This invention relates to intra ocular lenses and more particularly to intra ocular lenses that have a positive and negative lens that may be assembled within the eye as part of implantation or outside of the eye.
The lens within the human eye has the capability of changing shape and thereby focus so that objects both far and near can be registered sharply on the retina. This ability to change focus is known as accommodation. With age, the lens gradually loses its range of accommodation. The human lens not only loses accommodative range with aging, but also transparency. When the lens loses a significant amount of transparency (thus producing a blurry image on the retina), it is said that the lens is cataractous or has become a cataract. Treatment for a cataract requires the surgical removal of the cataract and the placing of a man made synthetic lens (intra ocular lens or IOL) in the eye. The earlier IOL's had a fixed focus and thus had no accommodative function.
However, in time a number of IOL's were designed in multifocal form. Different zones of a multifocal IOL have different dioptric powers. With such multifocal IOL's, light from objects, only within a specific range of viewing distances, passing through a particular zone will form sharply focused images on the retina. On the other hand, if an object is outside this range, its image formed by the zone under consideration will be blurry. Multifocal IOL's typically have two or more zones, each designed for a specific viewing distance. A consequence of this design approach is that the imagery of multifocal IOL's is never very sharp. The success of multifocal IOL's depends on the visual processing system of the patient's eye and brain that tends to pay attention to the light most sharply focused on the retina, and tends to ignore the light formed diffusely on the retina.
These were followed by IOL's that could move back and forth via ciliary muscle contraction and thus focus objects from different distances onto the retina. However, these IOL's have limited range of movement and thus a limited accommodative range.
Another form of IOL is made of an elastomer filled flexible balloon which is placed within the emptied lens capsule and alters lens shape under the influence of the ciliary muscle contraction.
Another accommodative IOL design is comprised of two positive lens elements (i.e. two plano-convex lenses) connected by two flexible hinges. The lens components are spread or come together in response to ciliary muscle contraction.
In our invention, we have an intra ocular lens that is a combination of a positive lens (i.e. lens is thicker at center than at edge), and a negative lens (i.e. lens is thinner at center than at edge). The positive-negative doublet combination of our invention yields a much larger focusing range with small changes in separation between the component lenses, when compared to either a positive singlet configuration or a positive-positive doublet configuration. Also, the newly designed IOL can alter dioptric power if placed in either of two intra ocular locations after cataract removal: a) within the capsular bag, or b) placed within the ciliary sulcus. In both locations, the contraction of the ciliary muscle alters the separation between the positive and negative lenses.
The present invention provides:
1. Intra ocular lenses having the combination of a negative lens and a positive lens and forming a dual intra ocular lens in the eye by separately implanting the positive lens and the negative lens in the eye in such a manner that the positive lens will move relative to the negative lens along the optical axis in response to the movement of the ciliary muscle of the eye during accommodation response of the eye.
2. Intra ocular lenses having the combination of a negative lens and a positive lens which are joined together outside of the eye in such a manner that when the combination is implanted in the eye, the positive lens will move relative to the negative lens another along the optical axis in response to the movement of the ciliary muscle of the eye during accommodation response of the eye.
3. Intra ocular lenses having the combination of a negative lens and a positive lens and forming a dual intra ocular lens in the eye by implanting a positive lens or a negative lens into an eye already having implanted therein one of the lenses.
4. An intraocular lens having a lens linkage that provides relatively larger movement of the lens with a small movement of the ciliary muscle.
5. An intraocular lens having a first linkage having a first end connected to the lower portion of the intraocular lens and a second end to be connected to an upper eye portion of the ciliary muscle, and a second linkage having its first end connected to the upper portion of the intraocular lens and its second end to be connected to a lower eye portion of the ciliary muscle.
6. Intra ocular lenses as noted in above 1- 5 wherein the lenses are implanted in or outside of the lens capsule or capsular bag.
One embodiment of the present invention is to provide dual intra ocular lenses having the combination of a negative lens and a positive lens substantially coaxially aligned and separated along their optical axis and forming the dual intra ocular lens in the eye by separately implanting the positive lens and the negative lens in the eye such that the positive lens will move relative to the negative lens.
A second embodiment of the present invention is to provide an eye intra ocular lens that has a negative lens and a positive lens that are axially separated and said intra ocular lens is formed inside the eye as part of an implantation of the negative and positive lenses in an eye or outside of the eye by connecting the negative and positive lenses prior to implantation into the eye such that the positive lens will move relative to the negative lens.
A still further embodiment of the present invention is to provide a method of improving vision for an eye which has been diagnosed as being approved for intra ocular lens implants comprising implanting a negative lens with, before or after implanting a positive lens, and implanting said negative lens such that the positive lens will move relative to negative lens along the optical axis in response to the ciliary muscle of the eye during the accommodation response of the eye.
For the purpose of promoting an understanding of the principles of the invention, references will be made to the embodiment illustrated in the drawings. Specific language will also be used to describe the same. It will, nevertheless, be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention illustrated herein being contemplated as would normally occur to one skilled in the art to which the invention relates.
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Our invention relates to an IOL configuration having a positive lens and a negative lens with a variable focal length (or dioptric power) that depends on the distance along the optical axis separating the two lenses while maintaining a constant angular magnification for objects viewed over a wide range of distances (e.g. from infinity to typical reading distances). The positional order of the lenses in the eye can be either with the positive lens more anterior or the reverse, or with the negative lens more anterior or the reverse. Each negative and positive lens may be placed either in the capsular bag or the ciliary sulcus. The negative and positive lenses either may or may not be mechanically linked to one another by tabs and strut-like linkages (haptics) attached to the edges of the two lenses. During cataract surgery and IOL implantation, the positive and negative lenses may be inserted intra ocularly either one at a time (if the components are not mechanically linked to one another), or both at the same time (if the components are mechanically linked to one another). The linkages serve to hold the positive and negative lenses in place, as well as serve to adjust and control the distance separating the two lenses when powered by ciliary muscle contraction. It is the separation between the lenses that accounts for the change in IOL power (i.e. accommodation).
The lenses are located with their axes parallel (or nearly parallel) to one another and to the optical axis of the eye (coaxial configuration). This coaxial configuration is maintained during the change in separation of the lens elements which causes the eye's accommodative response. The positive-negative lens configuration provides a greater change of dioptric power with change in separation distance than any other configuration such as a positive-positive or a singlet positive configuration.
However, we also provide a linkage for our intraocular lens that provides larger axial movement of the lens than known linkages for IOLs. Our linkage can be used on either the negative or positive lens when a dual lens is used or on a single lens.
One general configuration of our dual intra ocular lens within the eye is shown in
The positive and negative lenses 4,5 generally will have spherical surfaces; however, since astigmatic and other aspherical-shaped singlet IOL's (both symmetric and asymmetric with respect to their optical axes) now are manufactured for implantation in the eye, the positive and negative lenses 4,5 may also have these more general surface shapes. Fresnel-type IOL lenses also are used in cataract surgery. These lenses generally have a succession of stepped-annular zones or facets which serve to minimize a Fresnel lens's thickness while maximizing it power. Fresnel-type positive and negative lenses are suitable lens components for use in our invention. Also, diffractive lens configurations are sometimes used (i.e., diffractive lenses or lenses with one surface diffractive and the other surface refractive.
Generally, a person is not reading and is looking at objects more than two feet away. In that condition, the ciliary muscle is relaxed and the general configuration of our dual IOL within the eye is shown in
1/f=1/f1+1/f2−d/(f1 *f2) (1)
Let f1 and f2 represent the respective focal lengths of the positive and negative lens components. Since f1>0 and f2<0, Equa. 1 shows that f decreases as d increases. As the eye accommodates as shown in
The easiest way to understand why a positive-negative doublet provides a greater change of dioptric power with change of separation distance than a positive-positive doublet is by examining the formula for the combined power of a pair of thin lenses, D, expressed in terms of the powers of the two lens components, D1 and D2, the spacing between them, d, and the refractive index of the medium, n, in which the lenses are situated. Multiply both sides of Equa. 1 by the refractive index, n, and then recognize that dioptric power is n/(focal length) in order to find Equa. 2.
D=D1+D2−D1*D2*d/n (2)
The change of dioptric power with change of separation distance, expressed as δD/δd, is obtained by differentiating Equa. 2.
δD/δd=−(D1*D2)/n (3)
When fitting a particular patient with an IOL, the doctor determines the correct IOL power for distance vision which, in terms of the above parameters, requires D1+D2 to have a particular value. By way of example, we will set D1+D2=24 diopters which is a typical value. Table 1 below shows δD/δd calculated from Equa. (3) for different values of D1 and D2 (constrained so that their sum equals 24 diopters) when the refractive index of the media n=1.33. Note in Table 1 that the largest values of δD/δd (i.e. the change of dioptric power with change of separation distance) occur when D1 is most positive and D2 is most negative.
As noted above, the preferred manner of correcting a patient's vision in one eye is to open the eye's lens capsule or capsule bag 31 (
The linkages A, B, C, and D(
In
Although the hinge configuration in
Another hinge configuration that may be used to move the two lenses during accommodation can have a more general “lambda” shape (i.e. the Greek letter λ) or, perhaps, a mirror-image λ shape. This kind of hinge has four (not three) flexure joints and, with a generalized λ-hinge configuration, the legs may have different lengths and angles. Within the practice of mechanical engineering and design, it is obvious to those skill in those fields that there are many other hinge configurations that will result in constraining the movements of the two lenses appropriately in order to achieve the benefits of our invention.
Although
Although the preferred two lenses are inserted into the eye separately, the two lenses could be joined prior to insertion to form a dual IOL and the dual IOL is inserted. This is not preferred because this requires a larger incision to be made after the cataract is removed.
A pair of inferior haptics (inferior linkage legs) 58 have their respective first ends 59 pivotally linked to the upper frame comers 53. The respective second ends 61 of the inferior haptics 58 are attached to the lower or inferior portion of the ciliary sulcus 22. The haptics 55 as shown are generally straight and are a parallel extending pair as are the haptics 58. Although a separate frame 52 is used to hold the IOL optic 51, the frame could be an integral part of the IOL optic 51 or the haptics could be connected directly to the IOL optic 51. That is the haptics 55 would be connected to the lower portion of the IOL optic below the center line dividing the upper and lower portion of the IOL i.e., the center line passing through the 3 and 9 o'clock position. The first end 56 of the haptics 55 is preferably connected at a position from 8 to 6 o'clock and the first end 59 of haptic 58 is preferably connected at a position from 3 to 6 o'clock. The haptics 55 and 58 are connected too the IOL in such a manner that the IOL moves in the optical axial direction.
Although we show the use of two pairs of haptics, the use of only two haptics would be possible as long as they are connected to provide the axial movement. However, at least two pairs are preferable to insure axial movement. The closer the haptics are to the 6 and 12 o'clock positions, the greater the length of the haptics can be made if the haptics are placed on a diagonal.
Ray Traces for Accommodating IOL Models:
The following
By comparing the collective results for
Mathematical model results for Separation of Accommodating IOL Doublet Lens:
By applying the well-known lens formula (i.e. the equation that relates object and image distances to the focal length of a “thin” lens, namely
1/u+1/v=1/f)
successively to the eye's corneal surface, then to its anterior positive IOL component lens, and finally to its posterior negative IOL component lens, one can derive by algebraic manipulations the mathematical equation which gives the separation of the IOL component lenses in terms of the physical dimensions and optical characteristics of the eye's components as well as its accommodative state. The results of that derivation are presented here. Furthermore, the equation is applied to a specific model eye for several different powers for the positive and negative IOL components (i.e. D1 and D2).
The specific model eye is described as follows:
The accommodation power of the eye is the variable D′ and typically ranges from 0 to 3 diopters.
Next in Equation 4, we define the following parameters that have no special significance except to make the final equation, which is Equation 5, relatively compact. The spacing between the positive and negative component lenses, d, may now be written in terms of the known input and other defined parameters as Equation 5.
Define D*=D0−D′ and A=(D2/n−1/L2)31 1−L1 (4)
d=L1+½(A−n/D*)[1−{1+[4n (n/(D1D*)+A(1/D*+1/D1)]/(A−n/D*)2}1/2 (5)
Equations 4 and Equa. 5 were used to find the change in separation distance of the IOL component lenses per change in the eye's accommodative power, 5d/5D′, for several sets of D1 and D2 values. These results are expressed in Table 2.
Note that the result given in the first row of Table 2 (i.e. 0.318 mm/diopter) is in fairly good agreement with the ray trace result given for a similar model eye (i.e. 0.29 mm/diopter) where D1=+44 diopter and D2=−22 diopter (see
Various features of the invention have been particularly shown and described in connection with the illustrated embodiment of the invention, however, it must be understood that these particular arrangements merely illustrate, and that the invention is to be given its fullest interpretation within the terms of the appended claims.
This is a continuation-in-part of our PCT application PCT/US02/19534 filed Jun. 21, 2002 which claims priority of our US provisional application 60/299,757 filed Jun. 22, 2001.
Number | Date | Country | |
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60299757 | Jun 2001 | US |
Number | Date | Country | |
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Parent | PCT/US02/19534 | Jun 2002 | US |
Child | 10738271 | Dec 2003 | US |