Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Eye prosthesis – Intraocular lens
Reexamination Certificate
1999-11-05
2004-07-27
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Eye prosthesis
Intraocular lens
C623S006370
Reexamination Certificate
active
06767363
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to an intraocular lens (IOL) system and a method for making and using the same. More particularly, the present invention relates to an accommodating IOL system designed for multi-distance visual imaging in aphakic eyes where a diseased natural lens has been surgically removed, such as in the case of cataracts.
BACKGROUND OF THE INVENTION
IOL implants have been used for many years in aphakic eyes as replacements for diseased natural crystalline lenses that have been surgically removed from the eyes. Many different IOL designs have been developed over past years and proven successful for use in aphakic eyes. Successful IOL designs to date primarily include an optic portion with supports therefor, called haptics, connected to and surrounding at least part of the optic portion. The haptic portions of an IOL are designed to support the optic portion of the IOL in the lens capsule, anterior chamber or posterior chamber of an eye.
Commercially successful IOLs have been made from a variety of biocompatible materials, ranging from more rigid materials such as polymethylmethacrylate (PMMA) to softer, more flexible materials capable of being folded or compressed such as silicones, certain acrylics, and hydrogels. Haptic-portions of the IOLs have been formed separately from the optic portion and later connected thereto through processes such as heat, physical staking and/or chemical bonding. Haptics have also been formed as an integral part of the optic portion in what is commonly referred to as “single-piece” IOLs.
Softer, more flexible IOLs have gained in popularity in more recent years due to their ability to be compressed, folded, rolled or otherwise deformed. Such softer IOLs may be deformed prior to insertion thereof through an incision in the cornea of an eye. Following insertion of the IOL in an eye, the IOL returns to its original pre-deformed shape due to the memory characteristics of the soft material. Softer, more flexible IOLs as just described may be implanted into an eye through an incision that is much smaller, i.e., 2.8 to 3.2 mm, than that necessary for more rigid IOLs, i.e., 4.8 to 6.0 mm. A larger incision is necessary for more rigid IOLs because the lens must be inserted through an incision in the cornea slightly larger than the diameter of the inflexible IOL optic portion. Accordingly, more rigid IOLs have become less popular in the market since larger incisions have been found to be associated with an increased incidence of postoperative complications, such as induced astigmatism.
After IOL implantation, both softer and more rigid IOLs are subject to compressive forces exerted on the outer edges thereof from natural brain-induced contraction and relaxation of the ciliary muscle and increases and decreases in vitreous pressure. Compressive forces of this kind are useful in a phakic eye for focusing the eye at various distances. Most commercially successful IOL designs for use in aphakic eyes have single focus optic portions that are fixed and focus the eye at only a certain fixed distance. Such fixed single focus IOLs require the wearing of glasses to change the focus of the eye. A few fixed bifocal IOLs have been introduced to the commercial market but suffer from the disadvantage that each bifocal image represents only about forty percent of the available light thus lessening visual acuity.
Because of the noted shortcomings of current IOL designs, there is a need for accommodating IOLs designed to provide improved visual imaging at various distances in aphakic eyes without the aid of eyeglasses.
SUMMARY OF THE INVENTION
An accommodating intraocular lens (IOL) system made in accordance with the present invention has a positive intraocular lens used in conjunction with a negative intraocular lens. The positive intraocular lens has a “higher” diopter, preferably approximately +20 diopter or greater, such as but not limited to +20 to +60 diopter, positive optic portion with an outer peripheral edge and two or more but preferably two, three or four haptic elements for supporting the optic portion in a patient's eye. The negative intraocular lens has a “lower” diopter, preferably approximately −10 diopter or less, such as but not limited to −10 to −50 diopter, negative optic portion also having an outer peripheral edge and preferably the same, but optionally a different number of haptics from that of the positive optic portion. Positive and negative intraocular lenses each having two haptic elements are balanced for stability within an eye to minimize decentration by having a haptic element integrally formed with or subsequently attached to two opposed edges of each of the two optic portions. Positive and negative intraocular lenses each having three haptic elements are balanced to achieve stability and minimize decentration by having a set of two haptic elements integrally formed with or subsequently attached to one edge of each of the optic portions and a third haptic element integrally formed with or subsequently attached to an opposite edge of each of the optic portions. Positive and negative lenses each having four haptic elements are balanced to achieve stability and minimize decentration by each optic portion having a set of two haptic elements integrally formed with or subsequently attached to one edge of the optic and a set of two haptic elements integrally formed with or subsequently attached to an opposite edge of the optic. Each haptic element has an attachment portion that permanently connects the haptic element to the outer peripheral edge of an optic portion. If the haptic element is of a looped design, the haptic element has generally two attachment portions that permanently connect the looped haptic element to the outer peripheral edge of the optic portion. In the case of lenses having three or four looped haptic elements, a set of two looped haptic elements may have three attachment portions rather than four. In such a case, one of the three attachment portions is common to each of the two looped haptic elements in the set. Each haptic element whether of a loop design or not includes a flexible central portion located between the attachment portion and a contact plate. The contact plate is designed to engage an inner surface of a patient's eye. The flexible central portions that extend between the contact plates and the attachment portions allow the optic portions of both the positive and negative lenses to move or to adjust to pressures exerted on the positive and negative lenses within the eye. Additionally, within these flexible central portions, each haptic element is designed to have less resistance to bending in a plane generally parallel to the optical axis of an eye than in a plane generally perpendicular to the optical axis of an eye. By providing haptic elements with this type of flexibility characteristic, the present accommodating IOL system achieves axial displacement of the positive optic portion with regard to the negative optic portion along the optical axis of the eye when compressive forces are exerted against the accommodating IOL system. Also, by combining a higher diopter positive optic portion with that of a lower diopter negative optic portion, an additive effect is achieved whereby even slight movement or axial displacement of the higher diopter positive optic portion with regard to the lower diopter negative optic portion achieves a significantly large increase in accommodative effect and improved multi-distance visual imaging without the aid of eyeglasses.
Accordingly, it is an object of the present invention to provide accommodating intraocular lens systems for use in aphakic eyes.
Another object of the present invention is to provide accommodating intraocular lens systems for use in aphakic eyes, which achieves axial displacement of the higher diopter optic portion with regard to the lower diopter optic portion along the optical axis of the eyes.
Another object of the present invention is to maximize accommodative effects of the i
Bandhauer Mark H.
Green George F.
Landreville Michael T.
Stenger Donald Carrol
Bausch & Lomb Surgical, Inc.
McGuire Katherine
Vacca Rita D.
Willse David H.
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