Gauze endoprosthesis usable in plastic surgery

FIELD: medical engineering.

SUBSTANCE: device has gauze fabric manufactured from synthetic fibers coated with bioresorbable biocompatible polymer poly-3-hydroxybutirate.

EFFECT: improved gauze endoprosthesis biocompatibility properties.

 

The invention relates to medical equipment, namely to the mesh implants for reconstructive surgery, implantable in the human body. Mesh implants are used for hernioplasty, and for repair of abdominal and thoracic walls, scalp, trachea, the orbit of the eye and other diseases related to the closure of the defects and strengthen the body's own tissue.

Known mesh implants for reconstructive surgery on the basis of synthetic materials: nylon, Silastic, polyesters, polypropylene, polyethylene, polytetrafluoroethylene [U.S. Patent No. 6287316, 2001; U.S. Patent No. 4452245, 1984]. They differ in thickness, surface structure, cell size, hardness, tensile strength. The main conditions for successful use of the prosthesis are its biocompatibility, resistance to infections, low thrombogenicity and antispecies properties, low permeability to proteins and formed elements of blood, mechanical strength, which find expression in the preservation of the physical-mechanical properties of the prosthesis during its integration into the body, and in the absence of allergic and inflammatory reactions and graft rejection by the body. Mesh implants on the basis of synthetic fibres possess insufficient biozones what cost and thromboresistance, that can lead to the development of inflammatory and adhesive processes [Fedorov I.V. Prosthetic surgery of hernias: a century of evolution, a New Surgical Archive, 2002, volume 1, number 4, s-133]. To improve engraftment of a mesh implant in the body tissues currently used polymer coatings on the basis of resorbable polymers: polylactide and polyglycolides. The main advantages of this composition should be, on the one hand, the stability of the support in the area of tissue reconstruction, on the other hand, stimulation of growth of connective tissue and the formation of a uniform connective tissue scar after implantation.

The closest to the essential features of the claimed mesh implant is a prosthesis, made in the form of a mesh woven fabric made of synthetic fibers with a coating based on bioresorbable polymers, polylactide and polyglycolides, company Ethicon Inc. [U.S. patent No. 6800082, 2004]. The polylactide and polyglycolides in the tissues of the body are subjected to hydrolytic and enzymatic hydrolysis, resulting in their active destruction. This can lead to an imbalance between the rate of resorption of the polymer coating mesh implants and reparative processes in the zone of implantation of the endoprosthesis.

Task is th invention is to provide a mesh implant for reconstructive surgery, representing a combination of woven fabric from synthetic fibers and resorbable biocompatible polymer coatings based on poly-3-hydroxybutyrate (FCB).

The practical result achieved in the present invention is to improve the biocompatibility, thromboresistance and protivospaechnyj properties of a mesh implant that improves the integration of the implant into the surrounding tissue, and the rate of bioresorbable coating can be adjusted to match the reparative processes in the zone of implantation of the endoprosthesis through the regulation of the molecular weight of the used polymer. This result is achieved in that the synthetic fibre mesh endoprosthesis covered with a bioresorbable, biocompatible and thromboresistant thermoplastic - FCB [Medical biopolymer FCB, THE 9393-001-0269944 1-00; Toxicological conclusion vniimt MOH No. 38899 from 10.01.2000,]. Highly FCB medical devices obtained by means of biotechnology [bonartzeva GA, Myshkin V.L., Zagreb DU, Purina E.K. Strain Azotobacter chroococcum - producer polyoxometalate. Patent for invention No. 2194759 on October 18, 2001; bonartzeva GA, Myshkin V.L., Zagreb DU, Nikolaev D.A. a Method of producing polyoxometalate desired molecular weight. Patent for invention No. 2201453 on October 18, 2001]. Bioresource FCB in cloth who's body is only enzymatic way. Used as the coating material of the claimed product FCB has a molecular weight of from 300 to 1500 kDa. Speed bioresorption FCB depends on the molecular weight of the polymer. FCB is a thermoplastic material that can easily be recycled by way of extrusion, methods of dry and wet molding. FCB thermally stable, resistant to acids, and ultraviolet light. An important advantage when using FCB is its sterilization by gamma-irradiation. FCB has low moisture absorption and articles thereof can maintain its performance over a long period (3-4 years) under normal conditions of storage, whereas products made of polylactide and polyglycolides due to their higher hydrophilicity require special storage conditions (absence of moisture and temperature is minus).

By its technological, mechanical and physico-chemical characteristics FCB corresponds to the traditional implantation biodegradiruemym the polyesters. The main characteristics of FCB: the melting point is 180°With a density of 1.25 g/cm3the degree of crystallinity of 65%, an elongation at break of 4%, the elastic modulus of 4 GPA.

The implant is a mesh woven webs of synthetic fibers based on polypropylene or polyester coated with bio is tiberuim biocompatible polymer FCB. The coating weight is from 1 to 10 mg/cm2the endoprosthesis. Mesh-implants with a polymer coating based on FCB on Toxicological-hygienic and sanitary-chemical indicators meet the requirements for medical devices in contact with the internal environment of the body and meet the requirements of normative documents [Standards series GOST R ISO 10993. "Evaluation of biological effects of medical products." GOST 31214-2003. "Medical products. Requirements for samples and documentation submitted for Toxicological, sanitary and chemical tests, tests for sterility and progenote". Mr. 2.3.3.972-00 "Maximum permissible amount of chemicals released from materials in contact with food". Toxicological conclusion on the "Mesh-implants for reconstructive surgery with a biopolymer coating" of the Institute of biochemistry. A.N. Bach wounds. No. 599-04 from 02.11.2004,].

Features mesh implants with a polymer coating on the basis of the FCB as close as possible to the properties of collagenous fibrous tissue of a person, i.e. implants:

- possess biocompatibility,

- biologically inert,

- possess resistance to infections,

- do not cause allergic reactions and sensitization,

- do not cause inflammation and rejection,

- have thromboresistance and antispace properties

- atraumatic,

- possess mechanical strength (sufficiently flexible and elastic to keep its integrity; strong enough to prevent the development of early recurrences; resistant to melting and razvlecheniy edges),

- do not have a General toxic effect on the human body.

In the coating of FCB synthetic fiber mesh implants made of polypropylene or polyester physico-mechanical characteristics of these implants are almost unchanged and correspond to the following indicators:

the punching shear strength of at least 100 N,

- elongation at break of not more than 130%,

- of a weight not exceeding 120 g/m2,

the pore size of the mesh of not less than 75 microns.

The configuration and the range of mesh implants is determined depending on the location of implantation of the product.

The main dimensions of the mesh-implants:

- overall thickness of the product depending on the functional use of from 300 to 600 μm,

the thickness of the coating on the basis of FCB depending on the functional use from 10 to 100 μm,

- standard series: 6×11 cm, 8×12 cm, 15×10 cm, 15×15 cm, 15×20 cm, 20×10 cm, 25×25 cm, 30×10 cm, 30×15 cm, 30×20 cm, 30×25 cm, 30×30 cm

- otnositel what I porosity (%) 5-50.

Mesh implants retain the properties within a given period of operation, and resorption of the coating of the FCB can be controlled to meet the specified requirements, but not earlier than 2 weeks after implantation, and the complete enzymatic hydrolysis of from 1 month to 4 months depending on the molecular weight FCB, size and thickness of the product. Degradation products FCB included in the metabolic processes in the body without exerting a negative influence on him. If not, then remaining in the body degradation products cover of FOB concentration does not exceed a physiologically acceptable norms (hydroxybutyrate concentration in the blood is not more than 0.1 mg/ml).

Example 1.

Mesh implant made of synthetic fibers based on polypropylene coated on the basis of the FCB. The thickness of the mesh implant is 530 μm, the coating thickness of the FCB - 20 μm, size - 8×12 cm, a porosity of 25%, a molecular weight of PGB - 1100 kDa.

A fragment of this sample (1,5×1.5 cm) mesh endoprosthesis implanted males rats "Wistar" (the average weight is 195 g) in the lateral abdominal wall. Implantation of sterile samples was carried out right under the aponeurosis and left on the aponeurosis. Studies of bioptates tissue of the anterior abdominal wall together with mesh endoprosthesis was performed on the 7th, 14th, 21st, 28th, 42-and 56-th days after implantation. Morphologically it has been established that the 7-th day after the operation in the cell region of a mesh endoprosthesis rising young granulation tissue with newly formed blood vessels capillary type. In the period from the 14th to the 28th day marked the transformation of granulation tissue in young connective tissue and replacing it by up to 50% of the area of the implant. Histological study of the area of implantation to the 56 th day showed that synthetic filament colorless, floor histologically not defined, adhesions is missing, the germination of loose connective tissue is observed on the entire surface of the implant. The investigation of the cytotoxicity of the extracts from samples of mesh implants on suspension culture of motile cells with the determination of the toxicity index. Toxicity index was 92-102% of the target value of 70-120%. Hoods do not have hemolytic effect in experiments in vitro with isolated rabbit erythrocytes hemolysis of 0.2-0.6% with valid scores no more than 2%.

Example 2.

Mesh implant made from polyester with a coating based on FCB. The thickness of the mesh implant is 340 μm, the coating thickness of the FCB - 10 ám size - 8×12 cm, a porosity of 20%, a molecular weight of PGB - 720 kDa.

Tests are carried out according to example 1. The test results showed that the 7-th day after the operation in the area of the t cells of a mesh endoprosthesis rising young granulation tissue with newly formed blood vessels capillary type. In the period from the 14th to the 21st day marked the transformation of granulation tissue in young connective tissue and replacing it by up to 70% of the area of the implant. Histological study of the area of implantation to the 42-th day showed that synthetic filament colorless, floor histologically not defined, adhesions is missing, the germination of loose connective tissue is observed on the entire surface of the implant. Toxicity index was 89-97%. Hoods do not have hemolytic effect in experiments in vitro with isolated rabbit erythrocytes hemolysis of 0.2-0.6%.

Mesh implant for reconstructive surgery, consisting of synthetic fibers, wherein the fibers are covered with a bioresorbable the biopolymer poly-3-hydroxybutyrate molecular weight of from 300 to 1500 kDa.



 

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