U.S. patent application number 12/170453 was filed with the patent office on 2009-03-19 for puncture indicating gloves.
Invention is credited to Gareth Hilton, Simon Pickard.
Application Number | 20090070918 12/170453 |
Document ID | / |
Family ID | 38670133 |
Filed Date | 2009-03-19 |
United States Patent
Application |
20090070918 |
Kind Code |
A1 |
Pickard; Simon ; et
al. |
March 19, 2009 |
PUNCTURE INDICATING GLOVES
Abstract
A puncture indicating glove comprises a bilayer formed by an
inner glove layer and an outer glove layer, the outer glove having
an opacity in the range of 23-34%. The opacity of the over glove is
controlled by the inclusion in the over glove of a fine particulate
material, in particular selected from the group comprising titanium
dioxide, silica, barite powder, barium sulphate, barium carbonate,
calcium carbonate, gypsum, clay, talc, alumina white, basic
magnesium carbonate, zinc oxide. The inner glove has a chroma range
C* which is controlled to result in a glove that indicates
optimally with transparent liquid and strongly coloured liquids
such as blood. The inner glove has a chroma C* which is greater
than 30, advantageously greater than 40, more preferably greater
than 43, and in particular greater than 46.
Inventors: |
Pickard; Simon; (Irlam,
GB) ; Hilton; Gareth; (Irlam, GB) |
Correspondence
Address: |
JOHN S. PRATT, ESQ;KILPATRICK STOCKTON, LLP
1100 PEACHTREE STREET
ATLANTA
GA
30309
US
|
Family ID: |
38670133 |
Appl. No.: |
12/170453 |
Filed: |
July 10, 2008 |
Current U.S.
Class: |
2/161.7 ;
2/167 |
Current CPC
Class: |
A61B 42/00 20160201;
A61B 42/30 20160201; A61L 31/14 20130101; B29L 2031/4864 20130101;
A41D 19/0058 20130101 |
Class at
Publication: |
2/161.7 ;
2/167 |
International
Class: |
A41D 19/00 20060101
A41D019/00 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 18, 2007 |
GB |
0718240.5 |
Jan 29, 2008 |
GB |
0801602.4 |
Claims
1. A puncture indicating glove comprising a bilayer formed by an
inner glove layer and an outer glove layer, the outer glove having
an opacity in the range of 15-40%.
2. A puncture indicating glove according to claim 1, wherein the
opacity is in the range of 18 to 38% , advantageously 20 to 35% and
more particularly 23 to 34%.
3. A puncture indicating glove according to claim 1, wherein the
opacity of the over glove is controlled by the inclusion in the
over glove of a fine particulate material, in particular selected
from the group comprising titanium dioxide, silica, barite powder,
barium sulphate, barium carbonate, calcium carbonate, gypsum, clay,
talc, alumina white, basic magnesium carbonate, zinc oxide.
4. A puncture indicating glove according to claim 1, wherein the
inner glove has a chroma range C* which is controlled to result in
a glove that indicates optimally with transparent liquid and
strongly coloured liquids such as blood.
5. A puncture indicating glove according to claim 1, wherein the
inner glove has a chroma C* which is greater than 30,
advantageously greater than 40, more preferably greater than 43,
and in particular greater than 46.
6. A puncture indicating glove according to claim 4, wherein the
inner glove includes pigment in order to control the chroma.
7. A puncture indicating glove according to claim 6, wherein the
chroma is varied by choosing pigments of relatively high values of
C* and/or increasing the amount of said pigment.
8. A puncture indicating glove according to claim 1, wherein L* of
the inner glove is less than 45, preferably less than 35 and more
preferably less than 32.
9. A puncture indicating glove according to claim 1, wherein the
product of C* and 1/L* is greater than 0.8, more preferably greater
than 1.2 and in particular greater than 1.5.
10. A puncture indicating glove according to claim 1, wherein the
inner glove is of a colour having a hue angle in the range of
160-300.degree., advantageously 180-280.degree., more preferably
220-270.degree. and in particular 250-270.degree..
11. A puncture indicating glove according to claim 1, wherein the
inner glove has a colour that contrasts with red.
12. A puncture indicating glove according to claim 1, wherein a
middle layer is disposed between the inner and outer layers, which
middle layer has a refractive index which varies depending on its
liquid content.
13. A puncture indicating glove according to claim 12, wherein the
opacity of the material of the middle layer decreases in the
presence of liquid, thereby increasing the visibility of the inner
layer when liquid is present.
14. A puncture indicating glove according to claim 1, wherein the
outer glove includes finely milled organic or inorganic pigments.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to Great Britain
Application No. GB 0718240.5 filed on Sep. 18, 2007 and to Great
Britain Application No. GB 0801602.4 filed on Jan. 29, 2008, the
contents of each of which are incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to gloves, in particular
surgical gloves which have puncture evident characteristics by
means of which a wearer can easily identify if the glove has been
pierced.
[0003] Surgical gloves perform an important function of protecting
the wearer's hands from exposure to bodily fluids such as blood
which might be infected and hence present a health risk as well as
protecting the patient's internal organs from exposure to sweat and
the like from the surgeons hands. Accordingly, the integrity of the
liquid barrier formed by the glove is very important. In practice,
surgical gloves are used within an environment where there is a
risk of piercing, for example from scalpels and other sharp
surgical implements, and it is therefore desirable for the wearer
to be able to easily identify if a glove has been pierced, either
before or during use, so as to minimize any potential contamination
either to the wearer or the patient.
[0004] U.S. Pat. No. 5,224,221 describes a tamper or damage evident
surgical glove in the form of a bi-layer glove, comprising an inner
layer and an outer layer, in which the outer layer is translucent,
in particular yellow, and the inner layer is a contrasting colour,
in particular a darker colour such as green or black. If either the
inner or outer layer is pierced, liquid can permeate between the
two layers. This liquid causes two effects; the colour of the inner
layer becomes more apparent through the outer layer, and or the
colour of the liquid becomes apparent through the outer layer. The
user sees this as a region of contrasting colour where the liquid
is present between the two layers of the bilayer. However, the
change in visibility produced by the indicating system in U.S. Pat.
No. 5,224,221 has been found, in practice to be dependent on
circumstance and in certain cases not to be that easily perceived
by the wearer.
[0005] To maximize the perception of loss of barrier properties it
is preferred that there is a large difference in colour or shade
between regions of the bilayer that have fluid present between the
two layers and regions of the bilayer that are absent of fluid.
Large differences in colour result in an obvious indication of loss
of barrier properties to the user. This is much preferred over a
bilayer that results in a small difference in colour that is much
less obvious to the user. As the user is reliant on a colour change
to indicate the bilayer has been compromised it is imperative that
the colour change is obvious. The present invention seeks to
provide a bilayer system of the type of U.S. Pat. No. 5,224,221
that results in a large colour change as fluid ingresses into the
region between the bilayers. In particular, the present invention
seeks to maximize the colour change that becomes apparent in a
double glove system by specifying the opacity of the outer glove
and the density and strength of colour of the under glove.
[0006] The fluids generally exposed to the indicating system in the
field of the invention are not of consistent colour. The colour of
the fluid can range from colourless, transparent fluid such as
water to strongly coloured fluid such as blood. As the fluid
provides the source for indication of loss of barrier properties it
is preferred to have a coloured under glove that contrasts with
indicating fluid such as blood. It is also preferred that the
colour of the under glove is strong enough to show through a
transparent over glove when the indicating fluid is colourless and
transparent.
DETAILED DESCRIPTION
[0007] The present invention is based on the realization that the
transparency of the over glove is key to generating optimal
indication. The user relies on a colour change visible from the
exterior of the glove on ingress of indicating fluid to indicate
that the barrier properties of the bilayer have been compromised.
The colour change occurs due to an increase in the amount of colour
from the under glove or the indicating fluid showing through the
outer glove. The intensity of colour of the inner glove does not
change but the fluid ingressing into the space between the gloves
results in the inner glove becoming more visible through the outer
glove. This colour has to contrast with the colour of the double
layer that is absent of fluid to be evident to the user. The level
of contrast or difference in colour between the bilayer containing
fluid and the bilayer absent of fluid is partially determined by
the transparency or opacity of the outer glove. The opacity of the
outer glove can be determined using a method similar to that
described in ISO 2814. Measurements are made using the automatic
(factory preset) controls for measuring opacity on the X-rite SP60
series. The reflectance of the outer glove is measured over a black
background and then measure over a white background.
Opacity=(Reflectance over black)/(Reflectance over
white).times.100. If the outer glove is truly transparent (that is
having an opacity of 0%) the colour of the underglove will always
be visible through the outer glove. If this is the case ingress of
a colourless fluid will have no impact on the colour of the double
layer when viewed from the outside. This results in little colour
change on indication and little perception of puncture to the user.
If the overglove is of low translucency (that is having an opacity
of 100%) the over glove will mask the under glove. Therefore the
apparent colour to the user will be of the overglove. When liquid
ingresses into the space between the two layers the over glove will
continue to mask the colour of the under glove and any colour
associated with the fluid. Therefore there will be little change of
colour on indication. Both these systems will result in a low
probability that the user will detect the occurrence of a puncture
in the barrier.
[0008] According to the present invention there is provided a
puncture indicating glove comprising a bilayer formed by an inner
glove layer and an outer glove layer, the outer glove having an
opacity in the range of 15-40%.
[0009] A puncture indicating glove in accordance with the invention
has the advantage that it provides particularly effective
indication of liquid penetration between the layers, making it
particularly easy for the wearer to identify if the integrity of
the barrier formed by the glove has been compromised.
[0010] The opacity range referred to above and hereinafter is based
on a range of 0%, being completely transparent, to 100% being
totally opaque. Preferably, the opacity is in the range of 18 to
38%, advantageously 20 to 35% and more particularly 23 to 34%. This
has the advantage that it results in the largest contrast in colour
when transparent liquids ingress between the layers.
[0011] The opacity of the over glove is preferably controlled by
the inclusion of a fine particulate material such as, but not
limited to: titanium dioxide, silica, barite powder, barium
sulphate, barium carbonate, calcium carbonate, gypsum, clay, talc,
alumina white, basic magnesium carbonate, zinc oxide etc in the
over glove. This can also be achieved by including finely milled
organic or inorganic pigments in the overglove. The levels of
materials required to achieve the desired opacity will depend on
the nature of the material and particle size of the particulate
material along with the amount of particulate material contained in
the compounding formulation for the polymer. For this reason it is
preferred to minimize the amount and size of particulate material
used in the formulation of the polymer constituents to make up the
glove.
[0012] The inner or under glove preferably has a chroma range C*
(which essentially is the strength of colour) which is controlled
to result in a glove that indicates optimally with transparent
liquid and strongly coloured liquids such as blood. The chroma of
the inner glove is preferably greater than 30, advantageously
greater than 40, more preferably greater than 43, and in particular
greater than 46. The chroma is preferably controlled by the
inclusion of pigment and can be increased by choosing pigments of
relatively high values of C* as well as increasing the levels of
said pigment. This ensures that the maximum colour difference is
observed on wetting with transparent fluid such as water or when
the indicating fluid is more highly coloured as in the case when
blood is the indicating medium. If the chroma of the underglove is
relatively small (weakly coloured) the indicator system will not
work well with fluids of low chroma (e.g. water).
[0013] The depth of density of colour is not solely controlled by
C* as black or dark grey undergloves would have a relatively low C*
but appear to provide good contrast on the ingress of liquid.
Therefore it is preferred that if C* is low L* should be relatively
low, and in particular that L* is less than 45, preferably less
than 35 and more preferably less than 32
[0014] Furthermore, to encompass both the properties of C* and L*
it is advantageous that the product of C* and 1/L* is greater than
0.8, more preferably greater than 1.2 and in particular greater
than 1.5.
[0015] Preferably the inner glove is of a colour having a hue angle
(hue angle being defined by h.degree.=arctan (b*/a*)) in the range
of 160-300.degree., advantageously 180-280.degree., more preferably
220-270.degree. and in particular 250-270.degree.). This has the
advantage that it results in a glove in which the inner glove
contrasts well with blood, so that in the case of the indicating
medium being blood, the inner layer may be visible through the
fluid that ingresses to give indication on puncture. To give the
greatest perception of colour change it is preferred that the under
glove has a colour that contrasts with red. This will also ensure
that indication becomes apparent when examining the gloves in an
environment that is predominantly red in colour.
[0016] In an advantageous development of the invention, a middle
layer is disposed between the inner and outer layers, which middle
layer has a refractive index which varies depending on its liquid
content--in particular, the opacity of the material of the middle
layer decreases, so that it becomes more transparent, in the
presence of liquid, thereby increasing the visibility of the inner
layer when liquid is present.
[0017] The inner and outer glove layers, and, indeed, if present
the middle layer, are formed as separate gloves which may be
connected together, for example at the cuff opening, so that the
assembly is donned as a unitary glove, or may be completely
separate from each other and donned separately in order, one over
another.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] Further details of the invention will now be provided by
description of embodiments, which are given by way of example, with
reference being made to the accompanying drawing, in which:
[0019] FIG. 1 is a graph of .DELTA.E* vs. opacity for various
different samples; and
[0020] FIG. 2 is a graph of .DELTA.E* vs. C*/L for various
different samples.
DETAILED DESCRIPTION OF THE DRAWINGS
[0021] The degree of colour change can be measured by determining
the value of .DELTA.E* (euclidean distance) on the ingress of fluid
between the layers--the larger the value of .DELTA.E* the greater
the colour change. This leads to and increased probability of
perception of failure of barrier properties. With regards to this
C*, L*, a*, b* (The three basic coordinates represent the lightness
of the color (L*, L*=0 yields black and L*=100 indicates white),
its position between red/magenta and green (a*, negative values
indicate green while positive values indicate magenta) and its
position between yellow and blue (b*, negative values indicate blue
and positive values indicate yellow), and .DELTA.E* values (all of
which are universally recognized parameters with regard to colour
within the art--CIE 1976 commission Internationale de l'Eclairage)
may be determined using a spectrophotometer such as an SP62
provided by X-Rite of Grandville Mich. This method can also be used
to determine the preferred properties of the underglove. The colour
characterization of gloves can be performed using either CIELAB
system or a CIELCH system. These systems have been demonstrated to
reflect the perception of an average observer demonstrating the
measurement in colour change is representative of that of
visualized by the user of the product. The data stated in this
document has been generated using an F2/2 illuminant and allowing
speculative light to be included in the measurement.
.DELTA.E*=((L*.sub.standard-L*.sub.sample).sup.2+(a*.sub.standard-a*.sub-
.sample).sup.2+(b*.sub.standard-b*.sub.sample).sup.2).sup.0.5
C*=(a*.sup.2+b*.sup.2).sup.0.5
h.degree.=arctan (b*/a*)
[0022] When performing these measurements it is important to ensure
the background is consistent, as the colour of the background may
affect the colour of the glove under evaluation. Measurements for
this document were all performed by placing a single layer of
material over either a ceramic plate or a ceramic former used for
glove manufacture with L* of 81.95 to 90.69, an a* of -0.87 to 0.13
and a b* of 2.79 to 11.82. The colour of the underglove was
measured on the former or plate. An overglove was placed over the
underglove and the colour measured of the composite. Liquid was
then injected into the gap between the underglove and the overglove
and the colour determined of the composite in a region containing
the liquid. It is important that sufficient liquid is injected into
the gap to give a large area in which the colour of the underglove
becomes more apparent through the overglove. For this purpose
approximately 0.1 ml of liquid was injected into the gap between
the two glove layers. Both distilled water and synthetic blood were
used as the liquid. The values for .DELTA.E* were then determined
on indication using the equation above. Where L*, a* and b* for the
standard refer to the values determined for the combination of the
gloves with no liquid present and L*, a* and b* for the sample all
refer to those measured for areas of the bilayer after injection of
liquid.
[0023] Synthetic blood was used to meet the specification described
in ASTMF 1862-00a. For this purpose synthetic blood meeting this
specification was purchased from Johnson, Moen & Co., 2505
Northridge Lane NE, Rochester, Minn. 55906.
[0024] The various parameter value ranges and sub-ranges recited
above can each individually be used in combination with the outer
glove opacity defined in connection with the present invention in
order to give advantageous results in terms of ease of recognition
of the ingress of liquid between the layers of the glove, but in a
particularly preferred embodiment, a puncture indicating glove is
provided which combines some and preferably all of these
parameters, at least with respect to the broadest ranges thereof
defined in each case.
EXAMPLES
Comparative Example:
[0025] Gloves were made with varying opacity these were then put
together with undergloves of varying colour. All the measurements
were made using an X-rite spectrophotometer using an F2/2
illuminant. Measurements were made that included speculative light.
The measurements of .DELTA.E* were performed as described
previously in this document. Gloves with high opacity were
generated in comparative examples A, B, D and E. It is clearly
demonstrated that all these examples give lower values for
.DELTA.E* when the indicating fluid is synthetic blood or water.
Higher values of .DELTA.E* are generated when the opacity of the
over glove is optimal. Comparative example C demonstrates that the
colour of the underglove is required with high C* to give good
level of indication with blood and water. This example has a low
value for C* and lower colour changes with low chroma indicating
fluids such as water. This further exemplified in the graph of
.DELTA.E* vs. opacity.
[0026] Examples A to G demonstrate the benefit of using overgloves
with optimal opacity in combination with high values for C*.
Examples F and G demonstrate the benefits of the correct
combination of the opacity of the overglove and colour of the
underglove.
[0027] The relationship between the strength of indication as
indicated by .DELTA.E* with C*/L is further exemplified in the
graph of .DELTA.E* vs. C*/L.
TABLE-US-00001 Overglove Underglove colour Results Example Opacity
L* a* b* C* h.degree. C*/L .DELTA.E* water .DELTA.E* blood Comp A
53.1 44.5 -35.6 -12.6 37.8 199.4 0.8 11.3 16.3 Comp B 50.2 35.5
-2.5 -42.7 42.8 266.6 1.2 18.6 15.6 Comp C 38.5 62.7 -23.4 -14.2
27.4 211.4 0.4 14.0 33.5 Comp D 45.7 57.4 -47.4 8.7 48.2 190.4 0.8
18.0 24.4 Comp E 55.5 57.4 -47.4 8.7 48.2 190.4 0.8 10.5 15.4 A
34.9 57.4 -47.4 8.7 48.2 190.4 0.8 18.0 27.7 B 33.8 35.5 -2.5 -42.7
42.8 266.6 1.2 27.2 29.5 C 33.8 57.4 -47.4 8.7 48.2 190.4 0.8 22.8
33.1 D 28.7 57.4 -47.4 8.7 48.2 190.4 0.8 20.3 31.1 E 33.8 29.2 7.7
-48.7 49.3 261.1 1.7 35.7 29.1 F 33.8 27.0 8.6 -42.3 43.2 258.5 1.6
32.4 29.8 G 37.7 57.4 -47.4 8.7 48.2 190.4 0.8 20.4 33.8
* * * * *