Multi-function surgical instrument for facilitating...

Surgery – Instruments – Corneal cutter or guide for corneal cutter

Reexamination Certificate

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C606S004000, C606S005000, C604S289000, C604S294000, C604S301000

Reexamination Certificate

active

06656197

ABSTRACT:

FIELD OF THE INVENTION
In the field of ophthalmic surgery the use of lasers is well known. In laser assisted in-situ kerotomileusis pulses of laser light are used to ablate desired portions of the stromal bed following temporary removal of the outer tissues of the cornea. After replacement of the temporarily removed tissues the cornea is reshaped. During such procedure, and other ophthalmic procedures involving ablation of eye tissue, positioning and fixation of the eye against movement is important, as is proper tissue hydration, control of smoke, plume and splatter, maintaining cleanliness of open tissues, etc. The invention disclosed and claimed herein relates to a multifunction instrument placed on the surface of the eye during ablative eye surgery to assist the ophthalmic surgeon to perform laser ablative eye surgery.
BACKGROUND OF THE INVENTION
In corneal surgery the use of lasers is well known. In such procedures precisely controlled pulses of laser light are used to remove thin layers of tissue by ablation. For instance, in photorefractive keratectomy (“PRK”) the cornea is reshaped by first removing the epithelium and Bowman's layer (by various means) and ablating the stromal bed by laser (after which the epithelium and Bowman's layer are left to re-form by healing). In laser assisted in-situ kerotomileusis (“LASIK”) the cornea is reshaped by temporarily removing the outer layers (epithelium, Bowman's layer and a portion of the stromal bed) thereof by sharp instrument, ablating selected areas of the underlying stromal bed by laser and then replacement of the removed tissues. Various other corneal surgery is also performed using a laser to ablatively remove selected eye tissue.
There procedures encounter some common challenges. Removed tissues must be set aside. The removed tissues should be set aside to a location which is clean, sterile, and where over or under hydration can be prevented. This is particularly problematic in LASIK where the outer layers of tissue (commonly called the corneal “flap”) typically remains attached to the eye by a “hinge” of tissue. The exposed stromal bed of the eye should also be protected from migration of exterior eye fluids, which may contain debris and/or bacteria and from either excessive or over hydration.
The eye must be positioned properly, and fixed against movement therefrom, so that laser pulses are applied, consistently, to only the selected tissues. Both the patient and the physician should be protected from airborne smoke, plume and splatter. Following ablation, the opened tissues should be well cleansed while maintaining proper hydration, and the temporarily removed tissues replaced with minimal handling.
The invention disclosed and claimed herein is a multifunction surgical instrument directed to each of the above-mentioned issue. It provides a convenient location to store temporarily removed tissues. It provides a means to isolate both stromal bed and removed tissues from cul-de-sac fluids. It provides means to fix the position of the eye as desired. It provides means for controlling hydration of open tissues. It provides means for removal of smoke, plume and splatter. It provides means for facilly cleansing open tissues prior to closure. It provides means to facilitate replacement of removed tissues with minimal handling.
Other art discloses ophthalmic tools which includes some, but not all, of the features of the multifunction tool herein disclosed and claimed. For instance U.S. Pat. No. 5,108,412 to Rosenbaum et al disclose a suction ring for attachment to the sclera in the limbal plane. This apparatus is used to guide a trepan perpendicularly to the limbal plane. In U.S. Pat. No. 5,980,543 to Carriazo et al a similar suction ring is used to guide a microkeratome parallel to the limbal plane. In neither of these patents is the suction ring used to fix the position of the eye during ablation. In neither of these patents does the suction ring include a platform for “storage” and replacement of a corneal flap during a surgical procedure. In neither of these patents are other attributes of the invention, such as plume and splatter evacuation means, means for creating flow of dehydrating gas over the aperture of the ring, means for improved irrigation for a surgical field, etc., disclosed.
Likewise U.S. Pat. Nos. 5,941,873 and 5,971,977 to Korenfeld shows one, but not other, attributes of the invention disclosed and claimed herein. In these patents there is disclosed a device having a ring-shaped tube with a plurality of apertures disposed about the inner circumference thereof, to aid in smoke, plume and splatter removal during an ablative procedure of the eye. These patents do not teach any structure for aspirating liquid away from an open stromal bed nor do they teach a sterile platform for storage and replacement of removed tissues.
The invention herein disclosed and claimed is directed to provision of a surgical instrument to facilitate the opthalmic surgeon accomplishing a plurality of desirable objectives associated with laser surgery of the eye, particularly LASIK, including isolation, controlling hydration and cleansing of open tissues; storage and replacement of temporarily removed tissues; positioning and fixation of the eye; and removal of smoke, plume and splatter.


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