RU2633490C1 - Material for soft tissues defects substitution - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention discloses a material for soft tissue defects substitution that contains polyacrylamide, water, Reamberin preparation with the following components content, wt %: polyacrylamide - 2.0-8.0; Reamberner - 10.0-18.0; water 74.0-88.0.

EFFECT: invention increases local immunity and reduces aseptic inflammation, resorption, gel migration to surrounding tissues and can be used to replace soft tissue defects.

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Description

The invention relates to medicine and is intended to replace soft tissue defects.

Today, there are many different materials for soft tissue replacement. The most common among them are polyacrylamide hydrogels for injection, which are jelly-like substances with thixotropic properties. The composition of such gels contains about 95% water. When a small pressure is applied, such gels are easily fragmented into small fractions, and after stress relief, the fragments are combined again. This property of the gels allows them to be injected into the body. After injection, the gel fragments should again form aggregates, filling the entire existing cavity.

Known medical supplies based on polyacrylamide hydrogel (WO 2015099578 A1), which includes components: a copolymer of acrylamide and N-N 'methylene-bis-acrylamide, water, hyaluronic acid, in the following ratio, wt. %: acrylamide 0.9-8.2; N-N ' methylene-bis-acrylamide 0.1-1.8; hyaluronic acid 0.1-2.0; water up to 100.0.

Known gel-like material for replacing soft tissues obtained by the method (patent No. 2127129, IPC A61L 27/00, C08F 220/56), taken as a prototype containing 1.0-8.0 wt. % copolymer of acrylamide and methylene bis-acrylamide with a mass ratio of 100: 0.5-5.0 and 92.0-99.0 wt. % and slightly alkaline water. The gel is obtained by copolymerization of acrylamide with methyl bis-acrylamide in an aqueous medium at a pH of 9.0-9.5 in the presence of a peroxide polymerization initiator. The reaction mixture is incubated at t = 20-90 ° C for 2-24 hours and then at t = 100-105 ° C for 2-4 hours

The disadvantages of the described gel-like materials based on polyacrylamide are the development of complications after their introduction into the soft tissues of a person. Severe aseptic inflammatory reaction to a foreign body is one of the main disadvantages of gel-like materials based on polyacrylamide. Polyacrylamide, like any foreign body, undergoes a change in a living organism. Due to their hydrophilic structure, polyacrylamide hydrogels interact intensively with a living organism. The phenomenon of gel dehydration occurs, that is, partial resorption of the material and, accordingly, a decrease in the volume of the introduced gel. Also, some plastic surgeons indicated the migration of the gel into the surrounding tissue, especially with mammoplasty.

The aim of the claimed invention is to increase local immunity and reduce complications.

The problem is solved in that according to the invention, the material for the replacement of soft tissue defects containing polyacrylamide and water, additionally contains "Reamberin" with the following components, wt. %:

polyacrylamide - 2.0-8.0;

Reamberin - 10.0-18.0;

water - 74.0-88.0.

"Reamberin", which is part of the polyacrylamide gel, helps to increase local immunity reactions and reduces the number of complications to its administration: severe aseptic inflammation, resorption and migration into the surrounding tissue. Reamberin, as a component of the described material, enhances local immunity, as a result of which a very thin connective tissue capsule is formed around the transplanted hydrogel, which prevents gel migration. The inflammatory reaction and gel resorption in the pericapsular zone is minimal.

An increase in the mass fraction of Reamberin (more than 18%) in the hydrogel does not lead to a greater improvement in the local immune response, and its decrease (less than 10%) worsens the results of hydrogel transplantation.

The described material is obtained in the following way: Reamberin is mixed homogeneously in an inert gas, such as argon, with a medical grade polyacrylamide hydrogel obtained by copolymerization of appropriate amounts of acrylamide and N, N'-methylene-bis-acrylamide in an aqueous dispersed medium in the presence of predominantly ammonium persulfate or hydrogen peroxide. As the hydrogel, you can use the finished polyacrylamide gel containing a copolymer of 0.9-8.2 wt. % acrylamide and 0.1-1.8 wt. % N-N 'methylene-bis-acrylamide and water obtained in accordance with the method described in patent No. 2127129.

Example 1. A 53-year-old patient with asymmetry of the mammary glands as a result of an injury to the left breast 3 years ago. The scar on the left mammary gland is located in the upper outer quadrant, 5 × 1 cm, somewhat retracted. In the area of the scar, a deficiency of soft tissues of the mammary gland. According to ultrasound and mammography, the glandular tissue of the mammary gland is practically absent; there has been a replacement for adipose tissue, which is typical for women of the climacteric period. Volumetric formations in the mammary glands were not detected. In order to fill the deficit of breast tissue, a polyacrylamide hydrogel with Reamberin in a volume of 50 ml was injected into the scar area of the left breast. The day after the introduction of the hydrogel, an increase in body temperature to 37.2 ° C was observed for three days, which was stopped by prednisolone and suprastin. Within 1 month of outpatient monitoring of the patient, no local inflammatory reactions to the introduced gel transplant were detected. After examination after six months, a good cosmetic effect was achieved - visually the asymmetry of the mammary glands is almost invisible. According to ultrasound, the hydrogel is located at the injection site, its migration did not occur, the gel volume decreased by 15%.

Example 2. Woman 34 years old with asymmetry of the gluteal region. Two years ago, the patient was operated on for a post-injection abscess of the right gluteal region, resulting in some tissue deficiency in the upper outer quadrant of the right gluteal region, where the scar is visualized after opening the abscess with dimensions 4 × 1 cm, retracted. Ultrasound of the volumetric formations of the right gluteal region was not found. Cicatricial deformity of the soft tissues of the right gluteal region. A 60 ml polyacrylamide hydrogel with Reamberin was injected into the postoperative scar area. On the next day and on the following days, the patient had no temperature reaction. There were no local inflammatory reactions to the introduction of the hydrogel. Six months later, according to ultrasound, the polyacrylamide gel did not migrate, located at the injection site, around it a thin connective tissue capsule, gel resorption by 10%.

Claims (2)

A material for the replacement of soft tissue defects containing polyacrylamide and water, characterized in that it additionally contains "Reamberin" in the following components, wt. %: polyacrylamide 2.0-8.0 Reamberin 10.0-18.0 water 74.0-88.0