RU2639852C1 - Tool kit for synustrabeculecectomy - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: kit of disposable tools contains tools, having a handle with metal working part and consists of conjunctival tweezers, episcleral scraper, double-toothed knife, scleral exfoliators - right and left, episcleral marker, iris-corneal tweezers, trabecular marker, general surgical knife. The episcleral scraper has a working part in the form of a "hockey stick" with an angle of horizontal elbow deviation of 75° in relation to the handle axis, and the whole length of the lower part is sharpened at an angle of 40° on both sides with formation of an acute lower edge. The double-toothed knife has a flat metal platform at the end, on the underside of which 2 parallel metal blades are soldered spaced from each other at a distance of 4 mm with a spacing of 350 mcm with a sharp edge extending from the vertical elbow at an angle of 60° and trailing off. Scleral exfoliators - right and left - have a working part coaxially connected to the handle. The end part is represented by a horizontal elbow, the end of which is a razor blade sharpened at an angle of 45°. The episcleral marker has a working part in the form of a 14 mm rod curved at an angle of 120°, at the end of which there is a U-shaped stamp-meter with base width 4 mm, free ends length of 3,5 mm and with lower edges sharpened from two sides. The trabecular marker has a working part in the form of a rod curved at an angle of 120°, at the end of which there is a rectangular plate with dimensions of 2.0×1.3 mm and thickness of 0.8 mm.EFFECT: kit application allows to standardize the tool impact on the glaucoma eye tissues by appropriate provision of more stable and deep hypotensive effect of the operation and traumatic effect reduction.4 cl, 8 dwg

Description

The invention relates to ophthalmology and is intended to carry out the anti-glaucoma sinusotrabeculectomy (STEC) proposed by Dr. J Cairns in 1968.

From the time of the invention, operations to the present, STEC have been carried out in different countries of the world, including Russia, using tool kits formed from reusable tools from various manufacturers. These sets are formed arbitrarily depending on the experience and preferences of the surgeon, as well as the traditions and requirements of each particular clinic.

Various separate instruments are known for performing penetrating anti-glaucoma surgery.

Known delaminating knife, which contains a handle, a curved working part made in the form of a rod and a cutting element made in the form of a plate in the shape of a parabola, having a radius of curvature of 0.1-0.5 mm at the distal end, with double sharpening edges and the maximum width of 1.0-3.5 mm in the proximal section, a thickness of 0.1-0.4 mm, a length of 3-8 mm and located in a plane perpendicular to the plane of bending of the working part. Moreover, the angle of bending of the working part, relative to the handle, is 140-160 degrees (RU 79242, 12/27/2008).

A known instrument for conducting ophthalmic microsurgical operations, which contains a handle and a working part. The working part is made in the form of two surfaces with an envelope on one side in the form of a steepest descent curve and on the opposite side of the Bernoulli curve smoothly conjugated to each other. The sides of both surfaces are inclined at an acute angle to the horizontal plane and sharpened. The use of this tool will reduce surgical complications while ensuring the organ-preserving tissue of the eyeball when opening the fibrous capsule of the eye during an ophthalmic microsurgical operation (RU 2525657, 10.06.14).

A known instrument for conducting ophthalmic microsurgical operations, which contains a handle and a working part. The working part is made in the form of a rectangular plate with a rounded front end surface. The rectangular plate is combined with the plate in the form of an isosceles trapezoid, which faces the lower side of the base in the direction opposite to the handle. The sides of the trapezoid are inclined at an acute angle to the horizontal plane and sharpened. The butt-end of the trapezoidal plate is rounded. Rectangular and trapezoidal plates lie in the same plane. The tool combines the functions of a delamination device and a cutting device (RU 2470617, 12.27.12).

All three examples of cutting tools are exfoliating knives, they are designed to cut out the surface sclera flaps as much as possible during anti-glaucoma operations. Whatever the sharp end of the working part of these knives - rounded, trapezoidal or in the form of a pointed triangle, all have one significant drawback, they are not dosed in depth and cannot provide the necessary thickness of the scleral flap. Working with them very much depends on the manual skills and experience of the surgeon.

Known ophthalmic device for marking in anti-glaucomatous operations, which contains the marking plate and the body in the form of two branches with working parts. The planes of the working frequencies are facing each other. At least two marking plates are located on both planes and perpendicular to them. The plates on the plane of one working part are located opposite the free space between the plates on the opposite plane of the working part. The distance between the plates is not less than 1.1 thickness of the plates. The device is used for marking non-perforating incisions during anti-glaucomatous operations at the stage of plastic surgery of the surface flap (RU 2196557, 01.20.03).

Known for spatula-trabeculot for anti-glaucomatous operations. The work item consists of three knees. The first elbow is connected to the handle and has a length of 10 mm. The next elbow has a length of 9 mm and a diameter of 0.4 mm. Both knees are located in the same plane and at an angle of 150 °. The last elbow has a length of 4.5 mm and a diameter of 0.2 mm and is located in a plane perpendicular to the previous one (RU 60859, 02/10/2007). This trabeculot is designed to perform destruction of the inner wall of the Schlemm's canal during non-penetrating operations in glaucoma. To perform sinusotrabeculectomy, it has no practical value.

A known instrument for conducting ophthalmic microsurgical operations, the working part of which is made in the form of a surface with an envelope of one side in the form of a Zhukovsky curve and on the opposite side of the Treftz curve, which are smoothly interconnected. The sides of both surfaces are inclined at an acute angle to the horizontal plane and sharpened. The device is used when opening the fibrous capsule of the eye during an ophthalmic microsurgical operation (RU 2515528, 05/10/14).

Known knife for anti-glaucomatous operations, the working part of which consists of a rectangular base made in the form of a plate. A cutting section is mounted perpendicular to the plate along the long side of the base. The upper edge of the cutting portion is pointed and curved in the shape of an arc. The arc begins at an acute angle at the free end of the base. Part of the arc adjoins the free end of the base and forms a point. The opposite end of the arc is rounded and connected to the beginning of the base, closest to the handle, a straight section perpendicular to the base. The convexity of the cutting section is turned in the direction opposite to the base. The handle is connected to the base in the middle of its short side (RU 2331393, 08.20.2008).

Kits as the main tools include microsurgical knives (general, non-dosed), various micro tweezers, spatulas, cannulas, scissors, cauters (coagulators), needle holders, microneedles with thread 8/0 and 10/0, eyelids.

Currently, surgical treatment of glaucoma remains one of the most pressing problems of ophthalmology, as glaucoma ranks first among the causes of irreversible blindness. All available anti-glaucoma operations are currently performed manually, according to descriptive, taking into account the main stages, technique, without quantitative, i.e. dosed accounting for the size of tissue flaps, depth and shape of cuts, a strict sequence of stages of the operation, using (at the discretion of the surgeon) heterogeneous in shape, size and material of the manufacture of tools. At the same time, in operations of the penetrating (filtering) type, auxiliary devices are often used, such as Ahmed, Molteno, Belvedere valves, Express shunts, collagen, silicone and other synthetic drains.

A set of reusable instruments for conducting anti-glaucoma surgery is known, consisting of 8 microsurgical instruments (tweezers, a diamond knife, a capsule, spatulas, etc.), produced in Kazan by LLC Titan Medical (Registration certificate of Roszdravnadzor 2016/4670 dated 09/05/2016 .).

The closest analogue of the present invention is a set of reusable instruments for conducting anti-glaucoma surgery, consisting of 11 reusable instruments (eyelid expander, needle holder, blade holder, scraper knife, scissors of various modifications, tweezers, spatulas) (“K-mT” ophthalmic surgery instrument kit manufactured by PTO Medtekhnika (FSR 2009/06404 of 04/19/2016). Tools are made of stainless steel, some of them are coated with tungsten carbide.

Using both sets, a sinusotrabeculectomy operation can be performed, however, the quality and depth of the scleral capsule incisions during the formation of a scleral flap will always be different and very dependent on the surgical technique of each particular glaucomatologist. In addition, the shape and dimensions of the scleral flap and trabeculectomy opening located under the scleral flap and the number of sutures on the scleral flap will be arbitrary. Its dimensions can vary from 3 × 3 mm to 6 × 6 mm, if the flap is square or triangular in shape or from 3 × 4 mm to 5 × 6 mm when the flap is rectangular or trapezoidal. The thickness of the flap can vary from 150 to 450 microns and can be uneven, which can greatly affect the occurrence of intra- and postoperative complications, as well as the severity of the hypotensive effect of sinusotrabeculectomy. These problems when using the above-mentioned sets of reusable instruments when performing sinusotrabeculectomy (STEC) arise primarily due to the lack of a dosed effect on the tissues of the sclera and trabeculae. They lack various markers that clearly define the geometry and dimensions of the scleral flap, as well as the dimensions of the trabeculectomy opening. These kits do not contain the dosed knives necessary for the exact depth of the incision of the scleral capsule of the eye during the formation of the scleral flap and convenient exfoliating knives for the qualitative formation of the surface of the scapular scapular bed. In these kits, there is no episcleral spatula-raspator with moderate severity for cleaning the episcleral surface at the site of STEC. All of the above-mentioned shortcomings in the quality of the instruments presented in the analogues, with the help of which STEC operations are currently performed for glaucoma, as well as their reusability requiring repeated sterilization, require the development of new approaches in the microsurgical sinusotrabeculectomy technique by creating metered-dose disposable instruments (set for STEC) That should raise the quality of operations to a new technological level.

For all the main stages of STEC, within the framework of the present invention, original microsurgical instruments have been created that significantly increase the depth and durability of the antihypertensive effect of the operation, virtually eliminating the subjective factor of the “hand” of the surgeon and corresponding to modern requirements for sterility and single use.

The objective of the invention was the creation of a set of disposable microsurgical instruments for anti-glaucoma surgery - STEC - with improved properties.

The technical result of the invention is the standardization of the effects of tools on the tissues of the glaucoma eye with the corresponding provision of a more stable and deep hypotensive effect of the operation and a decrease in the traumatic effect.

The technical result is achieved due to the staged use of disposable tools, providing a dosed effect on the tissue.

Through the use of 9 disposable instruments, it is possible to form a qualitatively new surface of the flap and sublap bed, as well as certain sizes of the trabeculectomy opening. This helps to strengthen the filtration of aqueous humor and significantly reduce the invasiveness of surgical intervention. In this case, only 2 sutures must be applied to the scleral capsule of the eye along the two free corners of the scleral flap. Considering the strictly specified dimensions of the scleral flap (4 × 3.5 mm) and its guaranteed thickness of 350 μm, when fixing sutures are applied to the corners of the flap, iatrogenic astigmatism is minimized, and the need for implantation of any foreign bodies in the form of implants into the operated glaucoma eye is excluded, drains or shunts. The combination of 2 scribers included in the kit allows you to create the optimal surface flap (4 × 3.5 mm) for STEC and the dimensions of the trabecular opening are also optimal for this operation and (2 × 1.3 mm).

The set for STEC operation consists of 9 disposable instruments designed to perform various stages of the operation.

1. 1-2-tooth conjunctival forceps, standard - designed to fix the tissue of the conjunctiva and tenon capsule during the formation of the conjunctival flap using teeth located at the end of the jaw, and is shown in FIG. 1, where pos. 1 - the total length of the tweezers (113 mm), pos. 2 - distance between open branches in a free state (6.7 mm), pos. 3 - thickness at the end of 2 closed branches (0.6 mm).

2. Scrapbook episcleral (Fig. 2) - the original tool, has a working part in the form of a “hockey stick" with an angle of deviation of the horizontal knee (pos. 4) - 75 ° relative to the axis of the handle (pos. 5), the thickness of the horizontal knee - pos. 6 (preferably 0.3 mm in size), and its lower part is sharpened over a length of 400 microns at an angle of 40 degrees - pos. 7 on both sides with the formation of a sharp lower edge (preferably with a radius of curvature of 0.01 mm), pos. 8 - the total length of the tool (preferably 130 mm), the metal working part - pos. 9 - (preferably 30 mm), made of stainless steel. This design of the tool with a given sharpness of the lower edge of the "stick" provides high-quality cleaning of the episcleral surface without damaging the episcleral vessels. The dimensions of the horizontal “knee” knee and its deviation angle of 75 ° allow the surgeon to freely work with the eye tissues within the palpebral fissure.

3. The double-toothed knife (Fig. 3.) is an original tool, on the end of the tool has a flat metal platform - pos. 10 (preferably with a width of 2.2 × 2.2 mm and a thickness of 1 mm), two parallel metal blades (key 11) with a stand of 350 μm (key 12), which are located at a distance from each other ( pos. 13) 4 mm, have a sharp edge extending from the vertical elbow at an angle of 60 ° (pos. 14) and converging to nothing within 1.5 mm of the lower plane of the metal platform. A similar design is necessary for the simultaneous execution of two strictly parallel dosed scleral sections to a depth of 350 microns and a width of 4 mm from the limb, up to 6.0-6.5 mm long towards the equator of the eye. The total length of the tool is pos. 15 (preferably 130 mm), the length of the working metal part is pos. 16 (preferably 20 mm). This section technology allows you to get a scleral flap of a given thickness and length, which is important to ensure a high-quality outflow of chamber moisture into the supraciliary space and under the conjunctiva due to vibrational micromotion of scleral autoclamp mechanisms.

4. Scleral exfoliators - right and left (Fig. 4). From the plastic handle - pos. 17 (preferably 110 mm long) and a diameter of pos. 18 (preferably 6.0 mm) the working metal part of the tool - pos. 19 (preferably 15 mm long) coaxially connected to the handle. The end part of the tool is presented in the form of a horizontal knee - pos. 20 (preferably 9.0 mm long), the last portion of which (preferably 6 mm) is a razor blade - pos. 21, sharpened at an angle of 45 ° - pos. 22, if the sharp edge of the blade is turned to the right - the right delaminator (pos. 23), if to the left - the left delaminator (pos. 24). This design of the delaminators allows you to get high-quality cutting of the scleral strip mainly, 2.1 mm wide and 350 microns thick, with the most even flat bottom of the scleral pocket. The presence of 2 options for the location of the sharpening of the blade left and right provides maximum convenience in the limb and trabeculae zone, also takes into account the individual preferences of the surgeon, who can be either “right-handed” or “left-handed”.

5. Episcleral scribe (Fig. 5) - an original tool designed for marking the episcleral surface of the eye with the aim of forming a metered scleral flap of a given size, with a plastic handle with a length of mainly 110 mm (pos. 25) and a diameter of mainly , 6 mm (pos. 26) there is a working part in the form of a curved metal rod 14 mm long: 10 mm - one elbow (pos. 27), an angle of 120 ° (pos. 28) and 4 mm - the second elbow (pos. 29) . At the end of the rod there is a U-shaped stamp marker with a base width of 4 mm (pos. 30), free ends 3.5 mm long (pos. 31) and lower edges pointed on both sides. The working part of the episcleral marker is made of stainless steel.

6. Rainbow-corneal forceps (Fig. 6) - 1-2x tooth - a standard tool for working with thin structures of the eye - trabecula tissue, iris, cornea. The total length of the tool is 113 mm (32), the thickness of the closed jaws at the end is 0.35 mm (33). The opening size of open jaws is 6.7 mm (34). The tweezers jaws are made of plastic, the working part is made of stainless steel.

7. The trabecular marker (Fig. 7) is an original tool designed for applying with a dye (for example, diamond green) a 2.0 × 1.3 mm marking figure in the underlap space of the trabecula zone for dosed execution of the trabeculectomy stage. The handle has a length of mainly 110 mm (35) and a diameter of 6 mm (36). The metal working part in the form of a rod (37) bent at an angle of 120 ° with 10 mm elbows (pos. 38) and 8.0 mm (pos. 39) has a rectangular plate (pos. 40) with dimensions 2 × 1.3 mm and a thickness of 0.8 at the end mm The working part of the metal scribe is made of stainless steel. The total length of the tool is mainly 130 mm (41).

8. General surgical knife (Fig. 8) - a standard microsurgical knife designed for paracentesis (micro incisions) of the cornea and sclera, as well as for performing incisions on the scleral capsule of the eye. Knife with a total length - pos. 42 (125 mm) is a plastic handle - pos. 43 (length 120 mm) and diameter - pos. 44 (6.0 mm) with a razor blade glued at the end with a sharpening angle of 30 ° - pos. 45 and blade standing - pos. 46 (5.0 mm). Width of the cutting ground part of the blade - pos. 47 (2.4 mm), and the radius of curvature of the cutting surface (sharpness) is 0.003 mm.

Thus, all the above-described disposable instruments represent a single set for performing the main stages of the sinusotrabeculectomy (STEC) operation.

Each of the disposable instruments is designed for a strictly defined stage of the operation. Dosing of incisions, marking of the operation area, original design of the double-toothed 350 micron knife, 2 exfoliators, episcleral scraper, as well as the use of 2 standard micro-forceps and a universal microsurgical knife make the kit complete and fully provide all the technological manipulations at the stages of the anti-glaucoma operation - sinusotrabeclectomy (STEC). The application of the proposed set allows with minimal trauma to the eye to carry out an already well-established operation and bring it to a new technological level with a pronounced hypotensive effect.

Claims (4)

1. A set of tools for sinus strabeculectomy, containing instruments having a handle and a working part, characterized in that it consists of disposable instruments with a metal working part - conjunctival forceps, episclair scraper, double-toothed knife, scleral exfoliators - left and right, episcleral scribe, rainbow tweezers - corneal, trabecular scribe, general surgical knife, while the episcleral scraper has a working part in the form of a horizontal knee located at an angle of 75 ° relative to to the axis of the handle, and the lower part for sharpened at an angle of 40 ° from two sides with the formation of a sharp lower edge; the double-toothed knife on the end part has a flat metal platform, on the lower side of which 2 parallel metal blades are soldered, located at a distance of 4 mm from each other with a distance of 350 μm with a sharp edge extending from the vertical knee at an angle of 60 ° and coming to naught; scleral delaminators - right and left - have a working part coaxially connected to the handle, while the end part is presented in the form of a horizontal knee, the end of which is a razor blade sharpened at an angle of 45 °; the episcleral marker has a working part in the form of a rod 14 mm long bent at an angle of 120 °, at the end of which there is a U-shaped marker marker with a base width of 4 mm, free ends 3.5 mm long and with lower edges pointed on both sides; the trabecular marker has a working part in the form of a rod bent at an angle of 120 °, at the end of which there is a rectangular plate with dimensions of 2.0 × 1.3 mm and a thickness of 0.8 mm. 2. The kit according to claim 1, characterized in that the horizontal elbow of the episcleral scraper has a size of 4.4 × 1.6 mm, a thickness of 0.3 mm, and the sharp lower edge has a radius of curvature of 0.01 mm, while the length of the working part is 30 mm. 3. The set according to claim 1, characterized in that the flat metal platform of the double-toothed knife has a width of 2.2 × 2.2 mm and a thickness of 1 mm, and the sharp edge extending from the vertical knee disappears within 1.5 mm the lower plane of the platform, the length of the working part is 20 mm. 4. The kit according to claim 1, characterized in that the scleral exfoliators have a metal part with a length of 15 mm, and the horizontal elbow has a length of 9.0 mm.

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