RU2287350C1 - Antiglaucomatous drainage - Google Patents

Abstract

FIELD: medicine, ophthalmology.

SUBSTANCE: the present innovation deals with a drainage for treating glaucoma that includes collagen types II-III immobilized in polymer of acrylic and vinyl rows, includes a cytostatic covalently bound with collagen types II-III, hypotensive preparation and not less than one rigidity rib at certain ratio of components. The innovation provides improved ocular hydrodynamics, suppression of reparative and cicatricial processes around the drainage suggested.

EFFECT: higher efficiency.

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Description

The invention relates to medicine, more specifically to ophthalmology, and is a drainage for the treatment of glaucoma.

There are various types of drains that are used to treat secondary glaucoma, which help maintain the outflow paths created during surgery, thereby achieving stabilization of the ophthalmotonus (US Pat. RF No. 2175535).

Known explant from polymer materials. Such drainage has a high percentage of water and an aqueous buffer shell, has softness and elasticity, and the ability to filter water, which determines the optimal biological tolerance of the material by body tissues (Cheglakov Yu.A. Abstract of dissertation for the degree of Doctor of Medical Sciences, Moscow, 1989, p. 19).

However, according to the author, persistent normalization of IOP can only be achieved in 70% of cases.

The cause of failure is mainly hemorrhagic complications and an inflammatory reaction of the eye, inducing scarring processes in the area of surgical intervention, which leads to obliteration of the created outflow pathways and increased IOP. The closest analogue is drainage for the treatment of neovascular glaucoma (RF patent No. 2239399), including a polymer and containing type II-III collagen immobilized in a polymer of acrylic and / or vinyl series.

However, this drainage does not fully compensate for intraocular pressure in cases of high reparative activity of the sclera in the area of operation, in addition, the absence of stiffening ribs in the drainage does not allow adequate resistance to the formation of a connective tissue capsule around it during postoperative scarring and, accordingly, worsening of the outflow of intraocular fluid in the remote postoperative period.

An object of the invention is the creation of drainage for the treatment of glaucoma, containing components that suppress reparative activity in the area of operation, and structurally reinforced with stiffeners to resist the formation of a dense connective tissue capsule around it.

The technical result is to improve the hydrodynamics of the eye, the suppression of reparative and cicatricial processes around the drainage.

The technical result is achieved by the fact that drainage for the treatment of glaucoma, including type II-III collagen, immobilized in a polymer of acrylic and / or vinyl series, additionally contains a cytostatic covalently attached to type II-III collagen, a hypotensive drug, and at least one stiffener with the following ratio of components:

Collagen type II-III - 0.1-50%

Cytostatic - 0.01-3

Antihypertensive drug - 0-2%

Polymers of acrylic and / or vinyl series - the rest

The polymer basis of the drainage contributes to the resilience of the drainage to resorption and its resistance over a long period of time. The additional content of collagen, which is gradually and metered released in the postoperative period, improves the filtration properties of the drainage, increases the level of filtration of intraocular fluid and prevents obliteration of the created outflow pathways.

The presence of a cytostatic covalently attached to type II-III collagen will prevent the migration of cells near the surface and in the thickness of the drainage, which will allow to maintain the achieved postoperative normal eyeball tone.

The presence of at least one stiffening rib will mechanically prevent the formation of a dense connective tissue capsule in the distant postoperative period and, accordingly, maintain the formed pathways of the outflow of intraocular fluid.

The presence of a hypotensive drug in the drainage is necessary in cases of increased production of intraocular fluid associated with traumatic, trophic or other lesions of the ciliary body.

The concentration of type II-III collagen cannot be less than 0.1% due to an insignificant therapeutic effect and cannot be more than 50% due to possible allergic reactions.

The total concentration of the covalently attached to the collagen cytostatic cannot be less than 0.01% due to the low therapeutic effect and cannot be more than 3% due to the increased risk of local necrotic changes in the adjacent tissues caused by its toxic effect. As a cytostatic agent, it is preferable to use the preparations Mitomycin, Mitotax and their analogues.

The concentration of the antihypertensive drug cannot be more than 2% to avoid persistent hypotension. As a hypotensive drug, it is preferable to use drugs from the group of a- or b-blockers, for example Proxonol, Proxodolol.

Stiffeners are formed during the copolymerization of collagen and polymers of acrylic and / or vinyl series. The most preferred forms of drainage with stiffeners are presented in figures 1-6. Figure 1 ribs presents a top view of the drainage, figure 2 - section aa drainage in figure 1; figure 3 is a top view of the drainage, figure 4 is a section along BB; figure 5 is a top view of the drainage, figure 6 is a section along CC.

Brief production technology. By chemical crosslinking, the cytostatic is attached to type II-III collagen, mixed with a monomeric or oligomeric mixture of acrylic and / or vinyl mono- or oligomers, and polymerized by pouring the mixture into molds. The shape follows the most preferred drainage designs shown in FIGS. 1-6. Stiffeners are formed in the polymerization process from the material of the drainage. The drainage is removed from the mold, if necessary, soaked in a solution of an antihypertensive drug, sterilized.

Example 1

Patient A. OS - glaucoma of the 2nd-3rd degree, IOP compensated by 33 mm Hg The operation was performed non-penetrating deep sclerectomy with implantation of drainage according to the invention of the following composition, wt.%:

Collagen type II-III - 6

Mitomycin C - 0.1

Polypropylpyrrolidone - 93.9

2 stiffeners

In the early and long-term postoperative period, eye pressure did not exceed 23 mmHg, no hypotension was observed. Cicatricial changes were not observed.

Example 2

Patient J. OD - glaucoma of the 4th degree, IOP uncompensated 46 mm Hg The operation was performed non-penetrating deep sclerectomy with implantation of drainage according to the invention of the following composition, wt.%:

Collagen type II-III - 30

Mitotax - 3

Proxonol - 2

Poly-2-hydroxyethyl methacrylate - 65

4 stiffeners

In the long-term postoperative period, IOP was no more than 23-24 mm Hg; in the early postoperative period, slight hypotension was observed within 17-18 mm Hg. Cicatricial changes were not observed.

Example 3

Patient A. OS - glaucoma of the 2nd degree, IOP compensated 24 mm Hg The operation was performed non-penetrating deep sclerectomy with implantation of a drainage according to the invention of the following composition, wt.%:

Collagen type II-III - 0.1

Mitomycin C - 0.01

Polyvinylpyrrolidone -99.89

1 stiffener

In the early and long-term postoperative period, the IOP was 20-21 mm Hg. No hypotension was observed. Reparative processes in the area of operation were not identified.

A total of 24 patients with various degrees of open-angle, angle-angle, refractory and neovascular glaucoma were operated using the drains according to this invention. Compensation of intraocular pressure was achieved in 100% of cases, any specific complications - excessive scarring, protrusion of the drainage, etc., were not detected. Thus, the drainage according to the invention can be recommended for widespread use in glaucoma surgery.

Claims (1)

Drainage for the treatment of glaucoma, including type II-III collagen immobilized in a polymer of acrylic and / or vinyl series, characterized in that it additionally contains a cytostatic covalently attached to type II-III collagen, a hypotensive drug and at least one stiffener made of material chemically identical to the drainage material and formed during its manufacture with the following ratios of components, wt%: Collagen type II-III 0.1-50 Cytostatic  0.01-3 Antihypertensive drug 0-2 Polymers of acrylic and / or vinyl series  Rest

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