RU2304946C2 - Draining means for surgically treating glaucoma cases - Google Patents

Abstract

FIELD: medical engineering.

SUBSTANCE: means has hydrogel, glycosamine glycanes, steroid anti-inflammatory preparation, cytostatics, buffer salts, water taken in known proportion between ingredients in % by mass.

EFFECT: reduced inflammatory response manifestations; created unfavorable conditions for cicatrix formation in surgical intervention zone.

Description

The invention relates to medicine, namely to ophthalmology, and is intended for the treatment of glaucoma.

Known hydrogel drainage for the treatment of glaucoma (RU 2154450). However, the use of this drainage for the treatment of glaucoma has a number of significant drawbacks associated with the lack of hydrogel drainage ability to prevent inflammation, early scarring in the operation area. This can lead to an increase in intraocular pressure due to impaired outflow of intraocular fluid. In addition, the lack of anti-inflammatory properties in the drainage does not prevent severe reactive inflammation in the surgical area and accelerate the proliferative reaction. Over time, a connective tissue capsule forms around the drainage, performing the entire space between the drainage and surrounding tissues, which can block the newly created outflow paths. Active inflammatory processes lead to the destruction of drainage in the distant postoperative period, which also worsens the outflow of intraocular fluid due to excessive scarring.

The technical result of the invention is to reduce the inflammatory response, create adverse conditions for the development of excessive scarring of the surgical area, reduce destruction by reducing the level of macrophage attack on the drainage material, while maintaining the structure in the long-term postoperative period.

The technical result of the present invention is achieved in that the drainage further comprises glycosaminoglycans, a non-steroidal anti-inflammatory drug, a steroidal anti-inflammatory drug, cytostatic, buffer salts, water, in the following ratio, wt.%:

Hydrogel 0.1-99 Glycosaminoglycans 0.001-10 Non-steroidal anti-inflammatory drug 0-5 Steroidal anti-inflammatory drug 0-5 Cytostatic 0-1 Buffer salts 0.5-1.5 Water Rest

Glycosaminoglycans, being an integral element of connective tissue, actively participate in water-salt metabolism, have a decongestant effect, as well as the ability to regulate the intensity of mitoses and phagocyte migration, participate in collagen fibrillogenesis and inhibit cell aggregation and adhesion. All this has an anti-inflammatory effect and reduces the processes of proliferation, excessive scarring in the area of tissue damage. Under the influence of glycosaminoglycans, the newly formed outflow pathways have a longer filtering ability. Thereby, the action of antiglaucomatous surgery is prolonged due to the cytostatic and anti-inflammatory effects of the chemical components contained in it and the mechanical properties of the drainage itself. The content of glycosaminoglycans in the drainage cannot be less than 0.001% due to a sharp decrease in decongestant and antiproliferative effects and cannot be more than 10% due to possible allergic reactions.

With developed and far-reaching stages, with increased proliferative activity of the sclera, anti-inflammatory drugs are introduced into the drainage composition, which reduce the inflammatory response and the processes of excessive scarring.

Due to the risk of an increase in IOP, the use of steroid drugs is undesirable in advanced stages. As a steroidal anti-inflammatory drug, drainage may contain: dexamethasone, hydrocortisone, prednisone, betamethasone, etc. in an amount of 0-5 wt.%.

As a non-steroidal anti-inflammatory drug, drainage may contain: diclofenac sodium, flurbiprofen, etc. in an amount of 0-5 wt.%. A content of anti-inflammatory substances of more than 5% can have a toxic effect on eye tissue.

The cytostatic drug is included in the drainage in cases of repeated operations for glaucoma and / or in the case of initially high proliferative activity of the sclera associated with the individual characteristics of the body. As a cytostatic agent, drainage may contain 5-fluorouracil (antimetabolite, an analog of pyrimidine), mitomycin-C (an antitumor antibiotic isolated from Streptomyces caespitosus), bleomycin (an antitumor antibiotic, a vital product of Str. Verticillus) 0-1%. Its concentration cannot be higher than 1% due to toxic effects on eye tissue.

The concentration of buffer salts cannot be less than 0.5% and more than 1.5% to create the corresponding osmolarity of the surrounding tissues.

Brief cooking technology.

Drainage is obtained as follows.

An aqueous solution of the hydrogel monomer is mixed with an aqueous glycosaminoglycan solution and polymerization is initiated to obtain a hydrogel containing glycosaminoglycans. The hydrogel is placed in a solution of a steroidal anti-inflammatory drug, non-steroidal anti-inflammatory drug, cytostatic, buffer salts and incubated for at least a day at a temperature of 37 ° C until an equilibrium concentration of the drugs in the hydrogel is reached. The concentration is controlled spectrophotometrically. The resulting drainage is a water-containing spongy material of arbitrary shape, having viscous or highly elastic properties depending on the content of the hydrogel. Depending on physical properties, drainage is placed under the surface sclera flap using a syringe, injector, tweezers, in a preformed scleral bed.

Example 1

Patient S. 52 years old, diagnosis: primary open-angle 1C glaucoma of the left eye. Visual acuity with correction 0.8 Perimetry: expansion of the blind spot, single scotomas in the Bierrum zone. Glaucomatous excavation of the optic disc 0.5.

Tonography: Po = 34; C = 0.02; F = 0.46; Po / C = 1725

The operation was performed non-penetrating deep sclerectomy (NGSE) using this drainage in the following ratio of components, wt.%:

Hydrogel 99 Glycosaminoglycans 0.1 Buffer salts 0.9

Drainage was implanted with tweezers, under the external scleral flap, into a preformed scleral bed. Complications in the postoperative period were not observed. The patient was discharged on the second day after surgery. 3 months after surgery: visual acuity has not changed. According to computer perimetry, no changes in the fields of vision were recorded. The filter cushion is flat, spilled.

Tonography: Po = 18; C = 0.25; F = 1.65; Po / C = 72.

The presence of an active filtration zone, without excessive proliferation, is confirmed by ultrasonic biomicroscopy (UBM).

Example 2

Patient K., 57 years old, diagnosis: primary open-angle 11 With glaucoma of the right eye. Visual acuity 0.6 with correction. The field of view is concentrically narrowed by 15 degrees along the nasal meridian. Excavation of the optic disc = 0.7.

Tonography: Po = 37; C = 0.04; F = 0.98; Po / C = 945;

An operation (NGSE) was performed using this drainage in the following ratio of components, wt.%:

Hydrogel 88.5 Glycosaminoglycans 5 Dexamethasone 5 Buffer salts 1.5

Drainage was implanted with tweezers, under the external scleral flap, into a preformed scleral bed.

Complications in the postoperative period were not observed.

The patient was discharged on the second day after surgery.

3 months after surgery: visual acuity has not changed. The field of view expanded 10 degrees from the bow.

Tonography: Po = 11.4; C = 0.37; F = 1.31; Po / C = 31.

The filter pad is flat.

Example 3

Patient A., 62 years old, diagnosis: primary open-angle 1V C glaucoma, initial complicated cataract of the left eye.

Visual acuity: light perception with the wrong projection of light.

Tonography: Po = 39; C = 0.03; F = 2.8; Po / C = 344.

Edge excavation of the optic disc.

An operation (NGSE) was performed using this drainage in the following ratio of components, wt.%:

Hydrogel 84.5 Glycosaminoglycans 10 Diclofenac Sodium 5 Buffer salts 0.5

Drainage was implanted with tweezers, under the external scleral flap, into a preformed scleral bed. Complications in the postoperative period were not observed. The patient was discharged on the second day after surgery.

In 6 months:

Visual acuity has not changed.

The filter pad is clearly contoured, flat.

Tonography: Po = 10.2; C = 0.39; F = 1.61; Po / C = 26;

According to the UBM, the filtration zone is actively functioning, there is no excessive proliferation.

Example 4

Patient B., 57 years old, diagnosed with primary open-angle operated 111 C glaucoma of the left eye.

Visual acuity with a correction of 0.3, the visual fields are narrowed to 10 degrees from the fixation point on the nasal side.

The filter cushion does not differentiate.

Tonography: Po = 43; C = 0.05; F = 1.57; Po / C = 872.

An operation (NGSE) was performed using this drainage in the following ratio of components, wt.%:

Hydrogel 0.1 Glycosaminoglycans 0.001 Buffer salts 1.5 5-fluorouracil one Water Rest

Drainage was implanted with a syringe, under the external scleral flap, into a preformed scleral bed. Complications in the postoperative period were not observed. The patient was discharged on the second day after surgery.

In 6 months:

Visual acuity has not changed.

The filter pad is clearly contoured, flat.

Tonography: Po = 12; C = 0.28; F = 0.95; Po / C = 42.

The field of view expanded by 5 degrees from the bow.

With UBM, a functionally active cavity in the area of the intervention is determined, without excessive proliferation.

Example 5

Patient K., 48 years old, diagnosed with secondary uveal open angle 111 C glaucoma of the left eye. Visual acuity 0.08, loss of the visual field to the fixation point along the nasal meridians, the filter pad is not determined.

Tonography: Po = 32.4; C = 0.09; F = 184; Po / C = 353.

An operation (NGSE) was performed using this drainage in the following ratio of components, wt.%:

Hydrogel 0.1 Glycosaminoglycans 0.001 Mitomycin-s one Flurbiprofen 5 Buffer salts 1.5 Water Rest

Drainage was implanted with a syringe, under the external scleral flap, into a preformed scleral bed. In the early postoperative period, a reactive course was observed, the filtration cushion was clearly expressed. In the long-term postoperative period:

The acuity and field of view have not changed, tonography:

Po = 17.3; C = 0.16; F = 1.17; Po / C = 108.

According to the UBM in the operation zone, the presence of a functionally active filtration zone is determined, without excessive proliferation.

Example 6:

Patient B., 50 years old, diagnosis: secondary neovascular glaucoma. Visual acuity 0.3 with correction, the field of view is narrowed to 10 degrees from the fixation point on the nasal side. Edge excavation of the optic disc.

Tonography: Po = 41.0; C = 0.03; F = 2; Po / C = 1366.

The operation was performed deep sclerectomy, using this drainage in the following ratio, wt.%:

Hydrogel fifty Glycosaminoglycans 10 5-fluorouracil one Buffer salts 1.5 Water Rest

Drainage was implanted with tweezers, under the external scleral flap, into a preformed scleral bed. In the early postoperative period, a reactive course was observed, the filtration cushion was clearly expressed. In the long-term postoperative period:

The acuity and field of view have not changed, tonography:

Po = 17.0; C = 0.5; F = 1.5; Po / C = 113.

Fields of view expanded by 5 degrees from the bow.

According to the UBM in the operation zone, the presence of a functionally active filtration zone is determined, without excessive proliferation.

Claims (1)

Drainage for the surgical treatment of glaucoma, including a hydrogel, characterized in that it additionally contains glycosaminoglycans, a non-steroidal anti-inflammatory drug, a steroidal anti-inflammatory drug, buffer salts, cytostatic and water in the following ratio, wt.%: Hydrogel 0,1-99 Glycosaminoglycans 0.001-10 Non-steroidal anti-inflammatory drug 0-5 Steroidal anti-inflammatory drug 0-5 Buffer salts 0.5-1.5 Cytostatic 0-1 Water Rest