Surgery – Instruments – Means for removing – inserting or aiding in the removal or...
Reissue Patent
1999-09-20
2001-09-18
Yu, Justine R. (Department: 3764)
Surgery
Instruments
Means for removing, inserting or aiding in the removal or...
C623S006510
Reissue Patent
active
RE037387
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to an apparatus for inserting a deformable or foldable lens into an eye. More particularly, the invention relates to such an apparatus constructed so as to fold the intraocular lens and to be proximally loaded with the intraocular lens to be inserted.
An intraocular lens (IOL) is implanted in the eye, for example, as a replacement for the natural crystalline lens after cataract surgery or to alter the optical properties of (provide vision correction to) an eye in which the natural lens remains. IOLs often include an optic, and preferably at least one flexible fixation member or haptic that extends from the optic and becomes affixed in the eye to secure the lens in position. The optic normally includes an optically clear lens. Implantation of such IOLs into the eye involves making an incision in the eye. It is advantageous, to reduce trauma and speed healing, to have the incision sized as small as possible.
IOLs are known which are foldable (deformable) so that the IOL can be inserted through a smaller incision into the eye. A substantial number of instruments have been proposed to aid in inserting such a foldable lens in the eye. Many of these instruments involve pre-folding the lens before the lens is placed in the insertion device. While this hand folding allows the lens to be inserted through a relatively small incision, it is time consuming and the added handling can damage the lens.
Many of the prior art IOL insertion systems load and/or fold the IOL at the distal end, that is at the end closest to the eye or the end inserted into the eye. Such “distal loading” systems often disadvantageously include a space consuming loading component at or near the distal end of the system which causes the distal end to be relatively large. This relatively large distal end makes inserting the IOL through a small incision more difficult, if not impossible. Also, the IOL itself may structurally compromise the distal end of the inserter as a result of the distal end loading operation. Systems which fold and load the IOL proximally of the distal end provide certain advantages, such as reduced stress on the IOL and/or inserter, relative to “distal loading” systems.
Mazzocco U.S. Pat. No. 4,573,998 discloses a number of IOL insertion devices. One of these, in which the IOL is loaded proximally, provides that the unfolded IOL is maintained in a suitable liquid medium in a chamber integral with the insertion tube. Fluid pressure is used to cause the unfolded IOL to pass from the chamber into the insertion tube or cannula and then into the eye. Using fluid pressure to move the IOL from the chamber through the cannula into the eye can result in exposing the eye to relatively high fluid pressures which can damage the eye. The construction of this device, particularly proximally of the chamber, makes folding the IOL in the chamber by mechanical means, such as by using forceps, very difficult, if not impossible.
SUMMARY OF THE INVENTION
New apparatus and methods useful for surgically inserting a foldable IOL into an eye have been discovered. The present invention allows the use of a relatively small incision in the eye for IOL insertion purposes. In addition, the present apparatus can be proximally loaded with the IOL at the time of the surgery. This allows the surgeon to inspect the IOL, in its unfolded state, immediately before insertion. Further, this proximal loading of the IOL is done with a reduced amount of stress on the lens. Thus, the IOL has a reduced chance or probability of being damaged during the loading process. Moreover, the loading process is performed very speedily and reliably. The present apparatus are straightforward in construction and can be produced and used in a number of forms to suit the individual needs of the surgical application involved and/or the likes and dislikes of the surgeon. Using the present apparatus, the surgeon can easily and controllably place an IOL into a patient's eye.
In one broad aspect of the present invention, apparatus for insertion of an IOL into a small incision of an eye are provided and comprise a loading chamber and an injection cone. In one embodiment, the loading chamber has a proximal end and a distally extending opening, preferably a distally extending proximal end opening. The loading chamber defines a first lumen and is adapted to receive an IOL, preferably in an unfolded state, at the distally extending opening and to fold the IOL and maintain the IOL folded as the IOL is placed in the first lumen. In another embodiment, the loading chamber defines a first lumen and includes an open proximal end defining a non-circular proximal opening in communication with the first lumen. The loading chamber is adapted to receive an IOL, preferably in an unfolded state, at the open proximal end and to fold the IOL and maintain the IOL folded as the IOL is passed into and through the first lumen. The injection portion defines a second lumen aligned, preferably contiguous, with the first lumen. The injection portion is adapted to receive the folded IOL from the first lumen in the second lumen. The injection portion has an open distal end through which the folded IOL from the second lumen passes to be inserted into an eye.
The inclusion of a distally extending opening or a non-circular proximal opening in the loading chamber provides important advantages. The distally extending opening or the non-circular proximal opening acts to facilitate the folding of the IOL as the IOL is placed in the first lumen. The loading chamber can thus be considered to be foldable about the IOL in that the distally extending opening or the non-circular proximal opening of the loading chamber is sized and configured to facilitate the folding of the IOL passing through the distally extending opening or the non-circular proximal opening into the first lumen defined by the loading chamber.
In a further embodiment of the present invention, the loading chamber has an open proximal end and defines a first lumen, and the injection portion is as described previously. The open proximal end of the loading chamber is the proximal terminus of the first lumen. The loading chamber is adapted to receive an IOL, preferably in an unfolded state, at the open proximal end and to fold the IOL and maintain the IOL folded as the IOL is passed into and through the first lumen. In this embodiment, the loading chamber and the injection portion are a unitary or integral structure which structure proximally terminates at the open proximal end of the loading chamber. This structure is designed to facilitate the use of mechanical means, such as a forceps and the like, to insert the IOL into and through the open proximal end of the loading chamber. In so doing, the IOL is folded and is maintained folded in the first lumen of the loading chamber. The use of a forceps and the like to fold the IOL in the first lumen has substantial advantages, for example, enhanced safety, relative to the system employed by the above-noted Mazzocco patent which uses fluid pressure to pass the unfolded IOL into a tube for folding.
The present systems are preferably packaged in sterile condition. Also, since the injection portion may be inserted into the eye, it is preferred that the injection portion be made of a material which is biocompatible. Further, it is preferred that the distal end of the injection portion be sized to pass into a 3.2 mm or smaller incision in an eye.
The diameter of at least one of the first lumen and the second lumen, preferably both of such lumens, gradually decreases in the distal direction along its length. This preferred tapering facilitates folding of the IOL and/or maintaining the IOL folded as it passes through the first lumen and the second lumen.
The present invention further includes methods for inserting an IOL into an eye, preferably through a small incision into an eye. Such methods comprise placing an IOL in a insertion apparatus, as described above; placing the distal end of the injection portion of the insertion apparatus
Brady Daniel G.
Lemus Anthony V.
Zaleski Edward R.
Allergan
Stout, Uxa Buyan & Mullins, LLP
Uxa Frank J.
Yu Justine R.
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