Surgery – Body protecting or restraining devices for patients or infants
Reexamination Certificate
1999-11-23
2001-02-27
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
C128S858000, C606S004000
Reexamination Certificate
active
06192888
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to a method of using a medical device in ophthalmic surgery. More particularly, this invention relates to a method of using a surgical ophthalmic sponge in laser refractive surgery or other similar surgery where the sponge protects the corneal cap while absorbing excess fluid and blood from the surgery.
BACKGROUND OF THE INVENTION
In the medical arts, refractive surgery is a term used for a group of various surgical procedures that alter relationships of the focusing components of the eye in an attempt to bring light to a sharp focal point on the retina without the assistance of the use of glasses or contact lenses. Possible options for refractive surgery are radial keratectomy (RK), automated lamellar keratoplasty (ALK), photorefractive keratectomy (PRK) and laser assisted in-situ keratomileusis (LASIK).
The procedure of automated lamellar keratoplasty has been performed since about 1949. However, only in recent years has it improved as a result of advancements in equipment. To treat myopia, a sophisticated instrument referred to as an automated microkeratome is used to fold back a thin superficial layer of the cornea. This layer is called the corneal cap. Under this cap, a predetermined amount of corneal tissue is removed from the center of the cornea with the microkeratome blade. The cap is then folded back into place without the need for sutures. Removal of the central corneal tissue allows flattening of the cornea thus reducing nearsightedness.
In LASIK surgery, a corneal cap is fashioned by the microkeratome as previously indicated. The reshaping of the corneal is accomplished with the laser. The bed of the cornea under the cap is flattened or re-molded to correct for areas of shortsightedness, farsightedness, and a stigmatism. After the central cornea is re-molded by the laser, the cap is folded back over the central cornea and allowed to heal in place without any need for sutures. The patient is very comfortable afterwards and can return to normal activities by the next day. Generally, sight is restored within that following day.
The drawback of these procedures, however, is that the corneal cap is unprotected during the tissue removal or re-molding portion of surgery. The corneal cap can become distorted or contaminated with excess fluid and blood during the surgery. The corneal cap needs to be kept clean and protected during the surgery.
Thus, there remains a need to provide a method that will allow excess fluid and blood to be absorbed during these types of surgery as well as protect the corneal cap prior to repositioning on the cornea.
SUMMARY OF THE INVENTION
The present invention avoids the disadvantages of the prior art by allowing the corneal cap to be protected and excess fluid and blood to be absorbed during eye surgery. Accordingly, there is provided in the present invention a method of using a surgical sponge having a base having a top, and a bottom. The ophthalmic surgical sponge also includes a corneal shield assembly. The corneal shield assembly may be part of the base or a separate component. The corneal shield assembly may have an inner flap portion, and a posterior flap portion for protecting the corneal cap during eye surgery. If the corneal shield assembly is a separate component, the corneal shield assembly is preferably attached to the base. It is not required that the assembly be attached and it may be a separate component. The corneal shield assembly could be a one-piece unitary structure or two separate pieces to comprise the anterior and posterior flap portions. The ophthalmic surgical sponge can also include a hinge that would connect the anterior flap portion to the posterior flap portion. The hinge allows the flap portions to rotate and cover the corneal cap during eye surgery. Once the ophthalmic sponge is wetted with a solution, the anterior and posterior flap portions can cohesively seal the corneal cap thereby permitting further protection. The cohesive seal is releasable and the anterior and posterior flaps can be removed to expose the corneal cap at the end of the eye surgery. This protection allows the corneal cap to avoid scatter rays and other debris from laser ablation or other tissue removal procedures. Once the corneal cap is re-exposed it is replaced back on the cornea and the operation is completed. The base allows absorption of the fluid around the cornea preventing under correction of laser ablation. The corneal shield assembly could also include a flat edge on the posterior flap portion which protects the hinge of the corneal cap. The flat edge is designed to cover the shape of the hinge of the corneal cap.
Chandler Lamar
Salz James J.
Becton Dickinson and Company
Brown Michael A.
Fiedler, Esq. Alan W.
Voellmicke Esq. John L.
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