Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Eye prosthesis – Intraocular lens
Reexamination Certificate
1999-04-29
2001-03-13
Nguyen, Dinh X. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Eye prosthesis
Intraocular lens
C623S006110, C623S006380, C623S006400, C623S006430
Reexamination Certificate
active
06200344
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to intraocular lenses (IOLs) and a method for making and using the same. More particularly, the present invention relates to IOLs designed primarily for refractive correction in aphakic eyes. IOLs made in accordance with the present invention are used in aphakic eyes to replace a surgically removed diseased natural lens, such as in the case of cataracts. IOLs made in accordance with the present invention may also be used in phakic eyes in conjunction with a natural lens to correct vision impairments.
BACKGROUND OF THE INVENTION
IOL implants have been used for 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. The 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 or posterior chamber of an eye when used in aphakic eyes or in the posterior or anterior chamber of an eye when used in phakic eyes.
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 in either phakic or aphakic applications, both softer and more rigid IOLs are subject to compressive forces exerted on the outer edges thereof, which typically occur when an individual squints or rubs the eye. These compressive forces may result in decentration of the IOL and distortion of the visual image. Compressive forces exerted on an IOL also tend to cause the lens to tilt or have axial displacement of the IOL along the optical axis of an eye. Movement of an IOL along the optical axis of an eye has the potential to cause the IOL to contact and damage delicate eye tissues. Also, IOLs of current designs, whether formed of either softer or more rigid materials, tend to deflect along the optical axis of an eye when the haptics are compressed. IOL manufacturers provide a wide range of IOL sizes to more precisely fit IOLs to each particular patient's eye size. Providing a wide range of IOL sizes is an attempt to minimize the potential for axial displacement of the IOL along the optical axis of an eye.
Because of the noted shortcomings of current IOL designs, there is a need for IOLs designed to minimize tilt or axial displacement of the IOL optic portion along the optical axis of the eye when compressive forces are exerted against the outer edges thereof. By lessening an IOL's movement along the optical axis of an eye, more certain refractive correction may be achieved and the risk of tissue damage may be reduced.
SUMMARY OF THE INVENTION
An intraocular lens (IOL) made in accordance with the present invention has an optic portion with an outer peripheral edge and two, three or four, but preferably two, looped haptic elements for supporting the optic portion in a patient's eye. The subject IOL is balanced having preferably one looped haptic element formed on one edge of the optic and the other looped haptic element formed on an opposed edge of the optic. However, alternative balanced embodiments having three or four looped haptic elements are also considered to be within the scope of the present invention. In accordance with the present invention, each of the looped haptic elements has two broad connecting portions, two radial orientation portions, two spring portions and a linking portion connecting the two spring portions. The two broad connecting portions of each looped haptic element are connected to the outer peripheral edge of the optic portion. Each looped haptic element forms a large fenestration to enhance capsular fixation once within an eye. The looped haptic elements' spring portions and linking portions are designed to engage an inner surface of a patient's eye.
Each looped haptic element's broad connecting portions are designed to achieve optimal optic stability by avoiding tilt and axial displacement. Within these broad connecting portions, each looped haptic element is designed to bend in a plane generally perpendicular to the optical axis of an eye rather than in a plane generally parallel to the optical axis of an eye. By providing looped haptic elements with this type of flexibility characteristic, the present IOL tends to have maximized stability within an eye. The flexibility characteristic of the subject looped haptic elements relative to the optic portion eliminates unacceptable tilting or axial displacement of the optic portion along the optical axis when compressive forces are exerted against the looped haptic elements of the IOL.
Accordingly, it is an object of the present invention to provide intraocular lenses for use in aphakic or phakic eyes.
Another object of the present invention is to provide intraocular lenses for use in aphakic or phakic eyes with flexibility characteristics which maximize stability thereof.
Another object of the present invention is to provide intraocular lenses for use in aphakic or phakic eyes, which minimize tilt or axial displacement of the optic portions of the lenses along the optical axis of the eyes.
Another object of the present invention is to provide intraocular lenses for use in aphakic or phakic eyes, which minimize damage to tissues in the interior of the eyes.
Still another object of the present invention is to provide intraocular lenses, which are resistant to decentration within the eyes.
These and other objectives and advantages of the present invention, some of which are specifically described and others that are not, will become apparent from the detailed description, drawings and claims that follow, wherein like features are designated by like numerals.
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Blanchard Vincent
Hoffmann Laurent
Lamielle Helene
Bausch & Lomb Surgical, Inc.
Nguyen Dinh X.
Vacca Rita D.
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