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Title:
SUTURE-FREE SCLERAL LENS
Document Type and Number:
WIPO Patent Application WO/2017/116357
Kind Code:
A1
Abstract:
An intraocular lens used in cataract surgery of people who have visual impairment. A lens (1) used when there is no capsule support, and comprising holder indentations (13) formed on the leg (12) part of the lens (1) and enabling fitting of the lens (1) into the eye, a tip knob structure (14) preventing sliding and falling, and rounded lens edges (15), and it is characterized in that; it comprises holder indentations and/or protrusions (13) formed in spiral structure from said tip knob structure (14) (b) to the haptic (12) bottom area (d), and a twist (16) and/or notch applied on the leg structure when required.

Inventors:
OZDEMIR, Halim (Atalar Mahallesi Simal Sokak No:8 D:5, Korfez/Kocaeli, TR)
BAYKARA, Mehmet (Uludag Universitesi Tip Fakultesi Oftalmatoloji Bolumu, Nilufer/Bursa, TR)
HARMANKAYA, Ibrahim (Yeni Karaman Mahallesi Ata Sokak No:1213, Osmangazi/Bursa, TR)
Application Number:
TR2016/050514
Publication Date:
July 06, 2017
Filing Date:
December 19, 2016
Export Citation:
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Assignee:
OZDEMIR, Halim (Atalar Mahallesi Simal Sokak No:8 D:5, Korfez/Kocaeli, TR)
BAYKARA, Mehmet (Uludag Universitesi Tip Fakultesi Oftalmatoloji Bolumu, Nilufer/Bursa, TR)
HARMANKAYA, Ibrahim (Yeni Karaman Mahallesi Ata Sokak No:1213, Osmangazi/Bursa, TR)
International Classes:
A61F2/16
Domestic Patent References:
WO2014137306A12014-09-12
WO2015194335A12015-12-23
Foreign References:
US4990159A1991-02-05
JP2013022273A2013-02-04
Attorney, Agent or Firm:
DESTEK PATENT, INC. (Lefkose Cad. NM Ofis Park B Blok No:36/5 Besevler, Bursa, 16110, TR)
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Claims:
CLAIMS

1 . A lens (1 ) used when there is no intraocular lens support during cataract surgery, on people who have visual impairment, and comprising holder indentations (13) formed on the haptic (12) part of the lens (1 ) and enabling fitting of the lens (1 ) into the eye, and a tip knob structure (14), and it is characterized in that;

- it comprises holder indentations (13) formed in spiral structure from said reduced tip knob structure (14) (b) to the haptic (12) bottom area (d).

2. The lens (1 ) according to Claim 1 , characterized in that; said knob structure (14) comprises reduced surfaces (14.1 ) having lower thickness than the haptic (12) thickness. 3. The lens (1 ) according to Claim 1 , characterized in that; it comprises rounded lens edges (15) that facilitate the contact of the lens (1 ) to be fitted on the sulcus or capsule, with the iris.

4. The lens (1 ) according to Claim 1 , characterized in that; said lens (1 ) comprises twists (16) formed on the haptic (12).

5. The lens (1 ) according to Claim 1 , characterized in that; said lens (1 ) comprises indentations/protrusions (17) formed on the haptic (12) in helical or spiral or non-helical flat structure.

6. The lens (1 ) according to Claim 1 , characterized in that; said spiral-structure holder indentations (13) comprise indentations and/or protrusions facing inward (13.1 ) and/or indentations and/or protrusions facing outward (13.2).

Description:
Suture-free Scleral Lens DESCRIPTION

The Related Art The invention relates to production of suture-free (sutureless) intraocular lenses, used on people who have visual impairment, and attached in intraocularly in a flexible and steady manner due to its leg structure, when there is no intraocular lens support in cataract surgery. The Prior Art

The light reaching our eyes from the outside is focused at the cornea (the outermost transparent layer of the eye) and the lens and then reach on the retina. Image quality depends on many factors including size and shape of the eye, and the transparency of the cornea and the lens. The opacity of the eye lens decreases with advanced age and diseases. Accordingly; vision is distorted by reduced light transmitted to the retina, and this inadequacy in the eye lens is known as cataract. Treatment of this disease is made by removal of the eye lens and replacement of the eye lens by an artificial intraocular lens.

Presently used intraocular lenses are placed in the natural capsule (membrane) in the eye of the patient. However, when this support, that is, this natural capsule, is lost, the lenses are attached either to the iris layer or to the sclera by suture (stitch). Suturing is dangerous and increases infection risk, and prolongs the operation time. The procedure called scleral fixation (attaching the lens to the outher eye layer) increases the trauma risk to the eye during and after the operation, disrupts the adaptability of the surgery with the eye and may adversely affect healing. It may cause especially late-term edema of the cornea, tissue and implant rejection and infection risks, and thus it may lead to long-term treatment and cause visual loss. Japanese patent No. JP2013022273A comprises a structure that has a lens body contacting the spherical part of the eye and two arms integrated to this lens body. It has a feature that includes stitching areas for stitching the lens body on the eye wall.

In most lenses used in the prior technique, the lens structure and the leg structure are not produced integrally, which in turn increases unnecessary extra invasive procedures and production costs. In the prior technique, there are problems in contact of the lens with the iris, since the lens would fit in the sulcus as the sides of the lens are flat. Lack of contact of the lens causes various problems due to external factors that prevent healthy use of the lens. In this way, late-term infection risks and drug use rates increase. In the prior technique, problems in the strength of the lens leg causes problems such as tilting (rotating) the lens and decentralization from the optical center.

The lenses used in the prior technique do not provide flexibility to the operator and lead the operation to take longer time and be inefficient in patients that have capsule problem.

Prior used intraocular lenses can be manufactured as single piece or the optic and the leg can be manufactured separately. This increases the production costs depending upon the technique of production.

In the prior technique, in cases where the natural capsule is inadequate, the lenses are attached to the sclera or iris by suture (stitching); and this operation is both risky, prolongs the operation time, and increases infection risks and treatment costs in long term. In the prior technique, the thicker and sharp edged structure of the lens legs deteriorates the lens-eye compatibility after fixation, and causes problems such as late-term infection and implant rejection. Purpose of the Invention

The purpose of the invention is to provide the surgeon with the flexibility of embedding and attaching a lens into the eye due to its structural characteristic, by means of suturing it into the capsule and the area behind the iris and also to the sclera, if required, or without suturing into the sclera, so that the surgeon would complete his/her work without the need for another lens during a cataract operation.

A purpose of the invention is to facilitate scleral embedding operation, prevent sliding, and form a basis for suturing, if required, due to its design.

The most significant purpose of the invention is to form helical-teeted indentations and/or protrusions at the leg (haptic) part. In this way; it increases the holding force on the sclera and capsule.

A purpose of the invention is to stabilize the lens to stay at the closest position to the iris by means of increasing the contact force with the capsule and/or sclera via the balanced and increased centrifugal force formed by the (teethed) twist structure found on the leg. Another purpose of the invention is to be applied on the eye without any suture. In this way, it is aimed to eliminate all possible health problems and treatment costs that may occur when stitching is applied.

A purpose of the invention is to reduce extra invasive operations due to its specially designed leg/haptic structure integrated to the lens body, and thus provide convenience to the surgeon.

Another purpose of the invention is to allow embedding /inserting into the sclera by means of additional indentations and/or indents and protrusions found on the special leg structure of the lens and with the flatter tip part (reduced knob).

Another purpose of the invention is to prevent problems encountered in terms of the contact of the lens to be fitted in the sulcus, with the iris, by means of rounding the lens edges. Increasing the hold/adherence of the lens would eliminate various problems caused by external factors that prevent healthy use of the lens. In this way, it is aimed to reduce late-term infection risks and drug use rates.

Another purpose of the invention is to enlarge the area fitting on the capsule due to the increased total diameter and allow more efficient transfer of the force so as to facilitate centralization, increase adherence to the capsule, and minimize late-term dislocation risks.

Another purpose of the invention is to allow the operation to be conducted in a quicker and more efficient manner by making the work of the operator easier. These superiorities also increase patient satisfaction.

Another purpose of the invention is to bring new applications and operation techniques into the sector and also provide advantages to the operator due to its versatile use in surgery.

Another purpose of the invention is to increase the ways of usage by means of placing the indents and/or indentations and protrusions in a helical, teeted or spiral manner on the leg (haptic). Moreover, a twist (helix) point and/or a notch (inflexion point) that can be used without twist, when required, is/are added to the design. In this way, the centrifugal force is balanced and becomes protective against dislocation.

Another purpose of the invention is to be produced as a single piece structure and without comprising a mechanical piece, so that the production costs would be reduced. At the same time, the invention can also be produced together with the other methods used in lens production sector.

Another purpose of the invention is to be applied on various intraocular lens body types already present in the system, as a leg (haptic).

Figures for Better Understanding of the Invention

Figure 1 ; is a two-dimensional representative front view of the suture-free intraocular lens according to the invention.

Figure 1.1 ; is a two-dimensional representative side view of the suture-free intraocular lens according to the invention.

Figure 2; is a close-up view of the leg part of the lens according to the invention. Figure 3; is a two-dimensional representative front view of an alternative structure of the suture-free intraocular lens according to the invention.

Figure 3.1 ; is a two-dimensional representative side view of the suture-free intraocular lens according to the invention.

Figure 4; is a close-up view of an alternative structure of the leg part of the lens according to the invention.

Figure 5; is an alternative view of the lens body having a twisted structure with an indented part.

Figure 6; is an alternative view of the leg part having an indented structure.

Figure 7; is another alternative view of the lens body having a twisted structure. Figure 8; is another alternative view of the leg part having a spiral structure

Figure 8.1 ; is another alternative view of the leg part. Reference Numbers

1 . Lens

10. Lens body

1 1.Leg body connection

12. Leg

13. Holder indentations

131 . Indentations and protrusions facing inward

132. Indentations and protrusions facing outward

14. Tip knob structure

14.1 Reduced surfaces

15. Rounded lens edge

16. Twists

17. Indentations/protrusions

b. beginning

d. bottom area

Detailed Description of the Invention

The invention mainly is a lens (1 ) used when there is no intraocular lens support during cataract surgery, on people who have visual impairment, and comprising holder indentations (13) formed on the leg (12) part of the lens (1 ) and enabling fitting of the lens (1 ) into the eye, and a reduced or flat tip knob structure (14), and it is characterized in that; it comprises a holder indentation (13) formed in spiral structure from said tip knob structure (14) (b) to the leg (12) bottom area (d). The twisted structure (16) found on the legs increases the centrifugal force of the leg (12) and increases the holding force on the sclera or capsule. Besides, it stabilizes the lens (1 ) to stay at the closest position to the iris. On the other hand, it facilitates scleral embedding operation, prevents sliding, and form a basis for stitching operation, if required. Said spiral-structure holder indentations (13) comprise indentations and/or protrusions facing inward (13.1 ) and indentations and/or protrusions facing outward (13.2). In the leg (1 2) structure of the suture-free lens, a leg (12) technology that is developed, which allows fitting in the sulcus (the pit found in the capsule or sclera) and prevents sliding and falling by means of the increased total diameter increasing the attachment force of the lens (1 ), novel leg helical structure, leg (12) inner and/or outer surface and/or spiral indents and the reduced knob structure (14) found at the tip. In this way extra invasive operations are reduced. The leg (12) inner surface indents and the leg (12) reduced knob structure tip part being flatter eliminates the need for perforated scleral fixation (sutured surgery). Also, the contact of the lens to be fitted in the sulcus, with the iris is facilitated by means of rounding the lens edges and at the same time, it is also used for connection to the sclera with the different leg structure with rounded edges. The leg-body connection of the lens (1 ), the helical structure in the leg structure and the leg inner surface indents are manufactured so as to improve strength of all kinds of sutures (stitches) and fixation operations. The lens body (10) found at the middle part of the lens (1 ) given in Figure 1 acts as the optical center. A leg body connection (11 ) is formed from the lens body (10) part as a connection with the optic area and the legs (12). In the leg (12) structure of the suture-free lens, the holder indentations (13) allowing the lens (1 ) to hold onto the capsule or sclera, and a reduced tip knob structure (14) fitting in the sulcus or capsule and preventing sliding and falling, are formed. In this way extra invasive operations are reduced. The holder indentations (13) and the leg tip knob structure (14) part having flatter edges eliminates the need for perforated scleral fixation. Also, since the rounded lens edges (15) found on the lens are rounded, it becomes easier for the lens to be fitted on the sulcus to contact with the iris. Alternatively, the leg surface holder indentations (13) found on the leg (12) structure are produced such that they would increase durability/strength of all kinds of suture and fixation operations.

With the invention, changes can be made on the leg (12) size and also the surface interval and shape of the leg surface holder indentations (13) can be changed. Only the outer surface of the leg (12) or both outer and inner surfaces can be produced with indentations and protrusions (17). Also, the inflexion radiuses of the legs (haptics) (12) can be changed. The total diameter of the lens can be changed. The number, angle, position, thickness, and application direction of the helix/teeted (twist) area positioned on the leg and formed by rotation of the leg structure on itself, can be changed. If required, it can be applied as a notch and its numbers, size, and position can be changed. When required, it is not applied and production can be made with indentations facing inward at the lens leg.

The numbers, shapes, arrangement, and heights of the indents and/or indentations and protrusions (17) used for fixing the lens can be changed arbitrarily. These indentations/protrusions (17) are formed in Spiral, teeted, helical, and/or non-helical flat structures. On the other hand, the sizes of the haptics (12) can be changed and the surface intervals, numbers, and shapes of the indentations and/or protrusions facing inward and/or outward on the haptic (12) can be changed. Only the outer surface of the haptic (12) or both outer and inner surfaces can be produced with indentations and protrusions with different sizes and ways (17). The inflexion radiuses of said haptics (12) can be changed. Material thickness, transparency, hardness, and all kinds of dimensions can be changed.

The lens (1 ) can be prepared by silicone, polyprolen, propyl ethylene, PMMA, and photopolymers, and can be made of different materials. It can be hydrophobic or hydrophilic. Moreover, the diameter, shape, and length of the lens (1 ), and if required, the leg inner and outer diameters can be changed. All dimensions, optic ratios, and production techniques of the lens body (10) can be changed. The invention can be produced by cutting system and photopolymerization technique used in lens (1 ) production nowadays in single piece and without comprising any mechanical piece. In this way, production costs are reduced. When required, the body can be produced separately and the leg (haptic) can be added on. The body of the lens (10) is the same as the prior art systems, and it does not require additional study or experimentation. The invention can also be applied as haptic (leg) on various lens bodies that are already being produced commercially. Lens leg (haptic) can be produced different sizes and types (C, J, S, L, plate, open and closed loop).