The present invention relates generally to a protective elastomeric article, and more particularly to a protective elastomeric article, such as a glove, for medical and non-medical uses that is coated for beneficial effect.
Disposable gloves made from various synthetic and natural raw materials are used to protect against transmission of viral and bacterial agents and other pathogens, and to protect against chemical and radiological contamination. Users who must wear gloves for extended periods often suffer from dried or chapped hands, skin irritation, hand fatigue and premature wrinkling.
Gloves using aloe vera as a moisturizer are described in U.S. Pat. Nos. 6,274,154, 6,423,328, 6,630,152. Aloe vera is used in many skin care products, but it has an oil content that can have an adverse reaction when used with natural rubber and other materials, breaking down capability of rubber to act as a barrier. Some gloves also use lotions, which may have a similar effect on the barrier properties of gloves made from different raw materials. Other coatings used in gloves include cucumber extract and/or glycerin, but there is no evidence that common moisturizers used singly or in combination with another, have significantly improved the therapeutic properties of a disposable glove.
Water soluble silicone has been used as a coating in disposable gloves since 1991, as a moisturizer and lubricant for ease of donning. Silicone has been shown to substantially reduce skin irritations when used in conjunction with natural rubber latex gloves.
Allantoin, a botanical extract of comfrey also known as glyoxyldiureide has been recognized by the US FDA OTC panel as a skin protectant. It is believed to regenerate and stimulate cells, softens skin and acts to remove unhealthy tissue and is an anti-irritant.
Hydrolyzed collagen imparts protective colloid effect to formulations with anti-irritancy benefits. It increases the ability of skin to hold moisture. It is one of the long, fibrous structural proteins whose functions are quite different from those of globular proteins such as enzymes. Strong, tough bundles of collagen called collagen fibers are a major component of the extracellular matrix that supports most tissues and gives cells structure from the outside, but collagen is also found inside certain cells. Collagen has high tensile strength, and is the main component of cartilage, ligaments, tendons, bone and teeth. Along with soft keratin, it is responsible for skin strength and elasticity, and its degradation leads to wrinkles that accompany aging. It strengthens blood vessels and plays a role in tissue development.
The glove of the present invention incorporates a compound made up of a combination of silicone, allantoin, and collagen. The invention further provides a method of coating a glove with such a compound.
An exemplary version of an elastomeric article is shown in the figures wherein like reference numerals refer to equivalent structure throughout, and wherein:
As shown in
Next, the formed substrate, still on the form, will be subjected to optional chlorination (30) to remove impurities and residual proteins that may have come to the surface of the gloves during curing. Optional chlorination (30) is followed by further leaching. As an alternative to or in addition to chlorination (30), the substrate may instead be dipped into a polymer solution that will act as a donning agent to make the surface of the article slippery for easy donning. The thickness of the polymer layer is adjusted by varying the rate at which the form is dipped into the polymer, by varying the speed of the production line, or by adjusting the consistency and density of the polymer, or a combination of these approaches.
In step 40, the coating 11 is applied. There are two viable methods for applying the coating 11: a dipping method (
The following table shows an example of the concentrations, experimentally determined, of the components of the compound and parameters for application by dipping:
One such embodiment employs water-based silicone polymer solution, hydrolyzed collagen and allantoin powder.
The thickness of the coating 11 is adjusted by varying the rate at which the form is dipped into the compound, by varying the speed of the chain on which the form are mounted, or by adjusting the consistency and density of the compound, or a combination of these approaches.
Through experimentation, the concentrations and parameters shown in the table above were determined to yield a glove of suitable thickness with a noticeable beneficial effect. Higher dipping time yielded a thicker film coating and therefore a thicker glove providing undesired reduction of tactile sense through the glove. Lower dipping time yielded a coating that was too thin to provide a noticeable therapeutic effect. The concentration levels noted in the chart were subjected to and passed biocompatibility tests, determining that these concentrations would not cause allergy problems in users. Higher concentrations yielded uneven coating and drip marks. Lower concentrations did not yield a noticeable therapeutic effect. Higher temperatures cause the compound to be too thin to form the desired layer. At lower temperatures, the components may not dissolve thoroughly or consistently through the compound. Further, at lower temperatures, the coating is not picked up by the substrate in an even manner.
Next, the coated substrate is dried (45), such as by passing the form through a blow drying oven heated to 65-70° C. for about 10 minutes. The heat from the ovens allows the silicone, collagen and allantoin compound gel to evaporate and form an even layer on the surface of the glove.
The coated substrates are then stripped (50) from the forms, turning them inside out, such that the coating 11 resides on the inside surface of the glove 2. The gloves then cool (55).
In the spraying method,
In typical manufacturing, to achieve efficiency, the manufacturing process is performed on an assembly line with multiple forms being dipped or dried at one time. The chlorination process and the process of adding a donning agent may optionally be conducted “off-line”, using tumblers and dryers.
Although an illustrative version of the article and method of making it is shown, it should be clear that many modifications to the device may be made without departing from the scope of the invention. The above details are provided merely to illustrate a typical process of manifesting the invention into a product. The parameters and process described are a guideline, and may be modified to suit the production environment as long as the end product is within the scope and spirit of this invention. The exact parameters used depend upon a number of variables, such as the raw material used, age of the production line, ultimate user application of the glove, and other factors.
This application is a continuation application of U.S. patent application Ser. No. 11/985,252, filed Nov. 14, 2007, now U.S. Pat. No. 8,365,314 B2 which claims the benefit of U.S. Provisional Patent Application No. 60/858,854, filed Nov. 14, 2006, the disclosure of which are incorporated by reference herein.
Number | Name | Date | Kind |
---|---|---|---|
6274154 | Chou | Aug 2001 | B1 |
6423328 | Chou | Jul 2002 | B2 |
6630152 | Chou | Oct 2003 | B2 |
20040122382 | Johnson et al. | Jun 2004 | A1 |
20050127552 | Modha et al. | Jun 2005 | A1 |
20050228538 | Limburger | Oct 2005 | A1 |
20060115653 | Soerens et al. | Jun 2006 | A1 |
Number | Date | Country |
---|---|---|
41 36 540 | May 1992 | DE |
101 14 060 | Jan 2002 | DE |
1 709 879 | Oct 2006 | EP |
WO 2005072856 | Aug 2005 | WO |
Entry |
---|
PCT/US07/23884 International Search report dated Mar. 31, 2008, 2 pages. |
PCT/US07/23884 Supplemental European Search report dated Feb. 25, 2010, 5 pages. |
Number | Date | Country | |
---|---|---|---|
20130145517 A1 | Jun 2013 | US |
Number | Date | Country | |
---|---|---|---|
60858854 | Nov 2006 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 11985252 | Nov 2007 | US |
Child | 13758697 | US |