EA029263B1 - Scleral incision template and special blade-knife for eye surgery - Google Patents

Abstract

A scleral incision template (SIT) and blade-knife are provided that facilitate adequate, efficient and smooth sclera-corneal tunnel dissection by achieving high quality scleral incision that may be close to ideal. The completed scleral incision has a correct predetermined size, shape, length, site and even depth throughout the length of the incisional groove. The synergetic action of the SIT with blade unit makes the sclero-corneal flaps uniform in thickness and tunnel uniform in depth. This facilitates the passage for the extraction of the cataract nucleus, as well as to implant the IOL inside the eyeball and also reduces complications more efficiently than when an incision is taken with help of blade-knife available.

Description

The invention relates to surgery for small incisions for cataract removal, in particular, to a method and equipment used for the surgical treatment of cataracts.

Background of the invention

Recently, the treatment of cataract-induced blindness has involved cataract removal and subsequent implantation of intraocular lenses in the eye using various surgical procedures, including small incisions to remove cataracts or phacoemulsification. Small incision cataract surgery is a well-established surgical technique in which a scleral incision provides access for sufficient effective and smooth dissection of the sclerocorneal tunnel. This provides access for the extraction of the cataract nucleus, as well as for the implantation of an intraocular lens inside the eyeball. However, any irregularities of the scleral incision and tunnel formation can cause damage to tissue or cells, as well as subsequent complications.

The present invention provides for the creation of devices for an eye surgeon, allowing him to achieve a much higher degree of precision when performing a scleral incision.

Summary of the Invention

The present invention includes a template complete with a blade, or a cutting device, for eye surgery: (a) the template includes at least one profile / cut made in it; and (b) a scalpel blade (ί), having dimensions that coincide with the profile / cut-out dimensions in the template, allowing the introduction of the blade, or the cutting device. through the cut profile / cut-out (ίί) to make an incision in the sclera in order to carry out a subsequent operation.

The design of the template with the cutting device can be approached in various ways that are not beyond the scope of the description in the above paragraph. In the illustrated embodiments of the present invention, the pattern is made and intended for its positioning when performing eye operations on the eyeball, while the scalpel blade has dimensions corresponding to the size of the profile / cutout in the pattern; the dimensions additionally provide for insertion of the blade through the profile / cut made in order to penetrate the tip of the scalpel blade into the sclera at one end of the profile / cut by piercing the sclera only to the depth required for the operation, and moving the blade along the length of the profile / cut without rotating around its axis for making an incision necessary for further operation.

The present invention also provides for the creation of a process or method for the surgical treatment of an eye cataract, including the use of: (a) a template containing at least one profile / cut made therein for positioning it when performing an eye operation on the eyeball, and (b) a scalpel blade , or a cutting device having dimensions corresponding to the profile / cut-out dimensions in the template for inserting the blade through the completed profile / cut-out, puncturing the tip of the sclera scalpel only to the depth well, required for the operation, and moving the blade, or the cutting device, along the length of the profile / cut to make the cut, necessary for further operation.

In one embodiment of the present invention, the template includes at least one of the following elements: (a) at least one notch or one notch on a flat surface, (b) an elongated element and (or) a label to provide alignment, (c) a design ( i) providing (s) stabilization, (k) construction (s) providing (s) fixation above the eyeball, in order to prevent accidental displacement, sliding or tilting of the template above the eyeball and for fixing the eyeball during the incision process, ( e) pen, (ί) n In this pattern, it is given such a shape that provides contact with the sclera, sufficient to ensure the immobilization of the eyeball.

The template in accordance with the present invention further includes at least one of the following elements: (a) a notch, or a slit of a rectilinear form (26) formed by the front part of the template between two projections, or an arcuate form (29) or a Y-shaped chevron shape , (B) elongated elements, which are two protrusions (27-a) and (27-b), and a label, which is a label in the form of a triangle or arrow (28), (c) a structure that provides stabilization and includes two directed back protrusion ("tail") (31), with the specified the design additionally performs the function of a retractor when it is placed above the eyeball during the incision, pulling the dissected conjunctiva and tenon capsule away from the surgical site (k), the structures providing fixation and including the “teeth” (30) on the bottom surface intended for installation on the surface the eyeball, while the teeth are placed in such a way as to ensure their penetration into the sclera when installing the lower surface of the template in contact with the eyeball, these teeth can preferably be arranged in two rows, (e) a handle made with several bends (32), (ί) the specified pattern has a toroidal or ellipsoidal shape (FIG. 6-T), (e) said template is made of sheet metal or disposable material, including plastic, and (j) the template handle can be attached to the blade holder (38).

- 1 029263

The blade in accordance with the present invention consists of at least several elements: (a) the tip of the blade (37), (b) of the middle part, called the body (36), (c) the third part, called the connecting element (35), (ά) the fourth part, called the limiter (34), and (e) the fifth part, called the handle (33).

The blade in accordance with the present invention further consists of at least one of the following elements: (a) a tip, which is a semicircular cutting edge of the blade, the height of which is equal to the depth to which the notch should be cut, (b) of the body or middle part having the shape and thickness, ensuring that it is precisely positioned inside the cut-out of the pattern so that when an appropriate force is applied to it to move in the same direction in which the notch is intended to occur, About its smooth movement inside the cutout with a snug fit, and because of its unique tetrahedral or oval shape, the body prevents self-rotation in the slot or cutout of the template, (c) a connecting element having a diameter exceeding the width of the cutout or slot in the template, to prevent deep penetration into the eye an apple or its deep perforation, (ά) a stopper designed to limit further advancement of the blade forward when inserted into the blade holder forming the surface against which it abuts the end of the blade holder and ensuring stable operation of the blade while preventing the slightest unintentional movement of the blade when it is used to cut, (e) the handle of the blade attached to the blade holder (38).

Another embodiment of the present invention includes a process or method for making an incision according to claim 2, comprising the following steps:

(a) using a toroidal or ellipsoidal pattern to ensure contact with the sclera, allowing for the immobilization of the eyeball, the template further includes the following elements: (ί) at least one notch or one notch of a rectilinear shape (26) or arcuate shape ( 29), or a Y-shaped chevron shape on a flat surface, (and) elongated elements, representing two protrusions (27), and a label, which is a label in the form of a triangle or an arrow (28), providing a combination, () two directions backward protrusion ("tail") (31), providing stabilization and also performing the function of a retractor, (ίν) "teeth" (30), arranged in two rows on the bottom surface intended to be mounted on the surface of the eyeball, while the teeth are placed so that their penetration into the sclera is ensured when the lower surface of the template is in contact with the eyeball, resulting in its fixation above the eyeball, preventing accidental displacement, sliding or tilting of the template above the eye I Locke, and allowing to fix the eyeball during the execution of the notch, (ν) the handle (32) formed with several bends and connected to the blade holder (38);

(b) using a blade, additionally containing (ί) the tip of the blade (37), which is a semicircular cutting edge of the blade, the height of which is equal to the depth to which the notch should be cut, (and) the middle part, called the body (36), having a thickness, ensuring that it is precisely placed inside the cutout of the template so that when an appropriate force is applied to it to move in the same direction in which the cut is to be made, it will move smoothly inside the cutout with a snug fit The (,) third part, called the connecting element (35), has a diameter greater than the width of the cut or slot in the template and is designed to prevent self-rotation, (ίν) a stop to restrict further advance of the blade when it is inserted into the blade holder forming the surface against which the end of the blade holder rests and ensuring stable operation of the blade while preventing the slightest unintentional movement of the blade when it is used to make an incision, and (ν) p chku (33) attachable to the blade holder (39);

(c) detaching the dissected conjunctiva and tenon capsule by inserting the “tails” of the pattern between them, placing both protrusions parallel to the limbus and touching the intercostal line on the eyelids, aligning the top of the mark on the pattern with a steeper curvature 'K' or 12 hours above the section scleral incision, while ensuring that the incision of the incision from the limbus is approximately 2 mm;

(ά) smoothly submerging the teeth in the sclera by applying a constant force to the base of the template handle, fixing the template to the eyeball and securely immobilizing the eyeball to prepare it for the incision;

(e) inserting the blade into the selected notch to make a notch on the template, holding the blade vertically with respect to the pattern, deeper insertion of the blade in the downward direction over the sclera, applying a constant force to the handle through the notch, piercing the sclera with the blade until further introduction the blade is not securely limited to the connecting element (35), the slow and continuous movement of the blade handle along the notch shape when a constant force is applied to the blade holder, reaching the other end of the notch, completing cut tions and the slow recovery of the scalpel blade from the cut-out pattern;

(£) Repeat step (e) if necessary before deleting the pattern.

- 2 029263

The aforementioned cutting device may also be a laser beam capable of making an incision, ensuring the effectiveness of performing eye operations.

Detailed Description of the Invention Brief Description of the Drawings

The present invention is illustrated with reference to the accompanying drawings, in which

FIG. 1- forms of standard cuts;

FIG. 2 - notches with uneven and normal edges;

FIG. 3 is a vertical sectional view of the eyeball and the position of the shallow, normal and deep incisions;

FIG. 4 - temporal, supratemporal position and position of cuts at 12 o'clock;

FIG. 5 - the required incision of the sclera, characterized by the exact area, shape, length, edges, depth and size, corresponding to the size of intraocular lenses;

FIG. 6 - scleral incision template: P - front view, T - top view and L - side view;

FIG. 7 - a special blade and its parts: P - front view, f - side view and K - bottom view.

FIG. 8 - template for scleral incision with blade assembly in the form of a set (scleral incision template set) with separate holders.

When conducting a seamless surgery for small incisions to remove cataracts, complications may occur due to various reasons. Complications invariably arise from the first scleral incision, depending on its shape, length and depth. The length of the incision is mainly due to the size and material of the intraocular lenses, and also depends on whether the lenses are flexible or rigid. A small incision is preferred for intraocular lenses made from soft materials, including flexible intraocular lenses made from silicone, acrylic hydrogel, etc., while a large incision is necessary for hard intraocular lenses made from hard materials such as polymethyl methacrylate .

The surgeon prefers to make cuts, the geometric shape of which involves the use of simplest or technically not very complicated methods of forming the incision. FIG. 1 illustrates various incisions in the eyeball (1), for example, incisions of a rectilinear shape parallel to the limbus, an arcuate shape, a Blumenthal shape, or a Y-shaped chevron shape, etc. Making a straightline incision (2) is the simplest, however, in the postoperative period, such an incision causes moderate astigmatism. Astigmatism occurs when all the rays from an object are not focused at a single point on the retina, with the result that a blurred image of the object falls on the retina. Such a complication is common in the healing of a corneal scleral wound in the postoperative period. The implementation of the arc notch (3) is characterized by the complexity of implementation, however, in this case, astigmatism is minimal.

The Y-shaped chevron notch (4) is also characterized by the complexity of execution, however, with this cut, there is minimal or zero astigmatism. Thus, despite the fact that the surgeon may prefer to make an incision in a rectilinear form, he would also be satisfied if he could make cuts in an arcuate or Y-shaped chevron shape using a simple and convenient method.

The length of the scleral incision also depends on the surgical method used to remove the cataract, which can be removed manually or by the phacoemulsification method. Despite the fact that the incision is marked on the sclera using a caliper when performing an operation on the table, its quality in terms of accuracy, continuity and compliance with the requirements depends on the qualifications of each surgeon and the patient with whom each surgeon works. Thus, in many cases, the incisions are characterized by irregular shape, irregular length and often torn edges. FIG. 2 illustrates an incision of a regular shape (6) and incisions having an irregular shape (5a), length (5b) depth (5c), and uneven edges (5ά).

In addition, despite the fact that the external scleral incision looks extremely clean and even with current practice, the depth of the incision can be uneven, however, due to the uncontrolled force and pressure applied to the blade as well as to the direction of the blade. As a result, the depth of the scleral incision may be too small or too large.

An exceptionally deep scleral incision can cause scleral detachment, i.e. complete separation of the lower sclera and sclera, located above the incision. As a result, a large gap is formed, leading to prolonged wound healing or even to prolapse of the iris or vitreous body. FIG. 3 illustrates a vertical sectional view of the eyeball and the incision position — shallow (7), correct (8) and deep (9) cuts. The drawing also illustrates the position of the cornea (10), anterior chamber (11), trabecular meshwork (12), iris (13), ciliary body (14) and lens (15).

An insufficiently deep incision of the sclera can also lead to thinning of the scleral and corneal flaps. An insufficiently deep or superficial corneal incision leads to numerous corneal ruptures or "looping" in the tissue, resulting in an exceptional 3 029263

but the subsequent surgical steps, such as the formation, completion, and use of the scleral-corneal tunnel, are complicated. The only way to eliminate such complications on the table is to re-perform the scleral incision and careful dissection in another plane, which in itself is a complex procedure.

Above were given numerous factors causing multiple complications during an operation or during the postoperative period, namely, a shallow anterior chamber, bleeding through a scleral tunnel, obstructed extraction of the cataract nucleus, rupture of the posterior lens capsule, prolapse of the iris tissue or prolapse vitreous body, corneal endothelium damage resulting in corneal edema, bullous keratopathy or complete corneal opacification, postoperative ac igmatizmu and blindness due to phthisis bulbi, also known as wrinkled blind eye.

The aim of the present invention is to make a scleral incision having a controlled size, shape, length, area, and most importantly, a uniform depth along the entire length of the scleral incision. The purpose of the present invention also provides for the creation of a knife, ensuring the achievement of the above purpose.

The above objective has been achieved in the present invention by creating a user-friendly mechanical device and a method for its use in eye surgery. The specified device can be used using the method based on the principle of "push and pull". In the manufacture of a surgical device in accordance with the present invention from disposable materials, it can also be used on the basis of the "use and throw away" principle. The specified device allows to obtain controlled and predictable results, being at the same time reliable, time-saving and an exceptionally convenient tool when used in eye surgery. The present invention provides procedures, characterized by the highest level of risk, in the surgery of small incisions for the removal of cataracts.

The tool and the method of its use ensure the penetration of the scalpel blade into the sclera only at a certain depth, specifying the length of the tool movement after its penetration into the sclera, specifying the shape of the incision, its depth and achieving an even cut without torn edges or tearing the cut edges of the tissue.

Despite the fact that eye surgeons can make an incision anywhere on the sclera, the most standard site for performing an incision is the temporal, supratemporal and 12 o'clock positions, illustrated in FIG. 4 relative to the eyeball.

In one embodiment of the present invention, the goal is achieved through the use of a scleral template equipped with a handle, complete with a special blade attached to a special handle. The specified special blade can also be replaced by any other cutting device, including without limitation laser beams.

The specified pattern, which can be placed on the eyeball, is provided with notches of various shapes, from which the surgeon can choose the required cutout. A knife was created that provides penetration to the required depth and smooth movement when a corresponding force applied by the surgeon's hand is applied to it, through the selected cut to perform the required scleral incision, characterized by the exact section (19), the correct shape (20), length (21), edges (22), depth (23) and size (24) with respect to the size and type of the intraocular lens (25), as shown in FIG. five.

It should be noted in this context that, without being tied to any particular idea regarding the above, the description below includes the possible role / function performed by the described element (s) of the device (s) in accordance with the present invention in eye surgery. The materials and dimensions given in the description should be considered as illustrative and not as limiting the scope of the present invention. The description of the inventor's perceptions regarding the function of the various elements of the claimed tools should be interpreted solely as the inventor's perception of their function and the perception accuracy, or the inventor's perception of the idea on which this function is based, and this function should not be construed as binding or limiting the scope of the present invention.

One exemplary embodiment of the present invention incorporated in an illustrative scleral pattern is illustrated in FIG. 6: P is a front view, T is a top view and L is a side view.

The scleral incision template, which is referred to in this description of the invention as a scleral template or template, is made of a metal plate with a thickness of preferably about 1 mm (1000 μm). The scleral incision template has various elements characterized by unique functions. In the illustrative template for a scleral incision, the two most widely used incision forms are presented as cuts or cuts on the flat surface of the template. The first (26) rectilinear form is intended for carrying out phacoemulsification and (or) for implantation of flexible intraocular lenses, and this notch is located between two elongated protrusions (27), the second notch (29) is intended to make an arcuate incision. The second incision is a longer incision and is intended for the installation of larger and stiff intraocular

- 4 029263

lenses. The scleral pattern is provided with two parallel telescopic protruding parts extending from the flat end of the pattern, called "antennas" (27). The antennas touch at two parallel points of the intercostal line on the eyelids above the limb of the cornea - the intercostal line on the eyelids is the junction of the cornea and the sclera - in order to provide an accurate section for making an incision. The arrow on the flat surface of the template is called the "tip" (26). It allows the blade to be combined with any meridian or corneal radius, called 'K' in keratometry, or simply the upper pole, or to provide a temporal, supratemporal position and a 12-hour position above the sclera, as shown in FIG. four.

At the far end of the scleral pattern, near the base of the handle (32), there are two backward protrusions, called "tails" (31). These "tails" provide stabilization of the instrument above the eyeball. In the absence of these tails, the base of the handle can act as an axis of rotation, leading to lifting of the tool from the surface of the eyeball, vibrations at the top and then to an unsatisfactory fit of the template to the surface of the eyeball, resulting in a gap between the bottom surface of the template and the eyeball. This, ultimately, can lead to making a notch of inconsiderable depth, jagged edges or tightening the fabric along the entire length of the notch. The above factors can be eliminated by creating a strong contact between the "tails" of the template and the eyeball, thereby eliminating the torque of the handle. The chance of accidental displacement, sliding or tilting of the pattern on the eyeball is prevented by two rows of "teeth" (30). When immersing these teeth in the sclera due to the fixation of the pattern for scleral incision in the process of incision ensures the immobility of the eyeball.

Attached to the template is a small and durable handle. A handle made with several bends (Fig. 6-b) provides an unimpeded surgical view through an operating microscope during the scleral incision. The shape of the template is toroidal or ellipsoidal, thereby ensuring close contact with the sclera, which is sufficient to ensure the immobilization of the eyeball (Fig. 6-T, top view). The manipulation of the template is achieved by attaching the handle (32) to the blade holder (38) available on the market.

Another exemplary embodiment of the present invention, which is a special blade and handle, includes the elements illustrated in FIG. 7

The unique shape of the blade allows in practice to effectively perform the perfect scleral incision. The blade consists of five parts, and it is made stepwise in three steps of reduction in thickness. These parts include: a) blade tip (37), b) body (36), c) connecting element (35), b) stop (34) and e) handle (33) for fixing in the blade holder.

a) The tip of the blade, or the semicircular cutting edge of the blade (37): the tip of the blade when it is inserted through the selected shape of the scleral incision template pierces the sclera in the process of making the incision, and as it moves along the cut from one end to the other, the semicircular blade tip cuts through clean, smooth, without breaks, the initial scleral incision;

b) the blade body (36) has a tetrahedral or oval shape with rounded smooth corners that allow the body to move without friction inside the notch, in addition, due to this, self-rotation is prevented when it is installed in the cut-out of the template. When an appropriate force is applied and moving in the same direction as the making of the cut is envisaged, the body slides smoothly and smoothly inside the cutout. The cut-out shape of the scleral incision pattern in which the blade moves is the shape of the notch performed in the sclera;

c) connecting element (35): the connecting element resting on the surface of the template acts as an abutment preventing deep penetration of the cutting edge and as a result providing an exact cut depth along the entire length of the scleral incision;

b) limiter (34): when the blade assembly is fixed in the blade holder, the limiter prevents further movement forward and ensures stability and stability when making an incision;

e) blade handle (33): the handle is an elongated element of the blade assembly fixed in the blade holder (39).

The blade holder is similar to the scleral template holder, and the holder is designed to fix the blade handle in the clamping jaws of the blade holder by screwing in or unscrewing the second clamping jaw of the blade holder. These blade holders are available on the market.

Although any material allowed for the manufacture of tools can be used, it is preferable to use disposable material for making the template and the blade in order to ensure their sterility, razor sharpness of the blade, high tooth sharpness and low tool cost, however, used any other materials that allow reuse of the template and the blade of the knife or during single or mass surgical interventions as in any mobile ophthalmosurgeon cal clinic. In addition, although the present invention is illustrated by the example of a multi-component handle that holds a scleral template or blade, it is possible to make a template for scleral incision with a hand and (or) a blade with a handle in accordance with the present invention as a solid element in such a way so that a template is created through which the blade can be entered and moved by - 5 029263

Thus, in order to ensure that the incision is made in the form of a template without torn edges on the eyeball, as well as on the width and depth of the incision required for performing eye surgery. Such an operation may include cataract surgery. Thus, the present invention allows to eliminate the factor of the degree of professionalism of each individual surgeon, as well as to increase predictability and control during the operation to remove cataracts by providing an almost perfect scleral incision. Although the present invention is illustrated and standardized for the manual use of the scleral pattern and blade in accordance with the present invention, the invention has the advantage that it can be used to mechanically manipulate the scleral pattern and blade, and this method is also included in of the present invention.

Despite the fact that the two most widely used scleral incisions are included in the illustrated template, any other forms are also provided for in the template. In addition, the shape of the tip of the blade used is semi-circular, as in the illustrated example provided in this description, but the tip can be given any other shape.

The preferred dimensions and specifications of the various elements of the scleral incision template are shown below.

A preferred experimental embodiment of the scleral incision pattern is made of sheet metal. The thickness of the sheet metal is approximately 1.00 mm (1000 μm), the dimensions of the basic rectangular structure are 10x20 mm, and the structure is equipped with 3 pairs of main protruding elements, for example, "antennas", teeth and "tails". The thickness of the template in the preferred embodiment is equal to the thickness of the blade body (36), which is preferably about 1 mm (1000 μm) in both tools.

The arrow (28) on the flat surface of the template, plotted as a mark in the middle between two antennas, provides for the alignment of any steeper corneal axis or 'K' with the center of the scleral template. Due to this, the risk of postoperative astigmatism is reduced to a minimum. A pair of parallel telescopic elongated elements protruding from the left and right corners of the flat surface of the template in the outward direction are “antennas” (27), the length of which is approximately 1.00 mm. They provide placement of the notch and the site of the incision at a distance and parallel to the limb of the cornea.

The first cut-out (26), illustrated in FIG. 6, designed for phacoemulsification with flexible intraocular lenses, either on the scleral or on the corneal region. The length of the cut is approximately 3.5 mm and is effective for applying a phacoemulsification probe or any other tool using other manual methods for crushing the nucleus of the cataract-damaged lens into small fragments and then for implanting a flexible intraocular lens into the inside of the eyeball. The second cut-out (29) is designed to make arcuate cuts. An incision in the shape of an inverted smile, or an arcuate incision, is most widely used by eye surgeons to perform an initial scleral incision in the field of small incision surgery for cataract removal. This incision is a small semicircular curve, the angle of which between the two ends of the notch is 120-130 °. The length of the incision is approximately 6 mm, which is acceptable for the implantation of a hard intraocular lens.

Although only two cuts are illustrated, it is also possible to make cuts of a different shape using a template, for example a Y-shaped incision.

To the left and right of the rear end of the flat portion of the template are “tails” (31), which are elongated, rearwardly projecting elements with a length of approximately 1 mm. "Tails" allow you to create a reliable contact between the template and the eyeball. The template is provided with two rows of teeth (30), having a length of approximately 200 μm (0.2 mm), turned downward in the direction of the sclera to ensure firm fixation of the template on the eyeball. Between the two "tails" there is a handle (32) extending from the flat portion of the pattern and extending backward and upward and forming an angle of approximately 90 ° with respect to the flat portion of the pattern. This 8- or Ζ-shaped handle with several bends (Fig. 6-b) prevents the occurrence of any accidental obstacle that interferes with the view through the microscope and is created by the fingers of the surgeon working at the surgical site. The front and back bend, taking into account the medial and lateral bend of the eyeball, which is ellipsoidal or toroidal in shape, is performed on the template in such a way as to ensure tight contact between the template and the eyeball.

The blade has five parts that perform unique functions.

The tip of the blade (37) is a semicircular cutting edge. The tip length is approximately 450 microns (0.45 mm).

The actually specified (required) notch depth is determined by the length of the semicircular cutting blade from the tip to the base of the blade.

The tip of the blade is connected to the housing (36), i.e. the middle part that is installed in each cut- 6 029263

This is a template for making an incision and having a tetrahedral or oval shape (Fig. 7-K) across the width in cross section, as a result of which the body moves smoothly inside the cutout and, moreover, any self-rotation around its axis is prevented. The housing guides the cutting blade inside the template vertically and parallel to the thickness of the sclera along the entire length of the incision, while ensuring the reproduction of the notch shape in the sclera. The connecting element (35) acts as a stop defining a predetermined blade penetration depth and as a stopper preventing deep blade penetration into the sclera. This element also distributes the excessive penetration force and weight of the surgeon's hand over the entire area of the template and the eyeball. The connecting element prevents any accidental piercing of the eyeball, as well as insufficiently deep or too deep dissection of the sclera. The handle (33) is an element that connects the blade with the blade holder by placing it in the corresponding slot of the blade holder (Fig. 8), and the stop (34) is an element that prevents the blade from being inserted too deeply into the blade holder.

The following is a description of an example of the use of a scleral template and blade in accordance with the present invention in the field of small incision surgery for cataract removal. This description is illustrative in nature and is intended to illustrate the general principles of the methods by which an ophthalmic operation is performed using a scleral template and blade in accordance with the present invention, and this description does not limit the scope of the present invention. Various changes and additions that are obvious to those skilled in the art and who are within the scope of the present invention are also meant to be included in the description of the present invention. For example, after making a scleral incision using a scleral pattern and a blade, the further steps of the operation may differ from the steps given in this description. Similarly, the dimensions and materials used in this specification are illustrative only, and any acceptable changes in dimensions and materials are included in the present specification, taking into account the requirements of eye surgery.

The following is an example of manually performing an operating procedure in the field of surgery for small incisions for cataract removal. Peribulbar anesthesia is preferred. An injection of a mixture of a solution of 2% xylocaine and 0.50% bupiracainum in an amount of 5-7 ml is done in the lower temporal portion of the orbit. For reliable fixation of the surgical field under a microscope and for immobilization of the eyeball, the upper rectus muscle is attached. In order to examine the site of the scleral incision, a flap of the conjunctiva and the tenon capsule is cut with the base to the arch near the limbus, and, if necessary, superficial and minimal cauterization of the probing blood vessels or large superficial vessels is performed using the \ Us1-Hc14 apparatus. The scleral incision depends on a number of factors. For an illustrative example of eye surgery, rigid lenses with a diameter of 5.5 or 6 mm were considered for the implantation of intraocular lenses. For this purpose, a second notch (29) was chosen to make a scleral incision with a length of 6 mm. The length of the blade used was equal to the required notch depth in the scleral groove, for example, 450 microns (0.450 mm).

Conjunctiva dissect. The dissected conjunctiva and the tenon capsule were delayed by inserting the “tails” of the pattern between them, and then the “antennas” were placed parallel to the limbus with the intercostal line touching the eyelids. The top of the mark on the template was combined with a steeper 'K' axis or 12 hours over the scleral incision area, while checking that the notch distance to make a notch from the limbus was approximately 2 mm.

By applying a constant force to the base of the handle of the template, the teeth were smoothly immersed in the sclera, the template was fixed on the eyeball and the eyeball was securely immobilized, thereby preparing to make an incision. Then the scalpel blade was inserted into the selected cutout of the pattern to make the incision. The blade was held vertically with respect to the template, while the edge of the tip of the semi-circular blade was placed parallel to the notch and then deeply inserted into the notch downwards above the sclera. The blade punctured the sclera until further insertion of the blade was reliably limited to the connecting element (35).

When a constant force was applied to the blade holder, the holder slowly and continuously moved along the length of the notch, repeating its shape until it reached the opposite end of the notch, resulting in a notch. The knife was slowly removed from the cut-out pattern. Conducted a thorough check of the depth of the cut. This procedure can be repeated if unsatisfactory results are detected before the template is removed. Next, a scleral corneal tunnel was formed according to the description below.

To create a tunnel used 2.8 mm curved sickle knife with a blade with a bevel up. Cut to approximately 2 mm of the transparent cornea. Then, by tilting the blade, the scleral side pockets formed into the left and right sides. In the right or left eye, with the help of a sharply bent at an angle of 15 °, the blades formed, respectively, in the transparent cornea, the first 1 mm puncture cut for 3 or 9 hours. A second split incision was formed at the 5 or 7 o'clock position for the anterior chamber lock.

- 7 029263

The anterior chamber fixator was a hollow steel tube with an outer diameter of 0.9 mm and an inner diameter of 0.65 mm, which was inserted bevel up and which was further turned 180 ° so that the bevel was directed toward the iris. The anterior chamber retainer tube was connected to a vessel containing balanced salt solution and suspended at a height of 70 cm above the level of the patient's eyes.

A continuous circular capsulorhexis was formed with a bent needle of gauge 26. At a position of 3.2 mm in the downward direction, a curved blade was used to make an internal corneal incision to provide access to the anterior chamber to a depth of approximately 2 mm in the transparent cornea.

A hydroprocessing procedure was used to ensure rotation of the cataract core in order to extract it from the capsular bag into the anterior chamber.

A shallow anterior chamber with a loose lens substance indicates that the rotation, tilting, and displacement of the nucleus into the anterior chamber can be continued. Careful conduct of hydroprocessing allowed reducing the size of the core, which, in turn, made it possible to extract it from a small incision. Next, the free core in the anterior chamber was removed from the anterior chamber by applying a hydraulic pressure created by the anterior chamber lock. In cases where the extension of the nucleus did not occur, the nucleus was pulled into the tunnel with corneal scleral pockets using a thin loop to remove the nucleus. The rest of the surface layer was washed by irrigation and aspiration using a §1 cannula.

The anterior chamber fixer was removed, the capsular bag and the anterior chamber were filled with a viscoelastic solution. The lower haptic element and the optical element of the intraocular lens were tucked into the capsular bag, and the rear haptic element was rotated with the help of a hook in Section I8keu. Most of the corneal-scleral pocket tunnels were self-sealing. The corresponding air bubble and fluid pressure in the anterior chamber blocked the valvular opening. In those cases, if necessary, a suture was applied; FIG. 8. The conjunctiva and Tenon's capsule were returned to their original position at the limbus, then an antibiotic was instilled into the eye in the solution and a compression bandage was applied to wear during the day.

Claims (7)

CLAIM 1. A set of surgical instruments for making a scleral incision in a small incision surgery for cataract removal, including: a) a template made of sheet material as part of a toroidal surface to ensure close contact with the sclera sufficient to achieve the immobilization of the eyeball, and includes at least one notch made in it (26, 29), a template holder (32) and two backward protrusions of the “tails” (31) on the left and right on the posterior end of the template, mounted above the eyeball and providing stabilization and also performing the function of a retractor; and b) a surgical scalpel blade, including a body (36), having a shape and thickness, ensuring that it is placed precisely inside the cutout (26, 29) of the template so that when an appropriate force is applied to it and moving in the same direction as provided making the cut, it was smoothly moving inside the cutout with a snug fit, because its shape prevents self-rotation in the cutout of the template, while the middle part of the blade has a tetrahedral or oval shape and includes, at least e, the following elements: (a) the tip of the blade (37), (b) the connecting element (35), (c) the stopper (34) and (b) the blade holder (33). 2. Template for a kit according to claim 1, made from a sheet material in the form of a shallow part of the surface of a toroidal shape to ensure tight contact with the sclera sufficient to achieve the immobilization of the eyeball, and including at least one cutout made in it (26, 29) , a template holder (32) and two backward protrusion "tails" (31) on the left and right at the back end of the template, mounted above the eyeball and providing stabilization and also performing the function of a retractor. 3. Template according to claim 2, characterized in that (a) the notch is located on a gentle surface of the template, and the template further includes: (b) an elongated element (27) and / or a label (28) to ensure that the template is aligned with the eyeball and (c) the holder is made of a sheet of metal or of a disposable material, including plastic. 4. The template according to claim 3, further comprising: (a) neckline of rectilinear shape (26), or arcuate shape (29), or Y-shaped chevron shape, (b) elongated elements in the form of two “antennas” (27), (c) a label made in the form of a triangle or arrow (28), (b) "teeth" (30), made on the bottom surface, which is designed to be placed on - 8 029263 the surface of the eyeball, while the teeth can be preferably placed in two rows and arranged in such a way as to ensure their penetration into the sclera when installing the lower surface of the template to achieve contact with the eyeball, (e) the template holder (32) is made with several bends, (ί) The pattern handle (38) is attached to the pattern holder (32). 5. The blade of the surgical scalpel for the kit according to claim 1, including the body (36), having a shape and thickness, ensuring its exact placement inside the cut-out (26, 29) of the template so that when an appropriate force is applied to it and when moving in the direction in which the notch is to be made, it was smoothly moved inside the notch with a tight fit, because its shape prevents self-rotation in the cut-out of the template, while the middle part of the blade has a tetrahedral or oval shape and includes t, at least the following elements: (a) the tip of the blade (37), (b) the connecting element (35), (c) the stop (34) and () the holder (33). 6. The blade according to claim 5, where the blade has dimensions corresponding to the size of the cut in the template for inserting the blade through the cut to penetrate the tip of the blade of a surgical scalpel at one end of the cut by piercing the sclera only to the depth required for the operation and moving the blade along the length of the cut without rotation around its axis to make an incision necessary for the further operation. 7. The blade according to claim 6, further comprising at least the following elements: (a) the tip (37), having the form of a semicircular cutting edge of the blade, the height of which is equal to the depth to which an incision should be made, (b) a middle part or body (36), having a tetrahedral or oval shape and thickness, ensuring its exact placement within the cutout of the template, (c) a connecting element having a diameter greater than the width of the notch or slot in the pattern to prevent deep penetration into the eyeball or deep piercing thereof, (ά) a stopper designed to limit further advancement of the blade forward when inserted into the holder, forming the surface against which the end of the blade holder rests, and ensuring stable operation of the blade while preventing self-rotation in the slot or cutout of the blade and the slightest unintentional movement of the blade when it is used to cut, (e) a blade handle (39) adapted to be attached to the blade holder (33). - 9 029263