U.S. patent application number 09/840342 was filed with the patent office on 2001-09-27 for absorbent interlabial device.
This patent application is currently assigned to The Procter & Gamble Company. Invention is credited to Brown, Pamela Jean, Osborn, Thomas Ward III.
Application Number | 20010025163 09/840342 |
Document ID | / |
Family ID | 26752208 |
Filed Date | 2001-09-27 |
United States Patent
Application |
20010025163 |
Kind Code |
A1 |
Brown, Pamela Jean ; et
al. |
September 27, 2001 |
Absorbent interlabial device
Abstract
An absorbent interlabial device worn by female wearers for
catamenial purposes, incontinence protection, or both, is
disclosed. The absorbent interlabial device of the present
invention includes a liquid pervious topsheet, a liquid impervious
backsheet, and an absorbent core positioned between the two. The
length of the device is between about 60 mm and about 130 mm. The
width is between about 25 mm and 50 mm. The device has an axis of
preferred bending along its longitudinal centerline. When folded
along the axis and inserted into the wearer's interlabial space,
the topsheet maintains contact with the walls of the wearer's
labia. A method of using a system of feminine hygiene products is
also disclosed. The system includes the use of an absorbent
interlabial device in combination with a sanitary napkin. The
absorbent interlabial device of the present invention may also be
used in combination with an absorbent tampon. The absorbent
interlabial device may be packaged in a common package with a
sanitary napkin or a tampon as a feminine hygiene kit.
Inventors: |
Brown, Pamela Jean;
(Maineville, OH) ; Osborn, Thomas Ward III;
(Cincinnati, OH) |
Correspondence
Address: |
THE PROCTER & GAMBLE COMPANY
PATENT DIVISION
IVORYDALE TECHNICAL CENTER - BOX 474
5299 SPRING GROVE AVENUE
CINCINNATI
OH
45217
US
|
Assignee: |
The Procter & Gamble
Company
|
Family ID: |
26752208 |
Appl. No.: |
09/840342 |
Filed: |
April 23, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09840342 |
Apr 23, 2001 |
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09071425 |
May 1, 1998 |
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09071425 |
May 1, 1998 |
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08876206 |
Jun 16, 1997 |
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Current U.S.
Class: |
604/385.17 |
Current CPC
Class: |
A61F 13/82 20130101;
Y10S 604/904 20130101; A61F 13/47209 20130101 |
Class at
Publication: |
604/385.17 |
International
Class: |
A61F 013/15 |
Claims
What is claimed is:
1. An absorbent device insertable into the interlabial space of a
female wearer, said absorbent device having a length, a width, a
thickness, and a longitudinal centerline, said absorbent device
comprising: a liquid pervious topsheet; a liquid impervious
backsheet joined to said topsheet; and an absorbent core positioned
between said topsheet and said backsheet; wherein said length of
said absorbent device is greater than about 60 mm and less than
about 127 mm, said width of said absorbent device is between about
25 mm and about 40 mm, said width and said length of said absorbent
device each exceed said thickness of said absorbent device, said
absorbent device comprises an axis of preferred bending, such that
when said absorbent device is folded along said axis and inserted
into the wearer's interlabial space said topsheet of said absorbent
device maintains contact with the walls of the wearer's labia.
2. The absorbent device of claim 1 wherein said length of absorbent
device is between about 85 mm and about 100 mm.
3. The absorbent device of claim 1 wherein said liquid pervious
topsheet comprises needle punched rayon.
4. The absorbent device of claim 1 wherein said absorbent core
comprises rayon.
5. The absorbent device of claim 4 wherein said absorbent core
comprises a blend of rayon and cotton.
6. The absorbent device of claim 1 wherein said absorbent core
further comprises a superabsorbent polymer.
7. The absorbent device of claim 1 wherein the time required for
said absorbent device to disperse into at least two fragments as
measured by the Water Dispersion Test is less than about two
hours.
8. The absorbent device of claim 6 wherein the time required for
said absorbent device to disperse into at least two fragments as
measured by the Water Dispersion Test is less than about 1
hour.
9. The absorbent device of claim 7 wherein the time required for
said absorbent device to disperse into at least two fragments as
measured by the Water Dispersion Test is less than about 30
minutes.
10. The absorbent device of claim 6 wherein said liquid impervious
backsheet comprises polyvinyl alcohol.
11. The absorbent device of claim 1 wherein said absorbent device
is at least about 70% biodegradable.
12. The absorbent device of claim 11 wherein said absorbent device
is at least about 90% biodegradable.
13. The absorbent device of claim 1 wherein said backsheet is at
least about 70% biodegradable.
14. The absorbent device of claim 1 wherein said backsheet is at
least about 90% biodegradable.
15. The absorbent device of claim 1 further comprising a removal
tab joined to said backsheet.
16. The absorbent device of claim 1 wherein said device has a
substantially ovoid planar shape.
17. The absorbent device of claim 16 wherein said device tapers to
a lesser width at each end.
18. The absorbent device of claim 1 wherein said device is
resiliently biased to unfold along said axis of preferred
bending.
19. The absorbent device of claim 1 wherein said device is
sufficiently flushable that it completely clears the bowl under the
Flushability Test at least about 70% of the time in two or fewer
flushes.
20. The absorbent device of claim 19 wherein said device is
sufficiently flushable that it completely clears the bowl under the
Flushability Test at least about 90% of the time in one flush.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation of application Ser. No. 09/071,425,
filed on May 1, 1998, pending, which is a continuation-in-part of
application Ser. No. 08/876,206, filed Jul. 16, 1997,
abandoned.
FIELD OF THE INVENTION
[0002] This invention relates to absorbent devices, and more
particularly to an improved absorbent device that is worn
interlabially by female wearers for catamenial purposes,
incontinence protection, or both.
BACKGROUND OF THE INVENTION
[0003] All manner and variety of absorbent articles configured for
the absorption of body fluids such as menses, urine and feces are
well known. With respect to feminine protection devices, the art
has offered two basic types; sanitary napkins have been developed
for external wear about the pudendal region while tampons have been
developed for internal wear within the vaginal cavity for
interruption of menstrual flow therefrom. Such tampon devices are
disclosed in U.S. Pat. No. 4,412,833, entitled "Tampon Applicator",
issued to Weigner, et al. on Nov. 1, 1983, and U.S. Pat. No.
4,413,986, entitled "Tampon Assembly With Means For Sterile
Insertion", issued to Jacobs on Nov. 8, 1983.
[0004] Hybrid devices which attempt to merge the structural
features of the sanitary napkins and the tampons into a single
device have also been proposed. Such hybrid devices are disclosed
in U.S. Pat. No. 2,092,346, entitled "Catamenial Pad", issued to
Arone on Sep. 7, 1937, and U.S. Pat. No. 3,905,372, entitled
"Feminine Hygiene Protective Shield", issued to Denkinger on Sep.
16, 1975. Other less intrusive hybrid devices are known as labial
or interlabial sanitary napkins and are characterized by having a
portion which at least partially resides within the wearer's
vestibule and a portion which at least partially resides external
of the wearer's vestibule. Such devices are disclosed in U.S. Pat.
No. 2,662,527, entitled "Sanitary Pad", issued to Jacks on Dec. 15,
1953, and U.S. Pat. No. 4,631,062, entitled "Labial Sanitary Pad",
issued to Lassen, et al. on Dec. 23, 1986.
[0005] Interlabial pads have the potential to provide even greater
freedom from inconvenience because of their small size and reduced
risk of leakage. Numerous attempts have been made in the past to
produce an interlabial pad which would combine the best features of
tampons and sanitary napkins while avoiding at least some of the
disadvantages associated with each of these types of devices.
Examples of such devices are described in U.S. Pat. No. 2,917,049
issued to Delaney on Dec. 15, 1959, U.S. Pat. No. 3,420,235 issued
to Harmon on Jan. 7, 1969, U.S. Pat. No. 4,595,392 issued to
Johnson, et al. on Jun. 17, 1986, and U.S. Pat. Nos. 5,074,855 and
5,336,208 issued to Rosenbluth, et al. on Dec. 24, 1991 and Aug. 9,
1994 respectively, and U.S. Pat. No. 5,484,429 issued to Vukos, et
al. on Jan. 16, 1996. A commercially available interlabial device
is the "FRESH 'N FIT PADETTE" (also known as "INSYNC" or "INSYNC
MINIFORM") interlabial pad which is marketed by Athena Medical
Corp. (now known as A-Fem) of Portland, Oreg. and described in U.S.
Pat. Nos. 3,983,873 and 4,175,561 issued to Hirschman on Oct. 5,
1976 and Nov. 27, 1979, respectively.
[0006] Many of these devices have not met with great commercial
success, however. There are drawbacks associated with all of the
above products. For example, the device described in the Delaney
patent does not appear to be capable of an easy and comfortable
insertion, due to the possibility of the layers of absorbent
material opening up during insertion. The commercially available
"PADETTE" (or "IN-SYNC") interlabial device suffers from the
disadvantage that many consumers find it difficult to insert
properly and may cause some consumers discomfort especially if not
properly inserted. Even when such a device is properly inserted, it
may tend to allow by-pass flow around its edges. Such flow can
cause body soiling or panty soiling which many consumers find
unacceptable. Additionally, previously known interlabial devices
such as the "PADETTE" interlabial pad may not reliably cover the
urethra and/or the vaginal introitus during all body movements
(e.g. when the wearer is squatting). Such products may also not be
reliably expelled when the wearer urinates.
[0007] Therefore, a need exists for an improved interlabial device
which will reduce the incidence of body and panty soiling when
used. Such a device should be easy to insert and be comfortable
during wear. A need exists for an interlabial device which also
covers the walls of the wearer's labia throughout a range of body
motions and reliably covers the vaginal introitus and preferably
also the urethra during such motions. A need also exists for an
improved absorbent interlabial device which may be used as part of
a system of feminine hygiene protection or with a feminine hygiene
kit.
SUMMARY OF THE INVENTION
[0008] This invention relates to absorbent devices, and more
particularly to an improved absorbent device that is insertable
into the interlabial space of a female wearer for catamenial
purposes, incontinence protection, or both.
[0009] The absorbent interlabial device of the present invention
comprises a liquid pervious topsheet, a liquid impervious backsheet
which is joined to the topsheet, and an absorbent core positioned
between the topsheet and backsheet. The length of the absorbent
interlabial device is greater than about 60 mm and less than about
130 mm. The width of the device is between about 25 and about 50
mm. The width and length of the device each exceed its thickness.
Additionally, the device comprises an axis of preferred bending,
preferably located generally along the longitudinal centerline of
the device. When the device is folded along this axis and inserted
into the wearer's interlabial space, the topsheet maintains contact
with the walls of the wearer's labia.
[0010] In a preferred embodiment, the length of the device may be
between about 90 and about 105 mm. Preferably, the liquid pervious
topsheet may be constructed of rayon or needle punched rayon. The
absorbent core may also be constructed of rayon, cotton, or a blend
of rayon and cotton. The backsheet of the absorbent interlabial
device is preferably water dispersible. Preferably, the device
comprises biodegradable materials. A tab may be attached to the
backsheet of the device to facilitate insertion and optional
removal of the device with the fingers.
[0011] The present invention also relates to a method of using an
absorbent interlabial device, such as the absorbent interlabial
device described above, as part of a system of feminine hygiene
products. The method comprises the steps of inserting an
interlabial device into the interlabial space of the wearer,
placing a sanitary napkin in the crotch portion of a panty-type
undergarment, then pulling the undergarment into its usual wearing
position without removing the sanitary napkin from the undergarment
or the interlabial device from the wearer's interlabial space such
that the sanitary napkin rests adjacent the pudendal region of the
wearer and the interlabial device and the sanitary napkin are worn
simultaneously. In preferred methods of the present invention, the
method may further include the steps of removing the interlabial
device prior to urination then, subsequent to urination, inserting
a new interlabial device which is worn simultaneously with the
sanitary napkin. Optionally, the interlabial device may be expelled
by urination, then a second interlabial device may be inserted into
the wearer's interlabial space and worn simultaneously with the
sanitary napkin.
[0012] In another aspect of the present invention, the invention
comprises a feminine hygiene kit. The kit is comprised of a
sanitary napkin and an absorbent interlabial device packaged in a
common package. Such a kit facilitates use of a system of feminine
hygiene products such as in the method described above. The
sanitary napkin and interlabial device are each adapted such that
they may be worn simultaneously. Preferably, the absorbent
interlabial device included in the kit has all of the preferred
features of the absorbent interlabial device described above.
[0013] The absorbent interlabial device of the present invention
may also be used as part of a system of feminine hygiene products
in conjunction with an absorbent tampon. Such a method comprises
the steps of inserting a tampon into the vaginal cavity of the
wearer, inserting an absorbent interlabial device into the
interlabial space of the wearer, and wearing the tampon and the
absorbent interlabial device simultaneously for a period of time.
The absorbent interlabial device used in such a method comprises a
liquid pervious topsheet, and liquid impervious backsheet joined to
said topsheet, and an absorbent core positioned between the
two.
[0014] Another feminine hygiene kit comprises the absorbent
interlabial device of the present invention packaged in a common
package with an absorbent vaginal tampon. The absorbent interlabial
device comprises a liquid pervious topsheet, a liquid impervious
backsheet joined to the topsheet, and an absorbent core positioned
between the topsheet and the backsheet. The absorbent interlabial
device is adapted to be worn within the interlabial space of the
wearer wherein at least half of the device resides within such
interlabial space. Each of the absorbent vaginal tampon and the
absorbent interlabial device are adapted such that both may be worn
simultaneously.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] While the specification concludes with claims particularly
pointing out and distinctly claiming the subject matter which is
regarded as forming the present invention, it is believed that the
invention will be better understood from the following description
taken in conjunction with the accompanying drawings, in which:
[0016] FIG. 1 is a top plan view of the absorbent interlabial
device of the present invention.
[0017] FIG. 2 is a cross sectional view of the absorbent
interlabial device of the present invention, taken along line 2-2
of FIG. 1.
[0018] FIG. 3 is a side view of the absorbent interlabial device of
the present invention.
[0019] FIG. 4 shows the absorbent interlabial device of the present
invention folded along the axis of preferred bending and being
grasped for insertion by the wearer's fingers.
[0020] FIG. 5 is a cross-sectional saggital view of a human female
wearer showing the placement of the absorbent interlabial device in
the wearer's interlabial space.
[0021] FIG. 6 is a typical prior art sanitary napkin which may be
used in a method of using a system of feminine hygiene products or
as part of a feminine protection kit of the present invention.
[0022] FIG. 7 is a typical prior art tampon which may be used in a
method of using a system of feminine hygiene products or as part of
an additional feminine protection kit of the present invention.
[0023] FIG. 8 is front view of an individual package for the
interlabial device in an unopened condition.
[0024] FIG. 9 is front view of the individual package in an opened
condition with the folded interlabial device inside.
[0025] FIG. 10 is a plan view of an apparatus suitable for
flushability determination according to the method described in the
TEST METHODS section, below.
[0026] FIG. 11 is a cross-section of the flushability apparatus of
FIG. 10 taken along line 11-11 thereof.
DETAILED DESCRIPTION OF THE INVENTION
[0027] The present invention is directed to an absorbent
interlabial device. FIGS. 1-3 shows one embodiment of an absorbent
interlabial device, interlabial device 20. The present invention,
however, is not limited to a structure having the particular
configuration shown in the drawings.
[0028] As used herein the term "absorbent interlabial device"
refers to a structure which has at least some absorbent components,
and which is specifically configured to reside within the
interlabial space of a female wearer during use. When the absorbent
interlabial device 20 is properly sized for an individual wearer,
more than half of the entire absorbent interlabial device 20 of the
present invention resides within such interlabial space. Preferably
substantially the entire absorbent interlabial device 20 resides
within such interlabial space, and more preferably the entire
absorbent interlabial device 20 resides within such interlabial
space of a female wearer during use.
[0029] As used herein, the term "interlabial space" refers to that
space in the pudendal region of the female anatomy which is located
between the inside surfaces of the labia majora extending into the
vestibule. Located within this interlabial space are the labia
minor, the vestibule and the principal urogenital members including
the clitoris, the orifice of the urethra, and the orifice of the
vagina. Standard medical authorities teach that the vestibule
refers to the space bounded laterally by the inside surfaces of the
labia minora and extending interiorly to the floor between the
clitoris and the orifice of the vagina. Therefore, it will be
recognized that the interlabial space as defined above may refer to
the space between the inside surfaces of the labia majora,
including the space between the inside surfaces of the labia minora
also known as the vestibule. The interlabial space for purposes of
the present description does not extend substantially beyond the
orifice of the vagina into the vaginal interior.
[0030] The term "labia" as used herein refers generally to both the
labia majora and labia minora. The labia terminate anteriorly and
posteriorly at the anterior commissure and the posterior
commissure, respectively. It will be recognized by those skilled in
the art that there is a wide range of variation among women with
respect to the relative size and shape of labia majora and labia
minora. For purposes of the present description, however, such
differences need not be specifically addressed. It will be
recognized that the disposition of the absorbent interlabial device
into the interlabial space of a wearer as defined above will
require placement between the inside surfaces of the labia majora
without regard to the precise location of the boundary between the
labia majora and the labia minora for a particular wearer. For a
more detailed description of this portion of the female anatomy,
attention is directed to Gray's Anatomy, Running Press 1901 Ed.
(1974), at 1025-1027.
[0031] The absorbent interlabial device 20 shown in FIG. 1 has a
longitudinal centerline L which runs along the "x" axis. The term
"longitudinal", as used herein, refers to a line, axis or direction
in the plane of the interlabial device 20 that is generally aligned
with (e.g., approximately parallel to) a vertical plane which
bisects a standing wearer into left and right body halves when the
interlabial device 20 is worn. The terms "transverse," "lateral,"
or "y direction" as used herein, are interchangeable, and refer to
a line axis or direction that is generally perpendicular to the
longitudinal direction. The lateral direction is shown in FIG. 1 as
the "y" direction. The absorbent interlabial device 20 shown in
FIG. 1 also has a transverse centerline T. The "z" direction, shown
in FIG. 2, is a direction parallel to the vertical plane described
above. The term "upper" refers to an orientation in the z-direction
toward the wearer's head. "Lower" or downwardly is toward the
wearer's feet.
[0032] As shown in FIGS. 1-2, the interlabial device comprises at
least a liquid pervious topsheet 42, a liquid impervious backsheet
38 joined to the topsheet 42, and an absorbent core 44 positioned
between the topsheet 42 and the backsheet 38. The interlabial
device 20 must be of a suitable size and shape that allows at least
the majority of the device 20 to fit comfortably within the
wearer's interlabial space and to cover the wearer's vaginal
orifice, and preferably also the wearer's urethra. The interlabial
device 20 at least partially blocks, and more preferably completely
blocks and intercepts the flow of menses, urine, and other bodily
exudates from the wearer's vaginal orifice and urethra.
[0033] The size of the interlabial device 20 is important to its
comfort and effectiveness. The length of the absorbent interlabial
device 20 is measured along the longitudinal centerline L in the
longitudinal direction (or "x"-direction). The absorbent
interlabial device 20 preferably has a length L.sub.1 which is
greater than about 60 mm and less than about 130 mm. More
preferably, the length L.sub.1 is between about 90 mm and about 105
mm. The width of the interlabial device 20 is measured along the
transverse centerline T in the transverse direction (or
"y"-direction). The absorbent interlabial device 20 preferably has
a width W.sub.1 which is between about 25 mm and about 50 mm. The
thickness (or caliper) is the "z"-direction dimension of the device
20. Caliper measurements given herein were measured using an AMES
gage with a 0.25 psi (1.7 kPa) (gauge) load and a 0.96 inch (2.44
cm) diameter foot. Those skilled in the art will recognize that if
a 0.96 inch (2.44 cm) diameter foot is not appropriate for a
particular sample size, the foot size may be varied while the load
on the gauge is accordingly varied to maintain a confining pressure
of 0.25 psi (1.7 kPa) (gauge). The caliper T.sub.1 of the absorbent
interlabial device 20 is less than the width W.sub.1 and the length
L.sub.1 of the device 20. Preferably the caliper T.sub.1 of the
absorbent interlabial device 20 is less than or equal to about 8
mm, more preferably the caliper T.sub.1 is less than about 6 mm,
and even more preferably less than about 4 mm.
[0034] Construction of the absorbent interlabial device 20
according to the particular size parameters given above results in
a product with increased comfort and effectiveness compared to
previous interlabial devices. For example, many women find
interlabial pads which are shorter than the absorbent interlabial
device 20 of the present invention (such as previous interlabial
pads) to be difficult to position properly within the interlabial
space. Even if such pads are positioned properly they have an
increased tendency to allow by-pass flow of body exudates around
the edges of the pad. Additionally, previous pads were not equipped
with a liquid impervious backsheet. These pads, therefore could
allow body and panty soiling as a result of contact with the bottom
surface of the pad.
[0035] The interlabial device 20 is preferably provided with
sufficient absorbency to absorb and retain the exudates discharged
from the wearer's body. The capacity of the product, however, is
dependent at least partially upon the physical volume of the
absorbent interlabial device 20. The absorbent interlabial device
preferably has a capacity of at least about 1 g of 0.9% by weight
saline solution, and may have a capacity of up to about 30 g by
using absorbent gels or foams that expand when wet. Capacities may
typically range from about 2 to about 10 grams, for saline.
Preferably, the capacity of the device 20 is greater than about 6 g
for saline. Those skilled in the art will recognize that the
capacity for absorption of body exudates such as menses will
typically be smaller than the capacities given above for absorption
of saline. A method for measuring absorbent capacity is described
in the Test Methods section, below. Since the interlabial space can
expand, larger volumes can be stored in the interlabial space, if
the fluid is stored as a gel, which adjusts to the body pressures.
Additionally, if the absorbent interlabial device 20 does not
reside completely within the wearer's interlabial space, some of
the absorbed exudates may be stored externally to the wearer's
interlabial space.
[0036] The individual components which may be suitable for the
various embodiments of the interlabial device 20 of the present
invention will now be looked at in greater detail with reference to
FIGS. 1-3.
[0037] The topsheet 42 comprises a first liquid pervious component.
The topsheet 42 should be compliant, soft feeling, and
non-irritating to the wearer's skin. Further, the topsheet 42 is
liquid pervious permitting liquids (e.g., menses and/or urine) to
readily penetrate through its thickness. A suitable topsheet 42 may
be manufactured from a wide range of materials such as woven and
nonwoven materials; polymeric materials such as apertured formed
thermoplastic films, apertured plastic films, and hydroformed
thermoplastic films; porous foams; reticulated foams; reticulated
thermoplastic films; and thermoplastic scrims. Suitable woven and
nonwoven materials can be comprised of natural fibers (e.g., wood
or cotton fibers), synthetic fibers (e.g., polymeric fibers such as
polyester, rayon, polypropylene, or polyethylene fibers) or from a
combination of natural and synthetic fibers.
[0038] A suitable topsheet 42 for use in the present invention is a
nonwoven material formed of rayon fibers with a basis weight of
about 18 g/m.sup.2 and is available from Veratec of Walpole, Mass.
sold under the designation grade 9313709070. This material is
particularly suitable for use as a topsheet 42 because it is a
biodegradable material.
[0039] As used herein, the term "biodegradable materials" refers to
a material having greater than or equal to about 70% biodegradation
(percentage of theoretical carbon dioxide evolution) after 28 days
when measured according to the Sturm Test which has been designated
Method 301B by the Organization for Economic Cooperation and
Development. Preferably, the materials comprising the present
invention have a biodegradation of greater than about 80% and, more
preferably, biodegradation is greater than or equal to about
90%.
[0040] The topsheet 42 may also comprise an apertured formed film.
Apertured formed films are pervious to body exudates and, if
properly apertured, have a reduced tendency to allow liquids to
pass back through and rewet the wearer's skin. Thus, the surface of
the formed film which is in contact with the body remains dry,
thereby reducing body soiling and creating a more comfortable feel
for the wearer. Suitable formed films are described in U.S. Pat.
No. 3,929,135, entitled "Absorptive Structures Having Tapered
Capillaries", which issued to Thompson on Dec. 30, 1975; U.S. Pat.
No. 4,324,246 entitled "Disposable Absorbent Article Having A Stain
Resistant Topsheet", which issued to Mullane, et al. on Apr. 13,
1982; U.S. Pat. No. 4,342,314 entitled "Resilient Plastic Web
Exhibiting Fiber-Like Properties", which issued to Radel, et al. on
Aug. 3, 1982; U.S. Pat. No. 4,463,045 entitled "Macroscopically
Expanded Three-Dimensional Plastic Web Exhibiting Non-Glossy
Visible Surface and Cloth-Like Tactile Impression", which issued to
Ahr, et al. on Jul. 31, 1984; and U.S. Pat. No. 5,006,394
"Multilayer Polymeric Film" issued to Baird on Apr. 9, 1991. A
preferred formed film topsheet for the present invention is the
formed film described in one or more of the above patents and
marketed on sanitary napkins by The Procter & Gamble Company of
Cincinnati, Ohio as the "DRI-WEAVE" topsheet.
[0041] Another suitable topsheet 42 for the present invention is
made in accordance with U.S. Pat. Nos. 4,609,518 and 4,629,643 both
issued to Curro et al. on Sep. 2, 1986 and Dec. 16, 1986,
respectively. Such a formed film is manufactured by Tredegar
Corporation of Terre Haute, Ind.
[0042] In a preferred embodiment of the present invention, the body
surface of the formed film topsheet is hydrophilic to help liquids
transfer through the topsheet 42 faster than if the body surface
was not hydrophilic so as to diminish the likelihood that menstrual
fluid will flow off the topsheet 42 rather than flowing into and
being absorbed by the absorbent core 44. The body surface of the
topsheet 42 can be made hydrophilic by treating it with a
surfactant such as is described in U.S. Pat. No. 4,950,254 issued
to Osborn, Ill. In a preferred embodiment, surfactant is
incorporated into the polymeric materials of the formed film
topsheet.
[0043] The inner surface of topsheet 42 may be secured in
contacting relation with an underlying absorbent layer. This
contacting relationship results in liquid penetrating topsheet 42
faster. The topsheet 42 may be kept in a contacting relationship
with an underlying layer by bonding the topsheet 42 to the
underlying layer. However, it is not absolutely necessary to bond
the face of the topsheet 42 to the face of the underlying layer.
The topsheet 42 can be maintained in contact with an underlying
absorbent component, by entangling the fibers of the underlying
layer with the topsheet, by fusing the topsheet 42 to an underlying
absorbent layer by a plurality of discrete individual fusion bonds,
or by any means known in the art.
[0044] It is not necessary that the topsheet 42 comprise a layer or
material which is separate or distinct from the absorbent core 44.
The topsheet 42 and absorbent core 44 may consist of one unitary
structure in which the body-contacting surface of the absorbent
core 44 will serve as the liquid pervious topsheet 42. In such an
embodiment, the liquid pervious body contacting surface may be
hydrophilic or treated so as to render it hydrophilic such that
fluids readily penetrate through the surface and into the interior
of the absorbent core 44. Additionally, the unitary topsheet 42 and
absorbent core 44 may be provided with a pore size, capillary, or
hydrophilicity gradient to assist in the absorption and retention
of fluids in the interior of the absorbent core 44.
[0045] The absorbent core 44, which is best seen in FIG. 2, is
positioned between the topsheet 42 and the backsheet 38. The
absorbent core 44 provides the means for absorbing exudates such as
menses and other body fluids. The absorbent core 44 preferably is
generally compressible, conformable, and non-irritating to the
user's skin.
[0046] The absorbent core 44 may comprise any suitable material
that is capable of absorbing and/or retaining liquids (e.g. menses
and/or urine). Preferably, the absorbent core 44 has the same
general shape as the overall absorbent interlabial device 20. The
absorbent core 44 (and the overall absorbent interlabial device 20)
may be manufactured in a wide variety of shapes. Non limiting
examples of shapes for the absorbent core 44 when viewed from the
top as in FIG. 1 include ovoid, elliptical, trapezoidal,
rectangular, triangular, diamond-shaped or any combination of the
above. As shown in FIG. 1, the preferred shape for the absorbent
core 22 and the overall absorbent interlabial device 20 is
generally ovoid or elliptical.
[0047] The absorbent core 44 be manufactured from a wide variety of
liquid-absorbent materials commonly used in absorbent articles such
as comminuted wood pulp which is generally referred to as airfelt.
Examples of other suitable absorbent materials include cotton
fibers or cotton lintels, creped cellulose wadding; meltblown
polymers including coform; chemically stiffened, modified or
cross-linked cellulosic fibers; synthetic fibers such as crimped
polyester fibers; peat moss; tissue including tissue wraps and
tissue laminates; absorbent foams; absorbent sponges;
superabsorbent polymers (in fibrous and particulate form);
absorbent gelling materials; or any equivalent material or
combinations of materials, or mixtures of these. Preferred
absorbent materials comprise folded tissues, cotton batts, woven
materials, nonwoven webs, rayon including needle punched rayon, and
thin layers of foam. The absorbent core 44 may comprise a single
material. Alternatively, the absorbent core 44 may comprise a
combination of materials.
[0048] A particularly preferred material for the absorbent core 44
is batt of rayon or a rayon/cotton blend. A tri-lobed rayon known
as GALAXY rayon available from Courtaulds Fibers, Inc. of Axis,
Ala. has been found to work well for the material comprising the
absorbent core 44.
[0049] The backsheet 38, which is best shown in FIGS. 2 and 3,
prevents the exudates absorbed and contained in the absorbent core
44 from wetting articles and/or body parts which may contact the
absorbent interlabial device 20 such as pants, pajamas,
undergarments, pubic hair, the wearer's thighs, etc. The backsheet
38 should be flexible and impervious to liquids (e.g., menses
and/or urine).
[0050] The backsheet 38 is impervious to liquids (e.g., menses
and/or urine) and is preferably flexible. As used herein, the term
"flexible" refers to materials which are compliant and will readily
conform to the general shape and contours of the human body. The
backsheet 38 also provides protection for the wearer's fingers as
the absorbent interlabial device 20 is inserted, or as the device
is optionally removed with the fingers.
[0051] The backsheet 38 may comprise a woven or nonwoven material,
polymeric films such as thermoplastic films of polyethylene or
polypropylene, composite materials such as a film-coated nonwoven
material, or organic material such as a collagen film. The
backsheet may be made from a polyethylene film having a thickness
of from about 0.012 mm (0.5 mil) to about 0.051 mm (2.0 mils). An
exemplary polyethylene film is manufactured by Clopay Corporation
of Cincinnati, Ohio, under the designation P18-0401. The backsheet
may permit vapors to escape from the device 20 (i.e., be
breathable) while still preventing exudates from passing through
the backsheet.
[0052] Preferably, the backsheet 38 is dispersible and/or
dissolvable in water. Polyvinyl alcohol (including co-polymers of
polyvinyl alcohol) has been found to be suitable as a material for
a dissolvable backsheet 38. The polyvinyl alcohol may be coated
with a tissue, with a wax or other hydrophobic coating to reduce
the rate at which it dissolves in water. This allows the backsheet
38 to maintain its integrity during use, while retaining the
ability to dissolve in water during disposal of the device 20.
[0053] The term "dispersible" as applied herein to an absorbent
interlabial device or a component thereof refers to an article or
material which will disperse into at least two fragments in mildly
agitated water. Such a device will break into pieces in a
conventional toilet and/or domestic plumbing system, and will
ultimately be effectively processed though a sewage treatment
system. The term "dissolvable" as applied herein to an absorbent
interlabial device or a component thereof refers to an article or
material which will at least partially dissolve and essentially
assume liquid form or otherwise be indistinguishable to the naked
eye from the liquid medium in which it is dissolved.
[0054] The components of the absorbent interlabial device 20
described above (topsheet 42, backsheet 38, absorbent core 44) can
be assembled in any suitable manner. In the preferred embodiment
shown in FIGS. 1-3, the components of the interlabial device are
assembled in a "sandwich" configuration with the components sized
so that the edges of the topsheet 42 and backsheet 38 extend
outward beyond the edges of the absorbent core 44. The topsheet 42
and backsheet 38 are preferably at least partially peripherally
joined using known techniques. As shown in FIGS. 1 and 2, the
topsheet 42 is preferably secured to backsheet 38 along a seam,
such as seam 60. Seam 60 is preferably liquid impervious. The seam
60 can be formed by any means commonly used in the art for this
purpose such as by gluing, crimping, or heat-sealing. The seam 60
and the area of the interlabial device 20 in the vicinity of the
seam 60 should be soft, compressible, and conformable. If the seam
60 and surrounding area are too stiff or non-compressible, the
wearer may experience discomfort when wearing the interlabial
device 20.
[0055] The term "joined," as used herein, encompasses
configurations in which an element is directly secured to another
element by affixing the element directly to the other element;
configurations in which the element in indirectly secured to the
other element by affixing the element to intermediate member(s)
which in turn are affixed to the other element; and configurations
in which one element is integral with the another element, i.e.,
one element is essentially part of the other element.
[0056] The components of the absorbent interlabial device 20 can be
joined together by adhesives, stitching, heat and/or pressure
bonds, dynamic mechanical bonds, ultrasonic bonds, intermingling or
entanglement of the fibers or other structural elements comprising
the components of the absorbent interlabial device 20, such as by
meltblowing the fibers comprising one component onto another
component, extruding one component onto another, or by any other
means known in the art. The components of the absorbent interlabial
device 20 may be joined with water soluble adhesives in order to
increase the tendency of the device 20 to disperse into a plurality
of fragments in mildly agitated water (such as in a toilet).
[0057] Preferably, the interlabial absorbent device 20 of the
present invention is toilet-disposable. The term
"toilet-disposable" as used herein includes the following
characteristics of an absorbent interlabial device: flushability,
dispersibility, settleability, disintegrateability, and
biodegradability. As used herein the terms "flushable" and
"flushability" refer to a product's ability to pass though
typically commercially available household toilets and plumbing
drainage systems without causing clogging or similar problems that
can be directly associated with the physical structure of the
product. It is recognized, however, that there can be many
differences between the various types of toilets available.
Therefore, for the purposes of the appended claims, a test to
determine the flushability of a catamenial product, such as an
absorbent interlabial device, is set out in the TEST METHODS
section of this specification.
[0058] "Settleability" refers to the tendency of an absorbent
interlabial device, such as absorbent interlabial device 20 to
eventually settle to the bottom of a septic tank or other sewage
treatment system rather than to float on the surface of such tanks
or sewage being processed.
[0059] Preferably, the absorbent interlabial device 20 of the
present invention is toilet-disposable and will disperse into at
least two fragments within two hours of exposure to mildly agitated
room temperature water as described in the Water Dispersion Test in
the TEST METHODS section, below. More preferably, the interlabial
absorbent device 20 will be dispersed into a plurality of fragments
within about 60 minutes or, even more preferably within about 30
minutes and most preferably, within about 15 minutes as measured by
the Water Dispersion Test. Preferably, the product will break into
fragments which are smaller than about 6 in.sup.2, more preferably
smaller than about 2 in.sup.2, most preferably smaller than about
1.5 in.sup.2.
[0060] In particularly preferred embodiments of the present
invention, each of the components of the interlabial absorbent
device 20 will disperse into a plurality of fragments when immersed
in mildly agitated water. Alternatively, the components of the
absorbent interlabial device 20 may separate from each other
without themselves breaking into a plurality of fragments (e.g. the
topsheet 42, backsheet 38, and core 44 may break apart from each
other while each otherwise remaining intact).
[0061] Preferably, the absorbent interlabial device 20 comprises
biodegradable materials. While biodegradable materials are
preferred for the absorbent interlabial device 20, it is not
necessary that each and every material used be biodegradable. For
example, the device 20 may comprise superabsorbent particles which
do not biodegrade, and this will not affect the ability of the
overall device 20 to remain toilet-disposable and to be effectively
processed in a sewage treatment system.
[0062] The absorbent interlabial device 20 of the present invention
in its fully assembled configuration comprises at least one axis of
preferred bending A. The axis of preferred bending A is preferably
located generally along the longitudinal centerline L of the
absorbent interlabial device 20. The axis of preferred bending A is
a line or axis along which the absorbent interlabial device 20 will
tend to bend or fold when subjected to compressive forces F
directed inwardly in the transverse direction at the sides 32 of
the device 20. The axis of preferred bending A may result naturally
from the product configuration, or the device 20 may be imparted
with a weakened axis or region in any or all of the topsheet 42,
backsheet 38 and core 44 to create the axis of preferred bending A.
Such a weakened axis may be created by any variety of known
techniques such as scoring, pre-folding, slitting, or the like. The
absorbent interlabial device 20 may comprise a region of preferred
bending made up of a plurality of axes of preferred bending. Any
number of such axes may comprise such a region of preferred bending
up to an infinite number.
[0063] The absorbent interlabial device 20 is folded along the axis
of preferred bending A, as shown in FIG. 4, prior to insertion
within the wearer's interlabial space. Once inserted, the device 20
will preferably tend to unfold slightly keeping the topsheet 42 of
the device 20 in contact with the inner walls of the wearer's
labia. The device 20 may be resiliently biased slightly along the
axis of preferred bending A to increase the tendency of the device
20 to unfold. This allows the folded device 20 to act as a "spring"
under both wet and dry conditions and, consequently, to increase
the tendency of the topsheet 42 of the device to remain in contact
with the inner surfaces of the labia when the absorbent interlabial
device 20 is in place. A device 20 constructed according to the
preferred embodiment described above, however, does not necessarily
require any additional structural features to provide the ability
to maintain such contact. The naturally moist surfaces of the labia
will have a tendency to adhere to the material comprising the
topsheet 42 further tending to keep the device 20 in contact with
the inner surfaces of the labia.
[0064] The absorbent interlabial device 20 described herein is both
flexible and compressible. Flexibility and compressibility are
important to product comport. If the absorbent interlabial device
20 is too flexible, the device is not conveniently or easily placed
between the folds of the labia, if it is too stiff, the device is
uncomfortable and when the user is in a sitting position, the
product can be forced forward against the clitoris causing
discomfort.
[0065] The absorbent interlabial device 20 of the present invention
is believed to offer several advantages over previous interlabial
pads. Devices constructed with the size ranges and preferred shapes
described above have been found to be particularly suited for
reliable insertion by a variety of wearers. Additionally, the
device 20 described above have been found to be particularly
effective at catching clots which may be formed from menstrual
discharges. This clot catching attribute is believed to be enhanced
by the generally flat topsheet 42 of the device 20 which is folded
along the axis of preferred bending A in use. The folded
configuration of the device 20 when properly sized as described
above allows for consistent coverage of the walls of the labia and
the vaginal introitus. Such coverage substantially reduces the
incidence of "by-pass" around the device 20 by menstrual or other
bodily discharges which are exhibited by previous interlabial
pads.
[0066] Superior performance in acquiring menstrual discharges, and
clots in particular, is demonstrated by an absorbent interlabial
device 20 of the present invention as described above in which the
topsheet 42 and the absorbent core 44 comprise rayon.
[0067] The preferred shape of the absorbent interlabial device 20
shown in FIGS. 1-3 (i.e. one in which the device is tapered at the
ends) allows the device to easily and comfortably fit the wearer's
interlabial space. A device 20 with such a tapered shape, when
folded along an axis of preferred bending A (as in FIG. 4) will
have a profile in which highest point along the axis of bending A
(as measured in the "z"-direction) is in the vicinity of the center
of the device 20 rather than at the ends.
[0068] The liquid impervious backsheet 38 of the absorbent
interlabial device 20 is also responsible for improved product
performance. As described above, the backsheet reduces the
likelihood of body or clothing soiling from discharges which are
absorbed by the device 20. Additionally when the device 20 is
folded along the axis of preferred bending A, the backsheet 38 will
form a recess 62 which protects the wearer's fingers from soiling
when the device 20 is inserted.
[0069] Previous interlabial pads have not combined the attributes
of the device 20 of the present invention to obtain the performance
and comfort results described herein. Several previous pads
consisted of a small generally cylindrically shaped absorbent
material which is inserted into the interlabial space. These
devices were not provided with a liquid impervious backsheet.
Consequently, they are characterized by a less cleanly insertion
and removal and may be associated with increased panty and body
soiling in comparison to the present device 20. Other previous pads
did include an impervious backsheet, but the pads were much larger
than the device 20 of the present invention and included
significant portions which resided externally to the interlabial
space. Such designs may also lead to increased body soiling as
discharged bodily fluids migrate to the external surfaces of such
pads. Additionally, the interlabial device 20 of the present
invention is believed to offer comfort advantages (e.g. reduced
wearing awareness) as compared to the above-described larger prior
art pads.
[0070] It has been found during development of the present
invention that the absorbent interlabial device 20 better conforms
to the labial vault than previously available interlabial pads.
Additionally, the generally flat and folded configuration of the
absorbent interlabial device 20 of the present invention is found
to give a better visual indication to users as to how to insert and
use the device. Therefore, the device 20 of the present invention
is associated with an easier and more accurate insertion as
compared to previous interlabial pads.
[0071] The absorbent interlabial device 20 is preferably provided
with an optional removal tab 52 joined to the backsheet 38. The tab
52 may be made of a variety of materials and need not be absorbent.
The tab 52 may be formed from a nonwoven material which is heat
bonded to a tissue layer. A suitable nonwoven material is known as
COROLIND and is available from Corovin, GmbH, Peine, Germany. A
suitable airlaid tissue is available from Merfin Hygenic Products,
Ltd., of Delta, British Columbia, Canada, having a basis weight of
about 61 g/m.sup.2 and having the designation grade number 176.
[0072] The tab 52 may be of any suitable size which provides for a
convenient finger grip during insertion and, optionally, removal of
the device 20. In the preferred embodiment shown in FIGS. 1-3, the
tab 52 is about 20 mm long, and about 13 mm in height (i.e.
measured in the "z"-direction after attachment).
[0073] The tab 52 is preferably joined to the surface of the
backsheet 38 which faces away from the topsheet 42. The tab 52
provides a location for the wearer to grasp the device 20 during
insertion. The absorbent interlabial device 20 is designed to be
expelled by urination. The tab 52, however, may provide an
alternative mechanism for removal of the device 20 (i.e. removal
with the fingers).
[0074] As previously discussed, the absorbent interlabial device 20
of the present invention is designed to be placed within the
interlabial space of a wearer. To use the absorbent interlabial
device 20 of the present invention, the wearer grasps the tab 52 of
the device 20. If the device 20 is not provided with a tab 52, the
wearer may hold the folded device 20 at the sides 32 and begin
insertion. The device 20 is then further inserted by pushing with a
finger or fingers in the recess 62 formed by the folded backsheet
38.
[0075] As shown in FIG. 4, the folded device 20 forms a recess 62
within the folded backsheet 38 which covers the tips of the
wearer's fingers during insertion. This feature provides for a
hygienic insertion of the absorbent interlabial device 20 of the
present invention. The wearer may assume a squatting position
during insertion to assist in spreading the labial surfaces. FIG. 5
shows a preferred embodiment of the absorbent interlabial device 20
of the present invention inserted into the interlabial space of a
wearer W. The urogenital members shown in FIG. 5 include the
bladder B, the vagina V, the urethra U, the clitoris C, the large
intestine I, the anus A, the vaginal introitus VI, the hymeneal
ring H, the labia minora N, and the labia majora J. FIG. 5 shows
the relationship of these anatomical features of the wearer W to
the absorbent interlabial device 20 when the device is properly
inserted for use. Once the absorbent interlabial device 20 is
inserted, the topsheet 42 tends to adhere to the inside surfaces of
the labia. When the wearer is standing, the labial walls close more
tightly around the folded absorbent interlabial device 20.
[0076] The interlabial device 20 is preferably at least partially
retained in place by exerting a slight laterally outwardly-oriented
pressure on the inner surfaces of the wearer's labia minora, labia
majora, or both. Additionally, the product may also be held by
attraction of naturally moist labial surfaces to the material
comprising the topsheet 42. Optionally, the topsheet 42 of the
device 20 may be provided with a bio-compatible adhesive to assist
the adhesion of the device 20 to the inside surfaces of the
wearer's labia. The strength of such an adhesive should be selected
to assist the absorbent interlabial device 20 in staying in place,
while still allowing for reliable, and comfortable removal of the
device from the wearer's interlabial space.
[0077] The absorbent interlabial device 20 can be worn as a "stand
alone" product. Additionally, superior performance in reducing body
and clothing soiling over extended periods of wear time (such as
overnight) can be obtained by using the absorbent interlabial
device 20 as part of a "system" of feminine hygiene products. One
such system which is effective in reducing soiling is an absorbent
interlabial device, such as absorbent interlabial device 20, which
is worn simultaneously with a sanitary napkin, such as sanitary
napkin 70 (shown in FIG. 6).
[0078] Such a system of an interlabial device in combination with a
sanitary napkin is more effective than either a sanitary napkin or
an interlabial pad worn alone. The absorbent interlabial device
used in the system of the present invention may, and preferably
does, have all of the preferred attributes of the absorbent
interlabial device 20 described above. The sanitary napkin 70 of
the present system may be any suitable conventional sanitary
napkin. The sanitary napkin 70 preferably comprises at least a
liquid pervious topsheet 72, a liquid impervious backsheet 74
joined to said topsheet, and an absorbent core 76 positioned
between the topsheet 72 and the backsheet 74. Additionally, the
sanitary napkin 70 preferably includes a pressure sensitive
adhesive 80 disposed on the garment facing side of the backsheet
74. The adhesive 80 allows the sanitary napkin 70 to be adhered to
the crotch portion of the wearer's undergarments. When the
undergarments are worn in their usual wearing position, the
sanitary napkin 70 will rest adjacent the pudendal region of the
wearer's body. The sanitary napkin 70 may also be provided with
additional features commonly found in sanitary napkins, including
"wings" or "flaps" such as wings 78. A suitable sanitary napkin for
use in the above-described system is the "ALWAYS" Ultra thin Maxi
with Wings sanitary napkin which is manufactured and packaged by
the Procter & Gamble Company of Cincinnati, Ohio under one or
more of U.S. Pat. Nos. 4,342,314; 4,463,045; 4,556,146; B1
4,589,876; 4,687,478; 4,950,264; 5,009,653; 5,267,992; 5,413,568;
5,460,623; 5,462,166; 5,489,283; 5,569,231; and Re. 32,649. Other
sanitary napkins are also acceptable, such as those without wings
78 or those which are not of the "Ultra-thin" type.
[0079] In order to use an absorbent interlabial device and a
sanitary napkin as a system of feminine hygiene products, the
wearer inserts the absorbent interlabial device into her
interlabial space and places a sanitary napkin in the crotch
portion of a panty-type undergarment. These two steps may be
performed in either order. Some women will prefer to place the
sanitary napkin in the panty crotch first in order to catch and
absorb and drops of menstrual flow which might be released prior to
the time that the absorbent interlabial device can be inserted.
Other women will chose to first insert the absorbent interlabial
device. After the absorbent interlabial device is inserted and the
sanitary napkin is positioned in the undergarment crotch, the
undergarment is pulled up into its usual wearing position.
Consequently, the sanitary napkin will rests adjacent the pudendal
region of the wearer's body and will be worn simultaneously with
the absorbent interlabial device.
[0080] Preferably, the absorbent interlabial device used with the
above-described system is changed each time the wearer urinates.
The associated sanitary napkin may be worn during for longer
periods of time (i.e. beyond the changing of the absorbent
interlabial device) because the bulk of the bodily fluids will be
deposited on and absorbed by the interlabial device as opposed to
the sanitary napkin. Particularly if the absorbent interlabial
device 20 is provided with a tab 52 for removal, some women will
prefer to remove the absorbent interlabial device 20 prior to
urination, then subsequently re-insert the same device 20 if it has
not yet absorbed near its full capacity.
[0081] The sanitary napkin and the absorbent interlabial device of
the above-described system may be packaged in a common package as a
feminine hygiene "kit." Such a kit facilitates use of the system of
the present invention. Preferably, the packaging associated with
such a kit will include instructions on how to use the absorbent
interlabial device and the sanitary napkin according to the
above-described method as a system of feminine hygiene
products.
[0082] An alternate suitable system of feminine hygiene products
comprises the absorbent interlabial device 20 of the present
invention used simultaneously with an absorbent tampon, such as
tampon 86 shown in FIG. 7. The absorbent tampon of this system of
feminine hygiene product may be any suitable conventional
catamenial tampon including any of the tampons sold under the
trademark "TAMPAX" and distributed by The Procter & Gamble
Company of Cincinnati, Ohio. The tampon used may be either of the
applicator insertion or digital insertion type and any suitable
applicator known in the art may be used. The tampon is first
inserted into the vaginal cavity of the wearer. Following insertion
of the tampon, the absorbent interlabial device is inserted into
the interlabial space of the wearer. The interlabial device and the
tampon are then worn simultaneously for a period of time. The
absorbent interlabial device may be removed and changed each time
the wearer urinates, or may be removed then re-inserted subsequent
to urination.
[0083] Similarly, the absorbent tampon and the absorbent
interlabial device 20 of this system may also be packaged in a
common package as a feminine hygiene kit. This kit facilitates use
of the alternate system of the present invention.
[0084] Systems and associated kits of the present invention may
also comprise the simultaneous use of an absorbent interlabial
device, tampon, and sanitary napkin. Kits comprising all three
types of feminine hygiene products may also be packaged in a common
package and include appropriate instructions for use of such
systems.
[0085] In addition to the systems described above, the absorbent
interlabial device 20 may be worn simultaneously with a pantiliner,
or incontinence pad for menstrual or incontinence use. The
absorbent interlabial device 20 described above may be combined and
packaged with a pantiliner, an incontinence pad, or a sanitary
napkin to form a feminine urinary incontinence kit. Such an
incontinence kit preferably includes appropriate packaging material
instructing the wearer as to how to use the feminine hygiene
products for light incontinence protection. The interlabial device
20 can be worn in conventional panties, or it can be used with
menstrual shorts.
[0086] Numerous alternative embodiments of the absorbent
interlabial device of the present invention are possible. For
example, these products are designed to be removed by urination,
although an alternative extraction string or loop may be used.
These products may also be used with emollients and/or medicinal
treatments. For example, a suitable emollient for use on the
absorbent interlabial device 20 of the present invention is
comprised of about 50% petrolatum, about 39% Cetearyl Alcohol, and
about 15% Ceteareth-10. An emollient coating of about 0.03 g/pad
has been found to be suitable.
[0087] The absorbent interlabial device 20 of the present invention
may be provided with a visual indication on the center of the
topsheet 42 designating the area of greatest absorbent capacity of
the device 20. Such an indication may consist of a differently
colored region such as a pink oval. The indication may be about 12
mm wide and about 20 mm long. The absorbent interlabial device 20
may also be provided with a visual change indication. In other
words, the device 20 may have a ring, bonding pattern, compression
lines, or other visual indicator provided on the surface of the
topsheet 42 at a predetermined distance inboard from the seam 60.
When absorbed bodily discharges reach the visual change indication
or outboard of the change indication, the user knows to replace the
absorbent interlabial device 20. Such a change indication is
particularly useful to users who remove the device 20 prior to
urination and then re-insert the same device 20 if it has not yet
reached its absorbent capacity.
[0088] If desired, the absorbent interlabial device 20 may be
packaged in an individual package, such as the package 50 shown in
FIGS. 8 and 9. The individual package 50 may be comprised of a
number of suitable materials, including films and toilet-disposable
materials. In FIGS. 8 and 9, the package 50 is made of a film which
is frangibly sealed at the edges. The package 50 is provided with
an opening tab 56 which can be of any suitable configuration.
Suitable methods for frangibly sealing packages are described in
U.S. Pat. No. 4,556,146 issued to Swanson and U.S. Pat. No.
5,462,166 issued to Minton, et al. Suitable tabs for such a package
U.S. Pat. No. 5,413,568 issued to Roach, et al.
[0089] The following examples are presented to provide a more
detailed understanding of the benefits which are achieved from the
absorbent interlabial device, the methods and the kits of the
present invention. The EXAMPLES are intended to be representative,
and are not intended to specifically limit the scope of the
invention.
EXAMPLES
[0090] Base Pad 1 is a commercially available "ALWAYS" ultra thin
Maxi sanitary napkin. Base Pad 2 is a commercially available
"ALWAYS" ultra thin Maxi with Wings sanitary napkin. Both are
manufactured by The Procter & Gamble Company of Cincinnati,
Ohio.
[0091] Interlabial Pad 1 is the commercially "IN-SYNC MINIFORM"
interlabial pad (also previously known as the "FRESH 'N FIT
PADETTE") manufactured by A-Fem (previously known as Athena Medical
Corp.) of Portland, Oreg.
[0092] Interlabial Pad 2 is an absorbent interlabial device of the
present invention constructed as described above. The topsheet is
100% rayon. The core is 50% cotton and 50% Galaxy Rayon. The
backsheet is a polyethylene film manufactured by Clopay Corporation
of Cincinnati, Ohio, under the designation P18-0401. The pad has a
removal tab constructed of a nonwoven material heat bonded to a
tissue layer. The nonwoven material is COROLIND available from
Corovin, GmbH, Peine, Germany. The tissue is an airlaid tissue is
available from Merfin Hygenic Products, Ltd., of Delta, British
Columbia, Canada, having the designation grade number 176. The pad
caliper is about 5.5 mm, the width about 40 mm, and the length
about 85 mm. Each pad is coated with about 0.03 g of emollient
comprised of about 50% petrolatum, about 39% Cetearyl Alcohol, and
about 15% Ceteareth-10.
[0093] Table 1 below describes systems of pads which are used by
groups of menstruating women for one complete menstrual cycle. The
below described systems are used exclusively during the cycle. The
participants are instructed to change all pads each time they
urinate (about every 2-3 hours). The table reports incidence of
panty soiling associated with each system or pad.
1TABLE 1 Base Pad Pad 1 Pad 1 Pad 1 Pad 2 Pad 2 Pad 2 Interlabial
Pad None Pad 1 Pad 2 None Pad 1 Pad 2 Number of 31 38 56 45 20 65
Women Panty 35% 22% 13% 19% 12% 6% Soiling
[0094] As is demonstrated above, significant performance
improvements are obtained from the method and kit of the present
invention, and from the interlabial device of the present
invention.
Test Methods
Absorbent Capacity
[0095] Absorbent capacity may be determined as follows. The test is
performed on samples that have been conditioned by leaving them in
a room at 50% relative humidity and at 73.degree. F. for a period
of two hours prior to the test. The test should be performed under
similar conditions.
[0096] The article is weighed to the nearest 0.1 gram. The article
is then submerged in a beaker of sterile 0.9% saline solution
(obtainable from the Baxter Travenol Company of Deerfield, Ill.),
such that the article is totally submerged and is not bent or
otherwise twisted or folded. The article is submerged for 10
minutes. The article is removed from the saline and laid
horizontally on a wire mesh screen having square openings 0.25
inches by 0.25 inches (0.64 cm by 0.64 cm) for five minutes to
allow the saline to drain out to the article. Both sides of the
article are then covered with absorbent blotters, such as the
filter paper #631 available from the Filtration Science Corp.,
Eaton-Dikeman Division of Mount Holly Springs, Pa. A uniform 1
pound per square inch load is placed over the article to squeeze
excess fluid out. The absorbent blotters are replaced every 30
seconds until the amount of fluid transferred to the absorbent
blotters is less than 0.5 grams in a 30 second period. Next, the
article is weighed to the nearest 0.1 gram and the dry weight of
the article is subtracted. The difference in grams is the absorbent
capacity of the article.
Water Dispersion Test
[0097] Apparatus
[0098] Shaker Junior Orbit Shaker available from Lab Line
Instruments of Melrose Park, Ill.
[0099] Thermometer 30 to 120.degree. F. with 1 degree divisions
[0100] Timer Digital stopwatch
[0101] Jar with Lid 16 oz. Glass jar with lid.
[0102] Conditioned Room Temperature and humidity should be
controlled to remain within the following limits:
[0103] Temperature: 73.+-.3.degree. F. (23.degree. C..+-.2.degree.
C.)
[0104] Humidity: 50.+-.2% Relative Humidity
[0105] Test Setup
[0106] 1. Fill the glass jar with 300 ml. of 3.+-.3.degree. F. tap
water.
[0107] 2. Set the speed on the Junior Orbit Shaker to 250 rpm
according to the manufacturer's directions.
[0108] Procedure
[0109] 1. Hold a sample (e.g. an absorbent interlabial device 20) 3
to 4 inches (7.6 to 10.2 centimeters) above the surface of the
water in the jar. Gently drop the sample onto the water
surface.
[0110] 2. Place the lid on the jar.
[0111] 3. Place the jar into the Junior Orbit Shaker such that the
jar is oriented on its side.
[0112] 4. Start the Junior Orbit shaker with the on/off switch,
starting the timer when the shaker is turned on.
[0113] 5. Record the time required until the sample separates into
at least two pieces. Separation does not include the disassociation
of a few individual fibers from an otherwise intact sample. The
time is the total time the sample is being shaken.
[0114] 6. Repeat steps 1 through 5 with an additional 3
samples.
[0115] Calculation and Reporting
[0116] Calculate and report the mean and standard deviation of the
water dispersibility time for the four samples tested.
Flushability Test
[0117] Overview
[0118] As noted above, the terms "flushable or flushability" refer
to a product's capacity to pass through typical commercially
available household toilets and plumbing drainage systems without
causing clogging or similar problems that can be directly
associated with the physical characteristics of the product. For
the purpose of the appended claims, catamenial products are
evaluated for flushability via relative ease of toilet bowl and
trap evacuation and subsequent transport through a simulated
plumbing system. The flushability of such a device should be
measured by the following test procedure.
[0119] The test procedure is designed to simulate two days of
normal toilet usage for a family of 4 (2 men, 2 women). The test
employs a flushing sequence to simulate the following conditions:
male urination visits, female urination visits (including post
urinary drying with tissue), disposal of catamenial product (that
is, the interlabial device or other device to be tested) with
cleaning using tissue, and bowel movement visits. The amount of
tissue to be used for each tissue flush is a normal loading of 2
strips of seven sheets. The normal loading is based on consumer
research regarding typical habits and practices. The test is
designed to simulate the conditions a product will encounter if it
is flushed through a conventional toilet and into a municipal sewer
or into a septic tank. Samples are evaluated for: 1) toilet bowl
and trap clearance, 2) drain line blockage, and 3) disintegration
during flushing.
[0120] Apparatus
[0121] An apparatus suitable for the flushability test is shown in
plan view in FIG. 10. The apparatus includes:
[0122] a 3.5 gallon (13.2 liter) water saver siphon vortex toilet
referred to as 210 (additional toilets can also be attached to the
piping layout shown in FIG. 10 to evaluate the behavior of test
samples using different flushing mechanisms such as commercial,
pressure toilets);
[0123] approximately 59 feet (18 meters) of 4 inch (10 cm) inside
diameter acrylic pipe (As can be seen from FIG. 10, the piping is
assembled in roughly a square configuration having linear runs 211,
213, 215, 217, 219, 221 approximately 10 feet (3 meters) long);
[0124] a cast iron tee 223 slightly downstream of the toilet 210
that is open to the atmosphere for venting;
[0125] five cast iron ninety degree elbows 212, 214, 216, 218, and
220;
[0126] a snag 222 positioned vertically (FIG. 11) approximately 15
feet from the pipe's terminal end and approximately 1 inch (2.5 cm)
long; and
[0127] a screen 224 (No. 4 Tyler sieve) to capture solid effluent
for evaluation of disintegration.
[0128] The apparatus used for this method is set up to be
equivalent to ANSI Standard A112.19.2M-1990 for Vitreous China
fixtures. The piping is plumbed to provide a drop of 0.25 inch per
foot (2 centimeters/meter) of pipe length.
[0129] Materials
[0130] Tissue Product used in Test: standard "CHARMIN" toilet
tissue manufactured by The Procter & Gamble Company of
Cincinnati, Ohio.
[0131] Synthetic Fecal Material Prepared according to the method
described below
[0132] Test Flushing Sequence
[0133] The test flushing sequence simulates 2 days of normal toilet
usage for a family of 4 (2 men, 2 women; based on consumer habits
and practices research). The sequence of 34 total flushes consists
of 14 flushes with an empty bowl, 8 flushes with tissue only, 6
flushes with tissue and a catamenial product and 6 flushes with
tissue and simulated fecal matter (SFM). When it is used, the SFM
is placed in the bowl just prior to the addition of tissue. The SFM
loading of 160 g.sup.+5 g consists of two 1 inch (2.5
centimeter).times.4 inch (10 centimeter) pieces and one 1 inch (2.5
centimeter).times.2 inch (5 centimeter) piece. Folded tissue strips
(or the catamenial product) are placed in the bowl at 10 second
intervals. Ten seconds after the final strip or catamenial product
is placed into the bowl, the toilet is flushed. The flushing
sequence is described below as a series of two routines combined in
the following order:
[0134] Routine #1 (To be performed first 6 times for a total of 30
flushes)
[0135] 1) Flush With Tissue Only--Take a drain line blockage
reading 2 minutes after the water reaches the simulated
obstruction, wait 1 additional minute, and move to step 2.
[0136] 2) Flush With Empty Bowl. Take a drain line blockage reading
2 minutes after the water reaches the snag point and move to step
3.
[0137] 3) Flush With Tissue and Catamenial Product--Take a drain
line blockage reading 2 minutes after the water reaches the snag
point, wait 1 additional minute, and move to step 4.
[0138] 4) Flush With Empty Bowl. Take a drain line blockage reading
2 minutes after the water reaches the snag point and move to step
5.
[0139] 5) Flush With Tissue and Simulated Fecal Matter (SFM). Take
a drain line blockage reading 2 minutes after the water reaches the
snag point, wait 1 additional minute.
[0140] Routine #2 (To be performed 1 time)
[0141] 1) Flush With Tissue Only--Take a drain line blockage
reading 2 minutes after the water reaches the snag point, wait 1
additional minute, and move to step 2.
[0142] 2) Flush With Empty Bowl. Take a drain line blockage reading
2 minutes after the water reaches the snag point and move to step
3.
[0143] 3) Flush With Tissue Only--Take a drain line blockage
reading 2 minutes after the water reaches the snag point, wait 1
additional minute, and move to step 4.
[0144] 4) Flush With Empty Bowl. Take a drain line blockage reading
2 minutes after the water reaches the snag point.
[0145] Total number of flushes per sequence is 34.
[0146] If, after the second flush in the flushing sequence, the
product remains in the bowl or trap after flushing, the tissue and
or catamenial product is plunged into the drainage line manually
and the flushing sequence will continue. After completion of each
trial loading, the drainage pipe will be cleared prior to beginning
subsequent testing.
[0147] The above described flushing sequence is repeated three
times for each test product.
[0148] Data Reporting
[0149] The degree of drain line blockage is determined by measuring
the length of water dammed up behind the obstruction. Graduations
are marked every 12 inches (30 centimeters) on the drainpipe
upstream of the obstruction. Each one foot length that the water is
backed up corresponds to 0.25 inch (0.6 centimeter) or 6.25% of
blockage at the obstruction point. Test product residues which exit
the drainpipe are also collected.
[0150] The following data are recorded for each evaluation:
[0151] 1) Incidence of failure (%) of catamenial product to clear
bowl and trap in one flush
[0152] 2) Incidence of failure (%) of catamenial product to clear
bowl and trap in two flushes
[0153] 3) Incidence of product on simulated snag
[0154] 4) Maximum level (%) of drain line blockage
[0155] 5) Cumulative level (%) of drain line blockage over the 2
day simulated test period.
[0156] Preferably, the products described herein will completely
clear the bowl at least about 70% of the time in two or fewer
flushes, more preferably at least about 80% of the time in one
flush, even more preferably at least about 90% of the time in one
flush, and most preferably at least about 95% of the time in one
flush. The products described herein will preferably have a maximum
level of drain line blockage of less than or equal to about 80%.
The products described herein will preferably have a cumulative
level of drain line blockage over the 2 day simulated test period
of less than or equal to about 50%.
[0157] Preparation of Synthetic Fecal Material
[0158] I. Materials Needed:
[0159] Feclone synthetic fecal matter (900 grams);
[0160] (Available from Siliclone Studio, Valley Forge, Pa. as
product BFPS-7 dry concentrate)
[0161] Tap water at 100.degree. C. (6066 grams)
[0162] II. Equipment Needed:
[0163] Mixer (Available from Hobart Corp., Troy, Ohio as Model
A200)
[0164] Extruder (Available from Hobart Corp., Troy, Ohio as Model
4812)
[0165] Disposable Centrifuge tubes with screw caps (50 ml)
(Available from VWR Scientific, Chicago, Ill. as Catalog No.
21-008-176)
[0166] Water Bath to control temperature to 37.degree. C.
[0167] III. Preparation:
[0168] 1. Pour the 100.degree. C. water into the mixing bowl of the
mixer and add the dry Feclone concentrate.
[0169] 2. Mix on low for 1 minute.
[0170] 3. Mix on medium speed for 2 minutes.
[0171] 4. After the material is well mixed, transfer to the
extruder.
[0172] 5. Using an ice pick, punch a small hole in the tip of each
centrifuge tube.
[0173] 6. Extrude the Feclone into the centrifuge tubes.
[0174] 7. Cap the centrifuge tubes and store in the
refrigerator.
[0175] 8. Before using, put the tubes in the water bath at
38.degree. C.
[0176] This concludes the test.
[0177] The disclosure of all patents, patent applications (and any
patents which issue thereon, as well as any corresponding published
foreign patent applications), and publications mentioned throughout
this description are hereby incorporated by reference herein. It is
expressly not admitted, however, that any of the documents
incorporated by reference herein teach or disclose the present
invention.
[0178] 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.
* * * * *