RU2568848C1 - Tubular implant of human and animal organs and method of obtaining thereof - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: described is tubular implant of human and animal organs, made from non-woven porous polymer material, formed from nano- and/or microfibers with diameter 50-8000 nm from aliphatic alcohol-soluble (co)polyamide, with internal tube diameter 0.2-150 mm, thickness of wall 0.05-5 mm, pore diameter 0.1-500 mcm. Described method of obtaining fibre, which consists in preparation of mould 3-40% solution of aliphatic alcohol-soluble (co)polymer in alcohol or in water-alcohol mixture with content of alcohol 40-99 vol % at temperature 20-100°C, which is filtered, de-aired, supplied through electrode-spinneret into electric field with strength E = 1.5×10⁴ - 8.0×10⁵ V/m onto rotating at rate 0.1-6000 rev/min cylindrical electrode with diameter 0.2-100.0 mm, with obtaining on electrode surface non-woven porous material, formed from nano- and microfibers, after which target tubular implant is taken off from electrode and dried.

EFFECT: tubular implant, bioinert, biocompatible, preserves strength and elasticity in water medium.

25 cl, 5 dwg, 73 ex

Description

Technical field

The invention relates to medical equipment, more specifically to tubular implants of non-woven porous materials based on aliphatic alcohol-soluble (co) polyamides and the technology for their preparation.

The claimed invention can be applied in medicine and veterinary medicine, specifically in the field of transplantation, to replace in the body the tubular organs, in particular blood vessels, as well as the trachea, esophagus, intestinal fragments, and ureters.

State of the art

The main requirements for the materials used in transplantology are, first of all, to ensure their bioinertness and biocompatibility. The most important factor is the lack of cytotoxicity of both the material itself and its biodegradation products. Implants should have a set of physicomechanical characteristics that guarantee the necessary level of strength and elasticity in an active biological medium under the action of hydrodynamic functional loads, as well as mechanical stresses arising from anastomization at the junction of the implant and the vessel.

Implants are known, which are bioinert, elastic, durable tubes made of synthetic polymeric materials: polytetrafluoroethylene (PTFE), polyester (PE), polyurethane (PU), polyethylene (PE), polypropylene (PP). Collagen and umbilical cord materials from humans and animals are also used to obtain a vascular implant.

The successful functioning of the implant for a long time ensures the absence of an autoimmune reaction of the body to the implant and the possibility of formation of tissues identical to the tissues of the recipient based on the polymer matrix. The process of tissue formation of an animal or human involves adhesion on the implant surface of somatic cells, their differentiation and proliferation. Therefore, the walls of the tubular implant must have a porous structure with a high specific surface area, ensuring cell adhesion, as well as the transport of amino acids and ions.

There are a number of limitations to the materials used as blood vessel implants. Thus, a vascular implant must have barrier properties for blood and its elements under conditions of increased hydrodynamic pressure. It has been established that the barrier properties of currently known polymer implants increase 20 or more days after implantation in parallel with the fouling of the polymer matrix by cells, which is a significant drawback. For example, there is a method of increasing the barrier properties of vascular implants [US patent No. 4743250]. Vascular implants in the form of tubes of woven, woven or knitted material based on polyethylene terephthalate (PET) were treated with a stream of water under pressure. When tested in vivo as a dog’s artery, cessation of blood leakage through the walls of the tubular implant was observed on day 21.

US Pat. No. 5,688,836 describes a method for producing porous tubes with satisfactory permeability based on PTFE. To create a porous structure, fusible resins with a melting point lower than the melting point of the base polymer were added to the PTFE powder with a particle size of 0.1-0.5 μm. As additives, copolymers of tetrafluoroethylene with hexafluoropropylene, polyether ether ketone, and perfluoroalkyl vinyl ether were chosen. After extrusion of the polymer through the die, the tubes were subjected to drawing and subsequent heat setting. The tubes with a diameter of 5 mm had porous walls 1 mm thick. The cessation of blood leakage was observed after 20 days.

US Pat. No. 5,298,276 describes tubes made from PET, PP, cellulose or PU fibers and treated with a solution of polysiloxane, PU or their copolymers. The proposed method allowed to significantly reduce the permeability of tubular samples, however, a complete cessation of blood leakage was observed after 20 days.

Another important limitation when using tubular materials in vivo as vascular implants is to ensure the laminar flow of blood, the absence of turbulence in a pulsating mode. In vivo in a healthy organism with a laminar flow, which is characterized by a parabolic distribution of velocities in the cross section of the vessel, the likelihood of thrombosis is sharply reduced. For implants, this is a problem.

US Pat. No. 8,133,277 describes the design of PTFE-based tubes for passing human or animal blood, the surface of which has protrusions of 10-100 microns, increasing the laminarity of the blood flow.

To increase the laminarity of the blood flow and at the same time reduce its leakage through the walls of the implant, a method of growing tissues identical to natural on the tube surface has recently been used. Implants based on PTFE, PET, polyurethane, silicone rubber are described in US patent No. 6733747. It is stated that on the outer surface of the porous tubular implant, natural adhesion and cell proliferation are observed, while on the inner surface directly in contact with the blood stream, cell adhesion does not occur. To increase the adhesion ability, nucleic acids, proteins, and also cell growth stimulators were applied to the inner surface of the tubular sample. The walls of the tubes had pores from 0.1 to 500 μm.

Vascular implants based on porous PTFE are described in US Pat. No. 6,053,939. To increase adhesion to endothelial cells, the surfaces of the tubes were subjected to a treatment that increased their hydrophilicity. For this, the tube was first placed in a solution of lithium methylene and hexamethylphosphoramide in ethyl ether in an atmosphere of inert argon gas, then in a solution of acrylic acid. The inner surface of the tube thus modified contains hydrophilic groups to a depth of 5 to 96% with respect to the thickness of the tube. The inner surface was also treated with drugs that prevent the formation of blood clots, such as heparin. In order to increase cell adhesion, fibroblast growth stimulants were added to the inner surface of the tubular sample. The known method is technologically complex.

To reduce thrombosis, vascular implants based on porous PTFE were treated with polyurethane and polyamino acid, after which growth stimulants were applied to the implant surface, which promote cell proliferation and directed differentiation, and the formation of an endothelial cell layer on the inner tube surface [US Application No. 2008/0281408]. A known method of producing tubular samples of PTFE containing cermet [application US No. 2011/0014459]. However, the known patents do not provide specific data on the reduction or absence of thrombosis.

All of the above analogues do not have high porosity.

A general approach is known for producing polymer materials with high porosity. It consists in the application of the electroforming method, which consists in feeding a solution or polymer melt through a die plate into a high voltage electric field. When the polymer is deposited on the receiving electrode, a non-woven material is formed, consisting of fibers with a diameter of 50-1000 nm, the interfiber space is a pore of various sizes [US patent No. 7276271]. As a receiving electrode, a rotating metal cylinder is used, equipped with a device for creating sections with a densified structure of the tube walls.

Tubular samples based on nanofibers, obtained by electrospinning of biodegradable (collagen, elastin, fibrinogen, fibrin) and non-biodegradable (PET, PU, polyglycolic acid, PE, polyamides, PTFE and mixtures thereof) polymers are described in US application No. 2006/0129234. As the solvents used to obtain the solution or liquid composition for the electroformation of nanofibers, hexafluoroisopropanol, N, N-dimethylformamide, acetone, acetonitrile are used, which are highly toxic. To increase the biological activity of implants, cell growth stimulants — saccharides and polysaccharides — are introduced into the material. The introduction of growth stimulators of endothelial cells, epithelium, as well as fibroblasts into the structure of tubular porous vascular implants from porous PTFE is also described in US application No. 2011/0178592.

Closest to the claimed invention are porous tubes for implantation from PU and the method for their preparation described in US application No. 2007/7244272 (prototype analogue). In the known method, the rotation speed of the cylindrical electrode is 0.5-5 rad / s (4.7-47 rpm), the voltage is 50 kV, the field strength is 2 × 10 ⁵ V / m.

The known porous tube has an inner diameter of 6 mm. The walls of the tube consist of nanofibers obtained by the method of electroforming a solution of PU or its copolymers on a cylindrical electrode. As solvents, a mixture of toxic N, N-dimethylformamide and toluene was used, which significantly complicates the production technology, carries a large environmental burden. Traces of these solvents cannot be completely removed from the bulk material. Polycarbonate was used to increase cell adhesion. The strength of the implant in the dry state is σ = 3-6 MPa, information about the strength in aqueous media is not given.

The known tube has a structure characterized by layers with predetermined porosity and fiber arrangement. In the inner and outer layers of the fiber are oriented mainly perpendicular to the axis of the tube, in the intermediate layer the fibers are randomly located. Known tube has a high-quality porous structure. Nevertheless, it is necessary to introduce various drugs into the layers that promote the adhesion and proliferation of endothelial cells. A known tubular implant becomes impervious to blood after 20 days. The description of the invention does not indicate the behavior of the tube in relation to thrombosis. In the places of the anastamosis, scars are observed.

Analysis of known analogues indicates that the main biocompatible polymers for vascular implants are PTFE, PETF, PP, PU or their compositions. The listed polymers are hydrophobic, the adhesion of other macromolecules, as well as cell cultures on their surface is extremely difficult. This is a defect that prevents natural blood flow. The above hydrophilic polymers (polyvinyl alcohol, cellulose derivatives, polyethylene oxide) potentially having better adhesion, which process the inner surface of known implants, are still not used as independent implants, because do not have the necessary strength characteristics in aqueous media.

The polymer tubular prosthesis should be as inert as possible with respect to the body as a whole, but especially to the blood flow passing inside, so as not to slow down and stop the blood flow, i.e. thrombosis. In the body, this function is performed by the endothelium, lining all blood vessels and the heart from the inside and preventing the "sticking" of blood to the vessel. Hydrophobic fluoroplasts are the most inert, however, due to this, a disadvantage arises - the vessel does not grow well along the edges of the implant and thrombosis occurs in this place, even if the surface of the implant is treated with heparin.

To obtain a high-quality porous structure of hydrophobic polymers that promotes cell adhesion, organic solvents are used by electroforming nanofibers from polymer solutions, in some cases toxic solvents, traces of which in the resulting material adversely affect cellular processes. Tissue fouling occurs in 20 or more days, which is critical for the body. The adhesion of endothelial cells, their fixation on the inner surface of the implant, the formation of a layer of endothelial cells identical to the natural one, is also complicated by large hydrodynamic loads acting on the inner surface of the tube during blood flow in a pulsating mode. To solve these problems, surface modification is used with other polymers that increase adhesion, the introduction of various drugs and cell growth stimulants into it.

It should be noted that the well-known approaches to obtaining tubular implants are reduced, with rare exceptions, to the improvement of one or two necessary parameters, which, of course, is explained by the complexity of the object.

Thus, the creation of a polymer tubular implant remains an urgent problem.

Disclosure of invention

The objective of the invention is the creation of a universal implant of tubular organs, satisfying all the basic requirements for implants of this purpose, without using additional stimulating reagents. The material created must be bioinert, biocompatible, maintain strength and elasticity in the aquatic environment. The material should not contain traces of chemicals with potential cytotoxicity, have high adhesion to endothelial cells. The wall structure of the tubular samples should provide the metabolic processes necessary for the proliferation and differentiation of cells, i.e. implant fouling with tissue in less than 20 days. In the case of a vascular implant, it is necessary to ensure the laminarity of the blood flow and the barrier properties that prevent the leakage of blood and its shaped particles.

This problem is solved by the claimed group of two inventions - a tubular implant of human and animal organs and the method of its preparation.

The inventive tubular implant is characterized by the following set of essential features:

1. A tubular implant for replacing tubular organs of a human or animal made of non-woven porous polymer material formed from nano and / or microfibers with a diameter of 50-8000 nm from an aliphatic alcohol-soluble (co) polyamide which is a polycondensation product in a melt of ε-caprolactam, salt hexamethylenediaminadipinate or salts of hexamethylene diaminesebacinate or a mixture thereof, with an inner tube diameter of 0.2-40 mm, a wall thickness of 0.05-5 mm, a pore diameter of 0.1-500 microns.

2. The tubular implant according to claim 1, characterized in that the fibers of aliphatic alcohol-soluble (co) polyamide additionally contain 0.1-50 wt. % of the regulators of their water resistance, porosity and prolonged release of drugs in the form of water-soluble polymers from the series: N, N-polyvinylpyrrolidone, polyvinyl alcohol, polyethylene oxide, polysaccharides, peptides, or in the form of alcohol-soluble polymers from the series: polyvinyl acetate, polyvinyl butyral, polymers, polymethylmethyl series containing water-soluble drugs.

3. A tubular implant according to claim 1, characterized in that the non-woven material additionally contains 0.1-50 wt. % of the regulators of its water resistance, porosity and prolonged release of drugs in the form of nano- and / or microfibers from water-soluble polymers from the series: N, N-polyvinylpyrrolidone, polyvinyl alcohol, polyethylene oxide, cellulose derivatives, polysaccharides, peptides, or as alcohol-soluble polymers from the series: polyvinyl acetate, polyvinyl butyral, polymethyl methacrylate, or polymers of the indicated series containing water-soluble drugs.

4. The tubular implant according to claim 1, characterized in that the fibers of aliphatic alcohol-soluble (co) polyamide additionally contain 0.1-50 wt. % bioresorbable polymers from the series: polylactides, polyglycolides, caprolactone-based polymers, polyanhydrides, polyamines, polyetheramides, polyorthoesters, polydioxanones, polyacetals, polyketals, polycarbonates, polyphosphoric esters, polyesters, polybutylene terephosphonates, polybutylene terephosphonates, apple polyesters, polybutylene terephthalates, , poly (amino acids), N, N-polyvinylpyrrolidone, polyethylene glycol, cellulose derivatives, polysaccharides, chitin, chitosan, polygialuronic acids, polypeptides, their copolymers or mixtures of any leaving.

5. A tubular implant according to claim 1, characterized in that the non-woven material further comprises 0.1-50 wt. % nano- and / or microfibers from bioresorbable polymers from the series: polylactides, polyglycolides, caprolactone-based polymers, polyanhydrides, polyamines, polyetheramides, polyorthoesters, polydioxanones, polyacetals, polyketals, polycarbonates, polyphosphorophosphates, polyesters, polyesters, polyesters, polyesters, polyesters, polyesters, polysuccinates, poly (malic acid), poly (amino acids), N, N-polyvinylpyrrolidone, polyethylene glycol, cellulose derivatives, polysaccharides, chitin, chitosan, polygialuronic acids, polypeptides, their copolymer s or mixtures of arbitrary composition.

6. The tubular implant according to claim 1, characterized in that the non-woven material further comprises 0.1-50 wt. % hydrophobicity regulator, physicomechanical characteristics in the form of nano- and / or microfibers of hydrophobic polymers from the series: polyethylene, polypropylene, polyisobutylene, polyvinyl chloride, polystyrene, polyvinyl acetate, polymethyl methacrylate, polycarbonate, polyurethane, polyethylene terephthalate, polyethylene halide, polyvinylidene chloride, polycaprolactam.

7. The tubular implant according to claim 1, characterized in that it contains additional layer (s) of non-woven porous polymer material formed from nano- and / or microfibers of a bioresorbable and / or hydrophobic polymer.

8. A tubular implant according to claim 1, characterized in that the fibers are arranged in the nonwoven material in parallel, or perpendicular to the axis of the tube, or randomly or in layers with different types of orientation.

9. The tubular implant according to claim 1, characterized in that the composition of the fibers directly and / or non-woven material in the form of impregnation additionally includes anticoagulants, antibiotics, antiseptics, anti-inflammatory drugs, antioxidants, vitamins, sorbents, drugs that separately or together stimulate wound healing and cell growth.

10. The tubular implant according to claim 1, characterized in that the composition of the fibers directly and / or non-woven material in the form of impregnation additionally includes a plasticizer from the series: glycerin, sorbitol, mannitol, propylene glycol and other polyhydric alcohols or mixtures thereof of an arbitrary composition.

11. The tubular implant according to claim 1, characterized in that the tube is perforated with openings with a diameter of 20 μm to 3 mm at the locations of the supposed branches of the vessels and the openings themselves are filled with non-woven porous polymer material formed from nano- and / or microfibres of a bioresorbable polymer, or the tube is coated an additional layer (s) of non-woven porous polymer material formed from nano- and / or microfibers of a bioresorbable polymer.

Lining (patches) for tubular organs can be cut from a tubular implant.

The set of essential features of the claimed tubular implant provides a technical result - the maximum approximation in properties to the tubular organs of a person and an animal.

Obtained tubular implants from a biocompatible hydrophilic polymer, the walls of which are characterized by a developed porous structure. Implants have good strength characteristics in aqueous media - at or even above a dry implant. The combination of the chemical structure of the polymer, the relief of the inner surface of the tube and porosity contribute to the effective adhesion of cells, their proliferation and the formation of tissue identical to the tissue of the recipient's organ (on average, for 7 days); a scar does not form at the junction with a natural vessel. The barrier properties and laminarity of the blood flow in the bed are observed immediately after suturing of the prosthesis and improve within 7 days.

The inventive tubular implant differs from the known prototype implant primarily in that it is made not of hydrophobic, but of hydrophilic alcohol-soluble aliphatic (co) polyamides. Their chemical structure and the presence of pores of a given size promotes the formation of tissues identical to recipient tissues, without the use of additional treatments with hydrophilic surface polymers and the mandatory introduction of drugs and cell growth stimulators into the porous structure. The declared interval parameters: the diameter of the nano and microfibers from which the nonwoven material of the implant is formed (50-8000 nm), the inner diameter of the tube (0.2-40 mm), the wall thickness (0.05-5 mm), the pore diameter is ( 0.1-500 microns), wider than that of the analogue of the prototype. This allows the use of the claimed implants not only in vascular transplantology, but to replace other, larger tubular organs. The uniqueness of the claimed tubular implant is that the nature of the artificial polymer used was so organic for the inner diameter of the tube (0.2-40 mm), wall thickness (0.05-5 mm), pore diameter - (0.1-500 microns) , wider than that of the analog prototype. This allows the use of the claimed implants not only in vascular transplantology, but to replace other, larger tubular organs. The uniqueness of the claimed tubular implant lies in the fact that the nature of the artificial polymer used was so organic for the task that it ensured not only fouling of the implant with tissue identical to the recipient’s tissue, but also barrier properties and laminar flow of blood. A similar effect is not observed with known analogues.

The analysis of the prior art did not allow to find a solution that completely coincides in the totality of essential features with the claimed, which may indicate the novelty of the tubular implant of human and animal organs.

The prior art method developed by the authors of the claimed invention is a method for producing nanofibers from aliphatic copolyamides (RF patent No. 2447207). Known nanofibres obtained on a flat electrode, contain a copolymer of polyhexamethylene adipinamide and polyhexamethylene sebacinamide and have a diameter of 50-4500 nm, water resistant. The resulting material is loose, unstable, the number and size of pores are uncontrolled. It has been suggested that the fibers can form a material with high porosity, vapor and water permeability, high hydrophilicity, and bioinertness. It is also assumed that the material can be used for the manufacture of wound dressings, filters for cleaning liquid and gaseous media, matrices for the proliferation of stem cells. In the patent description there is no specific information about the receipt and characteristics of these materials from fibers and evidence of their possible use.

Known fibers do not discredit the novelty of the claimed invention, because, firstly, other copolymers based on ε-caprolactam were used to obtain the claimed implant, and secondly, tubular samples and their ability to adhere and proliferate endothelial cells in a stream are not described blood, use as an implant of blood vessels. Fibers obtained on a flat electrode cannot form a complex dense structure of non-woven material obtained on a rotating cylindrical electrode, showing the properties necessary for transplantation of tubular organs.

The prior art method developed by the inventors of the claimed invention for producing a porous film material based on an aliphatic copolyamide formed directly onto a flat substrate without the use of electroforming is known [RF patent No. 2504561]. The composition of the films includes a copolymer of polyhexamethylene adipinamide and polyhexamethylene sebacinamide or a copolymer of ε-caprolactam and polyhexamethylene adipinamide.

Known films do not discredit the novelty of the claimed invention, because do not have a nonwoven fabric structure, the pore diameter is limited to 5-10 microns, and they are designed to produce membranes for filtering liquids or gases. It has been suggested that the films are used as wound dressings, but there is no evidence or any characteristics in the description. It is technically difficult and therefore impractical to obtain a tubular implant from a known film and films.

The prior art also known previously developed by the authors of the claimed invention, nanofibers based on aliphatic copolyamide [nanofibres based on aliphatic copolyamide obtained by electrospinning / I.P. Dobrovolskaya, P.V. Popryadukhin, V.E. Yudin et al. // Journal of Applied Chemistry. - 2011. - T. 84, No. 10. - S. 1713-1716]. Known nanofibres obtained on a flat electrode, contain a copolymer of poly-ε-caprolactam and polyhexamethylene adipinamide and have a diameter of 200-4500 nm. The article is devoted to the study of the rheology and stability of molding aqueous-alcoholic solutions to obtain filters for fine purification of liquid and gaseous media. It was found that the fibers in some cases have defects — a drop-like shape, which leads to poor reproducibility of the results and a decrease in the strength of the filters. It has been suggested that fibers can be promising for medical use, in particular for the manufacture of wound dressings. The article lacks specific information about the receipt and characteristics of fiber materials and evidence of their possible use.

Known fibers do not discredit the novelty of the claimed invention, because, firstly, other copolymers were used to obtain the claimed implant, and secondly, tubular samples and their ability to adhere and proliferate endothelial cells in the blood stream are not described, used as implants of blood vessels and other tubular organs. As mentioned above, the fibers obtained on a flat electrode cannot form a complex dense and homogeneous structure of a nonwoven material obtained on a rotating cylindrical electrode and exhibiting the properties necessary for transplantation of tubular organs.

Only the combination of essential features of the claimed tubular implant - polymer composition, structural characteristics and design parameters, allows to achieve the specified technical result. The fact, the pore size, which does not directly follow from the use of a cylindrical electrode, turned out to be completely unexpected. None of the analogues succeeded directly from the polymer and even with additional surface treatment of the implant to obtain the result of the claimed invention. In known analogues, in contrast to the claimed invention, hydrophobic polymers are used. Until now, it was believed that an implant cannot be obtained from a hydrophilic polymer. This allows us to confirm the compliance of the claimed tubular implant with the eligibility condition "inventive step" ("non-obviousness").

The inventive method of obtaining an implant of human or animal organs has the following set of essential features:

1 (12). The method of producing a tubular implant for replacing the tubular organs of a human or animal according to claim 1, which consists in preparing a molding 3-40% solution of an aliphatic alcohol-soluble (co) polymer, which is a polycondensation product in the melt of ε-caprolactam, hexamethylene diaminadipinate salt or salts of hexamethylenediaminesebacinate or a mixture thereof, in alcohol or in a water-alcohol mixture with an alcohol content of 40-99 vol. % at a temperature of 20-100 ° C, filtered, dehydrated, fed through an electrode die into an electric field with a strength of E = 1.5 × 10 ⁴ - 8.0 × 10 ⁵ V / m per rotating at a speed of 0.1-6000 rpm a cylindrical electrode with a diameter of 0.2-40 mm, while on the surface of the electrode receive non-woven porous material formed from nano- and microfibers, the target tubular implant is removed from the electrode, dried.

2 (13). A method of producing a tubular implant according to claim 12, characterized in that ethyl, methyl, propyl alcohol or mixtures thereof of any composition are used as the alcohol.

3 (14). A method of obtaining a tubular implant according to claim 12, characterized in that the molding solution of an aliphatic alcohol-soluble (co) polyamide in alcohol or in a water-alcohol mixture further comprises 0.1-50 wt. % water-soluble polymers from the series: N, N-polyvinylpyrrolidone, polyvinyl alcohol, polyethylene oxide, polysaccharides, peptides, or in the form of alcohol-soluble polymers from the series: polyvinyl acetate, polyvinyl butyral, polymethylmethacrylate, or polymers from this series containing water-soluble drugs.

4 (15). A method of producing a tubular implant according to claim 12, characterized in that they use an additional (e) die-plate electrode (s) through which (e) simultaneously or fractionally alcohol or water-alcohol solutions of water-soluble polymers are continuously or fractionally fed to the cylindrical electrode from the series: N, N-polyvinylpyrrolidone, polyvinyl alcohol, polyethylene oxide, polysaccharides, peptides, or in the form of alcohol-soluble polymers from the series: polyvinyl acetate, polyvinyl butyral, polymethyl methacrylate, or polymers from the specified series, containing s water-soluble drug, the rate of 0.1-50 wt. % content of nano and / or microfibers of these polymers in the nonwoven material.

5 (16). A method of obtaining a tubular implant according to claim 12, characterized in that the molding solution of an aliphatic alcohol-soluble (co) polyamide in alcohol or in a water-alcohol mixture further comprises 0.1-50 wt. % bioresorbable polymers from the series: polylactides, polyglycolides, caprolactone-based polymers, polyanhydrides, polyamines, polyetheramides, polyorthoesters, polydioxanones, polyacetals, polyketals, polycarbonates, polyphosphoric esters, polyesters, polybutylene terephosphonates, polybutylene terephosphonates, apple polyesters, polybutylene terephthalates, , poly (amino acids), N, N-polyvinylpyrrolidone, polyethylene glycol, cellulose derivatives, polysaccharides, chitin, chitosan, polygialuronic acids, polypeptides, their copolymers or mixtures of any leaving.

6 (17). A method of producing a tubular implant according to claim 12, characterized in that they use an additional (e) die-plate electrode (s) through which (e) simultaneously or fractionally alcohol or water-alcohol solutions of bioresorbable polymers are continuously or fractionally fed to the cylindrical electrode from the series: polylactides, polyglycolides, caprolactone-based polymers, polyanhydrides, polyamines, polyetheramides, polyorthoesters, polydioxanones, polyacetals, polyketals, polycarbonates, polyphosphoric acid esters, polyesters, polybutylene terephth alate, polyorthocarbonates, polyphosphazenes, polysuccinates, poly (malic acid), poly (amino acids), N, N-polyvinylpyrrolidone, polyethylene glycol, cellulose derivatives, polysaccharides, chitin, chitosan, polygialuronic acids, polypeptides, their copolymers or mixtures of arbitrary composition, from random formulations, 0.1-50 wt. % content of nano and / or microfibers of these polymers in the nonwoven material.

7 (18). A method of producing a tubular implant according to claim 12, characterized in that they use an additional (e) die-plate electrode (s) through which (e) simultaneously with the main electrode, the solutions of hydrophobic polymers in aprotic solvents from the series are continuously or fractionally fed to the cylindrical electrode : polyethylenes, polypropylene, polyisobutylene, polyvinyl chloride, polystyrene, polyvinyl acetate, polymethyl methacrylate, polycarbonate, polyurethane, polyethylene terephthalate, halogen-containing (co) polyethylenes, polyvinylidene fluoride, polyvinylidene chloride, polycaprolactam, at the rate of 0.1-50 wt. % content of nano and / or microfibers of these polymers in the nonwoven material.

8 (19). A method of producing a tubular implant according to claim 12, characterized in that they use an additional (e) die-plate electrode (s) through which (e) solutions of bioresorbable and / or hydrophobic polymers are fed to the cylindrical electrode before or after the main die-electrode is operated. form additional layers of nonwoven material from nano- and / or microfibers of these polymers on the tubular implant.

9 (20). A method of producing a tubular implant according to claim 12, characterized in that a certain value of the rotation speed of the cylindrical electrode is selected from the interval 0.1-6000 rpm and it is kept constant during the process of forming the nonwoven material, while the rotation speed of the cylindrical electrode specified in the range of 0.1-499 rpm, a nonwoven material is obtained in which the fibers are arranged in parallel, in the range of 500-1199 rpm - randomly, in the range of 1200-6000 rpm - perpendicular to the axis of the tube.

10 (21). A method for producing a tubular implant according to claim 20, characterized in that the rotation speed of the cylindrical electrode is varied from an interval of 0.1-6000 rpm during the process of forming a nonwoven material at least two times, and a nonwoven material is obtained in which fibers with parallel, perpendicular or chaotic orientation with respect to the axis of the tube are arranged in layers.

11 (22). A method for producing a tubular implant according to claim 12, characterized in that anticoagulants, antibiotics, antiseptics, sorbents, drugs, separately and together stimulating wound healing and cell growth, are additionally introduced into the molding solution and / or non-woven material as an impregnation.

12 (23). A method of producing a tubular implant according to claim 12, characterized in that a plasticizer from the series: glycerin, sorbitol, mannitol, propylene glycol and other polyhydric alcohols or mixtures of any composition are additionally introduced into the molding solution and / or non-woven material as an impregnation.

13 (24). A method for producing a tubular implant according to claim 12, characterized in that the target tubular implant is perforated on the cylindrical electrode with holes of 20 μm to 3 mm in diameter at the places of the supposed branching of the vessels and, using an additional die-electrode, alcohol or water is continuously or fractionally supplied to the cylindrical electrode an alcohol solution of a bioresorbable polymer, as a result of which the holes are covered with non-woven material from nano- and / or microfibers or the tube is covered with an additional layer (s) of non-woven porous a polymeric material formed from the nano and / or bioresorbable polymer microfibers.

14 (25). A method of obtaining a tubular implant according to claim 12, characterized in that the target tubular implant is cut into pads of various configurations and sizes for tubular organs.

The set of essential features of the proposed method allows to achieve the following technical result: creating a material of better quality than that of analogues - an almost universal implant, simplifying and cheapening the method, improving its environmental friendliness.

The inventive method for producing a tubular implant of human and animal organs differs from the known prototype method in that they use a different polymer base — aliphatic alcohol-soluble (co) polymers, environmentally friendly alcohol or water-alcohol molding solutions, wider ranges of electric field strength, diameter and rotation speed cylindrical electrode. In the final material there are no traces of starting materials and solvents (traces of toxic solvents are present in the prototype method). The inventive method is simpler, because the resulting tubular implant can function without the fillers introduced in the prototype method. For the same reason, it has better reproducibility. As a result of the implementation of the proposed method received a universal implant of tubular organs.

The analysis of the prior art did not allow to find a solution that completely coincides in the totality of essential features with the claimed, which may indicate the novelty of the method.

As mentioned above, from the prior art known previously developed by the authors of the claimed invention, methods for producing nanofibers from aliphatic copolyamides [RF patent 2447207, article of the authors in ZhPKh. - 2011. - T. 84, No. 10. - S. 1713-1716] and a method for producing a porous film material [RF patent No. 2504561]. Known methods do not discredit the novelty of the claimed invention, because their technology does not contain electroforming of non-woven material on a cylindrical electrode, the composition of the polymers is different.

Only the set of essential features of the proposed method for producing a tubular implant of human and animal organs allows to achieve the specified technical result. The possibility of obtaining an implant from a hydrophilic polymer, films and fibers of which were still used as gas separation membranes, was completely unobvious. In known analogues, as mentioned above, the prior art method for producing nanofibers from aliphatic copolyamides [patent of the Russian Federation 2447207, article of the authors in ZhPKh, developed by the authors of the claimed invention, is known from the prior art. - 2011. - T. 84, No. 10. - S. 1713-1716] and a method for producing a porous film material [RF patent No. 2504561]. Known methods do not discredit the novelty of the claimed invention, because their technology does not contain electroforming of non-woven material on a cylindrical electrode, the composition of the polymers is different.

Only the set of essential features of the proposed method for producing a tubular implant of human and animal organs allows to achieve the specified technical result. The possibility of obtaining an implant from a hydrophilic polymer, films and fibers of which were still used as gas separation membranes, was completely unobvious. In known analogues implants made of hydrophobic polymers were used, the hydrophilicity of which was metered up using special reagents. Only the totality of operations of the proposed method allowed us to create an environmentally friendly simpler and cheaper technology for producing material that has all the necessary set of characteristics of the implant. This allows us to confirm the compliance of the proposed method with the eligibility condition "inventive step" ("non-obviousness").

Thus, the group of claimed inventions, in General, has novelty and non-obviousness.

The claimed group of inventions allows to solve the problem of obtaining a universal tubular implant of human or animal organs.

Graphic materials

In FIG. 1 shows a photograph of an implant of a tubular organ (vessel with a diameter of 1 mm) based on nanofibers from aliphatic copolyamide ε-caprolactam, hexamethylene diamine and hexamethylene diamine sebacinate (see example 1)

In FIG. Figure 2 shows a cross-section of an implant of a tubular organ based on nanofibres of aliphatic copolyamide at different magnifications (a, b), it can be seen that the implant wall has a porous fibrous structure (b). Microphotographs taken with a Carl Zeiss Supra-55 VP scanning electron microscope (Germany).

In FIG. Figure 3 shows photographs of the implantation of a tubular sample based on nanofibres from aliphatic copolyamide into the rat abdominal aorta using microsurgery methods.

In FIG. Figure 4 shows endothelial cells and the subendothelial layer on the inner surface of the aortic implant based on nanofibres of aliphatic copolyamide after exposure in the rat abdominal aorta for 7 (a) and 90 (b) days. After 7 days of exposure, a monolayer of endothelial cells is clearly visible; after 90 days of exposure, a pronounced subendothelial layer is formed that is identical to the subendothelial layer of the native vessel. Microphotographs taken with a Carl Zeiss Supra-55 VP scanning electron microscope (Germany).

In FIG. Figure 5 shows the cross-section of an implant of a tubular organ based on nanofibres of aliphatic copolyamide and polylactide at different magnifications (a, b), it can be seen that the implant wall has a porous fibrous structure and consists of nanofibres of various polymers with different diameters. A tubular implant was obtained by layer-by-layer deposition of aliphatic copolyamide and polylactide. Microphotographs on a scanning electron microscope Supra-55 VP from Carl Zeiss (Germany).

To confirm the compliance of the claimed group of inventions with the requirement of "industrial applicability" we give examples of specific implementations.

Reagents:

Aliphatic copolyamide copolymers: commercially available polymers of Anid LLC (Russia) are polycondensation products in the ε-caprolactam melt, AG salts (hexamethylenediaminadipinate), SG salts (hexamethylene diaminesebacinate) in various combinations and ratios. OST 2224-438-02099342-93, OST 6-05-438-88.

Alcohols: ethyl, methyl, propyl, sales companies of LLC Vitokhim.

Polymers-regulators of properties are commercially available, Sigma-Aldrich Corporation.

Selling additives.

Methods and devices for determining the characteristics of a tubular implant:

Nanofibers were formed by electrospinning in a laboratory setup with various feeding and receiving electrodes.

Microscopic studies were carried out using a scanning electron microscope Supra-55 VP company Carl Zeiss (Germany).

Hydrodynamic test tube samples were performed in a laboratory, the hydrodynamic pressure is calculated by the formula: P = ρV ^2/2.

Porosity, specific surface area, pore size distribution were studied using the BET method and the method of mercury porosimetry.

The implantation of prostheses of blood vessels was carried out by microsurgery using an operating microscope of OJSC "LOMO" (Russia). Evaluation of blood flow parameters in tubular implants was carried out using a standard ultrasound method.

Fixation of endothelial cells on tubular implants was carried out by treatment with a 0.25% solution of glutaraldehyde, followed by washing and drying of the sample. To study the structure and function of cells and tissues formed on the prosthesis, a standard histological technique was used.

Examples of obtaining a tubular implant of human and animal organs.

Example 1

The copolyamide of ε-caprolactam, hexamethylenediaminadipinate and hexamethylene diaminesebacinate (1: 2: 2) is dissolved in a water-alcohol mixture containing 80 vol.% Ethanol at a temperature of T = 80 ° C, the solution concentration is 20 wt. % The resulting solution is placed in a dispenser equipped with a metal die 20 mm long and 0.6 mm in diameter, then fed through an electrode die into an electric field with a strength of E = 1.5 × 10 ⁴ V / m. The fibers are deposited on a cylindrical anode with a diameter of 1 mm rotating at a speed of 3000 rpm.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.9 MPa, in physiological saline - 7.4 MPa, the strength in the aqueous medium is maintained during the observation time of 30 days.

A tubular implant (Fig. 1) with an inner diameter of 1 mm, a wall thickness of 0.2 mm (Fig. 2a), consisting of nanofibres with a diameter of 500 nm, located mainly perpendicular to the axis of the tube with a pore diameter of 5-500 μm (bimodal pore size distribution ) (Fig. 2b) was first checked for barrier properties: blood did not initially leak out and biocompatibility by stem cell growth, then the prosthesis was implanted into the abdominal aorta of a group of rats (Fig. 3). After exposure for 7 days, the implant was removed from the body parts of the animals. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant (Fig. 4a). The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

After exposure for 90 days, the implant was removed from the body of the remaining animals. On the inner surface of the implant, the formation of endothelial and subanthelial layers identical to the natural one was observed (Fig. 4b).

In a number of rats, the implant was left for a year. After a year, the implant passes and performs its function.

The implant was also used in parallel as a patch on the vessel. The effect of engraftment of the patch and its characteristics as in the main tubular implant.

Below are examples, in some of which the implant was not exposed for 90 days, if it was previously assumed that its characteristics coincided with the implant according to example 1.

Example 2

The copolyamide of ε-caprolactam and hexamethylenediaminadipinate (1: 1) is dissolved in a water-alcohol mixture containing 80 vol.% Ethanol at a temperature of T = 80 ° C, a solution concentration of 20 wt. % The resulting solution is placed in a dispenser equipped with a metal die 20 mm long and 0.6 mm in diameter, then fed through an electrode die into an electric field with a strength of E = 1.5 × 10 ⁴ . The deposition of fibers occurs on a cylindrical anode with a diameter of 1 mm rotating at a speed of 6000 rpm.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.5 MPa, in physiological saline - 7 MPa, the strength in the aquatic environment is maintained during the observation time of 30 days.

A tubular implant with an inner diameter of 1 mm, a wall thickness of 0.2 mm, consisting of nanofibers with a diameter of 500 nm, located mainly perpendicular to the axis of the tube, with a pore diameter of 20-300 μm, was obtained.

The implant was checked for barrier properties: blood did not initially leak out, then the prosthesis was implanted into the abdominal aorta of a group of rats. They were examined in turn after 7, 90 days and a year later. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

After exposure for 90 days, the implant was removed from the animal. On the inner surface of the implant, the formation of the subantelial and endothelial layers identical to the natural one was observed.

After a year, the implant passes and performs its function.

Example 3

The copolyamide of ε-caprolactam, hexamethylenediaminadipinate and hexamethylene diaminesebacinate (1: 2: 2) is dissolved in a water-alcohol mixture containing 40 vol.% Ethanol at a temperature of T = 50 ° C, the solution concentration is 40 wt. % The resulting solution is placed in a dispenser equipped with a metal die 20 mm long and 0.6 mm in diameter, then fed through an electrode die into an electric field with a strength of E = 8.0 × 10 ⁵ V / m. Deposition of fibers occurs on a cylindrical anode with a diameter of 0.2 mm rotating at a speed of 5000 rpm.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.2 MPa, in physiological saline - 6.1 MPa, the strength in the aquatic environment is maintained during the observation time of 30 days.

The tubular implant had an internal diameter of 0.2 mm, a wall thickness of 5.0 mm, consisting of microfibers with a diameter of 8000 nm, located mainly perpendicular to the axis of the tube, with a pore diameter of 20-300 microns.

The implant was checked for barrier properties: blood did not initially leak out, then the prosthesis was implanted into the abdominal aorta of a group of rats. They were examined in turn after 7, 90 days and a year later. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

After exposure for 90 days, the implant was removed from the animal. On the inner surface of the implant, the formation of the subantelial and endothelial layers identical to the natural one was observed.

After a year, the implant passes and performs its function.

Example 4

The copolyamide of ε-caprolactam and hexamethylene diaminesebacinate is dissolved in ethanol at a temperature of T = 80 ° C, the solution concentration is 3 wt. % The resulting solution is placed in a dispenser equipped with a metal die 20 mm long and 0.6 mm in diameter, then fed through an electrode die into an electric field with a strength of E = 8.0 × 10 ⁵ V / m. Deposition of fibers occurs on a cylindrical anode with a diameter of 40 mm rotating at a speed of 0.1 rpm.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.8 MPa, in physiological saline - 7.2 MPa, the strength in the aqueous medium is maintained during the observation time of 30 days.

The tubular implant had an internal diameter of 40 mm, a wall thickness of 0.05 mm, consisting of nanofibers with a diameter of 50 nm, located mainly parallel to the axis of the tube (Fig. 4), and a pore diameter of 0.1-400 μm.

This example shows the principal technical feasibility of obtaining an implant of a large tubular organ of a human or animal. Due to the lack of information about transplantation of large tubular organs at present and at the same time, given the rapid development of transplantology, the production of such large tubes, in terms of their composition, strength characteristics, and biocompatibility satisfying the requirements for implants, indicates the prospects of their use during the term of the patent.

Example 5

The copolyamide of ε-caprolactam, hexamethylenediaminadipinate and hexamethylene diaminesebacinate (1: 2: 1) is dissolved in a water-alcohol mixture containing 80 vol.% Ethanol at a temperature of T = 80 ° C, the solution concentration is 20 wt. % The resulting solution is placed in a dispenser equipped with a metal die 20 mm long and 0.6 mm in diameter, then fed through an electrode die into an electric field with a strength of E = 1.5 × 10 ⁴ . The fibers are deposited on a cylindrical anode with a diameter of 30 mm rotating at a speed of 1200 rpm.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.5 MPa, in physiological saline - 6.5 MPa, the strength in the aqueous medium is maintained during the observation time of 30 days.

The tubular implant had an internal diameter of 30 mm, a wall thickness of 5 mm, consisting of nanofibres with a diameter of 800 nm, located randomly with respect to the axis of the tube, the pore diameter of 10-200 μm.

Under the same conditions, but with an anode of 20 mm in diameter, an implant with an internal diameter of 20 mm and similar strength characteristics was obtained.

The resulting implants, due to their large size, could not be tested on rats. Prospects for their use are similar to the implant of example 4.

Example 6

Performed in the conditions of example 1. The concentration of the molding solution is 30%. Used polyhexamethylene sebacinamide. A tubular implant with an inner diameter of 1 mm and a wall thickness of 0.2 mm was obtained, consisting of nanofibers and microfibers with a diameter of 3000-7000 nm, located mainly perpendicular to the axis of the tube, with a pore diameter of 20-500 microns.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.7 MPa, in physiological saline - 7.0 MPa, the strength in the aqueous medium is maintained during the observation time of 30 days.

The implant was checked for barrier properties: the blood no longer initially leaks, then the prosthesis was implanted into the abdominal aorta of rats. They were examined in turn after 7, 90 days and a year later. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

After exposure for 90 days, the implant was removed from the animal. On the inner surface of the implant, the formation of the subantelial and endothelial layers identical to the natural one was observed.

After a year, the implant passes and performs its function.

Example 7

Performed under the conditions of example 1. Used polyhexamethylene adipinamide.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.8 MPa, in physiological saline - 7.3 MPa, the strength in the aqueous medium is maintained during the observation time of 30 days.

A tubular implant with an inner diameter of 1 mm, a wall thickness of 0.2 mm, consisting of nanofibers with a diameter of 500 nm, located mainly perpendicular to the axis of the tube, with a pore diameter of 20-500 μm, was obtained.

The implant was checked for barrier properties: blood did not initially leak out, then the prosthesis was implanted into the abdominal aorta of a group of rats. They were examined in turn after 7, 90 days and a year later. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

After exposure for 90 days, the implant was removed from the animal. On the inner surface of the implant, the formation of the subantelial and endothelial layers identical to the natural one was observed.

After a year, the implant passes and performs its function.

Example 8

Performed under the conditions of example 1. Used a mixture of copolyamide ε-caprolactam and hexamethylene diaminadipinate and copolyamide ε-caprolactam and hexamethylene diamine sebacinate (1: 1), propyl alcohol.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.8 MPa, in physiological saline - 6.9 MPa, the strength in the aqueous medium is maintained during the observation time of 30 days.

A tubular implant with an inner diameter of 1 mm, a wall thickness of 0.2 mm, consisting of nanofibers with a diameter of 500 nm, located mainly perpendicular to the axis of the tube, with a pore size of 10-450 μm, was obtained.

The implant was checked for barrier properties: blood did not initially leak out, then the prosthesis was implanted into the abdominal aorta of a group of rats. They were examined in turn after 7, 90 days and a year later. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

After exposure for 90 days, the implant was removed from the animal. On the inner surface of the implant, the formation of the subantelial and endothelial layers identical to the natural one was observed.

After a year, the implant passes and performs its function.

Example 9

Performed under the conditions of example 1, the rotation speed of the electrode is 500 rpm A mixture of copolyamide ε-caprolactam and hexamethylene diammonium adipate and polyhexamethylene sebacinamide (2: 1) was used. E = 1.6 × 10 ⁵ V / m. Received non-woven material with a random orientation of the fibers.

A tubular implant with an inner diameter of 1 mm, a wall thickness of 0.2 mm, consisting of nanofibers with a diameter of 500 nm, located mainly perpendicular to the axis of the tube, with a pore size of 20-500 microns, was obtained.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.7 MPa, in physiological saline - 6.6 MPa, the strength in the aqueous medium is maintained during the observation time of 30 days.

The implant was checked for barrier properties: blood did not initially leak out, then the prosthesis was implanted into the abdominal aorta of a group of rats. They were examined in turn after 7, 90 days and a year later. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

After exposure for 90 days, the implant was removed from the animal. On the inner surface of the implant, the formation of the subantelial and endothelial layers identical to the natural one was observed.

After a year, the implant passes and performs its function.

Example 10

Performed under the conditions of example 1. The copolyamide of hexamethylenediaminadipinate and hexamethylene diaminesebacinate. Consistently fix the speed of rotation of the cylindrical electrode in the values of 490, 500, 1200 rpm and incubated for 20 minutes A tubular implant with layer-by-layer orientation of fibers was obtained: parallel, chaotic, perpendicular; with an inner diameter of 1 mm, a wall thickness of 0.2 mm, consisting of nanofibres with a diameter of 1000 nm, with a pore diameter of 20-500 microns.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.8 MPa, in physiological saline - 7.1 MPa, the strength in the aqueous medium is maintained during the observation time of 30 days.

The implant was checked for barrier properties: blood did not initially leak out, then the prosthesis was implanted into the abdominal aorta of a group of rats. They were examined in turn after 7, 90 days and a year later. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

After exposure for 90 days, the implant was removed from the animal. On the inner surface of the implant, the formation of the subantelial and endothelial layers identical to the natural one was observed.

After a year, the implant passes and performs its function.

The results shown in examples No. 1-10 indicate that the implants work without additives.

The following are examples with additives. Additives give additional useful properties, for example, an increase or decrease in the rate of resorption, prolonged action of drugs, and increased bactericidal activity.

Additives of regulators of water resistance, porosity and prolonged action of drugs:

The used regulators reduce the water resistance of the implant, increase the porosity, which contributes, if necessary, to an increase in the rate of resorption.

Example 11

Performed in the conditions of example 1. In the molding solution added 0.1 wt. % water resistance regulator - PVA. The size characteristics of the fibers, tube and pores of the implant coincide with the implant of example 1.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.2 MPa, in physiological saline - 4.5 MPa, the strength in the aquatic environment is maintained during the observation time of 30 days. The implant resorption rate is higher than that of the implants indicated in Examples No. 1-10, as a result of reduced water resistance.

The implant was checked for barrier properties: blood did not initially leak out, then the prosthesis was implanted into the abdominal aorta of a group of rats. They were examined in turn after 7, 90 days and a year later. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

Example 12

Performed under the conditions of example 1, the concentration of methyl alcohol 99 vol.%, 100 ° C, the rotation speed of the cylindrical electrode is 6000 rpm An additional electrode die for supplying a molding solution with 50 wt. % PVA. The pore diameter of 0.2-150 microns. The remaining characteristics of the size of the fibers of the implant tube coincide with the implant of example 1.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.2 MPa, in physiological saline - 2.5 MPa, the strength in the aqueous medium is maintained during the observation time of 30 days. The decrease in strength occurs to a value sufficient for the functioning of the implant. The rate of resorption increases.

The implant was checked for barrier properties: blood did not initially leak out, then the prosthesis was implanted into the abdominal aorta of a group of rats. They were examined in turn after 7, 90 days and a year later. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

After exposure for 90 days, the implant was removed from the animal. On the inner surface of the implant, the formation of the subantelial and endothelial layers identical to the natural one was observed.

After a year, the implant passes and performs its function.

Below in examples 13-15, 17-22, 24-51, the exposure was limited to 7 days, because the result after 90 days and a year was obvious.

Example 13

Performed in the conditions of example 1. An additional electrode die for supplying a molding solution of 20 wt. % PVA, fractional feed. Layers of base material and containing PVA. The size characteristics of the fibers, tube and pores of the implant coincide with the implant of example 1.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.2 MPa, in physiological saline - 3.5 MPa, the strength in the aquatic environment is maintained during the observation time of 30 days.

The implant was checked for barrier properties: the blood no longer initially leaks, then the prosthesis was implanted into the abdominal aorta of rats. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

Example 14

Performed in the conditions of example 11. Additive 50 wt. % PVP. The size characteristics of the fibers, tube and pores of the implant coincide with the implant of example 1.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.2 MPa, in physiological saline - 2 MPa (sufficient for the functioning of the implant), the strength in the aqueous medium remains during the observation time of 30 days.

The implant was checked for barrier properties: the blood no longer initially leaks, then the prosthesis was implanted into the abdominal aorta of rats. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

Example 15

Performed under the conditions of example 12. Additive 5% PVP. The size characteristics of the fibers, tube and pores of the implant coincide with the implant of example 1.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.2 MPa, in physiological saline - 4.7 MPa, the strength in the aquatic environment is maintained during the observation time of 30 days.

The implant was checked for barrier properties: the blood no longer initially leaks, then the prosthesis was implanted into the abdominal aorta of rats. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

Example 16

Performed under the conditions of example 12 at 20 ° C. Additive 0.1 wt. % polyethylene oxide and 1 wt. % chlorhexidine. The size characteristics of the fibers, tube and pores of the implant coincide with the implant of example 1.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.7 MPa, in physiological saline - 5 MPa, the strength in the aqueous medium is maintained during the observation time of 30 days.

The implant was checked for barrier properties: blood did not initially leak out, then the prosthesis was implanted into the abdominal aorta of a group of rats. They were examined in turn after 7, 90 days and a year later. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

After exposure for 90 days, the implant was removed from the animal. On the inner surface of the implant, the formation of the subantelial and endothelial layers identical to the natural one was observed.

After a year, the implant passes and performs its function.

The number of infectious complications in the postoperative period is reduced by 2 times.

Example 17-19

Performed in the conditions of example 12. Additive 10 wt. % cellulose derivative - methyl cellulose, or polysaccharide, or polypeptide. The dimensions of the fibers, tubes and pores of the implants coincide with the implant of example 1.

There is no trace of solvent in the target material. The strength of the implants in the dry state is σ = 6.2-6.4 MPa, in physiological saline - 4.0-4.5 MPa, the strength in the aqueous medium is maintained during the observation time of 30 days.

The implant was checked for barrier properties: the blood no longer initially leaks, then the prosthesis was implanted into the abdominal aorta of rats. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

Examples 20-22.

Performed in the conditions of example 1. Additive 50 wt. % alcohol-soluble polymer - polyvinyl acetate, or polyvinyl butyral, or polymethyl methacrylate. The dimensions of the fibers, tubes and pores of the implants coincide with the implant of example 1.

There is no trace of solvent in the target material. The strength of implants in the dry state is σ = 6.2-6.8 MPa, in physiological saline - 2.5-3.5 MPa, the strength in the aqueous medium is maintained during the observation time of 30 days.

The implant was checked for barrier properties: the blood no longer initially leaks, then the prosthesis was implanted into the abdominal aorta of rats. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

Additives bioresorbable polymers:

Example 23

Performed in the conditions of example 11. Used 50 wt. % bioresorbable polymer - chitosan. The size characteristics of the fibers, tube and pores of the implant coincide with the implant of example 1.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.7 MPa, in physiological saline - 5.0 MPa, the strength in the aqueous medium is maintained during the observation time of 30 days.

The implant was checked for barrier properties: blood did not initially leak out, then the prosthesis was implanted into the abdominal aorta of a group of rats, it was assumed that its characteristics coincided with the implant in Example 1. After exposure for 7 days, the implant was removed from the animal's body. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

After exposure for 90 days, the implant was removed from the animal. On the inner surface of the implant, the formation of the subantelial and endothelial layers identical to the natural one was observed.

After a year, the implant passes and performs its function.

Examples 24-50.

Performed in the conditions of example 12. Used 0.1 wt. % of one of the following bioresorbable polymers: chitosan, polyglycolide, polycaprolactone, polyanhydride, polyamine, polyetheramide, polyorthoester, polydioxanone, polyacetal, polyketal, polycarbonate, polyphosphoric acid ester, polyester, polybutylene terephthalate, polyisulfonate, polyorthosorbate (amino acid), N, N-polyvinylpyrrolidone, polyethylene glycol, cellulose derivative-methyl cellulose, polysaccharide, chitin, polygialuronic acid, polypeptide, or a mixture of chitin, chitosan of arbitrary composition. The dimensions of the fibers, tubes and pores of the implants coincide with the implant of example 1.

There is no trace of solvent in the target material. The strength of the implants in the dry state is σ = 6.2-6.7 MPa, in physiological saline - 5.8-6.0 MPa, the strength of the input medium is maintained during the observation time of 30 days.

The implant was checked for barrier properties: the blood no longer initially leaks, then the prosthesis was implanted into the abdominal aorta of rats. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

Impregnation:

Example 51

Performed in the conditions of example 1. Impregnation of the nonwoven material with a medicinal product-antibiotic ampicillin and a plasticizer-glycerin. The size characteristics of the fibers, tube and pores of the implant coincide with the implant of example 1.

There is no trace of solvent in the target material. The strength of the implant at the level of implant strength in example 1.

The implant was checked for barrier properties: the blood no longer initially leaks, then the prosthesis was implanted into the abdominal aorta of rats. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

The number of infectious complications in the postoperative period is reduced by 2 times.

Perforation:

Example 52

Performed in the conditions of example 1. In the molding solution added a drug-antiseptic aseptoline and plasticizer-sorbitol.

The implant is perforated with holes with a diameter of 20 μm in the places of germination of small vessels, the holes are covered with polyethylene glycol microfibers. The size characteristics of the fibers, tube and pores of the implant coincide with the implant of example 1.

The implant was checked for barrier properties: blood did not initially leak out, then the prosthesis was implanted into the abdominal aorta of a group of rats. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

After exposure for 90 days, the implant was removed from the animal. On the inner surface of the implant, the formation of the subantelial and endothelial layers identical to the natural one was observed. The formation of small vessels at the perforation sites was observed.

The number of infectious complications in the postoperative period is reduced by 2 times.

Example 53

Performed in the conditions of example 52. The implant is perforated with holes with a diameter of 3 mm in the places of germination of blood vessels, the holes are covered with polypeptide nano- and microfibers.

The implant was checked for barrier properties: blood did not initially leak out, then the prosthesis was implanted into the abdominal aorta of a group of rats. They were examined in turn after 7, 90 days and a year later. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

After exposure for 90 days, the implant was removed from the animal. On the inner surface of the implant, the formation of the subantelial and endothelial layers identical to the natural one was observed. The formation of small vessels at the perforation sites was observed.

Example 54

Performed in the conditions of example 52. The implant is perforated with holes with a diameter of 3 mm in the places of vascular germination, the tube is coated on the outside with a layer of polypeptide nano- and microfibers in the form of non-woven material 1 mm thick.

The implant was checked for barrier properties: blood did not initially leak out, then the prosthesis was implanted into the abdominal aorta of a group of rats. They were examined in turn after 7, 90 days and a year later. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

After exposure for 90 days, the implant was removed from the animal. On the inner surface of the implant, the formation of the subantelial and endothelial layers identical to the natural one was observed. The formation of small vessels at the perforation sites was observed.

Additive hydrophobic polymer. Allows you to adjust the rate of resorption in the direction of its decrease and the strength of the implant:

Examples 55-70.

Performed in the conditions of example 1. An additional electrode-die for feeding the molding solution in N, N-dimethylformamide with 50 wt. % hydrophobic polymer from the series: PET, polyethylene, polypropylene, polyisobutylene, polyvinyl chloride, polystyrene, polyvinyl acetate, polymethyl methacrylate, polycarbonate, polyurethane, polyethylene terephthalate, halogen-containing (co) polyethylenes, polyvinylidene fluoride, polyvinylidene chloride. The size characteristics of the fibers, tube and pores of the implant coincide with the implant of example 1.

There is no trace of solvent in the target material. The strength of implants in the dry state is σ = 7.0-7.6 MPa, in physiological saline - 7.2-7.9 MPa, the strength in the aqueous medium is maintained during the observation time of 30 days.

A decrease in the rate of resorption is observed.

The implant was checked for barrier properties: blood did not initially leak out, then the prosthesis was implanted into the abdominal aorta of a group of rats. They were examined in turn after 7, 90 days and a year later. After exposure for 7 days, the implant was removed from the animal. At the same time, in the places of anastamosis, scar tissue was not observed. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

After exposure for 90 days, the implant was removed from the animal. On the inner surface of the implant, the formation of the subantelial and endothelial layers identical to the natural one was observed.

After a year, the implant passes and performs its function.

Example 71

Performed under the conditions of Example 55. Through additional electrode dies, 20% molding solutions of a hydrophobic polymer — PET and a bioresorbable polymer — N, N-polyvinylpyrrolidone — are successively fed. A layered implant is obtained.

There is no trace of solvent in the implants. The strength of the implants at the level of implant strength in example 1.

The implant was checked for barrier properties: blood did not initially leak out, then the prosthesis was implanted into the abdominal aorta of a group of rats. They were examined in turn after 7, 90 days and a year later. After exposure for 7 days, the implant was removed from the animal’s body. At the same time, scar tissue was not observed at the sites of anastamosis. The formation of endothelial cells was observed on the inner surface of the implant. The section of the tube along: the endothelial layer is uniform in thickness, even. This indicates the absence of cytotoxicity. No thrombosis was observed, which indicates the absence of turbulence and laminar flow.

After exposure for 90 days, the implant was removed from the animal. On the inner surface of the implant, the formation of the subantelial and endothelial layers identical to the natural one was observed. The formation of small vessels at the perforation sites was observed.

After a year, the implant passes and performs its function.

The inventive implants were also tested on the trachea and esophagus of rats. High biocompatibility, lack of scar tissue at the sites of anastamoses are shown.

Example 72

The copolyamide of ε-caprolactam and hexamethylene diaminesebacinate is dissolved in ethanol at a temperature of T = 80 ° C, the solution concentration is 3 wt. % The resulting solution is placed in a dispenser equipped with a metal die 20 mm long and 0.6 mm in diameter, then fed through an electrode die into an electric field with a strength of E = 8.0 × 10 ⁵ V / m. Deposition of fibers occurs on a cylindrical anode with a diameter of 3 mm rotating at a speed of 0.1 rpm.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.8 MPa, in physiological saline - 7.2 MPa, the strength in the aqueous medium is maintained during the observation time of 30 days.

The tubular implant had an internal diameter of 3 mm, a wall thickness of 0.05 mm, consisting of nanofibers with a diameter of 50 nm, located mainly parallel to the axis of the tube, the pore diameter of 0.1-400 microns.

The prosthesis was implanted into the rat trachea. After exposure for 7 days, the implant was removed from the animal. Germination of fibroblasts was observed on the outer surface of the implant. This indicates the absence of cytotoxicity. After exposure for 30 days, the implant was removed from the animal. The formation of connective tissue was observed on the external surface of the implant.

Example 73

The copolyamide of ε-caprolactam, hexamethylenediaminadipinate and hexamethylene diaminesebacinate (1: 2: 1) is dissolved in a water-alcohol mixture containing 80 vol.% Ethanol at a temperature of T = 80 ° C, the solution concentration is 20 wt. % The resulting solution is placed in a dispenser equipped with a metal die 20 mm long and 0.6 mm in diameter, then fed through an electrode die into an electric field with a strength of E = 1.5 × 10 ⁴ . The deposition of fibers occurs on a cylindrical anode with a diameter of 5 mm rotating at a speed of 1200 rpm.

There is no trace of solvent in the target material. The strength of the implant in the dry state is σ = 6.5 MPa, in physiological saline - 6.5 MPa, the strength in the aqueous medium is maintained during the observation time of 30 days.

The tubular implant had an internal diameter of 5 mm, a wall thickness of 0.05 mm, consisting of nanofibers with a diameter of 50 nm, located mainly parallel to the axis of the tube, the pore diameter of 0.1-400 microns.

The prosthesis was implanted into the rat trachea. After exposure for 7 days, the implant was removed from the animal. Germination of fibroblasts was observed on the outer surface of the implant. This indicates the absence of cytotoxicity.

After exposure for 90 days, the implant was removed from the animal. The formation of connective tissue was observed on the external surface of the implant.

The implementation of the claimed invention is not limited to the above examples.

Going beyond the lower boundaries of the claimed intervals leads to a sharp decrease in the quality of the claimed implant, or to the inability to obtain it. Going beyond the upper boundaries of the claimed intervals also leads to a decrease in the quality of the claimed implant, loss of barrier properties; increasing the diameter of the tubes is impractical, since it is determined by the size of the tubular organs.

The data given in examples No. 1-73 indicate that, as a result of the implementation of the claimed group of inventions, universal tubular implants of human or animal organs were obtained. They are not cytotoxic, unlike analogues, these implants are obtained without resorting to additional polymer hydrophilic coatings of the inner surface of the tube, which contributes to good reproducibility of the material. The implants correspond to tubular organs, the implants are overgrown with tissue identical to the recipient's tissue for 7 days. Pads for tubular organs can be cut and used from the implant. In the case of vascular implantation, there are no conditions for the formation of blood clots.

Claims (25)

1. A tubular implant for replacing tubular organs of a human or animal made of non-woven porous polymer material formed from nano and / or microfibers with a diameter of 50-8000 nm from an aliphatic alcohol-soluble (co) polyamide which is a polycondensation product in a melt of ε-caprolactam, salt hexamethylenediaminadipinate or salts of hexamethylene diaminesebacinate or a mixture thereof, with an inner tube diameter of 0.2-40 mm, a wall thickness of 0.05-5 mm, a pore diameter of 0.1-500 microns. 2. The tubular implant according to claim 1, characterized in that the fibers of aliphatic alcohol-soluble (co) polyamide additionally contain 0.1-50 wt. % of the regulators of their water resistance, porosity and prolonged release of drugs in the form of water-soluble polymers from the series: N, N-polyvinylpyrrolidone, polyvinyl alcohol, polyethylene oxide, polysaccharides, peptides, or in the form of alcohol-soluble polymers from the series: polyvinyl acetate, polyvinyl butyral, polymers, polymethylmethyl series containing water-soluble drugs. 3. The tubular implant according to claim 1, characterized in that the non-woven material additionally contains 0.1-50 wt.% Of regulators of its water resistance, porosity and prolonged release of drugs in the form of nano and / or microfibers from water-soluble polymers from the series: N, N-polyvinylpyrrolidone, polyvinyl alcohol, polyethylene oxide, cellulose derivatives, polysaccharides, peptides, or in the form of alcohol-soluble polymers from the series: polyvinyl acetate, polyvinyl butyral, polymethyl methacrylate, or polymers from this series containing water-soluble drugs. 4. The tubular implant according to claim 1, characterized in that the fibers from aliphatic alcohol-soluble (co) polyamide additionally contain 0.1-50 wt.% Bioresorbable polymers from the series: polylactides, polyglycolides, caprolactone-based polymers, polyanhydrides, polyamines, polyetheramides , polyorthoesters, polydioxanones, polyacetals, polyketals, polycarbonates, polyphosphoric acid esters, polyesters, polybutylene terephthalate, polyorthocarbonates, polyphosphazenes, polysuccinates, poly (malic acid), poly (amino acids), N, N-polyvinylpyrrolide nglikol, cellulose derivatives, polysaccharides, chitin, chitosan, poligialuronovye acids, polypeptides, copolymers thereof or mixtures thereof. 5. The tubular implant according to claim 1, characterized in that the non-woven material additionally contains 0.1-50 wt.% Nano- and / or microfibers from bioresorbable polymers from the series: polylactides, polyglycolides, caprolactone-based polymers, polyanhydrides, polyamines, polyetheramides, polyorthoesters, polydioxanones, polyacetals, polyketals, polycarbonates, polyphosphoric esters, polyesters, polybutylene terephthalate, polyorthocarbonates, polyphosphazenes, polysuccinates, poly (malic acid), poly (amino acids), N, N-polyvinylvinyl, stock celluloses, polysaccharides, chitin, chitosan, polygialuronic acids, polypeptides, their copolymers or mixtures thereof. 6. The tubular implant according to claim 1, characterized in that the non-woven material additionally contains 0.1-50 wt.% A hydrophobicity regulator, physical and mechanical characteristics in the form of nano- and / or microfibers of hydrophobic polymers from the series: polyethylene, polypropylene, polyisobutylene, polyvinyl chloride, polystyrene, polyvinyl acetate, polymethyl methacrylate, polycarbonate, polyurethane, polyethylene terephthalate, halogen-containing (co) polyethylenes, polyvinylidene fluoride, polyvinylidene chloride, polycaprolactam. 7. The tubular implant according to claim 1, characterized in that it contains additional layer (s) of non-woven porous polymer material formed from nano- and / or microfibers of a bioresorbable and / or hydrophobic polymer. 8. A tubular implant according to claim 1, characterized in that the fibers are arranged in the nonwoven material in parallel, or perpendicular to the axis of the tube, or randomly or in layers with different types of orientation. 9. The tubular implant according to claim 1, characterized in that the composition of the fibers directly and / or non-woven material in the form of impregnation additionally includes anticoagulants, antibiotics, antiseptics, anti-inflammatory drugs, antioxidants, vitamins, sorbents, drugs that separately or together stimulate wound healing and cell growth. 10. The tubular implant according to claim 1, characterized in that the composition of the fibers directly and / or non-woven material in the form of impregnation additionally includes a plasticizer from the series: glycerin, sorbitol, mannitol, propylene glycol and other polyhydric alcohols or mixtures thereof. 11. The tubular implant according to claim 1, characterized in that the tube is perforated with openings with a diameter of 20 μm to 3 mm at the locations of the supposed branches of the vessels and the openings themselves are filled with non-woven porous polymer material formed from nano- and / or microfibres of a bioresorbable polymer, or the tube is coated an additional layer (s) of non-woven porous polymer material formed from nano- and / or microfibers of a bioresorbable polymer. 12. A method of producing a tubular implant for replacing the tubular organs of a human or animal according to claim 1, which consists in preparing a molding 3-40% solution of an aliphatic alcohol-soluble (co) polymer which is a polycondensation product in the melt of ε-caprolactam, hexamethylene diaminadipinate salt or salts of hexamethylenediaminesebacinate or a mixture thereof, in alcohol or in a water-alcohol mixture with an alcohol content of 40-99 vol.% at a temperature of 20-100 ° C, is filtered, dehydrated, and fed through an die plate into an electric ole with a strength of E = 1.5 × 10 ⁴ - 8.0 × 10 ⁵ V / m on a cylindrical electrode rotating at a speed of 0.1-6000 rpm with a diameter of 0.2-40 mm, while on the electrode surface a non-woven porous material formed from nano- and microfibers, the target tubular implant is removed from the electrode, dried. 13. A method of producing a tubular implant according to claim 12, characterized in that ethyl, methyl, propyl alcohol or mixtures thereof are used as the alcohol. 14. A method of producing a tubular implant according to claim 12, characterized in that the molding solution of an aliphatic alcohol-soluble (co) polyamide in alcohol or in a water-alcohol mixture additionally contains 0.1-50 wt.% Water-soluble polymers from the series: N, N- polyvinylpyrrolidone, polyvinyl alcohol, polyethylene oxide, polysaccharides, peptides, or in the form of alcohol-soluble polymers from the series: polyvinyl acetate, polyvinyl butyral, polymethylmethacrylate, or polymers from this series containing water-soluble drugs. 15. A method of producing a tubular implant according to claim 12, characterized in that they use an additional (e) die-plate electrode (s) through which (e) simultaneously or fractionally alcohol or water-alcohol solutions are continuously or fractionally supplied to the cylindrical electrode water-soluble polymers from the series: N, N-polyvinylpyrrolidone, polyvinyl alcohol, polyethylene oxide, polysaccharides, peptides, or in the form of alcohol-soluble polymers from the series: polyvinyl acetate, polyvinyl butyral, polymethyl methacrylate, or polymers from the specified series, soder aschie soluble drug, the rate of 0.1-50 wt% -. Nogo content nano- and / or microfibers of these polymers in the nonwoven fabric. 16. A method of producing a tubular implant according to claim 12, characterized in that the molding solution of an aliphatic alcohol-soluble (co) polyamide in alcohol or in a water-alcohol mixture additionally contains 0.1-50 wt.% Bioresorbable polymers from the series: polylactides, polyglycolides, caprolactone-based polymers, polyanhydrides, polyamines, polyetheramides, polyorthoesters, polydioxanones, polyacetals, polyketals, polycarbonates, polyphosphoric acid esters, polyesters, polybutylene terephthalate, polyorthocarbonates, polyphosphazenes, polysuccinates, poly (apple) acid), poly (amino acids), N, N-polyvinylpyrrolidone, polyethylene glycol, cellulose derivatives, polysaccharides, chitin, chitosan, polygialuronic acids, polypeptides, their copolymers or mixtures thereof. 17. A method of producing a tubular implant according to claim 12, characterized in that they use an additional (e) die-plate electrode (s) through which (e) simultaneously or fractionally alcohol or water-alcohol solutions are continuously or fractionally fed to the cylindrical electrode bioresorbable polymers from the series: polylactides, polyglycolides, caprolactone-based polymers, polyanhydrides, polyamines, polyetheramides, polyorthoesters, polydioxanones, polyacetals, polyketals, polycarbonates, polyphosphoric acid esters, polyesters, polybutyleneterent phthalate, polyorthocarbonates, polyphosphazenes, polysuccinates, poly (malic acid), poly (amino acids), N, N-polyvinylpyrrolidone, polyethylene glycol, cellulose derivatives, polysaccharides, chitin, chitosan, polygialuronic acids, polypeptides, their copolymers or mixtures thereof, 0 from calculation, or mixtures thereof, 0 , 1-50 wt.% - the content of nano- and / or microfibers of these polymers in non-woven material. 18. The method of producing a tubular implant according to claim 12, characterized in that they use an additional (e) die-plate electrode (s) through which (e) simultaneously with the main electrode the solutions of hydrophobic polymers in aprotic solvents are continuously or fractionally fed to the cylindrical electrode from the series: polyethylenes, polypropylene, polyisobutylene, polyvinyl chloride, polystyrene, polyvinyl acetate, polymethyl methacrylate, polycarbonate, polyurethane, polyethylene terephthalate, halogen-containing (co) polyethylene, polyvinylidene fluoride, polyvinylidene chloride d, polycaprolactam, from the calculation of 0.1-50 wt.% - the content of nano - and / or microfibers of these polymers in the nonwoven material. 19. A method for producing a tubular implant according to claim 12, characterized in that they use an additional (e) die-plate electrode (s) through which (e) bioresorbable and / or hydrophobic solutions are supplied to the cylindrical electrode before or after the main die-electrode is operating. polymers and form additional layers of non-woven material from nano- and / or microfibers from these polymers on the tubular implant. 20. The method of producing a tubular implant according to claim 12, characterized in that a certain value of the rotation speed of the cylindrical electrode is selected from the interval 0.1-6000 rpm and is kept constant during the process of forming the nonwoven material, while the rotation speed of the cylindrical electrode set in the range of 0.1-499 rpm, a non-woven material is obtained in which the fibers are arranged in parallel, randomly in the range of 500-1199 rpm, perpendicular to the tube axis in the range of 1200-6000 rpm. 21. A method for producing a tubular implant according to claim 20, characterized in that the rotation speed of the cylindrical electrode is varied from an interval of 0.1-6000 rpm during the process of forming the nonwoven material at least two times, and a nonwoven material is obtained in which fibers with parallel, perpendicular or random orientation with respect to the tube axis are layered. 22. The method of producing a tubular implant according to claim 12, characterized in that anticoagulants, antibiotics, antiseptics, sorbents, drugs, separately and together stimulating wound healing and cell growth, are additionally introduced into the molding solution and / or non-woven material as an impregnation. 23. A method for producing a tubular implant according to claim 12, characterized in that a plasticizer from the series: glycerin, sorbitol, mannitol, propylene glycol and other polyhydric alcohols or mixtures thereof is additionally introduced into the molding solution and / or into the nonwoven fabric as an impregnation. 24. A method of producing a tubular implant according to claim 12, characterized in that the target tubular implant is perforated on the cylindrical electrode with holes of 20 μm to 3 mm in diameter at the locations of the supposed branches of the vessels and using the additional die electrode, the alcohol is continuously or fractionally supplied to the cylindrical electrode a water-alcohol solution of a bioresorbable polymer, as a result of which the holes are covered with non-woven material from nano- and / or microfibers or the tube is covered with an additional layer (s) of non-woven porous th polymeric material formed from the nano and / or bioresorbable polymer microfibers. 25. The method of producing a tubular implant according to claim 12, characterized in that the target tubular implant is cut into pads of various configurations and sizes for tubular organs.

Images