Surgery – Body protecting or restraining devices for patients or infants – Drapes
Reexamination Certificate
2003-02-20
2004-01-13
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Drapes
C128S856000
Reexamination Certificate
active
06675805
ABSTRACT:
BACKGROUND OF THE INVENTION
It is well known that the majority of intraocular infections related to surgery are caused by organisms from the patient's own lids and lashes. Many different styles of draping the eye for surgery have been advanced, but none has adequately and consistently isolated the surgical field from potential contamination from the surrounding tissues. Also, present methods of draping and the intrusion of an external speculum may limit access to the surgical field or impede a view of the field through the surgical microscope. A separate speculum may cause external pressure on the eye, which can be dangerous, when the eye is open for surgical maneuvers.
It is therefore the objective of this invention to provide a method and apparatus for draping an eye for surgical procedures which will have the following characteristics:
1. It must effectively and consistently isolate the surgical field from the lids and lashes.
2. It must be easy to apply and remove.
3. It must be comfortable under topical anesthesia.
4. It must provide good exposure of the surgical field.
5. It must not cause excessive external pressure on the globe.
6. It must be economical to use in both cost and time.
7. It must allow adequate drainage of debris from the surgical field.
SUMMARY OF THE INVENTION
The speculum-drape of the invention has two components: (1) a thin (50 mm) polyethylene drape fabric and (2) a stainless-steel wire speculum. The two are joined at a central aperture by flaps secured with a water-resistant, double-sided adhesive tape or by ultrasonic welding to anchor the flaps to the surrounding fabric. The speculum is self-retaining, anchored by clips to the lid margin and the internal ring structure. The spring action on the lid margin and the traction on the drape fabric open the lid aperture for surgery. No speculum separate from the drape is usually required.
The external clips and tabs of the U-shaped speculum make it easy to compress the drape for insertion beneath the lids and anchor the speculum to the lids when released. The arcuate closed end of the speculum engages the under surface of the lid especially at the outer canthus tendon and creates a three point stable fixation for the speculum.
The closed end of the speculum also presents a smooth, rounded surface that makes insertion beneath the lid atraumatic. When in place, the aperture in the drape fabric contacts the bulbar conjunctive to form a seal, and the drape completely covers and isolates the lids and lashes from the surgical field. Because the traction on the lids by the fabric is in a direction away from the eye, no external pressure is induced to raise the intraocular pressure or distort the globe.
To anchor it in place after insertion, the speculum-drape has adhesive strips attached to the undersurface with a pull-off membrane to expose the adhesive. Alternatively, the drape may be supplied with a separate double adhesive U-shaped device that would be placed around the eye prior to insertion of the drape.
REFERENCES:
patent: 5213114 (1993-05-01), Bailey, Jr.
patent: 5433190 (1995-07-01), Sunalp
patent: 5632284 (1997-05-01), Graether
patent: 6440065 (2002-08-01), Hered
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