Apparel – Hand or arm coverings – Gloves
Reexamination Certificate
1992-10-26
2001-01-23
Vanatta, Amy B. (Department: 3741)
Apparel
Hand or arm coverings
Gloves
C002S168000, C128S918000
Reexamination Certificate
active
06175962
ABSTRACT:
BACKGROUND
The use of flexible latex gloves by surgical personnel began as a protection against the commonly used antiseptic carbolic acid. However, with advances in microbiology the wearing of gloves during surgery to prevent wound sepsis became well established. Because of the relatively new situation which has arisen in regard to virally transmitted illnesses, such as Acquired Immune Deficiency Syndrome (AIDS) and hepatitis, there now is significant concern about protecting the surgical personnel from contamination by the patient.
Almost all surgical gloves are presently made of latex. Most surgical personnel now wear two pairs of gloves simultaneously in the hope of obtaining some degree of enhanced protection. Numerous studies have shown that people's hands, including those of medical personnel, frequently contain microcracks in the skin which could serve as entrance sites for live viruses. The use of two gloves on each hand provides some enhancement of safety to the wearer as a hole in the outer glove will not result in the patient's blood contacting the wearer's skin as long as the inner glove remains intact. However, it is quite possible, due to either faulty manufacturing or during the operation, to have holes through both the outer and inner gloves. Since surgical gloves are usually bloody, the user would not be aware that such holes exist until after the surgery is completed and the gloves are removed.
The greatest threat to the surgeon from contamination is posed by a needle puncture as it almost virtually guarantees that both gloves and the wearer's skin will be punctured simultaneously. Since the needle has usually passed through the patient's tissues, inoculation with the patient's blood and any viruses which it may contain will in fact occur. Since there is a loss of sensitivity to the surgeon when wearing two gloves, the likelihood of this accidental puncturing is increased.
While puncture resistant gloves made of fine metal mesh, such as Kevlar or Kevlar and wire, are known, these prior gloves have many disadvantages. They are incapable of stopping a fine needle puncture, are not waterproof, and they lack the pliancy needed to function as surgical gloves.
THE PRESENT INVENTION
The present invention consists of a latex surgical glove, or equivalent, reinforced over the high risk areas, with thin segments of a hard material which is inpenetrable by a needle or blade such as plastic, including Lexan, polypropylene, polycarbonate, PVC, etc. or any other equally thin, pliant and puncture proof material. Such segments may be applied to the outer surface of a single or double layered glove, or may be permanently sealed between two layers of the gloves.
In the preferred embodiment, an iodinated coating is applied between the two layers of latex and a fine dusting of cornstarch is applied to the interior of the inner glove only. The cornstarch facilitates the donning of the gloves acting as a dry lubricant. As is the custom, the surgeon would rinse the outer glove after donning to moisten its outer surface. If, as a result of a defect in manufacturing, packaging, or as a degradative change from prolonged storage, both of the gloves are already perforated at the time of application, then fluid passing through the iodinated layer to the cornstarch dusting would cause a ninhydrin reaction to occur from the mixing of the two chemicals with fluid. The mixing will produce a bright blue purple spot to appear, thus alerting the wearer immediately to the presence of a glove puncture. While iodine and starch are described, the use of other chemicals that cause a color change when mixed could be utilized as well.
Furthermore, both chemical agents could be mixed and placed in a dry form between the two layers of the glove so that the color change would occur when fluid, such as blood, was introduced through an opening in the outer layer only, rather than through both layers of the glove. This would alert the wearer to a puncture of only the outer glove, while the inner glove still remained intact. Just as the detection mechanism will indicate a glove defect immediately upon donning when wetted, the same mechanism will also detect a glove rupture occurring any time thereafter and by the means just described, when mixed with blood.
While the above described gloves would be for medical and scientific personnel requiring sterilizable and highly pliant gloves, other applications of the innovative concept may be employed. For example, dual layered condoms could be made so that wetting of the condom, would reveal any holes in the outer layer, and more importantly holes in both of the layers.
OBJECTS OF THE INVENTION
It is an object of the present invention to provide for an improved surgical glove that is more resistant to needle punctures and thus, safer to the patient and the wearer.
It is another object of the present invention to provide for an improved surgical glove that provides the advantages of a double glove in a single laminated form.
It is still another object of the present invention to provide for an improved surgical glove that is capable of detecting and indicating the integrity of either the outer of two layers or both layers of the glove throughout the surgical procedure.
It is still another object of the present invention to provide for an improved condom that would reveal any leaks, either before or after use.
These and other objects of the present invention will be apparent from a review of the following specification and accompanying drawings.
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Martin & Ferraro LLP
Vanatta Amy B.
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