Surgery – Instruments – Means for removing – inserting or aiding in the removal or...
Reexamination Certificate
1999-06-25
2001-04-24
Smith, Jeffrey A. (Department: 3732)
Surgery
Instruments
Means for removing, inserting or aiding in the removal or...
Reexamination Certificate
active
06221078
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to surgical devices and more specifically to an apparatus for introducing a glaucoma drain to the eye of a human or animal.
BACKGROUND OF THE INVENTION
Aqueous humor, the fluid of the eye, is produced by the ciliary body in the posterior chamber. In the normal eye, the fluid migrates into the anterior chamber and filters through the trabecular meshwork into the canal of Schlemm. The canal of Schlemm drains into veins which carry the aqueous humor away from the eye.
Intraocular pressure is a function of the rate at which aqueous humor is produced in and released from the eye. Glaucoma is a disease of the eye characterized by an abnormally high intraocular pressure. Usually, glaucoma is caused by a problem with release, as opposed to production, of aqueous humor.
One method of treating glaucoma is to surgically introduce a drainage device to the eye. Such devices are generally configured to provide a controlled release of aqueous humor to alleviate intraocular pressure. It is critical to the proper functioning of these devices that they be introduced to the eye properly.
SUMMARY OF THE INVENTION
Accordingly, it is a first object of the present invention to provide an apparatus for introducing a glaucoma drain to the eye.
It is a second object of the present invention to provide an improved apparatus for introducing a glaucoma drain to the eye.
It is a third object of the present invention to provide an apparatus which is configured such that the distal end thereof closely contours the surface of the eye.
It is a fourth object of the present invention to provide an apparatus device which is easy to use.
It is a fifth object of the present invention to provide an apparatus which is configured such that an operable portion thereof is encased until placed into position proximal to the eye.
It is a sixth object of the present invention to provide an apparatus device which is safe to use.
It is a seventh object of the present invention to provide an apparatus device which may be used to perform multiple functions involved in the introduction of a glaucoma drain to the eye.
It is an eighth object of the present invention to provide an apparatus for introducing a glaucoma drain to the eye including an outer hub including a longitudinal slot, a nosepiece retractably mounted within the outer hub, a handle having a gripping portion and an extending portion, the extending portion removably attached to the retractable nosepiece through the longitudinal slot in the outer hub, and, a tool operably disposed within the retractable nosepiece within the outer hub.
It is a ninth object of the present invention to provide a method of introducing a glaucoma drain to the eye including the steps of inserting a stylette into a retractable nosepiece slidably mounted within an outer hub, retracting the nosepiece into the outer hub, operating said stylette to create a small wound in the eye at a location along the periphery of the cornea, removing the stylette from the retractable nosepiece and the outer hub, extending the retractable nosepiece, loading a glaucoma drain into a distal end of the retractable nosepiece, inserting a plunger having a plunger tip including a planar end face into the retractable nosepiece slidably disposed within the outer hub, retracting the nosepiece into the outer hub, placing the outer hub in contact with the eye over the wound, and, operating the plunger to advance the glaucoma drain out the distal end of the retractable nosepiece and into the wound.
The present invention provides an apparatus for introducing a glaucoma drain to the eye. A preferred embodiment of the apparatus includes a tubular elongated outer hub having an open flared proximal end. The outer hub also has an open distal end which defines a plane having a normal which intersects the longitudinal axis of the outer hub at an angle.
A preferred embodiment of the apparatus also includes a tubular retractable nosepiece disposed within the outer hub. A longitudinal slot in the outer hub is configured such that the extending portion of a handle may pass therethrough and threadedly engage the retractable nosepiece. The slot provides a range of motion for the retractable nosepiece relative to the outer hub. Specifically, the extending portion of the handle on the nosepiece travels within the slot to allow the nosepiece to extend and to retract relative to the outer hub. The slot in the outer hub also includes a transverse portion, preferably, located at the distal end of the slot, for locking the nosepiece relative to the outer hub, preferably, in an extended position.
The outer hub and retractable nosepiece are adapted to receive a glaucoma drain tool. Specifically, the apparatus is provided with a stylette having a flared proximal end which is configured to engage the flared proximal end of the outer hub when the stylette is inserted therein. The distal end of the stylette defines a plane having a normal which intersects the longitudinal axis of the stylette at an angle. The stylette is preferably configured such that when the retractable nosepiece is an extended position, the distal end of the stylette does not extend beyond the distal end of the retractable nosepiece.
The apparatus is also preferably provided with an elongated cylindrical plunger having a planar end faced plunger tip. The plunger tip is configured for translating a glaucoma drain out of the retractable nosepiece and into the tissue of the eye. The plunger further includes a collar which is configured to engage the outer hub to prevent the plunger tip from extending beyond the retractable nosepiece when the retractable nosepiece is an extended position. The plunger also includes a thumb rest at the proximal end thereof.
In a preferred method of introducing a glaucoma drain to the eye with the present invention, the apparatus is brought into position proximally to the eye with the stylette operably disposed within the retractable nosepiece and outer hub. The retractable nosepiece is preferably in an extended position with the extending portion of the handle locked into the transverse portion of the slot in the outer hub.
Once in position near the eye, the retractable nosepiece is retracted into the outer hub by disengaging the extending portion of the handle from the transverse portion of the slot in the outer hub and sliding the nosepiece proximally relative to the outer hub. The open distal end of the outer hub is angled, as described above, relative to the longitudinal axis of the outer hub. This feature allows the longitudinal axis of the apparatus to be perpendicular to the face of the patient and simultaneously for the distal end of the outer hub to closely contour the curved surface of the eye thus providing an improved surgical orientation of the apparatus for the surgeon.
With the outer hub in contact with the eye at a location along the periphery of the cornea, the stylette is then advanced to create a small wound in the eye. The diameter of the wound is controlled by the diameter of the stylette. The stylette is preferably provided with a through bore such that a small volume of tissue is excised during formation of the wound. The depth of the ocular wound is limited by the extent to which the distal end of the stylette extends beyond the distal end of the outer hub when the flared proximal end of the stylette engages the flared proximal end of the outer hub. Wound depth may therefore by easily configured according to the dimensions of the glaucoma drain to be introduced to the eye with the apparatus.
Once the ocular wound is formed in the eye, the apparatus is moved away from the eye and the stylette is removed from the outer hub and retractable nosepiece. The retractable nosepiece is returned to and locked in the extended position. A glaucoma drain, preferably, a small cylindrical section of porous biocompatible material, is loaded into the distal end of the retractable nosepiece. The plunger is then inserted into the proximal end of the outer hub and the apparatus is again brou
Klima William L.
Law Offices of William L. Klima, PLC
Robert Eduardo C.
Smith Jeffrey A.
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