Surgery – Instruments – Means for removing – inserting or aiding in the removal or...
Reexamination Certificate
2000-11-14
2003-03-25
Truong, Kevin T. (Department: 3731)
Surgery
Instruments
Means for removing, inserting or aiding in the removal or...
C623S006180
Reexamination Certificate
active
06537282
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to a device for bending an intraocular lens with a flexible optical part, before the lens is implanted in the bent condition, by being passed through a small-sized incision (conventionally of 3 to 4 mm) provided in the eye (in general in the cornea).
DESCRIPTION OF THE RELATED ART
Intraocular lenses with a flexible optical part have the advantage that they can be bent before they are introduced into the eye, which allows them to be passed into a small-sized incision. After it has been put into place in the eye, the optical part is opened out, and resumes its initial shape.
Intraocular lenses which can be bent have an optical part made of flexible material, which in particular can be selected from amongst the elastomers of polyurethane, the elastomers of silicon, and synthetic or organic gels (hydrogel, hydrated PMMA and/or HEMA, etc.).
Intraocular lenses additionally comprise a haptic part for securing to the inner wall of the eye, which can be formed from the same material as the optical part, or on the other hand can be formed from haptic loops made from another material, for example PMMA, added to the optical part.
Some intraocular lenses with a flexible optical part can be bent, at the choice of the surgeon, according to one or the other of several different bending lines, which are selected in particular according to the shape of the lens, its location or method for implantation, or the habits of the surgeon.
Thus, intraocular lenses comprising two curved haptic loops which are in the shape of a so-called “C” can be bent as a whole according to one or the other of two methods for bending.
According to the first method for bending, known as 6 o'clock-12 o'clock, the optical part is bent according to a diametral bending line, the extensions of which beyond the optical part intersect the free end part of each haptic loop.
When the lens has been bent, its two haptic loops extend longitudinally opposite one another, on the bent optical part. The implantation is then carried out in two steps. In a first step, the surgeon, who is holding grippers, between the jaws of which the bent optical part is gripped, introduces the first haptic loop, then the optical part, into the eye (into the capsule for a cataract operation), then opens the grippers in order to release the optical part. In a second step, the surgeon grips in the grippers the second haptic loop, which is still extending through the incision, and introduces it into the eye.
This first method for bending has the advantage that it is relatively easy to execute. However, it requires two implantation steps, and two passages of the grippers through the incision. The operation is thus relatively lengthy, and these repeated passages through the incision are a risk factor for the patient.
According to the second method for bending, which is known as 3 o'clock-9 o'clock, the optical part is bent along a diametral bending line, the extensions of which beyond the optical part do not intersect the haptic loops. When the lens has been bent, its two haptic loops overlap and intersect, on the same side of the bent optical part. The implantation can then be carried out in a single step, by introducing through the incision firstly the free ends of the two haptic loops, then, after rotation, the optical part.
According to this second method for bending, the operation of implantation is faster, but far more delicate, since the surgeon must control satisfactory passage and correct positioning of the lens in the incision, and opening out of the optical part, in the eye. In addition, it may happen that the haptic loops, which are presented in the incision with their free end facing forwards, collide with an ocular wall, which can give rise to lesions of the eye, or even breakage of a haptic loop.
Consequently, neither method for bending is preferable to the other, and in fact the inventors have found that, for the same intraocular lens, there are some surgeons who recommend and use the first method for bending, i.e. 6 o'clock-12 o'clock, and others who recommend and use the second method for bending, i.e. 3 o'clock-9 o'clock. In addition, it has been found that the method for bending selected can vary according to the personality of the surgeon, i.e. according to his tastes or habits, but also, for the same surgeon, according to the cases of surgical operations to be carried out, such that it is not possible to know in advance the method for bending which the surgeon will select for an operation.
U.S. Pat. No. 5,290,293 describes bending grippers in a single piece, which comprise receptacles to accommodate the implant, and a pair of bending support surfaces, which approach one another substantially in translation, according to a diametral direction of the lens, when manoeuvring handles are actuated, which are connected to one another by a flexible portion which forms a hinge. By means of this device, when the intraocular lens has been placed in the accommodation receptacles, it can be bent only according to a single bending line, perpendicular to the said diametral direction, only according to the 6 o'clock-12 o'clock bending method. In addition, the lens must firstly be handled in order to be put into place in the accommodation receptacles of the gripper, in order to be bent.
U.S. Pat. No. 5,139,501 describes a device for bending comprising a bending support surface which is secured onto a frame, and a bending support surface which is formed at the end of a slide, which is fitted such as to be mobile in translation relative to the frame, with studs for attachment of the haptic loops. This device permits bending only according to the 3 o'clock-9 o'clock method for bending. In addition, it should be noted that the slide is guided in translation towards the lens in a dovetail slide, such that any wear dust resulting from the friction of the parts during this displacement tends to be carried towards the lens, with the risk of dirtying the latter before the implantation takes place.
These devices for bending are only slightly successful commercially. In fact, when they are provided together with the lens (for example as packaging for the lens, which is placed in the device in the factory), the surgeon can use the lens only with the method for bending of the corresponding device for bending. It is therefore necessary either to plan to select the method for bending before the purchase is made, which is rarely possible, or to constitute stocks with each type of device for bending. In addition, if the device for bending is provided independently from the lens, risky handling is necessary in order to place the lens in the device for bending, which increases the time necessary for the operation, and the risks of dirtying and deterioration of the lens.
U.S. Pat. No. 5,281,227 describes a device for bending a flexible lens comprising a frame, a one-way bending unit comprising a pair of bending jaws supported by resilient flexible side members of this bending unit, which is fitted such as to rotate on the frame, and can be disconnected from the frame, and a cap. In order to bend the lens in place between the jaws of the bending unit, the cap is removed, then the bending unit is placed according to the required orientation, by being pivoted relative to the frame, the frame preventing the lens from pivoting on its support, then the bending unit is disconnected from the frame, the lens remaining in place between the jaws of the bending unit, then a gripper to grasp the lens is inserted between the jaws of the bending unit, and the two jaws are drawn close to one another by resilient deformation of the side members. This device has the disadvantage in particular that it requires sliding of the lens support of the bending unit relative to the lens, during pivoting for orientation of the bending unit, with the risk of damaging the condition of the surface of the optical part of the lens, which is particularly sensitive. In addition, bending of the lens
David Florian
Pynson Joël
Chauvin Opsia
Truong Kevin T.
Young & Thompson
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