WO2008103754A2

WO2008103754A2 - Aesthetic intraocular implant

Info

Publication number: WO2008103754A2
Application number: PCT/US2008/054458
Authority: WO
Inventors: Janet C. Tseng; Yichieh Shiuey
Original assignee: Individual
Current assignee: Individual
Priority date: 2007-02-21
Filing date: 2008-02-20
Publication date: 2008-08-28
Anticipated expiration: 2009-08-21
Also published as: WO2008103754A3

Abstract

An intraocular implant comprises a continuous side wall having a large opening at the bottom and a small opening at the top. The implant is intended to be positioned above the iris in the anterior chamber of an eye beneath the cornea. The implant is preferably colored in order to provide cosmetic re-coloring of the iris.

Description

AESTHETIC INTRAOCULAR IMPLANT

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention. The present invention relates generally to intraocular implants and more specifically to an implant having a tapered configuration that can be implanted between a cornea and an iris and can be dyed to impart a color to the iris.

[0002] 2. Description of the Background Art. The ability to permanently change iris color for cosmetic purposes would be highly desirable to many women. Whereas, the changing of hair color is relatively easy, the ability to change the appearance of the iris color is still relatively difficult.

[0003] At the present time, the most common way that the apparent appearance of the iris is changed is through the use of colored cosmetic contact lenses. The appearance of these contact lenses may be quite good when viewed straight ahead, but are quite obviously unnatural when viewed from the side. This is because the opacity of the contact lens covers the normally clear cornea and anterior chamber. An implant in the anterior chamber which covered or modified the appearance of the underlying iris would give a more natural appearance, since the implant would not obscure either the clear cornea or anterior chamber.

[0004] U.S. Pat. No. 5,628,797 (Richer) describes an intraocular implant, which is disposed in the anterior chamber. The implant comprises a transparent material, particularly a rigid transparent plastics such as polymethacrylate (PMMA). The implant includes two ring halves, which can be combined to a closed ring, wherein the resulting annular surface rests on the pupil of the eye. This type of implant would be difficult to manufacture because it requires mechanical fittings which are microscopic in scale. Another disadvantage is that the implant requires assembly within the anterior chamber, which is a very small space, typically having a maximum height less than 4 mm. This limited space would make it extremely difficult for the surgeon to manipulate the interlocking pieces.

[0005] U.S. Pat No. 7,037,337 (Carriazo) describes a flexible intraocular implant which is an annular ring which contains openings within the ring through which iris tissue is pinched in order to achieve attachment of the implant to the iris. The pinching nature of the attachments will damage the iris, potentially causing localized atrophy. In addition, it may cause iritis, which is painful and potentially vision threatening. [0006] In both U.S. Pat No. 5,628,797 and U.S. Pat No. 7,037,337, the implants are described as annular or ring like. A flat annular shape is not ideal for an iris implant because in the typical normal human eye the iris is angulated upward by the presence of the crystalline lens. Therefore, an annular shape of the implant would mean that the implant would have to be touching the iris which causes chafing and irritation, especially because of the dynamic nature of the iris diaphragm.

[0007] Therefore, it is clear that there is still a need for improved systems and methods for changing the iris color. In particular, it would be desirable to provide implants for the anterior chamber which are able to cover the iris with minimum touching of the iris and a reduced risk of chafing and irritation. The implants should be suitable for implantation without the need to assemble within the anterior chamber. At least some of these objectives will be met by the inventions described hereinafter.

BRIEF SUMMARY OF THE INVENTION [0008] According to the present invention, an intraocular implant comprises a continuous sidewall having a top and a bottom. The sidewall is adapted to be implanted in an anterior chamber under the cornea and above the lens in an eye. In particular, the implant will be adapted to reside or rest over the iris with minimum touching of the iris. This positioning may be achieved using an implant which is tapered from the bottom toward the top. In particular, a conical or dome-shaped implant having a lower peripheral lip or edge which engages the outer edge of the iris near the junction with the cornea and is angled upwardly from the edge, typically at an angle in the range from 1° to 60°, preferably from 1° to 45°. The top of the implant will typically be open, but in some embodiments could include a lens for corrective or other purposes. While in some instances, the implant may be clear (without color), in most cases the implant will be dyed or otherwise colored in order to provide for aesthetic coloring or re-coloring of the iris.

[0009] Methods according to the present invention comprise implanting an implant interior to the iris, where the implant has a tapered geometry that reduces contact with the iris. Usually, the tapered geometry will provide a peripheral edge which rests against the outer periphery of the iris near the junction with the cornea. The continuous wall of the implant will be angled upwardly, as discussed above, so that contact with the iris is eliminated or minimized. Typically, the implant will be made from a biocompatible polymer which can be rolled or otherwise reduced in profile to permit implantation through a small incision in the eye. In preferred aspects the aesthetic implant would be manufactured from acrylic polymers, silicone polymers, or collagen polymers. In alternative preferred aspects, the implant could be manufactured from a polymer which comprises one or more compounds selected from the group consisting of polyurethanes, poly(2-hydroxyethylmethacrylate), polyvinylpyrrolidone, polyglycerolmethacrylate, polyvinyl alcohol, polyethylene glycol, polymethacrylic acid, polyfluorocarbons, and polymers with phosphocholine. The polymer composition could be either hydrophilic or hydrophobic. The polymer may be a hydrogel or non-hydrogel. The dyes listed hereinafter may be introduced into the polymers of the implant in conventional manners. These methods could include painting of the dyes onto the polymer surface, mixing the dye with the polymer, or impregnating only the interior of the implant polymer with dye so that there is no dye exposed to the interior of the eye. The last method would minimize the chance of inciting any type of inflammatory reaction to the dye.

[0010] In preferred aspects, the implant of the present invention may comprise pertinent features which improve the performance. For example, footpads that project outwardly from the lower periphery of the implant may be provided in order to stabilize the implantation, hi preferred aspects the implant would be designed so that footpads would engage either the scleral spur or the iris root, both of which are relatively insensitive structures. Additionally, fenestrations or openings may be provided through the sidewall to permit aqueous flow through the implant to improve nourishment of the interior of the eye. Additionally, lenses may optionally be positioned within the upper opening of the implant to provide for vision correction or the like.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Fig. 1 is a cross-sectional view of a normal eye which demonstrates the normal upward angulation θ of the iris I in most humans because of the presence of the crystalline lens L. C is the cornea. V is the vitreous jelly.

[0012] Fig. 2 shows a cross-sectional view of a prior art annular implant A which touches the iris at T which may cause chafing and inflammation with movements of the iris and pupil. O is the opening of the annular implant.

[0013] Fig. 3 shows a cross-sectional view of an implant N according to the present invention. The implant N minimizes touching of intraocular structures because of its truncated cone or truncated dome shape. Note how the implant only touches the anterior chamber angle. O' is the top opening in the new implant.

[0014] Fig. 4 shows a three dimensional view of the new implant. The hatched line shows the back portion of the bottom of the implant N constructed in accordance with the principle of the present invention. An opening O' at the top of the implant overlies the pupil. A bottom opening O" is located at the bottom of the implant. The shape of the implant is generally tapered from the bottom toward the top, typically as a truncated cone or truncated dome. Also note that angle θ' will be such that it will generally correspond to the angle of the iris and cornea, so as to avoid touching intraocular structures. In preferred aspects, angle θ' will be between 1° and 60°, preferably being in the range from 1° to 45°. S is the side wall of the implant.

[0015] Figs. 5 and 5 A show a top view of an implant N' of the present invention. The top opening is seen as O¹. The side S of the implant receives the coloration. Footplates 10 will allow alternative fixation of the lens in the anterior chamber angle. In the side S of the implant, fenestrations 20 are shown which will allow normal flow of aqueous to nourish the interior of the eye. A faceted implant is shown in Fig. 5 A.

DETAILED DESCRIPTION OF THE INVENTION

[0016] An intraocular implant N' for the anterior chamber (Fig. 4) is shaped like a truncated cone or truncated dome, wherein the top of the truncated cone or truncated dome is either physically open or is covered partially or fully by a lens. While shown as a regular cone with a continuous or smooth side, the cone could also have flat faces or facets F and be a truncated pyramid rather than a simple cone (Fig. 5A). The structure could also include both flat and rounded portions so long as the total surface tapers from the base to the top. The bottom of the truncated cone, truncated dome or other tapered structure is physically open. It is important that the shape of the implant be a truncated cone or truncated dome or be otherwise tapered in order to allow the implant to have minimal contact with intraocular structures. The angle(s) of the side(s) of the truncated structure is such that it allows clearance or set back of the implant from the iris itself and from the cornea. Contact between the implant and the intraocular structures is preferably limited to the relatively insensitive anterior chamber angle or iris root. [0017] Although, we describe the shape of the implant as being either a truncated cone or truncated dome, our invention also includes shapes which are similar to either truncated domes or cones, which allows the implant to only touch the relatively insensitive anterior chamber angle or iris root. In addition, the bottom of the implant does not need to be perfectly round. In fact, a slight ovality would be preferable for the shape of the bottom of the implant to match the slight ovality of the cornea.

[0018] In preferred aspects, the implant would be made of a biocompatible flexible material which may be colored with biocompatible color additives. These color additives may include, but are not limited to one or more of the following:

[0019] l,4-Bis[(2-hydroxy-ethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester copolymers, 1,4-Bis [(2-methylphenyl)amino] -9,10-anthracenedione, 1,4-Bis[4- (2- methacryloxyethyl) phenylamino] anthraquinone copolymers, Carbazole violet, Chromium- cobalt-aluminum oxide, Chromium oxide greens (CI. Vat Orange, 2-[(2,5-Diethoxy- 4-[(4- methylphenyl)thiol] phenyl)azo] -1,3,5-benzenetriol, C.I. Vat brown 1: 16,23- Dihydrodinaphtho [2,3-a:2',3'-i] naphth [2',3':6,7] indolo [2,3-c] carbazole- 5,10,15,17,22,24- hexone, C.I. Vat yellow 3: N,N'-(9,10-Dihydro- 9,10-dioxo- 1,5-anthracenediyl) bisbenzamide, C.I. Vat blue 6: 7,16-Dichloro- 6,15-dihydro- 5,9,14,18-anthrazinetetrone, C.I. Vat green 1 : 16,17-Dimethoxydinaphtho (l,2,3-cd:3',2',l'-mi) perylene-5,10-dione, Poly(hydroxyethyl methacrylate) -dye copolymers: including one or more of C.I. Reactive black 5, C.I. Reactive blue 21, C.I. Reactive orange 78, C.I. Reactive yellow 15, C.I. Reactive blue 19, C.I. Reactive blue 4, C.I. Reactive red 11, C.I. Reactive yellow 86, C.I. Reactive blue 163, C.I. Reactive red 180; C.I. Solvent Yellow 18: 4-[(2,4-dimethylphenyl)azo]- 2,4- dihydro- 5-methyl-2-phenyl- 3H-pyrazol-3-one, CL Vat orange 5: 6-Ethoxy-2- (6-ethoxy-3- oxobenzo(b) thien-2(3H)- ylidene) benzo(b)thiophen- 3(2H)-one, Phthalocyanine green, Iron oxides, Titanium dioxide, Vinyl alcohol/methyl methacrylate-dye reaction products C.I. Reactive red 180, CI. Reactive black 5, C.I. Reactive orange 78, CI. Reactive yellow 15, C.I. Reactive blue 19, CI. Reactive blue 21), Mica-based pearlescent pigments, (Phthalocyaninato(2-)) copper, D&C Green No. 6, D&C Red No. 17, D&C Violet No. and D&C Yellow No. 10.

[0020] In other preferred aspects the implant would have at least two footplates 10, more preferably three, and still more preferably four footplates at the bottom of the truncated cone. The footplates 10 allow gentle positioning within the anterior chamber angle or against the iris root. The presence of footplates would further decrease the amount of contact between the implant and the intraocular structures. See Fig. 5. The presence of footplates is advantageous because it allows stable fixation of the implant while causing the least possible amount of irritation to the eye.

[0021] In additional preferred aspects, there would be fenestrations or openings in the implant which would allow aqueous to flow normally through the implant to allow nourishment of the interior of the eye.

[0022] Optionally, the implant would include a lens in the center of the implant.

[0023] Optionally, the system would include an implant inserter that would allow the implant to be reversibly deformed such that it could be injected through a small incision in the eye. Preferably the incision would be less than 3 mm, more preferably the incision would be less than 1 mm.

[0024] Optionally, the system would include a software program which would help determine the best shape and dimensions of the implant for an individual eye. The software program would take data obtained from imaging studies of an individual eye and use this data to determine the shape and dimensions of the implant which will minimize contact with intraocular structures. Types of imaging studies which could be used for this purpose include, but are not limited to: B-scan ultrasound, anterior segment optical coherence tomography, radiographic computed tomography and magnetic resonance imaging. In preferred aspects, the software program would be installed on the computer system of the imaging apparatus and the dimensional data of the eye would automatically be imported into the software program. This dimensional data could include, but is not limited to the angle to angle distance for 360 degrees and the angle of the iris relative to the plane of the scleral spur or some other fixed plane for 360 degrees. In alternate preferred aspects, the dimensional data of the eye could be exported via a memory device or over the internet and then be retrieved for use by the software program.

[0025] While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the appended claims.

Claims

WHAT IS CLAIMED IS:

1. An intraocular implant comprising: a continuous side wall having a top and a bottom, wherein the side wall is adapted to be implanted under a cornea and above a lens in an eye and at least the bottom is open and the side wall tapers from the bottom to the top.

2. An implant as in claim 1 , wherein at least a portion of the side wall is colored so that an iris appears to have the color of the side wall when the implant is implanted in the eye.

3. An implant as in claim 2, wherein the side wall is colored with a dye selected from the group consisting of: l,4-Bis[(2-hydroxy-ethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester copolymers, 1,4-Bis [(2-methylphenyl)amino] -9,10-anthracenedione, 1,4-Bis[4- (2-methacryloxyethyl) phenylamino] anthraquinone copolymers, Carbazole violet, Chromium-cobalt-aluminum oxide, Chromium oxide greens (CI. Vat Orange, 2-[(2,5- Diethoxy- 4-[(4-methylphenyl)thiol] phenyl)azo] -1,3,5-benzenetriol, C.I. Vat brown 1 : 16,23-Dihydrodinaphtho [2,3-a:2',3'-i] naphth [2',3':6,7] indolo [2,3-c] carbazole- 5,10,15,17,22,24-hexone, C.I. Vat yellow 3: N,N'-(9,10-Dihydro- 9,10-dioxo- 1,5- anthracenediyl) bisbenzamide, C.I. Vat blue 6: 7,16-Dichloro- 6,15-dihydro- 5,9,14,18- anthrazinetetrone, C.I. Vat green 1 : 16,17-Dimethoxydinaphtho (l,2,3-cd:3',2',l'-lm) perylene-5,10-dione, Poly(hydroxyethyl methacrylate) -dye copolymers: including one or more of C.I. Reactive black 5, C.I. Reactive blue 21, C.I. Reactive orange 78, C.I. Reactive yellow 15, C.I. Reactive blue 19, C.I. Reactive blue 4, C.I. Reactive red 11, C.I. Reactive yellow 86, C.I. Reactive blue 163, C.I. Reactive red 180; C.I. Solvent Yellow 18: 4-[(2,4- dimethylphenyl)azo]- 2,4-dihydro- 5-methyl-2-phenyl- 3H-pyrazol-3-one, C.I. Vat orange 5: 6-Ethoxy-2- (6-ethoxy-3-oxobenzo(b) thien-2(3H)- ylidene) benzo(b)thiophen- 3(2H)-one, Phthalocyanine green, Iron oxides, Titanium dioxide, Vinyl alcohol/methyl methacrylate-dye reaction products C.I. Reactive red 180, C.I. Reactive black 5, C.I. Reactive orange 78, C.I. Reactive yellow 15, C.I. Reactive blue 19, C.I. Reactive blue 21), Mica-based pearlescent pigments, (Phthalocyaninato(2-)) copper, D&C Green No. 6, D&C Red No. 17, D&C Violet No. 2, and D&C Yellow No. 10.

4. An implant as in claim 1, further comprising a corrective lens in the top of the implant.

5. An implant as in claim 1, wherein the side wall has a conical geometry.

6. An implant as in claim 1, wherein the side wall has a dome shaped geometry.

7. An implant as in claim 1, wherein the side wall has a faceted geometry.

8. An implant as in claim 1, wherein the side wall has an angle in the range from 1° to 60° relative to a central axis of the implant.

9. A method for coloring an iris of an eye, such method comprising implanting a colored implant anterior to the iris, wherein the implant has a tapered geometry that reduces contact with the iris.

10. A method as in claim 9, wherein the implant has a side wall that touches only the anterior chamber of the eye.