U.S. patent application number 10/916381 was filed with the patent office on 2006-02-09 for multilayered gloves having enhanced barrier protection.
Invention is credited to Fung Bor Chen.
Application Number | 20060026737 10/916381 |
Document ID | / |
Family ID | 35755910 |
Filed Date | 2006-02-09 |
United States Patent
Application |
20060026737 |
Kind Code |
A1 |
Chen; Fung Bor |
February 9, 2006 |
Multilayered gloves having enhanced barrier protection
Abstract
A type of multilayered glove consisting of an inner layer, an
outer layer, and pigments between the layers is disclosed. The
layers can be made of the same or different materials to
incorporate desired barrier properties such as oil or chemical
resistance to a glove. The layers can also be made of the same or
different colors. The glove can have the same physical barrier
protection as wearing two gloves, but without the discomfort of
wearing two gloves. The glove enhances barrier protection and
allows users to detect any breach of the outer layer during the
surgical procedure, which enables the user to execute corrective
actions before cross contamination occurs.
Inventors: |
Chen; Fung Bor; (Greer,
SC) |
Correspondence
Address: |
Fung Bor Chen
801 E. Silverleaf St.
Greer
SC
29650
US
|
Family ID: |
35755910 |
Appl. No.: |
10/916381 |
Filed: |
August 7, 2004 |
Current U.S.
Class: |
2/161.7 |
Current CPC
Class: |
A61B 42/30 20160201;
A61B 42/00 20160201; A41D 31/305 20190201; A61B 42/10 20160201;
A41D 19/0058 20130101 |
Class at
Publication: |
002/161.7 |
International
Class: |
A41D 19/00 20060101
A41D019/00 |
Claims
1. A type of multilayered glove comprises of an outer layer, an
inner layer, pigments embedded between the interface of the outer
layer and the inner layer, and linkages between the inner and the
outer layer.
2. A glove according to claim 1 wherein said inner layer and said
outer layers have the same or different colors.
3. A glove according to claim 1 wherein said inner layer and said
outer layers are made of the same or different type of latexes.
4. A glove according to claim 1 wherein the thickness of said inner
layer is either thicker or thinner than said outer layer, and the
thickness of said glove meets the ASTM D 3577 or ASTM D 3578
standard.
5. A glove according to claim 1 wherein said outer layer and said
inner layer are physically linked together.
6. A glove according to claim 1 wherein the pigments embedded
between said outer layer and said inner layer add the feature of
providing a warning for the breach of the outer layer of said
glove.
7. A glove according to claim 1 wherein said pigments consist of
a.Macrolex.RTM. Fluorescent Red G, Macrolex.RTM. Fluorescent Yellow
10GN, Macrolex.RTM. Green G Gran, Macrolex.RTM. Violet 3R Gran,
Macrolex.RTM. Blue RR Gran, cadmium red, diarylide yellow, azoic
yellow, chrome yellow, cadmium yellow, molybdate orange, pyrazolone
orange, dianisidine orange, cadmium orange, pyrazolone red, azoic
red, cadmium red, carbozole violet, perylene scarlet,
quinacridones, carbaxole dioxazine, phthalocyanine, magenta, chrome
oxide green, iron oxide, antimony oxide, sodium silicofluoride,
titanium dioxide, clay, zinc oxide, zinc carbonate, calcium
carbonate, silica, mica, animal black, charcoal, lampblack,
litharge, lead chromate, white lead, lead carbonate, cadmium
yellow, ultramarine, ferric ferrocyanide, vermilion (mercuric
sulfide), chlorophyll (green), xanthophyll (yellow), carotene,
anthocyanin, etc.
8. A glove according to claim 1 wherein said outer layer contains
natural rubber, carboxylated acrylonitrile butadiene latex, nitrile
rubber, polycholoroprene, polyurethane, polyisoprene,
isobutylene-isoprene, ethylene-propylene, styrene-butadiene rubber,
polybutadiene, polyvinyl alcohol, polyvinyacetate, silicone,
acrylonitrile-butadiene, butyl rubber, silicone rubber,
polyacrylate, and their blends, or mixtures thereof.
9. A glove according to claim 1 wherein said inner layer contains
natural rubber, carboxylated acrylonitrile butadiene latex, nitrile
rubber, polycholoroprene, polyurethane, polyisoprene,
isobutylene-isoprene, ethylene-propylene, styrene-butadiene rubber,
polybutadiene, polyvinyl alcohol, polyvinyacetate, silicone,
acrylonitrile-butadiene, butyl rubber, silicone rubber,
polyacrylate, and their blends, or mixtures thereof.
10. A method for making a glove according to claim 1 to form an
impermeable film is not limited to a surgical or an examination
glove but includes industrial gloves, balloons, condoms, finger
cots, tubes or sheaths.
11. A type of multilayered glove comprises of an outer layer, an
inner layer, and linkages between the inner layer and the outer
layer.
12. A glove according to claim 11 wherein said inner layer and said
outer layers have the same or different colors.
13. A glove according to claim 11 wherein said inner layer and said
outer layers are made of the same or different type of latexes.
14. A glove according to claim 11 wherein the thickness of said
inner layer is either thicker or thinner than said outer layer, and
the thickness of said glove meets the ASTM D3577 or ASTM D 3578
standard.
15. A glove according to claim 11 wherein said outer layer and said
inner layer are physically linked together.
16. A glove according to claim 11 wherein said outer layer contains
natural rubber, carboxylated acrylonitrile butadiene latex, nitrile
rubber, polycholoroprene, polyurethane, polyisoprene,
isobutylene-isoprene, ethylene-propylene, styrene-butadiene rubber,
polybutadiene, polyvinyl alcohol, polyvinyacetate, silicone,
acrylonitrile-butadiene, butyl rubber, silicone rubber,
polyacrylate, and their blends, or mixtures thereof.
17. A glove according to claim 11 wherein said inner layer contains
natural rubber, carboxylated acrylonitrile butadiene latex, nitrile
rubber, polycholoroprene, polyurethane, polyisoprene,
isobutylene-isoprene, ethylene-propylene, styrene-butadiene rubber,
polybutadiene, polyvinyl alcohol, polyvinyacetate, silicone,
acrylonitrile-butadiene, butyl rubber, silicone rubber,
polyacrylate, and their blends, or mixtures thereof.
18. A method for making a glove according to claim 11 to form an
impermeable multilayered film is not limited to a surgical or an
examination glove but includes industrial gloves, balloons,
condoms, finger cots, tubes or sheaths.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
U.S. PATENT DOCUMENTS
[0001] TABLE-US-00001 4,935,260 6/1990 Shlenker 5,357,636 10/1994
Dresdner, Jr. et al. 5,411,034 5/1995 Beck et al. 5,679,399 10/1997
Shlenker et al. 5,911,848 6/1999 Haber et al. 5,965,276 10/1999
Shlenker et al. 6,145,130 11/2000 Haber et al. 6,618,861 9/2003
Saks et al.
OTHER PUBLICATIONS
[0002] 1. Glove Materials and Their Uses, F. B. Chen and R. Tuck,
International Latex Conference at Akron, 2002.
[0003] 2. Macrolex.RTM. Fluorescent Red G, Bayer Product
Information, Product: 72325, October, 1996.
[0004] 3. Macrolex.RTM. Green G Gran, Bayer Product Information,
Product: 72612, March, 1999.
[0005] 4. Macrolex.RTM. Violet 3R Gran, Bayer Product Information,
Product: 72404, October, 1996.
[0006] 5. Macrolex.RTM. Blue RR Gran, Bayer Product Information,
Product: 72513, March, 1999.
[0007] 6. Standard Specification for Rubber Examination Gloves,
ASTM D 3578, January, 2002.
[0008] 7. Standard Specification for Rubber Surgical Gloves, ASTM D
3577, January, 2002.
BACKGROUND OF THE INVENTION
[0009] 1. Field of the Invention
[0010] The present invention discloses a type of multilayered glove
that can have the same physical barrier protection as wearing two
gloves, but without the discomfort of wearing two gloves. The
invention has enhanced barrier protection on the glove and allows
users to detect any breach of the outer layer during the surgical
procedure, which enables the users to execute corrective actions
before cross contamination occurs.
[0011] 2. Description of the Related Art
[0012] Surgical and examination gloves are worn during a medical
procedure to provide physical barriers between patients and health
care professionals. However, 1.about.3 percent of these gloves
produced continue to contain hole defects and fail to serve their
basic intended purpose of forming an impermeable physical barrier.
Despite the significant effort that has been put forth by glove
manufacturers, reducing hole defect to zero among gloves in mass
production is still a distant dream. At the same time, diseases
caused by infectious pathogens such as human immunodeficiency virus
(HIV), acquired immune deficiency syndrome (AIDS), and hepatitis B
virus (HBV), accelerate with increased human contact. Such
infections have created urgency for health care professionals
(users) to take extra precautions. Donning two gloves is a
recommended practice to reduce the chances of infectious pathogens
from passing through glove hole defects in any high-risk
procedure.
[0013] Traditionally, users don two gloves of the same size or don
the inner glove with one size smaller than the outer glove. In
either case, the outer glove is not bound together with the inner
glove. To don the outer glove over the inner glove, the outside
surface of the inner glove is often treated with chlorine, polymer
coating or FDA-approved absorbable powder. These processes produce
a less tacky outer surface and permit the outer glove to don over
the inner glove with ease. However, they create slippery issues for
the outer glove by causing it to be more difficult to hold in place
during procedures, and they also tend to cause sagging and
easy-to-roll-down issues from repeated hand manipulation. Slippery,
sagging and roll-down issues during procedures consequently
interfere with surgical procedures.
[0014] U.S. Pat. No. 5,357,636 discloses a glove comprising a thin
inner layer, a thin outer layer and a compartment between the
layers. The outer glove layer is slipped over the inner glove on
the hand mold. After applying the antiseptic composition, the
layers are sealed to create compartments. There is no contemplation
of creating color contrast between the layers and adding pigments
in the interface to amplify the breach of the outer layer. The
process to make the glove disclosed in the prior art is tedious and
labor intensive.
[0015] U.S. Pat. No. 5,411,034 discloses a condom device consisting
of two layers of material with a sandwiched layer that has an air
sensitive, colorless agent between the two layers. In the event
that the colorless agent is exposed to air, it changes color to
alert the user that the integrity of the condom is compromised. The
air sensitive color agent must be inserted between the first and
third layers in an oxygen free environment, such as a chamber of
carbon dioxide or nitrogen. There is no contemplation of preparing
the condom in normal air environment.
[0016] U.S. Pat. Nos. 5,911,848 and 6,145,130 disclose a visual
indicator for a surgical glove to alert the user when the integrity
of the glove is compromised. The glove includes outer and inner
layers that have a space between the layers and a vacuum
established within the space. There is no contemplation of creating
color contrast and adding pigments in the interface to amplify the
breach of the outer layer.
[0017] U.S. Pat. No. 6,618,861 discloses a glove with two distinct
portions, one portion clear and the other opaque. The glove allows
wearers to see through the transparent wrist portion and tell time
with the gloves on. There is no contemplation of creating color
contrast between the layers and adding pigments in the interface to
amplify the breach of the outer layer.
[0018] U.S. Pat. Nos. 4,935,260, 5,679,399, and 5,965,276 describe
a multilayered glove body comprising a latex outer layer, an
intermediate layer containing lubricant, biocide, spermicide, or
indicators, and a latex inner layer. The glove has discrete inner,
intermediate, or outer layers. There is no contemplation of
creating color contrast between the layers, adding pigments in the
interface to amplify the breach of the outer layer, and linking all
the layers together.
SUMMARY OF THE INVENTION
[0019] The present invention is to provide a novel approach to
produce a type of multilayered glove with enhanced barrier
protection. The layers can be made of different materials to
incorporate desired barrier properties such as oil or chemical
resistance to a glove. Dipping a coagulant over the outer layer
surface is directed toward eliminating hole defect. Making color
differences in layers shows color contrast, and adding pigments
between these layers creates a glaring visual indication to users
when the outer layer is breached.
[0020] The object of this invention is to make a type of
multilayered glove, particularly a surgical or an examination
glove, that can provide users with the same protection as wearing
two gloves. At the same time, the invention will eliminate the
uncomfortable feeling of wearing two gloves and provide enhanced
optical effect to indicate the breach of the outer layer during the
procedure.
BRIEF DESCRIPTION OF THE DRAWING
[0021] So that the present invention may be understood more
readily, the following description is given, merely by way of
example with reference to the accompanying drawings, in which:
[0022] FIG. 1 is a blow-up of a schematic view of the present
invention after the outer layer of the glove is formed to
shape.
[0023] FIG. 2 is a blow-up of a schematic view of the present
invention after the glove sandwich layer is dipped.
[0024] FIG. 3 is a blow-up of a schematic view of the present
invention after the glove inner layer is formed to shape.
[0025] FIG. 4 is a blow-up of a schematic view of the present
invention after the glove is stripped off.
[0026] FIG. 5 is a blow-up of schematic view of the cross section
marked 41-43 in FIG. 4.
DETAILED DESCRIPTION OF THE INVENTION
[0027] As shown in FIGS. 4 and 5, the present invention relates to
a type of multilayered medical glove 4, comprising an outer layer
11, an inner layer 13, and a sandwich layer 12 between the outer
layer 11 and the inner layer 13. The outer layer has the longest
length than all the other layers. The sandwich layer is the
shortest. The inner layer is longer than the sandwich layer but
shorter than the outer layer.
[0028] Surgical gloves and examination gloves have different
thickness requirements. Surgical glove thickness of the foregoing
outer layer 11 and inner layer 13 is preferably 0.05 mm or more
respectively in compliance with the regulations of ASTM D 3577 to
achieve a minimum glove thickness of 0.10 mm. The sandwich layer 12
is designed to cover most portions of the inner layer from the
finger tip to the wrist. The thickness is less than 0.01 mm.
Examination glove thickness of the foregoing outer layer 11 and
inner layer 13 is preferably 0.04 mm or more respectively in
compliance with the regulations of ASTM D 3578 to achieve a minimum
glove thickness of 0.08 mm.
[0029] The actual production process to form a multilayered glove
includes a series of dipping: coagulant, latex (outer layer
dipping), coagulant/pigments, and latex (inner layer dipping). A
glove-forming former is immersed in coagulant, dried, and then
immersed in latex to form an outer layer 11 of glove 4 (FIG. 1). It
is then immersed in a mixture of coagulant, fluorescent pigments or
color pigments, and dried to form a sandwich layer 12 of glove 4
(FIG. 2). Then the former is immersed in latex to form an inner
layer 13 and establish the linkages between the inner layer and the
outer layer of glove 4 (FIG. 3). Leaching and vulcanization follow
and then the glove is stripped off the former. After stripping the
glove, the inner layer 13 on the outside as shown in FIG. 3 stays
inside, and the outer layer 11 on the inside as shown in FIG. 3
becomes outside. The resulted glove is shown as glove 4 in FIG. 4.
Since the sandwich layer dipping consists of coagulant and
pigments, during the dipping of the inner layer, the coagulant is
dissolved and used completely to gel the latex and form an inner
layer and physical linkages between the outer layer and the inner
layer. The linkages between the inner layer and the outer layer are
very dense through the entire area of the inner layer. FIG. 5 is a
schematic view of the cross section of 41-43 from FIG. 4. The inner
layer and the outer layer are linked together and become
inseparable. The pigments are embedded inside the linkages between
the inner layer and the outer layer. The pigments are bound
together inside the latex matrix. The present invention is
completely different from U.S. Pat. No. 5,965,276. The prior art
emphasizes distinct layers. There is no proven linkage between the
distinct inner, intermediate, and outer layers.
[0030] The materials used to form a medical glove should be
flexible and should be capable of being made into a thin sheet. The
latexes commonly used for dipping surgical and examination gloves
are natural rubber latex, nitrile rubber latex,
acrylonitrile-butadiene latex, butyl rubber latex,
ethylene-propylene latex, styrene butadiene rubber latex,
polyisoprene latex, polychloroprene latex, silicone rubber latex,
polybutadiene latex, polyurethane latex, etc. All these latexes can
be used to make the inner layer and the outer layer of the glove
mentioned in the present invention. The inner layer and the outer
layer can be made from different latexes to achieve a synergetic
effect from respective material characteristics. Polychloroprene is
more resistant to oil and body fat, nitrile rubber is more
resistance to chemicals, polyisoprene is more flexible and easy for
hand manipulation, and butyl rubber is more impermeable to gas. The
selection of latex in making the inner layer and the outer layer is
strictly dependent on the preferences of the end user for a
finished glove.
[0031] Natural rubber latex, polychloroprene and polyisoprene are
preferred materials for surgical gloves. Nitrile, polyurethane,
thermoplastic rubbers, and vinyl gloves are dominant for
examination gloves. Since the majority of glove dipping machines
are equipped with one single dipping, the multilayered glove as
disclosed in the present invention is a novel approach to have
different layers of materials in a glove to enhance its
performance.
[0032] Coagulants used to dip gloves in the present invention
should be multivalent cations: calcium chloride, calcium nitrate,
aluminum chloride, aluminum sulfate, magnesium acetate, zinc
nitrate, zinc chloride; organic and inorganic acids; and
water-soluble organic solvents. Water and alcohol are common
materials to dilute the coagulants. Surfactants are often added to
smooth out the deposit of the coagulant.
[0033] A pigment is a dry colorant, usually an insoluble powder.
There are both natural and synthetic pigments, both organic and
inorganic ones. Pigments work by selectively absorbing some parts
of the visible spectrum whilst reflecting others. Pigments in the
interface of the inner layer and the outer layer include color
pigments, phosphorescent pigments or fluorescent pigments. The
basic requirement for the pigments used in the present invention is
that the pigments neither dissolve in water nor cause staining in
leaching. Typical materials are: Macrolex.RTM. Fluorescent Red G,
Macrolex.RTM. Fluorescent Yellow 10GN, Macrolex.RTM. Green G Gran,
Macrolex.RTM. Violet 3R Gran, Macrolex.RTM. Blue RR Gran, chrome
oxide green, iron oxide, antimony oxide, sodium silicofluoride,
titanium dioxide, clay, zinc oxide, zinc carbonate, calcium
carbonate, silica, mica, animal black, charcoal, lampblack,
litharge, lead chromate, white lead, lead carbonate, Cadmium
yellow, Ultramarine, ferric ferrocyanide, vermilion (mercuric
sulfide), chlorophyll (green), xanthophyll (yellow), carotene,
anthocyanin, etc.
[0034] The glove 4 of the present invention can be comprised of
completely different colors in the outer layer and the inner layer.
The inner layer 13 is preferred to be very bright in color. The
outer layer 11 is preferred to be dark in color to diffuse the
light glaring in the operation room. The pigments sandwiched
between the outer and the inner layers are preferred to be
fluorescent in nature. Should breaching of the outer layer occur,
the pigments between the layer will be exposed to the light source
and reflect glaring to user's eyes. Also, the contrasting colors
between the layers will prompt the user; therefore, the present
invention is designed to warn the user of the breach to the outer
layer.
[0035] In a normal dipping, the outer layer is inadvertently
produced with 1.about.3% of hole defects. As described in FIG. 2,
the coagulant is dipped over the outer layer and fills the voids in
the outer layer. During the inner layer dipping, the latex will be
destabilized by the coagulant and fills the voids. This process
shall reduce the potential for hole defects in a finished
glove.
[0036] The process is also completely different from normal double
dipping in the latex. Current common practice is to dip twice in
sequence into the latex with no coagulant dipping between the two
latex dips. In this case, the inner layer is significantly thinner
than the outer layer. It could be as thin as one tenth of the
thickness of the outer layer. This double dipping would reduce the
hole defect compared to single latex dipping, but wouldn't be as
effective as the process proposed in the present invention. The
invention could produce an inner layer thicker than the outer
layer. The efficiency of the thicker inner layer versus the normal
double dipping to cover hole defect is obvious.
[0037] The glove produced by the present invention could have the
same thickness as one or two single layer gloves. Therefore the
physical barrier from the present invention can be the same as
wearing two gloves. The color contrast between the inner layer and
the outer layer adds the feature to warn users when the outer layer
is breached and the inner layer with a different color is exposed
to the users. Pigments residing in the interface between the inner
layer and the outer layer amplify the effects further. The outer
layer and the inner layer can be made of different materials. The
variety of compositing two different spectrum materials together in
forming a glove enhances the resistance of the glove to oil or
chemicals as demanded from users. Even though the discussion is
focused on the glove, the present invention shall cover any device
of which the intention is to form an impermeable film but not
limited to the following: condoms, finger cots, sheaths, balloons,
and tubes. The subject matter of the present invention has not been
made obvious nor has it been suggested by the prior art.
* * * * *