A method of obtaining a biocompatible material

 

(57) Abstract:

The invention relates to medicine, namely to ophthalmology, and can be used for the manufacture intracorneal lenses and implants, keratoprosthesis and artificial irises. Spend the bulk radical polymerization of acrylic monomers and/or vinyl series in the presence of water and staple. In the polymerized mixture was added fibronectin or chemically modified fibronectin in the amount of 0.02 to 4.0 mg/ml When the polymerization is carried out using an exposure or by using a real initiation. The invention reduces the number of complications associated with excessive scarring or loss of transparency of the optical media of the eye in the area of the implant. 2 C.p. f-crystals.

The invention relates to medicine, namely to ophthalmology, and can be used for the manufacture of intracorneal lenses and implants, keratoprosthesis, artificial irises, etc.

A method of obtaining a plastic material made of collagen for ophthalmology (RF patent N 2033165), which is the copolymerization of sorbed on the polysilicon acid collagen monomers of acrylic and/or vinyl series put the it to the tissues of the eye, that is especially important for vnutripolostnyh implants.

The objective of the invention is to develop a method of producing a biocompatible material for intracorneal lenses and implants, implants for epikeratophakia, keratoprosthesis and artificial irises, which has specific affinity and adhesion to the connective tissues of the eye, allowing implantation to minimize the process of encapsulation.

The technical result that is achievable with the use of the invention is the reduction or absence of complications associated with excessive scarring or loss of transparency of the optical media of the eye in the area of the implant.

The technical result is achieved by that conduct bulk radical polymerization of acrylic monomers and/or vinyl series in the presence of water and a binder, and according to the invention in the polymerized mixture was added fibronectin or chemically modified fibronectin in the amount of 0.02 to 4.0 mg/ml, the polymerization is carried out using an exposure or by using a real initiation.

Fibronectin is a protein that is a key component of the extracellular matrix. One of the main function is in particularly important when the cornea surgery with implants, when it is necessary to minimize or avoid the formation of a capsule around the implant, reducing the optical properties. Introduction fibronectin in the polymer structure allows adhesion to the extracellular matrix and cells to the polymer by type of natural interaction without forming an additional layer capsule.

Chemically modified fibronectin - fibronectin containing one or more reaktionstechnik groups in the molecule. One of the methods of chemical modification of the protein is acylation. The acylation is carried out using an acid chloride of acrylic or methacrylic acid (J. all-Union chemical society them. D. I. Mendeleev, I. XXX, N 4, 1985, 402 - 410).

In the case of chemically modified fibronectin is more covalent joining of protein molecules to the polymer matrix. This is especially important when receiving redkostej polymers with high water content.

The range of concentration of fibronectin is selected experimentally. For this purpose, we studied the adhesion of cells to the peritoneal number of rats radiated polymers. This was prepared cell suspension in medium 199 and brought a concentration of up to 1,5106cells/ml In the article is the temperature value 37oC for 1 hour, then the solution was decanted and count the cells per unit area of the polymer surface with a microscope. The results were compared with the control, which was a polymer synthesized in identical conditions, but without addition of fibronectin.

When the concentration of fibronectin in the polymerized mixture is less than 0.02 mg/ml adhesion of the cells was identical reference samples of the polymer. In the concentration range of 0.02 to 4.0 mg/ml adhesion of cells in the test samples was significantly higher than the control. By increasing the concentration of fibronectin above 4.0 mg/ml did not observe a further increase in the number of adhered cells.

Biocompatible material was prepared as follows. To the monomer of acrylic or vinyl series or their mixture was added water, a binder and an aqueous solution of fibronectin or chemically modified fibronectin. The mixture was stirred, was degirolami, saturated with an inert gas, again degirolami, and then polymerizable using radiation, such as gamma irradiation or ultraviolet irradiation. Instead irradiation, the polymerization was performed using real initiators. To this end, in the polymerized mixture dobavljaca illustrated by examples.

Example 1. To 78,0 ml of monomer hydroxyethylmethacrylate add 2.0 ml of staple Triethylenetetramine and 20 ml of an aqueous solution of fibronectin with a concentration of 0.1 mg/ml and the concentration of fibronectin in the polymerized mixture is 0.02 mg/ml Solution is stirred, Tegaserod, is saturated with an inert gas and again Tegaserod. The mixture will polimerizuet using gamma radiation dose of 2 mrad. From the obtained polymer by the method of turning were formed intracorneal implants in the form of a ring thickness of 200 microns, with a diameter of 6.5 mm and a hole diameter of 5.5 mm

Patient A. 35 years with a diagnosis of right eye myopia of a high degree, the myopic maculodystrophia - operation alloplastic keratophakia with implantation intracorneal implant from FIBROSIS in the form of a ring. The operation carried out on the valve, seamless technique without complications. In the postoperative period, the cornea was transparent, visually defined by a slight swelling of the front flap of the cornea above the lens held on the 2nd day after surgery. By the same date, the cornea has received an estimated ophthalmometry with improvement of visual acuity.

Example 2. To 59,5 ml of monomer hydroxyethylmethacrylate add what situation 10 mg/ml The concentration of fibronectin in the polymerized mixture is 4 mg/ml Solution is stirred, Tegaserod and polimerizuet using gamma radiation dose of 2 mrad. From the obtained polymer by the method of turning were formed intracorneal implants in the form of a positive meniscus thickness of 180 microns and a diameter of 5 mm

Patient B. 65 years with a diagnosis of right eye postoperative aphakia, complicated hernia vitreous body, "dry" maculodystrophia - operation alloplastic keratophakia with implantation intracorneal implant from FIBROSIS. The operation carried out on the valve, seamless technique without complications. In the postoperative period, the cornea was transparent, visually defined by a slight swelling of the front flap of the cornea above the lens held on the 2nd day after surgery. By the same date, the cornea has received an estimated ophthalmometry with improvement of visual acuity.

Example 3. To 65 ml hydroxyethylmethacrylate add 25 ml of an aqueous solution of acidified fibronectin at a concentration of 4 mg/ml and 7.6 ml of water, the solution is thoroughly mixed, Tegaserod and add 0.8 ml of tetramethylethylenediamine and 1.6 ml of 10% aqueous solution of sodium persulfate. Received see the ducks polymer product is recovered from the mold, thoroughly washed and sterilized using gamma radiation.

The size of this form is a diameter of 3.5 mm, a thickness of 100 microns. The disk was implanted in the corneal stroma of the rabbit. The implant showed a good biocompatibility. Within 6 months there was no trophic disorders of the cornea. Morphologically did not identify specific infiltration of leukocyte cells and macrophages.

Example 4. To 60 ml of water, add 20 g of acrylamide and 40 ml of an aqueous solution of chemically modified fibronectin concentration 1 mg/ml Solution is stirred, Tegaserod and placed into a matrix having the form of a meniscus, with a diameter of 8 mm and a thickness of the center 100 microns. The polymerization mixture was performed in a matrix using gamma irradiation dose of 1.0 mrad. After that, the lens was removed from the matrix, thoroughly washed with water and sterilized.

Then decapitalizing the surface of the cornea of the rabbit was placed the lens in the form of a meniscus thickness of 100 microns (edge 20 to 30 microns) with the holes on the periphery, through which it podshivalsya to the stroma. The follow - up period was 2 weeks. Under the bio micro scope on the 3rd day was found barely noticeable Ostrovki cells on the periphery of the lens. A number of them in the follow-up period of up to 2 weeks led produced by scanning electron microscopy lenses. Throughout its surface is detected islet growth of epithelial cells, interconnected "tracks" of cells. Cells are arranged in a monolayer, are flush with each other, uniform in shape. Some cells of smaller size, probably younger. Inflammatory cells are virtually absent.

The results obtained indicate that FIBROGEN has a specific affinity to skin cells.

Thus, the proposed method of producing a biocompatible material FIBROGEN allows the manufacture of implants for ophthalmic surgery, which has a higher affinity to the tissues of the eye.

1. A method of obtaining a biocompatible material, including bulk radical polymerization of acrylic monomers and/or vinyl series in the presence of water and a binder, characterized in that the polymerized mixture was added fibronectin or chemically modified fibronectin in the amount of 0.02 - 43,0 mg/ml

2. The method according to p. 1, characterized in that the polymerization is carried out using an exposure.

3. The method according to p. 1, characterized in that the polymerization is carried out with the help of a real initiation.

 

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