Surgery – Instruments – Means for removing – inserting or aiding in the removal or...
Reexamination Certificate
1999-10-29
2001-06-26
Philogene, Pedro (Department: 3732)
Surgery
Instruments
Means for removing, inserting or aiding in the removal or...
Reexamination Certificate
active
06251114
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to apparatus and methods for inserting an intraocular lens through a small incision into an eye. More particularly, the invention relates to such apparatus and methods wherein the desired orientation of the lens being inserted in the eye is easily, controllably and effectively achieved.
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, which 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 often involves making an incision in the eye. Making the incision as small as possible reduces trauma and speeds healing.
IOLs are known which are foldable (deformable) so that the IOL can be inserted into the eye through an incision smaller than the diameter of the lens.
The success of foldable IOLs is enhanced by the surgeon's ability to control the orientation of the IOL during lens insertion. An IOL which is not correctly oriented as it is released from the inserter apparatus into the eye may require relatively difficult reorientation and/or can damage one or more parts of the eye.
Some of the most generally accepted insertion apparatus employ a hollow insertion tube having a diameter which permits the folded IOL to pass freely through the tube without permanent deformation, and without causing the surgeon to apply excessive force to overcome friction between the walls of the insertion tube and the IOL. Excessive force can result in the premature ejection of the IOL before the surgeon is ready to position it within the patient's eye. It would be advantageous to provide IOL insertion apparatus and methods which facilitate the passage of a folded IOL through the apparatus and the insertion of the IOL in the eye in easy, effective and controlled manner while avoiding damage to the IOL and undue trauma to the patient.
In these generally accepted apparatus, the insertion tube is held in a handpiece which is coupled to a plunger rod. The plunger rod is moved distally through the insertion tube to urge the IOL to pass through the tube and into the eye. Zaleski U.S. Pat. No. 5,643,276 discloses an IOL insertion apparatus in which the rod is rotated relative to the handpiece being held by the surgeon The rod, in turn, contacts the IOL and provides the IOL in the desired orientation for insertion into the eye. The disclosure of this patent is incorporated in its entirety herein by reference. Although the apparatus disclosed in this patent is often effective in properly orienting the IOL for insertion, it would be advantageous to have a system providing even more direct rotational control to provide proper orientation of the IOL prior to insertion.
SUMMARY OF THE INVENTION
New apparatus for inserting IOLs and methods for inserting IOLs have been discovered. The present apparatus and methods address one or more of the concerns of the prior art systems, such as those noted above. The present apparatus enable the surgeon to achieve a desired orientation, for example, rotational orientation, of the IOL as the lens is released from the insertion apparatus, thus providing for the use of effective, reliable, and non-excessive amounts of force to insert a folded IOL into an eye. This desired orientation is achieved very directly so that, for example, the insertion tube carrying the IOL is axially rotated. Thus, the surgeon can easily determine, and be assured, that the desired orientation of the IOL is being obtained. In addition, the present system reduces the need for additional manipulation of the IOL by the surgeon to achieve the desired placement of the IOL within the eye. The present invention is straightforward, easy to produce and practice, and involves little or no modification of surgical techniques. In other words, surgeons need not learn a different surgical procedure for inserting an IOL into the eye, nor does the IOL need to be modified to accommodate the present apparatus and methods.
In one broad aspect, the present invention comprises apparatus for inserting IOLs into an eye which include a tube, such as an insertion tube or cartridge, defining a hollow passage, for example, through at least a portion of which a folded IOL can be moved. This tube has an ejection port or opening, preferably at the distal end of the tube, from which the IOL is passed for insertion into an eye. An injector rod is also included and is longitudinally or axially movable within the hollow passage of the tube. The distal segment of the rod is adapted to urge the folded IOL distally through the passage, for example, by contacting the folded IOL as the distal segment of the rod passes distally in the passage. A housing is provided and includes a distal portion adapted to hold the tube, and a proximal portion coupled, preferably rotatably coupled, to the distal portion. A rotation assembly is located relative to the distal portion of the housing so that the distal portion is axially rotated, preferably axially rotated a controlled amount, relative to the proximal portion of the housing as the injector rod is moved distally through the tube. The rotation of the distal portion of the housing directly rotates the IOL in the held tube as it moves distally through the hollow passage of the tube. Rotating the IOL provides for the IOL, and in particular the leading or superior fixation member of the IOL, to be oriented during the IOL insertion process so as to reduce, or even eliminate, the risk of eye damage as the IOL is being inserted into the eye. In addition, the surgeon can visually observe the rotation of the distal housing, and thereby be provided with increased assurance that the orientation of the IOL as it exits the insertion tube is as desired, thereby making the entire insertion process easier and reducing the risk of surgical error. Also, the present system very effectively places the IOL in the desired location in the eye so that a reduced amount of repositioning of the IOL in the eye is needed.
In one embodiment, the rotation assembly comprises a cam race and a cam follower. A particularly useful embodiment provides for a rotation assembly in which a cam race is disposed on the injector rod and the cam follower is disposed on the distal portion of the housing. Of course, other constructions or configurations are effective to provide the desired controlled rotation and are included within the scope of the present invention. For example, the cam race can be disposed on the distal portion of the housing and the cam follower can be disposed on the injector rod. Also, the rotation assembly can include a worm gear and a worm gear guide. Additionally, the wall of the distal portion of the housing and the injector rod can be matingly configured, for example, threaded, to facilitate the desired degree of rotation. In fact, any suitable construction which provides for axial rotation, preferably controlled rotation, of the distal portion of the housing relative to the proximal end of the housing as the rod is moved distally in the tube may be employed and is within the scope of the present invention.
The proximal portion and the distal portion of the housing may be coupled together in any suitable manner provided that these two housing portions are rotatable, preferably axially rotatable, relative to each other, at least to the extent necessary to achieve the desired rotation of the IOL, as described herein. Although these two housing portions need not be directly coupled, it is preferred that the distal end portion be directly coupled to the proximal end portion. The proximal end portion preferably is adapted to be held in a hand of a surgeon when the apparatus is used to insert an IOL. For example, the proximal portion of the housing may
Farmer Christopher G.
Kerridge David
Allergan Sales Inc.
Philogene Pedro
Stout, Uxa, Buyan & Mullins
Uxa Frank J.
LandOfFree
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