Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Eye prosthesis – Intraocular lens
Reexamination Certificate
2000-08-21
2002-09-24
McDermott, Corrine (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Eye prosthesis
Intraocular lens
C623S006620
Reexamination Certificate
active
06454802
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to coated intraocular lens implants, methods for coating intraocular lens implants and a method of using coated intraocular lens implants to reduce or eliminate residual lens epithelial cell migration and posterior capsular opacification or secondary cataract formation following the extracapsular extraction of a cataractous lens. More particularly, the present invention is directed to coated intraocular lens implants that adhere to an interior surface of an aphakic eye's lens capsule to prevent residual lens epithelial cell migration.
BACKGROUND OF THE INVENTION
Cataract extraction is among the most commonly performed operations in the United States and the world. A cataractous lens is located within a capsular sac or lens capsule in the posterior chamber of the eye. In order to gain access to the cataractous lens, an incision typically is made at the limbus of the eye for the purpose of introducing a surgical instrument into the anterior chamber of the eye. In the case of extracapsular cataract extraction, a capsulorhexis procedure is performed in which a portion of the anterior membrane of the lens capsule adjacent to the iris is removed using a surgical cutting instrument to cut and/or tear the same in order to provide direct access to the cataractous lens from the anterior chamber. The diseased lens is then removed through various known methods, including phacoemulsification. Phacoemulsification is a procedure entailing the application of ultrasonic energy to the diseased lens in order to break the cataractous lens into small pieces that can be aspirated from the lens capsule. With the exception of the portion of the anterior membrane of the lens capsule removed during the capsulorhexis procedure, the lens capsule remains substantially intact throughout an extracapsular cataract extraction. Following removal of the cataractous lens, an artificial intraocular lens (IOL) implant is typically implanted within the lens capsule in order to mimic the refractive function of a healthy natural lens.
Although cataractous lens removal with IOL implant replacement provides significant benefits to most cataract patients, it is estimated that up to fifty percent (50%) of all patients who have IOL implants placed within the lens capsule will develop posterior capsular opacification (PCO) or secondary cataract within five years after surgery. PCO is caused by the deposition of cells and fibers on the IOL implant and especially on the posterior capsular membrane. The deposition of cells and fibers behind the IOL implant obstructs light passing through the IOL implant and obscures the patient's vision. Such cell deposits originate from two sources: (1) the proliferation of residual lens epithelial cells on the interior surface of the lens capsule after surgery; and (2) the accumulation of inflammatory cells and protein deposits on the IOL implant. Of these two sources, the major cause of PCO is the proliferation and migration of residual lens epithelial cells on the capsular membrane.
Ophthalmic surgeons, aware of the problems associated with residual lens epithelial cells, typically take considerable care in trying to remove all residual lens epithelial cells prior to implantation of an IOL implant. However, despite such efforts, a significant number of residual lens epithelial cells are typically left on the interior surface of the lens capsule. Residual lens epithelial cells are often left within the lens capsule due to their position within the lens capsule. The position of the cells on an interior surface within the lens capsule makes the same difficult to observe and difficult to reach. The most common treatment for PCO entails the application of laser energy to the posterior membrane of the lens capsule for the purpose of performing a capsulotomy on the opacified posterior capsule. However, the laser energy applied to the posterior membrane of the lens capsule is ordinarily directed through the IOL implant. Laser energy has the potential of possibly damaging the optical and/or structural characteristics of the IOL implant. The application of laser energy to the posterior membrane of the lens capsule by design results in the destruction of a portion of the lens capsule as well. The destruction of a portion of the lens capsule creates risks from exposure of tissues to the vitreous, possibly resulting in serious or irreparable damage to the eye, such as an increase in intraocular pressure, retinal detachment and cystoid macular edema. Accordingly, it is preferable to prevent the occurrence of PCO rather than attempt to treat it at a later date using laser energy.
Various procedures for the prevention of PCO have been suggested in recent years. Many such procedures have included the application of chemicals to the interior surface of the lens capsule in order to destroy residual lens epithelial cells. However, none of these procedures has proven to be particularly successful in the prevention of PCO due to the fact that it is extremely difficult to destroy residual lens epithelial cells without simultaneously destroying other cells within the eye, including the possible destruction of the corneal endothelium. Other procedures suggested for the prevention of PCO include the utilization of an IOL implant manufactured from a naturally tacky or sticky material. Such an IOL implant is used to prevent PCO by adhering the same via its tacky or sticky surface to an interior posterior surface of an eye's lens capsule. PCO is thus prevented by adhering the IOL implant to the interior surface of the lens capsule and preventing the migration of residual lens epithelial cells across the capsular membrane. However, this procedure has not proven to be particularly commercially successful due to numerous difficulties associated with implanting and manipulating a tacky or sticky IOL implant that has the tendency to adhere to itself as well as to surgical instrumentation.
Accordingly, a long felt need exists for a reliable and cost effective method of preventing posterior capsular opacification or secondary cataract in cataract patients having IOL implants.
BRIEF SUMMARY OF THE INVENTION
Posterior capsular opacification (PCO) is believed to result primarily from residual lens epithelial cells of the germinal layer. These cells eventually proliferate and migrate across an eye's lens capsule into the eye's optical zone. The coated intraocular lens (IOL) implant of the present invention promotes adhesion of the IOL implant to an interior surface of an eye's lens capsule to reduce or eliminate cellular migration across the lens capsule and IOL implant.
The preferred embodiment of the coated IOL implant of the present invention is an IOL implant having one or more protein, polypeptide, polyamino acid and/or polyamine agents covalently bound to the surface thereof. Once the coated IOL implant is implanted within an eye and in contact with the eye's lens capsule, the protein, polypeptide, polyamino acid and/or polyamine agent coating on the IOL implant binds to the tissue of the lens capsule to prevent migration of residual lens epithelial cells. The subject coated IOL implant as just described may be used as customary in the field of ophthalmology for the replacement of a natural lens such as a cataractous lens.
Accordingly, it is an object of the present invention to provide a coated IOL implant useful in the prevention of PCO.
Another object of the present invention is to provide a coated IOL implant useful in the prevention of PCO, which is reliable and cost effective.
Another object of the present invention is to provide an IOL implant protein, polypeptide, polyamino acid and/or polyamine agent coating for the prevention of PCO, which is effective on IOL implants manufactured from any one of a variety of materials.
Another object of the present invention is to provide a method of using a protein, polypeptide, polyamino acid and/or polyamine agent coated IOL implant to prevent PCO.
Still another object of the present inv
Bretton Randolph H.
Green George F.
Vanderbilt David P.
Bausch & Lomb Incorporated
McDermott Corrine
Phan Hieu
Vacca Rita D.
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