RU122879U1 - DEVICE FOR EXTENSION OF THE PUPPET AND FIXATION OF THE CAPSULE BAG - Google Patents

Abstract

A device for expanding the pupil and fixing the capsule bag, made of an elastic polymer material in the form of a closed figure, characterized in that it is made in the form of a hexagonal closed figure formed by six alternating convex and concave arcs, and two opposite arcs have a different configuration, and in the middle concave arcs are made of loops with a radius of 0.7-1.7 mm.

Description

The utility model relates to medicine, and more specifically to ophthalmic surgery, and can be used in cataract extraction in patients with pseudoexfoliation syndrome.

Modern requirements for phacoemulsification of cataracts solve the issues of gentle modes of exposure to ultrasound, minimizing surgical access, reducing intraoperative trauma, reducing the time of surgery. In cases with complicated cataracts, one of the factors that increase the time and invasiveness of the operation is a narrow or rigid pupil. In the presence of concomitant ocular pathology, the percentage of narrow pupils is 3.1% -10.8%, in elderly patients with pseudoexfoliation syndrome it can reach 40.2% (Bakutkin V.V. Study of the functional reserve of the pupil as applied to cataract microsurgery // Modern technologies of cataract surgery - 2004: Sat. scientific article on the materials of the V International scientific and practical conference. - M., 2004. - P.52-53).

There are various ways to solve this problem. The most traumatic are meridional iridotomy or sectoral iridectomy followed by iridoplasty (Burrato L. Cataract surgery. Transition from extracapsular cataract extraction to phacoemulsification / L.Burrato. - Fabiano Editor, 2000. - P.453). Of the more gentle methods - simple mechanical stretching of the pupil, the application of three to four polymer iris hooks through paracentesis or the use of various designs of closed devices for expanding the pupil (iris retractors) implanted in the pupil, etc. (Malyugin B.E. Comparative results of an experimental-clinical study of pupil rings and polymer retractors during phacoemulsification in the eyes with insufficient iris diaphragmatic function / B.E. Malyugin, M.V. Semikova, A.A. Verzin, etc. // Ophthalmosurgery . - 2003. - No. 3. - S.18-25).

A device for expanding the pupil (iris retractor) is made of an elastic material, having a curved shape, which is a sequence of seven identical-shaped arcs, inextricably linked with each other to form an open ring so that the vertices of all arcs are oriented from the center of this ring, while at the free ends of the extreme arcs of the sequence, tides are made with a rounding at the end so that the tides and even arcs of the sequence are located in one plane STI, and related to him the odd arc in the other, at an angle of 10 ° to the first (patent RU 58323 U1, op. 27.11.2006).

A disadvantage of the known device is the impossibility of introducing the device through the injector, as well as the need to perform a large number of manipulations during its installation.

A device for expanding the pupil (iris retractor) is made in the form of four pairwise symmetrical petals, while the petals can be made: all are rectangular in shape with rounded corners; one pair of rectangular-shaped petals with rounded corners, and the other pair is cone-shaped; one pair of petals is rectangular in shape with rounded corners, and the other pair is in a spherical shape, while the contour of the iris retractor in the section can have an oval, square and rectangular shape, and oligocarbonate methacrylate or polymethyl methacrylate can be used as an elastic material (patent RU 101917 U1, Op. 10.02.2011).

The disadvantages of the known device are limited functionality, the risk of traumatic damage to the pigment sheet of the iris with its petals, as well as the inability to use it for micro-incisions (less than 2.5 mm).

The closest analogue to the claimed device, the prototype, is a device for the expansion of the pupil made of polypropylene thread, in the form of four loops made in the form of hinges of the first kind, located at the same distance from each other and interconnected (patent RU 14506 U1, op 10.08.2000).

The disadvantages of the known device are the duration of the implantation and explantation procedures and the need to use a special device for these manipulations.

The objective of the proposed utility model is to develop a new, more advanced device design that provides uniform stretching of the pupil edge of the iris around the entire perimeter by a predetermined amount, as well as stable fixation of the capsule bag.

The technical result is to expand the functionality of the device, reducing the duration of implantation of the latter and eliminating the likelihood of injury to the iris.

The specified technical result is achieved by the proposed device for dilating the pupil and fixing the capsule bag made of elastic elastic polymer material in the form of a hexagonal closed figure (1) formed by six alternating convex (2) and concave arcs (3), and two opposite arcs have different configurations and in the middle of concave arcs, loops with a radius of 0.7-1.7 mm are made (4).

As the elastic flexible polymeric material, any available biocompatible material can be used, in particular polymethyl methacrylate, polyurethane methacrylate, polypropylene, oligocarbonate methacrylate.

The defining difference of the proposed device for expanding the pupil and fixing the capsule bag from the prototype is that the device is made in the form of a hexagonal closed figure formed by six alternating convex (2) and concave arcs (3) arcs, and two opposite arcs have different configurations, and on loops (4) with a radius of 0.7-1.7 mm are made in the middle of concave arcs, which allows you to expand the functionality of the device, since it can be used not only to expand the pupil, but also to fix capsule bag, which eliminates the risk of injury to the iris and prevent intraoperative complications, as well as reduce the duration of implantation of the device.

The implementation of the device in the form of a hexagonal closed shape formed by six alternating convex (2) and concave arcs (3) arcs, the two opposite arcs having a different configuration, ensures uniform stretching of the pupil edge of the iris around the entire perimeter by a predetermined amount, which eliminates the likelihood of a weak iris breaking .

The loops made on the middle of concave arches are intended for fixing the pupil edge of the iris. If necessary, fix the capsular bag loop loop over the edges of the anterior capsulorexis and placed under the front capsule of the lens.

The implementation of the device from an elastic elastic polymer material allows you to change the geometric shape of the structure, due to which the loops can wind up under the iris, and convex arches - on the iris, and also eliminates the risk of injury to the iris and other intraoperative complications, as it provides a good visualization of all manipulations.

The mobility of the device allows it to be implanted into the anterior chamber of the eye using an injector, the working hook of which hooks the expander at any of the angles. The alternation of convex and concave arcs of the same length and the position of the loops in the middle of the concave arcs allows us to create a compact design and implant the device through a micro-incision of 2.0-2.5 mm when filling the device into the injector under the action of the spring mechanism.

Figure 1 shows a General view of the device from above; figure 2 - view of the device in folded form (in the injector); figure 3 is a side view of the device (3D)

The implantation of the proposed device is as follows.

Perform limbal or corneal tunnel with a width of 2.0-2.5 mm. Corneal paracentesis is performed at 3 and 9 hours. The anterior chamber is filled with viscoelastic. Using the injector, a device is introduced through the tunnel into the front chamber and placed on the iris. With the help of a micro-hook and a manipulator, the loops (4) are brought under the iris. The pupil expands and takes on a hexagonal shape. If necessary, fix the capsule bag after the anterior capsulorhexis is performed, the loops (4) are placed under the front lens capsule, thus fixing both the pupil edge of the iris and the edge of the anterior capsulorexis.

To remove the device from the eye, the loops (4) of the device are brought out to the front chamber, then the working part of the injector is introduced through the tunnel into the front chamber, the device is hooked to the angle adjacent to the tunnel and the device is pulled into the injector, which is immediately taken out of the eye.

The utility model is illustrated by the following example of a specific application of the device.

Example

Patient B., Diagnosis: complicated incomplete cataract OS, pseudoexfoliation OS syndrome. On examination: severe dystrophy of the pigment border and iris stroma, pseudoexfoliation along the pupil edge and on the anterior lens capsule. Pupil 2.5 mm, rigid, diffuse opacification of all layers of the crystalline lens, pronounced iridonezon and phacodonesis.

After performing two paracentesis and corneal tunnel, the anterior chamber is filled with viscoelastic. Through the tunnel injector of the claimed device is introduced into the front chamber. With the help of a micro-hook and a manipulator, loops with a radius of 1.6 mm (4) are opened beyond the edges of the iris. The pupil expands and takes on a hexagonal shape. After the anterior capsulorexis is performed, the loops (4) are inserted over the edge of the capsulorexis and the capsular bag is fixed. Throughout all stages of the operation, the bag remains stable, and a wide pupil allows for good visual control. After completion of cataract phacoemulsification and IOL implantation, the loops (4) of the device are brought into the anterior chamber. Using the injector, the device is removed from the eye. Visual acuity after surgery 0.7.

Using the proposed device will provide a fixed mydriasis for an unlimited period of time, uniformly stretch the pupil edge of the iris around the entire perimeter by a predetermined amount, which reduces the risk of intra- and postoperative complications, ensure the preservation of the diaphragmatic function of the iris and reduce the duration of rehabilitation. If necessary, the device can be used to fix the capsule bag.

Claims (1)

A device for expanding the pupil and fixing the capsule bag made of elastic polymer material in the form of a closed figure, characterized in that it is made in the form of a hexagonal closed figure formed by six alternating convex and concave arcs, with two opposite arcs having different configurations, and in the middle concave arcs made loops with a radius of 0.7-1.7 mm