Surgery – Body protecting or restraining devices for patients or infants – Drapes
Reexamination Certificate
2000-09-11
2002-03-19
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Drapes
C128S853000
Reexamination Certificate
active
06357445
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Technical Field
This invention generally relates to a protective barrier for use in a medical setting, and more specifically relates to a surgical drape designed to protect medical personnel from bodily fluids, excretions, and other contaminants likely to be present during a medical procedure. The invention is particularly suited for use during a colonoscopy but would be useful in conjunction with any procedure in which contamination from patient secretions is a concern and where a tubular examining tool is used.
2. Background Art
A colonoscopy is a procedure in which the inside of the colon is examined using a long, flexible, fiber-optic viewing instrument called a colonoscope. The colon is located in the abdominal cavity and forms part of the large intestine. It is subject to various disorders, the diagnosis and treatment of which can sometimes be aided by the close-up view that a colonoscope provides. Besides providing a clearer visual picture of the colon, a colonoscope can also be fitted with a variety of attachments used by the examining physician to, for example, take biopsy specimens or remove unwanted growths from the colon's interior.
A physician performs a colonoscopy by lubricating the colonoscope and inserting it through the anus into the colon, which is inflated with air. As the scope is guided by the physician along the length of the colon it generates images that appear on a viewing device. The need to move the colonoscope to various locations within the colon during the procedure requires that the examining physician be in close proximity with the patient at all times during the exam.
In almost every colonoscopy, the air used to inflate the colon forces some of the colon's contents out of the anus. This includes undigested material not eliminated beforehand, the lubricant used to coat the colonoscope, and other colonic secretions. The laxatives typically taken by a patient prior to the exam tend to increase this effect. These expelled secretions obviously present a risk of contamination, a risk that becomes even greater if, as is often the case, the secretions are aerosolized, thereby contaminating the air of the examining room. Because of the requirement of close doctor-patient proximity during a colonoscopy, such expelled and aerosolized excretions present a serious health risk to medical personnel.
Basic precautions against contamination such as gloves and face masks offer some protection but are imperfect in that they permit the passage of contaminated substances around their edges or through tears or other openings in them. Surgical drapes generally provide a sanitary work area but do not provide protection from bodily fluids and excretions.
U.S. Pat. No. 5,960,794 granted Oct. 5, 1999 to the present inventor for “SURGICAL DRAPE” describes a drape with an adhesive periphery consisting of a flexible sheet having a valve thereon for maintaining a barrier between the patient and doctor during a medical procedure and allowing for the passage of a surgical instrument therethrough. During a colonoscopy an examining tool is inserted into the colon through the anus, a delicate and potentially painful process. The ability to see clearly what one is doing becomes very important for the medical worker performing this procedure. Therefore, providing a surgical drape that will allow good visibility would increase the ease with which the tool is inserted.
With prior U.S. Pat. No. 5,960,794 the drape is adhesive only in a small region around its periphery. This can lead to the need to stop the examination in order to reposition the drape if the seal between the patient and the drape is lost.
DISCLOSURE OF INVENTION
Therefore, there existed a need to provide a surgical drape suitable to protect a doctor and attending personnel from contamination during a medical procedure. The present invention is particularly suited to procedures such as a colonoscopy where patient excretions are typically present and there is a high risk of contaminant aerosolization.
According to the present invention, a flexible surgical drape has an adhesive side and a non-adhesive side. The adhesive side is adhesive across substantially its entire face. The drape consists of a flexible sheet suitable for covering a substantial portion of a patient's body. A pocket for catching patient secretions and other fluids is attached to the adhesive side of the drape. The pocket is also adhesive so that it can be securely affixed to the patient's body in the location where it will best catch such secretions. The drape contains an opening capable of receiving a removable insert which, when in place, seals off the opening and prevents the passage of gases, secretions, and fluids that are typically present during a colonoscopy. The insert is made to lock into the opening so as to reduce the likelihood of its inadvertent removal. The insert may also be thought of as a valve, in that an examining tool, such as a colonoscope, fits through a hole extending through the valve and thus can be passed from one side of the drape to the other. The insert will be referred to hereinafter as a valve.
The valve in its preferred embodiment has the general shape of a disk containing a small, hollow column in its center through which the colonoscope is passed, although other configurations are also possible. For example, any structure such as flaps that would create a collar around the colonoscope yet allow the colonoscope to be inserted and withdrawn through the opening would be acceptable. A reservoir suitable for holding a lubricating substance is securely attached to and forms part of the valve, and the colonoscope when inserted through the valve passes through this lubricating substance and is coated by it. The periphery of the valve structure contains the locking and sealing mechanism.
The continuously adhesive face of the drape facilitates its attachment to the patient in a way such that it contains patient secretions and keeps them away from the medical personnel performing the procedure. The fact that the valve is removable increases doctor visibility and the maneuverability of the scope, both of which aid in the scope insertion process. In rare cases, perhaps one out of a thousand, the physician will collect from the colon a specimen, possibly a polyp or part of a tumor, that is so large it must be removed before the examination can proceed. A removable valve in those instances provides the further advantage of allowing specimen removal after merely unlocking and displacing the valve. The entire drape need not be withdrawn and repositioned but can be left undisturbed.
The foregoing and other features and advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings.
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Pending Patent, Serial No. 08/964,511, Filing date Nov. 5, 1997, “Surgical Drape for Colonoscopy”, Timothy A. Shaw.
Brown Michael A.
Schmeiser, Olsen & Watta
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