WO2016159910A1

WO2016159910A1 - Intraocular lens comprising anchor-winged haptic

Info

Publication number: WO2016159910A1
Application number: PCT/TR2016/050036
Authority: WO
Inventors: Remzi KARADAG
Original assignee: Karadag Remzi
Priority date: 2015-04-01
Filing date: 2016-02-11
Publication date: 2016-10-06

Abstract

The invention particularly relates to a three-piece foldable intraocular lens (IOL) which is developed for aphakic patients who lost capsule support due to a cataract surgery or another reason; is implanted into an eye through a small corneal incision, and prevents displacement of the lens (1) owing to an anchor mechanism (3) within its haptics (2).

Description

DESCRIPTION

INTRAOCULAR LENS COMPRISING ANCHOR-WINGED HAPTIC TECHNICAL FIELD

The invention relates to an intraocular lens which is used in cataract and refractive surgeries in the field of eye surgery. The invention particularly relates to a three-piece foldable intraocular lens (IOL) which is developed for aphakic patients who lost capsule support due to a cataract surgery or another reason; is implanted into an eye through a small corneal incision, and prevents displacement of the lens owing to an anchor mechanism within its haptics. STATE OF THE ART

Intraocular implantation into the anterior chamber:

In this method, a lens with a special design is placed into the anterior chamber by forming a large incision in the cornea. In addition, a peripheral iridectomy is performed to prevent intraocular pressure increase by pupillary block formation after the lens is placed. Incision region is closed by a suture because a large corneal incision is made. Serious complications in eyes to which this technique is applied can develop over time. Endothelial cell loss and accordingly, pseudophakic bullous keratopathy can be seen as the lens is localized close to the endothelium in the anterior chamber. Uveitis glaucoma hyphema syndrome develops, and thus, patient's sight can be diminished. A lens dislocation can be seen as haptics of the lenses enter iridectomy area. In the patients who have anterior chamber lens, sufficient pupil dilatation cannot be achieved in order to see the problems in the periphery of the posterior segment.

Lenses fixed to Iris:

In this technique posterior chamber lenses may be fixed from posterior by a suture or iris claw lenses may be used. When rigid lenses are used as the lenses fixed to the iris from posterior, a large incision is formed, and this incision region is closed by a suture after the operation. When three- piece foldable lenses are used, a large incision is unnecessary. When iris claw lenses are used, a large incision is needed to place the IOL, and this incision is closed by a suture after the operation. In both techniques complications such as pupil irregularity, iris atrophy and lens dislocation may be seen.

Posterior Chamber Lens Implantation Fixated from Ciliary Sulcus to Sclera with a Suture:

Posterior chamber lens implantation fixated from ciliary sulcus to sclera may be performed with or without a scleral flap formation. In this technique, conjunctiva is opened, a cautery is applied to the scleral surface, and a scleral flap is formed based on the applied method.

Recently, rigid lenses have been used until foldable intraocular lenses are used in sutured scleral-fixated intraocular lens surgery. This lens requires a large incision region for displacement of the lens. Although the problem of the incision region is overcome by foldable lenses being used in this surgery method, suture-associated complications constitute some of the main problems of this technique as a suture is used. In this technique lens dislocations may be seen due to suture-related erosion, suture breaks or suture lysis in the long-term. One of the biggest disadvantages is that the lens introduced is fixated by a 10/0 nylon suture and that keeping the IOL in place depends on the durability of the suture. In addition, posterior segment complications occur more than the other methods.

Sutureless scleral-fixated intraocular lens implantation:

This technique has been recently developed in order to eliminate the problems arising from sutured scleral-fixated intraocular lens implantation, particularly related to the suture. This technique is applied with or without a tissue adhesive.

In the method using a tissue adhesive, the conjunctiva is opened, a scleral flap forms a scleral tunnel and sclerotomy that are parallel to the limbus, and a three-piece foldable lens is introduced into the anterior chamber through a corneal incision of 3 mm. After that, by holding haptics with appropriate forceps, these haptics removed out of the extraocular from the prepared sclerotomies and haptic ends are introduced into the scleral tunnel. Subsequently, the flap is adhered with a tissue adhesive. Moreover, in the last step of this method, the scleral flap may also be closed by a suture without using a tissue adhesive.

In the method in which a tissue adhesive is not used, the eye is accessed by a perpendicular entry into the sclera from a distance of about 1 ,5 mm to limbus by a needle, thereby a sclerotomy is formed. Thereafter a scleral tunnel of about 3 mm which is parallel to horizontal limbus is formed via a needle, and three-piece foldable IOL haptics are introduced into this tunnel.

Conjunctiva should be opened in these methods. In the sutureless scleral fixated IOL implantation using a trocar, which is newly developed by us, two opposed scleral tunnels of 3 mm in length at a distance of 1 ,5 mm to limbus are prepared by a transconjunctival sutureless vitrectomy without conjunctival flap formation and three- piece foldable IOL haptics are introduced into this tunnel. A safety suture which will be removed after one week is introduced close to the scleral tunnel exit by a 10/0 nylon suture. An adverse event that may be encountered in these methods is that IOL dislocation may develop in some patients with or without any traumas.

Intraocular lens embodiments developed in the technical field may be exemplified by European Patent Application Publication EP2042124B1 , titled "Intraocular Lens"; Turkish Application Publication No. 2012/10713, titled "Intraocular Lens"; and European Patent Application Publication No. EP2503962B1 . As a result, for intraocular lenses an improvement or development different from known methods is needed due to the abovementioned drawbacks and inability of current solutions to solve the subject problems. OBJECT OF THE INVENTION

The main object of the invention is to overcome the abovementioned problems in intraocular lens embodiments and the application of these lenses to patients, and to minimize the rate of complications which are encountered in these applications.

An object of the invention is to provide a sutureless scleral fixated lens implantation in aphakic patients who lost capsule support and to prevent IOL dislocations.

Another object of the invention to eliminate conventional scleral fixated IOL application known in the art and to provide an embodiment which is suitable for a surgery technique in which a completely sutureless implantation is performed and which may be used in all sutureless scleral fixated IOL implantation surgeries.

A further object of the invention is to perform sutureless intrascleral haptic fixation method using the intraocular lens of the invention which is only developed for this surgical method and to prevent possible complications.

Another object of the invention is to prevent the movement of lens haptics to the inside and the outside of the eyes owing to both anchor mechanism introduced intrasclerally in an opposite direction and thereby to provide a good axial and sagittal stability in the eyes.

DRAWINGS WHICH HELP UNDERSTANDING OF THE INVENTION The structural and characteristic features and all advantages of the invention will be understood more clearly with respect to the figures provided below and the detailed description provided by referring to these figures, and thus, an evaluation should be made by taking into consideration these figures and the detailed description. Figure 1 is a general view of an intraocular lens with an anchor mechanism according to the invention.

Figure 2 is a view of a flexible sheath covered on the anchor wing part of the intraocular lens with an anchor mechanism according to the invention.

DESCRIPTION OF REFERENCES

1 . Optic

2. Haptic

2.1 . End Part

3. Anchor wing

4. Flexible sheath a' : angle of between the anchor wings and haptic

The drawings do not need to be scaled, and unnecessary details which are not needed in order to understand the present invention may be omitted. Moreover, the elements which are substantially identical or which have substantially identical functions are denoted with same number.

DETAILED DESCRIPTION OF THE INVENTION

In this detailed description intraocular lens embodiments according to the invention in accordance with the sutureless scleral fixated IOL implantations are presented only for better understanding of the subject matter.

Intraocular lens of the invention comprises:

- an optic (1 ),

- a C-shaped haptic (2) made of polypropylene, propylene or PMMA material,

- anchor wings (3) placed in a distance of 1 mm to end part (2.1 ) of said haptic (2),

- a flexible sheath (4) which is preferably transparent, hollow and made of a biocompatible material and which is disposed onto the area (the anchor mechanism) in which there are anchor wings (3) in order to prevent the anchor wings (3) from damaging the surrounding tissues during the placement of the intraocular lens to the eye.

Anchor wings (3) face to optic part and have an angle a (an angle of about 30-45 degrees) with haptic (2) (Figure 1 , Detail A). When haptic (2) is drawn from the end thereof in the sclera, anchor wings are closed, thereby haptic (2) advances more easily. After drawing anchor process wings (3) are opened owing to material memory, and they prevent the lens from moving back. A silicon flexible sheath (4) is used to prevent the anchor wings (3) from damaging to surrounding tissues during the placement of the lens.

In an alternative embodiment of the invention, a part of haptic (2) in the anchor wings (3) may have differences. When the anchor wings (3) are closed, this part may have the same thickness as haptic (2), or this part may be slightly thicker. When the wings (3) of haptic (2) in the anchor part are closed, haptic (2) generally may be produced slightly thicker than normal lens haptics in order to provide the same thickness as haptic (2).

Surgical application of the intraocular lens of the invention is performed as follows:

The intraocular lens according to the invention generally is applied to the eyes by introducing haptics (2) with anchor wings (3) into different scleral tunnels and under flaps which are formed by a surgeon.

A corneal entry site is formed using the sutureless scleral fixation methods by forming an incision after a scleral tunnel is conveniently created using 23- or 25-gauge vitrectomy trocar systems. After the necessary anterior vitreous cleaning a three-piece foldable IOL which has anchor wings (3) in haptic (2) thereof (its haptic is anchor- shaped) is introduced into the anterior chamber through the corneal incision. Thereafter, lens haptic (2) is applied to a forceps introduced through the scleral tunnel via a forceps introduced through the corneal incision. Haptic is drawn (2), removed from the eye through the scleral tunnel and placed into the scleral tunnel. In the method performed via a needle method without a scleral flap formation, firstly conjunctiva should be opened. Subsequently, a scleral tunnel of 3 mm in length which is parallel to limbus will be formed from the sclerotomy entry site after sclerotomy is formed by a needle.

A silicone and transparent flexible sheath (4) is covered on the part of lOL haptics (2) in which there are anchor wings (2). IOL haptics (2) are taken out of the eye by forceps as defined in the previous method. The flexible sheath (4) is removed, and IOL haptic with anchor wings (3) is introduced into the prepared scleral tunnel. Again, stabilization of the intraocular lens is achieved owing to the anchor mechanism.

In the surgery in which a scleral flap is formed, IOL haptic (2) with anchor wings (3) is introduced under this scleral flap.

Claims

1. A foldable intraocular lens which is used both in cataract and refractive surgeries in the field of eye surgery and in sutureless implantation surgeries as well as in patients who do not have sufficient capsule support; can be implanted to an eye through a small corneal incision and includes an optic (1 ) and haptic (2), characterized in comprising anchor wings (3) within its haptics (2) in order to perform a sutureless scleral-fixated intraocular lens surgery.

2. The intraocular lens according to claim 1 , characterized in that said haptic (2) comprises anchor wings (3) placed at a distance of 1 mm to end part thereof (2.1 ).

3. The intraocular lens according to claim 2, characterized in comprising anchor wings which are placed in the direction of optic (1 ) part and at an angle a' with haptic (2).

4. The intraocular lens according to claim 3, characterized in that said angle a' is 35 or 40 degrees.

5. The intraocular lens according to claim 1 , characterized in that said haptic (2) is made of polypropylene or propylene or PMMA material.

6. The intraocular lens according to claim 1 , characterized in comprising a flexible sheath (4) made of a biocompatible material which is disposed onto the area in which there are anchor wings (3) in order to prevent the anchor wings (3) from damaging the surrounding tissues during the placement of the intraocular lens to the eye.