Multi-functional eyelid speculum

Surgery – Means for introducing or removing material from body for... – Treating material applied to or removed from external...

Reexamination Certificate

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C600S205000, C600S236000

Reexamination Certificate

active

06267752

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to an eyelid speculum for ophthalmic use, in particular an apparatus which irrigates and aspirates the corneal solutions automatically, and illuminates the interior and exterior of the eye.
BACKGROUND OF THE INVENTION
The eyelid speculum is a well known device in the field of ophthalmology, both for use in diagnostics and in surgery of the anterior and posterior segments of the eye. The purpose of an eyelid speculum is to mechanically retract the eyelids from the surface of the eyeball. Although retraction is necessary for a physician to work, it keeps the eyelids from performing their natural function of lubrication. Therefore, there is a risk of the cornea drying out. Current practice requires an assistant to irrigate the area manually every few moments, so as to provide artificial lubrication to neutralize the drying process caused by the speculum. Long-term non-lubrication of the eye when the speculum is in place may cause injury to the cornea, affecting its transparency and integrity.
There exist speculums with irrigation/aspiration features (Storz Ophthalmic Inc., U.S. and Moria Co., France), however these are provided in a manual form, requiring the physician to push or pull on the plunger of the syringe provided as needed. This is not practical as the physician's hands are required for the surgery and constant removal from the site is counter-productive. Therefore, there is no added benefit to this speculum, as a second set of hands is still necessary to make it useful.
Additionally, the physician working with the speculum requires an illumination source to illuminate the work area. The ophthalmic surgeon operates through use of a microscope with an illumination source which delivers coaxial light. The coaxial light source provides a high level of illumination which has a phototoxic effect on the eye tissue. It is necessary to use a combination of filters or light-dimming techniques to reduce these effects. Even so, the surgeon uses only a portion of the light which reaches the anterior eye tissue and the remaining, unnecessary light penetrates the eye and is absorbed by the retina. The intensity of the unnecessary light causes phototoxicity, damaging the photoreceptors on the retina. Research has shown that not only are the rods and cones affected, but the excess light on the retina may cause bums on the different layers of the retinal tissue. In addition, the intense light is uncomfortable for the patient and may cause excess tearing.
In certain techniques, such as vitrectomny and endo-photocoagulation, for the treatment of advanced retinal disorders, different types of miniature probes are introduced into the eye, by way of example, for cutting membranes, aspiration of residues, oil and gas infusions and laser photocoagulation therapy. Included in these probes is an illumination probe which functions in illuminating that small portion of the retina which is being treated. Consequently, a small portion of the retina receives a concentrated quantity of light delivered by the probe, which is connected to a strong light source. This type of light source also causes the phototoxic effect reported above.
U.S. Pat. No. 5,054,906 to Lyons discloses an indirectly illuminating ophthalmalogical speculum which is primarily suited for external illumination of the cornea in ophthalmogical procedures on the surface of the eye. The speculum is provided as a conventional eyelid speculum with two fiber optics mounted thereon. These fiber optics do not provide a circumferential or constant homogeneous illumination of the eye. Additionally, the Lyons speculum does not provide for trans-illumination of the eyeball, for use in cases where the physician must view the interior of the eye, but rather is designed for use on the surface of the eyeball.
U.S. Pat. Nos. 5,582,608 and 5,695,492 to Brown describe an embodiment with a ring illumination for hand-held use, or to be attached to a support. The device must be used in combination with an eyelid speculum, or the eyelids will occlude the field under observation. Brown provides interior trans-illumination for the purpose of retroillumination, i.e. for the physician to look at the light returning through the lens to see the pathology of the lens. However, the Brown patent does not provide for trans-illumination for the pupose of examining the retinal pathology. Examination of the retina requires a stronger light intensity, potentially causing damage to the retina during long-term radiation. The Brown patent does not allow for this use, or make accommodation for minimizing the damage of a light which is introduced conventionally through the pupil of the eye.
Therefore, it would be desirable to provide an eyelid speculum which would automatically irrigate and aspirate the eye surface, while optionally providing a light source which would provide homogeneous, constant, well-distributed illumination of either the interior or exterior of the eyeball as needed while not causing phototoxic effects on the eye tissue and would provide an illumination system independent of the optical system.
SUMMARY OF THE INVENTION
Accordingly, it is a broad object of the present invention to overcome the problems of the prior art and provide a multi-functional speculum which irrigates and aspirates the eyeball surface, and optionally provides a safe and homogeneous light source for illumination of both the interior and the exterior of the eye as needed, while not causing phototoxic effects on the eye tissue.
In accordance with a preferred embodiment of the present invention, there is provided a multi-functional eyelid speculum comprising:
a main body defining a perimeter of a work area;
an eyelid retractor extending from said main body, comprising a substantially flat ring fitting the angle of curvature of an eye, for separating a pair of eyelids so as not to obstruct access to the eye in said work area; and
means for automatically irrigating and aspirating an eye surface mounted on said main body at at least one point on said main body perimeter.
In a preferred embodiment of the invention there is provided an eyelid speculum for separation of the eyelids with an automatic system for irrigation and aspiration. The speculum is provided, by way of example, as a truncated cone-shaped main body with lid retractors extending out of it in the form of a ring, forming an angle appropriate to the curvature of the eye. Hollow rings are provided in the body of the cone with perforated channels for delivering irrigation fluid and for aspiration. Two syringes are provided, each connected by tubing to one of the hollow rings so as to either deliver irrigation or aspirate excess fluid. Each syringe is connected to a small motor by a screw wherein the direction of the motor rotor determines the intake and output of the syringe's piston. The irrigation and aspiration rates are controlled by an electronic processor which controls the rates of both activities independently.
A simplified version of this embodiment may be provided, in which one syringe, one tube and one hollow ring are used both for irrigation and for aspiration, as needed. Alternatively, two syringes may lead into a common tube and hollow ring allowing irrigation from one syringe and aspiration of material into a separate syringe.
In another preferred embodiment, the device is further provided with an illumination unit for trans-illumination via the sclera of the interior of the eyeball. The light which reaches the interior of the eyeball through the sclera is diffuse and homogeneous and thus comfortable for the surgeon to work with while not endangering the eye tissue. There is no need for the user to illuminate the eye with the harsh light of the microscope.
The illumination unit is provided as a light source connected to a plurality of light guiding elements which are circumferentially arranged in a hollow ring in the main body of the speculum. In one design, a single light source controls all of the light elements in the ring. In another variation, at

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