WO2019190352A1 - Drainage pour le traitement chirurgical du glaucome et procédé de sa fabrication - Google Patents

Drainage pour le traitement chirurgical du glaucome et procédé de sa fabrication Download PDF

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Publication number
WO2019190352A1
WO2019190352A1 PCT/RU2019/000186 RU2019000186W WO2019190352A1 WO 2019190352 A1 WO2019190352 A1 WO 2019190352A1 RU 2019000186 W RU2019000186 W RU 2019000186W WO 2019190352 A1 WO2019190352 A1 WO 2019190352A1
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Prior art keywords
drainage
protrusion
drainage according
base
preform
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Russian (ru)
Inventor
Александр Робертович КОРИГОДСКИЙ
Иван Дмитриевич ЗАХАРОВ
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Priority claimed from RU2018110661A external-priority patent/RU2771784C2/ru
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials

Definitions

  • the invention relates to medical equipment, namely to drains used in ophthalmic surgery for penetrating antiglaucomatous operations.
  • 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. Anti-glaucomatous surgery allows you to create new ways of outflow of aqueous humor from the eye.
  • intraocular fluid As you know, intraocular fluid (HPW), or aqueous humor, is an important source of nutrition for the internal structures of the eye. It circulates mainly in the anterior segment of the eye. It participates in the metabolism of the lens, cornea, trabecular apparatus, vitreous humor and plays an important role in maintaining a certain level of intraocular pressure (IOP) [E.N. Iomdina, S.M. Bauer, K.E. Kotlyar. Biomechanics of the eye: theoretical aspects and clinical applications. M., Real Time, 2015, 208 pp.].
  • IOP intraocular pressure
  • Intraocular fluid is continuously produced by the processes of the ciliary body, accumulates in the posterior chamber. Then most of it flows through the pupil, washing the lens, after which it enters the anterior chamber and passes through the drainage system of the eye located in the area of the anterior chamber angle — the trabecula and Schlemm canal.
  • Antiglaucomatous operations aimed at creating new outflow pathways can be divided into two main groups:
  • Non-penetrating operations during which a deep layer of corneoscleral tissues and the outer wall of the Schlemm canal are removed, as well as the epithelial layer of the inner wall of the Schlemm canal and the Descemet membrane is released. Filtration of the HPW is carried out through the pores of the remaining trabecular network and Descemet's membrane. The most widely used operation is non-penetrating deep sclerectomy, which minimizes the amount of intervention and the risk of postoperative complications.
  • Penetrating (fistulizing) operations during which the anterior chamber of the eye is opened with further formation of a fistula in the limbal zone, which is part of the newly created outflow pathways of the HPW. These operations, which primarily include trabeculectomy, are used in ophthalmosurgery due to the relative ease of implementation and a persistent reduction in IOP.
  • a scleral flap (triangular, rectangular or trapezoidal shape) is preliminarily cut, the base of which (2, 0-4, 0 mm in size) usually starts from the limb, and the apex is 3-5 mm from the limb.
  • the size of the scleral flap is 2, 0-4, 0 * 3, 0-5.0 mm.
  • drains in the area of surgical intervention is the most effective way to preserve the outflow pathway of the intraocular fluid (reduction of scar changes in the area of intervention) created during anti-glaucomatous operations.
  • Tubular drains having a different device and made of materials of various nature, in which the passage of water-borne fluids is regulated by the selection of the size of the inner diameter of the tube and a special valve, are widely used in penetrating operations. All of them have approximately the same devices - a polymer tube connected to the drainage body.
  • Molteno drainage consists of a thin silicone tube 14 mm long.
  • the inner diameter of the hole is 0.3 mm, the outer end ends with a circular platform with a diameter of 13 mm with a dosed unidirectional valve [B. V. Neroev, V.P. Bykov, O.I. Kvasha O.I., Belevtseva. Surgical treatment of glaucoma by microdraining.
  • Literature review Breast cancer "Clinical Ophthalmology”. 2009, N ° 3, p. 113].
  • Ahmed drainage is a valve device consisting of a tube connected to a silicone valve enclosed in a polypropylene tank housing.
  • the valve mechanism consists of two membranes based on the Venturi effect. It opens when the pressure rises above 8 mm Hg. Art. [O.L. Fabrikantov, S.I. Nikolashin. Surgical treatment of terminal glaucoma using Ahmed TM drainage valve system. Bulletin of the Tambov University. Series Estest. and tech. Sciences. Tambov, 2012, vol. 17, no. 1, 245-249].
  • Ex-Press is a device that is a tube with a beveled disk-shaped tip made of medical stainless steel 2.64-3.00 mm long, the outer diameter of which is 400 microns (27 G), and the inner one is 50 microns.
  • Ex-Press is installed using the injector into the anterior chamber without contact with the iris, with a slice deployed to the cornea, in the formed scleral bed in the area of the projection of the trabeculae.
  • the outer end of the device is a flat platform, this design ensures its correct position and reliable fixation.
  • Ex-Press drainage device contributes to a long hypotensive effect and is currently widely used in ophthalmic surgery.
  • non-resorbable drainage designed for penetrating anti-glaucomatous operations in the form of a device comprising a housing made of a polymer material based on hydrogel containing 70-76% water in the polymer [RF Patent D ° 2192821, 20.11 .2002. Drainage for the treatment of glaucoma. V.I. Sevastyanov, A.M. Immortal, V.P. Yerichev et al.].
  • the drainage housing is equipped with 2-3 cylindrical microtubules protruding above the surface of the housing made of a microporous polymer compound, and when implanted, these microtubules are placed in the anterior chamber, and the drainage housing is fixed intrasclerally.
  • the disadvantage of this drainage is the inevitable decrease of filtration of chamber moisture through the pores over time microtubules due to their clogging and clogging and, as a consequence, the rise of IOP (observation period was only 8 months).
  • drains for penetrating operations are usually performed from non-resorbable bioinert materials.
  • most of these materials especially polymeric ones, have significant disadvantages, in particular, calcification, which begins with the formation of hydroxyapatite crystals on the surface of the materials, if they are continuous, and in volume, if they are permeable to water (porous or containing water with its structure) [Biocompatibility . Under. ed. V.I. Sevastyanova. M., 1999, 368 pp.].
  • such materials include polytetrafluoroethylene (teflon), polyethylene terephthalate (lavsan), hydrogel materials, including polyhydroxyethyl methacrylate (poly-HEMA) (in crosslinked form) and collagen (in crosslinked form).
  • poly-HEMA polyhydroxyethyl methacrylate
  • collagen in crosslinked form
  • this drainage does not allow to prevent splicing in the area of trabeculectomy during penetrating operations, which makes the use of this drainage during penetrating operations ineffective.
  • this drainage enters only the subliminal zone of the scleroconjunctival region, not reaching the zone of active vascular outflow of the intraocular fluid, which can also reduce the effectiveness of its action.
  • the purpose of the present invention is the creation of bioresorbable drainage intended for penetrating antiglaucomatous operations, the use of which achieves a long hypotensive effect.
  • Another objective is the creation of drainage, which ensures the creation and maintenance of an additional scleral-conjunctival cavity in the area of active outflow, which significantly increases the filtration (outflow) area of the intraocular fluid into the capillary system and increases the efficiency of the drainage.
  • An additional objective is the creation of 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 with various options for penetrating antiglaucomatous operations.
  • the claimed drainage is used, used in penetrating anti-glaucomatous surgical operations, which is made of bioresorbable material, part of which is placed under a separated scleral flap and which has at least the first protrusion with the possibility of its introduction into the trabeculectomy zone until its edge (end) ) to the front camera.
  • the drainage may have a second protrusion facing in the opposite direction from the first protrusion, with the possibility of laying it under a pre-separated conjunctiva.
  • the drainage is made in the form of a closed-profile hollow profile product that is made of bioresorbable material and which has at least a first protrusion, with the possibility of through-threading the separated scleral flap through the drainage cavity with the possibility of introducing the specified protrusion into the trabeculectomy zone up to exit him edge (end) into the anterior chamber.
  • the base of the drainage (its distal part) has two walls.
  • the drainage is made in the form of an end product with an open circuit, which is made of bioresorbable material and which has a first and second end and a middle section located between them, as well as at least a first protrusion, with the possibility of introducing the specified protrusion into the zone trabeculectomy to the exit of its edge (end) in the anterior chamber and with the laying of the specified middle section under the separated scleral flap with the location of at least one end from the outside (on top) of the separated scleral flap or adjacent scleral area outside the scleral bed.
  • the protruding part of the implant - the first protrusion (the proximal part of the implant), is inserted into the preformed fistula channel that extends into the anterior chamber and ensures its functioning due to the prevention of adhesion of adjacent tissues.
  • the base of the drainage distal part
  • a scleral flap drainage with a closed circuit
  • laid on the surface of the sclera drainage with an open circuit
  • the subject of this application is a bioresorbable drainage intended for penetrating antiglaucomatous operations and representing a product consisting of at least two functional parts - the base of the drainage, which is a strip (in a bent or not bent form) or a closed strip (sleeve) and a front protrusion , which is a (lateral) protruding part of the strip, which is its continuation.
  • the first protrusion of the drainage in accordance with the present invention, during the operation should be able to enter into the channel formed in the area of the trabeculectomy, before its edge goes into the front chamber to prevent splicing of this channel.
  • the first protrusion must meet the following requirements:
  • - have a length of at least a certain value so that its end extends into the anterior chamber, i.e. its size would be no less than the formed channel (to avoid its coalescence) and would not be larger (by 0.2-1.0 mm) to avoid the subsequent penetration of the non-resorbable (excess) end portion of the protrusion into the anterior chamber during resorption of the entire drainage
  • - have a width (base size) of not less than a certain value so that the protrusion can be inserted into the formed channel (so that the protrusion is sufficiently rigid) and not more than a certain value so that its dimensions allow it to be inserted into the specified channel
  • the end portion (edge) of the first protrusion protrudes slightly into the front chamber, in order to prevent the incompletely resorbed portions of the protrusion-clove getting into it, it is necessary that it resorb faster. This is ensured in the inventive drains due to the shape of the end part of the protrusion, preferably having a narrowing (in the end proximal part).
  • the first protrusion may have a shape selected from the following group: a triangle, a rectangle or a trapezoid, or these figures with rounded or beveled corners or a semi-ellipse or the shape of a thread, loop or connected threads, but is not limited to these shapes.
  • the first protrusion being a continuation of the basis of the drainage, can be clearly expressed or implicitly expressed (so that it cannot be clearly distinguished).
  • the first protrusion can be formed by the end part (corner) of the drainage with an open circuit having, for example, a rectangular shape.
  • the first protrusion can be additionally bent in at least one line at an acute angle to its base (sketches 8a and 8b). This increases the rigidity of the protrusion introduced into the trabeculectomy zone without unnecessarily increasing the thickness of the drainage wall (and, accordingly, the resorption time).
  • At least one edge part of the drainage is laid so that it covers the scleral flap or fits under a pre-separated conjunctiva in the area of the sclera adjacent to a flap. Drainages with at least one bend, as well as drainages without bends, can be laid in this way (sketch 1.2b).
  • the drainage in addition to the first protrusion, in accordance with the present invention, may have a second protrusion, facing mainly in the opposite direction from the first protrusion, with the possibility of laying it under a pre-separated conjunctiva (between the sclera and conjunctiva). Its role is to create and maintain an additional scleral-conjunctival cavity in the area of active outflow, which significantly increases the filtering area of the HPW into the capillary system.
  • the second protrusion is its distal part.
  • the episclera (the vascular sclero-conjunctival zone is a thin layer of connective tissue between the conjunctiva and sclera), starting from the limbus (the edge of the cornea) and ending at the posterior pole of the eye, is penetrated by the vessels, and the main vortical veins (their number is 4-6), in the zone of which the most active vascular outflow of the hepatitis C occurs, are located in the equator (eyeball), 10-12 mm from the limbus, and 2, 5-3, 5 mm behind the equator [htp: //www.zdorlife.ru /page-id-5l2.html; E.A. Egorov S.N.
  • venous capillaries In glaucoma, venous capillaries, especially thin ones adjacent to the limb, lose their drainage ability due to spasm and sclerosis. Therefore, the zone of vascular outflow in patients with glaucoma is even more shifted from the limb towards the equator. For this reason, only starting at a distance of 5-6 mm and, especially, at a distance of 10-12 mm, making pockets between the sclera and the conjunctiva (separating the conjunctiva) and introducing into this space the distal portion of antiglaucomatous drainage is the most effective.
  • the edge of the scleral flap deviates from the limb by 4-6 mm, it is necessary that the length of the distal drainage section (which extends beyond the scleral bed) is at least 1-6 mm, preferably 6-12 mm, which ensures the most active outflow VGZh.
  • the second protrusion located under the scleral flap should preferably have dimensions that contribute to the highest filtration of the HPW in the capillary system, and it should also have holes (pores, perforations, separate large holes) that facilitate this process. These holes should preferably be of maximum size, but not to the detriment of the supporting functions of the drainage (retention of the arch of the outflow channels) and its mechanical strength.
  • the second protrusion of the drainage should preferably be significantly larger than the first protrusion.
  • the second protrusion may have a shape selected from the following group: triangle, rectangle or trapezoid, or these figures with rounded or beveled corners, or a semi-ellipse, or the shape of a thread, loop or connected threads, but not limited to these shapes.
  • the optimal size of the entire drainage and both protrusions depends on the individual characteristics of the patient’s eye and the technique of the operation. Correction of the size of both protrusions, if necessary, can be carried out during the operation due to the simulation of drainage.
  • the front protrusion of the drainage helps to prevent splicing of the canal formed in the trabeculectomy zone, and the basis of the drainage helps to prevent adhesions under the scleral bed (sclero-scleral), as well as between the scleral flap and the conjunctiva (sclero-conjunctival, partially) in the sublimal area.
  • improved utilization of the intraocular fluid in the area of active outflow is additionally provided and sclero-conjunctival splices are prevented (in the entire scleral region).
  • the drainage according to this application is made of bioresorbable material, which avoids adverse reactions and complications, exacerbated by long or constant implantation periods.
  • Synthetic polymers, microbiologically synthesized polymers and modified natural polymers can be used as bioresorbable material for the manufacture of drainage. Drainage can be made of solid material (film) or non-continuous material: a porous film, at least partially perforated film, as well as a microfibre or woven material or mesh.
  • the drainage can be made in the form of a thin-walled tube, the outer surface of which is made in the form of a part of a substantially cylindrical surface (base) and which has at least a first protrusion.
  • the specified thin-walled tube can be flatly folded, while the base of the drainage can be in plan essentially rectangular, diamond-shaped, triangular or other shape.
  • the inventive drainage has the following dimensions: the height of the base 1, 0-3.0, the width (of the base and the entire drainage) of 2.5-6.0 mm, the height of the first protrusion of 1.0-3.0 mm, the base of the first protrusion of 0.03 -3.0 mm, the height of the second protrusion of 1.0-16.0 mm, the base of the second protrusion of 0.03-6.0 mm, the wall thickness of 10-600 microns.
  • a biosorbable material is prepared from a bioresorbable material on a rod in the form of a hollow profile, a closed section (contour), and then a hollow profile with a closed contour and at least one protrusion is cut from the preform to insert the protrusion into the trabeculectomy zone before it leaves edges into the front chamber (for drainage in the form of the final product).
  • a preform is made of a bioresorbable material in the form of a flat sheet, at least one end element having a first and second end, as well as at least one protrusion located between the first and second end are further cut from the preform.
  • the first and second ends are interconnected to obtain a hollow profile with a closed loop and at least one protrusion for introducing the specified protrusion into the trabeculectomy zone until its edge enters the anterior chamber (to obtain renage as a final product).
  • a third option is possible, in which a blank is made in the form of a hollow profile, of a closed section and then a drainage base (sleeve) is cut from it that does not contain the first and second protrusion. After that, an extra elongated part (strip, thread) is welded (glued) perpendicularly to the long part of the flat folded base to create the first or both protrusions.
  • a fourth option is also possible, in which a blank is made in the form of a sheet and then a drainage base is cut from it that does not contain the first and second protrusion. After that, an extra elongated part (strip, thread) is welded (glued) perpendicularly to the long part of the obtained base to create the first or both protrusions.
  • the preform is preferably cast from a solution of bioresorbable polymeric material.
  • the preform is cast from a solution of a polymeric material containing a water-soluble filler, after which, before cutting at least one segment, the preform is dried and the filler is washed to obtain a preform from a porous film.
  • the resulting workpiece is at least partially perforated.
  • a preform is cast from a solution or molten polymer material by electroforming (electrospinning), crazing, lithography, bioprinting, or a combination thereof.
  • the workpiece in a method for producing drainage, is woven from threads or fibers.
  • a preform in a method for producing drainage, is made by winding a thread onto a rod and then sintering it to obtain a tube with a mesh wall.
  • Finished bioresorbable film, microfibre, woven material or mesh obtained in another way and / or for other purposes can also be used as a preform.
  • drainage can be made in the form of a final product having a first and second end and a middle section (base) located between them, as well as at least a first protrusion, with the possibility of introducing the specified protrusion into the trabeculectomy zone until its edge reaches the anterior the chamber and with the laying of the specified flat area under the separated scleral flap with the location of at least one end from the outer part (on top) of the separated scleral flap or adjacent area of the sclera behind scleral bed affairs.
  • the inventive open-loop drains should preferably be a flat product, i.e. one in which the longitudinal dimensions (length and width) are significantly greater than the thickness, since the drainage of a flat material (with a thickness of not more than the above value) allows the scleral flap to close closely after its fixation and the adjacent scleral region, which creates favorable conditions for the passage of the intraocular fluid and correct intergrowth of tissues.
  • the soft elastic structure of most of the claimed drainage, especially microfibre contributes to this.
  • the inventive flat drainage can be bent as shown below, which, however, does not thicken their part coming out from under the scleral flap.
  • the specified open-loop drainage can be used in an unbent form.
  • the drainage can be bent in at least one line and folded flat.
  • the drainage can be bent in one line with the formation of a substantially flat section with the possibility of its location from the outer part of the separated scleral flap or adjacent scleral section.
  • the drainage can also be bent along two lines with the formation of two marginal flat sections, each of which is adjacent to the middle section, with the possibility of arranging two of these marginal sections from the outside of the separated scleral flap or adjacent section of the sclera (preferred option), while the drainage base may have in plan essentially rectangular, rhomboid, triangular or other shape.
  • wall thickness will be used below, as for drainage with a closed circuit.
  • the inventive drainage has the following dimensions: the height of the base 1, 0-3.0 mm, the width (of the base and the entire drainage) 4.0-16.0 mm, the height of the first protrusion 1, 0-3.0 mm, the base of the first protrusion 0, 03-3.0 mm, the height of the second protrusion of 1.0-16.0 mm, the base of the second protrusion of 0.03-6.0 mm, the wall thickness of 10-600 microns.
  • the end sections of the drainage may have a rectangular (preferably), semicircular, acute-angled or other shape.
  • One of the end sections of the drainage for example, of a rectangular shape, with its angle can be introduced into the trabeculectomy zone as the first protrusion.
  • a preform in the form of a sheet is made from a bioresorbable material, after which at least one end element is cut from the preform, having a first and second end and a middle portion located between them, as well as at least a first protrusion intended to be introduced into the trabeculectomy zone until its edge exits into the anterior chamber (to obtain drainage in the form of a final product).
  • a blank in the form of a hollow profile with a closed loop is made from a bioresorbable material on the rod, after which a hollow profile with a closed loop and at least one protrusion is cut from the blank to introduce this protrusion into the trabeculectomy zone up to the exit of its edge into the anterior chamber, after which a hollow profile is cut (to obtain drainage in the form of the final product).
  • a third option is possible, in which a blank is made in the form of a sheet and then a drainage base is cut from it that does not contain the first and second protrusion. After that, an extra elongated part (strip, thread) is welded (glued) perpendicularly to the long part of the obtained base to create the first or both protrusions.
  • Specific methods for producing open-loop drains are the same as those for closed-loop drains described above.
  • a preform is obtained in the form of a thin-walled tube, and then at least one segment is cut from it — drainage with a closed loop, after which it is cut in the transverse direction to obtain the corresponding final product having one or two protrusions.
  • Fig.1.2b drainage with a rectangular base in the form of an unbent strip of continuous film with a first protrusion in the form of a triangle, having one end for laying from the outer part of the separated scleral flap;
  • the drainage according to the invention is generally made in the form of a product having a hollow profile with a closed loop and in the form of a product having an open loop.
  • the preferred or optimal shape and dimensions of the closed-loop drainage according to the invention can be selected taking into account the type and features the operation performed, the shape and size of the scleral flap excised during surgical intervention, the size and shape of the canal performed in the trabecular zone, as well as the size and shape of the separated conjunctiva in the sclero-conjunctival area (when using drainage with a second protrusion).
  • Such a preferred embodiment of the product is aimed at ensuring the convenience of working with it during surgery, as well as for its most effective functioning after implantation as an anti-glaucomatous drainage.
  • the most preferred drainage sizes are selected from the following ranges:
  • the height of the base is 1.0-3, 0 mm, preferably 1.5-2, 5 mm
  • the height of the first protrusion 1.0-3.0 mm, preferably 1, 2-2.0 mm
  • the height of the second protrusion 1.0-16.0 mm, preferably 5.0-12.0 mm
  • - wall thickness of 10-600 microns, preferably 50-150 microns.
  • the thickness of the claimed drainage is twice the thickness of each of its walls.
  • the optimal thickness for the various drainage options presented may have a different value.
  • closed-loop drainage (upon receipt) can be flattened or flat so that its base (excluding protrusions) can have a rectangular, diamond-shaped, triangular or other shape in plan.
  • Synthetic polymers, microbiologically synthesized polymers and modified natural polymers can be used as bioresorbable material.
  • polyglycolic acid polyglycolide
  • D-, L- or 0, L-polylactic acid polylactide
  • poly-c-caprolactone poly-p-dioxanone
  • polypropylene fumarate polytrimethylene carbonate
  • polyurethanes based on simple or polyesters
  • polyamides polyacetals
  • polyketals polyvinyl acetate
  • polyvinyl alcohol copolymers or block copolymers of these polymers or mixtures thereof.
  • microbiologically synthesized polymer one of the following materials can be used: poly-3-hydroxybutyrate, poly-3-hydroxyvalerate, poly-4-hydroxybutyrate, fibrillar protein, copolymers of these polymers or mixtures thereof.
  • one of the following materials can be used: ethyl cellulose, cellulose acetate (cellulose acetate, diacetate or triacetate), chitosan, silk, viscose, cellophane, or mixtures thereof.
  • Hydrophilic polymers from the above, for example, polyvinyl alcohol can be crosslinked by known methods (chemical or radiation) to obtain bioresorbable hydrogels.
  • bioresorbable materials available for use includes, but is not limited to, the above.
  • microfiber drainages described below can be obtained from synthetic polymers and microbiologically synthesized polymers, preferably hydrophobic.
  • Microfiber drainages from natural and modified natural polymers and other hydrophilic polymers, as well as composite materials based on them, have been found to be poorly reproducible due to their hydrophilic properties (the degree of equilibrium swelling in physiological media is more than 15 wt.%), in particular, deformation and strength, as well as the time of resorption. For this reason, they are less promising for practical use.
  • the inventive drainage having fulfilled its temporary function to stabilize the IOP in the postoperative period (due to the mechanical maintenance of the arches and to prevent the tissue from joining the channel formed during the penetrating operation), completely resolve within 1-12 months, the optimal time is 2-5 months. (which is necessary for the formation of stable outflow pathways from tissues).
  • the bioresorbable polymeric material of which the device is made upon application can be continuous or non-continuous, i.e. having pores and / or holes.
  • the use of non-continuous material is more preferable, since the pores, holes and cavities in it provide more efficient penetration of intraocular fluid and a greater filtering effect in general, while the structure of the non-continuous material depends on the method of its preparation.
  • options for a non-continuous material are considered, such as a porous film (obtained by washing out the filler), a perforated film, a material obtained by electrospinning (microfibre material), crazing, lithography, bioprinting, as well as woven material, mesh, although these options should not be regarded as restrictive.
  • non-continuous materials as microfiber and woven conditionally also have pores that differ in shape from traditional pores and are determined by the distances between adjacent fibers and threads, respectively.
  • the drainage of the invention is obtained in two main ways.
  • a billet is first obtained, which is a thin-walled tube made of bioresorbable material, after which it is cut flat into folded sections (rings, or couplings). These blanks can be obtained by casting from a solution or melt, as well as woven from threads or fibers.
  • pre-prepared blanks are used: flat sheets from a continuous, porous or perforated film, from a microwave or woven material or mesh. Tapes (preferably rectangular) having a width corresponding to the width of the resulting drainage can be cut from these sheets. After that, each tape is cut into short blanks (pieces) in the form of rectangles, as will be shown below. Further, these obtained blanks (pieces) are connected to the drain by fusing their ends, gluing or bonding with a bioresorbable thread.
  • a continuous film for producing drains is made in a known manner by evaporation of a solvent (organic or aqueous) from a previously prepared polymer solution. This process can be carried out at room temperature or by heating. In this case, the thickness of the obtained film is primarily determined by the concentration of the initial polymer solution.
  • a porous film for producing drains is made in a similar way by introducing a filler subsequently washed into a previously prepared polymer solution in an organic solvent or into its melt. This inert additive, organic or inorganic, being well 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 determines, respectively, both the size of the formed pores and the total porosity of the resulting material.
  • Such an initial porous film in accordance with the present invention can be made both in a flat form (with its subsequent cutting and welding, gluing or braiding into a product), and immediately in the form of a thin-walled tube.
  • 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:
  • D is the apparent density of the porous material, kg / m 3 ,
  • D 0 is the density of the starting polymer, kg / m 3 .
  • This value should preferably be 70-90%.
  • a total porosity of the material of more than 90%, the deformation-strength characteristics of the drains (both tensile strength and elongation) noticeably deteriorate, which can lead to destruction of the product during implantation.
  • a total porosity of less than 50% 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 stiffness can significantly increase, 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, woven and, especially, microfiber material or mesh, the mechanical characteristics of the drains can remain at a high level even with a porosity of 90-95%.
  • the perforation of materials obtained from continuous or porous polymer films in accordance with the present invention can be carried out using a special perforator, for example, a dermatome, designed for applying through incisions on temporary wound dressings or using a laser, intended for laser microprocessing of film materials.
  • the resulting holes may have a diameter of from 20 to 2000 microns.
  • both pre-prepared blanks continuous sheets of film or thin-walled tubes
  • already prepared drains can be perforated. The first option is preferred because of the greater convenience of fixing the workpiece.
  • Drainage (drainage blank) with a non-continuous structure can also be made by other modern and widely described methods: using crazing, electroforming, lithography, and bioprinting.
  • the indicated methods for producing discontinuous bioresorbable materials were developed mainly to create various scaffolds (matrices) populated by cells and intended for cellular engineering [T.G. Volova. Materials for medicine, cell and tissue engineering. Krasnoyarsk, IPK SFU. 2009, 262 p.].
  • non-continuous bioresorbable drainages in accordance with this application can be obtained in the following ways:
  • Polymer crazing is the process of the formation of ordered fibrillar-porous structures upon orientational drawing of amorphous polymers in adsorption-active liquid media [http://thesaurus.rusnano.com/wiki/article22206].
  • the resulting nanopores can be filled with any medium in which the polymer was stretched, for example, with drugs.
  • the resulting material can be attributed to porous or nanoporous films;
  • Electroforming is a method of pulling fibers from a solution or polymer melt using a high DC voltage, resulting in porous materials with a microfiber structure (with stochastically distributed fibers) [T. Stylianopoulos, S.A. Bashur, AS Goldstein et al. Computational predictions of the tensile properties of electrospun fiber meshes: effect of fiber diameter and fiber orientation. J. Mech. Behav. Biomed Mater. 2008, vl, N ° 4, 326-335].
  • the diameter of the obtained fibers can be 0.2-20 microns, and the porosity of the structure varies from 70 to 95%.
  • Installation for electroforming consists of a perfuser (polymer supply system), a high-voltage power source and a stationary grounded collector (substrate) [A.Yu. Khomenko. Regulation of the morphology and properties of non-woven and highly dispersed biocompatible materials based on chitosan and polymers of lactic acid obtained by electrospinning. Diss. Ph.D., M., 2016, 168 pp .; V.N. Vasilets, I.V. Kazbanov, A.E. Efimov, V.I. Sevastyanov. Development of new methods for the formation of implant materials using electrospinning and bioprinting technologies. Bulletin of transplantology and artificial organs. 2009, vol. 11, N ° 2, 47-53].
  • a polymer solution is placed in the perfuser, which is a syringe, the piston of which is connected to a stepper motor.
  • organic compounds with high volatility for example, chloroform or methylene chloride, are usually used as a solvent, which leads to its evaporation already in the process of applying the fibers to the substrate.
  • the resulting microfibers are wound on a metal rod or drum and, partially sticking together, form microfiber material.
  • the resulting material can be attributed to microfiber materials;
  • the combined method for example, hybrid electro-spinning-jet bioprinting [http://medach.pro/innovations/bioinzheneriya/3d-bioprinting-of-tissues-and- organs /].
  • the resulting material can be attributed to porous or nanoporous films.
  • Microfiber material obtained by electrospinning can be characterized by the diameter or thickness of the (average) formed fibers.
  • the fiber diameter should be in the range of 0, 1-6.0 microns, preferably 0, 5 -4, 0 microns.
  • the microfiber materials used can also be characterized by pore size.
  • the “pores” in them can be conditionally divided into two categories: the pores that form the fibers in this plane (conventionally, two-dimensional pores) (this is important to consider for the unhindered passage of moisture) and through pores
  • the size of the “three-dimensional pores” is much smaller than the size of the “two-dimensional pores” (due to the random arrangement of the fibers) and the size of a particular pore is determined by the smallest distance between the fibers that form it.
  • Pore size and fiber diameter of microfiber material is determined using microphotographs taken using optical or electron microscopy.
  • the through pores should preferably have through pores of not more than 14 ⁇ m, preferably 4-12 ⁇ m. Along with them, larger pores may also be present.
  • VO drains are produced by the electrospinning method, in which the formed fibers are wound on a rotating rod of various diameters, such drains are anisotropic, i.e. their fibers are predominantly unidirectional along winding lines. Upon subsequent removal of the workpiece material from the rod in the form of a film, these fibers are directed mainly parallel to its surfaces.
  • draining from the resulting film of drains it is necessary to cut them so that they are a flat product, and their cross section is preferably in the form of a rectangle, the large sides of which (drainage width) are the upper and lower sides (surface) of the above film (the ratio of its sides , i.e. the width and thickness of the drainage, not less than 4: 1).
  • cut-out drains like the initial workpieces, in accordance with the production conditions given, have through channels, mainly along their plane, and upon their implantation, in the direction of flow of the water-repellent, which, in addition to the general porosity, contributes to the achievement of the hypotensive effect.
  • Drainage can also be made by spinning from bioresorbable threads or fibers.
  • numerous surgical resorbable sutures and fibers 5-100 microns thick, having high strength and a guaranteed biodegradation period, can be used.
  • Drainage can also be made directly from bioresorbable threads by pre-winding them on a special form (rod) with subsequent sintering.
  • the diameter of the thread used may be 4-250 microns, preferably 20-40 microns.
  • bioresorbable drainage can be made of the following types of materials having different structures: films (solid, porous, at least partially perforated), microfiber or woven material or mesh.
  • the first type of drainage in accordance with the present invention is a closed-loop base, which in flat form can have a rectangular, diamond-shaped, triangular or other shape and which contains a first protrusion, and may also contain a second protrusion from the side of the first protrusion but reversed in the opposite direction.
  • a blank with a closed loop (in the form of a thin-walled tube) or with an open loop (in the form of a flat sheet) can be used, respectively.
  • Cutting drainage from a closed-loop workpiece can be done in at least two ways.
  • a special flat technological insert for example, from a rigid polymer film (10-50 ⁇ m thick) with a width corresponding to the size of the inner cavity of the workpiece, is preliminarily inserted inside a flat-layered blank from a thin-walled tube.
  • at least one drainage with one or two protrusions is cut from the workpiece, after which the liner is pulled out.
  • a (not through) cut is made at an angle of 90 ° or less to the long side of the flat-layed workpiece, then change (smoothly or abruptly) the cut angle and end it at a smaller angle (for example, 25-40 °), thus forming the first protrusion located after cutting folded in half.
  • a cut (through cut) is made along a line parallel to the first cut line, thus obtaining the corresponding segment - drainage with a sharp first protrusion.
  • this (second) protrusion may, for example, be in the form of a semi-ellipse (sketches 13a and 14a) or trapezoid (sketch 15a).
  • the obtained segment is laid out (to the form of a segment of a cylindrical tube) and again compressed (to a flat state, using a short-term load) in the direction at an angle of 90 ° to the direction of the first compression.
  • this “folding” drainage is obtained in the form of a flatly folded segment of a thin-walled tube having, in the middle part of the first protrusion or the first and second protrusions, if the latter was formed.
  • angles at which cuts are made into the blanks during the manufacturing process of the drainage, and the size of the cuts made determine the type (shape) of the resulting drainage, which is in a flat state.
  • the beginning of the notch is at an angle of 90 °, and the notch itself has a size much larger than half the width of the workpiece, then sharply change the angle of the cut and end it at a smaller angle, then make a through cut (cut), parallel to the first initial cut: the result is a drainage with a rectangular base in plan and a relatively small (pronounced) first protrusion (sketch 1a).
  • the beginning of the cut is at an angle of 90 °, and the cut itself has a size comparable to half the width of the workpiece, then smoothly change the cut angle and end it at a smaller angle, then make a through cut (cut), parallel to the entire first cut: as a result it results in a drainage with a triangular-shaped base and a relatively large (implicit) first protrusion (sketch 10a).
  • the basis of the drainage after it is cut from the workpiece may also have an indefinite shape (for example, sketch 12a).
  • Cutting the workpieces with any method of obtaining drainages and their form is carried out with a cutting tool (a special precision knife or blade) or a laser. Moreover, in addition to individual cutting of drains (one at a time), a simultaneous cutting of the entire workpiece can be carried out to obtain the corresponding amount of drains. For this, a special device in the form of a stamp or a roller with a set of cutting knives equally spaced from each other by a distance that determines the size of the cut-out drainage can be used. In addition, drainage can be cut out from the workpiece with an appropriate tool.
  • connection of the strips of material obtained from a flat workpiece can be carried out by heat 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 medical equipment adhesive that cures quickly under UV radiation.
  • Numerous surgical resorbable sutures having high strength and a guaranteed biodegradation time can be used for plexus, usually manual.
  • the optimal shape and dimensions of the open-loop drainage according to the invention can be selected taking into account the features of the operation performed, the shape and size of the scleral flap cut out during surgical intervention, the size and shape of the canal performed in the trabecular zone, as well as the size and shape of the separated conjunctiva in the sclero-conjunctival zone (when using drainage with a second ledge).
  • the most preferred drainage sizes are selected from the following ranges:
  • the height of the base 1, 0-3.0 mm, preferably 1.5-2, 5 mm
  • the height of the second protrusion 1.0-16.0 mm, preferably 5.0-12.0 mm
  • - wall thickness of 10-600 microns, preferably 50-100 microns.
  • the thickness of the drainage in an unbent form is equal to the thickness of its wall
  • the thickness of the drain in a bent form is equal to twice the thickness of its wall.
  • the optimal thickness for the various drainage options presented may have a different value.
  • open-loop drainage is obtained by methods similar to those used to obtain the closed-loop drainage indicated above.
  • the optimal product dimensions, their design and composition of the material used can be selected for the type of surgical operation used, the features of its conduct and the available indications.
  • the size of the flap to be cut is 1.5-2 times smaller than during normal operations, which requires the use of drains also much smaller than usual.
  • the simulation of drainage can be carried out by the surgeon directly during the operation, depending on the size and shape of the scleral flap formed by him and the features of the operation.
  • a closed-loop drain can be transformed into an open-loop drain (using a cross section), or other manipulations with the original drain can be performed. If necessary, the claimed drainage for penetrating operations can be transformed into drainage for non-penetrating operations.
  • the surgeon preferably control the position of the first protrusion when it is introduced into the trabeculectomy zone: enter the specified protrusion until its edge (end) exits into the anterior chamber.
  • the middle part of the drainage is placed under the scleral flap that has been detached and folded onto the cornea and the first protrusion of the drainage is inserted into the trabeculectomy opening (into the preformed channel), which is conveniently visually controlled. Then, after placing the superficial flap in the scleral bed, the end sections of the drainage are bent so that they cover the installed scleral flap or the scleral site adjacent to the flap. It is important that the last manipulations do not lead to a displacement of the middle part of the drainage with the first protrusion and, accordingly, of an optimally installed protrusion in the area of the trabeculectomy opening.
  • the first protrusion be more rigid, which can be achieved by increasing the size of its base and thickness and using a different shape than a narrow triangular one.
  • the base of the drainage does not obscure the trabeculectomy zone and does not create inconvenience when the first protrusion is inserted into it.
  • the claimed drainage having fulfilled its temporary function to stabilize the IOP in the postoperative period (due to the mechanical maintenance of the arches and preventing the coalescence of the outflow paths formed in the process surgical intervention), completely resolves within an optimal time, which contributes to the creation of stable ways of the outflow of intraocular pressure and, accordingly, stabilization of IOP.
  • Sterilization of the manufactured drains is carried out by radiation or gas method (ethylene oxide) under standard conditions.
  • bioresorbable drainage having a discontinuous (porous, fibrous and microfibrous) structure, is capable of sorbing significant amounts of various drugs. This is due both to their nature and to the presence of a well-developed surface.
  • the inventive drainage can be used to immobilize ex tempore the following drugs: steroidal anti-inflammatory drugs (dexamethasone, hydrocortisone, prednisolone, triamcinolone, betamethasone, diprospan and others), non-steroidal anti-inflammatory drugs (sodium diclofenac, indomethacin, i-5, other) fluorouracil, mitomycin-C, bleomycin and others) or other types of drugs.
  • steroidal anti-inflammatory drugs diclofenac, indomethacin, i-5, other
  • fluorouracil mitomycin-C, bleomycin and others
  • the use of drainage contributes to the unhindered passage of the IHC throughout the formed outflow paths - from the filtration zone (trabeculectomy) to the vasculature of the conjunctiva, including the zone of active vascular outflow (when using drainage with a second protrusion), preventing their fusion, which ensures a stable hypotensive effect
  • Example 1 Drainage with a closed loop of a continuous film.
  • a solution of a bioresorbable polymer in an organic solvent was prepared. To do this, 0.84 g of poly (0, L-lactide) (reduced viscosity 2.0 dl / g, Corbion, Purac) was dissolved in 9.8 g of freshly distilled hexafluoroisopropanol (7.9 wt.% Solution). A polished brass rod with a diameter of 3.5 mm and a height of 12.0 cm was immersed in the resulting solution for a short time, after which the coated rod was dried in an upright position at 40 ° C for 60 min.
  • the obtained coating was removed from the rod in the form of a thin elastic tube (sleeve), which was dried to completely remove residual solvent in a vacuum oven at 35 ° C for 4 h.
  • the polymer tube was squeezed to a flat state on a glass surface by briefly applying a metal plates weighing 120 g.
  • a flat blank was obtained with a wall thickness of 50 ⁇ m, a width of 5.5 mm and a length of 7.5 cm.
  • a flat technological insert was introduced from a dacron film 20 ⁇ m thick and wide inside the blank, corresponding to the size of the inner cavity of the workpiece.
  • Example 2 Drainage from a porous film.
  • the coated core was dried in an upright position at 30 ° C for 20 minutes, and then at 40 ° C for 40 minutes. After that, to remove residual solvent, the coating on the rod was dried in a vacuum oven at 30 ° C for 4 hours. Next, the coated rod was placed in a beaker with distilled water and kept in an oven at a temperature of 60 ° C for 10 hours until the filler (blowing agent) is completely washed out. After that, the coating on the rod was dried at 80 ° C for 2 hours, then it was removed from the rod in the form of a thin elastic tube (sleeve), which was flat folded as in example 1.
  • the result was a flat workpiece with a wall thickness of 70 ⁇ m, a width of 5 , 5 mm and a length of 8.0 cm.
  • a flat technological insert from a dacron film 20 ⁇ m thick and wide corresponding to the size of the inner cavity of the preform was introduced inside the preform.
  • segments were cut from the workpiece with a rectangular base in plan with a height of 3.0 mm, having a first protrusion (from the proximal part) in the form of a triangle with a base of 1.0 mm and a height of 1.5 mm.
  • drainages were obtained in the form of a flatly folded section — a thin-walled tube having a width of 5.5 mm, a total height (with a protrusion) of 4.5 mm, and wall thickness 70 microns. After that, the drains were placed in a polypropylene blister and sterilized by the radiation method (fast electrons, 2.5 MPa).
  • Example 3 In the conditions of example 2 received drainage from a perforated film. A 4.0% solution of poly (L-lactide) (reduced viscosity 1.0 dl / g, Corbion, Purac) in freshly distilled chloroform was prepared, to which 4.2 g of finely divided sucrose (particle size 15-30 ⁇ m) was added ) After washing the blowing agent and drying, a coating was obtained in the form of a thin elastic tube, which was folded flat as in Example 1. The result was a flat blank with a wall thickness of 85 ⁇ m, a width of 5.5 mm, and a length of 8.0 cm. Next, the coating was perforated using fiber laser MiniMarker 2, NTO "IRE-Polyus", RF.
  • the holes with a diameter of 100 ⁇ m were staggered in increments of 400 ⁇ m. After that, segments were cut from it with a rectangular base in plan with a height of 3.5 mm, having a first protrusion in the form of a triangle with a base of 3.0 mm and a height of 3.0 mm.
  • drainages were obtained in the form of a flatly folded segment of a thin-walled tube having a width of 5.5 mm, a total height of 6.5 mm and a thickness of (perforated) wall of 85 ⁇ m and a first protrusion in the form of a triangle with a base of 3.0 mm and a height of 3.0 mm
  • the drains were placed in a polypropylene blister and sterilized by the radiation method (gamma radiation, Co-60 source, 2.0 MPa).
  • Example 4 In the conditions of example 1 received drainage from a continuous film. A 1.5% solution of poly (glycolide) (reduced viscosity 1.4 dl / g, Corbion, Purac) in hexafluoroisopropanol was prepared. The resulting coating on the rod was removed in the form of a thin elastic tube, which was folded flat as in Example 1.
  • poly (glycolide) reduced viscosity 1.4 dl / g, Corbion, Purac) in hexafluoroisopropanol was prepared. The resulting coating on the rod was removed in the form of a thin elastic tube, which was folded flat as in Example 1.
  • the result was a flat workpiece with a wall thickness of 280 ⁇ m, a width of 5.5 mm and a length of 7.0 cm, after which the resulting workpiece was cut into pieces with a rectangular base in plan with a height of 2.0 mm, having a first protrusion in the form of a rectangle with a base of 2.0 mm and a height of 3.0 mm
  • drainages were obtained in the form of a flatly folded segment of a thin-walled tube having a width of 5.5 mm, a total height of 5.0 mm, and a wall thickness of 280 ⁇ m.
  • the drains were laid in polypropylene blister and sterilized by the radiation method (gamma radiation, Co-60 source, 2.0 MPa).
  • Example 5 Drainage from a continuous film obtained from a blank in the form of a sheet.
  • a 3.6% solution of poly (b-caprolactone) (reduced viscosity 1.2 dl / g, Corbion, Purac) 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 hours. After this, a pre-preparation in the form of a sheet (film) 60 ⁇ m thick was removed from the substrate, after which narrow strips 11.0 wide were cut from this pre-preparation mm, which were used as blanks.
  • poly (b-caprolactone) reduced viscosity 1.2 dl / g, Corbion, Purac
  • segments were cut from this preform with a rectangular base in plan width 11.0 mm, height 2.0 mm, having a first protrusion in the form of a trapezoid with bases 2.5 and 5.5 mm and a height of 1.5 mm, with the middle of this the protrusion was at a distance of 2.75 mm from the edge of the workpiece (1/4 of the width of the workpiece), so that after folding the protrusion was in the middle of the drainage.
  • the preform was folded in half and both ends, folded together, were thermally welded to each other (temperature about 120 ° C) using a CNT-200/2, CAS, PRC polymer film welding device.
  • the resulting drains had a width of 5.5 mm, a total height of 3.5 mm, and a wall thickness of 60 ⁇ m.
  • the drains were placed in a polypropylene blister and sterilized by a gas method (ethylene oxide).
  • Example 6 Drainage from a porous preform in the form of a sheet obtained by 3D bioprinting. Based on poly (e-caprolactone) (reduced viscosity 1.2 dl / g, Corbion, Purac) by ZO bioprinting [Y. Yu, L Zheng, H. Chen et al. Fabrication of hierarchical polycaprolactone / gel scaffolds via combined 3D bioprinting and electrospinning for tissue engineering. Advances in Manufacturing. 2014, v.2, N ° 3, 231-238] a film was obtained having a linear size of 6 cm * 4 cm, a thickness of 120 ⁇ m, a porosity of 70% and pores in the form of squares of 20 * 20 ⁇ m in size.
  • poly (e-caprolactone) reduced viscosity 1.2 dl / g, Corbion, Purac) by ZO bioprinting
  • ZO bioprinting Y. Yu, L Zheng, H. Chen et al. Fabrication
  • Example 5 drainage was obtained under the conditions of Example 5, while the first protrusion was made in the form of a semi-ellipse with a base of 2.5 mm and a height of 1.5 mm. As a result, the resulting drains had a width of 5.5 mm, a total height of 3.5 mm, and wall thickness 120 microns. After that, the drains were placed in a polypropylene blister and sterilized by a gas method (ethylene oxide).
  • ethylene oxide ethylene oxide
  • Example 7 In the conditions of example 5 received drainage from a continuous film obtained from the workpiece in the form of a sheet. A 1.8% solution of a poly (0, L-lactide-co-glycolide) copolymer (50:50, reduced viscosity 0.62-0.65 dl / g, DURECT Co.) In freshly distilled dioxane was used. Further, the drainage was obtained under the conditions of Example 5. In this case, the first protrusion was made in the form of a rounded rectangle with a base of 2.5 mm and a height of 1.5 mm, and the ends of the workpiece strip were fastened together with 2-octyl cyanoacrylate adhesive Dermabond, Johnson & Johnson (glued joint width was 0.6 mm). As a result, the resulting drains had a width of 5.5 mm, a total height of 3.5 mm, and a wall thickness of 12 ⁇ m.
  • a poly (0, L-lactide-co-glycolide) copolymer 50:
  • Example 8 In the conditions of example 1 received drainage from a continuous film of composite material. A 7.2% solution of a mixture (70:30) of a poly (0, L-lactide-co-glycolide) copolymer was used (85:15, reduced viscosity 0.76-0.85 dl / g, DURECT Comp.) And polyvinyl acetate ( Mw 100000, Aldrich) in chloroform. Sections with a rectangular base in plan with a height of 1.0 mm, having a first protrusion in the form of a rectangle with beveled corners with a base of 1.0 mm and a height of 1.0 mm, were cut from the obtained blank. As a result, drainages were obtained in the form of a flatly folded segment of a thin-walled tube having a width of 5.5 mm, a total height of 2.0 mm, and a wall thickness of 65 ⁇ m.
  • Example 9 In the conditions of example 1 received drainage from a continuous film having a first and second protrusion. Used a 5.8% solution of a three-block block copolymer of polylactide (5000) -polyethylene glycol (SOOO) -polylactide (5000), Polysciences, Inc. in chloroform.
  • Sections with a rectangular base in plan with a height of 1.5 mm were cut from the obtained blank, having a first protrusion (from the proximal part) in the form of a triangle with a base of 1.0 mm and a height of 1.5 mm and a second protrusion in the form of a triangle (with a distal parts, from the side of the first protrusion, but facing in the opposite direction) with a base of 2.0 mm and a height of 2.0 mm.
  • drainages were obtained in the form of a flatly folded thin-walled segment a tube having a width of 5.5 mm, a total height (with protrusions) of 5.0 mm and a wall thickness of 45 ⁇ m.
  • Example 10 In the conditions of example 1 received drainage from a continuous film having a first and second protrusion. A 6.2% solution of poly-3-hydroxybutyrate (reduced viscosity 0.46 dl / g) in chloroform was used. Sections with a rectangular base in plan with a height of 1.5 mm were cut from the obtained blank, having a first protrusion in the form of a triangle with a base of 1.0 mm and a height of 1.5 mm and a second protrusion in the form of a rectangle with a base of 5.5 mm and a height 10.0 mm As a result, drainages were obtained in the form of a flatly folded segment of a thin-walled tube having a width of 5.5 mm, a total height of 13.0 mm, and a wall thickness of 50 ⁇ m.
  • Example 11 In the conditions of example 1 received drainage from a perforated film having a first and second protrusion. A 7.0% solution of poly-3-hydroxyvalerate (reduced viscosity 0.53 dl / g) in chloroform was used. Then, the resulting coating was perforated after it was compressed using a MiniMarker 2 fiber laser, NTO "IRE-Polyus", RF. The holes with a diameter of 100 ⁇ m were staggered in increments of 400 ⁇ m.
  • drainages were obtained in the form of a flatly folded section of a perforated thin-walled tube having a width of 5.5 mm, a total height of 17.5 mm, and a wall thickness of 70 ⁇ m.
  • Example 12 In the conditions of example 1 received drainage from a perforated film having a first and second protrusion.
  • Sections with a rectangular base in plan with a height of 2.0 mm were cut from the obtained blank, having a first protrusion in the form of a triangle with a base of 1.0 mm and a height of 1.5 mm and a second protrusion in the form of a semi-ellipse with a base of 5.5 mm and a height 15.0 mm
  • a first protrusion in the form of a triangle with a base of 1.0 mm and a height of 1.5 mm and a second protrusion in the form of a semi-ellipse with a base of 5.5 mm and a height 15.0 mm
  • we received drains in the form of a flat folded section of a perforated thin-walled tube having a width of 5.5 mm, a total height of 18.5 mm and a wall thickness of 45 ⁇ m.
  • Example 13 In the conditions of example 1 received drainage from a continuous film having a first and second protrusion (with perforation). A 7.0% solution of poly (3-hydroxybutyrate-co-3-hydroxyvalerate) (reduced viscosity 0.58 dl / g) in chloroform was used. Sections with a rectangular base in plan with a height of 2.0 mm were cut from the obtained preform, having a first protrusion in the form of a triangle with a base of 1.0 mm and a height of 1.5 mm and a second protrusion in the form of a rectangle with rounded corners with a base of 4.0 mm and a height of 6.0 mm.
  • the second protrusion of the drainage was perforated using a MiniMarker 2 fiber laser, NTO IRE-Polyus, RF. Holes with a diameter of 80 microns were made in a checkerboard pattern with a pitch of 200 microns. As a result, drainages were obtained in the form of a flatly folded segment of a thin-walled tube having a width of 5.5 mm, a total height of 9.5 mm, and a wall thickness of 65 ⁇ m.
  • Example 14 Drainage from a porous film having a first and second protrusion.
  • a solution of fibrillar protein, recombinant spidroin-1 was prepared. For this, a weighed 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 ⁇ m was added to this solution. Next, the resulting suspension was applied to a brass rod with a diameter of 3.5 mm and dried on it at a temperature of 40 ° C for 3 hours. Next, the coating on the rod was kept in 96% ethanol for 2 hours, in distilled water for another 2 hours, after which it was dried in vacuum at 40 ° C for 3 hours.
  • a flat preform was obtained with a wall thickness of 70 ⁇ m, a width of 5.5 mm and a length of 8.0 cm.
  • a flat technological insert was introduced from a dacron film with a thickness of 20 ⁇ m and a width corresponding to the size of the inner cavity of the preform inside the preform.
  • metal sections were cut from the workpiece with a rectangular base in plan with a height of 3.0 mm, having a first protrusion in the form of a triangle with a base of 1.0 mm and a height of 1.5 mm and a second protrusion in the form of a rectangle with beveled corners with a base of 4 , 0 mm and a height of 6.0 mm.
  • Example 15 Drainage from a continuous film of composite material.
  • drainages were obtained in the form of a flat-folded section of a thin-walled tube having a width of 5.5 mm, a total height of 3.5 mm and a wall thickness of 80 ⁇ m and the first protrusion in the form a triangle with a base of 1.0 mm and a height of 1.5 mm.
  • Example 16 Drainage from a continuous film obtained from a blank in the form of a sheet.
  • Example 17 Drainage of microfiber material.
  • the workpiece was cast from a solution of a polymer material by electrospinning [A.Yu. Khomenko. Regulation of the morphology and properties of non-woven and highly dispersed biocompatible materials based on chitosan and polymers of lactic acid, obtained by electrospinning. Diss. Ph.D., M., 2016, 168 pp .;ierits V.N., Kazbanov I.V., Efimov A.E., Sevastyanov V.I. Development of new methods for the formation of implant materials using electrospinning and bioprinting technologies. Bulletin of transplantology and artificial organs. 2009, vol. 11, 2, 47-53].
  • a 4.0% solution of poly-3-hydroxybutyrate (reduced viscosity 0.46 dl / g) in methylene chloride was used, which was applied to a brass rod with a diameter of 1.6 mm and a height of 10 cm.
  • the rotation speed of the installation stepper motor was 8 -10 Hz, which corresponds to a polymer feed rate of 0.28-0.35 ml / min, a voltage of 25 kV.
  • the thickness of the resulting coating is 50 ⁇ m.
  • the coated rod was placed in distilled water. After that, the obtained microfiber tube was removed from the rod and dried at 80 ° C.
  • a flat preform was obtained with a wall thickness of 50 ⁇ m, a width of 2.5 mm and a length of 7.0 cm.
  • a flat technological insert was introduced from a dacron film 20 ⁇ m thick and wide in width corresponding to the size of the inner cavity of the preform.
  • metal sections were cut from the workpiece with a rectangular base in plan with a height of 2.0 mm, having a first protrusion in the form of a triangle with a base of 2.0 mm and a height of 2.5 mm.
  • drainages were obtained in the form of a flatly folded section of a thin-walled tube having a width of 2.5 mm, a total height of 4.5 mm, and a wall thickness of 50 ⁇ m.
  • the through pore size of the material is 3 ⁇ m, the average fiber diameter is 0.2 ⁇ m
  • Example 18 Drainage of microfiber composite material.
  • the preform was cast under the conditions of Example 17.
  • a 10.0% solution of a mixture of poly-3-hydroxybutyrate (reduced viscosity 0.46 dl / g) and a poly (0, E-lactide-co-caprolactone) copolymer was used (25:75, reduced viscosity 0.70-0.90 dl / g, DURECT Co.) (50/50) in chloroform.
  • the thickness of the resulting coating is 170 ⁇ m.
  • a flat billet with a wall thickness of 170 ⁇ m, a width of 2.5 mm and a length of 7.0 cm was obtained.
  • a flat technological liner of a dacron film with a thickness of 20 ⁇ m and a width corresponding to the size of the inner cavity of the billet was introduced inside the billet.
  • segments were cut from the workpiece with a rectangular base in plan with 2.0 mm high, having a first protrusion in the shape of a triangle with a base of 2.0 mm and a height of 2.0 mm.
  • drainages were obtained in the form of a flatly folded segment of a thin-walled tube having a width of 2.5 mm, a total height of 4.0 mm, and a wall thickness of 170 ⁇ m.
  • the through pore size of the material is 14 microns, the average fiber diameter is 4.0 microns.
  • Example 19 Drainage from woven material.
  • segments were cut out of it with a rectangular base in plan with a height of 2.0 mm, having a first protrusion in the form of a triangle with a base of 2.0 mm and a height of 2.5 mm.
  • drainages were obtained in the form of a flatly folded segment of a thin-walled tube having a width of 4.9 mm, a total height of 4.5 mm, and a wall thickness of 130 ⁇ m.
  • Example 20 Drainage from woven material.
  • a sleeve 20 cm long with an inner diameter of 2.5 mm and a wall thickness of 180 microns is woven from silk thread N ° 8 with a thickness of 45 ⁇ m.
  • segments were cut out of it with a rectangular base in plan with a height of 2.0 mm, having a first protrusion in the form of a triangle with a base of 2.0 mm and a height of 2.5 mm.
  • drainages were obtained in the form of a flatly folded segment of a thin-walled tube having a width of 4.3 mm, a total height of 4.5 mm, and a wall thickness of 180 ⁇ m.
  • Example 21 Drainage from the resulting mesh.
  • the preform is made by winding a thread on a rod with its subsequent sintering to obtain a tube with a mesh wall.
  • This rod was placed in an oven, kept at 190 ° C for 3 minutes, cooled and placed in distilled water. After that, the obtained tube in the form of a mesh was removed from rod and dried at 80 ° C.
  • a flat preform was obtained with a wall thickness of 120 ⁇ m, a width of 5.0 mm and a length of 7.0 cm.
  • a flat technological insert was introduced from a dacron film with a thickness of 20 ⁇ m and a width corresponding to the size of the inner cavity of the preform inside the preform.
  • metal sections were cut from the workpiece with a rectangular base in plan with a height of 2.0 mm.
  • a piece of the original thread 2.5 mm in size was welded to the obtained segment perpendicularly to its larger side using a CNT-200/2, CAS, PRC polymer film welding device.
  • drainages were obtained in the form of a flatly folded segment of a thin-walled mesh tube having a width of 5.0 mm, a total height of 4.5 mm and a wall thickness of 120 ⁇ m and a first protrusion in the form of a thread with a diameter (base) of 0.035 mm and a height of 2.5 mm (depicted in sketch 6a).
  • Example 22 Drainage from the grid.
  • drainage was obtained in the form of a flatly folded segment of a thin-walled mesh tube having a width of 5.0 mm, a total height of 6.0 mm and a wall thickness of 180 ⁇ m and a first protrusion in the form of a loop with a base of 2.5 mm and a height of 3.0 mm.
  • Example 23 Drainage from the grid.
  • Example 24 A drainage of a porous film having a first protrusion in the form of a bent rectangle.
  • segments were obtained with a rectangular base in plan with a height of 2.0 mm, having a first protrusion in the form of a rectangle with a base of 2.0 mm and a height of 3.0 mm.
  • the first protrusion was bent diagonally of the rectangle and it took the form of a double triangle.
  • drainages were obtained in the form of a flatly folded segment of a thin-walled tube having a width of 5.5 mm, a total height of 5.0 mm, and a wall thickness of 280 ⁇ m (shown in sketch 8a).
  • Example 25 Drainage diamond-shaped solid film.
  • a flat workpiece was obtained with a wall thickness of 50 ⁇ m, a width of 5.5 mm and a length of 7.5 cm, which was cut with a metal cutter as follows: a cut was made at an angle of 75 ° to the long side of the workpiece, then backing 3.0 mm on the long side of the workpiece (the size determines the height of the closed base of the drainage) a 5.0 mm (not through) incision was made (sketch 9.0). Then, the incision angle was sharply changed and it was made at a smaller angle ( ⁇ 30 °), as a result of which the first protrusion was formed, which, after cutting, was folded in half.
  • the obtained flat-folded segment was laid out (to the form of a segment of a cylindrical tube) and again compressed (to a flat state, using a short-term load) in the direction at an angle of 90 ° to the direction of the first compression.
  • the result was a drainage in the form of a flat folded a segment of a thin-walled tube with a diamond-shaped base having a width of 5.5 mm, a total height of 7.6 mm and a wall thickness of 50 ⁇ m and the first protrusion in the form of a triangle with a base of 1.8 mm and a height of 2.6 mm (shown in sketch 9a) .
  • Example 26 Drainage of a triangular shape from a continuous film.
  • a flat preform was obtained with a wall thickness of 50 ⁇ m, a width of 5.5 mm and a length of 7.5 cm, which was cut with a metal cutter as follows: a (non-through) incision was made at an angle of 90 ° to the long side of the workpiece by 3.5 mm, after which the cut angle was smoothly changed and finished at a smaller angle (towards the end -45 °) (sketch 10.0). Then, having retreated 1.7 mm along the long side of the workpiece (the size determines the height of the closed base of the drainage), a cut (through cut) was made along a line parallel to the first, thus obtaining the corresponding cut.
  • the obtained segment was laid out (to the form of a segment of a cylindrical tube) and again compressed (to a flat state, using a short-term load) in the direction at an angle of 90 ° to the direction of the first compression.
  • drainage was obtained in the form of a flatly folded segment of a thin-walled tube with a triangular base, having a width of 5.5 mm, a total height of 3.6 mm and a wall thickness of 50 ⁇ m and the first protrusion in the shape of a triangle (shown in sketch 10a).
  • Example 27 Drainage diamond-shaped solid film.
  • a flat workpiece was obtained with a wall thickness of 50 ⁇ m, a width of 5.5 mm and a length of 7.5 cm, which was cut with a metal cutter as follows: an incision was made at an angle of 80 ° to the long side of the workpiece by 3.5 mm, after which gradually changed the cutting angle and finished it at a smaller angle (towards the end ⁇ 30 °) (sketch 11.0). Further, having retreated 3.0 mm along the long side of the workpiece (the size determines the height of the closed base of the drainage), a cut was made along a line parallel to the first, thus obtaining the corresponding cut.
  • the obtained segment was laid out (to the form of a segment of a cylindrical tube) and again compressed (to a flat state, using a short-term load) in the direction at an angle of 90 ° to the direction of the first compression.
  • the result was a drainage in the form of a flat-folded segment of a thin-walled tube with a diamond-shaped base a shape having a width of 5.5 mm, a total height of 8.7 mm and a first protrusion in the shape of a triangle (shown in sketch 11a).
  • Example 28 Drainage of complex shape from a continuous film.
  • Drainage was made under the conditions of Example 27 using a flat blank (thin-walled tube) with a wall thickness of 50 ⁇ m, a width of 5.5 mm and a length of 7.5 cm. A drain was cut from the blank, the base of which and the first protrusion had a complex shape with a width of 5.5 mm and a height of 7.2 mm (depicted in sketch 12a).
  • Example 29 Drainage with an open circuit in the form of a strip bent in two lines from a continuous film.
  • Drainage was obtained under the conditions of example 1.
  • An additionally closed base of flat-folded drainage (wall) in the place opposite the first protrusion was cut perpendicularly to its long side with a metal cutter.
  • drainage was obtained in the form of a flatly folded strip with a rectangular base having a width (when folded) of 5.5 mm, a total height (with a protrusion) of 3.5 mm and a wall thickness of 50 ⁇ m and a first protrusion (from the proximal part) in the shape of a triangle with a base of 1.0 mm and a height of 1.5 mm (shown in sketch lb).
  • the drains were placed in a polypropylene blister and sterilized by the radiation method (fast electrons, 2.5 MPa).
  • Example 30 Drainage in the form of a strip bent in one line from a continuous film.
  • Open-loop drainage was obtained under the conditions of Example 1. Additionally, the closed base of the flat-folded drainage with a metal cutter was cut along one of the bends, receiving a folded strip in half. As a result, drainage was obtained in the form of a flat folded strip with a rectangular base having a width (when folded) of 5.5 mm, a total height of 3.5 mm and a wall thickness of 50 ⁇ m and a first protrusion (from the proximal part) in the form of a triangle with a base 1.0 mm and a height of 1.5 mm (depicted in the sketch 1 L). After that, the drains were laid in polypropylene blister and sterilized by the radiation method (fast electrons, 2.5 MPa).
  • Example 31 Drainage in the form of a single (unbent) strip of continuous film.
  • Drainage was obtained under the conditions of Example 1.
  • An additionally closed base of flat-folded drainage in the place opposite the first protrusion was cut perpendicular to its long side and the folded edge sections were unfolded (unbent).
  • the drains were placed in a polypropylene blister and sterilized by the radiation method (fast electrons, 2.5 MPa).
  • Example 32 Drainage in the form of a strip bent in two lines from a porous film.
  • Drainage was obtained under the conditions of example 2. Additionally, the closed base of the flat-folded drainage in the place opposite the first protrusion was cut perpendicular to its long side. The result was a drainage in the form of a flat folded strip with a rectangular base having a width (when folded) of 5.5 mm, a total height of 4.5 mm and a wall thickness of 70 ⁇ m and a first protrusion in the shape of a triangle with a base of 1.0 mm and 1.5 mm high. After that, the drains were placed in a polypropylene blister and sterilized by the radiation method (gamma radiation, Co-60 source, 2.0 MPa).
  • the radiation method gamma radiation, Co-60 source, 2.0 MPa
  • Example 33 Drainage in the form of a strip bent in two lines from a perforated film.
  • Drainage was obtained under the conditions of Example 3.
  • An additionally closed base of flat-folded drainage was cut perpendicularly to its long side in a place opposite the first protrusion.
  • drainage was obtained in the form of a flatly folded strip with a rectangular base having a width (when folded) of 5.5 mm, a total height of 6.5 mm and a thickness (perforated) of the wall of 85 ⁇ m and a first protrusion in the shape of a triangle with a base of 3, 0 mm and a height of 3.0 mm.
  • This drainage was placed in a polypropylene blister and sterilized by the radiation method (gamma radiation, Co-60 source, 2.0 MPa).
  • Example 34 Drainage in the form of a strip bent in two lines from a continuous film.
  • Drainage was obtained under the conditions of example 4. Additionally, the closed base of the flat-folded drainage in the place opposite the first protrusion was cut perpendicular to its long side. As a result, drainage was obtained in the form of a flat folded strip with a rectangular base having a width (when folded) of 5.5 mm, a total height of 5.0 mm and a wall thickness of 280 ⁇ m and a first protrusion in the form of a rectangle with a base of 2.0 mm and 3.0 mm high. After that, the drains were placed in a polypropylene blister and sterilized by a gas method (ethylene oxide).
  • ethylene oxide ethylene oxide
  • Example 35 Drainage in the form of a strip bent in two lines from a continuous film.
  • Drainage was obtained under the conditions of example 5. From the obtained blank in the form of a sheet, segments of a rectangular shape were cut in plan with a width of 11.0 mm, a height of 2.0 mm, having a first protrusion in the form of a trapezoid with a base of 2.5 and 5.5 mm and a height of 1 , 5 mm, and the middle of this protrusion was in the middle of the workpiece. After that, the workpiece was folded along two lines so that its end parts closed (their total length was equal to the length of the central part). As a result, drainage was obtained in the form of a flatly folded strip with a rectangular base having a width (when folded) of 5.5 mm, a total height of 3.5 mm, and a wall thickness of 60 ⁇ m.
  • Example 36 Drainage in the form of a strip bent in two lines from a porous film obtained by the method of BO-bioprinting.
  • Drainage was obtained under the conditions of example 6. From the obtained blank in the form of a sheet, rectangular sections were cut in plan with a width of 11.0 mm, a height of 2.0 mm, having a first protrusion in the form of a semi-ellipse with a base of 2.5 mm and a height of 1.5 mm, and the middle of this protrusion was in the middle of the workpiece. After that, the workpiece was folded along two lines so that its end parts closed (their total length was equal to the length of the central part). As a result, drainage was obtained in the form of a flatly folded strip with a rectangular base having a width (in the folded state) of 5.5 mm, a total height of 3.5 mm, and a wall thickness of 120 ⁇ m.
  • Example 37 Drainage in the form of a strip bent in two lines from a continuous film.
  • Drainage was obtained under the conditions of Example 7. Rectangular sections were cut off from the obtained blank in the form of a width of 11.0 mm and a height of 2.0 mm, having a first protrusion in the form of a rectangle with rounded corners with a base of 2.5 mm and a height of 1.5 mm, and the middle of this protrusion was in the middle of the workpiece. After that, the workpiece was folded along two lines so that its end parts closed (their total length was equal to the length of the central part). As a result, drainage was obtained in the form of a flatly folded strip with a rectangular base having a width (in the folded state) of 5.5 mm, a total height of 3.5 mm, and a wall thickness of 12 ⁇ m.
  • Example 38 Drainage from a continuous film of composite material.
  • Drainage was obtained under the conditions of example 8. Additionally, the closed base of the flat-folded drainage in the place opposite the first protrusion was cut perpendicular to its long side. As a result, drainage was obtained in the form of a flatly folded strip with a rectangular base having a width of 5.5 mm, a total height of 2.0 mm and a wall thickness of 65 ⁇ m and a first projection in the form of a rectangle with beveled corners with a base of 1.0 mm and a height of 1 , 0 mm.
  • Example 39 A continuous film drainage having a first and second protrusion.
  • Drainage was obtained under the conditions of example 9. Additionally, the closed base of the flat-folded drainage in the place opposite the first protrusion was cut perpendicular to its long side. As a result, drainage was obtained in the form of a flatly folded strip with a rectangular base having a width of 5.5 mm, a total height of 5.0 mm and a wall thickness of 45 ⁇ m and a first protrusion (from the proximal part) in the form of a triangle with a base of 1.0 mm and 1.5 mm high and a second protrusion in the form of triangle (from the distal part, facing in the opposite direction from the first protrusion) with a base of 2.0 mm and a height of 2.0 mm
  • Example 40 A continuous film drainage having a first and second protrusion.
  • Drainage was obtained under the conditions of example 10. Additionally, the closed base of the flat-folded drainage in the place opposite the first protrusion was cut perpendicular to its long side. As a result, drainage was obtained in the form of a flatly folded strip with a rectangular base having a width of 5.5 mm, a total height of 13.0 mm and a wall thickness of 50 ⁇ m and a first protrusion in the shape of a triangle with a base of 1.0 mm and a height of 1.5 mm and a second projection in the form of a rectangle with a base of 5.5 mm and a height of 10.0 mm.
  • Example 41 Drainage from a perforated film having a first and second protrusion.
  • Drainage was obtained under the conditions of example 11. Additionally, the closed base of the flat-folded drainage in the place opposite the first protrusion was cut perpendicular to its long side. As a result, drainage was obtained in the form of a flatly folded perforated strip with a rectangular base having a width of 5.5 mm, a total height of 17.5 mm and a wall thickness of 70 ⁇ m and a first protrusion in the shape of a triangle with a base of 1.0 mm and a height of 1.5 mm and the second protrusion in the form of a trapezoid with bases 2.0 and 5.5 mm and a height of 14.0 mm
  • Example 42 Drainage from a perforated film having a first and second protrusion.
  • Example 43 A continuous film drainage having a first and second protrusion.
  • Drainage was obtained under the conditions of example 13. Additionally, the closed base of the flat-folded drainage in the place opposite the first protrusion was cut perpendicular to its long side. As a result, drainage was obtained in the form of a flatly folded strip with a rectangular base having a width of 5.5 mm, a total height of 9.5 mm and a wall thickness of 65 ⁇ m and a first protrusion in the shape of a triangle with a base of 1.0 mm and a height of 1.5 mm and a second projection with perforation in the form of a rounded rectangle with a base of 4.0 mm and a height of 6.0 mm
  • Example 44 A drainage of a porous film having a first and second protrusion.
  • Drainage was obtained under the conditions of example 14. Additionally, the closed base of the flat-folded drainage in the place opposite the first protrusion was cut perpendicular to its long side. As a result, drainage was obtained in the form of a flatly folded strip with a rectangular base having a width of 5.5 mm, a total height of 10.5 mm and a wall thickness of 70 ⁇ m and a first protrusion in the shape of a triangle with a base of 1.0 mm and a height of 1.5 mm and a second projection in the form of a rectangle with beveled corners with a base of 4.0 mm and a height of 6.0 mm
  • Example 45 Drainage from a continuous film of composite material.
  • Drainage was obtained under the conditions of Example 15.
  • the closed base of the flat-folded drainage was cut so that the edge curved sections of the drainage were 3.5 mm and 2.0 mm, respectively.
  • drainage was obtained in the form of a flatly folded strip with a rectangular base having a width of 5.5 mm, a total height of 3.5 mm and a wall thickness of 80 ⁇ m and a first protrusion in the shape of a triangle with a base of 1.0 mm and a height of 1.5 mm .
  • Example 46 Drainage from a continuous film obtained from a blank in the form of a sheet.
  • the preform was cast from a solution of a polymer material by electrospinning under the conditions of Example 17.
  • An additionally closed base of a flat-folded drainage in the place opposite the first protrusion was cut perpendicular to its long side.
  • drainage was obtained in the form of a flatly folded strip with a rectangular base having a width of 2.5 mm, a total height of 4.5 mm and a wall thickness of 50 ⁇ m and a first protrusion in the form of a triangle with a base of 2.0 mm and a height of 2.5 mm .
  • the pore size of the material is 3 ⁇ m, the average fiber diameter is 0.2 ⁇ m.
  • Example 48 Drainage of microfiber composite material.
  • Drainage was obtained under the conditions of Example 18.
  • An additionally closed base of flat-folded drainage was cut perpendicularly to its long side in a place opposite to the first protrusion.
  • drainage was obtained in the form of a flatly folded strip with a rectangular base having a width of 2.5 mm, a total height of 4.0 mm and a wall thickness of 170 ⁇ m and a first protrusion in the shape of a triangle with a base of 2.0 mm and a height of 2.0 mm .
  • the through pore size of the material is 14 microns, the average fiber diameter is 4.0 microns.
  • Example 49 Drainage from woven material.
  • Drainage was obtained under the conditions of Example 19.
  • An additionally closed base of flat-folded drainage was cut perpendicularly to its long side in a place opposite the first protrusion.
  • drainage was obtained in the form of a flat folded strip with a rectangular base having a width of 4.9 mm, a total height of 4.5 mm and a wall thickness of 130 ⁇ m and a first protrusion in the form of a triangle with a base of 2.0 mm and a height of 2.5 mm .
  • Example 50 Drainage from woven material.
  • Drainage was obtained under the conditions of Example 20.
  • An additionally closed base of flat-folded drainage was cut perpendicularly to its long side in a place opposite the first protrusion.
  • drainage was obtained in the form of a flatly folded strip with a rectangular base having a width of 4.3 mm, the total a height of 4.5 mm and a wall thickness of 180 ⁇ m and a first protrusion in the shape of a triangle with a base of 2.0 mm and a height of 2.5 mm.
  • Example 51 Drainage from the grid.
  • Drainage was obtained under the conditions of example 21. Additionally, the closed base of the flat-folded drainage in the place opposite the first protrusion was cut perpendicular to its long side. As a result, drainage was obtained in the form of a flat folded strip with a rectangular base having a width of 5.0 mm, a total height of 4.5 mm and a wall thickness of 120 ⁇ m and a first protrusion in the form of a thread with a diameter (base) of 0.035 mm and a height of 2.5 mm (shown in sketch 6b).
  • Example 52 Drainage from the mesh obtained from the workpiece.
  • Example 53 Drainage from the mesh obtained from the workpiece.
  • Example 54 A drainage of a porous film having a first protrusion in the form of a bent rectangle.
  • Example 33 rectangular segments were obtained in plan with a height of 2.0 mm, having a first projection in the form of a rectangle with a base of 2.0 mm and a height of 3.0 mm.
  • the first protrusion was bent diagonally of the rectangle and it took the form of a double triangle.
  • drainages were obtained in the form of a flatly folded segment of a thin-walled tube having a width of 5.5 mm, a total height of 5.0 mm, and a wall thickness of 70 ⁇ m (shown in sketch 8a).
  • Example 55 Drainage diamond-shaped solid film.
  • Drainage was obtained under the conditions of Example 25. Additionally, the closed base of the flat-folded drainage was cut in a place opposite the first protrusion. As a result, drainage was obtained in the form of a flatly folded strip with a diamond-shaped base having a width of 5.5 mm, a total height of 7.6 mm and a wall thickness of 50 ⁇ m and a first protrusion in the shape of a triangle with a base of 1.8 mm and a height of 2.6 mm (depicted in sketch 9b).
  • Example 56 Drainage of a triangular shape from a continuous film.
  • Example 26 Drainage was obtained under the conditions of Example 26. An additionally closed base of flat-folded drainage was cut perpendicularly to its long side in a place opposite the first protrusion. As a result, we obtained drainage in the form of a flatly folded strip with a triangular-shaped base having a width of 5.5 mm, a total height of 3.6 mm and a wall thickness of 50 ⁇ m and the first protrusion in the form of a triangle with rounded corners (shown in sketch 10b).
  • Example 57 Drainage diamond-shaped solid film.
  • Example 27 Drainage was obtained under the conditions of Example 27. Additionally, the closed base of the flat-folded drainage was cut in a place opposite the first protrusion. As a result, we obtained drainage in the form of a flatly folded strip with a diamond-shaped base having a width of 5.5 mm, a total height of 8.7 mm, and the first protrusion in the form of a triangle with rounded corners (shown in the sketch 1 lb).
  • Example 58 Drainage of complex shape from a porous film.
  • a 4.0% solution of poly (L-lactide) (reduced viscosity 1.0 dl / g, Corbion, Purac) in freshly distilled chloroform was prepared, to which 4.2 g of finely divided sucrose (particle size 15- 30 ⁇ m).
  • This suspension 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. Next, the film was removed from the substrate and placed in a beaker with distilled water and kept in an oven at a temperature of 60 ° C for 10 hours until the filler was completely washed out.
  • the film was dried at 80 ° C for 2 hours and then still in a vacuum drying oven at 35 ° C for 2 hours. After that, drainages in the form of a triangle with concave sides having a base of 9.0 were cut from a 105 ⁇ m thick blank. mm and a height of 6.0 mm. Then, two angles - the end of the base - were folded so that they converged in the middle of the base, as a result, they received a drainage of complex shape with a base of 4.5 mm and a height of 6.0 mm (shown in sketch 12b).
  • Example 59 An example of installing a closed-circuit drainage with a first protrusion (shown in sketch 16a).
  • the superficial flap of the sclera along with the conjunctiva is thrown back onto the cornea.
  • a fabric strip 1 * 3 mm in size was cut.
  • a basal iridectomy was performed.
  • Closed circuit bioresorbable drainage (sketch 1a) is put on the superficial scleral flap (so that the proximal protrusion is inserted into the trabeculectomy opening) and is advanced to the limb (to the stop).
  • the superficial flap is fixed to the sclera with two 8.0 sutures. Continuous stitch 8.0 per conjunctiva.
  • Example 60 An example is the installation of a closed loop diamond-shaped drainage with a first protrusion (shown in sketch 17a).
  • the superficial flap of the sclera along with the conjunctiva is thrown back onto the cornea.
  • a fabric strip 1 * 3 mm in size was cut.
  • a basal iridectomy was performed.
  • To surface the scleral flap is put on and advanced to the limb (to the stop) a bioresorbable drainage with a closed loop in the form of a rhombus (sketch 9a) so that the proximal protrusion of the rhombus is located under the scleral flap and inserted into the trabeculectomy hole, and the distal end is on the surface of the scleral flap.
  • the superficial flap is fixed to the sclera with two 8.0 sutures. Continuous stitch 8.0 per conjunctiva.
  • Aseptic mono-sticker is a bioresorbable drainage with a closed loop in the form of a rhombus
  • the anterior chamber is about 2 mm (slightly finer than average), the moisture is transparent. Over the upper limb spilled filtration. At 12 o’clock. the proximal protrusion of the drainage is visible paralymbally in the anterior chamber.
  • Example 61 An example is a closed loop installation with a first and second protrusion (shown in sketch 18a).
  • the superficial flap of the sclera along with the conjunctiva is thrown back onto the cornea.
  • a fabric strip 1 * 3 mm in size was cut.
  • a basal iridectomy was performed.
  • Closed circuit bioresorbable drainage (sketch 13 a) is put on and advanced to the limb scleral flap (to the stop) so that its proximal end is under the scleral flap and inserted into the trabeculectomy opening triangular end, and the distal end - comes out from under the scleral flap by 6 mm.
  • the superficial flap is fixed to the sclera with two 8.0 sutures. Continuous stitch 8.0 per conjunctiva.
  • Aseptic mono-sticker is the superficial flap of the sclera along with the conjunctiva.
  • Example 62 An example of the installation of drainage with an open circuit with the first protrusion (shown in sketch 16b).
  • the superficial flap of the sclera along with the conjunctiva is thrown back onto the cornea.
  • a fabric strip 1 * 3 mm in size was cut.
  • a basal iridectomy was performed.
  • An open contour bioresorbable drainage (sketch lb) is placed on the scleral bed, under the superficial scleral flap (sketch lb) in such a way that the triangular protrusion is located in the sinus strabeclectomy area and partially, by 1, 0 mm, is promoted into the anterior chamber.
  • the superficial flap is fixed to the sclera with two 8.0 sutures.
  • the protruding ends of the drainage are bent and placed on a superficial scleral flap.
  • Example 63 An example of an open-loop drainage installation in the form of an unbent strip (shown in sketch 17b).
  • Clinical example Patient K., 70 years old, diagnosed with OD - primary open-angle far-reaching subcompensated glaucoma at maximum hypotensive mode. Operation OD - Sinustrabekulectomy with basal iridectomy with implantation of bioresorbable drainage. Processing of the surgical field is common.
  • Anesthesia Sol. Lidocaini 2% - 2.0 r / b. Suture-holder on the upper rectus muscle. Conjunctival incision for 12 hours. 7 mm from the limb 6 mm long. Hemostasis. From the surface layers of the sclera to a depth of 1/2 of its thickness, a rectangular flap with sides of 4 and 3 mm to the transparent layers of the cornea is cut out with the base to the cornea.
  • the superficial flap of the sclera along with the conjunctiva is thrown back onto the cornea.
  • a fabric strip 1 * 3 mm in size was cut.
  • a basal iridectomy was performed.
  • an open-loop bioresorbable drainage (sketch 1.2b) is placed in such a way that the triangular protrusion is located in the sinus strabeclectomy area and partially, by 0.5 mm, is promoted into the anterior chamber.
  • the superficial flap is fixed to the sclera with two 8.0 sutures. The protruding ends of the drainage are bent and placed on the surface of the sclera adjacent to the scleral flap.
  • Example 64 An example of an open-loop drainage installation with a first and second protrusion (shown in sketch 18b).
  • Clinical example Patient M., 67 years old, diagnosed with OD - primary open-angle laser-operated, far-reaching subcompensated glaucoma at maximum hypotensive mode. Operation OD - Sinustrabekulectomy with basal iridectomy with implantation of bioresorbable drainage. Processing of the surgical field is common.
  • a rectangular flap with sides of 4 and 3 mm to the transparent layers of the cornea is cut out with the base to the cornea.
  • the superficial flap of the sclera along with the conjunctiva is thrown back onto the cornea.
  • a fabric strip 1 * 3 mm in size was cut. A basal iridectomy was performed.
  • an open-loop bioresorbable drainage (sketch 1 H) is placed in such a way that the triangular protrusion is located in the sinus strabeculectomy zone and partially, by 0.5 mm, will mediate into the anterior chamber, and the distal end, leaving under the scleral flap 12 mm, located on the surface of the sclera.
  • the superficial flap along with the drainage is fixed to the sclera with two sutures 8.0.
  • the ends of the drainage protruding on both sides of the flap are bent and placed on the superficial scleral flap, covered with conjunctiva. Continuous stitch 8.0 per conjunctiva.
  • Gentamycini 0.2 under conjunctiva Aseptic mono-sticker. The day after surgery: the eye is almost calm. The front camera is about 2.3 mm (slightly finer than average), the moisture is transparent. Over the upper limb spilled filtration. At 12 o’clock. the proximal protrusion of the drainage is visible paralymbally in the anterior chamber. Under the conjunctiva of the upper limb, a drainage contour is visible. Tn OD 9 mm Hg (air). 3 months after surgery: OD - calm. Spilled filter pad above the upper limb. Under the conjunctiva of the upper limb, a drainage contour is visible. Tn OD 12 mm Hg. 6 months after surgery, OD is calm. Filtration pad for 12 hours. Drainage under the conjunctiva is not visible. Tn OD 16 mm Hg.
  • the invention can be used in medicine in penetrating operations in the surgical treatment of various types of glaucoma (primary, refractory, with repeated surgical interventions, in complex cases with secondary glaucoma).

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne les techniques médicales et notamment les drainages utilisés en chirurgie ophtalmique dans de opérations anti-glaucome à pénétration. Dans une première variante, le drainage pour opérations anti-glaucome à pénétration se présente comme un profilé creux à contour fermé en matériau biorésorbable et possède au moins une première saillie, avec possibilité de passage direct de lambeau scléral séparé par la cavité de drainage et avec possibilité d'introduction de ladite saillie dans la zone de trabéculectomie jusqu'à l'avancement de son bord dans la chambre avant. Dans une deuxième variante, le drainage pour opérations anti-glaucome à pénétration se présente comme un article fini en matériau biorésorbable et possède une première et une deuxième extrémités et une zone médiane disposée entre elles et au moins une première saillie assurant la possibilité d'introduction de ladite saillie dans la zone de trabéculectomie jusqu'à l'avancement de son bord dans la chambre avant et de pose de ladite zone médiane pour lambeau scléral séparés, avec disposition d'au moins une extrémité du côté extérieur du lambeau scléral séparé ou de la zone adjacente de sclère hors les limites du lit scléral. L'invention concerne également des procédés de fabrication de deux variantes de drainages.
PCT/RU2019/000186 2018-03-26 2019-03-26 Drainage pour le traitement chirurgical du glaucome et procédé de sa fabrication Ceased WO2019190352A1 (fr)

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RU2018110661A RU2771784C2 (ru) 2018-03-26 Дренаж для хирургического лечения глаукомы и способ его получения

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111728767A (zh) * 2020-04-24 2020-10-02 海南省眼科医院(中山大学中山眼科中心海南眼科医院) 一种角膜内皮保护镜及其用途
US20230146222A1 (en) * 2021-11-09 2023-05-11 Valsigna Gmbh Glaucoma implant device
RU236553U1 (ru) * 2024-12-30 2025-08-12 Иван Дмитриевич Захаров Дренаж для хирургического лечения глаукомы

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU126931U1 (ru) * 2012-04-12 2013-04-20 Александр Робертович Коригодский Дренажное устройство
RU134787U1 (ru) * 2012-09-05 2013-11-27 Иван Дмитриевич Захаров Дренаж для хирургического лечения глаукомы
RU2613414C1 (ru) * 2016-01-21 2017-03-16 Федеральное государственное автономное учреждение "Межотраслевой научно-технический комплекс "Микрохирургия глаза" имени академика С.Н. Федорова" Министерства здравоохранения Российской Федерации Дренаж для хирургического лечения глаукомы

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU126931U1 (ru) * 2012-04-12 2013-04-20 Александр Робертович Коригодский Дренажное устройство
RU134787U1 (ru) * 2012-09-05 2013-11-27 Иван Дмитриевич Захаров Дренаж для хирургического лечения глаукомы
RU2613414C1 (ru) * 2016-01-21 2017-03-16 Федеральное государственное автономное учреждение "Межотраслевой научно-технический комплекс "Микрохирургия глаза" имени академика С.Н. Федорова" Министерства здравоохранения Российской Федерации Дренаж для хирургического лечения глаукомы

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111728767A (zh) * 2020-04-24 2020-10-02 海南省眼科医院(中山大学中山眼科中心海南眼科医院) 一种角膜内皮保护镜及其用途
US20230146222A1 (en) * 2021-11-09 2023-05-11 Valsigna Gmbh Glaucoma implant device
US11903875B2 (en) * 2021-11-09 2024-02-20 Valsigna Gmbh Glaucoma implant device
RU236553U1 (ru) * 2024-12-30 2025-08-12 Иван Дмитриевич Захаров Дренаж для хирургического лечения глаукомы

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RU2018110661A3 (fr) 2020-12-30

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