RU122289U1 - 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 curvilinear closed figure formed by four arcs interconnected by four radial bends with a radius of 0.7-1.5 mm facing inside the device, two opposite arcs are made oval, and the other two have an angular shape with a rounded and asymmetrically located top, and the tops of four radial bends visually form a square.

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 a 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-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 is made of a flexible, elastic material, having the form of an open ring with a groove on the outer edge, in which the pupil edge of the iris is fixed, while the dimensions of the groove correspond to the thickness of the pupil edge of the iris (patent RU 2103966 C1, op. 10.02.1998 )

A disadvantage of the known device is the impossibility of introducing the device through the injector, as well as limited functionality, since it cannot be used to stabilize the capsule bag.

A device for dilating the pupil, made in the form of a curved figure with hinges of the first kind, located at the same distance from each other, characterized in that it is made in the form of an open ring with eyelets at both ends and contains at least three hinges of the first kind, with this step 1 mm from each loop made one hinge of the first kind (patent RU 2295941 C1, op. 27.03.2007)

The disadvantages of the known device are its limited functionality and the inability to introduce the device through the injector.

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).

A disadvantage of the known device is the impossibility of its injection through micro-incisions (less than 2.5 mm).

A device for expanding the pupil, made of an elastic elastic polymer material, having the form of a closed ring with a groove on its outer side, the inner side is rounded, and the diameter (D) of the groove base corresponds to the specified magnitude of the pupil expansion (patent RU 25998 U1, op. 11/10/2002). For its implantation, a device is used that includes springy branches with working elements at the ends.

The disadvantages of the known device are limited functionality, as well as the duration of the procedure for its implantation using a specially designed device in the anterior chamber of the eye, 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 flexible polymer material, in the form of a curved closed figure (1) formed by four arcs (2), interconnected by four radial bends (3) with a radius of 0.7- 1.5 mm facing the device, the two opposite arcs made oval (4), and the other two have an angular shape with a rounded and asymmetrically located vertex (5), and the vertices of the four bend s visually form a square.

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 curved closed figure formed by four arcs connected by four radial bends with a radius of 0.7-1.5 mm, facing the inside of the device, and two opposite arcs are oval, and the other two have an angular shape with a rounded and asymmetrically located vertex, which allows to expand the functionality of the device, since ku, it can be used not only for the expansion of the pupil, but also for fixation of the capsular bag that allows you to eliminate the possibility of injury to the iris and prevent intraoperative complications and shorten the duration of implantation of the device.

The implementation of the device in the form of a curved closed figure, consisting of four angular arcs connected by four radial bends, 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.

Radial bends are designed to fix the pupil edge of the iris. If necessary, fix the capsular bag of the arc, having an oval shape, lead over the edges of the anterior capsulorhexis and placed under the front capsule of the lens.

The implementation of the device from an elastic elastic polymeric material allows you to change the geometric shape of the structure, due to which opposite arcs, having an angular shape with a rounded and asymmetric vertex, can be paired to the iris, and arcs having an oval shape to the iris, respectively, and also eliminates the probability 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 offset of the bends relative to the middle of each side causes them to be sucked in alternately by the action of the spring mechanism when filling the injector, creating a compact design that allows implantation through a 1.8-2.2 mm micro incision.

Figure 1 presents 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.

The implantation of the proposed device is as follows.

Perform limbal or corneal tunnel with a width of 1.8-2.5 mm. Corneal paracentesis is performed at 2 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, two oval arcs (4) are brought under the iris. Radial bends (3) fix the pupil edge and dilate the pupil. If it is necessary to fix the capsule bag after performing the anterior capsulorexis, the oval arches (4) are inserted under the anterior lens capsule, radial bends (3), thus, both the pupil edge of the iris and the edge of the anterior capsulorhexis are fixed.

To remove the device from the eye, the oval arcs (4) of the device are led out into 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 P., was admitted to the Novosibirsk branch of MNTK “Eye Microsurgery” with a diagnosis of complicated incomplete cataract OS, pseudoexfoliation syndrome OS. 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, oval arcs (4) are brought under the iris, radial bends (3) with a radius of 0.7 mm fix the pupil edge. The pupil expands and takes a square shape. After the anterior capsulorexis is performed, the oval arcs (4) are inserted beyond 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 oval arches (4) of the device are led 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 an elastic polymer material in the form of a closed figure, characterized in that it is made in the form of a curved closed figure formed by four arcs connected by four radial bends with a radius of 0.7-1.5 mm facing the device, and two opposite arcs are oval, and the other two have an angular shape with a rounded and asymmetrically located vertex, and the vertices of the four radial bends are visual but form a square.