Surgery – Instruments – Means for removing – inserting or aiding in the removal or...
Reexamination Certificate
1999-08-06
2001-06-19
Hirsch, Paul J. (Department: 3732)
Surgery
Instruments
Means for removing, inserting or aiding in the removal or...
Reexamination Certificate
active
06248111
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to apparatus for inserting an intraocular lens through a small incision into an eye, and to methods for inserting an intraocular lens into an eye. More particularly, the invention relates to apparatus which are designed to facilitate inserting a foldable or deformable intraocular lens into an eye and to methods using such apparatus to insert such an intraocular lens into an eye.
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 involves making an incision in the eye. It is advantageous, to reduce trauma and speed healing, to have an incision size 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.
One additional factor to be considered in inserting foldable or deformable IOLs into the eye relates to the amount of force required for such inserting. Advantageously, the amount of force required is reduced, for example, to reduce the risk of damaging the IOL and to reduce the risk of detrimentally affecting the patient.
Makker et al U.S. Pat. No. 5,716,364 discloses a very useful apparatus for inserting IOLs including a lubricity enhancing component to facilitate the IOL insertion process and, preferably, to reduce the amount of force required. The disclosure of this patent is hereby incorporated in its entirety herein by reference.
There continues to be a need to provide IOL insertion apparatus which are effective to facilitate the passage of folded or deformed IOLs through the apparatus in a controlled manner without using excessive force.
SUMMARY OF THE INVENTION
New apparatus for injecting or inserting IOLs and methods for using such apparatus have been discovered. The present apparatus achieve reduced friction between the IOL and the insertion apparatus as the IOL is being passed through the insertion apparatus and into the eye. Thus, IOLs can be inserted using the present apparatus preferably with reduced amounts of force, for example, relative to prior art apparatus. The present apparatus are easy to produce and are straightforward in construction. The methods of use included in the present invention are straightforward and easy to practice, and may involve surgical techniques which are well practiced and conventionally used to insert IOLs into eyes.
In one broad aspect of the present invention, apparatus for inserting an IOL including a deformable optic through a small incision into an eye are provided. The apparatus comprises a hollow tube including a material, preferably a polymeric material. The hollow tube has an interior wall defining a hollow space through which the IOL is passed and an outlet through which the IOL is passed from the hollow space into the eye. In one embodiment, the interior wall is configured so that a portion of the interior wall remains out of contact with the deformable optic as the IOL passes through the hollow space. This reduced contact between the IOL and the interior wall of the hollow tube advantageously reduces the friction between the IOL and the hollow tube which, preferably, reduces the amount of force required to pass the IOL from a fixed position through the hollow space relative to the force required to pass an identical IOL including an identical deformable optic from a fixed position through a similar hollow space defined by a similar interior wall configured so that substantially all of the similar interior wall contacts the identical deformable optic as the identical IOL passes through the similar hollow space. The present apparatus preferably require reduced amounts of force to pass IOLs including deformable optics through the hollow space and into the eye relative to prior art apparatus.
The interior wall of the hollow tube may have any suitable configuration so that a portion of the interior wall remains out of contact with the deformable optic as the IOL passes through the hollow space. For example, at least a portion of the interior wall or surface can be roughened or include rifling. The interior surface can include at least one groove, preferably a plurality of spaced apart grooves, for example, such groove or grooves extending substantially parallel to the longitudinal axis of the hollow tube, that is one or more substantially longitudinal grooves. In a further embodiment, the interior wall includes a plurality of spaced apart inwardly extending projections or bumps which provide the desired configuration to the interior wall, as described herein.
In a very useful embodiment, the present apparatus further include a lubricity enhancing component secured, preferably physically secured, to the hollow tube and concentrated at or near the interior wall. This lubricity enhancing component is effective to facilitate the passage of the IOL through the hollow space. More preferably, the lubricity enhancing component is effective to further reduce the force needed to pass the IOL through the hollow space relative to the force needed to pass an identical IOL through the hollow space of a similar apparatus without the lubricity enhancing component.
By “physically” securing or bonding is meant, a non-covalent chemical bonding joining or coupling, and preferably a non-chemical bonding, joining or coupling. Some interaction, for example, some interaction, for example, ionic and/or electrical interactions may occur between the lubricity enhancing component and the other material or materials making up the hollow tube. However, the present “physical” securing or bonding is clearly distinguished from forming covalent chemical bonds between the lubricity enhancing component and the other material or materials making up the hollow tube.
As used herein, the term “concentrated” means that the lubricity enhancing component is located in a higher concentration at or near one or more portions, for example, the surfaces, of an article than at one or more other portions, for example, the interior, of the article. This includes the situation in which the lubricity enhancing component is located as a coating on the interior surface of the hollow tube and is not present in the hollow tube itself. Also included is a situation in which the hollow tube includes a concentration of lubricity enhancing component throughout with a locally higher concentration present at or near the interior surface of the hollow tube.
The interior wall may be exposed to a plasma. Alternately, the interior wall is not subjected to plasma exposure. In one embodiment, the interior wall is a plasma- exposed interior wall which has an enhanced ability to physically secure the lubricity enhancing component relative to a substantially identical interior wall which is not plasma exposed. The plasma-exposed interior wall preferably facilitates forming the lubricity enhancing component concentrated at or near the interior wall.
A suitable lubricity component which functions as described herein may be employed. The lubricity enhancing component may be selected from hydrophilic components, oleophilic components and mixtures thereof. In a very useful embodiment, the lubricity enhancing component is selected from water soluble components and mixtures thereof. Such water soluble components have the substantial advantage of dispersing relatively rapidly in the eye, for example, after being introduced into the eye with the IOL. Thus, the use of water soluble lubricity enhancing components reduce the risk of long term, or even transient, detrimental effects on the eye or on t
Glick Robert E.
Makker Harish
Ott Robert D.
Allergan Sales Inc.
Hirsch Paul J.
Stout, Uxa, Bryan & Mullins
Uxa Frank J.
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