Surgery – Body protecting or restraining devices for patients or infants – Drapes
Reexamination Certificate
2000-02-18
2002-02-12
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Drapes
C128S853000
Reexamination Certificate
active
06345621
ABSTRACT:
FIELD OF INVENTION
This invention relates generally to a medical device used in ophthalmic surgery. More particularly, this invention relates to a drape that can be used in refractive eye surgery and configured in sixteen different ways for both single or bilateral eye surgical procedures. The drape includes an adhesive liner that acts as a cover for the non-surgical eye and a tent portion that allows the patient to blink or comfortably keep open the non-surgical eye, which is important for eye fixation.
BACKGROUND OF THE INVENTION
Surgical drapes are well known in the medical arts as being used to maintain a sterile environment during surgery. Drapes also assist in preventing foreign matter and organisms from entering the surgical area. Surgical drapes are made in a wide variety of sizes and shapes for covering portions of the body during surgery. In ophthalmic surgical procedures, eye drapes are frequently used to surround and protect the eyeball. A traditional eye drape typically includes a base sheet with a fenestration to expose the eye that is to undergo surgery.
In recent years, refractive surgery has become an increasingly popular surgical procedure for the eye. Refractive surgery refers to a range of surgical procedures using knives, lasers, or some combination to alter the cornea resulting in structural changes in the cornea's curvature. The resultant change in the cornea's shape often produces a significant change in its refractive power. Thus, the use of glasses or contacts to correct vision is minimized or totally eliminated.
Various types of refractive surgery include radial keratectomy (RK), automated lamellar keratoplasty (ALK), photorefractive keratectomy (PRK), and laser assisted in-situ keratomileusis (LASIK). Of these surgical procedures, LASIK is considered the fastest growing refractive procedure in the United States.
In LASIK surgery, a microkeratome blade is typically used. The microkeratome is a surgical instrument used to cut and fold back a thin superficial layer of the cornea. This layer is called the corneal cap. After the corneal cap is formed, the re-shaping of the cornea is accomplished with a laser. The bed of the cornea under the corneal cap is flattened or re-molded to correct for areas of shortsightedness, farsightedness, and astigmatism. 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 after the surgery and can return to normal activities by the next day. Generally, sight is restored within that following day.
During LASIK surgery, the patient can be exposed to scatter rays from the laser or projectile debris from laser ablation or other tissue removal procedures. Some prior art ophthalmic drapes can sufficiently protect the patient from the debris. However, these prior art drapes often lack the material characteristics required to reflect scatter rays from the laser.
Prior art ophthalmic drapes made of a laser reflective material still lack the flexibility of being used in other refractive procedures that require various draping configurations. Additionally, prior art drapes used specifically for refractive surgery lack the drape configuration necessary in other similar vision corrective surgical procedures. Such surgeries may include implantation of phakic intraocular lenses, implantation of intrastromal corneal ring segments, and phototherapeutic keratectomy (PTK). Thus, a specific prior art drape would have to be used for each specific surgery. This type of prior art drape would contribute to decreased economic efficiencies, increased medical waste, and increased healthcare costs.
Finally, prior art ophthalmic drapes do not have the ability or features to cover the non-surgical eye, and provide the flexibility of various draping configurations while giving the patient the ability to blink or comfortably keep open the non-surgical eye. Keeping the non-surgical eye open is preferred during refractive surgery because the patient can not lose eye fixation during laser ablation. If fixation of the surgical eye does not occur and the eye moves, the surgery may result in an off-centered ablation of the operated eye and impaired vision.
In summary, prior art ophthalmic drape designs have many disadvantages. First, many prior art drapes do not have the material characteristics required to reflect scatter rays from the laser during LASIK refractive surgery. Second, those prior art drapes that are made of a laser reflective material still lack the flexibility of being used in any refractive procedure or other ophthalmic surgery that may require various draping configurations. Therefore, specific prior art drapes would have to be used for each specific surgery thereby increasing medical waste, healthcare costs and decreasing economic efficiencies. Third, prior art ophthalmic drapes do not have the ability or features to cover the non-surgical eye and provide the flexibility of various draping configurations. Prior art ophthalmic drapes that do cover the non-surgical eye do not give the patient the ability to blink or comfortably keep open the non-surgical eye that is important for eye fixation.
Therefore, a need still exists in the art that allows an ophthalmic drape to be configured in various shapes and physical arrangements for use in many eye surgical procedures including refractive surgery. The improved drape should provide protection for the patient from scatter rays and projectile debris due to laser ablation. It should also act as a cover for the non-surgical eye and allow the patient to blink the non-surgical eye in comfort to facilitate eye fixation.
SUMMARY OF THE INVENTION
The present invention avoids the disadvantages of the prior art by allowing an ophthalmic drape to be configured in various shapes and physical arrangements for use in many eye surgical procedures including refractive surgery. The improved drape provides protection to the patient and surgeon from scatter rays and projectile debris due to laser ablation. It also acts as a cover for the non-surgical eye and allows the patient to blink and keep the nonsurgical eye open in comfort to facilitate eye fixation.
Accordingly, there is provided in the present invention a sheet having a top, a bottom, a right aperture and a left aperture. The sheet further defines at least one first perforation and at least one-second perforation such that the first perforation is positioned between and about the right and left apertures. The second perforation is positioned so that the apertures are divided by the second perforation. It is the positioning of the first and second perforations that allows the sheet to be configured in various shapes and physical arrangements.
The sheet may include further features such as a tent portion formed about the second perforation for providing clearance between the eye and the sheet. The drape can be made of a laser reflective material to protect the patient and surgeon from scatter rays caused by the laser. The drape can further comprising an adhesive liner for covering the non-surgical eye.
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Chandler Lamar
Quattrone Tony D.
Becton Dickinson and Company
Brown Michael A.
Fiedler Alan W.
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