The material for the manufacture of soft tissue implants

 

(57) Abstract:

The invention relates to medicine, namely transplantation, and can be used for the manufacture of breast prostheses, the male testes and other non-rigid implants, to fill the hollow areas of the body. The invention consists in that the material for the manufacture of implants soft tissue, including hydroxyethylmethacrylate, a crosslinking agent and water as a cross-linking agent used dimethacrylate tredecillion in the following ratio, wt. % hydroxyethylmethacrylate 13 - 34; dimethacrylate tredecillion 0,2 - 2,0; water 64,0 - 86,8. The material is biologically inert. Has a high moisture content and high speed reaching equilibrium degree of swelling. Thus the elasticity of the material is easily adjustable by varying the ratio of its components. A high degree of elasticity of the material allows you to quickly restore the specified form. The material has no toxic, safe for the body. During implantation, the material does not cause pathological changes in the surrounding tissues, not rejected, so it can be used for the manufacture of prosthetic testicles, the NGOs transplantation, and can be used for the manufacture of breast prostheses, the male testes and other non-rigid implants, to fill the hollow areas of the body.

The most widely used material for the manufacture of implants is a siloxane rubber (N. A. Plate. The compilation. Synthetic polymers for medical purposes. Tashkent. Fang, 1984, S. 30-31). Siloxane rubber obtained by vulcanization of a mixture of polydimethylsiloxane filled with Aerosil and antistructure additive.

The disadvantage of this material is its low mechanical strength, so that the implants based on it is manufactured by coating material a thin polymer film, which can be damaged during surgical intervention with the release of the contents into the surrounding tissue. Furthermore, the material does not have sufficient for long-term implant biocompatibility and shows increased toxicity, particularly when the violation of the integrity of the protective polymer film.

As the prototype is accepted material based on crosslinked polyhydroxyethylmethacrylate used for the manufacture of artificial crystalline lens of the eye [1] the Material consists of 61-65 wt. sewn the tion of hydroxyethylmethacrylate and a crosslinking agent in an aqueous solution in the following ratio of components, wt.

Hydroxyethylmethacrylate 60-65

A crosslinking agent 1-2

Water 33-39 as a cross-linking agent used equimolar mixture of triethylene glycol dimethacrylate and dimethacrylate of tridecemlineatus.

The disadvantage of this material is its low moisture content, which is determined by the chemical nature of the used compounds and conditions for the material. With the removal of water from the material cannot be achieved by mechanical impact, and only evaporation at elevated temperatures. The disadvantages of the material include a long time swelling after drying, which depends on the shape of the product and for a sphere with a diameter of 20 mm is not less than 10 hours

The aim of the invention is the creation of a universal plastic and inert material for the manufacture of soft tissue implants.

The aim is achieved in that the material for the manufacture of implants soft tissue, including hydroxyethylmethacrylate, a crosslinking agent and water as a cross-linking agent used dimethacrylate of tridecemlineatus in the following ratio, wt.

Hydroxyethylmethacrylate 13-34

Dimethacrylate of Tribeca-e and high speed reaching equilibrium degree of swelling. Ball from the resulting material with an initial diameter of 20 mm, which is almost completely removed the water, when immersed in water takes the original form for 1 min. the elasticity of the material can be easily adjusted by changing the ratio of its components. High elasticity allows you to quickly restore the specified form and save it. The material has no toxic, safe for the body.

During implantation, the material does not cause pathological changes in the surrounding tissues, not rejected, so it can be used for the manufacture of prosthetic testicles, breast cancer, to fill the empty cavities, repair cosmetic defects.

P R I m e R 1. In 86.8 ml bidistilled water dissolve 13 g of hydroxyethylmethacrylate (HEMA) and 0.2 g dimethacrylate of tridecemlineatus (TGM-13). To the solution was added a polymerization initiator: 0.02 mg of ammonium persulfate and 0.002 ml of N,N,N,N-tetramethyl Ethylenediamine. The solution is poured into a mold, which represents an ellipsoid of rotation with the axes 40 and 25 mm and incubated for 1 h at room temperature (18aboutC). During this period of polymerization. The form is opened and the polymer is removed, it is Sebaa and 80 g of water. The modulus of elasticity of the material is 0.06 kg/mm2.

The testicular prosthesis implanted patient. The patient is followed over the years. In this note a distinct cosmetic effect (endoprosthesis palpation mimics a healthy testicle). Edema and inflammatory changes of the scrotum during the whole observation period is not noted.

P R I m m e R 2. In 85 ml of bidistilled water dissolve 13,0 g hydroxyethylmethacrylate (HEMA) and 2.0 g dimethacrylate of tridecemlineatus (TGM-13).

To the solution was added a polymerization initiator: 0.02 mg of ammonium persulfate and 0.002 ml of N,N,N,N-tetramethylethylenediamine. The solution is poured into a mold and incubated for 2 h at room temperature. During this period of polymerization. The form is opened and the polymer is removed, it is porous, soft mass of white. Receive material in the form of a breast prosthesis. The modulus of elasticity of the material equal to 0.04 kg/mm2.

P R I m e R 3. In 65 ml of bidistilled water dissolve 34,0 g hydroxyethylmethacrylate (HEMA) and 1.0 g of dimethylacrylate of tridecemlineatus (TGM-13). To the solution was added a polymerization initiator: 0.02 mg of ammonium persulfate and 0.002 ml of N,N,N,N-tetramethylethylenediamine. The solution Ecrivait and the polymer removed. Receive material with modulus of elasticity of 0.08 kg/mm2.

P R I m e R 4. In 79,8 ml bidistilled water was dissolved 20 g of hydroxyethylmethacrylate (HEMA) and 0.2 g dimethacrylate of tridecemlineatus (TGM-13). To the solution was added a polymerization initiator: 0.02 mg of ammonium persulfate and 0.002 ml of N,N,N,N-tetramethylethylenediamine. The solution is poured into a mold and incubated for 1 h at room temperature. After polymerization the form is opened and the polymer removed. Receive material with modulus of elasticity of 0.06 kg/mm2.

P R I m e R 5. In 74,2 ml bidistilled water dissolve 25 g of hydroxyethylmethacrylate (HEMA) and 0.8 dimethacrylate of tridecemlineatus (TGM-13). To the solution was added a polymerization initiator: 0.02 mg of ammonium persulfate and 0.002 ml of N,N,N,N-tetramethylethylenediamine. The solution is poured into a mold and incubated for 1 h at room temperature. After polymerization the form is opened and the polymer removed. Receive material with modulus of elasticity of 0.07 kg/mm2.

The MATERIAL FOR the MANUFACTURE of IMPLANTS SOFT TISSUE, including hydroxyethylmethacrylate, a crosslinking agent and water, characterized in that as the cross-linking agent used cricketcricket tridecapeptide tredecillion - 0,2 - 2,0

Water - 64,0 - 86,2

 

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