioned artificial Dura mater according to the invention, obtained in conjunction with the technology beobachte.

Figure 8B is an enlarged image type III on Figure 8A.

Position in the figures represent the following:

1. Electrodiathermy spray apparatus;

2. Spinning fibers;

3. The power source of high voltage;

4. The receiving device;

5. Bioacademy head;

6. Vessel;

7. Hydrophobic textile fibre;

8. Drug;

9. Hydrophilic spinning fibers;

10. Cytokine or drug;

11. Spinning fiber transition layer;

A. Hydrophobic electropla any layer;

Century Hydrophilic electroplating layer;

C. Transition layer.

The best option of carrying out the invention

Now consider the examples of carrying out the invention in more detail. Examples will be illustrated on the accompanying drawings in which the same number represents the same elements. The examples described with reference to the drawings are only images that are intended to explain the invention and do not represent limitations of the invention.

Now together with Figures 1 through 8 describe the artificial Dura mater according to the present invention and the method of its production.

The image process electroprecizia for artificial Dura mater is shown in Figure 1, electrodiathermy the spray apparatus 1 contains a polymer solution, the end of the high voltage power supply high voltage 3 is connected with the spray apparatus 1. The receiving device 4 has a cylindrical shape, and can move left and/or right along the axis of the cylinder or the direction of the rod long axis of the cylinder. Moving the receiving device 4 can be installed using a computer program that generated electroplating layer will have the same thickness. In fact, the receiving device can be set as a flat surface is knost, and by moving left and right or forward and backward, you can provide a uniform reception. The receiving device 4 is connected to the end of the low voltage power supply high voltage 3, so that between the spray apparatus 1 and the receiver 4 there is a large voltage difference.

Before starting electroprecizia, it is necessary to prepare an appropriate polymer solution to electroplate.

You can choose the solution of hydrophobic polymer to electroprecizia, such a solution is made by dissolving a hydrophobic polymer in a solvent. While the above-mentioned hydrophobic polymer includes, without limitation, hydrophobic aliphatic polyester (including polylactic acid, polyglycolide, polycaprolactone and polyhydroxybutyrate), polyester-ether copolymer (e.g., polydioxanone), polychaetes, polyurethane, polyanhydride (for example, polyanhydride policeacademy acid-cetane two-acid anhydride), polyphosphazene, polyaminoamide and mixtures thereof.

Depending on the performance, if the hydrophilic electroplating layer is necessary after hydrophobic electroplating layer is finished, it is necessary to prepare a solution of a hydrophilic polymer to electroprecizia. While the above-mentioned hydrophilic polymer includes, among other things, chondro is in the sulfate, heparin, agar, Toucan, Algin, modified cellulose, sodium alginate, starch, cellulose, gelatin, fibrinogen, silk protein, polymer-peptide mimic of elastin, collagen, chitosan, a modified chitosan, a hydrophilic polyurethane, polyethylene, polymethylmethacrylate, polymethylmethacrylate, hydroxybutyrate co-hydroxyvalerate, polyhydroxybutyrate-co-hydroxyhexanoate (Mwnh), polyvinylalcohol and polylactide. On the basis of actual needs, you can install multiple spraying devices 1, which are respectively placed above hydrophobic polymer solution and the above-mentioned hydrophilic polymer solution. Or you can replace the solution in the spray apparatus 1 after it is made hydrophobic layer.

The solvent solution to electroplate can be water or volatile organic solvent, which includes, among other things, methanoic acid, acetic acid, ethanol, acetone, dimethylformamide, dimethylacetamide, dimethylsulfoxide, hexafluoroisopropyl alcohol, cryptonemiales alcohol, dichloromethane, trichloromethane, methyl alcohol, ethyl alcohol, chloroform, dioxane, trifluoroethane and triperoxonane acid.

As soon as the solution for electroprecizia is ready, you must set the parameters. After that, the power is turned on, and e is cropadile device is activated. Since spinning fibers 2 are formed by the spinning of the spray apparatus 1, the receiving device 4 will move in the prescribed manner so as to create a homogeneous structure elektroprijenos shell.

The parameters of the process of creating the above-mentioned hydrophobic electroplating layer are the following: microfranchise pump performance 0.1-5.0 ml/h, high voltage generator, operating with a voltage 5-40 kV, and the distance delivery 5,0-30,0 see the Above-mentioned hydrophobic electroplating layer consists of fibers, the diameter of which can be controlled in the range from 50 to 1000 μm, and pores that are smaller than 3 microns.

The parameters of the process of creating the above-mentioned hydrophilic electroplating layer are the following: microfranchise pump performance 0.1 to 20.0 ml/h, high voltage generator, operating with a voltage 10-45 kV, and the distance delivery 5,0-30,0 see the Above-mentioned hydrophilic electroplating layer consists of fibers, the diameter of which can be controlled in the range from 5 to 200 μm, and pores, the size of which is 20-200 μm.

In fact, the procedure described above can be repeated to create a multi-layered hydrophobic layers and/or multi-layered hydrophilic layers, as shown in Figures 3 and 4.

In Figure 3 the image is and the artificial Dura mater with three hydrophobic layers, strength, similar strength Dura mater of humans. As layers are formed of hydrophobic materials, they are not suitable for moving and linking cells. However, what the materials look forward to a safe, non-toxic and absorbed by the human body, they ensure antiadhesive.

The Figure 4 shows the artificial Dura mater comprising two hydrophobic layers (a) and three hydrophilic layers (). When transplants of Dura mater in the brain, anti-adhesive hydrophobic layers (A) are placed near the surface of the brain, while the hydrophilic layers (C) are placed away from the surface of the brain, providing this nanofiber thin the us for adhesion, migration, proliferation and differentiation of cells. As hydrophilic layers are made of hydrophilic materials that provide good biocompatibility and have a larger pore size, which is suitable to move stem cells and fibroblasts, which, therefore, favorable for the growth of autologous Dura.

As soon as electroprecizia layers will be created, you have to dry them in the oven or in a natural way, depending on the composition of the solution. If the solvent of the solution to electroplate - volatile organic solvent, takoyaki hexafluoroisopropyl alcohol, the drying procedure can be neglected, since the solvent completely evaporates, while spinning fibers 2 are produced by extrusion in the receiving device 4, and the voltage difference.

As the hydrophobic layer is very different from the hydrophilic layer in regard to hydrophilicity, to maintain the stability of patterns in practice is not easy. To resolve this problematic increase in hydrophilicity between the two layers, you must use the transition layer. Above the transition layer has a hydrophilic nature, which gradually increases from the side closest to the above-mentioned hydrophobic electroprecizia layer to the side closest to the above-mentioned hydrophilic electroprecizia layer. In fact, the solution to electroplate above the transition layer may contain one or more polymers and an appropriate solvent, which is determined by the requirements of hydrophilicity. Then the above solution is placed in a sputtering apparatus to obtain the above-mentioned transition layer to the above-mentioned hydrophilic layer. The process parameters of a transition layer are the following: microfranchise pump performance 0.1-5.0 ml/h, high voltage generator, R is because voltage 5-40 kV and distance delivery 5,0-30,0 see

The artificial Dura mater with the transitional layer is depicted in Figure 5. This figure is above the hydrophobic layer consists of two layers, the above-mentioned hydrophilic layer consists of three layers. Between the above-mentioned hydrophobic layers (A) and the above-mentioned hydrophilic layer (B) provides a transition layer consisting of two layers, the layer closest to the above-mentioned hydrophobic layer (A)has a finer hydrophilicity than the layer that is closest to the above-mentioned hydrophilic layer.

In addition, to add a cytokine and/or drugs in the artificial Dura mater of the you can use mixing electroprecision. In particular, cytokine and/or medicine can be mixed with any one or several layers of the above-mentioned hydrophobic, hydrophilic and transition layers. Cytokine and/or medicine should be placed in the appropriate solution. After this is electroprecizia and cytokine and/or drug will be either with spinning fibers 2 as the formation of spinning fibers. The shell structure is formed in the receiving device 4. In addition, this procedure can be repeated. Cytokine and/or medicine to be added each time, may be the same or different is mi. The obtained artificial Dura mater is shown in Figure 6. In Figure 6A the hydrophobic layer has a two-layer structure, and the hydrophilic layer has a three-layer structure. In Figure 6B hydrophobic textile fibre 7 contains the drug 8 and hydrophilic textile fibre 9 is mixed with 10 cytokine.

Figure 7A has two transitional layer on the basis of Figure 6. One of them, the closest to the above-mentioned hydrophobic layer And has a finer hydrophilicity than the layer that is closest to the hydrophilic layer V. From Figure 7 In hydrophobic textile fibre 7 is mixed with the drug 8, hydrophilic textile fibre 9 is mixed with 10 cytokine, spinning fiber two transition layers 11, respectively, are mixed with the drug 8 and cytokine 9.

In addition, the invention provides a method, which combines electroprecizia and beobachte for artificial Dura mater. The above beobachte is the latest technology that has recently been developed in recent years are used in the biomedical field. This technology uses a special cell in a solution or a biologically active solution, such as biochemie", and in accordance with the development provides printing the same spot that a certain substra is a (referred to as "biomega"), which can be degraded in the human body. After printing biomega placed in a certain sequence. When using printing technology biochemie composed of cells and/or cytokines, can be placed accurately on the required areas. Biomega, put in order, forms a three-dimensional structure.

A specific example of implementation shown in Figure 2. On the basis of the device represented in Figure 1, is installed bioacademy head 5, this head can be obtained by modification of an existing industrial inkjet printer, similar to the way, for example, opened in patent US 7051654. The head contains the cytokine and/or medicine. Printing method and printed operating position when printing can be pre-set via the computer program. Certain printing procedures can be based on modern technologies.

In accordance with one variant of the invention, the cytokine and/or medicine can be included in the hydrogel. The above-mentioned hydrogel solution may be an aqueous solution of a polysaccharide polymer, a polypeptide polymer or a synthetic hydrophilic polymer. The above-mentioned polysaccharide polymer includes, without limitation, starch, cellulose, sodium alginate, hyaluronic acid and hee is Ozan. The above-mentioned polypeptide polymer includes, without limitation, collagen, poly-L-lysine and a copolymer of lactic and glycolic acids (PLGA). The above-mentioned synthetic hydrophilic polymer includes, among others, acrylic acid, polymethacrylic acid, polyacrylamide and N-izopropilakrilamid. Under normal conditions, the above-mentioned hydrogel liquid and turns into a gel at a certain temperature or under certain conditions. The hydrogel has good adhesion, which contributes to uniform distribution of cytokine and/or drugs by electrostatic spinning class.

Procedures beobachte with hydrogel include the following steps: 1) Place the cytokine and/or medicine that is prepared and mixed with the liquid hydrogel, bioacademy head 5. 2) After the formation electroplating layer to provide a seal on elektroprijenos layer using an inkjet printer according to a given program; based on the selection of the hydrogel, to create the appropriate conditions to ensure that the hydrogel quickly turned into a gel/jelly, providing good adhesion, glue cytokine and/or medicine to electroplating layers. 3) to Establish a uniform and homogeneous distribution of biochannel and to create an artificial Dura, as shown in Fig the re 8A, where each of the hydrophobic layer is printed using the layer medicines, and each of the hydrophilic layer is printed using a layer of a cytokine. As shown in the enlarged Figure 8, the film prepared by myopically differs from film prepared by mixing. Cytokine and/or medicine is applied on the surface layer, which is formed from a hydrophobic spinning fiber 7 and/or hydrophilic spinning fiber 9. The transplantation of this Dura in the human body above the cytokine and/or medicine to be released evenly. 4) If necessary, install the concentrated distribution on certain points and to print the above-mentioned cytokine and/or the above-mentioned drug in certain areas. The transplantation of this Dura in the human body above the cytokine and/or the above-mentioned drug release mainly on the required specific areas.

Solidification of some hydrogels requires the use of a cross-linking agent. In this case, biopact using hydrogel includes the following procedures: 1) Put a certain amount of cross-linking agent in the vessel 6. As soon as the electrical energy is spinning, the receiving device 4, the moving axis or left-right, will begin to interact with matter, and formed electroprecizia layers glued to the cross-linking agent (2) to Perform biopact, as described above. When interacting liquid hydrogel with a cross-linking agent electroplating layers inside the head 5, the hydrogel quickly turns into a gel/becomes jelly-like and helps to ensure that the cytokine and/or medicine is glued to electroplating layers. The choice of cross-linking agent depends on the type of hydrogel. For example, if the hydrogel is alginate sodium, cross-linking agent is calcium chloride; if the hydrogel is fibrinogen, the agent is thrombin.

According to one embodiments of the invention the above-mentioned solution of hydrophobic polymer may be hydrophobic poly(L-lactide) (PLLA) and ε-caprolactone dissolved in hexafluoroisopropanol alcohol or dichloromethane, the ratio of the above two polymers can be 50:50, 30:70 or 70:30. As the copolymer, it srednekislye molecular weight is 150000-500000. If you need mixing in the hydrophobic solution can be added is 0.01-3% solution of the antibiotic and/or 0.001-3% medicinal product for hemostasis and antiadhesive. Together with a solution of poly(L-lactide) (PLLA) and ε-caprolactone will receive the final of the hydrated solution.

According to another variant embodiment of the invention the solution of hydrophilic polymer can vlucht hydrophilic polyurethane plus natural gelatin, chondroitin sulfate or polyethylene glycol as solvent(s). The ratio of the mass is 20-80:80-20. The spinning solution is 3-15% of the total mass. When mixed in a solution of hydrophilic polymer can be added to the solution of the basic fibroblast growth factor and to ensure that the concentration of the cytokine 0,001-0,5%.

The drug is added when mixing or beobachte, you can choose according to the actual situation, antibiotic or drug for hemostasis or antiadhesive. The transplantation of Dura taken due to the removal of the tumor, it is possible to add compounds for chemotherapy of brain tumors.

Antibiotics include cephalosporins, ampicillin, spiramycin, sulfonamides, and quinolones. Most preferred option - Ceftriaxone sodium. During operations on the soft brain membranes often arises the need of opening the skull and currently intracranial infection is often caused by a bacterium, mainly including Staphylococcus aureus, Streptococcus, Streptococcus pneumoniae, Escherichia coli, Salmonella and Pseudomonas aeruginosa. The most common virus - Golden is Staphylococcus. According to clinical reports Ceftriaxone sodium provides the best therapeutic effect.

Antitumor agent includes, inter alia, nimustine, semustine, liposomal doxorubicin, actinomycin D and vincristine. Vincristine is the most preferable option.

Drug for hemostasis or antiadhesive can accelerate the wound-healing process and prevent adhesion. This drug includes, among other things, the factor of hemostasis (which contributes to the fact that the material acquires the function of hemostasis), retarder collagen synthase (for example, tranilast and alamast, which suspends recovery of collagen), protivosvertyvayuschih the drug (for example, difenacoum heparin, sodium and hirudin), anti-inflammatory medication (e.g., promethazine, dexamethasone, hydrocortisone, prednisolone, ibuprofen and oxyphenbutazone), calcium channel blockers (eg, diltiazem hydrochloride, nifedipine, and verapamil hydrochloride), an inhibitor of cell growth (e.g., fluorouracil), hydrolase (e.g., hyaluronidase, streptokinase, urokinase, pepsin and tissue plasminogen activator (tPA)and the drug with redox properties (e.g., methylene blue).

According to one variant of the invention, the mixing of races is a thief for electroprecizia added cytokine and/or medicine by the formula: basic fibroblast growth factor is 0.001 to 0.05% by weight of the solution to electroplate, ampicillin is 3% by weight of the solution to electroplate, factor hemostasis is 0.001 to 0.05% by weight of the solution to electroplate. When the recovery operation, the soft meninges due to a brain tumor can be added nimustine, which is 0.01-5% by weight.

The obtained artificial Dura wash, sterilize, package and pay for storage.

Example 1

Poly (L-lactide) (PLLA) and ε-caprolacton mass ratio of 50:50 and with srednekamennogo molecular weight 260000 dissolved in the solvent hexafluoroisopropanol alcohol to create a hydrophobic solution for electroprecizia. Place the solution in a spray apparatus for electroprecizia. Microfranchise pump works with a capacity of 5 ml/h; high voltage generator operates with a voltage of 30 kV and distance delivery is 20 see Come fibers to create a shell structure of an average diameter of 300 nm. After completing the application process for the spinning device is closed.

The obtained artificial Dura washed five times with ethyl alcohol and distilled water. Then after lyophilization Dura Packed in vacuum. After sterilization 25 kGy cobalt-60 Dura is stored at t is mperature minus 20°C.

Example 2

The method of obtaining the same as in Example 1.

For hydrophilic solution for electroprecizia to choose poly oxalic acid and chondroitin sulfate in a weight ratio of 70:30 and mass fractions of the spinning liquid 9%.

Driven electromedicine device, and is formed of hydrophilic electroplating layer on the hydrophobic layer has already been formed in Embodiment 1. Distance delivery is 11 cm, the voltage is 20 kV and the resulting hydrophilic layer consists of fibers, the average diameter of which is 10 μm.

Rinse and store in the same way as in Embodiment 1.

Example 3

Hydrophobic electroplating layer is made the same as in Embodiment 1.

The transition layer has a polymer solution of polyurethane and hyaluronic acid in a mass ratio of 70:30 and has a mass fraction of 10%. Spinning is activated when the feed distance of 11 cm and a voltage of 20 kV. The fibers have an average diameter of 5 microns. On the hydrophobic layer is a transition layer.

Then on the transition layer are produced by spinning a hydrophilic layer as in Example 4. After that, the spinning stops.

Rinse and store in the same way as in Example 1.

Example 4

(1) to prepare hydrophobic electroplating layer: Select the hydrophobic polycaprolactone and a mixed solvent chlorine is in the form or methyl alcohol in a ratio of 1:1. Add Ceftriaxone sodium concentration 1%. To obtain a homogeneous solution.

Add the above solution in a spray device for electrostatic spinning and perform electroprecizia using microfranchises pump with a capacity of 0.8 ml/h, high voltage generator, operating with a voltage of 12 kV, and the distance of the feeder 15 see to Get the fiber in the structure of the shell. Fiber hydrophobic electroplating layer have a diameter of 600 nanometers.

Close spinning device.

(2) prepare hydrophilic electroplating layer: Add hydrophilic silk protein and natural gelatin in a ratio of 20-80:80-20 and mass fractions of the spinning liquid 9%.

Prepare a solution of basic fibroblast growth factor. Evenly mix the solution with the above electroplating solution, the final concentration of the cytokine should be 0.001%, distance delivery must be 10 cm and the voltage - 20 kV. To start electroprecizia and create a hydrophilic layer on the formed hydrophobic layer. The average diameter of the fibers of the hydrophilic layer is of the order of micron.

Rinse and store in the same way as in Example 1.

Example 5

(1) to prepare hydrophobic electroplating layer: select the hydrophobic polycaprolactone and a mixed solvent of chloroform and methyl alcohol in the ratio 1:1. Mix with vincristine at a concentration of 100 ng/ml and to obtain a homogeneous solution.

Add the above solution in a spray apparatus for electroprecizia, customize performance microfranchises pump 0.8 ml per hour, the voltage generator high voltage of 12 kV and the distance of the transport device 15 cm, and receive fibers in the structure of the shell. Fiber hydrophobic electroplating layer have a diameter of 600 nanometers.

Close spinning device.

(2) prepare the transition layer: Select the polyurethane and hyaluronic acid in a mass ratio of 70:30. Mass fraction of spinning solution should be 10%. Mix with ampicillin at a concentration of 3%. Prepared homogeneous solution.

To start spinning. To make progeniem transition layer on the formed hydrophobic layer.

Distance delivery is 11 cm, the voltage is 20 kV and the average diameter of the fibers is 5 microns.

Close spinning device.

(3) to prepare hydrophilic electroplating layer: Add hydrophilic silk protein and natural gelatin in a ratio of 20-80:80-20 and mass fractions of the spinning solution of 9%. Mix with a solution of ampicillin to a final concentration of 3%.

To enable the spinning device to adjust the distance of the feeder 10 cm and manufacture spinning hydrophilic layer on the already SFOR the new transition layer. The average diameter of the fibers should be of the order of micron.

Rinse and store in the same way as in Example 1.

Example 6

(1) to prepare hydrophobic electroplating layer by using beobachte:

As the hydrophobic solution is used hydrophobic poly(L-lactide) (PLLA) and ε-caprolacton, in a mass ratio of 50:50, srednekislye molecular weight of the copolymer dissolved in hexafluoroisopropanol alcohol, 260 000.

As a cross-linking agent used is 0.1 mol.% solution of calcium chloride.

The hydrogel containing cytokine, takes alginate solution factor hemostasis. Factor hemostasis has a concentration of 10 ppm by mass in cytokine alginate solution.

A solution of 0.1 mol.% calcium chloride should be placed in a Petri dish with a diameter of 150 mm, the Part of the receiving device common for spinning device and beobachte, placed in a Petri dish. When creating electroplating layer, the receiving device must interact with the solution in the Petri dish. The printhead is positioned under the needle for electroprecizia, which is located inside of the spinning device, which provides a fixed printing to a specific location by a factor of hemostasis. Prepared cytokine alginate solution is placed in a cartridge of an inkjet printer. In this WA ante, cartridge - NRA.

The hydrophobic solution for electroprecizia is placed in a sputtering apparatus for spinning. After this, you must configure the speed microfranchises pump at 5 ml/h, the voltage generator high voltage of 30 kV and a distance of the transport device 20 see the Fiber is placed in the shell structure. Spinning lasts 20 minutes before spinning the device is closed.

The hydrogel solution containing cytokine, is printed on the above-mentioned nanobionics the us using an inkjet printer. Once the hydrogel is solidified, by using beobachte obtained hydrophobic electroplating layer with a cytokine.

(2) prepare hydrophilic electroplating layer by using beobachte:

To prepare the solution for electroprecizia, the solution of the hydrogel with the drug and the solution cross-linking agent.

To use polyglycol and chondroitin sulfate, as well as hydrophilic materials in a mass ratio of 70:30. The spinning solution has a massive share of 9%. The solution cross-linking agent is 0.1 mol.% the solution of calcium chloride.

The hydrogel solution containing cytokine, takes alginate solution with basic fibroblast growth factor. Above the main alginate solution has a basic fibroblast growth factor in the concentration is 100 ppb.

The following options are set: set performance microfranchises pump at 0.8 ml/h, the voltage generator high voltage of 20 kV and a distance of the transport device 11 see Other preparatory procedures are the same as in the above first step. After placing the hydrophilic fiber in the structure of the shell by using beobachte solution of hydrogel containing basic fibroblast growth factor, is printed on nanobionics the us. Once the hydrogel is solidified, by using beobachte obtained hydrophilic electroplating layer with a cytokine.

Rinse and store in the same way as in Example 1.

Example 7

(1) preparation of hydrophobic electroplating layer by using beobachte the same way as in Example 6.

(2) prepare the transition layer by using beobachte.

Electroplating a liquid solution of the transition layer consists of polyurethane and hyaluronic acid in a mass ratio of 70:30. Mass fraction of spinning solution is 10%. The concentration of the mixed ampicillin 3%.

The solution cross-linking agent is 0.1 mol.% solution of calcium chloride.

The solution of the hydrogel with the cytokine is alginate solution factor hemostasis, the percentage by weight of factor hemostasis is 10 parts per million.

The parameters are configured as follows: p is the productivity microfranchises pump - 4 milliliters per hour, the voltage generator high voltage - 20 kV, and the distance of filing - 11 see the Other procedures are the same as described above. The fiber is placed in the shell structure. The hydrogel solution containing cytokine, will be printed on the transition layer. After the hydrogel is solidified, by using beobachte obtained hydrophobic electroplating layer with a cytokine.

(3) Hydrophilic electroplating layer is prepared by using beobachte the same way as in Example 6.

Rinse and store in the same way as in the above Example 1.

The example of experiment 1

Dura membrane obtained from Example 1 is applied to the dogs to experiment on animals, and the use of the serial control experimental animal and regenerating material xenogenic soft meninges, applicable in clinical practice. Choose three healthy dogs, male or female, the weight of which ranges from 10 to 15 kg, watching them for 2-3 months. Dogs selected for participation in the experiment are under General anesthesia. Their skulls open with the left and right sides. Their Dura mater removed surgically, thus, creates damage to the dural membranes and injury of brain tissue. Then, using data Dura obolos and, received for Option exercise 1, to transfer the control and experimental animals, respectively, in order to restore the hard tissue of the meninges with the left and right sides of the brain of the dog. After surgery dogs fed as usual, and periodically observing them. Of the implanted area at the end of each observation period the sample is taken. At the end of the observation period after General anesthesia skull dogs reveal the above-mentioned method after General anesthesia. Open and separate the outer surface of the restorative material. To obtain samples of these dogs killed by an intravenous injection of air. The skull is opened surgically. Take out the implants and the surrounding tissue. The samples are carefully examined, including their appearance, characteristic features, their interaction with the environment, a protective shell, amosulalol, as well as the adhesion between the inner surface and brain tissue. The sample is stored in a vessel is treated formaldehyde solution. To mark the vessel. After a week remove local tissue; pour paraffin slice and histological dye with hematoxylin and eosin.

A few days after transplantation, three dogs recovering fast, scars heal well without any obvious discharge. Dogs who eat and drink normally, however, their activity in normal without any apparent violations of the functions of the movement. Three months after implantation, three dogs killed by an intravenous injection of air. Then, taking the operating field for the centre, the sample is taken at one inch larger than the size of the operated place, and it includes regenerating material surrounding Dura and brain tissue. After the sample will be taken to separate the skull from the soft meninges properly. It is established that Pia mater, which was transplanted Dura, fully formed; the transplanted material was replaced by fibrous tissue, and firmly connected with natural the meninges without scarring. The inner surface of the newly formed soft meninges on the site of transplantation protected from adhesion to brain tissue, the surface of the corresponding brain tissue smooth and protected from adhesion to the implant. At implantirovannomu plot samples control and experimental animals transplantirovannam material began to deteriorate and there is some adhesion on the site of transplantation on the inner surface of the soft meninges.

Example of experiment 2

Dura trained in the Use of the e 2, now used in the experiment conducted on dogs. Five dogs weighing 15-20 kg, at the age of 1.5-2 years male or female. They are immersed in the General anesthesia by intramuscular injection of ketamine. After anesthesia and shaving animals placed on the operating table in position on the side of the abdomen. By disinfection with 2% iodine and 75% ethyl alcohol. Animal heads are opened surgically in the longitudinal direction. For separation of the periosteum from the skull probe is used for removing, with two open top area of the skull. For opening the skull uses a high-speed drill. In the apical point of the skull are formed two openings, two rectangular Dura size of 3 cm×3 cm in the upper part of the head cut out with scissors. Ultimately creates damage to the top of the Dura for subsequent transplantation of the artificial Dura mater and control of the animal. Outside on the surface of the brain is used electrocoagulation to create 6 damaged regions of size 1 mm×1 mm, Then, the artificial Dura made in the Embodiment 2, cut the shape and size of the damaged areas of the Dura and installed on the damaged area. The hydrophobic layer is placed on the surface the minute brain and the stitches to repair the damage to the Dura mater dogs make threads 4/0 with an interval of 4 mm For the connection of muscles used all surgical needle and thread 4/0. As a control experimental animal used serial clinically acceptable restorative material Dura animal origin. After surgery, the dogs are fed as usual and periodically observing them. Animals recovered well, and scars heal quickly. Explicit expiration of the cerebrospinal fluid or the occurrence of epilepsy is not detected. Dogs eat and drink as usual, their activity in normal without any apparent violations of the functions of the movement, and they live to average life expectancy.

Eighteen months after transplantation, dogs, kill, and take the sample on the operating field, which includes the artificial Dura mater of the surrounding Dura, and part of the surrounding brain tissue. If you examine the sample, shows that the connection between the artificial Dura mater and natural Dura mater dense and smooth, without clear boundaries, good zajivlenie, in addition, you can only see the thread. Own Dura does not show signs of redness, Gravois is iania or other reactions of rejection. The results of the monitoring show that the material of the implant has not yet decayed, and implantirovannomu portion inner surface of the soft meninges tissue somewhat sticks to the brain.

Example of experiment 3

The artificial Dura mater obtained from Example 3, is now used in the experiment conducted in the new Zealand rabbit.

Experimental animals reveal the skull and create damage to the Dura and brain tissue surgically. Then to repair the damage to the artificial Dura. After surgery, the rabbits fed as usual and periodically observing them. These animals are well restored. Eighteen months after transplantation of rabbit kill, and take the sample on the operating field. The sample includes artificial Dura mater of the surrounding Dura, and part of the surrounding brain tissue. If you look closely at the sample, it is clear that epithelial cells cover the inner surface of the Dura mater; under the epithelium formed fibrous tissue, growing rapidly precursor cells of the fibroblast, the number of collagen fibers increases. All this leads to the formation of a new vascularized tissue is th, growth natural Dura, biodegradable material of the implant, reducing the total mass of the implant and the formation of large capillary networks. On the border between old and new fabrics reaction neutrophilic inflammation, limfozitah or any other cells not detected, thus not formed a protective shell. Spider shell, and brain tissue was normal.

Example of experiment 4

Dura obtained from Example 4, is now used in the experiment conducted on dogs, the same way as in the Example of experiment 2.

Fifteen months after transplantation dogs kill, and take the sample on the operating field. The sample includes artificial Dura mater of the surrounding Dura, and part of the surrounding brain tissue. If you examine the sample, shows that the connection between the artificial Dura mater and natural Dura mater dense and smooth, without clear boundaries, fully zhivshie, and visible only to the thread. Natural Dura does not show reactions hyperemia, hemorrhage, or other reactions of rejection.

Example of experiment 5

Dura obtained from Example 5, is now used in the experiment conducted in new Zealand rabbits is E. As regenerative material is applied serial clinically acceptable product Dura animal.

The same way as in the Example of experiment 3. Fifteen months after transplantation rabbits kill and take the sample on the operating field. If you look closely at the sample, it is clear that epithelial cells cover the inner surface of the Dura mater; the epithelium is formed fibrous tissue, growing rapidly precursor cells of fibroblast, and produced collagen fibers. All this leads to the formation of a new vascularized tissue growth natural Dura, biodegradable material of the implant, reducing the total mass of the implant and the formation of large capillary networks. On the border between old and new fabrics reaction neutrophilic inflammation, limfozitah or any other cells not detected, thus not formed a protective shell. Spider shell, and brain tissue was normal. The results of the monitoring show that the material of the implant has not yet decayed, and implantirovannomu portion inner surface of the soft meninges tissue somewhat sticks to the brain.

Example of experiment 6

Dura obtained from When the EPA 6, now used in the experiment conducted on dogs, the same way as in the Example of experiment 2.

Twelve months after transplantation dogs kill and take the sample on the operating field. The sample includes artificial Dura mater of the surrounding Dura, and part of the surrounding brain tissue. If you examine the sample, shows that the connection between the artificial Dura mater and natural Dura mater dense and smooth, without clear boundaries, fully zhivshie, this is visible only to the thread. Natural Dura does not show reactions hyperemia, hemorrhage, or other reactions of rejection.

Example of experiment 7

Dura, obtained from Example 7, is now used in the experiment conducted in the new Zealand rabbit.

The method is the same as in the Example of experiment 3. Twelve months after transplantation of rabbit kill, and take the sample on the operating field. If you look closely at the sample, it is clear that epithelial cells cover the inner surface of the Dura mater; the epithelium is formed fibrous tissue, growing rapidly precursor cells of fibroblast, and increases the amount of collagen fibers. All this leads to formirovanie new vascularized tissue, growth natural Dura, biodegradable material of the implant, reducing the total mass of the implant and the formation of large capillary networks. On the border between old and new fabrics reaction neutrophilic inflammation, limfozitah or any of the other cells is not detected, and the protective sheath is not formed. Spider shell, and brain tissue was normal.

Regardless presents and the above-described embodiments of the present invention, specialist, skilled in the art may, without departing from the principles and theory, to change, modify or replace the data with embodiments of the present invention as described in the scope of the invention and the claims.

1. The artificial Dura mater, made of electroplating layers using technology electroprecizia, with the above electroplating layer consists of at least a hydrophobic electroplating layer, which is made of one or more hydrophobic polymer selected from polylactic acid and polycaprolactone.

2. Shell according to claim 1, characterized in that it comprises at least a hydrophilic electroplating layer located on the specified hydrophobic elektroprijenos layer.

3. Shell according to claim 2, characterized in that videopom is mentioned hydrophilic electroplating layer manufactured by the method, includes electroprecizia using one or more hydrophobic polymers selected from the group consisting of chondroitin sulfate, heparin, agar, glucan, algina, modified cellulose, sodium alginate, starch, cellulose, gelatin, fibrinogen, silk protein, polymer-peptide mimic of elastin, collagen, chitosan, modified chitosan, a hydrophilic polyurethane, polyethylene glycol, polymethylmethacrylate, hydroxybutyrate co-hydroxyvalerate, Rwnh (polyhydroxybutyrate-with-hydroxyhexanoate), polyvinyl alcohol, polylactide and mixtures thereof.

4. Shell according to claim 2, characterized in that it includes a transition layer located between the hydrophobic and hydrophilic electroparadise layers.

5. Shell according to claim 4, characterized in that above the transition layer is made by a method comprising electroprecizia using one or more hydrophobic polymers, while above the transition layer has a hydrophilic nature, which gradually increases from the side closest to the above-mentioned hydrophobic electroprecizia layer to the side closest to the above-mentioned hydrophilic electroprecizia layer.

6. The sheath according to any one of p or 5, characterized in that the above-mentioned polymers are mixed with the cytokine and/or medicine.

7. About the points according to any one of claims 1 or 6, characterized in that it further comprises a cytokine and/or medicine, which stick to the aforementioned hydrophobic electroprecizia layer and/or the above-mentioned hydrophilic electroprecizia layer.

8. Shell according to claim 7, characterized in that the above-mentioned cytokine selected from the group consisting of an interleukin, colony stimulating factor, tumor necrosis factor, platelet-derived growth factor, basic fibroblast growth factor and combinations thereof.

9. Shell according to claim 7, characterized in that the above-mentioned drug is one or more selected from the group consisting of antibiotics, hemostatic means, antiadhesive agents and anticancer drugs.

10. Shell according to claim 7, characterized in that the above-mentioned cytokine and/or medicine are introduced into the hydrogel.

11. Shell according to claim 7, characterized in that the above-mentioned hydrogel consists of one or more substances selected from the group consisting of a polysaccharide polymer, polypeptide polymer and synthetic hydrophilic high-molecular polymer.

12. The sheath according to any one of claims 1, 2 or 4, characterized in that the above-mentioned hydrophobic electroplating layer consists of fibers with a diameter of 50-1000 nm.

13. Shell 12, characterized in that above UTY hydrophobic electroplating layer consists of long smaller than 3 microns.

14. Shell according to claim 2 or 4, characterized in that the above-mentioned hydrophilic electroplating layer consists of fibers with a diameter of 5-200 μm and a pore size of 20-200 microns.

15. A method of manufacturing an artificial Dura mater comprising the following steps:
a) dissolving a hydrophobic polymer in a solvent in order to obtain a hydrophobic solution for electroprecizia, with the above-mentioned hydrophobic polymer selected from the group consisting of hydrophobic aliphatic polyester, a polyester-ether copolymer, polyarteritis, polyurethane, polyanhydride, polyphosphazene, polyaminoamide, copolymers and mixtures thereof,
b) the manufacture by electroprecizia hydrophobic electroplating layer film of the above-mentioned hydrophobic solution for electroprecizia with the manufacturer, so the above artificial Dura mater.

16. The method according to item 15, characterized in that the above-mentioned hydrophobic aliphatic polyester is at least one substance selected from the group consisting of polylactic acid, polyglycolide, polycaprolactone and polyhydroxybutyrate.

17. The method according to item 15, characterized in that the above-mentioned polyester-ether copolymer is at least one substance selected from the group consisting of on the of dioxanone, copolymer glycol/lactic acid, and copolymer of polybutylene terephthalate/glycol.

18. The method according to item 15, characterized in that the above-mentioned hydrophobic electroplating layer consists of fibers with a diameter of 50-1000 nm.

19. The method according to p, characterized in that the above-mentioned hydrophobic electroplating layer consists of pores smaller than 3 microns.

20. The method according to item 15, wherein in step (b) above, electroprecizia performed using microfranchises pump performance 0.1-5.0 ml/h, high voltage generator, operating with a voltage 5-40 kV, and the distance delivery 5,0-30,0 see

21. The method according to item 15, characterized in that it further includes creating a hydrophilic electroplating layer on the above-mentioned hydrophobic elektroprijenos layer, which includes the following steps:
a') dissolving the hydrophilic polymer in the solvent in order to obtain a hydrophilic solution for electroprecizia, with the above-mentioned hydrophilic polymer selected from the group consisting of chondroitin sulfate, heparin, agar, glucan, algina, modified cellulose, sodium alginate, starch, cellulose, gelatin, fibrinogen, silk protein, polymer-peptide mimic of elastin, collagen, chitosan, modified chitosan, a hydrophilic polyurethane, polyethylene is glycole, polymethylmethacrylate, hydroxybutyrate co-hydroxyvalerate, Rwnh (polyhydroxybutyrate-with-hydroxyhexanoate), polyvinyl alcohol, polylactide and their mixtures;
b') placement by electroprecizia the above-mentioned hydrophilic solution for electroprecizia on the above-mentioned hydrophobic elektroprijenos layer for forming the above-mentioned hydrophilic electroplating layer.

22. The method according to item 21, wherein the above-mentioned hydrophilic electroplating layer consists of fibers with a diameter of 5-200 μm and pores whose size 20-200 microns.

23. The method according to item 21, wherein the step (b') above electroprecizia do microfranchises pump performance 0.1 to 20.0 ml/h, high voltage generator, operating with a voltage 10-45 kV, and the distance delivery 5,0-30,0 see

24. The method according to item 15 or 21, characterized in that the above-mentioned solvent selected from the group consisting of methanoic acid, acetic acid, acetone, dimethylformamide, dimethylacetamide, dihydrofuran, dimethyl sulfoxide, hexafluoroisopropyl alcohol, triptoreline alcohol, dichloromethane, trichloromethane, methyl alcohol, ethyl alcohol, dioxane, triptorelin and mixtures thereof.

25. The method according to item 21, characterized in that it includes in addition to manufacturing the above is hydrophilinae electroplating layer the creation of a transitional layer by electroprecizia relevant electroplating solutions consisting of one or more polymers between the above-mentioned hydrophilic and hydrophobic layers, while above the transition layer has a hydrophilic nature, which gradually increases from the side closest to the above-mentioned hydrophilic electroprecizia layer to the side closest to the above-mentioned hydrophobic electroprecizia layer.

26. The method according to any of p, 21 or 25, characterized in that the above-mentioned polymer solution to electroprecizia also consists of a cytokine and/or drugs.

27. The method according to item 15 or 21, characterized in that it further includes the distribution by using beobachte cytokine and/or drugs on the above-mentioned hydrophobic elektroprijenos layer and/or the above-mentioned hydrophilic elektroprijenos layer.

28. The method according to item 27, characterized in that the above-mentioned beobachte includes the following steps:
a) mixing a solution of the hydrogel with the above cytokine and/or medicine to create a solution; and
b) printing the above-mentioned solution of the above-mentioned hydrophobic and/or hydrophilic electroplating layers using technology beobachte.

29. The method according to p, characterized in that it further includes pre-processing the above-mentioned hydrophobic and/or hydrophilic electroplate the th layer solution consisting of a cross-linking agent, to beobachte.

30. The method according to p, characterized in that the above-mentioned solution of the hydrogel consists of a polysaccharide polymer, polypeptide polymer, a synthetic hydrophilic high-molecular polymer or mixtures thereof.



 

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48 cl, 18 ex, 1 tbl, 9 dwg

FIELD: textiles, paper.

SUBSTANCE: invention relates to hollow fiber comprising a cavity located in the center of the hollow fiber, macropores located near the cavity, and mesopores and picopores located near macropores, and picopores are connected to each other in three dimensional space to form a three-dimensional net structure, and hollow fiber comprises polymer derived from polyimide, and polyimide comprises repeating structural unit derived from aromatic diamine comprising at least one functional group comprising OH, SH or NH2, which is in the ortho position in relation to the amino group, and dianhydride. Also the spinning solution composition for obtaining the above mentioned hollow fiber and method of producing the hollow fiber is described.

EFFECT: creation of hollow fibers having improved gas permeability and selectivity in relation to gases, creation of new membranes for separation of gases based on these materials.

48 cl, 18 ex, 1 tbl, 9 dwg

FIELD: textiles, paper.

SUBSTANCE: hollow fiber comprises a polymer derived from a polyimide precursor, moulded from a spin dope containing polyamine acid, and the hollow fiber has a cavity located in the center of the hollow fiber; macropores located around the cavity, and the mesopores and pikopores located around macropores where the pikopores are three-dimensionally interconnected to form a three-dimensional network structure. Polyamine acid contains a repeating unit derived from an aromatic diamine, comprising at least one functional group, which is in the ortho position with respect to the amino group and the dianhydride.

EFFECT: obtaining of hollow fiber with high permeability and good selectivity for the manufacture of membranes for gas separation.

44 cl, 1 tbl, 8 dwg, 17 ex

FIELD: textiles, paper.

SUBSTANCE: hollow fiber comprises a polymer derived from a polyimide precursor, moulded from a spin dope containing polyamine acid, and the hollow fiber has a cavity located in the center of the hollow fiber; macropores located around the cavity, and the mesopores and pikopores located around macropores where the pikopores are three-dimensionally interconnected to form a three-dimensional network structure. Polyamine acid contains a repeating unit derived from an aromatic diamine, comprising at least one functional group, which is in the ortho position with respect to the amino group and the dianhydride.

EFFECT: obtaining of hollow fiber with high permeability and good selectivity for the manufacture of membranes for gas separation.

44 cl, 1 tbl, 8 dwg, 17 ex

FIELD: machine building.

SUBSTANCE: spinneret has multiple holes while holes ends wherefrom filaments come out make spinneret hole outlet plane. Note here that bundle of filaments under spinneret is, first, cooled in first cooling zone by, at least, one transverses cooling gas flow and its suction device arranged opposite blower for said transverse cooling. Bundle of filaments is cooled in second cooling zone by drawing cooling gaseous medium located nearby said zone. In first cooling zone, at least one transverse blowing is performed at blowing section AC of length L. Said section AC has first start A facing the spinneret holes and bottom end C directed from said holes. Besides, said blowing section AC is located opposite section BD. The latter has start B facing spinneret holes and end D directed from said holes. Section (plane) AB between A and B extends parallel with surface of spinneret hole outlets while section BD features length L. Note here that section BD is divided into suction section BX of length LBX and section XD of length LXD. Note here that LBX:LXD ratio varies from 0.15:1 to 0.5:1.

EFFECT: higher quality of fibers.

29 cl, 1 dwg, 6 tbl, 4 ex

FIELD: process engineering.

SUBSTANCE: invention relates to production of strands of composite material by combining continuous glass fibers with continuous fibers of organic high-shrinkage material used as reinforcing material. Thermoplastic fibers, stretched and heated to softening point, are thrown on revolving drum 17 at the rate exceeding operating rpm of said drum. Web 10 of said thermoplastic fibers are mixed on drum surface with glass fiber bundle or web 2 to make composite material strand. Said drum 17 has multiple holes and element 19 dividing drum inside into, at least, two compartments, one with rarefaction to keep thermoplastic fibers in initial crimp state and another one with increased pressure to separated web from drum surface. Produced strand features uniform distribution of fibers and stable properties.

EFFECT: composite material with liner glass fibers and crimped thermoplastic fibers.

8 cl, 2 dwg

FIELD: polymer chemistry.

SUBSTANCE: invention refers to the devices for thread cooling during formation of thermoplastic materials for manufacturing of monofiber thread of fleece or fiber out of polymer materials, i.e. polypropylene. The device includes tank (1) made with possibility of running water supply and elements (2) of thread direction with cuts (3) for thread placements. The elements (2) of thread direction are made of elastic hygroscopic material and are established with possibility of filling the material with water from the tank (1) for thread cooling. The cuts (3) for thread placement are made as cuts in elastic hygroscopic material.

EFFECT: decrease of defects due to reduced probability of thread tearing during cooling with decreased size of cooling unit.

6 cl, 2 dwg

FIELD: medicine.

SUBSTANCE: invention refers to medicine, particularly to ophthalmic and maxillofacial surgery, and aims at repairing post-traumatic defects and deformations of the eye-pit bottom and walls. What is described is an implant in the form of a solid perforated plate which is formed by photocuring of a light curing composition; when heated the implant (a cure temperature 70-90°C) keeps the shape after self-cooling that provides high strength and biocompatible properties of the material. The cure temperature of the material is much higher than a temperature of a human body that ensures maintaining the physical and mechanical properties of the implant inserted in the human body, namely the material remains strong, when fixed it shows no cutting and breaking. Before the implantation, the plate is heated to the required temperature and bent so that it is congruently repeats the eye-pit shape in a place of the defect, overlaps the defect and supports the eye in the right anatomical position.

EFFECT: reducing the likelihood of graft rejection and reducing a quantity of various complications by improving the biocompatible properties of the material.

1 tbl, 5 ex

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine. In a method for making an antimicrobial silver-containing endoprosthesis according to the 1 version, a mesh material is made of synthetic polymer fibres with a silver-containing composition in a solution, dried; the endoprosthesis made of polyvinylidene fluoride monofilaments of the diameter of 0.09-0.15 mm in the form of a form-stable combined weaved knitted cloth at surface density of the endoprosthesis 80-200 g/m2, processed for 2-4 hours in 3-15% silver nitrate solution in dimethylsulphoxide, dried in air for 17-20 hours, processed again, dried, additionally processed in the composition consisting of 4-8 wt % of aqueous sodium hydroxide, 6-10 wt % of aqueous ammonium and 0.3-0.7 wt % of aqueous glucose in proportions 100:4:4, at temperature 20-25°C, and then washed in water, and dried. According to the 2 version, the endoprosthesis made of polypropylene monofilaments of the diameter of 0.07-0.15 mm, at surface density 20-120 g/m2, processed in 5-15% silver nitrate solution in dimethylsulphoxide, dried for 5-8 hours, processed again, dried, processed in the composition (as provided by the first version) in proportions 100:7:9 at temperature 20-25°C, and then washed in water, and dried.

EFFECT: group of inventions provides prolonged antimicrobial action of the endoprosthesis.

2 cl, 2 tbl, 3 dwg

FIELD: medicine.

SUBSTANCE: invention refers to medicine, particularly traumatology and orthopedics, and can find application in treating false joints of long bones. What is described is a method for preparing a non-toxic porous implant of polylactic acid with controlled pore size for building of long bone defects involving melting the polylactic acid granules in a melting pot immersed in thermally stable oil with porogen presented by sodium chloride crystals 100-250 nm to be washed out by aqueous solutions of antiseptics. The implant is prepared with no toxic solvents added and has a pre-set pore diameter.

EFFECT: improved efficiency of the method.

FIELD: chemistry.

SUBSTANCE: invention relates to a method of producing composite material from titanium nickelide-based alloys. The disclosed method involves process connection of a basic semi-finished product and porous components via self-propagating high-temperature synthesis, wherein titanium nickelide is additionally introduced into the structure of the composite material on selected areas of the semi-finished product. Titanium nickelide is a powder with the following grain-size distribution: 50-100 mcm - 60 wt %, 100-150 mcm - 40 wt %, and is introduced into said structure by sintering at 1260-1280°C for 1-5 minutes.

EFFECT: widening the pore size interval towards small values.

4 dwg, 1 ex

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

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine, and can be used for production of transplantable tissues. A method for cell-free organic tissue preparation for living cell reimplantation involves cell-free tissue preparation on a substantially flat surface and creation of a number of holes on the surface, spaced along the whole surface mentioned above and arranged so that they penetrate deep down at least a portion of thickness of said tissue with the holes designed for keeping the reimplanted living cells. Said number of the holes is created by means of one or more metal needles connected to a power supply which on each needle point induces current flow of such intensity and of such waveform to provide adequate energy for destruction of molecular couplings comprising organic tissue near to the needle point mentioned above. Each hole is formed by current flow and is great enough that the needle point mentioned above could penetrate into a space formed by opening of the molecular couplings. The group of inventions also refers to cell-free organic tissue for living cell reimplantation produced by said method.

EFFECT: group of inventions enables reducing time of producing transplantation tissue and provides living cell penetration along the whole thickness of cell-free tissue.

24 cl, 4 dwg

FIELD: medicine.

SUBSTANCE: invention refers to medicine and concerns composites for waxed reconstruction of the injured bone tissues. High-porous elastic chitosan-gelatin matrixes of porosity 90 % or more consist of chitosan and contain gelatin up to 60 wt % and sodium lauryl sulphate up to 0.2-0.4 wt %. The porous structure is produced by introducing the additives, freezing and sublimation drying.

EFFECT: due to elasticity and high porosity, said sponges fill bone defects with a minimum clearance that promotes the uniform formation of bone tissue throughout the defect; high solubility of matrixes provides fast bone tissue genesis.

1 tbl, 1 ex

FIELD: medicine.

SUBSTANCE: invention relates to field of medicine and deals with composite materials for plastic reconstruction of damaged bone tissues. Obtained is porous composite chitosan-gelatin sponge containing octacalcium phosphate in form of powder or granules. Introduction of gelatin increases sponge plasticity, which makes it possible to fill in bone defects of various form and size, as well as increases sponge solubility.

EFFECT: octacalcium phosphate contained in sponge demonstrates osteoinductive properties, which in combination with chitosan creates favourable conditions for formation of natural human bone tissue.

1 tbl, 9 ex

FIELD: chemistry.

SUBSTANCE: porous matrix based on biocompatible polymer or polymer mix for tissue engineering is obtained by compression of polymer and sodium chloride particle mix with defined particle size, and further removal of sodium chloride by dissolution. Porosity grade of matrix lies within 93 to 98%, its pores fall into different sizes, with definite pore distribution by size within certain limits.

EFFECT: obtained matrices are free-shaped yet pertain stability and hardness characteristics required to withstand surgical implantation methods and counteract mechanical forces applied at the implantation point.

40 cl, 2 tbl, 8 ex

FIELD: medicine.

SUBSTANCE: invention concerns medicine, namely to reconstructive surgery, traumatology-orthopedy, maxillofacial surgery, stomatology and can be applied at osteo-plastic operations. For delivery of medical products immediately in a zone of defect and their prolonged influence in the centre of a lesion medicinal preparations are dissolved in a normal saline solution in a dose providing local effect, collagen-containing component is added to a solution in the ratio 9-20 g: 100 ml of a solution also admix with the carrier from dispersed allotransplants in the ratio of 1:1-3.

EFFECT: method allows lowering a dose necessary for reception of medical effect in 10 times, and also allows accelerating reparative processes in a defect zone.

3 dwg

FIELD: chemistry.

SUBSTANCE: claimed invention relates to ophthalmological device, method of its obtaining. Device contains antimicrobial particles of metal salts, which have size less than approximately 200 nm, dispersed throughout polymer mass. Device ensures at least 0.5 log reduction of at least one of Pseudomonas aeruginosa and S.aureus, and opacity value constituting less than 100%, with 70 micron thickness, in comparison with CSI lens.

EFFECT: invention possesses high antibacterial activity 3 independent claims, 34 dependent claims of invention formula.

17 tbl, 46 ex, 5 dwg

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