Glove donning system

Details Glove donning system Glove donning system

2002-10-18

2004-12-21

Calvert, John J. (Department: 3765)

Apparel apparatus

Putting on or removing garments

Reexamination Certificate

active

06832708

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates primarily to a system and method for facilitating the donning of gloves in an automatic manner such that the user or wearer is not required to manually grasp the gloves during the donning operation. Such a system is of particular use for donning surgical gloves and for donning gloves used in clean rooms in the semiconductor/microprocessor and pharmaceutical industries where avoidance of contamination of gloves is of the highest priority.
BACKGROUND OF THE INVENTION
The importance of donning surgical gloves or gloves used in semiconductor “clean rooms” in a contamination-free manner is well known. The presence of microbial contaminants on the gloves, arising from manual manipulation of the gloves during donning, for example, can have adverse and even lethal effects on a patient undertaking surgery. Similarly, particulate contaminants passed on from a glove can destroy a semiconductor wafer.
Surgeon's and patient examination gloves are intended to provide an effective barrier against potentially infectious materials and other contaminants. However, the use of such gloves has been associated with a number of adverse health effects in patients and users, including allergic reactions, foreign body reactions and irritation. Natural rubber latex (NRL), from which such gloves are generally made, comprises a variety of naturally occurring substances, including plant proteins, which are believed to be the primary allergens associated with natural latex allergy. Nonetheless, NRL gloves provide users with great sensitivity and no suitable synthetic replacement is currently available. However, NRL gloves are difficult to don and doff, and thus glove powder, which comprises cornstarch as a main component thereof, is often used for lubricating the inside surfaces of the gloves. Natural latex allergens are known to bind to cornstarch, and thus the use of donning powder may be pose an additional hazard for allergic personnel and patients. Over the past 3 years, FDA has received requests to ban the use of all glove powders, due to the indications that cornstarch on surgical gloves can reduce tissue resistance to infection, enhance the development of infection and act as a carrier of natural latex protein from NRL products, among others [Federal Register: Jul. 30, 1999 (Volume 64, Number 146) Proposed Rules, Page 41709-41743 from the Federal Register Online via GPO Access (wais.access.gpo.gov), 21 CFR Parts 801, 878, and 880]. In June 1997, the National Institute of Occupational Safety and Health (NIOSH) of the US issued a safety alert recommending the use of powder-free, reduced protein content or synthetic gloves as a means to reduce exposure to natural latex allergens, specifically via the airborne route of exposure [Department of Health and Human Services (NIOSH), “National Institute of Occupational Safety and Health (NIOSH) Alert: Preventing Allergic Reactions to Natural Rubber Latex in the Workplace”, Publ. No. 97-135, June 1997.]. While the FDA agrees with the goal of reducing exposure to airborne allergens, it is at the same time concerned that efforts to produce powder-free gloves with satisfactory donning properties may require additional manufacturing processes that, if not appropriately controlled, have deleterious effects on physical properties, performance and shelf-life of the gloves [Aziz, N., “Chlorination of Gloves” Paper No. 5. of the Latex Protein Workshop of the International Rubber Technology Conference, June 1993, Kuala Lumpur, Malaysia; FDA, CDRH, “Environmental Degradation of Latex Gloves: The Effects of Elevated Temperature on Tensile Strength”, Division of Mechanics and Materials Science Report # 96-05, D. Walsh, D. Chwirut, R. Kotz, and J. Dawson, Rockville, Md., 1997]. In fact, the FDA is encouraging industry to find a balance between donning requirements—hitherto met by use of the powder—and reducing the risk of adverse health effects.
Rather than using donning powder, lubrication of the gloves may be provided, instead, by a coating or by chlorination. Various kinds of coating are in use. Their manufacture, like the chlorination process, must be carefully controlled to assure a good bond between the coating and the glove. Since the coatings may have different physical properties from that of the NRL glove, they may not generally have the same stretching characteristics, and thus provide a different “feel” to a user than regular NRL gloves.
Chlorination is widely used for reducing the tackiness of natural latex gloves and thus eliminates the need for donning powder. Chlorination works by degrading the surface of the gloves, and thus the chlorination process must be very carefully controlled to prevent destruction of the glove barrier. Improperly chlorinated gloves rapidly degrade, and breaks in the latex film may occur within a span of a few months.
Another concern is the presence of minute defects in the gloves known as pinholes, which directly affect the barrier integrity of the gloves. Studies show that particles such as dust, dirt and other debris may cause pinholes. Furthermore, the glove manufacturing process may also introduce pinholes due to factors such as former vibration, air bubbles in the dripping tanks, dirty formers, incorrect formulation, excessive curing temperatures, and so on. While manufacturers are supposed to comply to minimum manufacturing standards, and while randomised checks are performed, it is still possible for some gloves not meeting the minimum pinhole criteria to be used, leading to the possibility of viruses penetrating the glove, eliminating or reducing the glove's effectiveness as a barrier.
An alternative approach to using less effective synthetic gloves, or to providing NRL gloves with less or alternative forms of lubrication to donning powder, is to provide a glove donning system that reduces the need, and preferably does away with the need entirely, for lubrication. Such a donning system would thus enable regular NRL gloves (as well as any similar type of glove) to be donned without lubrication, in particular donning powder, by elastically deforming the inside of the glove to a volume greater than the hand of the user. In particular, such a system requires the cuff of the glove to be elastically expanded to a size such as to facilitate insertion of a hand therethrough and into the body of the glove.
Automatic glove donning devices are known. Typically, a glove to be donned is held in a vacuum chamber such that the cuff section of the glove is open providing communication between the inside of the glove and the environment of the wearer. The outer surface of the glove is exposed to the vacuum chamber, and thus remains substantially uncontaminated by the wearer environment. When a vacuum is applied to the vacuum chamber, the glove expands within the vacuum chamber by virtue of the greater ambient pressure in the wearer environment, sufficiently to permit a user to insert his hand into the extended glove relatively effortlessly, after which the glove is removed from the vacuum chamber donned on the wearer's hand. Many devices are equipped to don the right-hand and the left-hand gloves from separate dispensers.
These prior art devices, however, comprise inadequate systems for holding the glove within the vacuum chamber in the first place, such as to form an airtight seal between the cuff section of the glove and the chamber. For example, in U.S. Pat. No. 3,695,493, the donning device may only be used with gloves having a cuff portion comprising a special ring made from a rigid material. While the ring permits the glove to sealingly abut against the opening of the vacuum chamber, the device cannot be used with standard gloves, resulting in relatively high running costs for the device. Further, the rigid ring causes difficulties in sealing the cuff portion of the glove onto the wearer's arm.
In U.S. Pat. No. 4,002,276 and U.S. Pat. No. 4,275,812, the gloves come prepared with the cuff portion stretched over a special dedicated r

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