U.S. patent application number 12/781290 was filed with the patent office on 2010-09-09 for method for assessing adhesion of soils or exudates to the skin.
Invention is credited to Andrea Dannenberg, Randall Glenn Marsh, Kristin Hofmann Miller.
Application Number | 20100228107 12/781290 |
Document ID | / |
Family ID | 38646546 |
Filed Date | 2010-09-09 |
United States Patent
Application |
20100228107 |
Kind Code |
A1 |
Marsh; Randall Glenn ; et
al. |
September 9, 2010 |
Method for Assessing Adhesion of Soils or Exudates to the Skin
Abstract
Method of assessing the adhesion of soils or exudates to the
skin. The method may allow for an assessment of the amount of
artificial bowel movement remaining on the skin following treatment
with a lotion.
Inventors: |
Marsh; Randall Glenn;
(Hamilton, OH) ; Miller; Kristin Hofmann;
(Springboro, OH) ; Dannenberg; Andrea;
(Cincinnati, OH) |
Correspondence
Address: |
THE PROCTER & GAMBLE COMPANY;Global Legal Department - IP
Sycamore Building - 4th Floor, 299 East Sixth Street
CINCINNATI
OH
45202
US
|
Family ID: |
38646546 |
Appl. No.: |
12/781290 |
Filed: |
May 17, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11807289 |
May 25, 2007 |
7744531 |
|
|
12781290 |
|
|
|
|
60812782 |
Jun 12, 2006 |
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Current U.S.
Class: |
600/306 |
Current CPC
Class: |
A61K 8/0208 20130101;
A61Q 19/10 20130101 |
Class at
Publication: |
600/306 |
International
Class: |
A61B 5/00 20060101
A61B005/00 |
Claims
1. A method to assess soil or exudate removal from skin comprising:
a. applying the soil or exudate to the skin; b. applying a paper
substrate to the soil or exudate on the skin; and c. removing the
paper substrate by slowly peeling the paper substrate upwards, from
a first edge of the paper substrate toward a second edge opposite
the first edge.
2. The method of claim 1 wherein about 0.2 ml of soil or exudate is
applied to the skin.
3. The method of claim 2 further comprising weighing the paper
substrate before it is applied to the soil or exudate on the
skin.
4. The method of claim 3 further comprising weighing the paper
substrate after it is removed.
5. The method of claim 1 further comprising treating the skin with
a lotion.
6. The method of claim 5 further comprising treating the skin with
the lotion prior to applying the soil or exudate to the skin.
7. The method of claim 5 wherein the skin is treated with about 1
.mu.l/cm.sup.2 of the lotion.
8. The method of claim 5 wherein at least two different lotions are
applied to the skin to assess the soil or exudate removal from skin
after application of each of the lotions.
9. The method of claim 8 wherein each of the lotions is applied to
a different test site on the skin.
10. The method of claim 9 further comprising expressing at least
one lotion from at least one wet wipe product.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation application of U.S.
application Ser. No. 11/807,289, filed on May 26, 2007 which claims
the benefit of U.S. Provisional Application No. 60/812,782 filed on
Jun. 12, 2006 which is incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to a method for assessing the
adhesion of soils or exudates to the skin. The method may allow for
an assessment of the percent of artificial bowel movement remaining
on skin.
BACKGROUND OF THE INVENTION
[0003] Cleaning the skin is a personal hygiene problem not always
easily solved. Dry tissue products are the most commonly used
cleansing products post-defecation, post-urination and during
menstruation. Dry tissue products are also commonly used to remove
soils, such as food and dirt, from the skin. Dry tissue products,
such as those commonly used, are generally referred to as "toilet
paper," "toilet tissue," or "paper towels." In addition to the use
of dry tissue products, it is becoming increasingly frequent to use
moistened substrates, such as wet wipes, for the purpose of
cleansing the face and body after soiling, and the anus, the
genital area, the perinea, and the peri-anal area after the voiding
of bodily exudates. So called "wet wipes" are generally a fibrous
structure impregnated with a water or oil-based lotion.
[0004] For the purpose of the present document, the anus, the
perinea, the perineal area and the vulvar area are all terms
indicating the body area of the pelvis between, around and
including the anus and the external genitalia.
[0005] Both the perineal area and the vulvar area are marked by the
presence of fine folds/wrinkles (sulci) and hair follicles, both of
which make these regions more difficult anatomical areas to
cleanse. During defecation, fecal matter is excreted through the
anus and tends to accumulate in hard to reach locations such as
around the base of hairs and in the sulci of the skin's surface.
During menstruation, menses may accumulate on the skin and hair
after the use of a sanitary napkin. As the fecal or menstrual
matter dehydrates upon exposure to air or upon contact with an
absorbent implement such as tissue paper, diaper, or sanitary
napkin, it adheres more tenaciously to the skin and hair.
Subsequent removal of the remaining dehydrated exudates may be even
more difficult and may result in inadequate cleansing. Among those
negatives associated with the failure of adequate cleansing are
irritation, redness, desquamation, infections, unpleasant odor, or
other kinds of personal discomfort or health related issues.
[0006] People suffering from pathological conditions (such as
hemorrhoids, fissures, cryptitis, etc.) are even more susceptible
to the negatives listed above. Common hygienic concerns make the
benefits of a good cleansing after defecation, menstruation, and
urination very relevant to babies, toddlers, children and adults.
Cleansing must be efficient in terms of removal of residues and
gentle in terms of absence of irritation caused by the cleansing.
Wet-wipes bring a response to that basic need.
[0007] In comparison to dry tissue products, wet wipes have several
benefits including: [0008] The enabling of a better lubrication
during the use of the wipe, thereby reducing the abrasiveness of
the cleansing operation; [0009] The hydration of the residues, thus
enhancing their removal from the skin or hair; [0010] The hydration
of the skin tissue; and [0011] The ability to deliver a soothing or
protective lotion to the skin that can remain on the skin after the
cleansing operation.
[0012] Manufacturers of wet wipes have tried to develop wipes
products that deliver the right balance between normally
antagonistic concepts such as: [0013] Enhancing the removal of soil
while protecting the skin from irritation and abrasion. [0014] The
long lasting feeling of comfortable cleanliness while avoiding a
greasy feeling on the skin.
[0015] A variety of methods exist that may measure the strength of
adhesion between two materials and that may ascertain whether or
not the strength of the adhesive interactions between the two
materials may be impacted by surface treatments or other factors
such as temperature or relative humidity. Many of the methods may
be intended for industrial or academic applications where the
materials being studied generally may be non-biological, for
example metals, woods, or polymers. For example, ASTM D2919 and
ASTM D3528 determine the durability of adhesive joints stressed
under shear. Other methods, such as those described in Adhesion
Measurements of Films and Coatings edited by K. L. Mittal published
in 1995 as available from VSP Publishers, may be useful for
assessing the force required to peel a material away from a
surface. Again, these methods may be generally intended for
non-biological materials. Thus, there is the need for a method that
may assess the strength of adhesion between a material and a
biological surface. There exists a need for a method that may
assess the strength of adhesion between soils or exudates and the
skin surface.
SUMMARY OF THE INVENTION
[0016] A method to assess the percent residual artificial bowel
movement on skin comprising the steps of applying said artificial
bowel movement to said skin, applying weigh paper to said
artificial bowel movement and removing said weigh paper. The method
may further comprise the step of applying about 0.5 psi of a
downward force to said weigh paper. The skin may be treated with a
lotion.
[0017] The percent residual artificial bowel movement remaining on
the skin may be calculated as a comparison of artificial bowel
movement initially applied to the skin and artificial bowel
movement associated with the weigh paper.
[0018] At least two different lotions may be applied to the skin to
assess any difference between the percent residual artificial bowel
movement remaining on the skin after application of each of the
applied lotions.
[0019] A method to assess a change in the amount of adhesion of
artificial bowel movement to skin comprising the step of comparing
a percent of the artificial bowel movement remaining on non-lotion
treated skin to a percent of the artificial bowel movement
remaining on lotion treated skin.
BRIEF DESCRIPTION OF THE FIGURES
[0020] FIG. 1 is an example of the percent of artificial bowel
movement residual left on a forearm following anti-stick treatment
as demonstrated by the Anti-Stick Screening Method.
DETAILED DESCRIPTION OF THE INVENTION
[0021] The ease with which soils or bodily exudates are removed
from the skin may be related to the strength of the adhesive
interactions between the soils or exudates and the skin surface.
"Soils" refers herein to material from a source extraneous to the
body, such as dirt and food. "Exudates" refers herein to material
from a source internal to the body, such as urine, menses, feces,
and mucus. As defined herein, "weight/weight" or "w/w" refers to
the weight of the component being referenced versus the weight of
the total material in reference. The use of "w/w" for residual
artificial bowel movement (ABM) refers to the weight of the
remaining artificial bowel movement on the skin versus the total
weight of the artificial bowel movement applied to the skin.
Adhesion Screening Method
[0022] The strength of adhesion between two materials may be
analyzed in a variety of methods to determine whether or not the
adhesive interactions are impacted by surface treatments or other
factors. Examples of adhesion tests for determining if a treatment
has reduced adhesion between two materials (such as by reducing the
force of adhesion to less than the force of cohesion) include ASTM
D2919, ASTM D3528 and related methods referred to or described
therein. Such methods may test the strength of adhesion through the
application of shear.
[0023] A method for assessing the adhesion of soils or exudates to
the skin surface has been detailed herein. This method is used for
assessing the adhesion of soils or exudates to the skin by
quantifying the amount of residual artificial pasty bowel movement
("ABM") left on the skin surface after treatment. While artificial
ABM is utilized in the Adhesion Screening Method, the artificial
ABM may correlate in physical properties to soils or exudates. The
percent residual artificial ABM may, therefore, be utilized as an
equivalent measurement of the percent residual soils or
exudates.
[0024] Briefly, the Adhesion Screening Method treats the skin
surface with a defined amount of a lotion. A defined amount of an
artificial pasty bowel movement ("ABM") is applied, covered with a
square piece of paper, and compressed with a defined force for a
defined amount of time. The paper is then peeled away slowly with
forceps. The paper is tared before application of the ABM and is
re-weighed after removal from the skin. The percent residual ABM on
the skin is calculated by mass balance. The ABM, similar to real
infant BM, fails cohesively, resulting in part of the ABM remaining
on the skin surface and part of the ABM remaining on the piece of
paper. The more efficient the lotion, the less residual ABM on the
skin surface.
[0025] At least eight healthy adults participate in a single
screening study. Each of the panelists completes a four-day washout
period during which they use Olay.RTM. unscented moisturizing soap,
as distributed by The Procter and Gamble Company, Cincinnati, Ohio,
to wash their forearms. Panelists must refrain from using any
topical product, such as ointments, creams or lotions, on their
forearms during this washout-out period and also on the day of the
screening study. On the day of testing, panelist's arms are
inspected to ensure they are free of cuts, scratches, and rashes.
If any skin abnormalities are present, the panelist cannot
participate.
[0026] A template and a fine-tip marker are used to mark-off up to
ten 3 cm.times.3 cm sites on the volar forearms, i.e. up to ten
sites per panelist. All but one of these sites are treated with a
lotion. The remaining site receives no lotion treatment, i.e.
serves as a negative control. The location of the various
treatments, including the no-treatment site, may be randomized
among the sites on each panelist. Testing starts at the site
closest to the elbow on the left arm and, as testing on each site
is completed, progresses to the site closest to the wrist on the
left arm, then to the site closest to the elbow on the right arm,
and finally to the site closest to the wrist on the right arm.
Testing on each site requires approximately 4 minutes, for a total
time per panelist of approximately 40 minutes.
[0027] For each site that is treated, 1 .mu.l/cm.sup.2 or 9
.mu.l/site of lotion is applied in the center of the site using a
standard or positive displacement pipettor. The lotion is then
spread over the entire site (the boundary of which is defined by
the marks made using the template) using a powder-free finger cot,
Catalog #56613-413 as available from VWR Scientific of West
Chester, Pa., by placing the finger cot on top of the lotion
droplet and lightly rubbing the finger cot over the skin surface
using several side-to-side and up-and-down movements for a total
elapsed time of 10-15 seconds. Examining the site from an oblique
angle, the person conducting the test may ensure that a uniform
film has been formed over the entire area of the site. The film is
left exposed to air, untouched, for approximately 1 minute prior to
proceeding with the subsequent steps.
[0028] A 1 ml syringe, such as Catalog# BD-309628 as available from
VWR Scientific of West Chester, Pa., that has been filled with room
temperature ABM and is devoid of air bubbles, is placed onto a
tared four-place analytical balance. The weight is recorded. The
syringe with ABM is held over the center of the test site on the
forearm, in reasonably close proximity to the skin surface, and
approximately 0.2 ml of ABM is dispensed onto the skin by pressing
the plunger and by watching the gradations on the syringe. The ABM
should form a reasonably uniform, compact mound in the center of
the test site. The syringe is re-weighed on the analytical balance,
and the weight is recorded. The quantity of ABM that was delivered
to the forearm is calculated by subtracting the second weight from
the first weight.
[0029] A 4 cm.times.4 cm piece of weigh paper, Catalog #12578-201
as available from VWR Scientific of West Chester, Pa., is tared on
the four place analytical balance, centered over the ABM mound on
the forearm test site, and gently lowered onto the ABM using
forceps. The weigh paper must not be touched with fingertips, as
this may transfer oils onto its surface. Next, a 500 g
bottle-shaped weight, such as Catalog #12766-518 as available from
VWR Scientific of West Chester, Pa., that exerts approximately 0.5
psi of downward force is placed over the weigh paper such that the
mound of ABM under the weigh paper is approximately centered under
the weight. The weight may be gently held in place or balanced on
the forearm by the panelist for 30 seconds. After 30 seconds have
elapsed, two fingers are placed gently on either side of the weigh
paper to hold it in place, and the 500 g weight is slowly lifted.
Using a pair of forceps, the weigh paper is slowly and gently
peeled from the test site. The forceps are placed at the lower
right corner of the weigh paper, and the weigh paper is slowly
peeled upwards in the direction of the upper left corner of the
weigh paper. It should take approximately 1-2 seconds to remove the
weigh paper. Once removed, the weigh paper is placed back onto the
analytical balance that it was tared on, and the weight is recorded
to determine the amount of ABM removed.
[0030] The above steps are repeated until all sites per panelist
have been tested, i.e. the steps consisting of application of
lotion, application of ABM, application of weigh paper, application
of weight, and removal of weigh paper. For the no-treatment
control, application of the lotion is skipped and ABM is applied
directly to the skin site.
[0031] An example of a spreadsheet to collect the various weight
measurements and to calculate the percent (%) residual ABM left on
the arm may be as follows:
TABLE-US-00001 Syringe ABM ABM % ABM Sub Site Trtmnt Syringe After
Applied Removed Arm 101 1 I 7.8561 7.6351 0.2210 0.1678 24.07 101 2
J 7.6343 7.4241 0.2102 0.1967 6.42 101 3 H 7.4223 7.2208 0.2015
0.1473 26.90 101 4 A 7.2200 7.0090 0.2110 0.1754 16.87 101 5 G
7.0080 6.8087 0.1993 0.1755 11.94 101 6 B 7.8082 7.5957 0.2125
0.2042 3.91 101 7 F 7.5943 7.3862 0.2081 0.1536 26.19 101 8 C
6.9643 6.7592 0.2051 0.1526 25.60 101 9 E 7.3840 7.1725 0.2115
0.1984 6.19 101 10 D 7.1711 6.9678 0.2033 0.1788 12.05
Wherein:
[0032] Sub refers to the subject number, which is minimally 101 to
108 and ideally 101 to 110, i.e. the above chart would be
replicated 8 to 10 times to cover all panelists. [0033] Site refers
to arm location, starting with the left arm near the elbow (Site 1)
and proceeding to the right arm near the wrist (Site 10). [0034]
Trtmnt refers to the code of the treatment applied, typically a
letter from A-J. [0035] Syringe refers to the initial weight of the
syringe containing ABM. [0036] Syringe After refers to the final
weight of the syringe containing ABM once approximately 0.2 ml of
ABM has been dispensed onto a treatment site. [0037] ABM Applied is
a calculated value obtained from the equation Syringe-Syringe
After=ABM Applied. [0038] ABM Removed refers to the weight of the
ABM that has been captured on the tared weight paper after the
weigh paper has been peeled from a treatment site. [0039] % ABM Arm
is a calculated value obtained from the equation ((ABM Applied-ABM
Removed)/ABM Applied).times.100. This is a measure of the percent
(%) residual ABM on the skin surface after treatment.
[0040] The mean and standard error of the mean ("SEM") for each
treatment, e.g. A-J, for all panelists, e.g. 101-110, is calculated
and graphed. FIG. 1 is an illustration of an example of the percent
of artificial bowel movement residual left on a forearm following
treatment. In FIG. 1, the grey bar represents the mean of each
treatment. The error bar represents the SEM of each treatment. This
example graph shows only five treatments for simplicity.
Preparation of Lotion
[0041] This method may be used to assess expressed lotion
compositions from any available wipe product. Expressed lotion
compositions are prepared by inserting the entire wipe stack of a
non-expired wet wipe product into a pre-cleaned press capable of
exerting about 80 psi downward force on the stack. Ideally, the
lower plate of the press contains a channel into which the
expressed lotion may collect, and a hole through which the
expressed lotion may flow into a clean storage container. An
example of a suitable storage container is Catalog #83008-666 as
available from VWR Scientific of West Chester, Pa. All expressed
lotions are stored at room temperature prior to use.
[0042] On the day prior to the study, 10 ml of each lotion is
transferred into a glass scintillation vial such as Catalog
#66022-060 as available from VWR Scientific of West Chester, Pa.
Each vial is labeled with the treatment code, e.g. A-J. On the day
of the study, the lotion is drawn from the scintillation vial with
the standard or positive displacement pipettor and applied to the
respective treatment site as described in the method. By having the
various treatments in the scintillation vials, it is very easy to
rearrange the vials in between panelists to accommodate the
randomization scheme for the study.
[0043] To ensure reproducible results, the Adhesion Screening
Method should be run at a room temperature of 21.degree.
C..+-.2.degree. C. and at a relative humidity of 30-50%.
Preparation of Artificial Pasty Bowel Movement (ABM)
[0044] The following equipment is required: [0045] an analytical
balance accurate to .+-.0.001 g [0046] a homogenizer capable of
stirring the ingredients to homogeneity, such as an Ika
Labortechnik.TM. T25 basic or equivalent as available from
Ika-Werke GmbH and Co. KG of Staufen, Germany. [0047] a homogenizer
probe to be used with the homogenizer, such as Catalog #S25N 25F as
available from Ika-Werke GmbH and Co. KG of Staufen, Germany.
[0048] The following reagents are required: [0049] Feclone.TM.
Powder #4, available from SiliClone Studio, Valley Forge, Pa., as
Catalog Number Feclone BFPS-4. [0050] Feclone.TM. Powder #6,
available from SiliClone Studio, Valley Forge, Pa., as Catalog
Number BFPS-6. [0051] Feclone.TM. Powder #7, available from
SiliClone Studio, Valley Forge, Pa., as Catalog Number BFPS-7.
[0052] Carbopol.TM. 981, available from BF Goodrich, Cleveland,
Ohio. [0053] Deionized water.
[0054] The following quantities of the above reagents are
required:
TABLE-US-00002 Ingredient Grams Deionized water for Carbopol .TM.
solution 78.78 Feclone .TM. powder #4 6.600 Feclone .TM. powder #6
6.600 Feclone .TM. powder #7 6.600 Carbopol .TM. 981 0.900
[0055] The procedure to prepare the ABM consists of the following
steps:
A. Preparation of Carbopol.TM. Solution
[0056] 1. Weigh 78.78 g.+-.0.01 g of deionized water in a 250 ml
beaker. [0057] 2. Weigh 0.900 g.+-.0.001 g of Carbopol.TM. on weigh
paper. [0058] 3. Put beaker on a magnetic stirrer and set speed at
400 rpm. [0059] 4. Add Carbopol.TM. powder slowly to the water,
over the span of about 5 minutes. While adding the Carbopol.TM.,
increase the stirring speed slowly to 600 rpm. [0060] 5. Once the
Carbopol.TM. powder has been added to the water, cover the beaker
and continue mixing at 600 rpm for 15 minutes. The Carbopol.TM.
powder must be completely dispersed, i.e. a transparent gel without
any agglomerates. [0061] 6. Set up a hot plate at 150.degree. C.
Place the Carbopol.TM. solution on the hot plate and continue
mixing at 600 rpm until the solution is heated to 81.degree. C. to
83.degree. C.
B. Preparation of ABM Mixture
[0061] [0062] 1. Weigh 6.600 g.+-.0.01 g each of Feclone.TM.
powders #4, #6, and #7 into a beaker and mix well. [0063] 2. Using
a T25 basic or equivalent homogenizer with a homogenizer probe,
stir the Carbopol.TM. solution at 8000 rpm for about 30 seconds
before proceeding with Step 3. [0064] 3. To the Carbopol.TM.
solution that is being stirred, slowly add the Feclone.TM. powder
mixture, about one quarter of the total at a time. Ensure that the
Feclone.TM. powder mixture gets pulled through the homogenizer
probe during addition, i.e. is thoroughly mixed into the pasty
composition that is forming. If necessary, use a spatula to
facilitate incorporation of the Feclone.TM. powder mixture into the
composition. [0065] 4. After all of the Feclone.TM. powder mixture
has been added, continue mixing with the homogenizer at 8000 rpm
for an additional 5 minutes, using the spatula to push the pasty
composition towards the homogenizer probe. The composition should
be thoroughly mixed and appear homogeneous.
[0066] The finished ABM may be placed in a container, such as
Catalog #14233-954 as available from VWR Scientific of West
Chester, Pa., and stored in the refrigerator for up to 30 days.
After 30 days, a new sample should be prepared for further
experiments. The container must be tightly sealed to avoid drying
out of the ABM.
[0067] Prior to using the ABM in the Adhesion Screening Method, the
ABM must be removed from the refrigerator and allowed to adjust
back to room temperature. An easy way to accomplish this is to fill
a 10 ml syringe, such as Catalog #BD301604 as available from VWR
Scientific of West Chester, Pa., with cold ABM and then allow the
syringe to equilibrate to room temperature on a counter top.
Equilibration typically takes about 15 minutes. The 10 ml syringe
can then be used to fill the 1 ml syringe described in the Adhesion
Screening Method.
[0068] All documents cited in the Detailed Description of the
Invention are, in relevant part, incorporated herein by reference;
the citation of any document is not to be construed as an admission
that it is prior art with respect to the present invention. To the
extent that any meaning or definition of a term in this written
document conflicts with any meaning or definition of the term in a
document incorporated by reference, the meaning or definition
assigned to the term in this written document shall govern.
[0069] While particular embodiments of the present invention have
been illustrated and described, it would be obvious to those
skilled in the art that various other changes and modifications can
be made without departing from the spirit and scope of the
invention. It is therefore intended to cover in the appended claims
all such changes and modifications that are within the scope of
this invention.
[0070] The dimensions and values disclosed herein are not to be
understood as being strictly limited to the exact numerical values
recited. Instead, unless otherwise specified, each such dimension
is intended to mean both the recited value and a functionally
equivalent range surrounding that value. For example, a dimension
disclosed as "40 mm" is intended to mean "about 40 mm".
* * * * *