Method of manufacturing mesh prosthesis having antimicrobial properties for hernioplasty

FIELD: abdominal surgery.

SUBSTANCE: invention relates to manufacturing prostheses for abdominal surgery based on synthetic polymeric complex threads with coating, whose composition, in order to impart antimicrobial properties to allotransplant, is completed with various-type chemiotherapeutical materials, in particular antiseptic substance (Poviargol). Prosthesis of invention is designed for plastics of hernial defects of abdominal wall. Mesh prosthesis with antimicrobial properties for hernioplasty is manufactured as follows: polymeric composite consisting of (i) Poviargol substance, which is metal-polymer composition of ultrafine metallic silver stabilized with synthetic polymer Collidon, 40-45%, and (ii) medical-grade high-molecular weight polyvinylpyrrolidone, 55-60%, is applied onto synthetic polymer mesh, after which mesh with dispersion applied thereon is dried by way of blowing with hot air (60-80°C) for 20-30 min.

EFFECT: simplified manufacturing procedure and enhanced antimicrobial efficiency.

2 tbl, 8 ex

 

The invention relates to medical engineering, in particular to the manufacture of mesh prosthesis for abdominal surgery based on synthetic polymer filament yarn with a coating, which, for giving allograft antimicrobial properties, are introduced different types of chemotherapeutic agents, in particular antiseptic substance of powergel, and is intended for plastics hernia of abdominal wall defects.

When replacing defect in the aponeurosis of the abdominal wall are widely used mesh textile prostheses of various synthetic polymeric materials (nylon, Dacron, ftorlona, mersilene, marlex, Teflon) with different properties, with the most typical of them are the high physical and chemical inertness, low reactogenicity, no carcinogenic properties and some others. The main disadvantage of grafts of this type is a high percentage of the resulting post-operative wound infection complications. It is noted that the use of mesh prosthesis made of synthetic polymeric materials to strengthen areas hernioplasty increases the risk of postoperative wound infection complications to 25-66% [Maistrenko N.A., Tkachenko A.N. The negative effects of the surgical treatment of postoperative ventral hernias. In the moznosti forecast and ways of prevention. // The Bulletin of the surgery. - 1998. - T, No. 4. - S-136; Lukomski GI, soludo A.M., Antropov, NV Prospects abdominoplasty synthetic prostheses. // Surgery. - 1994. No. 5. - P.53-54]. So, when using polypropylene mesh prosthesis that gives the least number of complications, wound infection occurs in 6.6% and seroma - 4,4% of treated patients [Turkcapar A.G., Yerdel M.A., Aydinuraz K., S. Bayar, Kuterdem E. Repair of midline incisional hernias using Polypropylene grafts. // Surg. Today. - 1998, №28 (1). - R-63]. According to Vielikanov the use of nylon mesh, synthetic non-absorbable material, as a prosthesis that strengthens link between a tissue in the area of the hernia gate, contributes to chronic inflammatory process in the tissue, which increases the risk of hernia recurrence [Belokonev VI, Pushkin Way HE hernioplasty for large and giant ventral hernias by Belokoneva VI Patent RU 2137432 C1, registered by the Russian Agency for patents and trademarks 11.02.1998].

The high incidence of postoperative wound infection complications when applying mesh textile allografts to strengthen areas are completed and the resulting recurrence of the disease motivates us to search for new approaches to solving this problem. One of them is giving the mesh prosthesis antimicrobial properties by the immobile the sale of antimicrobial agents on the surface or introducing them to the structure of the medical device.

To prevent postoperative wound infection complications Eoulette et al. suggested method of surgical treatment of large and recurrent ventral hernias using a graft made from a biocompatible polymer grids enclosed between two layers of sponge from the restored telopeptide collagen with antibacterial medicinal additives, with a period of resorption in tissue not less than 30 days [levchik EJ, Kozlov V.A., Abant R.K., Istrana L.P., Rubies M.A. Allograft for plastic surgery of hernia gate. The patent RU 2143868 C1, registered by the Russian Agency for patents and trademarks 05.12.2000]. The disadvantage of this method of manufacturing a mesh prosthesis for hermoplastic with antimicrobial properties is used as a carrier antibacterial medicinal supplements restored telopeptide collagen. It is known that collagen as a heterogeneous protein, causes a strong inflammatory reaction in the surrounding tissues of the body, does not dissolve in the required time and even with the healing of wounds on the skin may enter the surface with the formation of nonhealing fistula, has expressed allergenicity. Resorption of collagen in the tissues of the body takes place with the participation of endogenous microorganisms produced in the circulation, the process of biodegradation is called rot [Adamyan A.A. Basic directions of a surgical suture materials in the USSR and abroad. // Proc. Dokl. 1st vsesojuz. proc. "Modern approaches to the development of effective dressing devices and suture materials. - M., 1989. - S-185; Wilensky T.S. lecture "New chemical fiber". M: all-Union Institute of improvement of professional skill of executives and experts of light industry, 1986. - 41 S.].

Known polyamide mesh prostheses with antimicrobial properties ("Amoxin)containing a semisynthetic antibiotics penicillin used for surgical treatment of postoperative ventral hernias [Vassilev Century, Otchet Century, Atanasov A. Application Bulgarian polyamide fabric "Amoxin" and polyamide threads "Policon in surgery. // Medical-biological information. - 1983. No. 4. - P.18-26; Vassilev Century, Krastanov P., Miladinova that is, the Use of biologically active materials "Amoxin", "Policon" and "Aletor in emergency surgery. // Modern surgery. - 1985. No. 10. - P.31-36].

Of all the methods described in the literature analogues on the closest in technical essence as a prototype is a method of obtaining a mesh prosthesis with antimicrobial properties are completed on the basis of knitted nylon transplant, sterilized usually the first method and placed in alcohol solution soluble antibiotic or mixture of antibiotics, for example erythromycin or chloramphenicol, where for 22-24 hours is the impregnation of synthetic fibres specified chemotherapy, after which the graft is dried in air and placed in 7%acetone solution medical glue Sulfacrylate. Processed into the denture adhesive is spread on sterile gauze cloth, where after 1-3 minutes is the polymerization of the adhesive coating. During implantation of the prosthesis into the wound occurs biodegradation covering synthetic fiber polymer, while ensuring long-term portion the release of antibiotics into the surrounding tissue, which, according to the authors, creates local bacteriology environment [places CENTURIES, Korniliev P.L., Shavaleev P.P., Murtazin SA a method of obtaining a transplant with antimicrobial action are completed. The patent RU 2126694 C1 27.02.1999 year].

The main advantage of the method of obtaining the mesh prosthesis with antimicrobial properties are completed, we have chosen as a prototype, as well as the above methods analogues is their underlying modern principle of prevention of postoperative wound infections using chemotherapeutic agents, formulated Vchost.exe and Vol. According to the authors to reduce the number of polioviral is the R infectious wound complications in the area of surgical intervention is required to create a depot of antibiotics due to immobilization and introduce them to the structure of the suture, plastic and draining materials [Postyshev VK, omelyanovski CENTURIES the ways and possibilities of prevention of infectious complications in surgery. // Surgery. - 1997. No. 8. - Page 11-15].

The main advantages of antibiotics are in their high activity, specificity, solubility in tissue fluids, rapid absorption and distribution through the body, effective biotransformation. However, the monotonous "antibiotic pressure is the main cause of the unprecedented increase of resistance of microorganisms, especially gram-negative, and, correspondingly, reduce the clinical effectiveness of basic antibiotics [Zaitsev A.A. Levofloxacin in the treatment of surgical and generalized infections. // Infection in surgery. - 2005. - T.1, No. 1. - P.1-5]. Therefore, most of the above benefits of chemotherapy, parenteral turn into disadvantages when local application. Rapid intake of antibiotics with space applications in the blood and lymph, as well as dilution and neutralization of their tissue fluids do not allow to create local hearth concentration, stable for the time necessary and sufficient for suppression of the pathogen [Eruhin I.A., Gelfand BYR, hatters S.A. Surgical infection. - SPb.: Peter, 2003. - 853 S.].

When antibiotics are used to prevent posleoperatsi the different infectious wound complications in the zone of implantation of the mesh prosthesis is not adhered to the basic principle of the strategy of modern antibiotic therapy, based on their high specificity and is subject to the law of dvuhetapnogo [Savel'ev V.S., Gelfand BYR Antibacterial therapy of abdominal surgical infections. - M: T-Visit, 2003. - 184 S.]. The first stage - as early treatment is the most effective broad-spectrum antibiotics or their combination, taking into account the location and nature of the primary site of infection, suspected pathogens and the projected sensitivity of pathogens to antibiotics. The second stage begins after receipt of culture results and susceptibility of the pathogen. The first correction of the chosen regimen should be carried out after 18-36 hours after intake of the studied material on the basis of antibiogram, re - 3-4 day according to the full bacteriological examination (identification of the pathogen, clarification of antibiogram and others). Thus, the basic principle of the strategy of modern antibiotic therapy cannot be applied in the manufacture of mesh prosthesis for hernioplasty with antimicrobial properties using antibiotics.

When analyzing the causes of failure when antibiotics are used in the method-prototype of particular importance is the fact that antibiotics are used without regard to the mandatory is polymicrobial etiology involving aerobes and anaerobes. Important role in the development of wound infections is changing the priority of the agents in the treatment of surgical infection and the development of antibioticresistance in the treatment process. Failure of antibiotic therapy may be associated with the involvement of an endogenous mechanism of translocation of bacteria [Savel'ev V.S., Gelfand BYR Antibacterial therapy of abdominal surgical infections. - M: T-Visit, 2003. - 184 S.].

Getting a mesh prosthesis with antimicrobial properties are completed by way of the prototype, which for 22-24 hours is the impregnation of synthetic fibres soluble antibiotics, it is not possible to calculate the optimum number of antimicrobial chemotherapy drugs (antibiotic or mixture of antibiotics), impregnated in the fiber mesh of the prosthesis. It is known that prolonged exposure to high concentrations of antibiotics on the fabric when the local application is accompanied by increased inflammatory reaction surrounding the implant body tissues, with a predominance of exudative component, and leads to the formation in this area of necrotic lesion in the toxic action of chemical [Shaposhnikov YG Diagnosis and treatment of injuries. - M.: Medicine, 1984. - 344 S.].

Thus, antibiotics cannot be used to the s in the manufacture of any polymeric medical devices with antimicrobial properties what is the main disadvantage of this method of obtaining the mesh prosthesis for hernioplasty with antimicrobial properties, chosen as a prototype.

The task of the invention to provide a method of manufacturing a mesh prosthesis for hernioplasty based on synthetic polymer filament yarn possessing prolonged antiseptic properties.

The problem is solved in that in the manufacture of mesh prosthesis with antimicrobial properties for hernioplasty, made of synthetic polymer filament yarn, on a grid of synthetic polymer applied polymer composite consisting of the poviargol representing a water-soluble silver-containing antibacterial composition on the basis of the fine metal silver and polymer stabilizer poly-N-vinylpyrrolidone, stable synthetic polymer by Calligonum - high-molecular polyvinylpyrrolidone medical, in the following ratio, wt.%: the substance of powergra - 40-45, polyvinylpyrrolidone molecular medical - 55-60. Followed by drying mesh coated on its surface with the dispersion of hot air by blowing at a temperature of 60-80°C for 20-30 minutes.

Poviargol is vocarstvo emuu silver-containing antibacterial composition on the basis of the fine metal silver and polymer stabilizer poly-N-vinylpyrrolidone [Afinogenov G., Kopeikin CENTURIES, Panarin E.F. water-Soluble silver-containing antibacterial composition and method of reception. The patent RU 2128047 C1 27.03.1999 year].

The process of manufacture of the mesh prosthesis for hernioplasty with antimicrobial properties is as follows.

The way to get poviargol in the form of a polymer composite, consisting of components, wt.%: the substance of powergra - 40-45, kollidon - 55-60, is that 100 g of impregnating the composite with a content of 40% powergra and 60% of kollidon receive the following way:

1) a portion of powergra in an amount of 5 g was dissolved in 10 g of distilled water.

2) a portion of the powder kollidon in the amount of 7.5 g pour distilled water in the amount of 77.5, heated to 50°C and stirred until complete dissolution.

3) the Obtained solutions powergra and kollidon mix and get the composite, which is then used for applying on the net.

The grid of known synthetic polymer filament yarn, such as polyester or polyamide, roll with the tape mechanism is passed through the bath with the obtained dispersion composite. Then the grid is stretched between crimping rolls to remove excess antimicrobial dispersion and fed to the drying with hot air, after which it is avtomaticheskij is cut into mesh prostheses required sizes and Packed in polyethylene bags.

A certain amount of variance in the tub and the selected bandwidth through her mesh provide the production of one batch of products with similar characteristics.

The force pressing on rollers provides the required quantity and uniform deposition of the dispersion of the composite to the surface of the grid. The adhesion of the composite mesh prosthesis is determined by measuring the weight gain of the control sample grid, which is maintained in the range of 15-20%.

Drying mesh on its surface dispersion is produced by hot air at a temperature of 60-80°C for 20-30 minutes to install termodov.

Cutting grid and its packaging are carried out automatically.

Ready Packed mesh prostheses certain size (depending on the scope of their application in surgical practice) sterilized by one of the authorized health Ministry sterilization methods.

Distinguishing the essential features of the claimed method of manufacturing a mesh prosthesis for hernioplasty with antimicrobial properties are:

1. Drawing on a grid of synthetic polymer filament yarn of polymer composite consisting of the poviargol representing a water-soluble silver-containing antibacterial composition on the basis of the fine metal silver and poly the EPA stabilizer poly-N-vinylpyrrolidone, stable synthetic polymer by Calligonum - high-molecular polyvinylpyrrolidone medical.

2. The ratio of components, wt.%: the substance of powergra - 40-45, polyvinylpyrrolidone molecular medical - 55-60.

3. Drying mesh on its surface dispersion (produced by hot air at a temperature of 60-80°C for 20-30 minutes by termodov).

A causal relationship between significant distinctive features and the result:

1. Nonspecific antimicrobial effect is achieved in that for the manufacture of mesh prosthesis for hernioplasty-based polymer synthetic filament yarn used in finished dosage form, the substance of powergra [Afinogenov G., Kopeikin CENTURIES, Panarin E.F. water-Soluble silver-containing antibacterial composition and method of reception. The patent RU 2128047 C1 27.03.1999 year]. Poviargol is a water-soluble silver-containing antibacterial composition on the basis of the fine metal silver and polymer stabilizer poly-N-vinylpyrrolidone.

Poviargol stabilized synthetic polymer by Calligonum - high-molecular polyvinylpyrrolidone medical, which gives the poviargol adhesive properties, allowing firmly occurring is activated it on the net.

According to small-angle x-ray scattering, electron microscopy and sedimentation analysis of zero-valent metal silver in the poviargol exists in the form of nanoclusters spherical shape with a narrow distribution of particle sizes in the range of 1-4 nm, and 80% of the particle sizes of 1-2 nm. For silver particles of this degree of dispersion of the number of surface atoms of silver and silver atoms inside the particle is comparable. Internal atoms form a cubic kernel, and surface - icosahedral lattice of silver. A consequence of the resulting deformation is the change of physico-chemical properties of silver: thermal conductivity, heat capacity, optical and other properties, and, most importantly, the ionization potential compared to the larger colloidal particles of silver or solid metal. Positively charged silver particles are surface-active agent of the cationic type, determining an antiseptic effect.

Synthetic polymer kollidon - high-molecular polyvinylpyrrolidone medical belongs to the class of surfactants nonionic type. It is better than other forms complexes with the largest number of chemical compounds [Berntsen YEAR Records of nature and human activity. - Minsk: E the European book 1994. - 287 S.]. Polyvinylpyrrolidone has pronounced adhesive properties of the polymer filaments of the mesh. Sorption of macromolecules polyvinylpyrrolidone polymer (polyester, polyamide) matrix occurs with lower free surface energy at the phase boundary: water grid. This is confirmed by the better wettability of the sample grid after treatment with a solution of polyvinylpyrrolidone. It can be assumed that the interaction between polyvinylpyrrolidone and polymer (polyester, polyamide) grid occurs with the formation of hydrogen bonds between nitrogen and oxygen through ester bonds. An additional strength of this connection is provided by the cooperative interaction of macromolecules.

Antiseptics have a number of advantages to chemotherapeutic drugs. First of all, the priority of antiseptics is a local application of chemotherapeutic drugs - system application. The advantage of antiseptic preparations before chemotherapy, especially antibiotics, also lies in the fact that they rarely formed sustainable options; mechanisms of selection of such options is less efficient, resulting in a frequency distribution sustainable antiseptics options, especially multiple steady among clinical strains bactericidal below. The main advantage of antiseptics in General, surface-active substances, in particular, is that unlike antibiotics, they are devoid of specific (selective) action on microbes, inhibit or kill various members of the microbial world. The effectiveness of ionic surfactants seen in sufficiently low concentrations [Afinogenov G., pancakes I.E. Antiseptics in surgery. - L.: Medicine, 1987. - 145 S.]. It is established that microorganisms that survived an antiseptic action, does not cause illness due to lack of infective dose and reduced virulence and, ultimately, destroyed by the immune system factors. It should also be borne in mind that most antibiotics (mainly betalaktamov) kill only the bacteria that are in the process of proliferation (logarithmic phase), while antiseptics, as the immune system (phagocytes, antibodies, lysozyme, complement, and others), destroy bacterial cells in any phase of the cell cycle [Savola D., Dmitrieva N.V. Antibiotic prophylaxis in medical practice. - M: Print Partner, 2000. - 128 S.].

According to Rasulgarh and Vfew when species variability of microbes and increasing their resistance to antibiotics the infection of wounds mixed microflora at the local level t is EBUY application of antiseptics, providing multicomponent effect on the wound healing process [Zulkharneev R.A., Chigaev SCI Peculiarities of the clinical course of festering wounds of the abdominal wall after removal of destructive modified Appendix. // The Bulletin of the surgery. - 1997. - T, No. 5. - Page 31-33]. Any, Vaishesika, Ihereby et al. also consider that at the local level is extremely important in the prevention of infectious complications RAS belongs efficient, have a prolonged effect antiseptical [Malinowski N.N., Reshetnikov, VA, Rubashka I.E. et al. Antiseptic preparations based onlinedigital. // Surgery. - 1997. No. 8. - P.8-10].

With chemotherapy, even for local administration of drugs that increase the risk of development of dysbiosis in the body systems responsible for the excretion of antimicrobial agent, while the use of antiseptics, even in high concentrations over a long period of time can cause dysbiosis, limited to one habitat. The absorption of drugs in the blood may also lead to toxic, allergenic, mutagenic action for weakly and slowly resorbable antiseptics uncharacteristically [Savel'ev V.S., Gelfand BYR Antibacterial therapy of abdominal surgical infections. - M: T-Visit, 2003. - 184 S.].

The literature review is vidualistic in favor of antiseptics when choosing antimicrobial substances for the manufacture of a prosthesis for hernioplasty with antimicrobial properties.

2. The optimal ratio of ingredients chosen empirically (see Tab. No. 1, 2). Introduction to floor mesh prosthesis for hernioplasty of poviargol at a concentration of 40-45% gives it a pronounced antimicrobial activity and promotes complete destruction in the wound of conditionally pathogenic microorganisms. Further increase in the concentration of poviargol in mesh prosthesis is limited to the amplification of inflammatory reactions around the implant body tissues and leads to the formation in this area of necrotic lesion in the toxic action of antiseptics, as well as requirements for toxicology.

3. The chosen heat treatment grid on its surface dispersion (drying with hot air at a temperature of 60-80°C for 20-30 minutes to install termodov) provides optimum output mode antimicrobial beginning of the implant into the surrounding tissue as a result of biodegradation of the polymer coating of the grid, what causes prolonged (at least 3 days) antiseptic effect in the area of surgical intervention (see Table. No. 2). It also creates a rather smooth surface and elasticity of a product, which does not injure the surrounding implant tissue and to optimize the comfort of the surgeon that the evidence is but in the course of experimental studies conducted on laboratory animals.

The distinctive set of essential features is new and allows to obtain a method of manufacturing a mesh prosthesis for hernioplasty based on synthetic polymer filament yarn possessing prolonged antiseptic properties.

Examples of a specific implementation method:

Example No. 1.

Mesh prosthesis for hernioplasty based on an integrated polyester yarn (Filament polyester complex nominal linear density of 9.4 Tex with the number of filaments in a complex 32, with twists per 1 m 350, brand: "Thread PE complex 9,4 Tex 32 torsion Z 350, TU RB 400031289.194-2003") was treated with polymer composite containing the substance of powergra and polyvinylpyrrolidone in the following ratio, wt.%: poviargol - 13, polyvinylpyrrolidone molecular medical - 87. Drying mesh coated on its surface with the dispersion produced by hot air at a temperature of 80°C for 30 minutes to install termodov.

Medico-biological testing of samples obtained from unsterilized mesh prosthesis were performed by standard techniques.

Originally approximate idea of the severity of antimicrobial activity of the investigated mesh prosthesis received in vitro m is Todd "diffusion in agar" largest zone of growth inhibition of the test strains Snaphylococcus aureus ATTS 6538, Escherichia coli ATTS 35218, Pseudomonas aerugunosa ATTS 15442, Candida albicans ATTS 10232 at a dose of 108CFU/cm2.

In subsequent in vivo was studied microbial colonization of postoperative wounds in the zone of implantation of fragments of the mesh prosthesis in the tissue of the experimental animals (Guinea pigs) in terms 1, 2 and 3 days. In vivo - fragments of the analyzed mesh prosthesis 15×15 mm aseptically implanted under the skin of experimental animals (adult male Guinea pigs weighing 250-300 grams), which drew from the experience of 1, 2 and 3 days after surgery, aseptically removed previously implanted fragments of the mesh prosthesis and studied the microflora of the Russian Academy of Sciences area of implantation on Petri dishes with MPA. The results are given in tables No. 1 and No. 2.

Example No. 2.

Mesh prosthesis for hernioplasty based on an integrated polyester threads ("Thread PE complex 9,4 Tex 32 torsion Z 350, brand B") was treated with polymer composite containing the substance of powergra and polyvinylpyrrolidone in the following ratio, wt.%: the substance of powergra - 23, polyvinylpyrrolidone molecular medical - 77. Drying mesh coated on its surface with the dispersion produced by hot air at a temperature of 75°C for 25 minutes to install termodov.

Medico-biological testing of samples obtained from netheril the series mesh prosthesis were performed by standard techniques, used in Example No. 1.

The results are given in tables No. 1 and No. 2.

Example No. 3.

Mesh prosthesis for hernioplasty based on an integrated polyester threads ("Thread PE complex 9,4 Tex 32 torsion Z 350, brand B") was treated with polymer composite containing the substance of powergra and polyvinylpyrrolidone in the following ratio, wt.%: the substance of powergra - 31, polyvinylpyrrolidone molecular medical - 69. Drying mesh coated on its surface with the dispersion produced by hot air at a temperature of 70°C for 20 minutes to install termodov.

Medico-biological testing of samples obtained from unsterilized mesh prosthesis were performed by standard techniques used in Example No. 1.

The results are given in tables No. 1 and No. 2.

Example No. 4.

Mesh prosthesis for hernioplasty based on an integrated polyester threads ("Thread PE complex 9,4 Tex 32 torsion Z 350, brand B") was treated with polymer composite containing the substance of powergra and polyvinylpyrrolidone in the following ratio, wt.%: poviargol - 43, polyvinylpyrrolidone molecular medical - 57. Drying mesh coated on its surface with the dispersion produced by hot air at a temperature of 60°C for 25 min is t on the set termodov.

Medico-biological testing of samples obtained from unsterilized mesh prosthesis were performed by standard techniques used in Example No. 1.

The results are given in tables No. 1 and No. 2.

Example No. 5.

Mesh prosthesis for hernioplasty based on an integrated polyester threads ("Thread PE complex 9,4 Tex 32 torsion Z 350, brand B") was treated with polymer composite containing the substance of powergra and polyvinylpyrrolidone in the following ratio, wt.%: poviargol - 13, polyvinylpyrrolidone molecular medical - 87. Drying mesh coated on its surface with the dispersion produced by hot air at a temperature of 80°C for 30 minutes to install termodov.

Biomedical testing samples of the received radiation sterilized by way of a mesh prosthesis were performed by standard techniques used in Example No. 1.

The results are given in tables No. 1 and No. 2.

Example No. 6.

Mesh prosthesis for hernioplasty based on an integrated polyester threads ("Thread PE complex 9,4 Tex 32 torsion Z 350, brand B") was treated with polymer composite containing the substance of powergra and polyvinylpyrrolidone in the following ratio, wt.%: substance poviargol - 23, polyvinylpyrrolidone high the molecular medical - 77. Drying mesh coated on its surface with the dispersion produced by hot air at a temperature of 75°C for 25 minutes to install termodov.

Biomedical testing samples of the received radiation sterilized by way of a mesh prosthesis were performed by standard techniques used in Example No. 1.

The results are given in tables No. 1 and No. 2.

Example No. 7.

Mesh prosthesis for hernioplasty based on an integrated polyester yarn ("Drinking PE complex 9,4 Tex 32 torsion Z 350, brand B") was treated with polymer composite containing the substance of powergra and polyvinylpyrrolidone in the following ratio, wt.%: the substance of powergra - 31, polyvinylpyrrolidone molecular medical - 69. Drying mesh coated on its surface with the dispersion produced by hot air at a temperature of 70°C for 20 minutes to install termodov.

Biomedical testing samples of the received radiation sterilized by way of a mesh prosthesis were performed by standard techniques used in Example No. 1.

The results are given in tables No. 1 and No. 2.

Example No. 8.

Mesh prosthesis for hernioplasty based on an integrated polyester yarn ("Drinking PE complex 9,4 Tex 32 torsion Z 350, marks") education is atively polymer composite, containing the substance of powergra and polyvinylpyrrolidone in the following ratio, wt.%: the substance of powergra - 43, polyvinylpyrrolidone molecular medical - 57. Drying mesh coated on its surface with the dispersion produced by hot air at a temperature of 65°C for 30 minutes to install termodov.

Biomedical testing samples of the received radiation sterilized by way of a mesh prosthesis were performed by standard techniques used in Example No. 1.

The results are given in tables No. 1 and No. 2.

Thus, as seen from the above examples, declare us a method of manufacturing a mesh prosthesis for hernioplasty, in contrast to the method of the prototype, lets give it a prolonged antiseptic properties against pathogenic microorganisms, whose role in the development of postoperative wound infection complications, at present, is considered to be unequivocally proven. It also allows you to create a sufficiently smooth surface and elasticity of the product, without injuring the surrounding implant tissue, and to optimize the comfort of the surgeon.

Table No. 1

The zone of growth inhibition of the test strain of microbe method "di is the fusion in agar in mm for fragments of the mesh prosthesis of polyester filament yarn with a coating of polyvinylpyrrolidone with an antiseptic substance of powergra
The test strain of microbeThe concentration of poviargol wt.%
13233143
The zone of growth inhibition of the test strain of the microbe by the method of diffusion in agar in mm
Staphylococcus aureus ATTS 6538 dose of 108CFU/cm2without sterilization
2,0±0,863,0±0,935,0±0,935,0±0,93
sterilization by radiation method
2,0±0,312,0±0,834,0±0,915,0±1,01
Escherichia coli ATTS 35218 at a dose of 108CFU/cm2without sterilization
4,0±0,877,0±1,019,0±0,3412,0±0,99
sterilization by radiation method
3,0±0,787,0±0,998,0±0,3712,0±1,11
Pseudomonas aerugunosa ATTS 15442 at a dose of 108CFU/cm2without sterilization
1,0±0,382,0±0,743,0±0,335,0±0,54
sterile the situation radiation method
1,0±0,341,0±0,582,0±0,335,0±0,62
Candida albicans ATTS 10232 at a dose of 108CFU/cm2without sterilization
2,0±0,123,0±0,334,0±1,015,0±0,93
sterilization by radiation method
2,0±0,082,0±0,504,0±0,495,0±0,33

A method of manufacturing a mesh prosthesis with antimicrobial properties for hernioplasty, made of synthetic polymer filament yarn, characterized in that the grid of synthetic polymer applied polymer composite consisting of the poviargol representing the metal composition of the fine metal silver, stabilized synthetic polymer by Calligonum, and high-molecular polyvinylpyrrolidone medical, in the following ratio, wt.%:

The substance of powergra40-45
The high-molecular polyvinylpyrrolidone medical55-60

followed by suck the grid on its surface a dispersion of hot air by blowing at a temperature of 60-80° C for 20-30 minutes



 

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2 cl, 13 dwg

FIELD: medicine.

SUBSTANCE: surgical thread is provided with inclined protrusions-notches formed as conical burrs with sharpened plastoelastic ends and sequentially positioned lengthwise of thread. Burrs are positioned at one or both sides of thread section (for example in staggered arrangement) with alternating inclination of burrs. Thread is not attached to surgical needle and is introduced into soft tissues through injection needle clearance.

EFFECT: increased efficiency by using protrusions formed as burrs allowing rupture strength of thread to be kept and functional designation, that is, usage in conducting of aesthetic cosmetic operations, to be fulfilled.

6 cl, 8 dwg

FIELD: medicine.

SUBSTANCE: surgical thread is provided with inclined protrusions-notches formed as conical burrs with sharpened plastoelastic ends and sequentially positioned lengthwise of thread. Burrs are positioned at one or both sides of thread section (for example in staggered arrangement) with alternating inclination of burrs. Thread is not attached to surgical needle and is introduced into soft tissues through injection needle clearance.

EFFECT: increased efficiency by using protrusions formed as burrs allowing rupture strength of thread to be kept and functional designation, that is, usage in conducting of aesthetic cosmetic operations, to be fulfilled.

6 cl, 8 dwg

FIELD: medicine.

SUBSTANCE: surgical thread is provided with inclined protrusions-notches formed as conical burrs with sharpened plastoelastic ends and sequentially positioned lengthwise of thread. Burrs are positioned at one or both sides of thread section (for example in staggered arrangement) with alternating inclination of burrs. Thread is not attached to surgical needle and is introduced into soft tissues through injection needle clearance.

EFFECT: increased efficiency by using protrusions formed as burrs allowing rupture strength of thread to be kept and functional designation, that is, usage in conducting of aesthetic cosmetic operations, to be fulfilled.

6 cl, 8 dwg

Surgical ligature // 2267332

FIELD: medicine, surgery.

SUBSTANCE: the suggested surgical ligature includes polyamide ligature with film covering based upon copolymer at additions of medicinal preparations. Ligature is being a nucleus out of polyamide twisted or woven thread with membrane out of copolymer being that copolyamide of E-caprolactam and hexamethylene diammonium adipinate and containing medicinal preparations - biologically active substances based upon plant biomass of Aralia family and doxicillin, at a certain ratio of components. The ligature in question is of high rupture loading and low lengthening that makes it more convenient in application. Ligature is more elastic and less traumatic.

EFFECT: higher efficiency of application.

10 ex, 2 tbl

Surgical ligature // 2267332

FIELD: medicine, surgery.

SUBSTANCE: the suggested surgical ligature includes polyamide ligature with film covering based upon copolymer at additions of medicinal preparations. Ligature is being a nucleus out of polyamide twisted or woven thread with membrane out of copolymer being that copolyamide of E-caprolactam and hexamethylene diammonium adipinate and containing medicinal preparations - biologically active substances based upon plant biomass of Aralia family and doxicillin, at a certain ratio of components. The ligature in question is of high rupture loading and low lengthening that makes it more convenient in application. Ligature is more elastic and less traumatic.

EFFECT: higher efficiency of application.

10 ex, 2 tbl

FIELD: medicine.

SUBSTANCE: the method deals with selecting primary raw material, followed by acidic-alkaline treatment, cutting, forming semi-finished ligatures, followed by drying, polishing and packing into ampoules or parcels, followed by sealing and sterilization. As primary raw material one should predominantly apply porcine viscera followed by elution of ballast substances with1.3 dimethylketone, treatment with succinic anhydride, then comes cutting for, at least, 2-4 parts to be sterilized in dry water-free state at no any preliminary conservation with predominantly radiation emission followed by material rehydration and packing into individual parcels, then comes conservation and sealing individual packing with sterile ligatures. Rehydration of ligatures should be performed, for example, for 16 h in 0.02% solution of (1.2-ethylene-bis N diethylcarbodecynoxymethyl) ammonium chloride. Power of radiation emission at sterilization corresponds to at least 15 kGy, as for polishing, it is predominantly fulfilled due to "drilling". Simultaneously one should perform group sterilization of ligatures without individual packing followed by packing the sterile material. Group sterilization of suture material should be performed without individual packing with gas method of ethylenoxide, the mixture of ethylenoxide with methyl bromide or beta-propiolactone followed by packing the sterile material. The method provides considerable decrease of production cost price, decreased expenses of primary raw material, improved histocompatibility, decreased allergic and purulent-inflammatory complications and keeping strong parameters during sterilization.

EFFECT: higher efficiency.

5 cl, 3 ex, 1 tbl

FIELD: medical engineering.

SUBSTANCE: device has textile cotton stockinet of 110-210 g/m2 saturated with aqueous solution of polyethylene glycols having molecular weight of 200-2000 and antiseptic and anesthetic drugs. Substrate bears polyethylene glycols 10-50 mg/cm2; antiseptics 0.03-1.0 mg/cm2; anesthetics 0.05-1.2 mg/cm2. Sorption layer is produced above the treatment layer, the former being fabricated from nonwoven fabric to secure bandage sorption power at the level of 10g/g. Textile drug carrier is optionally cotton gauze of 150-250 g/m2 and mesh dimensions of at least 1.5x1.5 mm. Chlorhexidine, Furagin, Iodopironum, povidone-iodine, Quinosol, or Dioxidine are taken as the antiseptic drugs. Lidocaine, Dicaine, Anylocine, and Trimecaine are taken as the anesthetic drugs. Fabric perforation is produced as through canals which total area makes up 20-40% of the whole treatment layer area.

EFFECT: improved sorption and atraumatic features.

5 cl, 1 tbl

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