Surgery – Instruments – Means for removing – inserting or aiding in the removal or...
Reexamination Certificate
1999-08-19
2001-05-08
Recla, Henry J. (Department: 3731)
Surgery
Instruments
Means for removing, inserting or aiding in the removal or...
Reexamination Certificate
active
06228094
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to storing and folding an intraocular lens prior to implantation.
BACKGROUND AND SUMMARY
An intraocular lens (IOL) is implanted in an eye of a patient to enhance or restore vision. Many configurations of IOLs are known. The IOL and the haptics, which hold the IOL in the eye, come in many forms. Until recently, the IOLs were generally inflexible and required an incision approximately equal in length to the diameter of the lens to be implanted. For a number of medical and clinical reasons, however, the length of the incision should be minimized.
Recently, foldable IOLs have been developed. Various configurations of foldable IOLs exist and the materials used to make them vary. The foldable IOL permits the incision for implantation to be smaller than that required for previous IOLs (e.g., fifty percent smaller or less). The inventors recognized the substantial benefits of using a smaller incision without jeopardizing the quality of the IOL.
Procedures have been developed for folding an IOL prior to implantation. These procedures generally involve using forceps to fold the IOL while a second forceps holds the IOL, or the IOL is positioned on a mechanical device and gripped by forceps. Variations on this procedure have been developed by different ophthalmologists commensurate with their particular manual dexterity, surgical skills, and preference of instruments.
Tubular IOL insertion devices have been developed to assist the ophthalmologist in inserting a foldable IOL into a patient's eye. The IOL is folded manually as described above and loaded into the insertion device. The distal end of the insertion device is passed through an incision in the eye and the folded IOL is then pushed through the distal end and expelled from the insertion device into the capsulary bag of the eye. The IOL is then centered within the eye and held in place by the haptics. In a limited number of cases, the IOL must be sutured into a desired position.
Various problems may arise while removing the IOL from its sterile storage container, manually folding the IOL, manually placing the folded IOL into the insertion device, and expelling the IOL into the eye. The professional must not drop the IOL, or damage the IOL by improperly folding it. Next, the professional must properly insert the folded IOL into the delivery device without damaging it. The IOL must be positioned in the insertion device in the proper orientation so that the IOL and associated haptics are not damaged during the process of expelling the IOL into the eye.
At all times, the professional must maintain the sterility of the IOL. Once the sterility of the IOL is broken, it must be discarded. Additionally, the folding and inserting process can be time consuming.
In view of the above problems recognized by the inventors, it is an object of the present invention to fold and insert an IOL into a lens delivery device without damaging the IOL.
It is another object of the present invention to fold and insert an IOL into a lens delivery device while maintaining the sterility of the IOL.
It is another object of the present invention to fold and insert an IOL into a lens delivery device quickly and without the need for special training or dexterity skills.
According to the present invention, a container that stores an IOL also functions as an “automatic” IOL folding and inserting device. The sterile IOL is positioned within the container. The container also includes a lens folding mechanism. The container may be coupled with a lens delivery device.
In one embodiment, the IOL is folded and inserted into a lens delivery device in a predetermined orientation during the coupling process. In another embodiment, after the lens delivery device is coupled with the container, a manipulation of the container folds and inserts the IOL into the lens delivery device in a predetermined orientation. In either embodiment, the sterility of the IOL is maintained, and the lens is folded and inserted in a manner that minimizes the possibility of damaging the IOL.
The present invention provides a number of advantages. Transfer and folding of the IOL is performed quickly and without the need for specialized training or skills. The IOL is never “directly” handled by a person (e.g., by forceps) minimizing the possibility of damaging the lens from mishandling, improper folding, or improper insertion into the lens delivery device. The IOL is always folded and positioned in the lens insertion device in a predetermined orientation.
Also, the sterility of the IOL is maintained. Finally, the lens container serves the dual purpose of (1) storing the IOL, and (2) folding and inserting the IOL into the lens delivery device. Other advantages and features will become apparent from the following description and claims.
REFERENCES:
patent: 5494484 (1996-02-01), Feingold
patent: 5578042 (1996-11-01), Cumming
patent: 5788706 (1998-08-01), Deminski
Bui Vy Q.
Fish & Richardson P.C.
Micro Medical Devices, Inc.
Recla Henry J.
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