Surgery – Instruments – Corneal cutter or guide for corneal cutter
Reexamination Certificate
2000-02-10
2002-04-16
Dawson, Glenn K. (Department: 3761)
Surgery
Instruments
Corneal cutter or guide for corneal cutter
C606S107000, C606S167000, C604S022000
Reexamination Certificate
active
06371966
ABSTRACT:
FIELD OF INVENTION
The present invention relates to surgical scalpels and more particularly to a device for making a precise incision in the eye of a patient.
BACKGROUND
Generally in surgical procedures, a practitioner makes an incision in the body of a patient in order to repair damaged tissue, modify tissue, remove tissue or to insert some sort of implantable device. Many procedures are combinations of these procedures. One example of such a combination is found in cataract surgery. Cataract surgery is performed to remove the lens of a patient's eye that has become substantially or partially opaque having an adverse effect on the patient's visual acuity. Practitioners have found that if the opacified lens is removed and replaced with an implantable intraocular lens (IOL), there are significant improvements in the patient's visual acuity. In order to perform this procedure, the practitioner makes an incision in the patient's eye sufficient to remove the non-functional lens and insert an appropriate IOL. The incision to facilitate the removal and replacement of the lens is made in the cornea or sclera of the eye. The incision provides the practitioner with access to the lens so that it may be removed.
There are a number of different procedures that are used to remove a non-functional lens from the eye, the most commonly practiced are referred to as extracapsular surgery and phacoemulsification. In extracapsular surgery, the practitioner removes the lens while allowing the posterior lens capsule to remain. In phacoemulsification, the practitioner reduces the lens to an emulsion by careful application of ultrasonic energy coupled with irrigation and suction, thereby removing the non-functional lens. In both of these procedures, the removed lens is then replaced by a synthetic polymeric IOL substantially restoring the visual acuity of the eye.
A critical component of this procedure is the incision that provides the practitioner with access to the non-functional natural lens so that it can be removed. The ideal incision for a lens removal and replacement is of a minimum size and accurately placed. The incision through which the several instruments used to conduct the procedure is preferably an opening substantially the same circumference as the instruments. Accurate sizing minimizes trauma to the eye and facilitates healing of the eye after the procedure is completed. In the case of the phacoemulsion procedure, if the incision is too small, corneal tissue adjacent the incision may be damaged by contact with the ultrasonic probe and alternatively, if the incision is too large, leakage from the eye may cause prolapse and loss of endothelial cells.
Another problem related to the incision in cataract surgery is suture induced astigmatism. An incision made in the eye must be closed after the procedure so that healing occurs and that there is no path for infection. Previously, sutures have been used to close the incision. A suture may alter the shape of the eye and result in astigmatism. Additionally, sutures may cause irritation, provide a location for infection and abscess or a foreign body reaction. Recently, sutureless techniques have been devised that allow the practitioner to make an incision of a particular shape or geometry that utilize the internal pressure in the eye to keep the incision closed until it heals without the use of sutures. Making such an accurately placed and sized incision for such a procedure is very technique sensitive. Apparatus and methods for making a properly sized and shaped incision for cataract removal procedures are available, but are still subject to variations in technique. If a device that made a practitioner's placement and sizing of an incision in the eye less technique sensitive, the art of eye surgery would be advanced. Such a device and a method for its use is disclosed hereinbelow.
SUMMARY
A corneal incision device of the present invention includes a surgical blade and a frame having an inner surface with a configuration that is generally in the shape of a ring-like segment of a hollow sphere. The frame has an aperture therein to allow the surgical blade to be inserted through the frame beyond the inner surface. The aperture defines a longitudinal axis and is sized and shaped to allow movement of the surgical blade in the longitudinal axis. The device has provisions for holding, advancing and withdrawing the surgical blade through the aperture, disposed on the frame. The device is releasably retained on the patient's eye by fixation elements disposed on the inner surface of the frame. There is a grip affixed to the frame to facilitate the practitioner's manipulation of device.
The device of the invention allows the practitioner to achieve a correct placement and precise shape for the desired incision. Once the practitioner has selectively positioned the device on the patient's eye, the surgical blade is correctly positioned and ready for selective activation by the practitioner. A further benefit of the blade placement provision is that the sharp blade is kept in a protected position until its use is desired by the practitioner. The device of the invention represents an improvement in the practitioner's ability to form, rapidly and correctly, a selectively precisely shaped incision in the patient's eye thereby improving the efficiency of a widely practiced and difficult procedure.
A corneal device for eye surgery of the present invention also includes a frame having a top, a bottom, and a side. The frame defines an aperture therein and has a hole to access the eye. A blade is supported by the frame and positioned at a fixed angle relative to the frame. An actuator is attached to the blade for advancing and withdrawing the blade in the fixed position through the aperture. By advancing the blade, an incision is created on the eye at the fixed angle on the blade. The blade can further withdraw back through the aperture of the frame.
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Cote Dana Michael
Keenan Joseph F.
Lee Edwin G.
Pierce Robert W.
Becton Dickinson and Company
Dawson Glenn K.
Fiedler Alan W.
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