Surgery – Body protecting or restraining devices for patients or infants – Drapes
Reexamination Certificate
2001-08-02
2002-06-18
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Drapes
C128S853000
Reexamination Certificate
active
06405730
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates generally to surgical drapes and methods of applying such drapes, and more specifically to ophthalmic drapes having adhesive portions that allow them to be adhered to the skin adjacent the eye and methods of applying such drapes. It is also contemplated that the drape could be used for extremity surgeries, ear, nose or throat procedures, tracheostomy or thyroidectomy, and breast surgeries, among other procedures.
In order to perform surgery on the eye it is frequently desirable to apply a surgical drape to the patient to isolate the eyelashes and eyelids from the surgical site to improve exposure of the eye, and provide a sterile drape surface to reduce the chance of infection. For example, in refractive surgery, draping may be primarily performed to pull eyelids and eyelashes away from the eye, and keep them out of the way of the surgical instruments such as microkeratomes.
One product used for this purpose is the Model 1020 ophthalmic drape commercially available from Minnesota Mining and Manufacturing Company, St. Paul, Minn. This drape includes a sheet of material having a generally round aperture roughly in the center. A field of skin compatible adhesive contacts a portion of one side of the sheet adjacent this aperture. This adhesive allows the drape to be adhered around the patient's eye, and the rest of the sheet drapes down over the patient's head, hair and face to provide a sterile surface over these areas.
A difficulty arises in that the eye is a delicate structure and the eyelids are very flexible and not the same size and shape in different individuals. In actual practice, medical practitioners sometimes find it inconvenient to conform the margins of the aperture to the edges of a particular patient's eyelids. When this occurs, one expedient that is known to some practitioners is to cut the drape, either partly or else completely into two sections, typically but not always before applying the drape to the patient. This is done to relieve tension in stretched areas, prevent bunching of the adhesive field, and allow the margin of the aperture to be more closely conformed to the margin of the patient's eye. In addition, cutting the drape before application is the preferred practice of many surgeons in order to facilitate one person applying the drape to the upper eyelid first without adhering the lower portions of the adhesive field to the lower eyelid until ready to do so.
It will be appreciated that this expedient is not without its drawbacks. Making such a cut will require the presence of a sterile scissors or the like. Also, making an appropriate cut is inconvenient to do while attempting to preserve the sterility of the drape.
SUMMARY OF THE INVENTION
This invention provides a ophthalmic surgical drape and a method of draping the eye for ophthalmic surgery that allow the drape to be easily conformed to both lids of the eye by a single person without additional tools. This invention solves the problems discussed above by providing a method of applying an ophthalmic drape so that it can easily be adhered to both the upper and lower margins of the eye without requiring the use of separate instruments for cutting and adjusting. This is accomplished by providing at least two tear lines in the sheet that forms the drape at least in the region adjacent to the aperture that permits access to the eye. The practitioner may then adhere a portion of the margin of the aperture to one of the patient's eyelids, and break as much or as little of the tear lines as necessary to create the needed slack to accurately match the rest of the margin of the aperture to the patient's other eyelid. The drape may be completely divided into two similar halves if such an action makes the practitioner's task in accurate placement of the drape easier.
The invention provides a method of applying an ophthalmic surgical drape to upper and lower eyelids of an eye of a patient. A surgical drape is provided comprising a sheet having a periphery and an aperture spaced from the periphery, and at least two tear lines in the sheet extending substantially from the aperture substantially to the periphery. The drape also has a field of skin compatible adhesive adjacent to the aperture, the field being traversed by each of the tear lines so as to divide the field into at least two portions. The sheet is torn partially or completely along at least one of the tear lines. Depending on the size and shape of that particular patient's eyes, more or less tearing might be needed, or it might be most convenient to tear the drape entirely into two portions. In either case the practitioner can conveniently accomplish the matter without the assistance of another person. The method also includes the step of adhering one of the portions of the field of skin compatible adhesive to one of the eyelids (e.g., the upper eyelid). Preferably, the margin of the aperture is curved so that it approximates the shape of the edges of the eyelids of the open human eye. Finally, the method then includes the step of adhering the other portion of the field of skin compatible adhesive to the other eyelid (e.g., the lower eyelid).
In preferred embodiments, the tear lines extend substantially completely from the aperture to the periphery, which provides the practitioner the greatest flexibility if substantial modifications need to be made to accommodate certain patients. Also, it has been found to be particularly convenient to prepare the aperture with a curved, symmetrical margin, and have the points where the lines of perforations extend from the aperture be on diametrically opposed points along the margin.
The tear lines may conveniently be a line of perforations in the sheet of material, or a scored line, or the sheet of material can be weakened by heat or some other physical process so as to readily permit and correctly propagate the desired tear. As used herein, “tear line” refers to a line along which manual tearing of the sheet is directed by any of these mechanisms.
As used herein, “oval-shaped” refers generally to oval and elliptical shapes, as well as elongated curved openings.
In some preferred embodiments, it is convenient to protect the field of skin compatible adhesive by adhering a release liner to the field. The release liner protects the adhesives during shipping and handling, but are peeled away by the user of the drape just before application to the patient. For the convenience during application, at least one edge of the release liner may extend beyond the edge of the adhesive field to provide a tab suitable for gripping.
Also, in preferred embodiments, the drape is provided in a folded condition, folded so that the tearing can be accomplished so as to divide the drape into two sections, such as two similar halves, before the drape is unfolded.
With this in mind, the invention can therefore be viewed in another manner. It can be thought of as an ophthalmic surgical drape comprising a sheet having a periphery, an aperture spaced from the periphery of the sheet, and a tear line in the sheet extending in opposite directions from the aperture to the periphery of the sheet to divide the sheet into two portions. Although there are two portions to the tear line, co-linear on opposite sides of the aperture, this embodiment is designed to be able to be divided before unfolding and therefore it is convenient to think of there being one tear line in two halves. This ophthalmic surgical drape has a field of skin compatible adhesive adjacent the aperture, the field being traversed by the line of perforations so as to divide the field into two adhesive portions, one on each of the two portions of the sheet. The sheet is folded in the direction perpendicular to the tear line, and also along the tear line such that the sheet can be unfolded over the tear line and the two portions of the sheet separated from one another by grasping them and tearing the sheet along the tear before the sheet is unfolded with respect to any fold that is perpendicular
Baker Dennis L.
Davis Robert A.
Hildebrandt Camille M.
Levitt Yolla B.
Reed Mary K.
3M Innovative Properties Company
Brown Michael A.
Burtis John A.
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