WO2017142437A1

WO2017142437A1 - Set of instruments for anti-glaucoma surgery: limbosclerectomy with valvular drainage

Info

Publication number: WO2017142437A1
Application number: PCT/RU2016/000775
Authority: WO
Inventors: Владимир Иванович ЛАПОЧКИН; Андрей Владимирович ЛАПОЧКИН; Дмитрий Владимирович ЛАПОЧКИН
Original assignee: Владимир Иванович ЛАПОЧКИН; Андрей Владимирович ЛАПОЧКИН; Дмитрий Владимирович ЛАПОЧКИН
Priority date: 2016-02-17
Filing date: 2016-11-14
Publication date: 2017-08-24
Also published as: RU2618895C1

Abstract

The invention relates to opthalmology and is intended for conducting an anti-glaucoma surgery, namely a limbosclerectomy with valvular drainage. A set consists of disposable instruments having a handle and a metal working portion, namely: conjunctival forceps, an episcleral scraper, a two-pronged dosed knife, a right scleral layer-separator and a left scleral layer-separator, a fenestrated spatula, iridocorneal forceps, a general-surgery knife and a plastic marker. The set allows for performing dosed scleral tissue interposition with minimal trauma to the eye and without the use of sutures, drains and expensive implants, while simultaneously regulating and activating two pathways for draining intraocular fluid, thus significantly increasing the effectiveness and hypotensive effect of a proposed microsurgical intervention in eyes with glaucoma.

Description

Tool kit for anti-glaucoma surgery - draining

autoclaptic limbosclerectomy

Description

The present invention relates to ophthalmology, and is intended for anti-glaucoma surgery - a draining autoclap limbosclerectomy.

Currently, surgical treatment of glaucoma remains one of the most pressing problems of ophthalmology, as glaucoma takes the 1st place among the causes of irreversible blindness of mankind. In the surgical treatment of glaucoma, a large number of operations have been proposed, for the implementation of which standard microsurgical instruments (single and reusable) are used, namely, microsurgical single-blade knives, tweezers, microscissors, spatulas, hooks, threads 8/0 and 10/0, needle holders, etc. .d. All available anti-glaucoma operations are currently performed manually, according to the 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.

The closest analogue of the proposed set of microsurgical instruments is the standard universal set AO - 1, manufactured by the Kazan Medical Instrument Plant (KMIZ) and consisting of 17 steel reusable tools. The kit includes 4 modifications of various microsurgical scissors, 5 types of microsurgical tweezers, 1 needle holder, 1 capsule, 2 microhooks, 2 spatulas for working in the front and rear camera of the eye, 1 universal blade holder, 1 eyelash. The kit is published in the catalog of the Kazan Medical Instrument Plant (KMIZ) - TITANIUM ophthalmic instraments p. 160-161. (Kazan, Saydasheva St. 12, Tatarstan, 420022, Russia www.micro-instruments.com).

Using this universal kit, you can perform the main types of anti-glaucoma operations - Cairns sinusotrabeculectomy, Fedorov’s deep sclerectomy, Kozlov-Fedorov’s non-penetrating deep sclerectomy, etc. However, the need for regular sterilization of metal instruments, loss of precision, sharpness and quality should be considered significant shortcomings working surfaces of scissors, micro-forceps, cystotomes, spatulas, which affects the quality of the tissues of the eye as a result of their application tions. A very important drawback can be considered the lack of a dosed effect on the eye tissue, in which the surgeon, in the process of performing the above types of operations, relies only on his own experience, tentatively selected sizes and thickness of the sclera flaps and limb zones. Also, with the use of this kit, there is no technological sequence in the implementation of the stages of anti-glaucoma operations, which, along with the subjective experience of each particular surgeon will undoubtedly affect the result and hypotensive effect of operations, often leading to relapses and a number of early and late postoperative complications.

The task of the invention is the development of a set of microsurgical instruments for a specific anti-glaucoma operation - a draining autoclap limbosclerectomy.

The technical result of the invention is the possibility of dosed interposition of tissues of the scleral capsule with minimal trauma for the eye without the use of sutures, drains and expensive implants while simultaneously regulating and activating two ways of the outflow of intraocular fluid, significantly increasing the effectiveness and hypotensive effect of the proposed microsurgical intervention in the eyes with glaucoma.

The technical result is achieved through the use of 9 microsurgical instruments, each of which ensures the execution of a certain stage of the antiglaucoma operation - a draining autoclap limbosclerectomy.

A set of disposable tools consists of conjunctival forceps, an episcleral scraper, a double-toothed dosed knife, scleral exfoliators - left and right, a trowel, a spatula, iris-corneal forceps, a plastic scribe, and a general surgical knife. In this case, conjunctival forceps, iris-corneal forceps and a general surgical knife are standard microsurgical instruments, and the scraper episcleral, double-toothed dosed knife, scleral exfoliators, fenestrated spatula, plastic scribe - these are original tools specially designed and modified for this operation. The working part of the tools is made of stainless steel, except for the plastic marker.

The tool kit is shown in FIG. 1-8.

1. Conjunctival forceps 1-2-tooth, standard - designed to fix the tissues 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 Figure 1, where item 1 is the total length of the tweezers ( 1 13 mm), pos. 2 - distance between open branches in the free state (6.7 mm), pos. З - thickness at the end of 2 closed branches (0.6 mm).

2. Scrapbook episcleral (figure 2) is an 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 ° with respect to the axis of the handle - pos.5, thickness of the horizontal knee - pos .6 (preferably with a size of 0.3 mm), and its lower part for 400 μm is sharpened 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), 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. A double-toothed dosed knife (Fig. Z.) is an original disposable tool, on the end part of the tool has a flat metal platform - item 10 (preferably 2.2x2.2 mm wide and 1 mm thick), two parallel soldered metal blades pos.1 1 with an extension of 350 μm pos.12, which are located at a distance of pos.13 from each other (preferably 2.1 mm), have a sharp edge extending from the vertical elbow at an angle of 60 °, pos.14 and coming to naught within 1, 5 mm of the lower plane of the metal platform. Such a design is necessary for the simultaneous execution of 2 strictly parallel dosed scleral sections to a depth of 350 microns and a width of mainly 2.1 mm from the limb 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 cutting technology allows you to get a scleral flap 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. Scleral exfoliators - right and left (figure 4).

From the plastic handle - pos.17 (preferably 1 10 mm long) and diameter - 18 (preferably 6.0 mm) the working metal part of the instrument - pos.19 (preferably 15 mm long), coaxially connected to the handle. The end part of the tool, presented in the form of a horizontal bend - pos.20 (length, preferably 9.0 mm), the last section 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, if to the left - the left delaminator. This design of the delaminators allows to obtain high-quality cutting of the scleral strip mainly with a width of 2.1 mm and a thickness of 350 microns 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. Finished spatula (Fig. 5) - a tool designed to hold a scleral flap in supraciliary space. Plastic handle - pos.23 (length, preferably 1 10 mm), the working part of the tool - pos.24 (length, preferably 20 mm). Her horizontal knee is 25 (preferably 14 mm long, 1.8 mm wide and 0.25 mm thick). The thickness of the edge surrounding the oval hole of the end part of the spatula is pos. 26 (preferably 0.25 mm). The horizontal knee is bent - pos. 27 at an angle of 60 ° to the vertical knee. The lower edge of the horizontal working part is rounded on both sides - pos. 28 (with a radius of curvature, preferably 0.5 mm), and its upper rib - pos. 29 has an angle of 90 °. At the end of the working part there is a rounded hole - pos. 30 (preferably, dimensions 1, 8x1.5). The end of the fenestrated spatula (preferably over the last 4 mm) is deflected at an angle of 4 ° up - pos.9 from the horizontal axis of the working part of the tool and rounded with a radius of 0.9 mm. The front vertical face of the end of the spatula is rounded from the bottom - pos.31 pos.32 - radius of curvature (preferably 0.5 mm). This is necessary for the most convenient exit of the fenestrated spatula into the trabecular opening and the filling of a scleral dosed flap into it. Such design features of the fenestrated spatula make it possible to separate the delicate choroid with minimal trauma. the smoothed and polished lower surface of the working part of the instrument from the inner surface of the sclera, to which the upper plane of the working part of the spatula with "hard" ribs faces, easily separating the adhesions between the sclera and choroid. This avoids damage to the vessels of the choroid and ciliary body, preventing bleeding inside the eye.

6. Rainbow-corneal forceps (Fig.6) - a standard 1-2-tooth tool for working with thin structures of the eye - trabecula tissue, iris, cornea. The total length of the tool is pos.ZZ (1 13 mm). The thickness of the closed branches at the end is pos. 34 (equal to 0.35 mm). The opening size of open jaws is pos. 35 (equal to 6.7 mm).

7. Plastic scribe (Fig. 7) - an auxiliary tool designed for applying with the help of a dye (for example, diamond green) strips-marks at a distance mainly of 6.5 mm from the limb on the sclera, which is necessary for dosing along the length of 350 micron notch with two teeth with a knife. The tool is a one-piece plastic product - key 36 (total length, preferably 130 mm), the working part (preferably 15 mm) in the form of a curved hook and in the form of a “hockey stick" - key 37, height - key 38 (preferably , 2 mm) and width - pos. 39 (preferably 0.5 mm), extending from the handle at an angle of 120 degrees - pos. 40, and a length of 41 (preferably 6.5 mm). At the base of the working part of the marker, on its lower surface there is a protrusion - pos. 42 with a lining down (preferably 0.7 mm), which is greased with diamond greens. The end part of the scribe is applied to the limbus, freed from the conjunctiva, and the distal end is applied to the episclera and a mark is formed at a distance mainly of 6.5 mm from the limb.

8. A general surgical knife (Fig. 8) is 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. The knife with a total length - item 43 (125 mm) is a plastic handle - item 44 (120 mm long) and a diameter - item 45 (6.0 mm) with a razor blade glued at the end with a sharpening angle - item 46 30 ° and standing - position 47 (5.0 mm). The width of the sharpened cutting part of the blade is pos. 48 (2.4 mm), and the radius of curvature of the cutting surface (sharpness) is 0.003 mm.

All of the above-described disposable instruments are a single set for performing an anti-glaucoma operation - a draining autocamp valve limbosclerectomy. Each of the tools is designed for a strictly defined stage of the operation. Dosage sections, marking the operation area, the original design of the 350-micron double-toothed knife, 2 exfoliators, an episcleral scraper and a fenestrated spatula, 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 anti-glaucoma surgery DALS. The use of the proposed set allows for minimal trauma to the eye to interposition tissues of the scleral capsule without the use of sutures, drains and expensive implants. The original autoplastic mechanism of operation allows you to simultaneously regulate and activate 2 ways of the outflow of intraocular fluid, significantly increasing the effectiveness and hypotensive effect of the proposed microsurgical intervention in the eyes with glaucoma.

The kit is used as follows.

When conducting anti-glaucoma surgery, the conjunctival flap is formed in the classical way with the base to the limb using conjunctival disposable two-prong tweezers that capture the conjunctiva and tenon sheath. The size of the closed working parts of the branches of the tweezers contributes to minimal tissue trauma. Then with an original instrument - an episcleral scraper, the episclera is cleaned of the remnants of tenon capsules to the limbus for the subsequent execution of a double parallel incision of the sclera. The next step is to make markings using the original plastic marker. The protrusion protrusion located on its lower surface is greased with brilliant green. The end of the scribe is mounted on a limb cleaned with an episcleral scraper, and a mark treated with brilliant green is formed a mark 6.5 mm distal to the limb on the surface of the episclera. Then, with the help of a metered double-toothed original knife, 2 scleral incisions are made simultaneously to a depth of 350 μm from the limb to the arch 6.5 mm long. Such a tool provides a dosed depth of penetration of the scleral capsule without damaging the choroid and, in subsequent stages, contributes to the formation of a high-quality scleral flap-valve, inserted into the supraciliary space. The next step is to use the microsurgical knife to connect the ends of the metered incisions in the distal section to a depth of 350 μm and, using one of the two (right and left) exfoliators, form a scleral flap 350 μm thick with the base to the limb with the most even bottom, represented by deep layers of the sclera. In the distal part of the bottom of the patchwork bed (6 mm from the limbus), a hole of the size of the sclera is cut with a standard microsurgical knife from the deep layers of the sclera 2.1x0.8mm (posterior sclerectomy). Through paracentesis performed by a general surgical knife on the meridian 11 in the limb, 0.2 ml of absorbable viscoelastic is introduced through a thin cannula into the anterior chamber to maintain the shape and depth of the anterior chamber. Then, with a general surgical knife, under the base of the flap, a limbectomy opening is cut out from the deep layers of the sclera and the semitransparent limb area 2.1x1.0 mm in size until the iris root is exposed in it. Conduct a traditional iridectomy. Next, the fenestrated spatula is introduced into the supraciliary space through the posterior sclerectomy opening, removed through the limbectomy opening and the terminal 1/3 of the scleral flap, the total length of which is 6.5 mm, is inserted into it. Then the flap is introduced into the supraciliary space, providing activation of the uveoscleral pathway of the outflow of intraocular fluid. After that, with a general surgical knife, 3 through cuts are applied in the deep layers of the sclera from the limbectomy opening to the periphery. The middle notch in the bottom of the scleral bed has a length of 1.2 mm, and two lateral notches are located at the edges of the central notch along the border of the bottom of the scleral bed and intact sclera and have a length of 0.6 mm.

At the end of the operation, the conjunctiva and tenon capsule are sealed with a continuous suture. Example. Patient G. born in 1938. with a diagnosis of glaucoma Zc stage of the right eye. Outpatient card _.218-1 1. IOP of the right eye 35 mm RT. Art. at the maximum drop mode: xalatan, trisopt, arutimol. Visual acuity OD = 0.2 sf + 1.5 = 0.3. The field of view along Armali Dranse along the 8 meridians is 185 degrees. The coefficient of ease of outflow according to tonography of the right eye, C = 0.04. The patient underwent an anti-glaucoma operation - a draining autocapital limbosclerectomy using the above set of instruments and observing the stages of their use. In the early postoperative period, the IOP of the right eye was 9mm Goldman. Over 4 years of observation of IOP of the right eye ranged from 9-11 mm RT. Art. without the use of drops to reduce IOP. Filtration pad spilled, well defined. Visual acuity OD = 0.3 sf + 1.75 = 0.4. The total field of view along the 8 meridians is 205 degrees. The coefficient of ease of outflow C = 0.25. Thus, there is a stable hypotensive effect of anti-glaucoma surgery. Complications and relapses during the observation period were not noted.

Thus, the use of a set of tools for anti-glaucoma surgery allows for the stages of surgical intervention to be dosed and with the lowest risk of complications both during the operation and in the postoperative period.

Claims

Claim

1. A set of tools for anti-glaucoma surgery - a draining autoclap limbosclerectomy containing instruments having a handle and a working part, characterized in that it consists of disposable instruments with a metal working part - conjunctival forceps, episcleral scraper, two-toothed dosed knife, scleral exfoliators - left and right , fenestrated spatula, iris-corneal forceps, general surgical knife and plastic scribe, while the episcleral scraper has a working part in the form of “ho Kane sticks "with the horizontal deflection angle of the knee at 75 ° with respect to the axis of the handle and the lower part over the sharpened at an angle of 40 ° on both sides to form an acute lower edge; the double-toothed metered knife on the end part has a flat metal platform, on the lower side of which 2 parallel metal blades with a stand of 350 μm are soldered 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 fenestrated spatula has a horizontal knee bent under 60 ° to the vertical elbow, the lower edge of the horizontal working part is rounded on both sides, and its upper rib has an angle of 90 °, there is a rounded hole at the end of the working part, the end of the fenders can be tilted upward at an angle of 4 ° from the horizontal axis of the working part of the tool rounded off the plastic marker has a working part in the form of a curved hook in the form of a “hockey stick”, extending from the handle at an angle of 120 °, moreover, at the base of the working part on its lower surface there is a ledge with a downward clearance,

2. The kit according to claim 1, characterized in that the horizontal elbow of the episcleral scraper has a size of 4.4x1.6 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 kit according to claim 1, characterized in that the flat metal platform of the double-toothed dosed knife has a width of 2.2x2.2 mm and a thickness of 1 mm, the metal blades are spaced 2.1 mm apart, and a sharp edge extending from the vertical elbow , disappears within 1.5 mm of 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,

5. The set according to claim 1, characterized in that the fenestrated spatula has a horizontal elbow of 14 mm long, 1.8 mm wide and 0.25 mm thick, the lower edge of the horizontal part is rounded on both sides with a radius of curvature of 0.5 mm, the rounded hole has a size of 1 , 8x1.5 mm, and the thickness of the edge surrounding the oval hole of the end of the spatula is 0.25 mm, the end of the fenestrated spatula is tilted upward over the last 4 mm and rounded with a radius of 0.9 mm, and the front vertical face of the end of the spatula is rounded down with a radius 0.5mm curvature

6. The kit according to claim 1, characterized in that the curved hook of the plastic marker has a height of 2 mm and a width of 0.5 mm, the protrusion of the working part of the marker on its lower surface has a width of 0.5 mm, and a downward clearance of 0.7 mm .