Intraocular Lens With Miniature Optic Having Expandable and Contractible Glare-Reducing Means

This invention relates to intraocular lenses for the human eye, and, more particularly, to intraocular lenses of the type which can be positioned in the anterior chamber, the posterior chamber, or partially in the anterior chamber and partially in the posterior chamber of the eye. The invention also relates to methods of inserting such lenses in a eye.

One type of intraocular lens is described and claimed in my U.S. Pat. No. 4,253,200 issued Mar. 3, 1981. Such a lens is inserted into the eye through a corneo-scleral incision that may be also used to remove a natural lens. To minimize the possibility of injury to the eye, it is important that the incision be made as small as possible. According to that patent the size of the incision is dependent nearly entirely on the diameter of the optic. In order to further reduce the size of the incision, therefore, the size of the optic would have to be reduced. This can be accomplished in several ways. First, the optic may be made in the form of a twopiece optic, allowing the surgeon to make an incision in the eye smaller than the diameter of the lens body, or optic, and inserting the two parts of the optic separately through the incision. In the case of the two-piece optic, depending on where the optic is split and depending on the means used for connecting the two pieces together there may result, in some instances, an undesirable glare effect at the juncture of the two pieces. A second possibility is to form the lens with an optic of reduced size, at least in the one dimension thereof which must pass through the incision. However, the undesirable glare effect described above has in the past also precluded the use of such optics which were substantially smaller than 5 mm in diameter, or at least had one dimension (transverse to the optical axis) of such substantially smaller size. The reason was that some of the light rays entering the eye would impinge on the peripheral marginal regions of such miniature optic which, because of the small dimensions involved, are located in the path of such light rays and would scatter the rays toward the retina.

A further possibility is to form the optic out of a flexible material such as silicone and to curl the optic into the shape of a small cylinder which can then be readily inserted into a small incision. This latter construction requires that the curled optic fully assumes its flat initial shape after it is inserted into the eye. Any deviation from such flat shape would result in optical distortion.

Also, if the material used for such flexible optic is silicone, materials in the eye, such as, for example, fibrin, may collect on the optic due to the surface characteristics of silicone. It is therefore preferred to make the optic out of a material such as polymethylmethacrylate (PMMA) which is not only relatively rigid but also does not have properties which cause any of the materials in the eye to adhere thereto. PMMA's physical properties are such that fibrin and other materials in the eye are constantly washed away from its surface rather than adhering thereto.

It is an object of the present invention, therefore, to provide a new and improved intraocular lens which avoids one or more of the limitations of prior such lenses.

It is another object of the invention to provide a new and improved intraocular lens which has a lens body which is smaller, in at least one transverse dimension thereof, than the lens body of conventional lenses, yet which does not result in undesirable glare.

Glare effect is produced whenever there is located, in the path of the light rays which pass through the pupil to the retina, an edge or similar boundary between regions which are both substantially transparent as distinguished from one being substantially opaque. For example, glare effect will result if a lens body is split into two parts along, e.g. a diameter, or if an optic has a 3 mm diameter while the bundle of light rays passing through the pupil has a transverse cross sectional area which is 6mm in diameter, since the outermost rays will pass through the optically transparent fluid in the eye while the innermost rays pass through the optic. No such edge glare results however in those cases in which one side of the edge or boundary in question is masked, i.e. is opaque, such as for example, the boundary formed by the iris at its inner edge defining the pupil. The opaque iris thus masks without causing glare effect.

In accordance with the invention an intraocular lens comprises a lens body and a position-fixation means extending from the lens body for fixating the lens body within the eye. The lens body is of minature size, i.e. it has at least one dimension sufficiently small in size to permit the lens to be inserted into the eye through an incision which is substantially smaller than the incision now generally required for insertion of conventional lenses. The lens also includes a deformable masking means integral with the lens body for preventing glare-effects when the masking means is in expanded condition. For insertion, the masking means are deformable into a contracted condition in which they pass, together with the lens body, through the desired substantially smaller incision.

In accordance with the invention an intraocular lens comprises a lens body for focusing light rays on the retina of an eye, the lens body has a pair of imaginary coordinate axes at right angles to one another and to the optical axis and has a maximum dimension of substantially less than 5 mm along any line drawn through the lens body parallel to a given one of its pair of coordinate axes, said maximum dimension being defined by a pair of opposite peripheral edge portions of the lens body transverse to said one coordinate axis and located apart a distance equal to said maximum dimension, and masking means integrally connected with the lens body and deformable between an expanded condition in which the masking means has a first portion thereof adjacent one of said peripheral edge portions of said lens body and a second portion thereof spaced from and located radially outwardly of said one peripheral edge portion of said lens body for inhibiting light rays which are directed toward said peripheral edge portion from being scattered thereby toward the retina after the lens has been implanted in an eye, and a contracted condition in which said masking means are located substantially entirely within said maximum dimension of said pair of opposite peripheral edge portions of said lens body for permitting insertion of said lens through an incision in an eye which is substantially less than 5 mm in length.

For a better understanding of the present invention, together with other and further objects thereof, reference is made to the following description, taken in connection with the accompanying drawings, and its scope will be pointed out in the appended claims.

Referring now to the drawings:

FIG. 1 is a front elevational view of the intraocular lens embodying a preferred form of the present invention with the masking means in normal expanded condition thereof;

FIG. 2 is a side elevational view of the intraocular lens represented in FIG. 1;

FIG. 3 is a front elevational view of the intraocular lens represented in FIGS. 1 and 2 showing the masking means in contracted condition;

FIG. 4 is a front elevational view similar to the view in FIG. 1, of another embodiment of a lens constructed in accordance with the invention showing the masking means in normal expanded condition;

FIG. 5 is a transverse sectional view along line 5--5 of FIG. 4;

FIG. 6 is a transverse sectional view similar to the view in FIG. 5 showing the masking means in contracted condition thereof;

FIG. 7 is a front elevational view of an intraocular lens according to still another embodiment of the invention and showing the masking means thereof in expanded condition;

FIG. 8 is a rear elevational view of the intraocular lens of FIG. 7 in contracted condition thereof.

Referring now particularly to FIGS. 1, 2 and 3 of the drawings, reference numeral 1 generally indicates an intraocular artificial lens according to the preferred embodiment of the present invention. The lens 1 can be formed of any suitable material compatible with the environment of the human eye, such as a non-toxic plastic, for example, polymethylmethacrylate.

The lens 1 includes a medial light focusing lens body, or optic 10, having, for example, a convex anterior surface and a generally flat posterior surface and having a pair of imaginary coordinate axes "x" and "y" perpendicular to each other and to the optical axis "o" of the lens body 10. While optics of conventional intraocular lenses are generally round and approximately five to six millimeters in diameter, the lens body 10, according to the present invention, may be of any suitable shape, for example, round, oval or rectangular, but has a maximum dimension, in the direction of at least one of said coordinate axes, of substantially less than 5mm, i.e. substantially less than the corresponding dimension of a conventional intraocular lens optic. According to the present invention the lens 1 further includes position-fixation means 30 having a pair of opposed curved position-fixation members 31, 32 which are preferably resilient filaments of polymethylmethacrylate, or similar material, integrally connected with the lens body.

The lens body 10 is preferably oval and is elongated along the Y--Y axis and the position-fixation members 31, 32 are preferably connected to opposite ends of such elongated lens body so as to extend generally in the direction of the Y--Y axis.

The lens 1 further includes a masking means 20 which in the preferred embodiment shown in FIGS. 1, 2 and 3, is in the form of a pair of wing members 21 and 22. These wing members are preferably elongated and preferably integrally connected at one end thereof to a connecting stem portion 11 which in turn is integrally connected with the lens body 10 at one of the longitudinal ends of that lens body. The wing members 21 and 22 are generally planar and are located in a plane which, as best seen in FIG. 2, is parallel to and closely adjacent to the plane of the lens body 10. Preferably, this is accomplished by forming the connecting stem 11 so that the latter extends both generally radially outwardly of the lens body 10 and posteriorly thereto beyond the posterior surface thereof. The wing members 21, 22 can thus be moved in sliding relation with respect to the flat posterior surface of the lens body 10.

According to the preferred embodiment of the present invention, the wing members 21, 22 are resiliently connected to the lens body 10 at the stem 11. Thus, the wing members 21, 22 are deformable with respect to the lens body 10 between an expanded condition seen in FIG. 1 and a contracted condition seen in FIG. 3. The wing members 21, 22 preferably have inner marginal edges 21a and 22a, respectively, which, in the normal expanded condition thereof, seen in FIG. 1, are located slighly, e.g. 1/4 mm inwardly of the opposed transverse marginal peripheral edges 10a of the lens body 10. The wing members thus overlap the opposed transverse peripheral edges 10a, i.e. those edges which are transverse to the X--X coordinate axis.

Wing members 21, 22, which form the masking means, are preferably optically opaque so as to inhibit light rays which would otherwise impinge upon the transverse peripheral edges 10a of the lens body, from being scattered by those peripheral edges to the retina of the eye to cause a glare effect. The outer marginal edges 21b, 22b, respectively, of wing members 21, 22 extend in expanded condition of the masking means to and preferably slightly beyond the perimeter of an imaginary circle P (see FIG. 3) of about 5 mm in diameter, which represents the size of the area desired to be covered. This area is covered in part by the lens body 10 and in remaining part by the masking means 20. The latter being of such size and shape as to accomplish that result.

By exerting a compressive force on the wing members 21, 22 they may be swivelled from the FIG. 1 to the FIG. 3 position thereof, so that even the outermost edges 21b and 22b thereof will be located within the maximum X--X dimension of the lens body 10. This permits the lens 1 to be inserted through an incision in the cornea which is no greater than would be required for the insertion of the lens body 10 alone in the direction parallel to the "y" axis thereof and which is therefore substantially smaller than the incision which is required for currently known intraocular lenses of this type.

It will be seen, that in order to swivel the wing members 21, 22 from the FIG. 1 to the FIG. 3 position thereof, an external force must be applied either by the surgeon placing and thereafter maintaining the wing members in the contracted condition with his surgical tools during insertion into the eye, or by use of a suture, not shown, maintaining the members in the condition seen in FIG. 3. In either event, upon release of the external force the wing members will automatically be returned by the resilient connections 11a, 11b at stem 11, to the expanded condition thereof seen in FIG. 1, in which condition they will remain after seating of the lens in the eye. It will be seen that, according to this embodiment of the invention, the wing members 21, 22 overlie the lens body 10 either only partially, when in the FIG. 1 expanded condition or substantially in their entirety, when in the contracted FIG. 3 condition. According to the preferred embodiment, the entire lens 1 may be of one-piece construction and may be of polymethylmethacrylate material. Once the material is fixed, the resiliency of the wing members can be controlled by the shape and thickness of the ends 11a, 11b of the individual wing members in the region thereof connected to the stem 11. Preferably the structure is formed such that the resilient connection at stem 11 will provide a memory which, upon release of the external force, will return the wing members 21, 22 to their normal expanded position seen in FIG. 1. In such one-piece construction, the opacity of the wing members 21, 22 is preferably achieved by leaving the flat surfaces of the wing members in rough, unground, condition. Alternatively, one of the surfaces of the wing members may be coated with an opaque coating.

Referring now more particularly to FIGS. 4, 5 and 6 there is shown another embodiment of the present invention. The lens 1' of FIGS. 4, 5 and 6 has a lens body 10' of rectangular shape, though it will be understood that it could also be of elliptical, or even of round shape. However, the elliptical or rectangular shape is preferred since such optics permit more light to enter the eye through the optic when the pupil is dilated, as for example for night vision. Since under normal light conditions, a pupil size of less than about 3 mm diameter is to be expected, a 3 mm diameter optic will be appropriate. Under poor light conditions, on the other hand, the pupil may dilate to about 5 mm in diameter. It is therefore preferred to have an elongated optic which while narrow in width will, at least along the length thereof, accommodate as much of the available light as possible under poor light conditions. According to this embodiment of the invention the masking means is in the form of a pair of sheet members 40a, 40b. As best seen in FIG. 5 these sheet members 40a, 40b are preferably flat and preferably of soft resilient material such as silicone bonded edge-to-edge to the elongated peripheral edges 10a', 10b' of the lens body 10' and thus overlying such peripheral edges. When reference is made herein to the masking means overlying portions of the periphery of the lens body, it is intended to include not only those structures in which the masking means is located anteriorly or posteriorly of the lens body but also those structures in which the masking means is located radially outwardly of the lens body, i.e. in edge-to-edge adjacency, as for example, in the lens of FIGS. 4, 5 and 6. Thus, the masking means 40a, 40b according to this latter embodiment, are substantially coplanar with the lens body 10' and, since they are of flexible sheet material, can be resiliently deformed into the condition thereof shown in FIG. 6, i.e., folded under the lens body 10' so as to overlie substantially in their entirety the posterior surface of the lens body 10'. Upon removal of the external force maintaining the masking means 40 in the condition shown in FIG. 6, the resilient nature of the masking means 40 will return the latter to the expanded condition thereof shown in FIGS. 4 and 5.

Whether the masking means are in the form of a pair of wing members as seen in FIGS. 1, 2 and 3 or in the form of a pair of sheet members as seen in FIGS. 4, 5 and 6, or in another form, it is important that the transverse peripheral edges 10a and 10b of the lens body 10 and the transverse peripheral edges 10a' and 10b' of lens body 10' are not left free to scatter light rays. Either they are covered by the wing members 21, 22 overlying them anteriorly or posteriorly, such as seen in FIGS. 1, 2, and 3, or they are covered by having directly bonded to them, edge-to-edge, a resilient sheet material such as shown in FIGS. 4, 5 and 6 in which event the masking means overlie the edge portion by being outwardly adjacent thereto. In either event, the glare effect which would result from light rays impinging on the transverse peripheral edges 10a and 10b, or 10a' and 10b' of the miniature optic 10 or 10' respectively and being thereby scattered toward the retina, is inhibited by the provision of an artificial iris in the form of the masking means shown.

It will be seen that in accordance with the present invention the lens 1' may alternatively be of round shape (not shown) and have a round ring-shaped masking means of a soft resilient material fully surrounding it.

The preferred lens body, according to the present invention, has a maximum dimension along any line therethrough in a direction parallel to a given one of the said pair of coordinate axes, of about 3 mm. For example, the dimension along the X axis of optic 10' in FIG. 4 may be about 3 mm and the dimension along the Y axis may be about 6 mm. This will provide the additional light needed for better night vision without increasing that dimension of the lens which controls the size of the incision, i.e., in this case, the "X" dimension. It will be seen that the masking means need only be provided in connection with the peripheral edges substantially transverse to the "X" axis, i.e. edges 10a and 10b for the FIG. 1 embodiment and 10a' and 10b' for the FIG. 4 embodiment and need not be provided along the marginal regions at the top and bottom of the elongated optic. As a consequence of the elongated shape of the optic, the only marginal edges which will normally be within the bundle of light rays impinging on the retina through the pupil of the eye and therefore the only edges which need to be masked are the transverse peripheral edges such as edges 10a', 10b' in FIG. 4.

In FIG. 7 there is shown still another embodiment of the present invention. Lens 1" in FIG. 7 has a rectangular optic 10" identical to the optic 10' in FIG. 4 except that optic 10" is provided with a pair of stems 11a and 11b extending at opposite elongated ends thereof. Position-fixation members 31, 32 preferably extend from the stems 11a and 11b as shown and may be formed as onepiece with the lens body 10". The masking means 50a, 50b according to the FIG. 7 embodiment are substantially identical to the masking means 20 in FIG. 1 except that instead of the wing members 50a and 50b being connected to a single stem 11, they are each connected to a different one of the stems 11a and 11b spaced from each other along the Y axis at opposite ends of lens body 10" and situated generally intermediate the transverse edge portions 10a" and 10b" of lens body 10". Elongated wing member 50a is integrally connected at one end thereof with stem 11a while elongated wing member 50b is integrally connected at one end thereof with stem 11b. The stems 11a, 11b, the connecting portions 51a, 51b and the wing members 50a, 50b are all part of the masking means and are shaped so as to cover that part of the imaginary circle P (which circle represents a transverse cross-sectional area of about 6 mm) which is not covered by the lens body 10". As is the case with the embodiment of FIGS. 1, 2 and 3, the wing members 50a, 50b are deflectable into the contacted condition of FIG. 8 by sliding under the posterior surface of lens body 10" so that the outer maximum dimension of any line drawn through the lens 1" in a direction parallel to the X axis will be no greater than the maximum X dimension of the lens body 10". The connecting portions 51a, 51b are sufficiently thin so as to permit the wing members 50a, 50b to flex from the expanded condition thereof in FIG. 7 to the contracted condition in FIG. 8.

From the foregoing description it will be apparent that an intraocular lens constructed in accordance with the invention has the advantage that the lens can be inserted into the eye through an incision which is smaller than the incisions currently required for conventional intraocular lenses. It should be noted that currently the incision must be at least 5 mm in length as determined by the minimum size optic in conventional use. Since incisions of only approximately 2.5 mm to 3 mm is length are required to remove the cataracted natural lens it is of course highly desirable to have an intraocular lens which will not require a larger incision.

While there have been described what are at present considered to be the preferred embodiments of this invention, it would be obvious to those skilled in the art that various changes and modifications may be made therein without departing from the invention, and it is, therefore, aimed to cover all such changes and modifications as fall within the true spirit and scope of the invention.