Note: Descriptions are shown in the official language in which they were submitted.
CA 02336025 2000-12-22
WO 00/00233 PCT/US99/14665
1
DISPOSABLE ARTICLE HAVING BODILY WASTE COMPONENT SENSOR
s
~o
FIELD OF THE INVENTION
The present invention relates to disposable articles and, more particularly,
to
disposable articles having biosensors having a bio-recognition element that
detects
microorganisms and/or other biomolecules in bodily waste and/or sensors
adapted to
v s detect and/or measure components of feces useful as health and/or
nutritional indicators.
BACKGROUND OF THE INVENTION
Today, disposable articles, such as diapers, adult incontinence briefs,
sanitary
napkins and tampons, are widely used in infant and toddler care and in the
care of
zo incontinent adults as a means of containing, isolating and disposing of
bodily wastes.
These articles have generally replaced reusable, washable cloth garments as
the preferred
means for these applications because of their convenience and reliability. The
disposable
articles respond to a defecation, urination or discharge event by absorbing or
containing
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7
bodily wastes deposited on the article. Some disposable articles also signal a
defecation,
urination or discharge event after it has occurred (e.g., wetness indicators,
temperature
change detection). Other disposable absorbent articles known in the art
comprise a
chemically reactive means to detect various substances, such as pH or ions. in
the
wearer's waste(s). e.g. urine. However, none of these specifically detect
target potentially
pathogenic microorganisms such as bacteria, viruses, fungi, and parasites
(e.g.,
protozoans) and/or related biomolecules, all of which require a high degree of
selectivity
(i.e.. specificity) and sensitivity versus purely chemical agents. Further,
none of these
specifically detect chemical components of the wearer's feces that function as
markers for
~o potential health issues and/or nutritional status. Additionally, the
articles do not predict
when a health or nutrition-related event is about to occur and signal wearer
or caregiver
that prophylactic or remedial action is required prior to the onset of
clinically observable
symptoms.
is SUMMARY OF THE INVENTION
A disposable article to be fitted to a wearer comprising: a biosensor
including at
least one bio-recognition element, the biosensor being adapted to detect a
target biological
analyte in bodily waste or on the wearer's skin. A disposable article to be
fitted to a
wearer comprising: a sensor adapted to detect health markers or nutritional
markers in the
Zo wearer's bodily waste or on the wearer's skin.
BRIEF DESCRIPTION OF THE DRAW1NGS
Figure 1 is a plan view of the article made in accordance with the present
invention in a flat-out state with portions of the structure being cut-away to
more clearly
zs show the construction of the article, wherein the article is a diaper.
Figure 2 shows a perspective view of a bodily waste isolation device of the
present
invention in a compressed state before activation.
Figure 2A shows a sectional view taken along line 2A-2A of Figure 2.
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WO 00/00233 PCT/US99/14665
Figure 3A shows an ideal output function of a discontinuous responsive system
of
the present invention having a single threshold level.
Figure 3B shows an ideal output function of a discontinuous responsive system
of
the present invention having multiple threshold levels.
s Figure 4A shows an exemplary output function of a discontinuous responsive
system of the present invention along with the first, second and third
derivatives of the
output function.
Figure 4B shows a transfer function of a control system having a series of
first
order lags having an equal time constant.
io Figures SA and SB show an embodiment of a responsive system of the present
invention including an electrically sensitive gel.
Figures 6A, 6B and 6C show another embodiment of a responsive system of the
present invention including an electrically sensitive gel.
Figure 7 is a perspective view of a waste bag embodiment of the present
~s invention.
Figure 8 is a perspective view of an absorbent article including a waste bag.
DETAILED DESCRIPTION OF THE INVENTION
As used herein, the term "absorbent article" refers to devices which absorb
and
Zo contain body exudates, and more specifically, refers to devices which are
placed against
or in proximity to the body of the wearer to absorb and contain the various
exudates
discharged from the body. The term "disposable" is used herein to describe
absorbent
articles which generally are not intended to be laundered or otherwise
restored or reused
as an absorbent article (i.e., they are intended to be discarded after a
single use and,
is preferably, to be recycled, composted or otherwise disposed of in an
environmentally
compatible manner). (As used herein, the term "disposed" is used to mean that
an
elements) of the diaper is formed (joined and positioned) in a particular
place or position
as a unitary structure with other elements of the diaper or as a separate
element joined to
another element of the diaper. As used herein, the term "joined" encompasses
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4
configurations whereby an element is directly secured to another element by
affixing the
element directly to the other element, and configurations whereby an element
is indirectly
secured to another element by affixing the element to intermediate members)
which in
turn are affixed to the other element.) A "unitary" absorbent article refers
to absorbent
s articles which are formed of separate parts united together to form a
coordinated entity so
that they do not require separate manipulative parts like a separate holder
and liner. A
preferred embodiment of an absorbent article of the present invention is a
unitary
disposable absorbent article, such as the diaper 20 shown in Figure 1. As used
herein. the
term "diaper" refers to an absorbent article generally worn by infants and
incontinent
io persons about the lower torso. The present invention is also applicable to
other absorbent
or non-absorbent articles such as incontinence briefs, incontinence
undergarments.
absorbent inserts, diaper holders and liners, disposable bed pads, colostomy
bags for a
natural or artificial anus, feminine hygiene garments, tampons, wipes,
disposable towels,
tissues, bibs, water absorbing articles, oil absorbing articles, spill cleanup
bags, desiccant
~s bags, disposable mops, bandages, disposable medical garments, disposable
plates and
cups, disposable food preparation and cutting surfaces, therapeutic wraps,
supports,
disposable heating pads and the like.
Figure I is a plan view of the diaper 20 of the present invention in a flat-
out, state
with portions of the structure being cut-away to more clearly show the
construction of the
zo diaper 20. The portion of the diaper 20 which faces the wearer is oriented
towards the
viewer. As shown in Figure l, the diaper 20 preferably comprises a liquid
pervious
topsheet 24; a liquid impervious backsheet 26; an absorbent core 28, which is
preferably
positioned between at least a portion of the topsheet 24 and the backsheet 26;
side panels
30; elasticized leg cuffs 32; an elastic waist feature 34; and a fastening
system generally
zs designated 40. Diaper 20 is shown in Figure 1 to have a first waist region
36, a second
waist region 38 opposed to the first waist region 36 and a crotch region 37
located
between the first waist region and the second waist region. The periphery of
the diaper 20
is defined by the outer edges of the diaper 20 in which the longitudinal edges
50 run
generally parallel to the longitudinal centerline 100 of the diaper 20 and the
end edges 52
CA 02336025 2004-09-27
run between the longitudinal edges 50 generally parallel to the lateral
centerline 110 of
the diaper 20.
The chassis 22 of the diaper 20 comprises the main body of the diaper 20. 'The
chassis ~2 comprises at least a portion of the absorbent core 28 and
preferably an outer
covering layer including the topsheet 24 and the backsheet 26. If the
absorbent article
comprises a separate holder and a liner, the chassis 22 generally comprises
the holder and
the liner. lFor example. the holder may comprise one or more layers of
material to form
the outer rover of the article and the liner may comprise an absorbent
assembly including
a topshm. a backsheet. and an absorbent core. In such cases. the holder andior
the liner
m may incluJe a fastening element which is used to hold the liner in place
throughout the
time ut use.) For unitan~ absorbent articles. the chassis 22 comprises the
main structure
of the diaper with other features added to form the composite diaper
structure. VJltile the
topshrrt 24. the backsheet 26, and the absorbent core 26 may be assembled in a
variety of
well l:nman configurations. preferred diaper configurations are described
generally in
~= U.S. Pit. No. r.860.003 entitled "Contractible Side Portions for Disposable
Diaper"
which issued to Kenneth B. Buell on January l4. 1975: L'.S. Pat. No. 5.l
51.092 issued to
13ur11 on September 9. 1992: and L'.S. Pat. No. 5.221.274 issued to Buell on
June 22.
1996: and L:.S. Pat. No. 5,554.145 entitled "Absorbent Article With Multiple
Zone
Structural Elastic-Like Film Web )=xtensible V~aist Feature" which issued to
Roe et al. on
September 10. J 996: U.S. Pat. No. 5.569.2 :4 entitled "Disposable Pull-On
Pant" which
issued to Buell et al. on October 29. 1996: U.S. Pat. No. 5.580.41 1 entitled
"Zero Scrap
Method For Manufacturing Side Panels For .Absorbent Articles" which issued to
Nease et
al. on December J_ 1996: and U.S. Patent No . 6 , 004 , 306 .
The backsheet 26 is generally that portion of the diaper 20 positioned
adjacent the
narment facing surface 45 of the absorbent core 28 which prevents the exudates
absorbed
and contained therein from soiling articles ~~hich may contact the diaper 20.
such as
bedsheets and undergarments. The backsheet 26 may be joined to the topsheet
24. the
CA 02336025 2004-09-27
6
absorbent core ?8 or any other element of the diaper 20 by any attaciunent
means known
in the art. Suitable backsheet films include those manufactured by Trede~ar
Industries
Inc. of Terre Haute. IN and sold under the trade names X 1 X306. X 1096? and X
10964.
Other suitable backsheet materials may include breathable materials such as
woven webs.
nonwoven webs. composite materials such as film-coated nonwoven webs. and
microporous fi-Ims such as manufactured by Mitsui Toatsu Co., of Japan under
the
designation ESPOIR NO; EXXON Chemical Co., of Bav City. TX. under the
designation
EXXAIRE: or monolithic films such as manufactured by Clopay Corporation.
Cincinnati.
TM
OH under the name HYTREL blend P18-3097. Such breathable composite materials
are
~o described in greater detail in PCT Application '~io. WO 95/16746, published
on June 22.
1995 in the name of E. I. DuPont; copending U.S. Patent No. ~.86~.823 issued
to Curro
on February 2, 1999: U.S. Pat. No. ~.~71.096 issued to Dobrin et al. on
November ~.
1996.
The backsheet 26. or any portion thereof. may be elastically extensible in one
or
more directions. In one embodiment. the backsheet 26 may comprise a structural
elastic-
like film ("SELF") web. A structural elastic-like film web is an extensible
material that
exhibits an elastic-like behavior in the direction of eioneation without the
use of added
elastic materials. SELF webs suitable for the present invention are described
in U.S_
Patent No. ~,~ 18.801 entitled Web Materials Exhibiting Elastic-Like Behavior,
which
'o issued to Chappell, et. al. on May 21, 1996. In
alternate embodiments, the backsheet 26 may comprise elastomeric films. foams.
strands,
or combinations of these or other suitable materials with nonwovens or
synthetic films.
The topsheet 24 is preferably compliant, soft feeling, and non-irritating to
the
wearer's skin. A suitable topsheet 24 may be manufactured from a wide range of
~s materials, such as porous foams: reticulated foams: apertured plastic
films: or woven or
nonwoven webs of natural fibers (e.g.. wood or cotton fibers), synthetic
fibers (e.g..
polyester or polypropylene fibers). or a combination of natural and synthetic
fibers. If the
topsheets include fibers. the fibers may be spunbond. carded. wet-laid.
meltblown.
hvdroentangled, or otherwise processed as is known in the art. One suitable
topsheet 24
CA 02336025 2004-09-27
comprising a web of staple length polypropylene fibers is manufactured by
\reratec. lnc..
a Division of International Paper Company. of Vvalpole. Massachusetts under
the
designation P-8.
Suitable formed film topsheets are described in U.S. Pat. No. 6.929.1=~.
entitled
":Absorptive Structures Having Tapered Capillaries". which issued to Thompson
on
December 30. 19?~: L'.S. Pat. No. 4.324.246 entitled "Disposable .Absorbent
Anicle
Having A Stain Resistant Topsheet". which issued to Mullane. et al. on .April
1 ~. 1982:
U.S. Patent 4.42.,14 entitled "Resilient Plastic \\%eb Exhibiting Fiber-Like
Progenies".
which issued to Radel. et al. on August ~. ) 982: U.S. Pat. No. 4.463.04
entitled
n "Macroscopically Expanded Three-Dimensional Plastic Vl~'eb Exhibiting l~on-
Glossy
\% isible Surface and Cloth-Like Tactile Impression.". which issued to .Ahr.
et al. on July
1. 1984: and L'.S. Pat. l~io. x.006.394 "Multilaver Polymeric Film" issued to
Baird on
.April 9. 1991. Other suitable topsheets 30 are made in accordance v~~ith
L;'.S. Pat. loos.
4.609.518 and 4.629.64 , which issued to Curro et al. on September =. l 98b
and
o December 16. 1986. respectively,
Such formed films are available from The Procter ~ Gamble Company of
Cincinnati.
Ohio as "DR1-VJE.A\%EM and from Tredegar Corporation of Terre Haute. Indiana
as
"CLIFF-T."
Preferably. the topsheet 24 is made of a pvdrophobic material or is treated to
be
~e hydrophobic in order to isolate the wearer's skin from )iquids contained in
the absorbent
core 28. If the topsheet 24 is made of a hydrophobic material. preferably at
least the
upper surface of the topsheet 24 is treated to be hydrophilic so that liquids
will transfer
through the topsheet more rapidly. The topsheet 24 can be rendered hydrophilic
by
treating it with a surfactant or by incorporating a surfactant into the
topsheet. Suitable
_ methods for treating the topsheet 24 with a surfactant include spraying the
topsheet 24
material with the surfactant and immersing the material into the surfactant. A
more
detailed discussion of such a treatmem and hydrophiiicity is contained in L.S.
Pat. No.
4.988.:44 entitled "Absorbem .Anicies with Multiple Layer Absorbent Layers"
issued to
Reising. et al. on Jan. 29. 1991 and L~.S. Pat. ?~o. 4.988.346 entitled
".Absorbent .Articles
CA 02336025 2004-09-27
v~~ith Rapid .Acquiring .Absorbent Cores" issued to Reining on Jan. '?9. 199:.
.A more
detailed discussion of some suitable methods for incorporating surfactant in
the topsheet
can be found in U_S. Statutory Invention Registration ~o. H 1670. published on
Julv l .
199 7 in the names of Aziz et al.
Anv portion of the topsheet 24 or other components of the article may be
coated
with a lotion as is knov~m in the art. Examples of suitable lotions include
those described
in U.S. Pat. Non. 5.607.760 entitled "Disposable Absorbent Article Having .A
Lotioned
l opshert Containing an Emollient and a Polyol Poivester Immobilizing Agent"
which
m issur~i to Roe on March 4. 1997: U.S. Pat. No. ~.609.587 entitled "Diaper
Having A
Lotion ~I ~psheet Comprising A Liquid Polvol Poivester Emollient And An
Immobilizing
.A~rnt" which issued to Roe on March 11. 1997: L'.S. Pat. No. 5.635.191
entitled "Diaper
llavinL A 1_otioned Topsheet Containing A Polvsiloxane Emollient" which issued
to Roe
et al. cm June 3. 1997: and Lt.S. Pat. No. x.64:.588 entitled "Diaper Having A
Lotioned
;= 7 opsheet" which issued to Roe et al. on July 1. 199 7. '»te lotion may
function alone or in
comhination with another agent as the hvdrophobizing treatment described
above. 'The
topshrct may also include or be treated with amibacterial agents. some
examples of which
arr di,closed in PCT Publication No. Vv'O 951241 73 entitled "Absorbent
.Articles
Containin= Antibacterial .Agents in the Topsheet For Odor Control" which was
published
on Scptrmber l4, 1995 in the name of 'Theresa Johnson. Further. the topsheet
24. the
backsheet 26 or arty portion of the topsheet or backsheet may be embossed
andior matte
finished to provide a more cloth like appearance.
The topsheet 24 and backsheet 26 may be ioined to each other. the absorbent
core
28 or arty other element of the diaper 20 by an attachment means knov~m in the
an- For
_. example. the attachment means may include a uniform continuous layer of
adhesive. a
panerned layer of adhesive. or an array of separate lines. spirals. or spots
of adhesive.
.Alternatively. the attachmem means may comprise heat bonds. pressure bonds.
ultrasonic
bonds. dynamic mechanical bonds. or any other suitable attachmem means or
combinations of these attachment means as are known in the an.
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9
The absorbent core 28 may comprise any absorbent material which is generally
compressible, conformable, non-irritating to the wearer's skin, and capable of
absorbing
and retaining liquids such as urine and other certain body exudates. The
absorbent core
28 may be manufactured in a wide variety of sizes and shapes (e.g.,
rectangular,
hourglass, "T"-shaped, asymmetric, etc.) and may comprise a wide variety of
liquid-
absorbent materials commonly used in disposable diapers and other absorbent
articles
such as comminuted wood pulp, which is generally referred to as airfelt.
Examples of
other suitable absorbent materials include creped cellulose wadding; meltblown
polymers,
including coform; chemically stiffened, modified or cross-linked cellulosic
fibers; tissue.
io including tissue wraps and tissue laminates; absorbent foams; absorbent
sponges;
superabsorbent polymers; absorbent gelling materials; or any other known
absorbent
material or combinations of materials.
The configuration and construction of the absorbent core 28 may also be varied
(e.g., the absorbent cores) or other absorbent structures) may have varying
caliper zones,
is a hydrophilic gradient, a superabsorbent gradient, or lower average density
and lower
average basis weight acquisition zones; or may comprise one or more layers or
structures).
Exemplary absorbent structures for use as the absorbent assemblies are
described
in U.S. Patent 4,610,678 entitled "High-Density Absorbent Structures" issued
to Weisman
zo et al. on September 9, 1986; U.S. Patent 4,673,402 entitled "Absorbent
Articles With
Dual-Layered Cores" issued to Weisman et al. on June 16, 1987; U.S. Patent
4,834,735,
entitled "High Density Absorbent Members Having Lower Density and Lower Basis
Weight Acquisition Zones", issued to Alemany et al. on May 30, 1989; U.S.
Patent
4,888,231 entitled "Absorbent Core Having A Dusting Layer" issued to Angstadt
on
zs December 19, 1989; U.S. Pat. No. 5,137,537 entitled "Absorbent Structure
Containing
Individualized, Polycarboxylic Acid Crosslinked Wood Pulp Cellulose Fibers"
which
issued to Herron et al. on August 11, 1992; U.S. Patent 5,147,345 entitled
"High
Efficiency Absorbent Articles For Incontinence Management" issued to Young et
al. on
September 15, 1992; U.S. Pat. No. 5,342,338 entitled "Disposable Absorbent
Article For
CA 02336025 2004-09-27
1U
Low-Viscosity Fecal Material" issued to Roe on .August 30. 1994: U.S. Pat.
'vo.
5.260. ~45 entitled ".Absorbent Foam Materials For Aqueous Body Fluids and
Absorbent
Articles Containing Such Materials" issued to DesMarais et al. on November 9.
199 ~:
L'.S. Pat. No. 5.387.207 entitled "'1-hin-Until-Vv et Absorbent Foam Materials
For Aqueous
Body Fluids And Process For Making Same" issued to Dver et al. on February 7.
199:
and L'.S. Pat. No. 5.625.222 entitled "Absorbent Foam I\~aterials For Aqueous
Fluids
Made From high Internal Phase Emulsions Having ~%erv High Water-To-Oil Ratios"
issued to DesMarais et al. on Julv 22. 1997.
v~ The diaper 20 may also comprise at least one elastic ~-aist feature 34 that
helps to
provide improved fit and containment. 'The elastic waist feature 34 preferably
extends at
least longitudinally outwardly from at least one waist edge 62 of the
absorbent core 28
and generally forms at least a portion of the end edge 52 of the diaper 20.
Disposable
diapers are often constructed so as to have two elastic waist features. one
positioned in the
n first waist region 36 and one positioned in the second waist region 38.
Further. while the
elastic N~aist feature 34 or any of its constituent elements may comprise one
or more
separate elements affixed to the diaper 20. the elastic waist feature 34 may
be constructed
as an extension of other elemerns of the diaper 20. such as the backsheet 26.
the topsheet
24. or both the backsheet 26 and the topsheet 24.
?c The elastic waist feature :4 may be constructed in a number of different
configurations including those described in U.S. Pat. No. 4.515.595 issued to
Kievit et al.
on Mav 7_ 1985: U.S_ Pat. No. 4.710.189 issued to Lash on December 1. 1987:
U.S. Pat.
No. 5. 151.092 issued to Buell on September 9. 199'': and U.S. Pat. No.
5.221.274 issued
to Buell on June 22. 199. Other suitable waist configurations may include
waistcap
features such as those described in L'_S. Pat. No. 5.026.364 issued to
Robertson on June
25. 1991 and L'.S. Pat. No. 4.816.025 issued to Foreman on March 28. 1989.
The diaper 2U may also include a fastening system 40. The fastening system 4O
preferably comprises tape tabs andior hook and loop fastening components.
although any
CA 02336025 2004-09-27
]1
other l:no~~n fastening means are ~enerallv acceptable. Some esemplar~-
fastening
systems are disclosed in L'.S. Patent 3.848.94 entitled "'Tape Fastening
System for
Disposable Diaper" issued to Buell on November l9. 1974: U.S. Patent B1
4.662.87
entitled "Absorbent .Ankle" issued to Hirotsu et a1. on May ~. 1987: Le.S.
Patem
4.846.815 entitled "Disposable Diaper Having .An Improved Fastening Device"
issued to
Scripps on July I1. 1989: L'.S. Patent 4.894.060 entitled "Disposable Diaper
With
Improved Hook Fastener Portion" issued to ?~estegard on Januaw 16. 1990: U.S.
Patern
4.946.? i entitled "Pressure-Sensitive .Adhesive Fastener And Method of Making
Same"
issued to Battrell on August i. 1990. and the herein before referenced U.S.
Pat. No.
m :.1:1.092 issued to Buell on September 9. 199%: and L'.S. Pat. No. 5.221.274
issued to
Buell on June 2~. 199 ~. 'The fastening system may also provide a means for
holding the
article in a disposal configuration as disclosed in L'.S. Pat. No. 4.963.140
issued to
Robertson et al. on October 16_ 1990.
In alternative embodiments. opposing sides of the garment may be seamed or
welded to form a pant. This allows the article to be used as a pull-on type
diaper. such as
a training pant.
The diaper 20 may also comprise side panels 30. The side panels 30 may be
elastic or extensible to provide a more comfortable and contouring fit by
initially
conformably fitting the diaper 20 to the wearer and sustaining this fit
throughout the time
n of ~~ear well past when the diaper 20 has been loaded with exudates since
the elasticized
side panels =0 allow the sides of the diaper 20 to expand and contract.
While the diaper '?0 of the present invention preferably has the side panels
30
disposed in the second waist region 38. the diaper 20 may be provided with
side panels 30
disposed in the first waist region 36 or in both the first y~~aist region 36
and the second
~~aist region 38. The side panels 30 may be constructed in any suitable
configurations.
Examples of diapers N~ith elastici2ed side panels are disclosed in LI.S.
Patent 4.87.067.
entitled "Disposable Diaper Haying Shirred )cars" issued to Wood. et al. on
August 1 ~.
1989: L.S. Patent 4.381.781 issued to Sciaraffa. et al. on May 3. 1983: Lt.S.
Patem
4.938.7~~ issued to ~%an Gompel. et al. on Julv ~. 1990: the herein before
referenced U.S.
CA 02336025 2004-09-27
Pat. No. ~.l ~ 1.092 issued to Bueli on September 9. 1992: and L.S. Pat. No.
~. 221.2 i4
issued to Bueli on June 22. 1993: L'.S. Patent No. x.669.897 issued to La~'on.
et al. on
September 2.. 1997 entitled ".Absorbent .Ankles Providing Sustained Dynamic
Fit": L.S.
Patent No. 6 , 004 , 306 .
The diaper 20 preferably further includes Ieg cuffs 32 which provide improved
containment of liquids and other body exudates. Lee cuffs may also be referred
to as leg
bands. side fiaps_ barrier cuffs. or elastic cuffs. L'.S. Patent .:.860.003
describes a
o disposable diaper which provides a contractible leg opening having a side
flap and one or
more elastic members to provide an elasticized leg cuff (a gasketing cuff).
L'.S. Patent
Nos. 4.808.178 and 4.909.803 issued to Aziz et al. on February 28. 1989 and
March 20.
1990. respectively. describe disposable diapers having "stand-up" elasticized
flaps (barrier
cuffs) which improve the containment of the leg regions. Lt.S. Pat. Nos.
4.695.278 and
t< 4.795.464 issued to Lawson on September 22. 1987 and to Dragoo on January
3. 1989.
respectively. describe disposable diapers having dual cuffs. including
gasketing cuffs and
barrier cuffs. In some embodiments, it may be desirable to treat all or a
portion of the leg
cuffs with a lotion. as described above.
Embodiments of the present invention may also include pockets for receiving
and
~c~ containing waste. spacers v~~hich provide voids for waste. barriers for
limiting the
movement of waste in the article. compartments or voids which accept and
contain v~-aste
materials deposited in the diaper. and the like. or arty combinations thereof.
Examples of
pockets and spacers for use in absorbent products are described in L.S. Patent
5.514.121
issued to Roe et al. on Mav 7. 1996. entitled "Diaper Having Expulsive
Spacer": U.S.
Patent 5.171.236 issued to Dreier et al on December l ~. 1992. entitled
"Disposable
Absorbent Article Having Core Spacers": U.S. Patent 5. X97.318 issued to
Dreier on
March 14. 1995. entitled ".Absorbent .Article Having A Pocket Cuff'. L'.S.
Patent
'.40.671 issued to Dreier on Julv 30. 1996. entitled "Absorbent Article Having
A Pocket
Cuff With .An Apex": and PCT .Application WO 931251 72 published December ~.
1993.
CA 02336025 2004-09-27
ernitled "Spacers For Lose In Hygienic Absorbent Articles And Disposable
.Absorbent
.Articles Having Such Spacer": and U.S. Patern x.306.266. entitled "Flexible
Spacers For
Use In Disposable Absorbem Articles". issued to Freeland on April 26. 1994.
Exampler
of compartments or voids are disclosed in U.S. Patern 4.968.312. entitled
"Disposable
Fecal Companmenting Diaper". issued to Khan on November 6. 1990: L'.S. Patent
4.990.147. entitled ",Absorbern .Article With Elastic Liner For ~~'aste
Material Isolation".
issued to Freeland on Februar-v ~, 1991: L:~.S. Patent 5.62.840. entitled
"Disposable
Diapers". issued to Holt et al on November ~. 1991: and U.S. Patent ~.?69.7~~
ernitled
"Trisection Topsheets For Disposable Absorbent .Articles .And Disposable
.Absorbent
m .Articles Having Such Trisection Topsheets"_ issued to Freeland et al on
December 14.
1993. Examples of suitable transverse barriers are described in U.S. Pat. No.
~.~~4.14?
entitled "Absorbent Article Having Multiple Effective Height Transverse
Partition" issued
September 10. 1996 in the name of Dreier et al.: PCT Patent WO 94/1439
entitled
".Absorbent Article Having An Upstanding 'Transverse Partition" published July
7. 1994
v in the name of Freeland. et al.: and L'.S. 5_6~3.i0s Absorbent Article
Having Angular
Upstanding Transverse Partition. issued Aug. ~. 1997 to Roe. et al.
Embodiments of the present invention may also include a waste management
device 1 10 such as is shov~~rt in Figure 7. 'The waste management device 110
may include
a waste bag 1 1 1 to collect feces. urine or both. The waste bag l 11 may have
an aperture
121 and a flange 112 surrounding the aperture for preferabiv adhesive
attachment to the
perianal area of a wearer. Further. the waste management device 1 10 has been
found to
be particularly useful and beneficial ~fien used in conjunction with a
garment. or diaper.
preferably a disposable diaper. One example of an absorbent article. such as
the diaper
120 including a waste bag 1 1 l is shov~m in Figure 8. if associated with a
diaper 120 or
other garment. the waste bag l l l may be disposed on or joined to any surface
of the
article. In one embodiment. the waste bag 1 1 1 is joined to the topsheet 124
of the diaper
120.
CA 02336025 2000-12-22
WO 00/00233 PCT/US99/14665
14
The waste bag 111 is preferably a flexible receptacle for the containment of
excreted fecal matter or urine. Thus, the waste bag 111 is preferably liquid
impermeable,
and yet it may be breathable. Further, the waste bag 111 is designed of
sufficient
strength to withstand typical wearing conditions, such as sitting.
s The waste bag 111 may comprise one or multiple layers. In one embodiment,
the
waste bag I 11 may comprise three layers, preferably one film and two non-
woven layers.
The layers of the bag material may comprise any material, preferably so that
the bag is
liquid impervious. In a preferred embodiment of the present invention a
laminate may be
formed from a non-woven layer and a film.
io Suitable film materials for any of the film layers preferably comprise a
thermoplastic material. The thermoplastic material can may be vapor pervious
or
impervious and can be selected from among all types of hot-melt adhesives,
polyolefins
especially polyethylene, polypropylene, amorphous polyolefins, and the Like;
material
containing meltable components comprising fibres or polymeric binders
including natural
is fibres such as cellulose - wood pulp, cotton, jute, hemp; synthetic fbres
such as
fibreglass, rayon, polyester, polyolefin, acrylic, polyamid, aramid,
polytetrafluroethylene
metal, polyimide; binders such as bicomponent high melt/low melt polymer,
copolymer
polyester, polyvinyl chloride, polyvinyl acetate/chloride copolymer, copolymer
polyamide, materials comprising blends wherein some of the constituent
materials are
zo not meltable; air and vapour permeable materials including microporous
films such as
those described above with respect to the backsheet and monolithic breathable
materials
such as HYTRELTM available from DuPont and PebaxTM available from ELF Atochem,
France.
The waste bag 111 may have any shape or size. Preferred shapes include flat
~s circular type bags, cone shaped bags, truncated cone shaped bags and
pyramidal or
truncated pyramidal shaped bags and flat T shaped bags. Further, the waste bag
111 may
be provided from a unitary piece of material or a number of separate pieces of
material
which may be identical or different and which may be sealed at their
respective
peripheries.
CA 02336025 2000-12-22
WO 00/00233 PCT/US99/14665
The waste bag 111 may also contain absorbent material. The absorbent material
may comprise any absorbent material which is capable of absorbing and
retaining liquids.
The absorbent material may comprise a wide variety of liquid-absorbent
materials
commonly used in disposable diapers and other absorbent articles. Some
examples are
described herein with respect to the absorbent core.
The waste bag 111 is provided with an aperture 121 whereby fecal matter or
urine
is received from the body prior to storage within the bag cavity. The aperture
121 is
preferably surrounded by a flange 112 and may be provided in any shape or
size, such as
circular, oblong, heart shaped and may be symmetrical or asymmetrical,
preferably the
~o aperture has an oblong configuration either in the longitudinal or in the
transversal
direction. The flange may comprise projections designed to fit the perineal,
genital
and/or coccygeal area of the wearer.
The flange 112 should be made of soft, flexible and malleable material to
allow
easy placement of the flange 112 to the perianal or uro-genital area. Typical
materials
~s include nonwoven materials, wovens, open celled thermoplastic foams, closed-
cell
thermoplastic foams, composites of open celled foams and stretch nonwoven, and
films.
The waste bag 111 preferably further comprises an attachment means to secure
the device to the wearer. Such means may comprise straps and or a body-
compatible
pressure sensitive adhesive applied to the wearer facing portion of the waste
bag 11 l or
zo the flange. Any skin-friendly water resistant pressure sensitive adhesive
may be used to
attach the device to the perianal or uro-genital area of the wearer, such as
hydrocolloid
adhesives and hydrogel adhesives. Particularly effective adhesives in
providing the
desired adhesive properties to secure the flange to the skin of the wearer at
the sensitive
perianal area, while allowing for relatively painless application and removal,
are formed
zs from crosslinking polymers with a plastisicer to form a 3-dimensional
matrix.
The article 20 preferably also includes at least one sensor 60 adapted to
detect one
or more health and/or nutritional markers in bodily waste and having the
capability to
provide a signal of said detection to the wearer, caretaker, or an actuator.
As used in this
application, the term "sensor" refers to a device that is capable of detecting
an event or a
CA 02336025 2000-12-22
WO 00/00233 PCT/US99/14665
16
parameter that is associated with an event. A parameter associated with an
event is any
measurable signal that correlates with the occurrence of an event within the
frame of
reference of the system (i.e., a signal caused by the waste, the wearer, or a
component
thereof). Sensors include anything that responds to one or more specific
inputs. Sensors
> may be chemical, electrochemical, biochemical, or biological, mechanical,
magnetic,
thermal, or other signals as are known in the art. The articles of the present
invention
specifically comprise sensors that provide a signal to the wearer, caretaker,
or actuator
indicating the presence and/or concentration of one or more health or
nutritional markers
in bodily waste such as feces, urine or menses. The signal may be an optical
signal,
io including visual signals (e.g., a colorimetric or flourescent indicator),
chemical signal
(e.g., a change in pH, enzyme activity, or concentration of any other chemical
species), or
an electrical signal.
"Health markers'' and "nutritional markers" (e.g., in human feces), as used
herein,
refer to any elemental, chemical, or biological components that may be found
in the
a waste, and any combinations of or relationships between (e.g., ratios, etc.)
the
components, having a defined relationship with the wearers' health (e.g.,
disease,
infection, poisoning, etc.) and nutritional status, respectively. The
nutritional status of the
wearer includes, for example, metabolic efficiency, nutrient deficiencies,
nutrient
absorption or malabsorption, food and drink intake, food allergies (e.g., to
peanuts), food
~o intolerance (e.g., lactose intolerance), colonic bacteria ecology (e.g.,
beneficial bacteria
such as bifidobacteria and lactobacillus), and total energy balance. Health
markers
may include heavy metals (e.g., lead, mercury, etc.), radioactive substances
(e.g., cesium,
strontium, uranium, etc.), fats, enzymes, endogenous secretions, proteinaceous
matter
(e.g., casts), mucous, and microorganisms (described in more detail
hereinafter in the
2s biosensor section) that may be related to various health issues such as
infection, diarrhea,
gastrointestinal distress or disease, or poisoning. Heavy metals, especially
in certain
developing countries and in older and/or less affluent areas of developed
countries, are a
serious health risk. For example, lead and mercury poisoning may occur upon
the
ingestion of these heavy metals from environmental sources (e.g., from lead
paint,
CA 02336025 2004-09-27
1l
unreguiatec heavy industries. etc. ~ and can be fatal I\-gore commonly. low-
ieve',
poisoning by these and other heave metals results in retarded imellectual
and/or physical
development. especially in children_ that may occur over a long time and have
lasttn
effects on the individual. Proteinaceous masses, such as casts ie.~.. in
urine) may be
sensed by targeting Tamm-Horsfall protein. .A suitable example of a sensor for
'1-amm-
Horsfall protein is described in L'S Patent 5.780.239.
Suitable sensors for heavy metals. andior the discriminating means useful for
the sensors. are described more detail in US Patents ~.~9~.6~~: s.865.97?:
J.814_2Q~:
5.468. ; 66.
~o '~~on-limiting examples of nutritional markers include calcium. vitamins
te.;~..
thiamine. ribof.~avin, niaein_ biotin. folic acid. pantothenic acid. ascorbic
acid. vitamin P.
etc.(- electrolwes (e.g.. sodium_ potassium. chlorine. bicarbonate. etc.).
fats. fatty acids
(long and shoe chain). soaps ~e.g.. calcium palmitate). amino acids. enzymes
(e.g..
lactose. amylase. lipase. trYpsin. etc.j. bile acids and salts thereof.
steroids. and
n carbohydrates- For example. calcium malabsorption is imponant in that it may
lead to a
long-term bone-mass deficiency. Vv'hile the imponance of calcium absorption in
adults.
panicularly older women. is much publicized, it is also an imponant
consideration in
children tespecially infants). lnfarn diet may impact calcium absorption and.
therefore.
bone mass and/or density. It has been shown- for example. that changing the
position of
~c~ palmittc acid on triglyeerides in infant formula from the %-position
(i.e., like human
breast-milk) to the 1- and/or ;-position ~e.g.. as in some infant formulas).
results in less
cleavage of the palmitic acid from the triglyceride "backbone'. and therefore
absorption.
of this nutrient by the body. The uncleaved palmitic acid binds calcium in the
digestive
tract as a soap (i.e.. calcium palmitatey and leaves the body in the feces.
(This process is
described in more detail in .Archive of Disease in Childhood (?soy. 19971 77
F178-F184. l
Therefore. the calcium andior soap content in feces is one potemial means of
assessinc
calcium absorption by the digestive system. Suitable colorimetnc calcium
sensors based
on .Arsenazo 111 ~ acidic environment > and Cresolphthaiein Complexone (basic
environment 1 are available from Siema-.Aldrich Chemical of St. Lois_ MO. as
catalog
CA 02336025 2004-09-27
is
numbers 588-~ and 58i-A. respectively. Other exemplary sensors for calcium.
andior the
discriminating means useful for the sensors_ are described more detail in L'S
Patent
5.705.620: 5.580.441: and 5,496.5?2_
The sensors of the present invention may be associated with a carrier
structure.
The carrier structure may hold. stabilize. andior at least paniallv
encapsulate the sensor.
Examples of carrier structures include one or more layers of woven and
nonwoyen webs.
films. foams. scrims. hvdrogeis. and the like. The sensor may be attached to
the carrier
structure_ held between two or more components. layers. or folds of the
carrier structure.
or mas be sealed within the carrier structure. The carrier structure may
optionalis
m comprise an adhesive or skin adhering composition or other attachment means
to secure
at least a ponion of said carrier structure to the aniele or a component
thereof or to the
wearers skin. Funher. at least a portion of the carrier may be water soluble.
In cenain embodiments of the present invention. the sensor 60 may comprise a
biosensor. .As used herein. the term "biosensor'~ is defined as a component
comprising
one or more biologically reactive means being adapted to detect one or more
target
pathogenic microorganisms or related biomolecules (e.g.. an enzyme sensor.
organella
sensor. tissue sensor. microorganism sensor. immunosensor or electrochemical
sensor.
The term "biologically reactive' is defined as having the capability to
selectively interact
with. and preferably bind. target pathogenic microorganisms and/or related
biomolecules
~o as described herein. Generally. biosensors function by providing a means of
specifically
binding. and therefore detecting. a target biologically active analvte. In
this way. the
biosensor is highly selective. even when presented with a mixture of many
chemical and
biological entities. such as feces. Chemical sensors. on the other hand. which
rely on
chemically reactive means. generally do not have either the high selectivity
or the
amplification propenies of biosensors and. therefore. are not well suited to
detect
biologically reactive analvtes. especially when they are present in low
concentrations
andlor in a complex media such as bodily waste. Often the target biological
analyte is
minor component of a complex mixture comprising a multiplicin- of biological
and other
components. Thus. in many biosensor applications. detection of target analvtes
to the
CA 02336025 2000-12-22
WO 00/00233 PCT/US99/14665
19
parts-per-billion, parts-per-trillion, or even lower levels is necessary.
Accordingly,
discrimination ratios of about 10'-10g or greater may be required for the
biosensor to
recognize the target biological analyte in a complex mixture.
The biosensor of the present invention may comprise a bio-recognition element,
or
molecular recognition element, that provides the highly specific binding or
detection
selectivity for a particular analyte. The bio-recognition element, or system,
may be a
biologically derived material such as an enzyme or sequence of enzymes; an
antibody; a
membrane receptor protein; DNA; an organelle, a natural or synthetic cell
membrane; an
intact or partial viable or nonviable bacterial, plant or animal cell; or a
piece of plant or
io mammalian tissues, and generally functions to interact specifically with a
target biological
analyte. The bio-recognition element is responsible for the selective
recognition of the
analyze and the physico-chemical signal that provides the basis for the output
signal.
Biosensors may include biocatalytic biosensors, and bioaffinity biosensors. In
biocatalytic biosensor embodiments, the bio-recognition element is
"biocatalytic" and
is may comprise an enzyme, organelle, piece of plant or mammalian tissue, or
whole cells,
the selective binding sites "turn over" (i.e., can be used again during the
detection
process), resulting in a significant amplification of the input signal.
Biocatalytic sensors
such as these are generally useful for real-time, continuous sensing.
Bioaffinity sensors are generally applicable to bacteria, viruses, and toxins
and
zo include chemoreceptor-based biosensors and/or immunological sensors (i.e.
immunosensors). Chemoreceptors are complex biomolecular macroassemblies
responsible, in part, for a viable organism's ability to sense chemicals in
its environment
with high selectivity. Chemoreceptor-based biosensors comprise one or more
natural or
synthetic chemoreceptors associated with a means to provide a signal (visual,
electrical,
is etc.) of the presence or concentration of a target biological analyte. In
certain
embodiments, the chemoreceptor may be associated with an electrode (i.e., an
electrical
transducer) so as to provide a detectable electrical signal. Chemoreceptors
may include
whole or partial nerve bundles (e.g., from antennae or other sensing organs)
and/or whole
or partial natural or synthetic cell membranes. On the other hand, the bio-
recognition
CA 02336025 2004-09-27
elements of immunosensors are generally antibodies. Antibodies are highly
specific and
can be made toward bacteria. viruses. fragments of microorganisms (e.g..
bacterial cell
walls. parasite eggs or ponions thereof_ etc. j. and large biomolecules_
Suitable antibodies
may be monoclonal or polvclonal. In any case. bioaffinitv biosensors are
~eneralls
irreversible because the receptor sites of the biosensor become saturated when
exposed to
the target biological analyze.
In cenain embodiments. biocatalvtic bioaffinitv biosensors may be combined.
such as KN.A!DNA probes or other high-affinity binding systems v~~herein the
initial bio-
rrcoLnition event is followed by biological amplification of the signal. For
example. a
m spmiti~ hactcria may be detected by a biosensor comprising genetic material.
such as
DIVA. as a bio-recognition element and PCR (i.e.. polymerase chain reaction j
~mplific~tiun to detect small numbers of organisms. preferably Less than or
equal to about
500 organisms. Biocatalvtic and bioaffinitv biosensor systems are described in
more
detail in .I~umal of Ch>-omatoeraphv. ~ 10 ( 1990) X47-3~4 and in the Kirk-
Othmer
Fncvclmnedia of Chemical Technoloev. 4'" ed. (1992 j. John Wiley & Sons. ;\~'.
The biosensors of the present invention preferably detect biologically active
analvtrs rrlated to impending (i_e.. future presentation of symptoms is
likely] or current
human systemic disease states. including. but not limited to. pathogenic
bacteria. parasites
u: le.~:.. any stage of the life cycle. including eggs or ponions thereof.
cysts. or mature
organisms). viruses. fungi such as fandida albicans. antibodies to pathogens,
andlor
microbially produced toxins. Additionally. the biosensor may target
biologically active
analyzes related to impending or current localized health issues. such as
stress proteins
(e.g., cyokinesl and IL-la (interleukin 1-alpha) that may precede the clinical
presentation
of skin irritation or inflammation. In preferred embodiments. the biosensor
functions as a
proactive sensor. detecting and signaling the wearer or caretaker of the
impendin~~
condition prior to the presentation of clinical symptoms. This allows time to
administer
prophylactic or remedial treatments to the wearer which can significantly
reduce. if not
prevent. the seyeritv and duration of the symptoms. Funher. the sensor 60. by
detecting
CA 02336025 2000-12-22
WO 00/00233 PCTNS99/14665
21
the presence of a target biological analyte in the wearer's bodily waste
(e.g., feces), may
detect residual contamination on a surface, such as skin, in contact with the
biosensor, and
provide and appropriate signal.
The physico-chemical signal generated by the bio-recognition element or
elements
s may be communicated visually to the wearer or caretaker (i.e., via a color
change visible
to the human eye). Other embodiments may produce optical signals, which may
require
other instrumentation to enhance the signal. These include flourescence,
bioluminesence,
total internal reflectance resonance, surface plasmon resonance, Raman methods
and other
laser-based methods. Exemplary surface plasmon resonance biosensors are
available as
io IBIS I and IBIS II from XanTec Analysensysteme of Muenster, Germany, which
may
comprise bioconjugate surfaces as biorecognition elements. Alternatively, the
signal may
be processed via an associated transducer which, for example, may produce an
electrical
signal (e.g., current, potential, inductance, or impedance) that may be
displayed (e.g., on a
readout such as an LED or LCD display) or which triggers an audible or tactile
(e.g.,
i s vibration) signal or which may trigger an actuator, as described herein.
The signal may be
qualitative (e.g., indicating the presence of the target biological analyte)
or quantitative
(i.e., a measurement of the amount or concentration of the target biological
analyte). In
such embodiments, the transducer may optionally produce an optical, thermal or
acoustic
signal.
2o In any case, the signal may also be durable (i.e., stable and readable over
a length
of time typically at least of the same magnitude as the usage life of the
article) or transient
(i.e., registering a real-time measurement). Additionally, the signal may be
transmitted to
a remote indicator site (e.g., via a wire, or transmitter, such as an infrared
or rf
transmitter) including other locations within or on the article or remote
devices. Further,
zs the sensor 60, or any of its components, may be adapted to detect and/or
signal only
concentrations of the target biological analyte above a predefined threshold
level (e.g., in
cases wherein the target biological analyte is normally present in the bodily
waste or
when the concentration of the analyte is below a known "danger" level).
CA 02336025 2004-09-27
As described above. the target analvtes that the biosen~ors of the present
invention
are adapted to detect may be pathogenic microorganisms such as the pathogenic
microorganisms implicated in human gastroirnestinal diseases. especially those
resultine
in diarrhea. This type of pathogen is particularly imponant to monitor due to
the number
_ of children N~ho become seriously ill or die each year from diarrheal
diseases. It has been
found that severe chronic diarrhea may result in weight loss and permanent
physical and
mental developmental retardation. A non-limiting list of pathogenic bacteria
that the
sensor 60 may detect include any of the various pathogenic strains of
Fscherichia toll
(commonly known as E. Colt): Salmonella strains, including S. ryphi. S.
paratyphi. S
~o emeriditis. S. tvphimurium. and S. heidelberg; Shigella strains such as
Shigella sonnet.
Shigella ,>'<exneri. Shigella boydii_ and Shigella dvsenreriae: L'ibrio
cholerae:
Mycobacterium tuberculosis: 7~ersiniu enmrocolirica: .9eromonas hydrophila:
Plesiomonas shigelloides: Campvlobacter strains such as C. jejuni and C. coil:
Bac~eroides fragilis: and Clostridia strains. including C. sepricum. C.
perfringens. C
a borulinum. and C. di~cile. A non-limiting example of a commercially
available
biosensor adapted to detect E. colt is available from AndCare. lnc. of Durham.
NC. as test
kit r4001. As another non-limiting example. ABTECH. Scientific. Inc.. of
Yardley. PA
offers "bioanalvtical biotransducers'~. available as BB .Au-1050.5-FD-X. which
may be
rendered biospecific (for microorganisms or other target bioio~icai analwes as
described
:o herein) by covalently immobilizing polypeptides. enzymes. antibodies. or
DNA fragment
to their surfaces. Other suitable microbial biosensors are described in US
Patents
5.869.?7~' (gram negative organisms): 5.795.717 (Shigella): 5.830.341:
5.795.45 ~:
5.354.661: 5.783.399: 5.840.488: 5_827.651: 5.723.330: and 5_496.700.
The target analwes that the biosensors of the Dresent invention are adapted to
detect may also be viruses. 'These may include diarrhea-inducing viruses such
a~
rotavirus. or other viruses such ac rhinovirus and human immunodeficiencv
virus (HI\';.
An exempian~ biosensor adapted to detect H1V is described in US Patents
5.830.347 and
CA 02336025 2004-09-27
~,79~.4 ~~ , referenced above.
In alternative embodiments. the target analytes that the biosensors of the
present
invention are adapted to detect may also be parasites. especially those
v~~hich inhabit the
gastroimestinal tract during some poim in their life-cycle. Such parasites may
include
protozoans. worms. and other gastroimestinal parasites. Other examples of
parasite
which may be detected include enramoeha hisrolvrica (which cause amoebic
dvsenters- 1.
rrt~ae~a crm~i fwhich causes Chagas disease). and plasmodium foic yarum.
In ~-et other embodiments. the target analvtes the biosensors of the presern
io invention are adapted to detect ma~~ fungi such as Candida altiicnns. In
addition tn
pathogenic bacteria. certain beneficial colonic bacteria may be detected
and/or measured
as a health indicator. such as Bifdobacrerio and Lucrobacillus strains.
'The target analvtes that the biosensors of the present invention are adapted
to
detect may also be proteins or antigens related to skin distress- Preferably.
these analvte~.
n are detectable on or at the skin surface. preferably prior to the
presentation of clinically
obsewable skin irritation. These may include stress proteins such as
cvtokines. histamine.
and other immune response factors including interieukins isuch as IL-la. IL-2.
IL-3. IL-
4. and lL-8.) and interferons (including imerferons a and g). .Again, these
are preferable
detectable by the sensor 60 prior to the onset of clinically obsen~able
redness. irritation. o:
zc~ dermatitis. .Additionally_ the biosensors of the present invention may be
adapted to detect
enzymes. or other biological factors_ implicated in skin irritation te.g..
diaper dermatitis).
including tryspin. chymotrypsin_ and lipase.
The biosensors of the present invernion may also comprise bio-recognition
systems. including enzymes or bindin~ proteins such as antibodies immobilized
onto thr
surface of phvsico-chemical transducer. For example. a specific strain of
bacteria mas
be detected via biosensors emplovin~ antibodies raised against that bacterial
strain.
Alternatively. a target bacteria may be detected by a bio-recognition element
(includinc
antibodies and synthetic or natural molecular receptors) specific to
exuacellular product
of the target bacteria. such as toxins produced by that strain re.c.. E.
toll). )rxemplarl
CA 02336025 2004-09-27
l ,~y
enzyme electrodes that may be used to detect phenols (e.g. in unne or feces)
include
tvrosinase based electrodes or polvpnenol oxidase enzyme electrodes described
in L;'.S.
Patent ?~o. x_676.820 entitled "Remote Electrochemical Sensor.~~ issued to
Joseph Vvang
et al. on October 14, 1997 and U.S. Patent No. 5.091.299 entitled ".An Enzyme
Electrode
For L~se In Organic Solvents," issued to Anthony P. F. Turner et al. on
February ?~. 199=.
respectively.
In any of the foregoing examples. the specific microorganism may be directly
detected or may be detected by bindine a toxin_ enzyme. or other protein
produced by the
organism or an antibody, such as a monoclonal antibody. specific to the
organism.
m Exemplary biosensors adapted to detect proteolvtic enzymes are described in
US Patent
5.607.56 7 and toxins in L'S Patents 5.496.4 5?: 5.521.101; and 5.~67.~ 01.
Any of the sensors 60 of the present invention may comprise one or more
"proactive sensors'. This is especially useful in embodiments where the
detection of the
target biologically reactive analyte, health andior nutritional marker
precedes the onset of
clinically obsen~able health symptoms. ,4s used in this application_ the term
"proactive
sensor" refers to a sensor that is capable of detecting changes or signals on
the body of the
wearer l i.e._ skin j or in the waste. i.e.. inputs. that directly relate or.
at a minimum.
correlate to the occurrence of an impending or potential health or skin
related even.
Proactive sensors may respond to one or more specific inputs as described
above.
n .A proactive sensor 60 may detect an impending event or detect a parameter
that
directly relates_ or at a minimum correlates to the occurrence of an impending
event.
particularly a systemic or skin health event or condition (i.e.. the
preservation of clinically
obsen~able indications or symptoms). .An impending evem that may be detected
or
predicted by a proactive sensor 60 of the present invention may include early
stages of
lead poisoning. early stages of malnutrition and/or vitamin deficiency caused
by nutrient
malabsorption. diarrhea) disease. skin irritation or rash (including
candidiasis j. andior
other types of illness or medical conditions of the wearer such as a parasitic
infestation.
The detected trealth_ nutritional marker andior biological analwe may be one
or more
steps removed from the actual presentation of clinical symptoms. For example.
the sensor
CA 02336025 2000-12-22
WO 00/00233 PCT/US99/14665
may detect potential precursors to the above conditions (e.g., fecal
contamination of the
skin that may precede the elicitation of stress proteins which may, in turn,
precede
clinically observable skin irritation). A parameter that correlates to an
event is any
measurable input, signal such as one or more of the potential inputs listed
above, that
s correlates with the occurrence of the event within the frame of reference of
the system
(i.e., a signal caused by the waste or the wearer). Proactive sensors 60 in an
article may
measure one or more different inputs in order to predict an event. For
example, the
proactive sensor 60 may monitor for Candida albicans in the feces and residual
colonic
bacteria on the skin (i.e., detecting residual contamination) both of which
are signals that
~o may precede skin irritation.
In biosensor embodiments wherein the bio-recognition element does not produce
an easily visible signal (e.g., a color change), the sensor 60 may include a
transducer in
communication with the bio-recognition element in order to convert the physico
chemical
signal from the bio-recognition element into a usable signal to the wearer,
caretaker, or
i s component of the article (e.g., and actuator). Exemplary transducers may
include
electrochemical transducers (including potentiometric, amperometric, and
conductimetric
transducers), optical transducers (including flourescence, bioluminesence,
total internal
reflective resonance, and surface plasmon resonance), thermal transducers, and
acoustic
transducers, as known in the art. A power source, such as a miniature 3 volt
watch battery
~o or printed thin film lithium battery, may be connected with the sensor 60
to provide any
required power.
The effectiveness of the biosensors of the present invention may be measured
with
the Response Factor Test described in the Test Method section below. The
Response
Factor describes the ratio of the response of the biosensor when exposed to
fecal test
is material compared to the response of the biosensor when exposed to
physiological saline
solution and is useful in assessing the sensitivity of the biosensor for
biologically active
analytes expected to be found preferentially in feces versus urine. The
biosensors of the
present invention preferably have a response factor of at least 2, 3, or 5,
more preferably
at least 10, and even more preferably at least 20 when exposed to fecal test
material in
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26
aqueous solution or test urine having a concentration of I gram of fecal test
material per I
gram of physiological saline solution. (Physiological saline solution is used
here to
represent the background input signal which is present in most natural
environments such
as aqueous body fluids.) Such biosensors are able to clearly distinguish
between the
a presence of fecal material and the presence of physiological saline solution
with respect to
a target biologically active analyte specific to feces.
One way to detect feces is to detect skatole, a substance commonly found in
fecal
material. It has been found that the skatole concentration in feces is about
180 microgram
per gram of fecal material whereas the skatole level in urine has been found
to be
io substantially lower. Skatole is generally a product of microbiological
degradation that
originates from the catabolism of tryptophane in the intestinal system.
In one preferred embodiment of a skatole detecting biosensor, the biosensor
comprises genetically engineered microorganisms which assimilate skatole and
or other
substances. The assimilation of skatole specific substances can be measured,
for example,
~s via the oxygen consumption during the assimilation process. Microorganisms
suitable for
detecting skatole include Acinetobacter baumannii TOI36 (FERM P-12891,
Japanese
patent publication JP05304947), and Bacillus sp TOI41(FREM P-I2914, disclosed
in
Japanese patent publication JP05304948). Suitable biosensors including such
microorganisms are commercially available for example from Institut fur Chemo-
and
2o Biosensorik of Munster, Germany, under the designation Mikrobielle
Sensoren.
If microorganisms are incorporated into a biosensor, they may be immobilized
in
the biosensor by techniques known in the art such as entrapment, adsorption,
crosslinking,
encapsulation, covalent attachment, any combination thereof, or the like.
Further, the
immobilization can be carried out on many different substrates such as known
the art. In
~s certain preferred embodiments, the immobilization substrate may be selected
from the
group of polymer based materials, hydrogels, tissues, nonwoven materials,
woven
materials.
In certain embodiments, the sensor 60, including any biosensor embodiments,
may
comprise, be disposed on, or be operatively associated with a microchip, such
as a silicon
CA 02336025 2000-12-22
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27
chip, MEMs (i.e., micro electromechanical system) device. or an integrated
circuit.
Microchip-based biosensors may be known as "biochips". Regardless of the type
of
sensor, the microchip may comprise a multiplicity of sensor components having
similar or
different sensitivities, kinetics, and/or target analytes (i.e., markers) in
an array adapted to
> detect differing levels or combinations of said analyte(s). Further, each
sensor in such an
array may provide a different type of signal, including those types disclosed
herein, and
may be associated with different actuators and/or controllers. Also, each
sensor in an
array may operate independently or in association with (e.g., in parallel,
combination, or
series) any number of other sensors in the array.
~o Any of the sensors 60 of the present invention may be disposed in and/or
operatively connected to any portion of a disposable article that will be
exposed to the
input that the sensor is designed to detect. For the purposes of the present
invention, the
term "operatively connected" refers to a means of communication such that the
sensor 60
may signal some portion of the article 20 when the sensor 60 detects an input.
The sensor
i, 60 may be separate from and operatively connected to another portion of the
sensor 60,
another sensor 60, an actuator, a controller or some other portion or
component of the
article 20. "Operatively connected" may, for example, include a means of
communication
such as an electrical connection via a conductive wire or member, via a
transmitted signal
such as radio frequency, infrared or another transmitted frequency
communication.
2o Alternatively, the sensor 60 may be operatively connected via a mechanical
connection
such as a pneumatic or a hydraulic connection.
In disposable article embodiments (e.g., diaper 20 of Fig. 1 ), the sensor 60
may be
located in the front waist region 36, the rear waist region 38 or the crotch
region 37 of
article 20, and may be integral with, disposed adjacent to, joined to, or
comprise a portion
zs of the chassis 22, the topsheet 24, the backsheet 26, the absorbent core
28, side panels 30,
leg cuffs 32, a waist feature 34, a fastening system 40, the longitudinal 50
or end 52
edges, etc. In certain preferred embodiments wherein the target biological
analyte is
associated with bodily waste, the sensor 60 may be disposed in the crotch
region of the
article 20 so as to maximize the probability of the bodily waste contacting
the sensor 60.
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28
In other preferred embodiments wherein the sensor is adapted to detect or
measure a
target biological agent on the wearer's skin, the sensor 60 may be disposed on
the
topsheet, cuff, a waist feature, a feces receiving pocket, spacer, or any
other portion of the
article that will contact the wearer's skin during the usage process. In
certain
s embodiments, the sensor may also be associated with the lotion or other skin
care
composition within the article.
The sensor 60 may be integral with the article 20, or may be installed by the
caretaker or the wearer. The sensor during the course of wearing the article,
may also
become at least partially detached from the article and may be adhered to the
wearer's
lo skin. The sensor may be affixed, permanently or detachably (e.g., via a
mechanical
fastening system like VelcroT"' or a water soluble adhesive) to a support
structure,
including adhesive tapes, cellulosic or synthetic webs, nonwoven highlofts,
films, scrims,
foams, and the like. Further, the sensor 60 may be completely contained within
the article
such as article 20 or may have a receiving portion located in the article such
that it will
l s come into contact with the desired input and another portion such as a
transmitting
portion located either in the article or outside the article. The sensor 60
may be external
to the article 20 yet operatively connected to some portion of the article 20
such that the
sensor 60 may detect an input external to the article 20 and provide a signal
to a controller
and/or an actuator. In some embodiments, the sensor may be separate from the
article,
Zo e.g., separately applied to some portion of the wearer via adhesive or
other means as
known in the art, and/or may have one or more components separate from the
article.
In some embodiments, a wiping means or element may be provided to allow the
wearer or caretaker to clean sufficient bodily waste from the sensor 60 to
allow a visual
assessment or reading of the signal (especially for sensor embodiments that
provide such
zs a signal). The wiping element may include a web (cellulosic or synthetic),
nonwoven
highloft, film, foam, rigid or semi-rigid squeegee like element, and the like
disposed in
the article and adapted such that the element may be used to clean the sensor
display. The
wiping element may be at least partially affixed the to a component of the
article, such as
a topsheet, in proximity to the sensor 60 by any known means in the art. The
wiping
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29
means may optionally comprise water or any other known cleaning aid to
facilitate
cleaning of the wearer or the sensor display.
In certain preferred embodiments, the article 20 also may comprise an
actuator.
As used in this application, the term ''actuator" refers to a device that
comprises
s ''potential" and a means of transforming that potential to perform or
activate a "responsive
function." The potential of the actuator may comprise either stored or
potential energy or
stored material. The actuator thus may perform or activate a responsive
function by
transforming potential energy to kinetic energy or by releasing or delivering
a stored
material. A "responsive function" is defined for the purposes of the present
invention as a
io function performed upon the bodily waste, the wearer, the article, or a
component or
components thereof, or a signal to the wearer or the caretaker. A component of
bodily
waste may include, for example, moisture, electrolytes, enzymes, volatile
gases, bacteria,
blood, etc. A component of the wearer may also include skin, genitalia, the
anus, the anal
sphincter muscle, etc. A component of the article may also include leg cuffs,
waist cuffs
is or other waste barriers and/or containment components, side panels, ears, a
chassis, an
absorbent core, an acquisition component, a fastening system, the longitudinal
or end
edges, etc. Potential energy may be stored as mechanical, electrical, chemical
or thermal
energy. "Kinetic energy" as used in this application refers to the capacity to
do work or
to perform a responsive function as described above (e.g., expansion of a
compressed
zo device, rotation of a twisted device, a gel that moves as it changes
phases, coating or
treatment of skin or feces, inhibition of an enzyme, adjustment of pH, etc.).
Triggering the creation of a three dimensional structure to capture waste, for
example, involves responsive functions performed on a component of the article
and,
ultimately, on the waste. Capturing waste, wiping the skin of the wearer or
treating the
is skin with a skin care composition, antimicrobial agent, antifungal agent or
enzyme
inhibitor, for example, are responsive functions performed on the waste and/or
the wearer.
Adjusting the article's geometry (in one, two or three dimensions) or physical
properties
(e.g., bending modulus, geometry, etc.) are examples of responsive functions,
which may
be performed on the article. Signaling a caretaker and/or the wearer that an
event has
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occurred, or is about to occur, is also considered a responsive function for
the purposes of
the present invention. The signal may be visual, auditory, tactile,
electrical, chemical, or
biological. An actuator of a disposable article may, for example, release or
deliver a
deodorant, enzyme inhibitor, antimicrobial agent, antifungal agent, skin care
composition
s or pH control agent; capture, wipe, cover, trap, immobilize, seal, pump, or
store bodily
waste; or trigger the release or creation of a structure or element designed
to perform one
or more of these functions or any other responsive function upon the waste,
wearer,
article. or a component thereof.
The actuator of the present invention may release potential energy to perform
or
io activate a responsive function upon the waste, the wearer, the article, or
a component
thereof. The release of potential energy may transform mechanical, electrical,
chemical
or thermal potential energy into mechanical, electrical or chemical kinetic
energy to
perform the responsive function. Actuators may be triggered by a threshold
level of an
input to release potential energy to perform a responsive function or may
respond
~s continuously to an input as described below. For example, a compressed foam
has stored
compressive mechanical potential energy and may provide mechanical kinetic
energy
when it is released. A twisted foam has stored torsional mechanical potential
energy that
may provide mechanical kinetic energy, i.e., rotation, when it is released. In
addition,
stored chemical, electrical or thermal energy may be used to release
electrical,
Zo mechanical, chemical or thermal kinetic energy. The actuator of a
disposable article, for
example, may include one or more of the following: stored lotion, anti-fungal
or
antimicrobial agents, feces modification agents, enzyme inhibitors, pH
buffers, dyes,
pressurized gas, a compressed foam, a twisted foam, a pump, a closed system
liquid
transport member, an electrically sensitive gel, a pH sensitive gel, a salt
concentration gel,
zs etc. Potential energy may be stored in any manner sufficient to maintain or
restrain it
until it is required. Suitable means for maintaining and/or restraining such
energy include
batteries and/or capacitors, elastically, torsionally, compressively tensioned
materials or
structures in the form of unreacted reagents, and materials capable of
performing physical
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31
or chemical functions (e.g., absorbents, emollients, pH buffers, enzyme
inhibitors, feces
modification agents; compressed gases, etc.).
Alternatively, the actuator of the present invention may comprise a quantity
of a
stored material that has the capacity to perform or activate a responsive
function upon the
s waste, the wearer, the article, or any component or components thereof. In
one
embodiment, for example, the actuator may release or deliver a stored material
that
performs a responsive function. In this embodiment, the actuator may be
triggered by a
threshold level of an input to discontinuously release or deliver the stored
material at a
given time or may release or deliver the material continuously. The actuator
may, for
io example. include stored lotion, skin care compositions. antifungal or
antimicrobial agents,
feces nu~ditication agents, enzyme inhibitors, pH buffers, dyes, etc. In
certain preferred
embudimcnts, the material may be delivered by an actuator such as an expanding
resilient
material. a released high pressure gas, etc.
Figures 2 and 2A illustrate an actuator 90 comprising a compressed resilient
i s material 9.1. such as a foam, sealed under at least a partial vacuum
within a pressure
differentiation device 91. A pressure differentiation device, as used herein,
is any device
or structure that can maintain a resilient material in a compressed state
(e.g., can store
energy by providing a constraining pressure on the compressed resilient
material 94). A
"compressed state" is defined as the condition in which a material is
maintained at a
zo smaller volume than the material would have if unconstrained and under zero
applied
pressure. With respect to resilient materials, a compressed state may
generally be
achieved by applying a pressure to a surface of the material or via any other
means known
in the art. The pressure differentiation device may, for example, comprise a
vacuum
sealed bag or tensioned materials, such as elastic or inelastic bands or
strands, strips,
zs films, nonwoven, scrims, or foams, that constrain a resilient material.
Preferably, the
compression of the resilient material maintained by the pressure
differentiation device 91
may be at least partially reduced (i.e., the compressed resilient material 94
may at least
partially expand) via a trigger mechanism. A trigger mechanism is any element
or device,
such as a sensor, actuator, or combination thereof, that responds to an input
to effect the
CA 02336025 2004-09-27
equalization of pressure in the pressure differentiation device 91 and allow
the
compressed resiiiem material 94 to at least paniallv expand. Upon release of
the
compressed material. such as when a target biologically active analvte is
detected. the
compressed resilient material may expand and deliver the stored material. In
some
embodiments. it may be advantageous for the actuator to comprise a void space
96.
?he resilient material may comprise any resilient material. including but not
limited to. an EV.A foam such as the ones available from Foamex Corporation of
Eddvstone. Pennsylvania identified as SIF;210PP) or Aquazone 80A foam. or from
Sentinel Products Corporation of Hvannis. M.A idemified as MC1900 EVA <
lb/ft'. or a
m HIPS foam as described in United States Patent ~~o. 5.260.345 entitled
".Absorbent Foam
Materials For Aqueous Bodv Fluids and Absorbent Anicles ComaininQ Such
Materials"
issued to DesMarais et al. on November 9. 1993: United States Patent No.
5.387.207
entitled "Thin-Until-Vl%et Absorbent Foam Materials For Aqueous Bodv Fluids
And
Process For Making Same" issued to Dver et al. on February 7. 1995: and United
States
a~ Patent No. 5.625.222 entitled "Absorbent Foam Materials For Aqueous Fluids
Made
From high Internal Phase Emulsions Having Verv High Water-To-Oil Ratio" issued
to
DesMarais et al. on Julv 22. 1997.
In some embodiments of the present invemion. the pressure differentiation
device
t 91 may comprise a soluble bag. The soluble bag may be soluble in the
presence of one or
more different types of input. such as water. urine. fecal enzymes. a pH
level. etc.. and
may have physical andlor chemical characteristics le.g.. thickness) that may
be designed
to set a threshold level of that input requited to dissolve the bag. The
soluble bag may.
for example. comprise a plastic film that is soluble to water such as PVA
films supplied
TM
.. by Chris-Craft Industrial Products. Inc. of South Holland. IL as MONOSOL
M7031.
M7030. M8630. M85:4. or E6030 film. or H. B. Fuller Company of St. Paul. M1T~
as
HL 1636 or HL 1669-Vii. The film thickness. for example. may also be modified
to
provide a desired acavauon. The film used may. for example. also have a
thickness in the
range from about 0.0005 to about O.OOlS inches. .An HL 1636 film having a
thickness of
CA 02336025 2000-12-22
WO 00/00233 PCT/US99/14665
33
about 0.001 inches, for example, will activate with a moisture content of
about 0.049
grams per square inch.
The actuator may alternatively comprise an electrically sensitive gel.
Electrically
sensitive gels are polymeric gel networks that, when at least partially
swollen with water,
s change volume and/or geometry under the application of an electric current
or field. For
example, certain partially ionized polyacrylamide gels will undergo
anisotropic
contraction of about 50 % under weak electric fields (e.g.. 0.5 volts/cm) when
immersed
in acetone and water. Alternative electrically sensitive gels may undergo
electrically
induced bending in the presence of water and a surfactant or may undergo an
oscillating
~o wave motion when subjected to an oscillating electric field. It is believed
that local
shrinkage may be induced in a portion of the gel, e.g., one side of a gel
element, by
concentrating positively charged surfactant molecules on the negatively
charged gel
polymer in an electric field. Changing the intensity and/or the polarity of
the field
induces a movement in the gel as one side decreases in length (e.g., a gel
formed in a strip
~s may curl). Electrically sensitive gels may comprise variable geometries
such as
rectangular, circular, reticulated grid, etc. patterns in order to provide a
valve to release a
material, allow a bodily waste to flow through, prevent a bodily waste from
flowing
through, encapsulate a bodily waste, etc. as they change volume and/or
geometry. An
electrically sensitive gel formed in a strip, for example, may be bent to
provide an
zo available void space for when electrical activity in the external anal
sphincter muscle
predictive of defecation or urination is detected.
In Figures SA and SB, for example, a strip of electrically sensitive gel 494
is
shown in a circuit in which fecal moisture may bridge the contacts 485 and
allow current
to flow to the electrically sensitive gel either bending or straightening the
strip.
zs Alternatively, an electrically sensitive gel 594 formed in a reticulated
grid pattern 595,
such as shown in Figures 6A, 6B and 6C, may be electrically induced to swell
or shrink
when an imminent urination is detected to form a valve that allows and/or
prevents urine
flow to another portion of the article 20. Figure 6A, for example, shows a
circuit
including a reticulated grid pattern of an electrically sensitive gel. Figures
6B and 6C
CA 02336025 2004-09-27
;4
further show a microscopic view of the grid in a shruril: and in a swelled
confyuration.
respectively. An exemplary material is a »~eaklv cross-linked PAMPs gel
~polmacrylamido-2-methyl propane) sulphonic acidj. This type of gel may
perform
various functions such as applying or delivering a chemical feces treatment
agent. Other
exempian~ electrically sensitive gels are described in lJnited States Patent
!~o. ~.100.9~
issued to 7-anaka on March 3l _ 1990 and WO 920200.
Alternatively. pH sensitive gels or salt concentration sensitive gels that
changer volume andior geometn~ at specific pH or salt concentrations.
respectively. may
be used as an actuator of the present invention.
,u The actuator may be disposed in andlor operatively connected to any portion
of
disposahlc article that will allow the actuator to perform a responsive
function upon the
b~diiv waste. the wearer. the article. or a component thereof. In article 20,
for example.
the actuator may be located in the front waist region ~6. the rear waist
region 38 or the
crotch region 37 of article 20. and may be integral with_ disposed adjacent to
or joined to
n a component of the chassis ?2. the topsheet 24. the backsheet 26. the
absorbent core 28_
side panels 30. leg cuffs 3~'. a waist feature ~4. a fastening system 40. the
longitudinal ~0
or end ~2 edges. etc. The actuator may also be completely contained within the
article
such as article 20, may have a portion located in the article and a portion
located outside
the article ?0. or may be completely external to the anicie 20. An actuator or
a portion of
an actuator may be operatively connected to one or more sensors 60. one or
more
controllers 80. another portion of the actuator or another portion of the
article 20. Further.
the actuator may be integral with the article 20. or may be installed by the
caretaker or the
wearer.
The article 20 may also include a controliei. A "controller" is defined for
the
purposes of this application as a device that receives an inset from a sensor
and
determines if one or more actions are to be taken. The controi,c~ may receive
a sienal
from the sensor 60 and direct the actuator to perform a responsive function
upon the
bodily v~~aste. the wearer. the article or a componem thereof. Alternatively.
the actuator
may receive the signal directly from the sensor 60 and perform a responsive
function
CA 02336025 2000-12-22
WO 00/00233 PCT/US99/14665
upon the wearer, the waste, the article or a component thereof. The controller
may
include materials that undergo chemical or physical change, may be a chemical,
mechanical or electrical device that processes information from a sensor, etc.
The
biosensor 60 may include a transducer comprising a polylayer Langmuir-Blodgett
film, at
s least a portion of which may function as a controller, wherein one or more
layers includes
a bio-recognition element. Upon contact with water, Langmuir-Blodgett films
are known
to spontaneously reorganize, resulting in regions with more layers than the
original f lm
and other regions having fewer layers. This reorganization may expose the bio-
recognition element to the environment preferentially in the presence of
water, such as in
lo bodily waste, which may contain the target biological analyte. This may
reduce false
positives and/or extend the shelf life of the biosensor. Alternatively, an
electrical
controller that receives signals such as electrical potential from an
electrochemical sensor
may receive and monitor multiple electrical signals and may repeatedly trigger
the
actuator. The controller may be integral with the sensor component, integral
with the
l s actuator component, or a separate component of the system.
The controller may be disposed in and/or operatively connected to any portion
of a
disposable article that will allow the controller to receive a signal from the
sensor 60 and
to provide a signal to the actuator. In article 20, for example, the
controller may be
located in the front waist region 36, the rear waist region 38 or the crotch
region 37 of
~o article 20, and may be integral with, disposed adjacent to or joined to the
chassis 22, or a
component of the topsheet 24, the backsheet 26, the absorbent core 28, side
panels 30, leg
cuffs 32, a waist feature 34, a fastening system 40, the longitudinal 50 or
end 52 edges,
etc. The controller may be integral with the article 20, or may be installed
by the
caretaker or the wearer. The controller may be completely contained within the
article
~s such as article 20, may have a portion located in the article and a portion
located outside
the article, or may be located completely outside the article 20. The
controller or a
portion of a controller may be operatively connected to one or more sensors
60, one or
more actuators 90, another portion of the controller or another portion of the
article 20.
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36
The controller, for example, may receive a signal from the sensor 60 and
provide a signal
to the actuator, e.g., by a radio frequency (rfj transmission.
Although distinct structural elements may perform the sensor 60, actuator and
controller functions, the sensor 60, actuator and/or controller functions of
the present
s invention need not be performed by distinct structural elements. The sensor
60 and
controller functions, for example, may be performed by the same structural
element.
A ''responsive system"' is defined for the purposes of this application as a
system
that includes a sensor 60 and an actuator that acts upon the bodily waste, the
wearer, the
article, or a component or components thereof when the sensor 60 detects the
appropriate
io triggering input. Upon sensing a given input parameter, the actuator
effects the release of
stored energy or the release or delivery of stored material to perform a
responsive
function. For example, when a proactive sensor 60 including a transducer
detects an
impending event, the transducer provides a signal to the actuator effecting
the release of
stored energy. By detecting an input signal prior to the impending event, a
responsive
is system in the article may be triggered to prepare for the event or to
signal the caregiver or
the wearer of the impending event. This allows construction of articles in
which the
waste-management or treating technology is initially "hidden" or unobtrusive,
but which
is available at, or just before, the moment of need and/or in which the
article may provide
the caregiver or the wearer the opportunity to prepare for an event in advance
(e.g.,
2o administer a prohylactic treatment to the wearer in the event of detected
pathogenic
microorganisms or residual fecal contamination). Regardless of the specific
input, the
sensor 60 in these embodiments may trigger an actuator to perform an action on
the
article, the wearer or the environment to prepare for the occurrence of the
event or provide
a signal to the caregiver that the impending event is about to occur. If the
sensor 60
is comprises a sensing system, one actuator may be triggered by different
sensors and/or
signals, or different actuators may be triggered by different sensors and/or
signals.
Alternatively, one sensor and/or signal may trigger multiple actuators.
A responsive system may respond in either a "continuous" or a "discontinuous"
manner. As used in this application, a "continuous responsive system" refers
to a
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J7
responsive system in which the output is quantitatively dependent upon the
quantity of the
input, i.e., continuously increasing quantities of the input are required to
effect
continuously increasing quantities of the output, or where the output of the
responsive
system comprises a passive release of a stored material. A super absorbent
polymer
s placed in an absorbent core of an article, for example, provides a
continuous response in
which the output is quantitatively dependent upon the quantity of the input,
i.e., as
increasing quantities of liquid waste contact the super absorbent polymer, an
increasing
amount of the polymer contains that liquid until the capacity of the polymer
is exhausted.
A stoichiometric chemical reaction is another example of a system having a
continuous
io response to increasing output. In the reaction A + excess B -~ C, for
example, the
amount of excess B converted to C is stoichiometrically and, therefore
"continuously,"
related to the amount of A available in the system.
A ''discontinuous responsive system" of the present invention, however, refers
to a
responsive system that has an output function that is essentially independent
of the
i s quantity of the input beyond a threshold level. For example, when one or
more threshold
levels of a given input are met, the responsive system may release all or a
pre-designated
portion of its stored energy or deliver, i.e., actively transport, all or a
pre-designated
portion of its stored material to perform a specific responsive function. In
an ideal
embodiment of the present invention, the output function, f(x), includes a
"step" function
Zo as shown in Figure 3A. In this embodiment, the rate of change in the output
with
increasing levels of input (d(output)/d(input)), i.e., the slope or first
derivative f (x) of the
output function f(x), is preferably essentially zero when the amount of input
is above or
below the threshold level. At the threshold level, however, the d(output)/
d(input) rate of
change preferably approaches infinity. Thus, in the ideal discontinuous
response, the
is limit of the function f(x-s) as E-->0 is not equal to the limit of the
function f(x+e) as e-~0,
i.e., lim f(x-s) ~ lim f(x+E).
s~0 E-~0
The present invention, however, recognizes that in the physical world an ideal
instantaneous step change at the threshold level is not necessary and may not
even be
CA 02336025 2000-12-22
WO 00/00233 PCT/US99/14665
38
possible in many instances. In a preferred embodiment, it is only necessary
that the
output function have a virtual step change with very little change in the
input at or around
the threshold level of the input. Thus, the present invention contemplates a
discontinuous
responsive system of the present invention having an output function that
responds in a
s sufficiently discontinuous manner in the transition region such that the
output function
has at least a minimum relative degree of steepness in the transition region.
While not
wishing to be limited to a particular method of describing or modeling a
discontinuous
system, in a preferred method of determining whether a given output function
performs in
a sufficiently discontinuous manner as defined for the purposes of the present
invention,
io the slope of the output curve at the inflection point is compared with the
relative slope of
a Iine between the first and last points of the transition region. For
example, Figure 4A
shows a graph of an exemplary output function, f(x) along with aligned graphs
of the first,
f (x), and second, f '(x), and third, f"(x), derivatives of the exemplary
output function.
The output function f(x) describes the effect of the in put (x or I) on the
output or
is response (R(I)). For purposes of the present invention, the transition
region is defined as
the region between the relative maxima, R(I,), and the minima, R(I,), of the
second
derivative, f '(x), of the output function, f(x). The relative maxima, R(I,),
and the relative
minima, R(I,), are points at which the third derivative, f- "(x), equals zero.
The inflection
point, Io, is defined as the point in the transition region at which the
second derivative,
zo f '(x), equals zero, i.e.,
d'-R
- 0.
dI2 ~ I=Io
The comparison of the slope of the output function at the inflection point to
the slope of a
zs line between the first and the last points of the transition region can be
described by the
equation:
dR ~ ( ORT)
- ~ - k
dI ~ I=Io ( SIT )
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WO 00/00233 PCT/US99/14665
39
In this equation dR/dI at the inflection point is the first derivative of the
output function at
that point. The term DIT is the change in the input to the responsive system
between the
first, I,, and last, I,, points of the transition region, i.e., I, - I,, and
the term 0 RT is the
change in the response of the output function between the first and last
points of the
s transition region, i.e., R(I,) - R(I,). The coefficient k is a proportional
constant that
describes the relative steepness of the slope of the output function at the
inflection point,
Io, compared to the slope of.a line between the first and last points of the
transition region.
In order that the responsive system have a discontinuous output function, the
proportional
constant k must be at least about 2.0, preferably at least about 3.0, more
preferably at least
lo about ~.0, even more preferably at least about 10.0, with at least about
100.0 being the
most preferred.
In certain embodiments, the relative degree of steepness in the transition
region of
a discontinuous responsive system may also be modeled by a transfer function
of a
control system having a series of an integer number, n, first order lags with
an equal time
is constant. The transfer function of the responsive system is defined for the
purposes of the
present invention as the ratio of the Laplace transforms of the output
(responding
variable) to the input (disturbing variable). See, e.g., Robert H. Perry & Don
Green,
Perry's Chemical Engineers' Handbook, Sixth Ed., Chap. 22 (MeGraw Hill, Inc.
1984).
As shown in Figure 4B, the relative degree of steepness of an output function
may be
?o approximated by the formula: KG(s) = K/(Ts + 1 )" in which KG(s) is the
transfer
function, K is a proportional element, T is the time constant of the system,
and n is the
integer number of first order time lags. In this model, as the number n
increases, the
steepness of the output function in the transition region increases, and the
model begins to
approximate a discontinuous responsive system. Certain discontinuous
responsive
zs systems of the present invention preferably may be modeled by the above
formula when n
is greater than or equal to about 25, with n being greater than or equal to
about 50 being
more preferred, and n being greater than or equal to about 100 being the most
preferred.
As shown in Figure 3A, a responsive system of the present invention may
include
a single threshold level at which the responsive system may release all of its
stored energy
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WO 00/00233 PCT/US99/14665
to perform a specific responsive function or may include multiple threshold
levels at
which the system may release a pre-designated portion of its stored energy to
perform one
or more specific responsive functions at each of the threshold levels. In an
embodiment
having a single threshold level, for example, the responsive system may
release all of its
s stored energy to perform the entire responsive function when that threshold
level is met.
In such a single threshold embodiment. In this example, the discontinuous
responsive
system includes a system that has two states such as on or off. When a
threshold quantity
of an input such as a target biological material is present in the absorbent
article, the
responsive system may perform a single responsive function upon the waste, the
wearer,
io the article or a component thereof, such as enveloping the waste away from
the skin of the
user or providing an easily detectable visual signal to the wearer or
caregiver. Thus, the
discontinuous responsive system may perform a one-time "switch-like" function
that
changes from one state to another in the presence of a threshold level of an
input.
Alternatively, as shown in Figure 3B, the responsive system may have multiple
~ s threshold levels at which when each threshold level is met the system may
release a given
"quanta" of energy or deliver a given quantity of material to perform a
specific responsive
function. In this embodiment, when each threshold level is met, a portion of
the entire
responsive function may be performed and/or different independent responsive
functions
may be performed in response to different threshold levels being met. For
example, a
zo responsive system may monitor a fecal enzyme and when each threshold enzyme
level is
met may deliver an equal or unequal quantity of enzyme inhibitors) or lotion,
or deliver a
pH buffer at the first threshold level and perform another responsive function
such as
delivering a quantity of enzyme inhibitor(sj at the second threshold level. In
each
transition region, the responsive system responds essentially the same as the
transition
zs region in the single threshold embodiment described above.
In addition, a responsive system may monitor multiple inputs such as one or
more
pathogenic bacteria and/or one or more fecal enzymes and perform one or more
responsive functions when the threshold levels of the different inputs are met
or may
perform one responsive function only when two or more of the threshold levels
of the
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41
different inputs are met. Thus, a controller may monitor multiple different
inputs and
perform a different responsive function when the threshold level of the
different inputs are
met. Alternatively, the controller may perform a logic OR-gate type function
such that a
responsive function may be performed when one or more threshold levels of the
multiple
s inputs are met. The controller may also perform a logic AND-gate type
function such that
a responsive function may be performed when each threshold level of two or
more
different inputs is met.
The responsive system may also comprise a ''closed loop" or an "open loop"
system. A "closed loop" system, which is also referred to as a ''feedback
control loop"
~o system, includes distinct sensor 60 and actuator components and performs a
responsive
function upon the input. In some preferred embodiments, the system may also
use a
detection or a measurement of an element or a parameter of the output
condition as at
least one trigger of the responsive function that is performed upon the input.
The output
condition may be the state of the input condition after the actuator has had
the opportunity
is to perform a responsive function on the input condition. The responsive
function may be
performed when the output condition reaches a threshold level, or may be
performed only
when the output condition and one or more other conditions are met. Acting
upon the
input may include acting upon the element sensed, e.g., sensing a
microorganism and
acting upon the microorganism, or may include acting upon a composition of
which the
zo element sensed is an integral component, e.g., sensing a fecal bacteria and
acting upon the
fecal mass or residual feces on the wearer's skin As described above, a
feedback control
loop system includes at least two distinct components: the sensor 60 and the
actuator.
The sensor 60 detects an event, or a parameter associated with that event. The
actuator
receives a signal and performs a responsive function on the input condition
detected by
~s the sensor 60. The feedback control loop may further include a controller.
In this case,
the sensor 60 may provide a signal to the controller, and the controller may
direct the
actuator to perform a responsive function upon the input condition. The
controller may
be a separate component of the responsive system or the controller function
may be
performed by the sensor 60 and/or the actuator.
CA 02336025 2004-09-27
4~
The feedback control loop may be "non-modulating~~ or "moduiatine." In a "non-
modulating" feedback control loop responsive system the responsive system acts
as a one-
time switch in which the actuator performs a responsive function on the input
when the
threshold level of the output condition is met. For example. the sensor 60 may
detect the
presence of or measure the concentration of a specific pathogenic
microorganism. and the
actuator may signal the caretaker of a potential incipient infection. In this
example. the
actuator acts upon the input detected by the sensor 60. A "modulating"
feedback control
loop. howsoever. includes a sensor 60. an actuator and a controller. In a
modulating
feedback control loop. the output condition is monitored constantly or
repeatedly, and the
n, controller directs the actuator to perform a responsive function on the
input in order to
maimain the output condition at a desired set point or within a desired range
or to provide
a continuous measurement of the level or concentration of the target
biological analvte.
.An "open loop" system, however, is a system that responds to the input to
perform
a responsive function without using feedback. i.e.. the output has no effect
upon the
sensed input entering the system. An open loop system may include a responsive
system
that has a single device that performs the functions of both the sensor 6U and
the actuator
or may have distinct sensor 60 and actuator components in v~~hich the actuator
acts upon
something other than the input. A super absorbent polymer placed in an
absorbent core of
a disposable absorbent anicle. for example. provides an open loop response
because the
~c~ polymer only includes a single device that performs the functions of the
sensor 60 and
actuator. Alternatively, an open loop responsive system may include a sensor
60 that
detects bodily waste or a component of that bodily waste, and an actuator that
performs a
responsive function in a continuous or a discontinuous manner on something
other than
the input detected by sensor 60.
Other responsive systems are described in Lnited States Patem
Nos. 6,160,198; 6,093,869 and 6,186,991.
CA 02336025 2004-09-27
4.
An example of a diaper 20 of the presern invention may include a responsive
system that includes a sensor 60 as shov~m in Figure 1 and an actuator as
shown in Figure
''. In this embodiment. the sensor 60 may comprise a transducer operatively
associated
with a hio-recognition element adapted to detect F. coli in feces. Upon the
specific
detection of a threshold level of F. coli by the bio-recognition element. the
transducer
signals the actuator with an electrical current. The article shown in FiQUre 1
may include
an actuator that comprises a compressed resilient material 94 vacuum sealed
under a
m water wluhle film 9i. as shown in Figure 2 (e.g.. a PVA film). Upon receipt
of the
proper signal from the censor. the actuator may close a switch. for example
may release a
smell amount of stored water to contact and dissolve the water soluble film
9l. This
result, in the release of the stored mechanical energy in the compressed foam.
The
rrsilimt mamrial 94 expands and forms a spacer to provide void volume for the
incipient
i= fccrs. .llmmativelv. the switch closure may additionally release an
antimicrobial to
cuntn~l the F. coli andior a visible dye to signal the F. coJi presence to the
clearer or
carct~km. In another embodiment_ the responsive wstem may include an actuator
that
alms thr caretaker or the wearer of an impending event such as a diarrheal
infection or a
skin irritation (e.g.. candidiasis).
~c~ In an alternative embodiment. the present invention may comprise a partial
body
covering such as a hand covering which can detect and alert the user to
specific biological
conditions. The hand cover can partially or wholly cover the hand or any other
pan of the
body. Preferably. the sensor is generally located at or near at least a
portion of the
exterior surface. Example forms of handcovers include but are not limited to
finger cots.
_. gloves. mittens and hand v~~aps. Preferably. such body coverings are
disposable. Such
coverings may be used for medical care and assessment. zoological and
veternarian care
and assessment. agricultural tasks associated v~~ith plant or livestock
products. food
preparation and handling both commercially and in-home either for intended
consumption
b~ humans or other iivinp creatures.
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WO 00/00233 PCT/US99/14665
44
In yet another embodiment, the present invention may comprise a food handling,
storage or preparation article used in connection with foodstuffs intended for
consumption
by humans or other living creatures which can detect and alert the user to
specific
biological conditions. Preferably, such articles are disposable. Preferably,
the sensor is
s generally located at or near a surface portion expected to come into
proximate location or
contact with a foodstuff. The articles may be used either in the handling of
raw foodstuffs
at various stages of handling or preparation, or in conjunction with a fully
prepared
foodstuff. Such articles may include food preparation mates, covers and
sheets, either
rigid or flexible; food storage materials such as rigid containers, linings
for rigid
~o containers or surfaces, food storage wrappers preferably made from flexible
materials;
and, food serving articles such as trays, plates, platters, bowls, food
wrappers, and sheets,
both rigid and flexible, acting in a manner as a surrogate plate.
Test Method
~s Response Factor Test:
With the Response Factor Test as described hereafter, the response of a
quantitative sensor as a reaction to exposure to a specific substance or
composition can be
measured.
The specific substances or compositions for which this test is suitable
include:
zo fecal test material in aqueous solution having a concentration of 1 gram of
fecal test
material per 1 gram of physiological saline solution;
fecal test material in test urine solution having a concentration of 1 gram of
fecal material
per 1 gram of test urine solution;
test urine solution;
zs a solution of skatole in physiological saline solution having a
concentration of 180
micrograms of skatole per gram of physiological saline solution; and
physiological saline solution.
All measurements are carried at body temperature (37° Celsius). The
method
includes the following steps in the following order:
CA 02336025 2004-09-27
4~
]'l Record quantitative response of the sensor after exposure to nhvsioio~ical
saline solution for 24 hours. The background response is the maximum
recorded response.
Expose the sensor to specified substance or composition.
3) Record quantitative response of the sensor while sensor is still exposed to
the specified substance or composition for 24 hours. Substance response is
the maximum recorded response.
The Response Factor is obtained by normaii2ing the substance response with the
background response. In case. the Response Factor is smaller than 1. the
reciprocal value
of the Response Factor is reported as the Response Factor.
Vvhile particular embodiments and/or individual features of the present
invention
have been illustrated and described. it would be obvious to those skilled in
the an that
various other changes and modifications can be made v~~ithout departing from
the spirit
and scope of the invention. For example. although the present invention is
illustrated and
described primarily with respect to a disposable diaper. the present invention
is not
limited to this embodiment. The present invention may also be used. for
example. in
articles that are applied directly to a wearer (e.g.. to the perianal or
perineal regions of the
wearer) prior to the application of a disposable diaper or in place of a
disposable diaper. in
a pull-on diaper. a diaper insert. a sanitary napkin. a tampon. etc. Further,
it should be
apparent that all combinations of such embodiments and features are possible
and can
result in preferred executions of the invention. Therefore. the appended
claims are
intended to cover. It is therefore intended to cover in the appended claims
all such
changes and modifications that are within the scope of this invention.
