RU134787U1 - DRAINAGE FOR SURGICAL TREATMENT OF GLAUCOMA - Google Patents

Abstract

1. Drainage for use in the surgical treatment of glaucoma, made in the form of a final elongated product from bioresorbable material, having a first and second end, as well as at least one flat section located between them so that it is possible to lay said flat section during surgical treatment under the separated scleral flap with the location of the first and second ends outside the scleral bed. 2. Drainage according to claim 1, characterized in that it is made in the form of a strip of bioresorbable material. The drainage according to claim 2, characterized in that it has a substantially rectangular shape with a length of 3.0-12.0 mm and a height of 1.0-3.5 mm, while the thickness of the drainage is 10-300 microns. . Drainage according to claim 1, characterized in that it is made in the form of a strip of bioresorbable material, which is bent at least in one line, essentially perpendicular to its long side. Drainage according to claim 4, characterized in that said strip is bent in one line with the formation of a second flat section with the possibility of its location on top of the separated scleral flap. Drainage according to claim 5, characterized in that the strip is folded flat. Drainage according to claim 4, characterized in that said strip is bent along two lines with the formation of two marginal flat sections, each of which is adjacent to one of the ends of the drainage with the possibility of placing two of these marginal sections on top of the separated scleral flap. Drainage according to claim 7, characterized in that the total length of two marginal flat sections does not exceed half the length of the entire drainage in a fully expanded state. �

Description

FIELD OF TECHNOLOGY

The utility model relates to medical equipment, namely to drainages used in ophthalmic surgery, and can be used in the surgical treatment of various types of glaucoma (primary, refractory, with repeated surgical interventions, in complex cases with secondary glaucoma).

BACKGROUND

Glaucoma is a large group of eye diseases with characteristic visual impairment. In many cases, the abandonment of the operation or its untimely execution leads to a progressive decline in visual functions and blindness. Fistulizing operations allow you to create new ways of outflow of aqueous humor from the eye.

The traditional operation of choice in the surgical treatment of glaucoma is valvular sinusastrabulectomy with basal iridectomy, described, for example, in A.P. NESTEROV. Glaucoma, 2nd edition, re., M., 2008. During the operation, an arcuate incision of the conjunctiva and tenon capsule is made 7-8 mm from the limbus. The tenon capsule is separated from the sclera to the limbus, the superficial scleral flap is cut out with the base to the limbus. The size of the flap varies from 3 to 5 mm (along the lateral and upper faces), the thickness is from 1/3 to 1/2 of the sclera thickness. The scleral flap is separated from the deep scleral plate until a transparent corneal tissue appears and, depending on its shape, 1 or 2 sutures are applied to the edges of the flap. A section of the deep corneoscleral plate is excised, the incision runs parallel to the limb across the entire width of the scleral pocket. The second same incision is made 1.0-1.5 mm anterior to the first in the corneal part of the subscleral pocket. Then, a section of deep corneoscleral tissue is excised between the two described incisions. Through the resulting defect, a peripheral iridectomy is performed. Nodal sutures are applied to the scleral flap. The operation ends with a thorough suturing of the wound of the conjunctiva.

Also known is a modification of trabeculectomy, a method for the surgical treatment of glaucoma (patent RU No. 2181273, 04/20/2002 Yerichev VP, Immortal A.M., Lobykina LB, Chervyakov A.Yu.). This operation is as follows - in the upper quadrant of the eyeball, the conjunctival flap is separated with the base to the limb. A scleral surface flap is formed at ½ of its thickness 4 * 4 mm (square) in size with the base to the limb. The lateral edges of the scleral bed are stitched in a zigzag fashion. In the limbal zone, a strip of sclera with trabecular tissue is cut out. Perform a basal iridectomy. Reposition the scleral flap with the imposition of two nodal sutures and the conjunctival flap with the continuous suture.

Also proposed is a surgical treatment option for glaucoma based on non-penetrating deep sclerectomy, a method for surgical treatment of secondary open-angle glaucoma (patent RU No. 2360657, July 10, 2009, Takhchidi H.P., Cheglakov V.Yu., Tsitov G.A., Valuev L.I. ., Method for the surgical treatment of secondary open-angle glaucoma). The method is as follows, the conjunctival and superficial scleral flaps are cut, the middle scleral layers are removed in the form of a rectangle to expose the inner layers of the corneoscleral part of the trabecula and the limbal edge of the descemetic membrane, and the scleral space is drained using hydrophilic drainage containing covalently bound immobilized recombinant and then recombinant fixation of the superficial scleral flap in the corners. The operation is completed by applying a continuous suture to the conjunctiva.

However, in some of the operated patients, at various times after the operation, cicatricial blockade occurs in the area of the scleral flap and filtration pad with a decrease in the antihypertensive effect.

To reduce the likelihood of such a complication, a modification of the surgical treatment of glaucoma using drainage was proposed (Patent RU No. 2348386, 09/10/2008, Batmanov Yu.E., Shvets PN The method of non-penetrating surgical treatment of primary open-angle glaucoma). This operation was carried out as follows - form a conjunctival flap 10 mm long 7 mm from the limb with the base to it. After gentle coagulation of the episcleral vessels, a superficial scleral flap of square shape with a side equal to 5 mm, 1/3 of the thickness is planned, which is then separated to transparent layers of the cornea. Then, three sides of a deep scleral flap of rectangular shape 4 * 3 mm are outlined, namely, the sides of a rectangle of 3 mm long, perpendicular to the limbus, and the long side connecting them, 4 mm long, which is located 2 mm behind the scleral spur. A deep scleral flap is separated over the entire thickness of the sclera. Thus, the venous sinus of the sclera is opened. A deep scleral flap is removed with Vannas scissors. If there is no filtration through the trabecula, the endothelium and juxtacanalicular tissue are removed from its surface. Then, under the superficial scleral flap, a thin collagen drainage 6 * 2 mm in size is laid, the ends of which extend beyond the surface scleral flap. The superficial scleral flap is fixed to the sclera with two interrupted sutures. Impose a continuous seam on the conjunctiva. The drainage used in the known method of treatment is selected as the closest analogue.

The disadvantages of the known method of treatment and drainage include the fact that in the early postoperative period, contact remains between the scleral flap and the conjunctiva, which usually leads to the formation of sclero-conjunctival adhesions, as well as sclero-scleral adhesions along the rib of the scleral flap, which reduces the effectiveness of treatment. In addition, the natural collagen from which the drainage is made is characterized by extremely slow resorption, which can lead to the occurrence of inflammatory or other undesirable reactions of the body.

ESSENCE OF A USEFUL MODEL

Based on the foregoing, the problem arises of creating drainage used in the surgical treatment of glaucoma, the use of which would prevent the formation of sclero-scleral and conjunctive-scleral adhesions. An additional objective is the creation of such drainage, which would be characterized by a minimal immune response of the body, greater biocompatibility than the known analogues in the prior art. Another objective is the creation of a relatively universal drainage, which could be used for various types of glaucomatous operations.

To solve this problem, a drainage is proposed for use in the surgical treatment of glaucoma, made in the form of a final elongated product from bioresorbable material, having a first and second end, as well as at least one flat section located between them so that it is possible to lay said flat section in surgical treatment under a separated scleral flap with the location of the first and second ends outside the scleral bed.

In this case, the term "final" should be understood as the implementation of drainage with an open circuit as opposed to a closed endless circuit. The term “elongated” should be understood to mean the product is made in excess of one of its dimensions (longitudinal, i.e. length) over other dimensions (width, thickness).

In one preferred embodiment, the drainage is in the form of a strip of bioresorbable material. While preferably it has a substantially rectangular shape with a length of 3.0-12.0 mm and a height of 1.0-3.5 mm, and the thickness of the drainage is 10-300 microns.

In another preferred embodiment, the drainage is in the form of a strip of bioresorbable material that is bent in at least one line, preferably (but not necessarily) substantially perpendicular to its long side.

Moreover, this strip can be bent in one line with the formation of a second flat section with the possibility of its location on top of the separated scleral flap. In this case, the strip can be folded flat, and the area for placement under the separated scleral flap and the area for placement on top of this flap are located one above the other.

In another preferred case, the strip of bioresorbable material can be bent in two lines with the formation of two marginal flat sections, each of which is adjacent to one end of the drainage with the possibility of placing two of these marginal sections on top of the separated scleral flap. Moreover, it is preferable that the total length of two marginal flat sections does not exceed half the length of the entire drainage in a fully expanded state.

In yet another preferred embodiment, the drainage can be made of two separate segments of bioresorbable material, interconnected by ends so that the first segment has one free end forming the first end of the drainage, and the second segment has one free end forming the second end of the drainage however, the first segment has a flat section for laying it under the separated scleral flap, and the second segment has a flat section for laying it on top of the separated scleral flap.

In another preferred case, the drainage can be made of three separate segments of bioresorbable material - one central and two marginal, and the first marginal segment has one free end forming the first end of the drainage, the second marginal segment has one free end forming the second end of the drainage the central segment is connected at its ends to the ends of the first and second segments with the possibility of laying the central segment under the separated scleral flap and the possibility of positioning Nia two said first and second marginal sections over the separated scleral flap.

In the described cases, it is preferable that the largest longitudinal dimension of the drainage does not exceed 7.0 mm, the height is 1.0-3.5 mm, and the thickness is 20-600 microns. In this case, the drainage may have a substantially rectangular shape with a length of 2.0-7.0 mm, or may have a trapezoidal shape with a large base of 2.5-7.0 mm and a smaller base of 2.0-5.0 mm.

The drainage may be made of a film, in particular a porous or at least partially perforated film. Drainage can also be made of mesh.

Bioresorbable material for the manufacture of drainage can be selected from the group including: synthetic polymers, microbiologically synthesized materials.

The synthetic polymer can be selected from the group including: polyglycolic acid (polyglycolide), L - or D, L-polylactic acid (polylactide), poly-ε-caprolactone, poly-p-dioxanone, copolymers of these materials, mixtures of these materials and / or copolymers.

A hydrogel based on polyvinyl alcohol or a grafted copolymer containing polyvinyl alcohol and polyethylene glycol can also be selected as a synthetic polymer.

As the microbiologically synthesized material, one of the following materials can be used: poly-3-hydroxybutyrate, poly-3-hydroxyvalerate or poly-4-hydroxybutyrate or their copolymers.

Finally, recombinant web proteins: speedroin-1 and speedroin-2 can be used as microbiologically synthesized material.

The claimed utility model covers many different particular cases of its implementation, some of which are disclosed in more detail later in the description. At the same time, the described specific cases of implementation should not be considered as limiting the scope of the requested legal protection, since other possible options for its implementation will be clear to the specialist within the framework of the presented utility model formula.

One of the most preferred particular cases of implementation is the implementation of drainage in the form of a piece of thin tape made of bioresorbable material, preferably of rectangular shape, the middle part of which is designed for laying under a separated scleral flap, and the ends protrude beyond the scleral bed.

Another preferred embodiment is a drainage containing two essentially flat sections (bicuspid drainage), which can be made of either a single segment of bioresorbable material, folded (preferably bent) along a line perpendicular to the long side, or performed the connection of the ends of two separate segments of bioresorbable material. The angle between the two flat sections thus obtained can be between 0 ° and 179 °. One of the parts (flaps) of such drainage is intended for laying under the separated scleral flap, while the second covers the flap from the outside. The ends of the drainage, as in the first case, extend beyond the scleral bed.

Another preferred embodiment is a drainage containing three essentially flat sections (tricuspid drainage), which can be obtained, for example, by bending one segment (preferably rectangular) of bioresorbable material in two lines (preferably perpendicular to the long side of the segment). At the same time, drainage can be obtained by joining three separate segments from bioresorbable material or joining two segments followed by bending one of them in the same way as described above to obtain a product with three essentially flat sections. In this case, the middle section is intended for laying under the scleral flap, while the marginal sections (and, accordingly, the ends of the drainage) are located outside the scleral bed and cover the flap from the outside.

In accordance with this utility model, the use of antiglaucomatous drainage in the form of a substantially flat tape prevents the formation of sclero-scleral adhesions, and drainage with two and three flat sections prevents the formation of sclero-scleral and sclero-conjunctival adhesions due to the absence of scleral contact a flap with the underlying sclera and conjunctiva through the drainage and the space between the drainage during the period of active tissue proliferation. As a result, a stable normalization of intraocular pressure is achieved with preservation of the effect for a long period, the likelihood of repeated surgical interventions is reduced.

The proposed drainage is much more convenient to install and operate compared to other drains. Its design allows to significantly simplify the installation procedure, provides simplicity and reliability of its fixation after laying under the scleral flap (for tape drainage) or putting on it (for drains with two and three flat sections) for any size of the separated flap without the need for additional fixation with a thread. The described design of the drainage makes it essentially universal and allows its use both in penetrating variants of anti-glaucomatous operations and in non-penetrating deep sclerectomy and its modifications.

The use of bioresorbable polymeric materials ensures the absence of swelling and pressure on the surrounding tissues, dimensional stability, drainage strength, and also provides the necessary biocompatibility (bioinertness) with an almost complete absence of an immune or inflammatory reaction. Complete resorption of drainage in an optimal time (3-6 months) allows (physiologically correct) the formation of ways of outflow of aqueous humor and to avoid long-term adverse reactions of the body that are possible when using non-resorbable material. The use of porous materials increases the degree of filtration of moisture in the postoperative period, prevents the development of postoperative hypotension.

BRIEF DESCRIPTION OF THE DRAWINGS

The utility model is explained below in more detail with reference to the accompanying drawings, which depict:

- figure 1 - tape drainage in the form of a strip of a continuous film;

- figure 2 - double-leaf drainage with two flat sections in the form of a once bent strip of porous film;

- figure 3 - double-leaf drainage with two flat sections in the form of a once bent strip of continuous film;

- figure 4 - bicuspid drainage in the form of a once bent strip of perforated film with a fixed bend;

- figure 5 - bicuspid drainage in the form of a once bent strip of mesh with fixation of the bend (by plexus);

- Fig.6 - tricuspid drainage with three flat sections in the form of a double folded strip of a continuous film with fixation of the bend;

in Fig.7 - double-leaf drainage of a porous film in the form of a double-sided trapezoid made of two segments connected to each other at one end;

- in Fig.8 - tape drainage laid under the scleral flap;

- figure 9 is a bicuspid drainage worn on a scleral flap;

- figure 10 - tricuspid drainage worn on a scleral flap.

PREFERRED EMBODIMENTS FOR USING THE USEFUL MODEL

As shown in the attached drawings, the proposed drainage in the General case is a final product of thin material (film, mesh), having a first and second end, which during operation are removed from under the separated scleral flap (Fig. 8-10).

The drainage can be a piece of tape made of bioresorbable material (Fig. 1), a once bent piece of porous or solid material or mesh (Fig. 2-5), a double-bent piece (Fig. 6), or can be made of interconnected segments - two , as shown in Fig.7, or three similarly to the variant depicted in Fig.6. Without loss of generality, the drainage may have a predominantly rectangular or trapezoidal shape.

Upon receipt of bicuspid drainage, the first and second flat sections can have both the same length (Fig. 2, 3) and differ in length (Fig. 4), while the longer section is intended to be placed under a separated scleral flap, while as a shorter area is located on the outside of the flap.

Similarly, in a tricuspid drainage with three flat sections (Fig.6), the marginal flat sections can be either the same or different lengths. It is not necessary, but it is preferable that the total length of the two marginal flat sections would not exceed the length of the middle flat section enclosed between them. Thus, the sum of the lengths of the marginal sections does not exceed half the length of the entire drainage in a fully expanded state. Accordingly, the length of the middle flat portion to be placed under the scleral flap will preferably (but not necessarily) be at least half the length of the entire drainage in a fully deployed state.

In the general case, the shape and dimensions of the drainage are selected so as to ensure that a part of the drainage is placed under the separated scleral flap with the drainage ends coming out from under it.

Accordingly, the shape and dimensions of the drainage can be selected taking into account the shape and dimensions of the scleral flap usually cut out during surgery (trapezoidal, lower base 4-5 mm, upper base 2-3 mm, trapezoid height 4-5 mm), under which it is laid and / or on which he puts on. For this reason, it is most preferable that the tape drainage has a length of 4.0-12.0 mm, a height of 1.5-3.5 mm with a thickness of 10-300 microns. Drains made by bending a strip of bioresorbable material, or by joining two or three separate segments, preferably have a length of up to 7.0 mm, a height of 1.0-3.5 mm, and a thickness of 20-600 microns. Moreover, when performing trapezoidal drainage, the smaller base is preferably not more than 5.0 mm.

As you can see, the total thickness of the drainage with two or three flat sections is two thicknesses of each of its walls (the original film or mesh). At the same time, the optimal thickness for the various drainage options presented may have a different value.

It should be noted that despite the above (in most cases, optimal) sizes, the design of the drainage and the method of its preparation provide the possibility of obtaining devices with individual sizes, and even by the surgeon himself during the operation, depending on the size and shape of the scleral flap created by him (for the final simulation of drainage dimensions).

Bioresorbable material (absorbable), from which drainage is made according to a utility model, can be continuous and non-continuous. The use of non-continuous material is more preferable, since the holes and cavities in it provide more efficient penetration of intraocular fluid and a greater filtering effect in general. In the framework of the claimed utility model, such variants of a non-continuous material are considered as a porous film, a perforated film, a mesh, although these options should not be considered as restrictive.

In the general case, drainage according to a utility model is obtained from a film or mesh made of bioresorbable material. In this case, ready-made (industrially produced) appropriate products that are widely available at present for various fields of surgery and having parameters suitable for solving the task, or specially prepared materials, the preparation of which are described in this patent, can be used. These films may be continuous, porous and / or perforated. These films are blanks for strip drains and, accordingly, pre-blanks for two other types of drains (two- and three-leaved).

Next, the film is cut into strips (tapes) with a given width, which, in turn, are cut into short pieces of a rectangular shape and a given length, as will be shown below. However, their ends may be slightly rounded. These obtained segments represent one of the three types of claimed drainage - tape drainage.

To obtain two other types of drains, similar workpiece strips of appropriate length (greater than that of tape drains) are bent from one or two ends. In the first case, this actually means simply a bend, preferably in half. In this case, bicuspid drainage is obtained (in a form similar to a small book). To obtain a tricuspid drainage with three flat sections at the strip-blanks, bend both its ends to the center of the drainage to obtain the marginal sections of preferably the same size.

For the two types of claimed drainages having bent parts, the final operation is their short compression to fix the (specified) kinks. The finished product in these cases is delivered in a flat folded form, convenient for storage and implantation.

In addition, the bent parts of the drainage can be welded, glued, braided to force the bends to be fixed. In this case, the adjoining sections of both strips elastically prevent the opening of the inflection zone (to a greater extent than just flatly folded ones), which is very convenient when putting such drains on the separated scleral flap, because in fact, provides fixation (already) of the drainage itself on the flap.

In addition, bicuspid drainage and drainage with three flat sections can be obtained not from one, but from several blanks of shorter length: two or three, respectively. Their fastening is carried out in the same way as the mentioned fixation of excesses, i.e. welding, gluing and braiding. In the first two cases, the products obtained by the two mentioned methods are externally completely identical. It should be noted that the noted method of obtaining drainage from several blanks is less convenient and longer.

In addition to a rectangular shape, drains with two or three flat sections can be obtained in the form of a double-sided trapezoid, which is convenient for subsequent putting on a trapezoidal sclera flap. It is most convenient to obtain them both from one workpiece and from, respectively, two and three, fixing the bend and fastening, respectively, by welding, and having the welded strip not perpendicular to the long side of the drainage, but at a certain angle, and then cutting the end part (unnecessary) parts of the product at the same angle.

A porous film is obtained in a known manner by introducing a subsequently washed filler, the so-called porophore, into the polymer material during its processing. This inert additive, organic or inorganic, being soluble in water, after receiving the product is easily and almost completely removed from it after being kept in water at a given temperature. The particle size of the additive used and its content (with respect to the polymer component) determines, respectively, both the size of the formed pores and the total porosity of the resulting material.

In addition, it is possible that the drainage is made from a material with a non-toxic porophore or plasticizer introduced, and it is washed out already (in the body) after implantation of this product.

The total porosity of the porous material is defined as the ratio of the pore volume in the material to the total volume of the material. It can be calculated by the formula:

P = (1-D / D _o ) * 100%,

where D is the apparent density of the porous material, kg / m ³ ,

D _{o the} density of the starting polymer, kg / m ³ .

Preferably, this value should be 70-85%. With a total porosity of the material of more than 90%, the deformation-strength characteristics of the drains noticeably deteriorate (both tensile strength and elongation at break), which can lead to destruction of the product during implantation or operation. With a total porosity of less than 25%, the effectiveness of the drainage is significantly reduced due to a decrease in its filtering ability (closed pores are formed to a greater extent), and its rigidity increases significantly, which can lead to injury to eye tissues. The foregoing relates primarily to porous drains obtained by leaching the filler; in the case of using a perforated film and, especially, a mesh (concept), “porosity” is relative and its actual value may be more than 90%, while the mechanical characteristics of the drains can remain at a high level.

Perforation of materials obtained from continuous polymer or porous films, in accordance with this utility model, can be carried out using a special perforator, for example, a dermatome, designed for applying through cuts on temporary wound dressings or using a laser designed for laser microprocessing of film materials. The resulting holes may have a diameter of from 20 to 2000 microns.

Fixation of bent parts of the drainage or the connection of strips-blanks when receiving drainages from several parts can be carried out by thermal welding, gluing or braiding. Numerous devices for welding polymer films are suitable for thermal welding. Cyanoacrylate adhesives are most suitable for bonding: topical skin adhesive that cures in the air and adhesive for medical equipment that cures quickly under UV radiation. Numerous surgical resorbable sutures with high strength and guaranteed biodegradation time can be used for plexus (manual). It should be noted that the plexus is most suitable in the case of using a mesh.

When choosing bioresorbable material in this patent, preference is given to synthetic and microbiologically synthesized polymers that are already widely used for the manufacture of surgical sutures, implants, matrixes for cell engineering and, naturally, approved for medical use by the FDA (US Food and Drug Administration) - Control Agency for US drugs and food.

The bioresorbable materials used can be of several types:

-synthetic polymers - polyesters based on hydroxyalkanecarboxylic (hydroxycarboxylic) acids, as well as their copolymers or their copolymers or mixtures thereof. In particular, they include polyglycolic acid (polyglycolide), L - or D, L-polylactic acid (polylactide), poly-ε-caprolactone, poly-p-dioxanone. When using copolymers, the molar ratio of both components is indicated.

- synthetic polymers - hydrogels based on polyvinyl alcohol or a grafted copolymer containing polyvinyl alcohol and polyethylene glycol.

- microbiologically synthesized polymers - polyesters based on b-hydroxyalkanecarboxylic (hydroxycarboxylic) acids, or polyhydroxyalkanoates, as well as their copolymers. In particular, these include poly-3-hydroxybutyrate, poly-3-hydroxyvalerate or poly-4-hydroxybutyrate.

- microbiologically synthesized materials - recombinant web proteins, in particular, speedroin-1 and speedroin-2.

- natural fibers, in particular silk, produced by transgenic silkworm caterpillars.

Of the above materials, all polyesters, regardless of the method of preparation, are hydrophobic materials, sorbing no more than 2-4 wt.% Water. Their use is preferable, since drainages based on them practically do not change their initial sizes after implantation. At the same time, hydrophilic materials can be used in principle if their equilibrium swelling in water is small, in particular, hydrogels based on polyvinyl alcohol and a recombinant web protein.

The drainage resorption time (resorption, biodegradation) can be 1-12 months, preferably 3-6 months. It is determined by their thickness and porosity, as well as the nature of the material used. This refers to the time of complete resorption of the material; the time during which the implant loses its strength characteristics is much less.

Sterilization of the manufactured drains is carried out by the radiation or gas method (ethylene oxide) method under standard conditions.

The following are examples of drainages in accordance with this utility model.

Obtaining drainage from a porous film.

Example 1

In 10.0 g of a 3.0% prepared solution of D, L-polylactic acid (poly-D, L-lactide) (reduced viscosity 0.70 dl / g, DURECT Corp.) in freshly distilled acetone was added 2.1 g of finely divided chloride sodium (particle size 40-65 μm) and this mixture was thoroughly mixed. The resulting solution was poured onto a glass substrate mounted horizontally. After evaporation of the solvent at room temperature, the film on the substrate was dried at 40 ° C for 60 min. After that, to remove residual solvent, the film was dried in a vacuum oven at 35 ° C for 2 h. Then it was removed from the substrate, placed in a beaker with distilled water and heated in an oven at 50 ° C for 10 hours until the filler is completely washed out. After that, the film was dried in a vacuum oven at 70 ° C for 2 hours. To obtain a drainage strip, this porous prefilm film with a thickness of 80 μm was cut into narrow rectangular strips 2.5 mm wide, and they (blanks), in turn, were cut into rectangular segments 6.0 mm long. As a result, the thus obtained drainage strips had a length of 6.0 mm, a width of 2.5 mm, and a thickness of 80 μm. The manufactured drains were placed in a polypropylene blister and sterilized by the radiation method (2.5 MPa).

Example 2

Under the conditions of Example 1, a porous film was obtained from a solution of L-polylactic acid (poly-L-lactide) (reduced viscosity 1.80 dl / g, PURAC biomaterials) in chloroform.

Example 3

Under the conditions of Example 1, a porous film was prepared from a solution of a poly (D, L-lactide-co-glycolide) copolymer 50:50 mol% (reduced viscosity 0.70 dl / g, DURECT Corp.) in ethyl acetate.

Example 4

Under the conditions of Example 1, a porous film was obtained from a solution of poly-ε-caprolactone (reduced viscosity 0.70 dl / g, PURAC biomaterials) in chloroform.

Example 5

Under the conditions of Example 1, a porous film was obtained from a solution of a poly (D, L-lactide-co-ε-caprolactone) copolymer 25:75 mol% (reduced viscosity 0.80 dl / g, PURAC biomaterials) in dioxane.

Example 6

A mixture of 5.0 g of a 3.0% solution of poly (L-lactide-co-glycolide) 85:15 mol% (reduced viscosity 2.30 dl / g, PURAC biomaterials) in freshly distilled chloroform and 5.0 g 3 was prepared. A 0% solution of poly-ε-caprolactone (reduced viscosity 0.70 dl / g, PURAC biomaterials) in freshly distilled chloroform was added 2.0 g of finely divided sodium chloride (particle size 40-65 μm) and this mixture was thoroughly mixed. Further, a porous film and then drainage were prepared under the conditions of Example 1.

Example 7

Under the conditions of Example 1, a porous film was obtained from a solution of poly-p-dioxanone (reduced viscosity 0.85 dl / g) in hexafluoroisopropanol.

Example 8

Under the conditions of Example 1, a porous film was obtained from a solution of poly-3-hydroxybutyrate (reduced viscosity 0.46 dl / g) in chloroform.

Example 9

Under the conditions of Example 1, a porous film was obtained from a solution of poly-3-hydroxyvalerate (reduced viscosity 0.53 dl / g) in chloroform.

Example 10

Under the conditions of Example 2, a porous film was obtained from a solution of poly-4-hydroxybutyrate (reduced viscosity 0.49 dl / g) in chloroform.

Example 11

Under the conditions of Example 1, a porous film was obtained from a solution of poly (3-hydroxybutyrate-co-4-hydroxybutyrate) (reduced viscosity 0.73 dl / g) in chloroform.

Example 12

In 15.0 g of a prepared 4.0% solution of poly (3-hydroxybutyrate-co-3-hydroxyvalerate) (reduced viscosity 0.58 dl / g) in freshly distilled chloroform, 4.0 g of finely divided polyethylene glycol (Mn 10000, particle size 70-90 microns) and this mixture was thoroughly mixed. The resulting suspension was poured onto a glass substrate mounted horizontally. Further, a porous film and then drainage were prepared under the conditions of Example 1.

Example 13

Drainage with a wall of material based on spidroin was obtained as follows. A portion of 0.3 g of recombinant spidroin-1 was dissolved in 4.0 ml of a 10% solution of lithium chloride in 90% formic acid. 0.9 g of sodium chloride with a particle size of 40-65 μm was added to this solution. Further, a porous film and then drainage were prepared under the conditions of Example 1.

Example 14

Under the conditions of example 1, a porous film based on recombinant spidroin-2 was obtained.

Obtaining drainage from a porous film with a washable plasticizer.

Example 15

To 30.0 g of the prepared 3.5% aqueous solution of polyvinyl alcohol (Mw 85000, 96% hydrolyzed groups, Aldrich), 0.22 g of a 25% aqueous solution of glutaraldehyde and 0.39 g of glycerol are added. The resulting solution was poured onto a glass substrate placed in an oven and installed horizontally. The applied coating is cured at 60 ° C for 2 hours, and then at 90 ° C for 1 hour. Next, the cured coating is removed in the form of a film and cut, as described in example 1, obtaining a drainage strip.

Example 16

To 35.0 g of a prepared 3.2% aqueous solution of a grafted copolymer based on polyvinyl alcohol and polyethylene glycol (PVA 75%, PEG 25%, Mw 45000, Kollicoat IR, BASF), 0.38 g of a 25% aqueous solution of glutaraldehyde and 0 52 g of glycerol. A film based on the composition used is obtained under the conditions of example 15. Next, the cured coating is removed in the form of a film and cut as described in example 1, obtaining a drainage strip.

Obtaining drainage from a perforated film.

Example 17

A solution of 10.0 g of a 3.0% solution of D, L-polylactic acid (poly-D, L-lactide) (reduced viscosity 0.70 dl / g, DURECT Corp.) in freshly distilled tetrahydrofuran was prepared. This solution was poured onto a glass substrate mounted horizontally. After evaporation of the solvent at room temperature, the film on the substrate was dried at 40 ° C for 60 min. After that, to remove residual solvent, the film was dried in a vacuum oven at 35 ° C for 2 h. Then it was removed from the substrate, placed in a beaker with distilled water and heated in an oven at 60 ° C for 10 hours until the filler is completely washed out. After that, the pre-film was dried at 80 ° C for 2 hours. The resulting continuous film having a thickness of 75 μm was perforated using an Excimer, ATL laser (5W, 5ns, 300Hz): holes with a diameter of 200 μm were made in a checkerboard pattern with a pitch of 400 μm. After this, the corresponding pre-cut was cut in width of 3.5 mm, from it blanks were cut with a length of 12.0 mm, from which bivalve drainages themselves were obtained by bending the blank in half and keeping it under a load of 40 g for 30 s. The drainage obtained in a flat folded form, had a length of 8.0 mm, a width of 3.5 mm and a thickness of 150 μm.

Example 18

Under the conditions of example 17, a continuous film was obtained, it was perforated using a dermatome D42, Humeca. Through cuts with 1.0 * 1.0 mm holes were staggered. After this, a corresponding pre-cut was cut with a width of 3.5 mm, billets 12.0 mm long were cut from it, from which bivalve drainage itself was obtained, by bending the workpiece at a distance of 5.0 mm from one of the edges of the strip and then keeping it under a load of 40 g in within 30 s. The drains obtained in a flat folded form had a length of bent parts of 5.0 mm and 7.0 mm, a width of 3.5 mm and a thickness of 150 μm.

Example 19

In the conditions of example 17, blanks were obtained with a length of 12.0 mm and a width of 3.5 mm, from which tricuspid drains were obtained by bending the blank on each side, but in the same direction, at a distance of 3.0 mm from each of the edges of the strip and then keeping it under a load of 40 g for 30 s. Tricuspid drains, obtained in a flat folded form, had a length of 6.0 mm (sashes - 3.0 mm each), a width of 3.5 mm and a thickness of 150 μm.

Obtaining drainage from a porous film by gluing.

Example 20

The pre-prepared strips obtained under the conditions of Example 1 were 3.5 mm wide, 12.0 mm long pre-cuts were cut from it and folded in half and glued together with Dermabond 2-octyl cyanoacrylate adhesive, Johnson and Johnson. The bicuspid drainages thus obtained had a length of 6.0 mm, a width of 2.5 mm and a thickness of 160 μm.

Example 21

The pre-prepared strips obtained under the conditions of Example 1 had a width of 3.5 mm, of which 6.0 mm long pre-cuts were cut, the pre-prepared preforms were superimposed on top of each other and glued to one another with Permabond 4UV80HV, Ellsworth cyanoacrylate adhesive Adhesives under the influence of a UV lamp with a power of 4 mW / cm ² . Glue fixing time 10 s. The width of the glued seam was 0.8 mm. As a result, the bicuspid drains obtained were essentially identical to the drains from Example 20, despite a different method for their preparation, and had a length of 6.0 mm, a width of 2.5 mm, and a thickness of 160 μm.

Getting drainage from the grid.

Example 22

An absorbable network of Vicryl, Johnson and Johnson based on poly (glycolide-Co-L-lactide) 90:10 mol.%, Having a thickness of 180 μm and close to square pores of 500 * 500 μm, which form braided filaments, was used. Stripes 3.0 mm wide and 11.0 mm long were cut from this mesh along the strands forming it so that they were contoured by the threads making up the mesh (so that sharp cut threads did not protrude from the ends). These strips of blanks were folded in half and the bend point perpendicular to the side length was thermally welded (temperature about 190 ° C) using the device for welding polymer films ST-320, ST Brand. The width of the weld was 0.5 mm. As a result, the obtained bicuspid drainage of a rectangular shape had a length of 5.5 mm, a width of 3.0 mm and a thickness of 360 μm.

Example 23

Under the conditions of Example 22, the preform strips were folded in half and the place of their bend was joined by weaving with a thread of poly (glycolide-co-L-lactide) 90:10 mol%, Vicryl, Johnson and Johnson with a thickness of 35 μm, perpendicular to the length of the drainage and connecting (attracting) one section of the mesh. As a result, the obtained bicuspid drainage had a length of 5.5 mm, a width of 3.0 mm and a thickness of 360 μm.

Obtaining drainage from a porous film in the form of a trapezoid.

Example 24

The pre-prepared strips based on a porous film obtained under the conditions of Example 1 had a width of 2.5 mm, of which 6.0 mm long blanks were cut, the blanks prepared in this way were superimposed in two on top of each other and were heat-welded on one side (temperature about 120 ° С) using the device for welding polymer films ST-320, ST Brand. In this case, the weld was at an angle of 60 ° to the side length, and its width was 0.5 mm. After welding, the corners from two ends of the coupler were cut off at an angle of 60 °. The resulting bicuspid drainage had the shape of a bilateral trapezoid with a large base of 5.5 mm, a smaller base of 4.3 mm, a height of 2.5 mm and a thickness of 160 μm.

The resulting drains are then used in anti-glaucoma surgery.

The method of penetrating anti-glaucoma surgery is sequentially as follows. The conjunctival flap is separated with the base to the limb and from the limb. A superficial scleral flap is formed (in the form of a trapezoid) with the base in the limb region at ½ of its thickness, 4 mm in size at the base and 2 mm at the top of the trapezoid, and the height is 4-5 mm. In the limbal zone, a deep strip of sclera with trabecular tissue is cut out and excised. Perform basal iridectomy. Next, a scleral flap is repositioned with a nodal suture in the apex region. The question of the need to impose 2 nodal sutures on the base of the scleral flap is decided by the surgeon during the operation.

When using drainage strips, tape drainage is placed under the scleral flap with tweezers, so that the centerline of the drainage coincides with the center line of the scleral flap.

When using bicuspid drainage, first one of the edges of the drainage under the scleral flap is superimposed into the separation zone, after which the flap itself is applied to it, and then the remaining, longer edge is folded over, covering the upper surface of the scleral flap. Center the drainage along its length.

When using tricuspid drainage, the central part of this drainage (“base”) is superimposed into the separation zone under the scleral flap, so that its center coincides with the center of the scleral flap, after which the flap is placed on it, and then the right and left are folded marginal drainage areas on a laid scleral flap by matching the edges of the drainage along the center line. Center the drainage along its length. The antiglaucomatous operation ends with the repositioning of the conjunctival flap with a continuous suture (tight suturing of the edges).

It is also possible to carry out a variant of non-penetrating deep sclerectomy, which is carried out as follows. Separation of the conjunctival flap with the base to the limbus or from the limbus. The formation of a superficial scleral flap (in the form of a trapezoid) with a base in the limb region at ½ of its thickness 4 mm in size at the base and 2 mm at the top of the trapezoid is 4-5 mm high. Removal of the middle layers of the sclera in the form of a rectangle before exposure of the inner layers of the corneoscleral part of the trabecula and the limbal edge of the descemet shell. Next, a scleral flap is repositioned with a nodal suture in the apex region.

When using drainage strips, the drainage is placed under the scleral flap with tweezers, so that the centerline of the drainage coincides with the center line of the scleral flap.

When using bicuspid drainage, first one of the edges of the drainage under the scleral flap is superimposed into the separation zone, after which the flap itself is applied to it, and then the remaining, longer edge is folded over, covering the upper surface of the scleral flap. Center the drainage along its length.

When using tricuspid drainage, the middle (central) part of the drainage is superimposed into the separation zone under the scleral flap, so that its center coincides with the center of the scleral flap, after which the flap is placed on it, and then the right and left marginal sections are folded drainage on a laid scleral flap by matching the edges of the drainage in a central line. Center the drainage along its length. The antiglaucomatous operation ends with the repositioning of the conjunctival flap with a continuous suture (tight suturing of the edges).

The following are examples of clinical trials of drainages according to a utility model in the treatment of glaucoma.

Patient A., 58 years old I / B No. 2928.11, was admitted to the hospital with a diagnosis of OS - operated III C glaucoma, initial cataract, OD - open-angle II A glaucoma, initial cataract. He was diagnosed with glaucoma since 2005, and in 2007 an antiglaucomatous operation was performed on the OS. Upon admission to the hospital, the tonometric pressure on the left eye is 32 mm Hg. at maximum antiglaucomatous mode, cicatricial changes are observed in the area of the filter pad. Given this clinical picture, it was decided to perform surgical treatment of glaucoma (penetrating antiglaucomatous surgery). Performed separation of the conjunctival flap with the base to the limb. A superficial scleral flap was formed in the form of a trapezoid with a large base in the limb region ½ of its thickness 5 mm long and a length of 3 mm less than the base of the trapezoid. A deep strip of sclera with trabecular tissue is cut and dissected in the limbal zone. Performed basal iridectomy. The scleral flap was repositioned with a nodal suture at the apex and two at the base of the scleral flap. A drainage strip is used. The drainage is placed under the scleral flap using suture forceps, so that its center line coincides with the center line of the scleral flap.

The antiglaucomatous operation was completed by repositioning the conjunctival flap with a continuous suture. When discharged from the hospital, palpation pressure is normal, the filter pad is moderate, it functions well. When re-examined 1.5 months after the operation Po 15 mm Hg, the filter pad functions well, according to ultrasound biomicroscopy, the preservation of the implanted material is observed. When viewed after 3 months, a flat filter pad, intraocular pressure - Po - 14 mm Hg. According to ultrasound biomicroscopy, the preservation of the implanted material is observed. After 6 months, intraocular pressure - Po - 15 mm Hg, according to ultrasound biomicroscopy, complete resorption of the drainage was confirmed and a subconjunctival cavity was formed. When examined after 9 months, a stable IOP is maintained at the level of Po - 16 mm Hg without visual impairment, and complete resorption of the implanted material is confirmed by ultrasound biomicroscopy.

Patient K., 78 years old I / B No. 8353.11, was admitted to the hospital with a diagnosis of OD - operated on III B glaucoma, artifakia, OS - open-angle II A glaucoma, initial cataract. Glaucoma was diagnosed in 1997. From the anamnesis in 2000, an antiglaucomatous operation was performed on OD. Upon admission to the hospital, tonometric pressure on the left eye is 30 mm Hg. at maximum antiglaucomatous mode, cicatricial changes are observed in the area of the filter pad. Given this clinical picture, it was decided to perform surgical treatment of glaucoma (penetrating antiglaucomatous surgery). Performed separation of the conjunctival flap with the base to the limb. A superficial scleral flap was formed in the form of a trapezoid with a large base in the limb region ½ of its thickness 5 mm long and a length smaller than the base of the trapezoid 3 mm, at 13 hours, taking into account gross cicatricial changes from a previous operation. A deep strip of sclera with trabecular tissue is cut and dissected in the limbal zone. Performed basal iridectomy. The scleral flap was repositioned with a nodal suture at the apex and two at the base of the scleral flap. Bicuspid drainage is used. The edge of this drainage is drawn under the scleral flap and the longer edge is bent so that it covers the upper surface of the scleral flap. Drainage was centered along its length relative to the scleral flap. The antiglaucomatous operation was completed by repositioning the conjunctival flap with a continuous suture. When discharged from the hospital, palpation pressure is normal, the filter pad is moderate, it functions well. When re-examined 1.5 months after the operation Po 13 mm Hg, the filter pad functions well, according to ultrasound biomicroscopy, the preservation of the implanted material is observed. When viewed after 3 months, a flat filter pad, intraocular pressure - Po - 12 mm Hg. According to ultrasound biomicroscopy, the preservation of the implanted material is observed. After 6 months, intraocular pressure - Po - 12 mm Hg, according to ultrasound biomicroscopy, complete resorption of the drainage was confirmed and a subconjunctival cavity was formed. When examined after 9 months, a stable IOP is maintained at the level of Po - 14 mm Hg without visual impairment, and complete resorption of the implanted material is confirmed by ultrasound biomicroscopy.

Patient S., 83 years old I / B No. 3404.11, was admitted to the hospital with a diagnosis of OD - open-angle II AB glaucoma, OS - open-angle IA Glaucoma, OU - immature cataract. Glaucoma was diagnosed in 2010. Upon admission to the hospital, the tonometric pressure on the left eye is 25 mm Hg. at maximum antiglaucomatous mode. Given this clinical picture, it was decided to perform surgical treatment of glaucoma (non-penetrating antiglaucomatous surgery). Performed separation of the conjunctival flap with the base of the limb. The formation of a superficial scleral flap (in the form of a trapezoid) with the base in the limb area at ½ of its thickness 4 mm in size at the base and 2 mm at the top of the trapezoid. Removal of the middle layers of the sclera in the form of a rectangle before exposure of the inner layers of the corneoscleral part of the trabecula and the limbal edge of the descemet shell. The scleral flap was repositioned with a nodal suture in the apex region. A tricuspid drainage with three flat sections is used. Threaded the edge of this drainage under the scleral flap, its center coincided with the center of the scleral flap, then the right and left edges of the drainage were bent. The edges of the drain are aligned along the center line on the upper surface of the scleral flap. Drainage was centered along its length. Antiglaucomatous surgery was completed by repositioning the conjunctival flap with a continuous suture. When discharged from the hospital, palpation pressure is normal, the filter pad is moderate, it functions well. When re-examined 1.5 months after the operation, the intraocular pressure Po is 12 mm Hg, the filter pad functions well, according to ultrasound biomicroscopy, the implant material is preserved. When viewed after 3 months, a flat filter pad, Po - 14 mm Hg. According to ultrasound biomicroscopy, the preservation of the implanted material is observed, with a subconjunctival cavity gradually forming. After 10 months, the intraocular pressure - Po - 13 mm Hg, according to ultrasound biomicroscopy, the complete resorption of the implanted material with the formed subconjunctival cavity is confirmed.

It is possible to use the inventive drainage in conjunction with a mini-shunt Ex-PRESS. The operation technique must be performed according to the following algorithm: separation of the conjunctival flap with the base to the limb or from the limb. The formation of a superficial scleral flap (in the form of a trapezoid) with the base in the limb area at ½ of its thickness 4 mm in size at the base and 2 mm at the top of the trapezoid. The bicuspid drainage is installed so that one half is placed under the scleral flap, and the other bent part covers the upper surface of the scleral flap. If necessary, the necessary drainage dimensions can be modeled. Implantation of the mini-shunt Ex-PRESS. Reposition of the scleral flap with a nodal suture in the apex. Completion of antiglaucomatous surgery by repositioning of the conjunctival flap with continuous suture. This operation allows you to save the outflow of intraocular fluid and prevent the path of the outflow from the mini-shunt to be blocked.

The specified method of the operation and the claimed drainage drainage were tested in the Ophthalmic Clinical Hospital in 23 patients who underwent antiglaucomatous operations with the installation of drainage devices according to the utility model. The mean follow-up was 12 months. In all cases, intraocular pressure is within normal limits, the absence of cicatricial changes in the area of the filter pad and scleral flap, the filter pad is flat, fully fulfilling its function.

In conclusion, it should be noted that the above examples of the implementation of the utility model should not be construed as the only possible and limiting the scope of the requested legal protection, which is fully determined exclusively by the attached formula.

Claims (22)

1. Drainage for use in the surgical treatment of glaucoma, made in the form of a final elongated product made of bioresorbable material, having a first and second end, and at least one flat section located between them so that it is possible to lay said flat section during surgical treatment under the separated scleral flap with the location of the first and second ends outside the scleral bed. 2. The drainage according to claim 1, characterized in that it is made in the form of a strip of bioresorbable material. 3. The drainage according to claim 2, characterized in that it has a substantially rectangular shape with a length of 3.0-12.0 mm and a height of 1.0-3.5 mm, while the thickness of the drainage is 10-300 microns . 4. The drainage according to claim 1, characterized in that it is made in the form of a strip of bioresorbable material, which is bent at least in one line, essentially perpendicular to its long side. 5. The drainage according to claim 4, characterized in that said strip is bent in one line with the formation of a second flat section with the possibility of its location on top of the separated scleral flap. 6. The drainage according to claim 5, characterized in that the strip is flatly folded. 7. The drainage according to claim 4, characterized in that said strip is bent along two lines with the formation of two marginal flat sections, each of which is adjacent to one end of the drainage with the possibility of placing two of these marginal sections on top of the separated scleral flap. 8. The drainage according to claim 7, characterized in that the total length of two marginal flat sections does not exceed half the length of the entire drainage in a fully expanded state. 9. The drainage according to claim 1, characterized in that it is made of two separate segments of bioresorbable material, interconnected by ends so that the first segment has one free end forming the first end of the drainage, and the second segment has one free end forming the second end of the drainage, while the first segment has a flat section for laying it under the separated scleral flap, and the second segment has a flat section for laying it on top of the separated scleral flap. 10. The drainage according to claim 1, characterized in that it is made of three separate segments of bioresorbable material, the first marginal section having one free end forming the first end of the drainage, the second marginal segment has one free end forming the second end of the drainage, the central segment is connected at its ends to the ends of the first and second segments with the possibility of laying the central segment under the separated scleral flap and the possibility of arranging the two indicated first and second marginal segments on top of the separated scleral flap. 11. Drainage according to any one of claims 4 to 10, characterized in that its largest longitudinal dimension does not exceed 7.0 mm, the height is 1.0-3.5 mm, and the thickness is 20-600 microns. 12. Drainage according to claims 7-10, characterized in that it has a trapezoidal shape with a large base of 2.5-7.0 mm, a smaller base of 2.0-5.0 mm. 13. Drainage according to claims 7-10, characterized in that it has a substantially rectangular shape with a length of 2.0-7.0 mm 14. Drainage according to any one of claims 1 to 10, characterized in that it is made of a film. 15. The drainage according to 14, characterized in that it is made of a porous film. 16. The drainage of claim 14, characterized in that it is made of at least partially perforated film. 17. Drainage according to any one of claims 1 to 10, characterized in that it is made of mesh. 18. Drainage according to any one of claims 1 to 10, characterized in that the bioresorbable material is selected from the group including: synthetic polymers, microbiologically synthesized materials. 19. The drainage according to claim 18, wherein the synthetic polymer is selected from the group consisting of: polyglycolic acid (polyglycolide), L- or D, L-polylactic acid (polylactide), poly-ε-caprolactone, poly-p-dioxanone , copolymers of these materials, mixtures of these materials and / or copolymers. 20. Drainage according to claim 18, characterized in that a hydrogel based on polyvinyl alcohol or a grafted copolymer containing polyvinyl alcohol and polyethylene glycol is selected as a synthetic polymer. 21. Drainage according to claim 18, characterized in that one of the following materials is used as the microbiologically synthesized material: poly-3-hydroxybutyrate, poly-3-hydroxyvalerate or poly-4-hydroxybutyrate or their copolymers. 22. Drainage according to claim 18, characterized in that the recombinant web proteins: speedroin-1 and speedroin-2 are used as microbiologically synthesized material.

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