Apparel – Guard or protector – Hand or arm
Reexamination Certificate
2001-06-05
2004-02-03
Singh, Arti R. (Department: 1771)
Apparel
Guard or protector
Hand or arm
C002S002500, C002S021000, C002S159000, C002S161700, C002S164000, C002S167000, C002S168000, C424S094100, C424S094600, C424S094630, C424S094640, C128S202250, C442S123000, C604S292000
Reexamination Certificate
active
06684405
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to surgical or examination gloves having a quick release interior. More particularly, there is provided a powdered coating for inhibiting skin irritations of users who become allergic to latex and for the prevention of accidental infections. The invention uses antiviral protease inhibitors and cromolyn compounds alone or in combination.
BACKGROUND OF INVENTION
Surgical and examination gloves perform a barrier function providing separation between a patient and a health care worker. In fulfilling this function, the gloves act to block the introduction of infectious agents, particularly bacteria and fungi, from the hands of the healthcare worker into a surgical incision or wound of the patient. In this regard, it has been recognized that bacteria present in pores of a healthcare workers hands frequently survive antibacterial scrubbing to be released with perspiration into the interior of the glove. These bacteria pose a significant risk for infection if a tear or hole in the glove allows their release. Thus, antimicrobial gloves have been proposed with the intention of killing these released bacteria within the glove. As disclosed in U.S. Pat. No. 4,853,978 to Stockum, which is herein incorporated by reference.
The barrier function of the gloves also serves as to protect the health care worker from pathogenic agents, particularly those present in blood or other body fluids of the patient. Of particular significance in this regard are viruses, such as HIV, the virus causing Acquired Immunodeficiency Syndrome (AIDS), and Hepatitis B virus (HBV) which may even penetrate through a glove that is not actually perforated but merely stretched. Agents which are effective against these pathogenic agents, however, are less common than those that will provide an effect against simple skin bacteria or fungi and must frequently be present at much higher levels to be efficacious. This can cause difficulties for the wearer whose skin is in contact with high levels of antiinfective agent sometimes for hours at a time. It would therefore be highly advantageous to provide gloves in which an effective virucidal agent were maintained in a “ready” state, available for quick or even instant release as needed to counter the effects of possible viral contamination.
The Stockum patent cited above provides a partial but incomplete solution to this problem. Stockum discloses gloves havng an interior coating of polyurethane, starch, and chlorhexideine. Chlorhexidine has the ability to kill the AIDS virus and HBV as shown in prior commonly assigned U.S. patent application Ser. No. 07/385,290, which is incorporated herein by reference. The release rates reported by Stockum, i.e., release from the coating over several hours, are not quick enough, however, to provide meaningful protection from viral pathogens. Moreover, we have found that gloves made by dipping cured gloves in an antimicrobial preparation suffer from significant activity loss on storage, and thus from poor reliability.
Still another problem associated with rubber latex gloves pertains to the latex proteins inherently found therein. Latex proteins, which exist naturally in natural rubber latex, are essential as an emulsifier to the polyisoprene for maintaining the latex state. Unfortunately, the proteins have caused allergic reactions and other serious health problems in humans, and the latex proteins appear to have a relatively progressive effect on humans such that the undesirable reactions increase in severity with increased exposure to the proteins. For example, conventional latex gloves include a powder or donning agent such as corn starch on the surfaces thereof which facilitates removal of the gloves from a mold and facilitates placing the gloves on (donning) and removing the gloves from the users hands. Although that powder acts as a layer between the latex gloves and the hand wearing the glove, the latex proteins readily pass through the powder to the skin. In light of the health problems associated with exposure to the latex proteins, two alternative treatments for the gloves have been conventionally utilized to significantly reduce or eliminate the possibility that persons wearing the latex covered gloves will contact the latex proteins therein. Gloves treated according to such additional treatments are known as “powder-free”. The first of such additional treatments is chlorination or chlorine leaching of the glove, which removes some of the proteins from the globes. Such chlorination treatment actually weakens the gloves because it initiates a deterioration process, but conventional sulfur-cure gloves remain sufficiently strong even after chlorination. The second of such additional processes involves application of a wax coating, whereby the surfaces of the conventional powdered gloves are coated with an ingestible, biodegradable wax material. The wax material may be carnauba wax, which is the same wax that is used on the candy shells of certain candy products such as M&Ms®. Although such wax coating does not degrade the desired characteristics of the latex glove, it does tend to melt to some extent after being maintained at body temperature over a period of time, and this is undesirable because the melted wax leaves a residue on the users' hands after the gloves are removed, which residue is often subsequently transferred to instruments or other articles handled by the user.
U.S. Pat. No. 5,376,633 to Lezdey et al discloses that certain protease inhibitors have anti-viral characteristics.
U.S. Pat No. 5,376,917 to Lezdey et al, which is herein incorporated by reference discloses that certain protease inhibitors are also anti-inflammatory, particularly alphal-antitrypsin.
Co-pending application Ser. No. 09/758,593 of Lezdey et al (now abandoned) which is herein incorporated by reference discloses that cromolyn compounds prevent the degradation of mast cells which occur during allergic reactions but also anti-PAR (Protease Activation Receptor).
U.S. Pat. No. 5,618,710 to Navia et al, which is herein incorporated by reference discloses a method for stabilizes proteins by crosslinking, which can be used to stabilize the protease of the invention.
SUMMARY OF THE INVENTION
The present invention relates to surgical and examination gloves, which are commonly made from polyvinyl chloride, polyurethane, and rubber. Natural rubber latex is the preferred material. The invention provides an inner coating of at least one compound, which will prevent or inhibit an allergic reaction from use of the gloves and/or provides for anti-infection in the event of accidental seepage of body fluids, accordingly, a cromolyn compound and/or an antiviral protease inhibitor.
The cromolyn compound is one, which can prevent degranulation of mast cells, such compounds include for example, cromolyn, cromolyn sodium, and disodium cromolyn.
The protease inhibitor preferably is a serine protease inhibitor selected from the group consisting of alpha-1 antitrypsin, secretory leucocyte protease inhibitor, alpha-2 macroglobulin, the derivatives, complexes and conjugates thereof. Some cystein protease inhibitors, which are anti-viral can be used.
The cromolyn compounds and/or the protease inhibitors can be used alone or in combination with conventional lubricating agents.
It is therefore an object of the invention to provide an inner coating to surgical and examination gloves, which will prevent irritation.
It is another object of the invention to provide a latex glove, which is non-allergenic.
It is still another object of the invention to provide a latex glove with an inner coating, which is antiviral.
It is yet another object for the invention to provide a latex glove which can be easily donned.
These and other objects and advantages will become more apparent from a reading of the Description of the Preferred Embodiments and the claims.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present invention resides in an elastomeric glove, which, is used for examination or in surgery have an inner coating of a compound, w
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