Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Eye prosthesis – Intraocular lens
Reexamination Certificate
1998-06-05
2001-02-06
Smith, Jeffrey A. (Department: 3732)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Eye prosthesis
Intraocular lens
C606S107000, C206S316100
Reexamination Certificate
active
06183513
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to an intraocular lens (IOL) implant packaging system, and more particularly, to a foldable IOL storage container equipped with means for holding and folding a foldable IOL having been packaged therein.
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 IOL implant is positioned therein. Originally, extracapsular cataract extraction was the preferred and most commonly used surgical technique for intraocular lens removal. However, over time surgeons found that by reducing the size of the incision made in the cornea and lens capsule, or capsular bag, complications were also reduced. Postoperative complications commonly associated with large incision ocular surgery include for example induced astigmatism. Accordingly, today, phacoemulsification is the more popular and most commonly used surgical technique for intraocular lens removal due in part to the relatively small incision required to be made through the cornea and lens capsule.
Once diseased lens tissue is removed from the lens capsule of an eye, an IOL implant is typically introduced. A typical IOL implant includes an optic portion and at least one support member or haptic for positioning and supporting the IOL within the lens capsule or capsular bag. The diameter of the optic portion varies depending on the design of the IOL within the range of about 5 millimeters (mm) to 7 mm. It is a goal of the surgeon to make and utilize as small of an incision as possible, such as about 3 mm, during the removal of diseased lens material. If a 5 to 7 mm rigid IOL were to be implanted in a lens capsule, the surgeon would have to widen a 3 mm incision significantly to allow the IOL to be inserted. However, such an enlargement of the incision would reduce one of the advantages of phacoemulsification surgical technique. Therefore, foldable IOLs have been developed which may be folded, inserted into an eye's capsular bag and then released or unfolded with minimal or no widening of the original approximately 3 mm incision.
As known to those skilled in the art, foldable IOLs generally are made from polyurethane elastomers, silicone elastomers, hydrogel polymers, collagen compounds, organic gel compounds, synthetic gel compounds or a combination thereof. The resultant IOL preferably has a soft foldable lens optic portion. However, lenses that are soft and foldable can in some cases be difficult to fold using known folding and insertion devices due to surface tackiness. However, most foldable lenses described above may be rolled, compressed or folded by a special syringe or forceps, and then placed into an eye's capsular bag by releasing the same without enlarging the original incision. IOL folding devices are described in detail in U.S. Pat. Nos. 5,281,227, 5,290,293, and 5,607,433. While such folding and insertion devices work well for many of the IOLs manufactured from the materials discussed above, the same is not true for all foldable IOLS depending on the particular composition and /or design of the IOL. Furthermore, many such folding and insertion devices are bulky and require much practice to perfect the use thereof.
In order for a surgeon to fold an IOL without the aid of a special folding device such as those described above, forceps or a similar type tool is used to remove the IOL from the IOL packaging. A second tool or forceps is then used to fold the IOL. The folded IOL is then typically transferred for proper gripping to a third tool or set of forceps for insertion into the capsular bag of an eye. Such a technique, while safe and effective, requires a great deal of practice to perfect.
Accordingly, a long felt need exists for an inexpensive tool or method that allows a surgeon to easily remove an IOL from its packaging, fold the IOL and implant the same within an eye without numerous transfers between tools.
BRIEF SUMMARY OF THE INVENTION
The present invention is a packaging system for IOL implants. The preferred embodiment of the subject packaging system includes a bottle or vial, a sealing apparatus and a cap member which removably locks onto the bottle and maintains the sealing apparatus in proper sealing alignment over an open end of the bottle. The sealing apparatus is generally a disk with one planar surface thereof having two arms extending therefrom. The arms are designed to provide a pair of jaw members for holding an IOL. A removable retainer member extends around a portion of the jaw members to retain the IOL in proper orientation between the jaw members by maintaining the relative position of the jaw members. The retainer member protects the IOL within the bottle during sterilization, storage and transportation such that the IOL is not dislocated or damaged before its intended use.
In using the subject packaging system, the cap member is removed from the bottle. The sealing apparatus is then removed from the bottle and inverted so that the arms extend upwardly. The retainer member is removed from around and between the jaw members such as by twisting in a counter-clockwise direction and then lifting the same. Once the retainer member is removed, the arms may then be squeezed together so that the jaw members move in closer proximity to one another. In bringing the jaws in closer proximity, the IOL is supported therebetween in a folded position. A pair of insertion forceps or the like is then used by a surgeon to remove the folded IOL from its packaging for insertion within a patient's eye.
Accordingly, it is an object of the present invention to provide packaging for an IOL, which protects the same from damage.
Another object of the present invention is to provide a single storage, holding and folding device for a foldable IOL.
Another object of the present invention is to provide an IOL folding device, which is easy to use.
Another object of the present invention is to provide IOL packaging that keeps a foldable IOL wet, free of contamination, and protected from damage during sterilization, storage and handling.
Another object of the present invention is to provide IOL packaging that delivers an accurately and precisely folded wet IOL to a surgeon and to eliminate the need for a separate folding tool.
Still another object of the present invention is to provide IOL packaging that requires the use of only one hand to fold the lens so that the surgeon's other hand can hold insertion forceps for removal of an IOL therefrom for insertion into a patient's eye.
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.
REFERENCES:
patent: 4257521 (1981-03-01), Poler
patent: 4326306 (1982-04-01), Poler
patent: 4423809 (1984-01-01), Mazzocco
patent: 4697697 (1987-10-01), Graham et al.
patent: 4844242 (1989-07-01), Chen et al.
patent: 5281227 (1994-01-01), Sussman
patent: 5290293 (1994-03-01), Van Noy et al.
patent: 5454818 (1995-10-01), Hambleton et al.
patent: 5607433 (1997-03-01), Polla et al.
Adams Bradly
Guenthner Gary L.
McMaster Brian Monroe
Stefaniak Glenn Thomas
Bausch & Lomb Surgical, Inc.
Smith Jeffrey A.
Vacca Rita D.
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