Surgery – Instruments – Light application
Reexamination Certificate
2001-04-25
2003-06-17
Dolinar, Andrew M. (Department: 3747)
Surgery
Instruments
Light application
C351S210000
Reexamination Certificate
active
06579282
ABSTRACT:
FIELD OF THE INVENTION
The present invention pertains generally to ophthalmic devices and procedures. More particularly, the present invention pertains to devices and methods that are useful for tracking the movement of an eye during a diagnosis of the eye or during a corrective procedure such as corneal laser surgery. The present invention is particularly, but not exclusively, useful for tracking rotational movements of the eye.
BACKGROUND OF THE INVENTION
The use of lasers is now almost commonplace in a variety of ophthalmic applications, including the diagnosis and treatment of ocular diseases, as well as the diagnosis and correction of optical deficiencies. As an example, corneal reshaping procedures using lasers, such as the well known LASIK procedure, are now widely available. When used, these procedures often obviate the need for glasses and/or contact lenses. In all of these procedures, the laser is chosen as the tool of choice because of the ability of the laser to be focused on extremely small amounts of ocular material. In addition, the ability of the laser to be guided to prescribed locations within the eye with precision and reliability has enabled a whole new class of ophthalmic procedures that require nothing short of pinpoint accuracy. Unfortunately, movements of the eye relative to the laser source can undermine the accuracy of the laser and reduce the efficacy of ocular laser procedures.
Movements of the eye can be classified broadly into voluntary and involuntary movements. Voluntary movements can often be almost completely eliminated in most patients by instructing the patient to concentrate (i.e. fixate) on a small light source. Still, a small percentage of patients, such as infants and some toddlers, are unable to follow instructions, and as such, voluntary movements in these patients can have adverse effects on a laser operation unless the movements are either compensated for or eliminated. Although involuntary eye movements cannot be remedied by instruction they must also be somehow controlled. Included in the involuntary eye movements are movements due to the patient's pulse or breathing. These involuntary eye movements, however, generally occur at a relatively low frequency (e.g. 1 Hz). Additionally, even psychotic eye movements, such as can occur when a patient is startled, generally occur at a frequency in the range of only approximately 50 Hz. Moreover, psychotic eye movements don't generally occur during eye fixation. A typical laser procedure, however, can be accomplished relatively quickly (e.g. several m Sec). Nevertheless, involuntary eye movement must either be compensated for, or effectively eliminated.
One way to reduce or effectively eliminate the adverse consequence of either voluntary or involuntary eye movements is to restrain the eye. In this regard, several devices have been disclosed in the art that mechanically apply a pressure to the eye for the purpose of restraining the eye. Generally, this pressure is applied to the surface of the eye (i.e. the sclera, limbus or cornea). It is to be appreciated, however, that eye restraint systems suffer from several drawbacks. First, the restraint device may need to be positioned along a desirable laser path. If so, the restraint device can interfere with the laser procedure. Further, the pressure applied to the eye can be sufficient to change the shape of the eye and, thereby, complicating the effort to focus the laser with high degrees of accuracy. Importantly, the pressure applied to the eye is often uncomfortable to the patient and can result in post-operative pain and scarring. Finally, the pressure can cause damage to the eye by increasing the intra-ocular pressure of the eye to dangerous levels.
Important for the present invention is the technique used to sense eye movement. Heretofore, several techniques for sensing eye movement have been disclosed. One way to track the eye is to find a pre-existing optical feature of the eye and track the optical feature. One such technique is to follow the displacement of one or more of the purkinje projections. Other devices use the visible contrast of the eye to track the eye. For example, one system tracks the edge between the iris and the pupil, and another system tracks the edge between the iris and the sclera. Another disclosed system uses the overall contrast of the eye to track movement with the use of photodetectors in an all analog system. However, the use of pre-existing landmarks requires custom system calibration for each patient (i.e. the surgeon must define and find the landmark (or at least verify that the system has found the correct pre-existing landmark) within the initial system coordinates. Further, eye contrasts vary from patient to patient, leading to scattered results.
Several benefits accrue to systems that establish a reference mark on the eye and then use the created reference mark to track eye movement. One advantage, as alluded to above, is consistency from eye to eye. In one respect, the contrast and spatial resolution of the created reference mark can be controlled. Also, and importantly for the present invention, the shape and location of the mark can be controlled. For example, in U.S. Pat. No. 4,848,340 entitled “Eyetracker and Method of Use”, a reference mark created by cutting a mark onto the surface of the cornea is described.
A general knowledge of the anatomy of the cornea of an eye is helpful for appreciating the problems that must be confronted when creating reference marks within the stroma of the cornea. The cornea comprises various layers of tissue which are structurally distinct. In order, going in a posterior direction from outside the eye toward the inside of the eye, the various layers in a cornea are: an epithelial layer, Bowman's membrane, the stroma, Decimet's membrane, and an endothelial layer. Of these various layers, the stroma is the most extensive and is generally around four hundred microns thick.
In detail, the stroma of the eye is comprised of identifiable and distinguishable layers of lamellae. Each of these layers of lamellae in the stroma is generally dome-shaped, like the cornea itself, and they extend across a circular area having a diameter of approximately six millimeters. Unlike the layer that a particular lamella is in, each lamella extends through a shorter distance of only about one tenth to one and one half millimeters. Thus, each layer includes several lamellae. Importantly, each lamella includes many fibrils which, within the lamella, are substantially parallel to each other. The fibrils in one lamella, however, are not generally parallel to the fibrils in other lamellae. This is so between lamellae in the same layer, as well as between lamellae in different layers. Finally, it is to be noted that, in a direction perpendicular to the layer, the individual lamella are only about two microns thick.
Within the general structure described above, there are at least three important factors concerning the stroma that are of interest insofar as the creation of a reference mark in the stroma of the cornea is concerned. The first of these factors is structural, and it is of interest here because there is a significant anisotropy in the stroma. Specifically, the strength of tissue within a lamella is approximately fifty times the strength that is provided by the adhesive tissue that holds the layers of lamella together. Thus, much less energy is required to separate one layer of lamella from another layer (i.e. peel them apart), than would be required to cut through a lamella.
The second factor is somewhat related to the first, and involves the stromal tissue response to photoablation. Specifically, for a given energy level in a photoablative laser beam, the bubble that is created by photoablation in the stronger lamella tissue will be noticeably smaller than a bubble created between layers of lamellae. Conversely, for a given energy level, a larger bubble can be created at the interface between layers of lamellae. Thus the present invention recognizes that it is prefer
Bille Josef
Loesel Frieder
20/10 Perfect Vision Optische Geraete GmbH
Dolinar Andrew M.
Nydegger & Associates
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