WO2020002719A1

WO2020002719A1 - Pupil dilator for ophthalmological operations

Info

Publication number: WO2020002719A1
Application number: PCT/ES2018/070459
Authority: WO
Inventors: Antonio PALOMINO MUÑOZ; Teodoro Javier PALOMINO MUÑOZ
Original assignee: Palomino Munoz Antonio; Palomino Munoz Teodoro Javier
Priority date: 2018-06-27
Filing date: 2018-06-27
Publication date: 2020-01-02

Abstract

The invention relates to a pupil dilator (1) for ophthalmological operations, which comprises at least two separators (2) for the edges (30) of the pupil (3), each separator (2) comprising: a base (4) for supporting the edge (30) of the pupil (3), and flanges (5) extending from the base (4) to accommodate therebetween the edge (30) of the pupil (3) when the pupil is supported on the base (4); and handling elements with a surgical instrument; the dilator having a curved or angular shape to generate a space (6) that leaves the operating area clear once the pupil (3) is dilated.

Description

PUPIL DILATOR FOR OPHTHALMOLOGICAL INTERVENTIONS

DESCRIPTION

OBJECT OF THE INVENTION

The present invention relates to a pupillary dilator for ophthalmologic interventions.

BACKGROUND OF THE INVENTION

For cataract surgery and other ophthalmologic interventions, extensive and sustained pupillary dilation is necessary. Under normal conditions it is achieved with mydriatic drops, but certain patients do not respond well to medication to dilate the pupil, such as patients undergoing treatment of prosthetic hypertrophy or with antihypertensives, which produce a flabby iris and little dilation.

Given this situation, a mechanical dilation with dilators or iris retractors is required. There are several types of them on the market: iris retractors from the outside of the eye, pupil rings of all kinds and all material, some incomplete rings that enter the eye by turning, others that by an applicator enter the eye folded and once inside they are deployed and manipulated. However, all of them require greater and additional ocular manipulation than the surgery itself, which requires additional incisions, which increases the risks of the operation and the recovery time.

DESCRIPTION OF THE INVENTION

The pupillary dilator for ophthalmic interventions of the invention comprises two independent separators for the edges of the pupil, each separator comprising:

-a bottom for support of the edge of the pupil, and wings adjacent to the bottom to accommodate between them the edge of the pupil when it is supported on the bottom,

-a handling elements with surgical instruments, and

- having a curved or angular shape to generate a space that leaves the intervention area clear, once the pupil is dilated. The mode of use of the dilator of the invention would be as follows:

- a first separator is inserted through the main incision or by the accessory incision of cataract surgery by means of an injector or with tweezers,

-the edge of the iris is introduced between the wings of each separator, which are directed radially outwards, so that it is supported on them and at the bottom of the separator,

-the separator is operated to open the pupil, thanks to the support on its wings and in its bottom, -a second separator is introduced (two separators will normally be required at most), and placed diametrically facing the first separator, introduced at the edge of the pupil and the same is manipulated until the desired pupil opening is achieved, in a square or polygonal shape depending on the configuration of the separators and their bottom.

In this way the following advantages are obtained:

-It can be easily inserted into the eye by the same incision corresponding to the intervention by an injector, avoiding additional incisions.

-Its use implies less intraocular manipulation.

-It has a simple and easy to handle configuration, in addition to being economical for a disposable sanitary waste after the intervention.

BRIEF DESCRIPTION OF THE DRAWINGS

Figures 1 and 2 show separate embodiments of the separator of a first variant of the pupillary dilator of the invention, wherein said separator is curved, Figure 1 corresponding to an embodiment with two end eyelets and Figure 2 to another embodiment which also has an eyelet. intermediate

Figures 3 and 4 show separate embodiments of the separator of a second variant of the pupillary dilator of the invention, wherein said separator is angular, Figure 3 corresponding to an embodiment with two end eyelets and Figure 4 to another embodiment which also has an eyelet. intermediate.

Figure 5 shows the use of the dilator of the invention in its angular variant with two extreme eyelets during an intervention, dilating the pupil. DESCRIPTION OF A PRACTICAL EMBODIMENT OF THE INVENTION

The pupillary dilator (1) for ophthalmological interventions of the invention (see fig. 5) comprises two independent separators (2) for the edges (30) of the pupil (3), each separator comprising (2) (see figs. 1 to 4) :

-a bottom (4) for supporting the edge (30) of the pupil (3), and wings (5) adjacent to the bottom (4) to accommodate between them the edge (30) of the pupil (3) when it is resting on the bottom (4), as seen in figure 5,

-a handling elements with surgical instruments, and

- having a curved or angular shape to generate a space (6) that leaves the intervention zone (100) clear, once the pupil (3) has been dilated.

The bottom (4) of the separator (2) most preferably comprises (see figs 1 to 4) semi-rigid crossbars (40), while the wings (5) comprise two semi-rigid strips (50), which are joined by the crossbars ( 40), being semi-rigid to flex during the introduction and positioning of the separator and at the same time having the necessary rigidity to hold the pupil (3). In addition, when the bottom (4) is configured by crossbars (40), an opening of the pupil (3) is achieved in a square or polygonal shape, whose vertices coincide with the pupil support areas (3) in the crossbars ( 40). It is enough that each separator (2) comprises two crossbars (40), generating a square opening, which reduces the manufacturing material and the amount of foreign matter that is introduced into the eye. For example, these two separators (2) can be placed:

-one of them separating iris in inferior temporal quadrant (inferior external) and superior temporal quadrant (superior external)

-the other one, even if it is inserted into the eye by the same incision, would separate the upper nasal quadrant and lower nasal quadrant.

These two separators (2) could also be placed horizontally entering the eye through the same surgical incision; the first of them would horizontally separate the inferior temporal and nasal quadrant, and the second would separate the inferior temporal and nasal quadrants. No matter if the result is a perfect square or rectangle.

In a first variant shown in Figures 1 and 2, the strips (50) have a curved shape, of curvature perpendicular to the crossings (40) to project radially on the part anterior and posterior pupil (3) following the natural curved shape of it.

In a second variant shown in Figures 3 and 4 the strips (50) are angular in shape, with branches (51) perpendicular to the crossbars (40), the vertices (55) of the strips (50) being projected radially on the part anterior and posterior of the pupil (3) as seen in Figure 5. In this case the vertices (55) form a more prone area for the flexion of the separator (2) which can increase the precision at the time of insertion and placement in the pupil (3).

It is preferred that the separators have a monobloc configuration which prevents them from being accidentally disassembled or awake during the intervention within the eye, and also having more robustness. They can be, for example, materialized in PMMA or silicone, being sanitary fit materials, suitable for their semi-rigid and competitively priced properties.

The strips (50) have a length between 6 and 9 millimeters to achieve the degree of semi-stiffness sought and are separated from each other a distance between 0.2 and 0.5 millimeters to adapt to the size of the human pupil. It is also preferred that they have a circular section, avoiding the existence of edges that can be harmful. In the proposed materials, the strips (50) can have a diameter between 0.1 and 0.5 millimeters to be manageable, achieve the degree of semi-stiffness sought and not be too bulky.

As for the operating elements with surgical instruments, they preferably comprise eyelets (8) for handling, for example, with a Sinskey hook. Said eyelets (8) may have a lateral opening (80) as shown in the figures, or they may not have it; and are ideally arranged at the ends of the strips (50), and / or in the central zone of the strips (50) which will be the most suitable areas for placement and centering. Specifically, in the case that the strips (50) are angular, the eyelets (8) may be arranged at the vertices (55) thereof, which together with the greater propensity to flex at these points increases the accuracy of handling.

Sufficiently described the nature of the invention, as well as the manner in which it is carried out in practice, it should be noted that the provisions indicated above and represented in the attached drawings are subject to detailed modifications in as long as they do not alter the fundamental principle.

Claims

REI VINDICATIONS

1.-Pupil dilator (1) for ophthalmological interventions, characterized in that it comprises two independent separators (2) for the edges (30) of the pupil (3), each separator (2) comprising:

-a bottom (4) for supporting the edge (30) of the pupil (3), and wings (5) adjacent to the bottom (4) to accommodate between them the edge (30) of the pupil (3) when it is supported on the bottom (4),

-a handling elements with surgical instruments, and

- having a curved or angular shape to generate a space (6) that leaves the intervention area clear, once the pupil (3) is dilated.

2. Pupil dilator (1) for ophthalmological interventions according to claim 1 characterized in that the bottom (4) of the separator (2) comprises semi-rigid crossbars (40), while the wings (5) comprise two semi-rigid strips (50), which they are joined by the crossbars (40).

3. Pupil dilator (1) for ophthalmological interventions according to claim 2 characterized in that the separator (2) comprises two crossbars (40).

4. Pupil dilator (1) for ophthalmological interventions according to any of claims 2 or 3 characterized in that the strips (50) have a curved shape, with a curvature perpendicular to the crossbars (40).

5. Pupil dilator (1) for ophthalmological interventions according to any of claims 2 or 3 characterized in that the strips (50) are angular in shape, with branches (51) perpendicular to the crossbars (40).

6. Pupil dilator (1) for ophthalmological interventions according to any of claims 2 to 5 characterized in that the separators have monobloc configuration.

7. Pupil dilator (1) for ophthalmologic interventions according to any of claims 2 to 6 characterized in that the separators are materialized in PMMA or Silicone.

8. Pupil dilator (1) for ophthalmological interventions according to any of claims 2 to 7, characterized in that the strips (50) have a length between 6 and 9 millimeters and are separated from each other a distance between 0.2 and 0 , 5 mm.

9. Pupil dilator (1) for ophthalmological interventions according to any of claims 2 to 8, characterized in that the strips (50) have a circular section.

10. Pupil dilator (1) for ophthalmologic interventions according to any of claims 2 to 9, characterized in that the strips (50) have a diameter between 0.1 and 0.5 millimeters.

1 1-Pupillary dilator (1) for ophthalmological interventions according to any of the preceding claims characterized in that the operating elements with surgical instruments comprise eyelets (8).

12 -Dilator (1) pupil for ophthalmological interventions according to claim 1 characterized in that the eyelets (8) have a lateral opening (80).

13 -Dilator (1) pupil for ophthalmological interventions according to claim 1 or 12 characterized in that the eyelets (8) are arranged in one or more sites selected from:

-the ends of the strips (50), and

-the central zone of the strips (50).

14 -Dilator (1) pupil for ophthalmological interventions according to claim 13 characterized in that the eyelets (8) are arranged in the vertices (55) of the strips

(50) angular.