Note: Descriptions are shown in the official language in which they were submitted.
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This application is a division of serial number 423,333,
filed March 10, 1983.
Background and Summaxy
While collection bags for incontinent patients are
known in the art, such devices have no~ been free of seriou
- shortcomings~ One major problem concerns the formation of
an effective external seal about the rectum, various types
of adhesive rings have been di~closed but no singl~ design
is known for its ease of application and remo~al, freedom
from leakag~ and unintentional d~tachment, and adaptabilit~,
conformabllity, and comfort in use. Patents 3,577,9~9 and
2,491,799 disclose collection bags which are strapped to
patients. The manipulation of such straps during attachment
and detachment/ and the need to move or repositio~ a patient
: during such operations, complicates ~he use of such devices
and increases patient inconvenience and discomfort~ Devices
with adhesive~coated att~chment rings, such as disclosed in
3,577,989, 3,734,096, 3,522,807; 3,952,336, and 3~29~,626
are also difficult to af~ix, at le~st if an effec~ive seal is
to be formed, because of the varying contours, and the
stretchability, contractability, and softnessJ of the perianal
surfaces. Making adequate sealing contact is only one problem;
maintaining such contact is another. If the adhesive used to
xetain such colle5tors is aggres5ive enough to 2revent
accidental detachment, such collec~ors may be relatively
dificult to remove without causing patie~t discomfort.
Conversely, if a less aggressi~e adhesive is used ko ~acilitate
in~entional removal, ~he posslbilities of acciden~al de~achmen~
are incxeased~ In addition, con~entional bags are frequently
dimensioned and shaped to have inadequate collection capacity
or, i of sufflcien~ ~ize, to become twisted and kinked in use,
or become wrapped about the leg of a bedridden .patient,
thereby increasing patient discom~ort and the likelihood of
accidental detachment.
~l~
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It is therefore an object of this invention to
provide an improved fecal collector which i~ accommodated
comfoxtably between ~he legs of a bedridden patient, has
relatively large capacity when considered in terms of its
length and collapsed dimensions, and has a highly effec~ive
attachment ring that is relatively easy to secure in place
and, because of its configuration, conformabilityr and
stretchability, is more likely to remaln adhered throughout
its intended period of use without causing pain or discomfor~
when intentional removal is under~aken. Another object is to
provide a fecal collec or having an adhesive-coated attachment
ring that is extendable and contractable, thereby reducing
shear forces on the adhe.~ive during body movements and
producing more uniform distribution of forces on the attachment
ring and bag, all with the result that a more affective ~ealing
engagement may be achieved while at the same time utilizing an
adhesive thatisnotunacceptably aggressive. Other features of
the bag, such as the location of the attachment riny and its
ang~lar relationship to the rest of the bag, the provision
of a protected vent to prevent gas buildup, and the pleated
construction of the bag, all contribute, along with the
extensibility and flexibility of the attachment ring, in
preventing concentration of forces in the areas of adhesive
attachment that might result in unintended detachment or leakage
of the appliance~
The adhesive-coated attachment ring is formed of a
soft, pliable, and stretchable closed-cell thermoplastic
foam. In an undeformed state, the ring is generally flat and
circ~lar in outline with inner and outer margins that are
non-concentric. The adhesive-coated surface has four
conc~ntrically-arranged portions, namely, a perineal surface
portion intended to seal against the perineal area, a
coccygeal surface portion, and a pair of relatively large
lateral surface portions. All four portions are covered by
individually-removable release sheet sections. Sequential
removal of such sheets or sheet sections to dispose the
respective adhesive-coated surface por~ions, starting with
the p~rineal por~ion, ~hen ~he coccygeal portion, and finally
the lateral portions, greatly facilitates complete and
effective adhesive attachment of the ring to a patient.
The bag is formed from a single shee~ of odor-
barrier film folded upon itself with the folded panels then
heat-sealed to each other along their free edges. The
a~tachment xing, or at least a liner for that ring, may be
heat sealed to the sheet prior to the sealing of the edges
of the side panels to form the finished bag. The capacity of
the enlongated bag i5 significantly increased, without
increasing the total length of the bag, by pleati~g at least
one of the slde panels prior ~o the final marginal heat
sealing operation~
The bag includes bo~h a vent for the escape o
gases and a passage for the insertion of a thermometer or
other instrument into the interior of the bag and into direct
contact with a patient. It has been found that the passage
and vent may be easily and effe~ti~ely formed hy providing
each side panel o the bag with a flap or tab portion, then
folding such flap portions reversely inwardly into con~iguous
relation to form a pair of adjacent pocke~s when the panels
are finally heat sealed together and, just before the heat
sealing operation, inserting a resilient foam paa into at
least one o the pockets. The self~closing passagP leading
into the interiox of the fini~hed bag extends between the
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contiguous infolded flaps of the pockets. The vent for the
escape o gases takes the form of one or more pinhol~s formed
in the wall of a pocket containing the foam pad.
Other features, objects, and advantages of the
invention will become apparent rom the specification and
drawings.
Drawings
~ igure 1 is a perspective view of a fecal collector
embodying the invention.
Figure 2 is a perspective view of the collector
showing (in solid lines) the relationship between the side
panels of the bag prior to marginal heat sealing and ( in
broken lines) the relationship between the bag material
.~ and the attachment ring at the time such parts are joined
together .
Figure 3 is an enlarged fragmentary sectional
view taken alon~ line 3-3 of Figure 1.
~igure 4 is a side elevational vlew of the collec~or.
Figure 5 .is a sectiona~ view taken along line 5-5
of Figure 4.
:
Figure 6 i5 aa~ enlarged fragmentary sect:ional view
take~ alor~g lin~ 6-6 of Figure 4.
.
i~ Figure 7 is an enlargi3d sectional view taken along
~'~
line 7-7 of Figure 4.
Figure B as a sectional viaw similar to Figure 7
but illustrating use of the p~ssage for the ins~3rtio~ of a
thermometer .
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Figuxe 9 is an exploded fragmentary perspective
view of the attachment ring and release sheets ~howing the
ralationship between 5uch el men~s.
Figures 10-12 are a serles of simplified arld
omewhat schematic views illustrating ~he sequence of ~teps
for properly securing the attachment ring ~o a patien~.
Det a i 1 ed De scr ipt i on
Referring to the drawings, the numeral 10 ger~erally
d~signates a fecal collector in the form of a collectioII bag
10 11 ha~ing an attachment ring 12. In the preferred em~odimer~
depicted, the bag is formed essentially fxom a single sheet
o~ odor-barrler thexmopla~tic f ilm folded alor~g ttertical
midline 13 to provide a pair of contiguous side panels 14 and
15 ~Figure 2 ) O The panels are heat sealed together along
their upper, lower~ and distal edges lla, llb, and llCt
respectively~ Just prior to such heat sealing, one or both
o~ the panels may be pleated or olded along generally vertical
lines, as shown at 16, to increase the capacity of the bag
without adding o its length.
It will be noted Prom Figure 2 that each of the
lower edges llb of the side panels i5 contoured to def in~ a
depending tab or fïap 17, 18. Prior to heat sealing of the
pan~ls, the flaps 17 and 18 ar~ folded upwardly and inwardly
to defin~ pockets 17a and 18a, respectively. A foam pad 19
is inserted into one (or both) or~ the pockets 18a and, durin~
a f inal heat sealing operation, the pan~ls and f laps ar~ heat
sealed together along spaced paxallel lines 20 and 21 to
d~fine a normally-closed passage 22 (Figures 6-8) between the
opposed f lap5 17 and 1 8 of the Ee~pective paneis . Venting
rneans, in the form of or~e or mor~ pinholes 2 3, are formed in
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~he wall o~ the pocket 18a that xetains the resilient foam
pad 19. The pad performs ~he functions of restraining the
outflow of liquids and solids through vent 23 without at the
same time preventing the escape of gases, and of exerting a
: ge~tle orce against flap 18 to maintain passage 22 in closed
condition when not in use (Figures 6, 7). To the extent that
the excretory contents of the bag may enter and expand pockets
17a and 18a, the walls of pascage 22 tend to be sealed even more
tightly in use~ ~owever, should access to the rec~al area beeome
lo necessary for purposes of insertinq a thermometer T or other
medical instrument, such a procedure may be carried out without
de~ac~ing the collector from the patient simply by inserting the
instrument through passage 22 (Figure 8) and into contact with
the wearer.
The attachment xing 12 is formed essentially of soft,
flexible, and stretchable closed-cell thermoplastic foam having
normal planar opposite surfaces 26 and 27 (Figure 3) and pre-
ferably having generally circular out~r and inner ~argins,
respectively. A closed-cell foam of polyethylene ha~ing a thick
; 20 ness within the general range of 2 to 10 millimeters (preferably
about 3 millimeters) has been found particularly effective, other
thermoplastic foam materials such as polyurethane, or other
suitable plastic sheet materials having the described propertie~
of such foams (i~e., softness, pliability, stretchability, and
contractability) migh~ be usedO
`. Surface 26 of foam ring 12 is coated with a layer
of pressure-sensitive and water-resistant medically-approved
adhesive. The tacky adhesive coating is in turn covered by
removable release sheets as will be described in detall
hereinater, The inner mar~in 29 of the foam xing 12 define~
a generally circular aperture 30 that is substantially the
same size~ and is directly aligned with, opening 31 in one
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end of the elongated plastic bag 11~ The bag and ring may
bP permanently secured together along the inner margin of the
ring in any suitable manner~ Since the bag and ring are both
formed of thermoplastic material, the two may be heat sealed
together along the inne~ margin of the ring. However, to
a~oid deformation of the foam that might occur during heat
sealing, ik is believed preferable ta adhesively secure the
~ag to the ring as indicated in Figure 3. Such adhesive
attachment is facilitated i a thermoplastic annular liner 32
o is first heat sealed to the bag along a heat seal zone 32a
extending about opening 31. Thereafter, the ou~er surface of
the annular liner is adhesively bonded to the foam ring 12.
While the inner and outer margins 29 and 28 of the
foam attachment ring 12 are preferably circular, they are
not concentric. Specifically, inner margin 29 is displaced
upwardly as ~iewed in Figures 1 and 9, or anteriorly in
relation to a patient wearing the collection device. The
adhesive-covered face 26 of the ring therefore has surface
portions of different sizes or areas disposed about aperture 30
Four such portions are depicted in ~igure 9 as demareated by
vertical phantom lines along face 26. A relatively small
perineal zone or portion 26a is located at the upper margin
of the ring, such portion having a maximum radial width
subs~antially less than the minimum radial width of the
diametrically-disposed coccygeal portion or zone 26b. A
pair o lateral portions or zones 26c extend between the perineal
and lower coccygeal por~ions 26a and 26b and, as depicted in
~igure 9, have circum~erential or angular dimensions sub-
stantially greater than either of the perineal and coccygeal
portions.
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~77~7
~ removahle protec~ive coverirlg 3~ extends over the
adh~sive-coated surface of the foam xing 12. The coveril~g
may he foxmed of paper, suitably coated with a relea e layer
to permit the covering to be peeled away from the adhPsive
~oating of the rin~. A polyethylene coating on th@ paper,
to which a silicone coating is applied O has been fotlnd
efective, but other coat.ing materials such as waxes may be
used. As illustrated in Figure 9, the covering has an overall
~hape and size conformirag with surface 26 of foam ring 12 and
0 i5 composed of our individually removable sectio~s or portions,
namely, a perineal section 34a csvering perineal portiosl 26a
of the ring, a coccygeal section 34b over ring E~ortion 25b,
and a pair of la~eral sect ion~ 34c over portions 26c o:f ~he
foam ring. In the embodiment depicted in the drawings, such
sec:tions of the release sheet or covering 34 are defined by
lines of perforation 35 that coincide with the phantorn lirles
shown on ring 12 in ~igure 9, and the sheet 34 is readily torn
along those li~les of perfora~is~ to permit indi~7idual and
sequerlti~l removal of sections 34a-3~c; however, it is to be
20 understood that instead of having perforation line~ 35
detachably connecting the several sections of the release
sheet, those sec~ions may be ::ompletely separated from each
other so that no tearing apart is required at the time of
sequential removal.
The individually-removable s~ctions 34a~34c o~
the release sheet, and the particular areas or zones of the
adhesive-coated ring sur~ace 26 which they cover, gr~akly
facilitate e~ective attachment o the foam ring to a patientO
In such an attachment proc~dure, the perineal section 34a is
~irst r~moved to expose the a~he~iv~-coated pe~ineal ~ur~ace
portion 26a of th~ ring, and that portion is pressed into
~ ~ ~ ~a ~
: firm contac~ with thq perineal. area 40 of patien~ P as
: somewha~ ~chematically depic~ed in Figure 10~ During
adhesive attachment of the perineal portion 26a of the
ring to the perin~um cf the patien~, by pressure applied iA
the direction of arrow 41, the pliable ring 12 becomes
deformed or wedged between the patient's buttocks 42. The
coccygeal sheet section 34b is then stripped from ~he ring
(alternatively, it may have been xemoved from the ring at
the time that perineal sectlon 34a was removed) and the
o exposed adhesive-covered surfaoe of csccygeal ring por~ion 26b
is pressed into contact with the patient's coccygeal area
(Figure 11). It is only after the perineal a~d coccygaal
`. portions 26a and 26b are firmly secured to the patient, with
th~ ring folded between the buttocks as shown in Figure 11,
that one of the lateral sections 34c is removed to permit
on~ of the side portions 26c of the ring to become adhesively
sealed to the patient. The proceduxe is then repeated by
;~ removing the other lateral section 34c of the release sheet
and pressing the other adhesive-covered portion 2Sc of the
ring into sealing contact with the patient (Figur~ 12). The
collection device is thus compLetely and adhesively sealed
to the patient in the perianal area.
The collection bag may be ormed of any suitable
thermoplastic film or ilm laminate. ~or example~ 1exible
walls of ~he bag may be formed o a polyolefin f.ilm lamina~ed
: with an appropriate gas barrier film. A particulaxly
suitable commercial material compri~es low density polyethylen~
coextru~ed with a coextensive layer or core of polyvinylidene
chloride, but any of a wide variety of other materials may
be employed.
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While in the foregoing I ha~re disclosed an
embodiment o the invention in considerable detail :or
purposes of illustration, it will be undç~rstood by those
skilled in the art that many o:~ these details may b2
varied without departing from the ~pirit and scope of
the in~ention.
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