RU2216358C1 - Polymeric dressing - Google Patents

Abstract

FIELD: medicine, surgery. SUBSTANCE: the present method deals with restoring the defects of soft tissues after organoremoving operations and correcting inherent anomalies of development. The suggested material is made of polymeric composition including acrylamide, N,N,- methylenebisacrylamide, potassium persulfate, triethanolamine and distilled water in certain quantitative ratio. Application of new dressing indicates the absence of allergenic, stimulating, generally toxic and carcinogenic action. EFFECT: higher efficiency. 6 dwg

Description

 The invention relates to medicine, in particular to surgery, and can be used as a dressing and for the repair of soft tissue defects after organ-bearing operations and correction of congenital malformations.

A known method of obtaining a soft contact lens (P. 2104675, RU, IPC ⁶ : A 61 F 2/16). The starting components for obtaining a soft contact lens are taken in the following ratio: acrylamide 25-60%; a crosslinking agent of 0.07-1.20%; potassium or sodium persulfate 0.05-0.40%; N, N, N ', N'-tetramethylethylenediamine 0.08-0.30%; distilled water - the rest is up to 100%.

An injection composition for endoprosthetics is also known (P. 2034465, RU, IPC ⁶ : A 01 N 1/00), which is a ready-made polymer composition PAG "Interfall" containing tetramethylethyldiamine 0.001-1.0%; acrylamide 3.5-9.0%; methylene bis acrylamide 0.01-1.0%; ammonium persulfate 0.001-1.0%; distilled water - the rest is up to 100%.

 However, the described compositions cannot be used due to toxicity.

 The task of the invention is to eliminate the toxic reaction.

The problem is solved in that as the inventive polymer material using a finished polymer composition containing acrylamide, N, N-methylenebisacrylamide, potassium sulfate or ammonium sulfate, N, N, N, N-tetramethylenediamine or triethanolamine in the following ratio, wt.%:
Acrylamide - 15-20
N, N-methylene bisacrylamide - 0.019-0.132
Potassium sulphate or ammonium sulphate - 0.084-0.1
N, N, N, N-tetramethylenediamine or triethanolamine - 0.075-0.106
Distilled Water - Else
A polymerizing composition is prepared from the starting components as follows.

Preparation of solution 1
3.1 g of ammonium sulfate are weighed, placed in a glass with a capacity of 800 ml, 460 ml of distilled water are measured with a cylinder and poured into a glass. The solution is stirred.

Preparation of solutions 2 and 3
0.75 g of N, N-methylenebisacrylamide is weighed, placed in a 3 liter bottle. 1248 ml of a 40% aqueous solution of acrylamide are measured with a cylinder and placed there. When using dry acrylamide, a 40% aqueous solution is preliminarily prepared as follows: 800 g of acrylamide are weighed, placed in a volumetric flask or cylinder with a capacity of 2 l, the volume is adjusted with distilled water to 2 l, stirred until the acrylamide is completely dissolved and filtered through a funnel with a paper filter .

 3.1 g of triethanolamine are weighed, placed in a bottle. 1287 ml of distilled water is measured with a cylinder and also placed in a bottle. Get solution 2, which is thoroughly mixed manually or using a mixer and filtered through a Buchner funnel with a paper filter into a Bunsen flask, after which solution 2 is transferred again to the bottle and the solution is added 1. Solution 3 is obtained. Solutions 1 and 2 are drained immediately before loading the reactor.

 The disassembled reactor is thoroughly washed with running water using detergent and rinsed with distilled water. After drying, the reactor is collected.

 Solution 3 is poured into a polymerization reactor. The polymerization is carried out at ambient temperature for 40 ± 5 minutes. At the end of the polymerization process, the plate block is removed and disassembled: the molds and gaskets are separated, the gel plates are removed from the molds and transferred to the cleaning stage.

The resulting plates are washed from residual monomers, linear polyacrylamide, traces of initiator and catalyst, as well as their decomposition products. The plates are placed in the collector and when sparging with compressed air, they are washed as follows:
1st washing - the plates are poured with distilled water at the rate of 50 ml per rectangular plate (i.e. 10 l per 200 plates). The washing is carried out for 30 minutes, the washing water is drained;
2nd and 3rd flushing - the same as the first;
4th and 5th rinses - the plates are filled with distilled water at the rate of 80 ml per rectangle and they are washed under the same conditions for an hour.

 The linear dimensions of the obtained plates after washing increase by 1.5 times, the volume - by 3.24 times in comparison with the corresponding parameters before washing.

The resulting plates are controlled on:
a) appearance (visually);
b) color;
c) mass fraction of ash;
d) the presence of heavy metals;
d) the presence of residual monomers.

The resulting plates are placed in plastic bags and sterilized by the method of tindalization on a water thermobahn at a temperature of 65 ^o C for 60 min twice with an interval of 24 hours.

 The resulting plates are used in clinical practice as a dressing (insulating and therapeutic) material, a carrier of various biological substances. Depending on the purpose of the medium, varying the ratio of components, it can be obtained with different density and pore sizes, as well as in various forms (beveled columns, disks, granules, etc.). It is absolutely transparent, insensitive to high temperatures, radiation and UV radiation, biologically inert, able to be saturated with any nutrients, the resulting nutrient medium can be sterilized by thermal or radiation method. For clinical practice (surgery, dermatology, plastic surgery, etc.), it is produced in the form of various forms by order of the consumer. Finished forms are delivered hermetically packed in plastic bags and sterile. Shelf life 2 years.

 It was found that when the claimed polymer material came into contact with various tissues and organs of experimental animals, no pathology was detected. The results of long-term studies indicate the absence of allergenic, irritating and general toxic effects, as well as carcinogenic effects.

 Clinical testing of the use of the proposed plates as dressings was carried out in the hospital surgery clinic of the Siberian State Medical University (Tomsk).

The properties of the polymer material used in the treatment of trophic ulcers:
1. Synthetic material is a biologically inert material.

 2. Ease of preparation and dressing.

 3. Hydrophilicity.

 4. The ability to saturate with liquid drugs.

 5. The possibility of individual preparation for the patient, given the stage of the wound process and the sensitivity of microflora.

 6. Osmotically active on the wound, due to which it forms a drug-active gel.

 7. Has a smooth surface, so it does not injure granulation and skin grafts.

Drugs used for saturation:
1. A solution of Dioxidine 1%.

 2. Trypsin solutions.

 3. Sococeryl.

 4. Gentamicin.

 The method of application.

 The polymer material comes in sterile, packaged in a plastic bag, having a soft-elastic consistency, transparent, in the form of a plate.

 The plate is removed from the bag and immersed in a pre-prepared solution for 48 hours in a sterile container, for ease of extraction on a gauze napkin.

 The maximum saturation of the plate occurs in the first day, significantly slowing down in the subsequent. The material is placed on a gauze napkin and placed in a container with a saturated liquid.

 The plate increases in size, becomes a jelly-like consistency, maintaining its transparency, starting from the second day the plate practically does not increase in size (Fig. 1).

 The most optimal option for preparing the plate: saturation of the plate for 24-48 hours before use. The plate is removed from the container with the solution, on a sterile dressing table is modeled by the size of the ulcer or several plates are placed depending on the size of the ulcer. A plate is modeled on a gauze napkin, with which the drug is placed on the ulcer, followed by fixation to the lower leg with several rounds of gauze bandage and partially adhesive fixation.

 Dressing in the stage of purulent-necrotic process is performed daily. The plate is removed from the wound, subjected to mechanical cleaning with a jet of water from the tap, after which it is placed in a solution of furacilin 1/5000 for several hours and dried in air. Re-sterilization - by autoclaving. According to this scheme, the plate in dressings can be used up to 3 times. After which the plate loses its elastic and hydrophilic properties.

 In the stage of elimination of purulent-necrotic complications between the wound surface and the plate, a layer of pus and necrotic tissue is formed, which is removed mechanically during ligation (figure 2).

 In the stage of stimulation of reparative processes, a combination with ointment was used: solcoseryl jelly or ointment was placed between the plate and the wound, and ligation is performed every other day. Between the surface of the ulcer and the plate, a gel layer is formed that has active regenerative properties. This layer during removal of the plate is not injured, and the next plate is laid on it. The appearance of the wound gel is visible in figure 3.

 With success, the plate is applied to the wound after plastic surgery of the skin. In most cases, skin plastic surgery was performed according to Yanovich-Chaynsky-Davis. Immediately after surgery, a wafer saturated with an antibacterial solution is placed on the wound. The first ligation was carried out for 2-3 days. The gauze dressing was removed from the wound and the wound was examined through the plate, if there are no local accumulations of blood, exudate between the wound and the plate, then the plate is left for another day. In case of accumulation of liquid under the plate, the plate changes. Having a smooth surface, the plate does not injure the skin graft and granulation surface of the wound, contributing to their engraftment and epithelization of the wound. Figure 4 shows the dressing after plastic surgery of the skin for 4 days.

 The main advantage of the proposed dressing in the clinic is that a wound gel forms between the smooth surface of the plate and the ulcer, therefore, during the dressing and after the dressing, the patient does not experience pain. This factor and the presence of wound gel favorably affect the healing process of the ulcer (figure 5).

 Trophic ulcers are cleared of necrotic tissues 1.7 times faster than in the control group (mechanical purification with hydrogen peroxide 3%, furatsillin solution 1: 5000, dressing with small levomikol and others). As a result, the duration of treatment decreased by 1.3 times.

 The proposed composition for arthroplasty was used as follows.

 Patient K. was hospitalized in November 2000 at the Surgical Hospital Clinic named after A.G. Savinyh Siberian State Medical University (Tomsk).

 Complaints about a cosmetic defect in the breast (Fig.6) and psychoemotional depression.

 From the anamnesis: in 1999, a Halstead mastectomy was performed for breast cancer. The postoperative period was uneventful.

 Objectively: on the front wall of the right half of the chest (at the site of removal of the breast) postoperative scar 15 cm, soft, elastic, healing by primary intention. No signs of relapse were found.

 The patient was offered several types of breast prostheses. Due to the high cost of implants, the patient refused them. The expressed depressive syndrome due to a cosmetic defect in the breast allowed us to offer it a breast implant developed by us from the inventive polymer material, which was investigated in the experiment, and there was no negative effect on the body.

 On November 15, implantation of the breast prosthesis developed by us from the proposed material under the skin was performed. The implant had the shape of a truncated cone, a base diameter of 7 cm, a truncated cone 3 cm, a height of 4 cm. The postoperative period was uneventful. Over two years, the implant doubled in volume.

 The patient does not show complaints at the time of the control examination, her mental state is satisfactory.

Claims (1)

Polymer dressings made of a polymer composition comprising acrylamide, N, N-methylenebisacrylamide, potassium sulfate or ammonium sulfate, triethanolamine and distilled water, in the following ratio, wt. %:
Acrylamide - 15-20
N, N-methylene bisacrylamide - 0.019-0.132
Potassium sulphate or ammonium sulphate - 0.084-0.1
Triethanolamine - 0.075-0.106
Distilled Water - Else

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