# Patent

## Title
Intraocular lens

## Abstract

An accommodating intraocular lens comprising a lens optic coupled to at least one haptic and a torsion bar positioned between the lens optic and the at least one haptic such that the torsion bar facilitates accommodation by deforming in response to a vitreous pressure change.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is based on U.S. Provisional Application No. 61/689,394, filed on Jun. 5, 2011, the contents and disclosures of which are fully incorporated herein by reference.
BACKGROUND OF THE INVENTION
Premium intraocular lenses (IOLs) implanted during cataract surgery are categorized three ways: accommodating, multifocal and toric intraocular lenses.
The best visual acuity is achieved with the single focus accommodating lenses. The optic of these lenses moves forward and backward upon constriction and relaxation of the ciliary muscle. However, for reading in dim lighting conditions, or for small print, week reading glasses are often necessary.
The multifocal lenses focus light on the retina at either two or three focal lengths. Thus, there is more than one image on the retina simultaneously. This creates problems since the amount of light in focus is divided between the multiple focal points, and contrast sensitivity is thereby reduced, making vision at all distances difficult in dim lighting. In addition, there are severe problems when driving at night when the pupil is dilated. Many patients experience severe glare and halos and many have had to have the multifocal lenses explanted and replaced with a single vision standard lens, because of this problem. However, the near vision with the multifocal lenses is superior to that of the current accommodating lens.
The toric lenses correct the eyes that have significant astigmatism.
The currently marketed plate accommodating intraocular lenses provide excellent distance and intermediate vision but sometimes require weak, +1.00, reading glasses for prolonged reading, for seeing small print, or reading in dim lighting conditions.
Furthermore, it is important for intraocular lenses to have a consistent location along the axis of the eye to provide good uncorrected distance vision and to center in the middle of the vertical meridian of the eye. Without excellent uncorrected distance vision there is no point in implanting lenses designed to give seamless vision from far to near.
The original intraocular lens consisted of a single optic. These lenses frequently de-centered and dislocated and it was discovered that there was a need to center and fixate the lens optic in the vertical meridian of the eye.
Attachments to the optic that center and fixate the lens within the capsular bag are called haptics. Traditionally, haptics consist of multiple flexible loops of various designs, J loops, C loops, closed loops and flexible radial arms. Recently, traditional haptics have been replaced in some lens designs with oblong, flat flexible plates, called plate haptics. These plate haptics usually made from silicone, are solid, flat, flexible and between 3.0 and 6.0 mm in width, 0.20 to 0.75 mm thick, and may have tapered, rounded or parallel sides. Plate haptics often have flexible loops or fingers that help center and fixate the lens within the capsular bag. These flexible fingers extend beyond the distal or outer end of the plate haptics and slightly beyond the diameter of the capsular bag and are designed to flex centrally to center and fixate the lens and its optic within the capsular bag.
An intraocular lens (IOL) is a lens implanted into the eye, usually replacing a normal human lens that has been clouded over by a cataract, or can replace a normal human lens as a form of refractive surgery to change the eye's optical power.
An accommodating IOL (AIOL) permits refocusing of the eye by means of movement along the optical axis in response to the constriction or relaxation of ciliary muscles. Near vision results from a forward movement of the optic upon constriction of the ciliary muscle which increases the pressure in the posterior part of the eye with a simultaneous decrease in pressure in the anterior part of the eye. Distance vision results from the reverse pressure change that takes place upon relaxation of the ciliary muscle and the resultant backwards movement of the lens. The movement of the optic enables the patient implanted with the lens to automatically change their vision between far, intermediate and near.
AIOLs are known to consist of opposing haptics positioned on either side of a lens optic. Once a patient's cataract is removed, e.g. by phacoemulsification, the AIOL is placed into the empty capsular bag. The haptics help to center the AIOL and fixate it within the capsular bag by fibrosis. Such AIOLs are described in U.S. Pat. Nos. 5,674,282, 5,476,514, and 5,496,366, to Cumming, herein incorporated by reference in its entirety.
And although current AIOLs provide patients with significantly restored distance and intermediate vision, adequate near vision is commonly lacking—often requiring that patients use weak reading glasses to enhance near vision. Multi-focal and toric lens solutions suffer from the disadvantages identified above.
SUMMARY OF THE INVENTION
An intraocular lens according to an embodiment of the present invention is described that overcomes the deficiencies of present designs noted above.
The field of the invention is an intraocular lens that provides seamless vision from distance to near.
An intraocular lens is provided comprising a lens optic coupled to at least one haptic and a torsion bar positioned between the lens optic and the at least one haptic.
The intraocular lens may comprise, for example, an intraocular lens for improving vision wherein the intraocular lens is configured for implantation in a capsular bag of a patient. The lens comprises: a single focus, biconvex optic and a pair of plate haptics.
The single focus, biconvex optic comprises an optical material. The optic has a circular configuration configured to be centered about an optical axis of the eye when implanted. The lens has a longitudinal axis defining a length dimension of the lens and a transverse axis defining a width dimension of the lens, both of which are orthogonal to the optical axis of the eye when implanted. The transverse axis of the lens is perpendicular to the longitudinal axis of the lens. The optic has a first side and a second side. The first side of the optic and the second side of the optic are on opposite sides of the transverse axis of the lens.
One of the plate haptics is coupled to the first side of the optic, and the other plate haptic is coupled to the second side of the optic. The longitudinal axis of the lens extends through the optic and the pair of haptics. Each plate haptic comprises a proximal end and a distal end, a frame, and a pair of opposing lateral paddles. The proximal end is closer to the optic than the distal end. Each plate haptic comprises a haptic material. The frame is embedded within the haptic material. The frame comprises a different material that is more rigid than the haptic material to provide longitudinal rigidity to the haptic. The pair of opposing lateral paddles are configured to stabilize the lens to prevent the intraocular lens from tilting. The pair of lateral paddles form bilateral extensions of the haptic to at least partially surround the optic. The pair of lateral paddles are configured to locate the optic in a posterior position along the optical axis of the eye when implanted. The more rigid material of the frame extends into each lateral paddle to provide longitudinal rigidity to the pair of lateral paddles and the plate haptic. The haptics are configured to vault posteriorly in response to an end-to-end compressive force from the capsular bag such that the paddles are posterior to the distal ends of the haptics, the paddles being configured to apply force on the vitreous cavity. Each plate haptic is flexibly coupled to the optic by a haptic coupling system. The haptic coupling system comprises a strap, a transverse slot, and a connecting bar. The strap is coupled to the optic. An elongate axis of the strap is substantially perpendicular to the longitudinal axis of the lens. A length of the strap is measured along the elongate axis of the strap. The transverse slot extends completely through the haptic coupling system. The transverse slot is distal to the strap. An elongate axis of the slot is substantially perpendicular to the longitudinal axis of the lens. A length of the slot measured along its elongate axis is between 2.0 mm and 5.0 mm. The connecting bar is distal to the strap and proximal to the elongate slot such that the connecting bar is between the strap and the elongate slot. The longitudinal axis of the lens extends through the strap, the connecting bar, and the slot. The connecting bar extends laterally from one of the lateral paddles to the other of the lateral paddles. Each of the connecting bars is configured to stretch and twist upon the end-to-end compressive force from the capsular bag to position the optic posteriorly in the capsular bag upon implantation.
Other features and advantages of the present invention will become apparent from the following more detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the presently described apparatus and method of its use.



BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)
Illustrated in the accompanying drawing(s) is at least one of the best mode embodiments of the present invention In such drawing(s):
FIG. 1 illustrates a top plan view of an AIOL according to at least one embodiment of the present invention.



DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The above described drawing figures illustrate the described invention in at least one of its preferred, best mode embodiment, which is further defined in detail in the following description. Those having ordinary skill in the art may be able to make alterations and modifications to what is described herein without departing from its spirit and scope. Therefore, it should be understood that what is illustrated is set forth only for the purposes of example and should not be taken as a limitation on the scope of the present invention.
A preferred embodiment will now be described with reference to FIG. 1.
An accommodating intraocular lens (AIOL) 100 comprises: an optic 200 coupled to at least one haptic 300.
The AIOL 100 is placed into the capsular bag of a patient's eye after cataract surgery via known techniques such as, for example, phacoemulsification. The lens is centered so that the optical axis of the lens coincides with that of the patient's eye. The haptics 300 contact the capsular bag and the natural fibrosis of the tissue secures the haptics 300, and consequently the AIOL 100, in place.
The optic 200 is preferably a single focus optic that gathers the incoming light and focuses it on the retina of the patient so as to effect vision. The optic 200 may be bioconvex, refractive, diffractive, plano-convex, Fresnell, spheric, aspheric, toric, or of any other type that is substantially single focus. In order to permit the optic 200 to be inserted into the eye through a small incision, the optic 200 is preferably made of a flexible optical material, such as, for example, silicone, acrylic, hydrogel, or other flexible optical material now known or hereafter developed.
The at least one haptic 300 comprises a proximal end 320 opposite a distal end 340. The proximal end 320 is flexibly coupled to a periphery of the optic 200. In at least one embodiment, the AIOL 100 comprises opposing haptics positioned linearly along a longitudinal axis A of the AIOL 100.
The haptic body may be substantially flexible in the transverse direction and substantially rigid in the longitudinal direction so as to enable the AIOL 100 to be folded and inserted into the eye via a small incision. One of ordinary skill will appreciate that while substantial rigidity may promote vaulting; the degree of rigidity imposed is not intended to preclude an effective vault of the optic. It is preferable that the haptic be constructed of the same or similar flexible material as the optic, including, but not limited to: silicone, hydrogel, acrylic, or similar material.
The plate haptic 300 may comprise opposing lateral paddles 310, the haptic and paddles operable to engage, fixate and center the haptic into the capsular bag. Such exemplary haptics and paddles are discussed in U.S. Pat. Nos. 13/017,189; 13/092,359; 13/111,599; and 13/155,327; 13/472,893; and 13/472,354, incorporated herein by reference in their entireties.
A frame 330 may be embedded within the haptic 300 so as to promote the longitudinal rigidity thereof. The frame may be formed of polyimide, prolene, polymethylmethanylate (PMMA), titanium, or similar material. The frame may be a meshwork of rigid material molded into the flexible material and/or a lattice of such material. Such exemplary frames are discussed in U.S. Pat. Nos. 13/017,189; 13/092,359; 13/111,599; and 13/155,327; 13/472,893; and 13/472,354, incorporated herein by reference in their entireties.
The haptic 300 may further comprise projections 350, or fingers, extending from the distal end to engage the capsular bag and secure and center the AIOL thereto. The projections may be homogeneous with the frame and may be made of either polyimide, PMMA, acrylic or any other inert material. Such exemplary projections are discussed in U.S. Pat. Nos. 13/017,189; 13/092,359; 13/111,599; and 13/155,327; 13/472,893; and 13/472,354, incorporated herein by reference in their entireties.
The proximal end 320 of the haptic 300 may be coupled to the optic via connecting portion 360 that operates to permit contraction of the ciliary muscles to cause an end-to-end compression of opposing haptics with an increase in vitreous pressure, thus moving the optic substantially forward. The connecting portion 360 preferably comprises a strap 362 adjacent the optic periphery and flexibly coupled thereto, a torsion bar 364 adjacent the strap opposite the optic, and an elongate slot 366 adjacent the torsion bar opposite the strap. Accordingly, the strap, torsion bar and slot are arranged linearly along the longitudinal axis of the AIOL.
The strap 362 couples the optic to the haptic and is preferably of the same material as the haptic. The strap assists in accommodation in that they decrease the resistance to the pressure that pushes the optic forward. Exemplary straps are described in U.S. Pat. Nos. 13/017,189; 13/092,359; 13/111,599; and 13/155,327; 13/472,893; and 13/472,354, incorporated herein by reference in their entireties.
The torsion bar 364 extends laterally between opposing paddles of the haptic. Moreover, the torsion bar is preferably integral to the haptic at each of the lateral ends (with respect to the longitudinal axis A) of the torsion bar, and is preferably of the same flexible material as the haptic. However, the torsion bar may also be of a different material than the haptic such that the torsion bar is substantially more rigid or more flexible than the haptic. As mentioned above, the torsion bar is adjacent the strap at one longitudinal end (with respect to the longitudinal axis A), and adjacent the elongate slot. In at least one embodiment, the torsion bar may be from 0.1 to 2.0 mm in length. Preferably, the torsion bar has a circular cross-section, but all cross-sectional shapes are specifically contemplated.
The elongate slot 366 is an aperture formed in the haptic that extends laterally and parallel to the torsion bar and partially separating the torsion bar from the balance of the haptic. Preferably, the slot comprises an oval shape, but all shapes are specifically contemplated. As mentioned above, the slot is adjacent the torsion bar distal to the optic. Preferably, the slot dimensions ranging from 0.1 to 0.5 mm in height and 2.0 to 5.0 mm in length.
On insertion into the eye, the haptics are vaulted posteriorly. The haptics move centrally and posteriorly in response to ciliary muscle contraction, i.e. end-to-end compression. Such movement, combined with the change in vitreous pressure, causes the optic to vault anteriorly and the haptics to vault centrally and posteriorly to further increase the pressure in the posterior vitreous cavity of the eye. This increase in pressure is further facilitated by the paddles dipping posteriorly into the vitreous cavity, thereby causing the optic to move forward. This effect is further facilitated by the stretching and/or rotation of the torsion bars in response to the movement. Relaxation of the ciliary muscle causes an increase in the diameter of the ciliary muscle and a reduction in vitreous cavity pressure with an increase in pressure in the anterior part of the eye such that the optic 200 moves posteriorly to the distant vision position.
In at least one embodiment, the longitudinal length of the AIOL (i.e. from distal end to distal end) may be between approximately 9.0-11.0 mm, with the diameter as measured from the tips of the lateral projections being between approximately 11.5-12.0 mm. The haptics are preferably between 3.0-6.0 mm wide and 0.20-0.75 mm thick, while the optic may be approximately 5.0 mm.
The enablements described in detail above are considered novel over the prior art of record and are considered critical to the operation of at least one aspect of the invention and to the achievement of the above described objectives. The words used in this specification to describe the instant embodiments are to be understood not only in the sense of their commonly defined meanings, but to include by special definition in this specification: structure, material or acts beyond the scope of the commonly defined meanings Thus if an element can be understood in the context of this specification as including more than one meaning, then its use must be understood as being generic to all possible meanings supported by the specification and by the word or words describing the element.
The definitions of the words or drawing elements described herein are meant to include not only the combination of elements which are literally set forth, but all equivalent structure, material or acts for performing substantially the same function in substantially the same way to obtain substantially the same result. In this sense it is therefore contemplated that an equivalent substitution of two or more elements may be made for any one of the elements described and its various embodiments or that a single element may be substituted for two or more elements in a claim.
Changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalents within the scope intended and its various embodiments. Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements. This disclosure is thus meant to be understood to include what is specifically illustrated and described above, what is conceptually equivalent, what can be obviously substituted, and also what incorporates the essential ideas.
The scope of this description is to be interpreted only in conjunction with the appended claims and it is made clear, here, that the named inventor believes that the claimed subject matter is what is intended to be patented.

## Claims

1. An intraocular lens for improving vision, the intraocular lens configured for implantation in a capsular bag of an eye of a patient, the lens comprising:
a single focus, biconvex optic comprising an optical material, the optic having a circular configuration configured to be centered about an optical axis of the eye when implanted, the lens having a longitudinal axis defining a length dimension of the lens and a transverse axis defining a width dimension of the lens, both of which are orthogonal to the optical axis of the eye when implanted, the transverse axis of the lens being perpendicular to the longitudinal axis of the lens, the optic having a first side and a second side, the first side of the optic and the second side of the optic being on opposite sides of the transverse axis of the lens;
a pair of plate haptics, one of the plate haptics coupled to the first side of the optic and the other plate haptic coupled to the second side of the optic, the longitudinal axis of the lens extending through the optic and the pair of haptics, each plate haptic comprising:
a proximal end and a distal end, the proximal end being closer to the optic than the distal end, each plate haptic comprising a haptic material;
a frame embedded within the haptic material, the frame comprising a different material that is more rigid than the haptic material to provide longitudinal rigidity to the haptic; and
a pair of opposing lateral paddles that are configured to stabilize the lens to prevent the intraocular lens from tilting, the pair of lateral paddles forming bilateral extensions of the haptic to at least partially surround the optic, the pair of lateral paddles configured to locate the optic in a posterior position along the optical axis of the eye when implanted;
wherein the more rigid material of the frame extends into each lateral paddle to provide longitudinal rigidity to the pair of lateral paddles and the plate haptic;

wherein the haptics are configured to vault posteriorly in response to an end-to-end compressive force from the capsular bag such that the paddles are posterior to the distal ends of the haptics, the paddles being configured to apply force on the vitreous cavity;
wherein each plate haptic is flexibly coupled to the optic by a haptic coupling system comprising:
a strap coupled to the optic, an elongate axis of the strap being substantially perpendicular to the longitudinal axis of the lens, a length of the strap measured along the elongate axis of the strap;
a transverse slot extending completely through the haptic coupling system, the transverse slot being distal to the strap, an elongate axis of the slot being substantially perpendicular to the longitudinal axis of the lens, a length of the slot measured along its elongate axis being between 2.0 mm and 5.0 mm; and
a connecting bar distal to the strap and proximal to the elongate slot such that the connecting bar is between the strap and the elongate slot, the longitudinal axis of the lens extends through the strap, the connecting bar, and the slot, the connecting bar extending laterally from one of the lateral paddles to the other of the lateral paddles,

wherein each of the connecting bars is configured to stretch and twist upon the end-to-end compressive force from the capsular bag to position the optic posteriorly in the capsular bag upon implantation.

2. The intraocular lens of claim 1, wherein the haptic material and the optic comprise a same material.

3. The intraocular lens of claim 2, wherein the same material is acrylic.

4. The intraocular lens of claim 2, wherein the same material is silicone.

5. The intraocular lens of claim 1, wherein each frame is shaped to make its respective plate haptic more flexible about a longitudinal axis of the plate haptic than about a transverse axis of the plate haptic to enable the intraocular lens to be folded and inserted into the eye, the longitudinal axis of the plate haptic being perpendicular to the transverse axis of the plate haptic and collinear with the longitudinal axis of the lens, and wherein the transverse axis of the haptic is parallel to the transverse axis of the lens.

6. The intraocular lens of claim 1, wherein each frame comprises polyimide.

7. The intraocular lens of claim 1, wherein each frame comprises PMMA.

8. The intraocular lens of claim 1, wherein the length dimension of the lens is between 9.0 mm and 11.0 mm.

9. The intraocular lens of claim 1 wherein each haptic and associated pair of lateral paddles are contiguous and form a structure which is more flexible about a longitudinal axis of the structure than about its transverse axis, wherein the longitudinal axis of the structure is co-linear with the longitudinal axis of the lens.