Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Eye prosthesis – Intraocular lens
Reexamination Certificate
1998-12-11
2001-07-24
Nguyen, Dinh X. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Eye prosthesis
Intraocular lens
C351S177000
Reexamination Certificate
active
06264693
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to an air abrasive texturing process for use in the production of ophthalmic devices. More particularly, the present invention relates to an air abrasive texturing process and equipment necessary for the air abrasive texturing process to impart non-halo-inducing surfaces on intraocular lenses.
BACKGROUND OF THE INVENTION
For many years, the usual method of treating a diseased intraocular lens has been to remove the diseased lens and replace it with an IOL implant. Two surgical procedures have each been found useful in the removal of a diseased lens, i.e., extracapsular cataract extraction and phacoemulsification. Extracapsular cataract extraction involves the removal of a diseased lens in a relatively intact condition through the use of forceps or an instrument similar thereto. Phacoemulsification involves contacting a diseased lens of an eye with a vibrating cutting tip of an ultrasonically driven surgical handpiece to emulsify the lens. Once emulsified, the lens is aspirated from the eye. Both surgical procedures require the cornea (or sclera) and the anterior lens capsule of the eye to be opened to allow access to the interior of the lens capsule. Once within the lens capsule, the diseased lens is removed and an intraocular lens (IOL) implant is positioned therein.
Visual acuity deficiencies such as myopia (nearsightedness) and hyperopia (farsightedness) are typically corrected with the use of refractive lenses such as spectacles or contact lenses. Although these types of lenses are effective in correcting a wearer's eyesight, many wearers consider the lenses inconvenient. The lenses must be located, worn at certain times, removed periodically and may be lost or misplaced. The lenses may also be dangerous or cumbersome if the wearer participates in athletic activities or suffers an impact in an area near the eyes.
The use of surgically implanted IOLs as a permanent form of refractive correction has been gaining in popularity. As noted above, IOL implants have been used for years in aphakic eyes as replacements for diseased natural crystalline lenses, which 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 a part of the optic portion. The haptic portions of an IOL are designed to support the optic portion of the IOL in either the anterior or posterior 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 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. More rigid IOLs must be inserted through an incision in the cornea slightly larger than the diameter of the IOL's optic portion. 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 eyes, some patients experience visual distortions commonly referred to as “halos”. Halo visual distortions are caused by light entering a patient's eye reflecting off of the edge of the IOL. For this reason, some IOLs are produced with glare reduction zones. Glare reduction zones are typically located around an outer peripheral edge of the optic portion of the IOL and may be colored, opaque or patterned to block or diffuse light.
Unfortunately, depending on the style and material of the IOL, manufacturing an IOL with a glare reduction zone using today's techniques is often times difficult and in some cases impossible for a variety of reasons.
Because of the noted shortcomings in today's techniques for imparting a glare reduction zone on IOL implants, there is a need for a process capable of imparting a glare reduction zone on most if not all IOL styles to minimize halo visual distortions and the like.
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 at least one but preferably two or more haptic elements for supporting the optic portion in a patient's eye. The subject IOL is preferably formed of any suitable foldable or compressible IOL material known to those skilled in the art. Each haptic element preferably has an inner portion and an outer portion with the inner portion being connected to the outer peripheral edge of the optic portion. Each haptic element also preferably includes at least one contact plate on the outer portion and a central portion that extends between the contact plate and the inner portion. The contact plates are designed to engage an inner surface of a patient's eye.
Each IOL manufactured in accordance with the present invention has a glare reduction zone adjacent to an outer peripheral edge of the IOL's optic portion for reducing glare when struck by light entering the eye during high light or at times when the eye's pupil is dilated. The glare reduction zone is produced on the IOL using a highly regulated low-pressure spray of powder to impart an abraded pattern on the surface of the IOL in the desired location and pattern.
Accordingly, it is an object of the present invention to provide intraocular lenses with a glare reduction zone for use in phakic or aphakic eyes.
Another object of the present invention is to provide a process for producing a glare reduction zone on a variety of intraocular lens styles.
Another object of the present invention is to provide intraocular lenses for use in phakic or aphakic eyes, which minimize halo visual distortions.
Another object of the present invention is to provide a process for producing a glare reduction zone on a variety of intraocular lens materials.
Still another object of the present invention is to provide equipment suitable for a process for producing a glare reduction zone on a variety of intraocular lens styles and materials.
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Bausch & Lomb Surgical, Inc.
Nguyen Dinh X.
Vacca Rita D.
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