Note: Descriptions are shown in the official language in which they were submitted.
Background of the Invention
This invention relates to medical drainage pouches,
and, more particularly, to an improved sealing assembly for
such drainage pouches, which include surgical pouches for stoma
or wound drainage, fecal collectors, enema bags, urostomy bags,
etc.
Certain surgery, such as abdominal surgery known as
colostomy, ileostomy, ureterostomy and the like, results in an
opening, for example, in the abdominal wall, which permits
1~ drainage from the interior of a body cavity. The patient cannot
control the drainage, and therefore a surgical drainage appliance
in the form of a pouch or bag is used to contain the drainage.
United States Patent Nos. 3,302,647 and 3,822,704 dis-
close prior art surgical drainage pouches, as used particularly
for stoma or wound drainage. Each of these pouches includes a
plastic bag for containing the fluid which is drained from the
body and a relatively rigid plastic retainer xing which is heat-
sealed to the bag around the drainage opening in the bag. The
..
; drainage pouch described in Patent No. 3,302,647 includes a
20 sealing pad or ring formed from a mixture of karaya powder and
glycerol. The drainage pouch described in Patent No. 3,822,704
includes an adhesive patch which is secured to the relatively
rigid retaining ring. A release paper covers the adhesive sur-
face of the adhesive patch, and when the release paper is removed,
the adhesive patch can be adhesively secured to the patient's body.
Current commercial surgical drainage pouches are similar
to the pouch descrihed in Patent No. 3,822,704. The adhesive patch
.i ~
~,
.,"~ '
ii6~
i. .ormed froM a nonporous surgical adhesive tape. This tape
may comprise a backing sheet of nonporous polyethylene coated
with a layer oE pressure-sensitive adhesive. The relatively
rigid retainer ring can be formed of poly~thylene, and the
adhesive patch secured to the retainer ring by 'neat~sealing the
polyethylene backing of the adhesive patch to the polyethylene
retainer ring. ~lternatively, the nonporous adhesive patch can
be heat-sealed directly to the pouch around the opening.
Drainage pouches which are provided with such a nonporous
lOpolyethylene adhesive patch are sold with and without a karaya
sealing ring of the type described in Patent No. 3,302,647. The
adhesive patch is much larger than the karaya sealing ring, which
is intended to seal the area adjacent the stoma against irritating
fluids. The adhesive patch is adhesively secured to the body
readially outwardly of the karaya ring to provide additional
mechanical securement.
While such nonporous adhesive patches provide good adhe-
sive and mechanical securement, certain problems have arisen.
Since polyethylene or similar patches are not porous, the skin
20cannot breathe through the patch. The patch traps moisture against
the s]cin and might cause an increase in the skin irritation of the
patient.
Porous non-woven surgical adhesive tape is available.
For example, a porous non-woven surgical tape is available under ;~"~r`
the brand name "Micropore" from Minnesota Mining & Manufacturing
Company, of Minneapolis, Minnesota. This tape is formed from a
bac~ing layer o porous t non-woven rayon fabric and a layer of
hypo-allergenic, synthètic, acrylic pressure-sensitive adhesive.
Such tape is essentially continuous in appearance and is non-
3~perforatecl but exhibits a porosity which permits the skin to breathethrough the tape. Because the pores o the tape are quite small
-the tape appears to be essentially continuous, the tape is
considered microporous.
Our attempts to substitute a porous non-woven surgical
adhesive tape Eor the polyethylene adhesi~e patch on the drainage
pouch were initially unsuccessful. First of all, the non-woven
fabric backing layer of the tape cannot be satisfactorily heat-
sealea directly to the plastic retainer ring or to the pouch.
r~e found that some other means of attaching the fabric backing
to the retainer ring must be used. We also found that the very
10thin non~woven fabric is very easily torn at any concentrated
stress polnt. For example, the fabric is easily tearable when it
is subjected to a force tending to peel it away from an area of
attachment or when it is subjected to a force which is directed
angularly with respect to the plane of the fabric. Since the
drainage pouch fills with fluid and becomes quite heavy, the force
~hich tends to peel the retainer ring away from the adhesive patch
which secures the pouch to the skin can become substantial and
tear the patch cauSincJ leakage.
Summary o~ the Invention
We have been able to overcome the problems of using non-
woven porous fabric with drainage pouches by attaching the fabric
to the retainer ring of the pouch with a ~lexible attachiny ring.
The flexible attaching ring is made from a material, for example,
polyethylene, which can be easily heat-sealed to the retainer ring ~æ~-
or to the pouch. The porous non-woven fabric is attached to the
flexible at-taching ring or bag in a circular area extending radially
outwardly of the heat-sealed~area between the attaching ring and
the retainer ring or the bag. The attachment between the micro-
porous bac~in~ sheet and the attaching ring can be made by heat- ~-
~
30 sealable adhesive, which is applied either to the attaching ring,or to the backing sheet, or both. For example, a hot melt
adhesive can be used on the attaching ring which when
-- 4 --
i6~
ted flows into the pores of the ~abric and provides a good
adhesive and mechanical bond between the a-ttaching ring and
the microporous sheet. A force which tends to peel the retainer
ring of the pouch away from the microporous adhesive patch is
resisted by the heat seal attachment between the flexible plastic
attaching ring and the plastic retainer ring or bag, and the heat
seal bond between these parts is extremely s-trong and will resist
normal tearing forces. Since the attaching ring is flexible, the ~ -
attaching ring and the fabric will extend linearly or in a plane
in the area of the bond between the attaching ring and the fabric.
The force tending to separate the attaching ring and the adhesive
patch is essentially a shear force which is aligned with the
planes of the attaching ring and the patch in the area of the
bond, and even though the microporous backing is easy to tear, it
has sufficient streng-th to resist such linearly directed forces
of the magnitude which would normally be encountered. We have
found that microporous patches provide better adhesion to the
skin than nonporous polyethylene tape since the breathable patches
do not trap moisture between the patch and tlle s}~in. ~urther,
20the attachillg ring may be utilized as a moisture barrier around
the bag opening when no retainer ring is employed.
Descxiption of the Drawing
The inven-tion will be explained in conjunction with
illustrative embodiments shown in the accompanying drawing, in
which--
Fig. 1 is an elevational view, partially broken away,of a drainage pouch equipped with a sealing assembly formed in
accordance with the invention;
Fig. 2 is a sectional view taken along the line 2-2 o
30Fig. l;
Fig. 3 is a fragmentary sectional view showing the pouch
secured to the body o~ a patient;
-- 5 --
Fig. ~ is an enlarged fragmentary sectional view showing
a force applied to the adhesive patch tencling to pull the patch
away from the skin;
Fig. 5 is an enlarged view of a portion of Fig. 4;
ig. 6 is an exploded fragmentary perspective view of
the drainage pouch;
Fig. 7 is a plan view of the flexible attaching ring; ~'
Fig. 8 is a sectional view taken along the line 8-8 of
Fig. 7;
Fig. 9 is a sectional view of the adhesive patch;
Fig. 10 is a fragmentary sectional view similar to
Fig. 2 showing a modified embodiment of the sealing assembly;
Fig. 11 is a fragmentary sectional view showing a modi-
fied method of bonding the adhesive patch to the flexible attaching
ring;
Fig. 12 is an exploded fragmentary perspective view of
a modifiecl drainage pouch of a modified construction in which the
attaching ring is heat sealed directly to l:he bag;
Fig. 13 is a vertical sectional view of the exploded
20 pouch components of Fig. 12, upper and lower portions of the ba~
~ .
being shown broken away; and
Fig. 14 is an enlarged detailed sectional view showing
the components of the pouch o Figs. 12 and 13 in assembled rela-
tion, the adhesive patch and attachment ring being flexed outwardly.
General Description
~,
The invention relates to a sealing and attachment assembly
for a drainage pouch having a moisture-impermeable bag formed of
thermoplastic sheet material with the drainage opening in one side
thereof and including an adhesive patch formed of microporous sheet
material with an opening therein generally concentric with the bag
; 30 opening. The outer side of the adhesive patch is coated with the
,
~;essure-sensitive adhesive for attachment to the body of a wearer
and the inner side is connected to the bag. The improvement
comprises means for connecting the microporous patch to the bag
including an annular attaching ring formed of nonporous flexible
plastic sheet material. The ring is positioned adjacent the
patch inner side and arranged concentrically with respect to the
bag and patch openings. At least the opposed annular outer por-
tion of the ring is adhesively attached to the patch inner side.
The annular inner portion of the o-ther side of the ring provides
a heat-sealed connection to the bag, either directly or through
a retaining ring which in turn is heat-sealed to the bag. The
annular outer portion of the inside of the attaching ring is
unconnected and free to flex with the patch.
Description of Preferred Embodiments
.
Referring first to Figs. l and 2, the numeral 15 desig-
na-tes generally a drainage pouch of tl-e type described in U.S.
Patent Nos. 3,302,6~7 and 3,822,704. The pouch includes a bag
16 which is Eormed from a pair of moisture-impermeable thermo-
~j
plastic films 17 and 18~ such as polyethylene film, which are
20 heat-sealed together around the periphery l9 thereof. The bottom
of the bag may be provided with a drainage valve 20, if desired.
The plastic film 17 is pro~ided with a circular drainage
opening 22 in the upper portion thereof, and a thermoplastic
retainer ring or gasket 23 is secured to the plastic film around jr~
the o?ening 22. The retainer ring is provided with a central
opening 24 which is defined by an axially enlarged flanc~e 25
- (Fig. 2), and the retainer ring is secured to the plastic film
17 by heat-sealing the film and the retainer ring in an annularly
shaped area around the drainag~ opening of the bag indicated at
30 2G in Fig. 2. The retainer ring is advantageously formed of
polyethylene so that it can be easily heat-sealed to the poly-
ethylene plastic film of the bag.
-- 7
5~ ~
Referring a~ain to E'ig. 1, the retainer ring includes
a pair oE radially outwardly extending wings 27 and 2~, each of
which is provided with a slotted opening 29 which permits the
retainer ring to be attached to the conventional belt which
surrounds the patient and helps support the drainage pouch.
The retainer ring is relatively thick and rigid and is capable
of retaining its shape under the stress imposed by the belt.
A flexible ~lastic annular attaching ring 31 is secured
to the retainer ring 23 on the side of the retainer ring opposite
the plastic bag. Preferably, ring 31 or the inner layer thereof
is formed of a thermoplastic film having a thickness of not over
10 mils, such as 2-5 mils, thereby being highly flexible. In
the particular embodiment illustrated the flexible attaching ring
has inside and outside diameters which are sli~htly greater than
the inside and outside diameters, respectively, of the retainer
ring 2,3 so that an annular outer portion of the attachihg ring
extends radially outwardly beyond the periphery of the retainer
ring (except in -the area of the wings 27 and 28). The attaching
ring 31 is heat-sealed to the re-tainer rin~ 23 by a generally
20annularly shaped heat sealed area indicated at 32 in Fig. 2
which is adjacent the inner periphery of the attachin~ ring and
which generally overlies the heat seal attachment 26 between
the retainer ring and the plastic bag.
generally rectilinear patch 34 of porous adhesive tape
is secured to the annular attaching ring 31 Oll the surface of the
ring oppostie the surface which is bonded to the retainer ring 23.
The adhes~'~e patch is provided with an opening 34 having a dia-
meter substantially the same as the inner diameter of the annular
attaching ring, and the adhesive patch extends substantially out-
30wardly of -the attaching ring and retainer ring and terminates in
a generally rectilinear periphery 36.
~2~
The porous adhesive patch is advantageously Eormed of
non-woven microporous sheet material such as rayon, paper, etc.,
coated with a surgical pressure-sensitive adhesive. For example
non-woven rayon fabric can be used. Such porous non-woven fabric,
is available from Minnesota Mining & Manufacturing Company ~3M)
of Minneapolis, Minnesota. It is sold in roll form under the
brand name "Micropore" by 3M. Similar microporous tape is "
available from other manufacturers, such as Johnson ~ Johnson
under the brand name "Permacel". Both o these adhesive tapes
Oare porous and breathable but are capable o~ being torn quite
easily. One particular "~icropore" tape which has been used
has a thickness of 0.00~5 + 0.0015 inch. While this tape had
a specified tensile breaking strength of at least 5 pounds per
inch, the tape could be torn by a force substantially less than
5 pounds.
~ore speciEically, the adhesive tape for the patch may
consist of a backing layer o~ porous non-woven rayon Eabric and
an adhesive layer of hypo-allergenic, synt:hetic, acrylic pressure~
sensi-tive adhesive. ~he pressure-sensitive adhesive can be
~ covered by a silicone-coated release paper 37 which has a central
opening 3~.
In order to provide a good bond between the annular
attaching ring 31 and the fabric layer of the adhesive patch 3~,
the attaching ring can be provided with a layer 40 (Fig. 3) of
; hot melt adhesive which is extrusion coated to a polyethylene
layer al. Since the adhesive layer is extrusion coated to the
polyetl~ylene layer a satisfactorv bond is obtained. The poly-
ethylene layer of the attaching ring is easily heat-sealed or
fused to the polyethylene retainer ring 23, and when the hot
30 melt adhesive layer oE the at-taching ring is pressed against
the fabric layer oE the adhesive patch under heat, the hot melt
adhesive will flow into the pores o~ the fabric and provide a
good mechanical and adhesive bond between the attaching ring
and the adhesive patch. One particular type of hot melt adhe-
9 _
~25ii~
~ e that has been used is an ethyl vinyl acetate copol~mer
adhesive. In one embodiment of the annular attachin~ ring, the
polyethylene layer 41 was 0.003 inch tnick and the adhesive layer
40 was also 0.003 inch thick.
An enlarged sectional view of the adhesive patch 34
is shown in Fig. 9. The patch includes a laYer 42 of non-woven
fabric which is bonded to the adhesive layer 40 of the attaching
rin~, a layer 43 of pressure-sensitive adhesive which is intended
to be applied to the skin of the patient, and the liner 37 of
10 silicone-coated release paper.
Referring again to Fig. 2, the fabric layer of the
adhesive ~atch 34 is bonded to the adhesive-coated attaching
ring 31 in an annularly shaped heat-seal area designated ~5 which
is spaced radially outwardly of the the heat seal 32 between
the attaching ring and the retainer ring 23. In one specific
embodiment of the invention the width of both of the annularly
shaped heat seal zones 32 and 45, i.e., the distance between
the inner and outer diameters of the heat seal zones, was 1/8
inch, and the distance between the outer diameter of the inner
20 heat seal zone 32 and the inner diameter of the outer heat seal
zone 45 on the attachiny ring was about 5/32 inch. The heat
seal areas 32 and/or 45 can be made wider or made to overlap
providing the area 45 extends outwardly a subs~antial distance
be~ond area 32.
The particular drainage pouch illustrated in Figs. 1
and 2 inc]udes an annular adhesive sealing pad or ring 47. The
sealing pacl is formed from a mixture of karaya and glycerol as
clescribed in U.S. Patènt ~o. 3,302,647 and is intended to provide
a seal around the drainage opening in the body to protect the ~`
30 skin. The sealing pad 47 is provided with a central opening 43
which is concentric with the openings in the retainer ring 23,
-- 1 0 -- !~
~taching ring 31, and adhesive patch 34, and the circular
outer periphery 49 of the sealing pad has a diame-ter greater
than the diameter of -the opening 33 in the release paper 37.
The sealing pad 47 is secured to the adhesive patch by the
adhesive property of the sealing pad and the adhesive layer
of the adhesive patch.
Fig. 3 illustrates the drainage pouch secured to the
skin 51 of a patient around a drainage opening. The release
paper 37 is first removed from the adhesive surface of the
lO adhesive patch 34, and the Karaya sealing pad 47 is pressed
against the skin around the drainage opening called the stoma.
The Karaya pad is deformable and will be flattened somewhat as
it is pressed against the skin. The adhesive patch is then
pressed against the skin outwardly of the Karaya pad and adhe-
sively secured thereto. The drainage pouch can be further
supported by attachment of the conventiona] belt to the attaching~
wings 27 and 2g of the retainer ring 23.
Fi~s. 4 and 5 illustrate the drainage pouch and sealing
assembly when a force tending to pull the adhesive patch away
20 from ti~e skin is applied to the pouch, e.g., by the weight of
fluid contained by the plastic bag. The upper portion of the
retainer ring 23 tends to pivot about the lower edge thereof,
and the aclhesive patch 3~ is subjected to a force -tending to
pull the patch away from the skin. However, because both the
annular attaching ring 31 and the adhesive patch 34 are flexibler
the pulling force A exerted by the retainer ring 23 on the
attaching ring 31 and the adhesive patch 34 -tends to straighten
the attaching ring and the adhesive patch along a line extending
between the attachment of the a-ttaching ring to the retainer ring -
30 and the attachment of the aclhesive patch to the skin as shownin Fig. 5. Accordingly, -the force B exerted on the adhesive
patch in the area of the hea-t seal bond 45 is essentially linearly
~ 11. --
6:~
rected, l.e., the force vector lies substantially in the plane
of the adhesive patch. Although the adllesive patch can be torn
easily, the adhesive patch is sufficiently strong to resist
linearly directed forces of the magnitude which would ordinarily
be encountered during use of the pouch. mhe portion of the
adhesive patch adjacent the skin curves smoothly into contact
with the skin because the skin will be pulled outwardly somewhat,
and concentrated stress areas which could tear the patch are
thereby avoided in that area.
The force indicated by the arrow A tends to peel the
a-ttaching ring away from the retainer rin~ and is resisted by
the heat seal bond 32 between the attaching ring and the retainer
ring. Since the heat seal bond between the polyethylene layer
of the attaching rint3 and the polyethylene retainer ring is a
fusion bond, the bond is extremely strong and is easily capable
of resisting this peeling force.
In the embodiment illustrated ln Figs. l-~, the diameter
of the opening in the adhesive patch is substantially the same as
~ the inside diameter of the annular attaching ring 31. According-
- ~ ly, the adhesive patch extends radially inwardly beyond the outer
heat seal bond 45 and is also bonded to the adhesive layer of
the attaching ring in the heat seal zone 32. EIowever, this
inner attachment between the adhesive patch and the attaching
ring is not requlred to withstand any peeling forces since the
force tendint~ to separate the adhesive patch and the attaching
ring is taken up by the outer heat seal zone 45.
; Fig. 6 illustrates the ~anner in which the drainage
pouch is assembled. The attaching ring 31 is first bonded to
the adhesive patch 34, which is covered with the release paper ~~
3037, by the outer annular hea-t seal ring 45. Thereafter, the
attaching ring and adhesive patch is placed over the retainer
- 12 -
' '..
g 23 which has already been heat sealed to the'plastic film
17. The attaching ring is then heat sealed to the retainer
ring by the inner heat seal ring 32 (Fig. 2), which also
bonds the adhesive patch to the attaching ring. The Karaya
sealing pad 47 is then secured to the portion of the adhesive
patch which is exposed by the opening in the release paper 37.
If desired, the drainage pouch can be sold without a
Karaya sealing pad 47, and the user can apply a Karaya sealing
or an equivalent sealing means himsel~ before using the
10 drainage pouch. If the drainage pouch is sold without a Karaya
sealing pad, the central opening in the release paper is reduced
so that the release paper covers the entire adhesive surface of
the adhesive patch. For applications other than stoma drainage,
the Karaya ring is frequently omitted.
Fig. 10 illustrates a modified embodiment in which the
diameter of the central opening 135 of the adhesive patch 134 ~ -t
is greater than the diameter of the inner heat sealing ring 132.
The adhesive patch is therefore heat-sealed to the attaching
ring 132 only in the area of the ou-ter heat seal ring 1~5. The
~0 adhesive surface of the adhesive patch is protected by the
release paper 137.
The embodiment shown in Fig. 10 will function in the
same way as-the embodiment shown in Fig. 5. A ~orce which tends
to pull the adhcsive patch away from the s]cin will cause the
flexible attaching ring to extend in a substantially straight
line between the inner heat seal ring 132 and the area of
attachment between the adhesive patch and the s]cin, and the
force tending to pull the adhesive pa-tch and the attaching ring
apart will be substantially linearly directed. --.
Fig. 11 illustrates an alternate method of attaching
the adhesive patch to the sealing ring. The attaching ring 231
Z~Gl~
formed Erom a single layer of polyethylene, and layer 240
of breathable heat-sealable adhesive is impregnated into the
non-woven fabric layer 242 of the adhesive patch 234. The
adhesive patch 23~ is provided with a coating 2~3 of pressure-
sensitive adhesive which is protected by a release paper 237.
When the adhesive patch 234 is heat-sealed to the attaching
ring 231, the heat-sealable adhesive 240 bonds to the poly-
ethylene attaching ring. If desired, the attaching ring 231 can
be provided with a layer o hot melt adhesive, as previously
described, which will fuse with the impregnated adhesive 240,
thereby providing an even more secure attachment.
We have referred to the attachment between the poly-
ethylene retainer ring and the polyethylene layer of the attach-
ing ring as well as the attachment between the heat-sealable
adhesive layer of the attaching ring and the fabric layer of the
adhesive patch as "heat seal" bonds. However, these two attach- ~, '
ments are different in character. The inner polyethylene to
polyethylene attachment is a fusion bond which is obtained by
melting and fusing the confronting thermoplastic surfaces. The
20 outer attachment is both'an adhesive and a mechanical bond,
being obtained when the hot melt adhesive melts and flows into
the pores of the fabric. Moreover, the bond between the poly-
ethylene layer and the hot melt adhesive layer of the attaching
ring in the preferred embodiment is obtained when the two layers
are extruded together under heat, and this is a fusion or a --
chemical bond so that the two layers are essentially integrated.
ln alternate embodiments where no gasket or retainer
ring, such as ring 23, is provided around the pouch opening the
attaching ring, such as ring 31, can be directly heat-sealed
30 (fusion bonded) -to the pouch, which will be formed of a heat-
sealable material, such as polye-t11ylene. Such embodiments
will find use as wound drainage pouches, ecal collectors,
enema bags, urostomy bags, etc. One such embodiment is illustrated
- 14 -
2~6: L~
ln Figs. 12 to 14 of the drawings, whereln the parts corresponding
to those of Figs. 1 to 6 have been given the same numbers except
that the numbers have been primed.
As shown in Figs. 12 and 13, the inner side of attaching
ring 31 prime is opposed to side 17 prime of bag 16 prime. There
is no intervening retaining ring, as in the embodiment of Figs.
1 to 6. The inner layer of attachinc3 ring 31 prime is formed of
thin, flexible thermoplastic sheet material, such as polyethylene,
and the outer layer 40 prime is formed of a hot melt adhesive, as
10 previously described. The bac~ sides17 prime and 18 prime are
formed of a thermoplastic sheet material such as polyethylene.
In the assembly oE the components, inner side 41 prime of the
attaching riny is heat sealed in an annular area around bag
opening 22 prime to bag wall 17 prime, as indicated at 32 prime
in Fig. 14. The inner side of microporous adhesive patch 34
prime is heat-sealed fused to the outer side of attachinc3 ring ~ -
~31 prime by means of hot melt adhesive layer 40 prime, as pre-
viously described with respect to the prior embodiments. As
shown more clearly in Fig. 14, the adhesive attachment of patch
20 34 prime to the outer side of ring 31 prime extends substantially
across the full width of the ring, the outer attached portion
extending beyond the heat sealed attachment 32 prime. In other
words, -the annular outer portion of the inner side of attaching
ring 31 prime is unconnected to bag wall 17 prime and is thereby
free to flex with patch 34 prime, as indicated in Fig. 14. As ~ ~~
previously described, this provides a secure connection which
minimizes the tendency of the microporous patch to tear while
being worn.
Attaching ring 31 prime, being ~ormed o nonporous
30 plastic sheet material, effectively seals the portion of micro-
porous adhesive patch 34 prime which is opposed thereto. Thus
~æ~
any fluids which tend to seep be-tween the inner side of the
microporous patch and the patient's body are prevented from
passing through the microporous patch material unless the
seepage extends to a point outwardly of the outer end of
attaching ring 31 prime. Since this ia unlikely to occur
during normal use of the drainage pouch, an effective liquid
barrier is provided by the construction while at the same time
retaining the advantages of the breathable microporous adhesive
patch which extends outwardly around attaching ring 31 prime.
- 16 -
