U.S. patent number 3,690,320 [Application Number 05/079,826] was granted by the patent office on 1972-09-12 for ostomy bag and deodorizing packet therefor.
This patent grant is currently assigned to International Paper Company. Invention is credited to Phyllis E. Riely.
United States Patent |
3,690,320 |
Riely |
September 12, 1972 |
OSTOMY BAG AND DEODORIZING PACKET THEREFOR
Abstract
The ostomy bag comprises a receptacle pouch containing an inlet
aperture and means for providing communication between the pouch
interior and the ostomy orifice on the surface of the wearer's
body. This means comprises (a) a thin, flexible, essentially planar
member containing a conduit which provides communication between
the pouch inlet aperture and the ostomy orifice; (b) an upwardly
projecting rim surrounding the conduit, over which the pouch inlet
aperture is fitted; (c) a continuous groove in one surface of the
planar member which surrounds the rim and in which the receptacle
pouch is mounted, and (d) a recess in the surface of the planar
member opposed to the grooved surface, this recess surrounding the
conduit and adapted to receive a gasket or suitable means for
sealing the ostomy bag to the body. The planar member is provided
with means for affixing it to the body by use of a belt. The ostomy
bag contains a gas permeable section in the pouch wall to permit
release of intestinal gas from the interior to the exterior of the
pouch. The pouch also contains a deodorizing packet affixed to the
inner pouch wall. This packet comprises an inner sealed envelope
containing a volatile deodorizing composition and an outer sealed
envelope which contains the inner sealed envelope. The inner
envelope is ruptured to discharge its contents into the inner space
between the two envelopes. The outer envelope has microbial barrier
properties and is permeable to the vapors emanating from the
deodorizing composition. These deodorizing vapors pass through the
outer envelope and into the environment surrounding the outer
envelope.
Inventors: |
Riely; Phyllis E. (Warwick,
NY) |
Assignee: |
International Paper Company
(New York, NY)
|
Family
ID: |
22153054 |
Appl.
No.: |
05/079,826 |
Filed: |
October 12, 1970 |
Current U.S.
Class: |
604/333; D24/118;
604/335; 604/336 |
Current CPC
Class: |
A61F
5/441 (20130101); A61F 5/4407 (20130101) |
Current International
Class: |
A61F
5/441 (20060101); A61F 5/44 (20060101); A61f
005/44 () |
Field of
Search: |
;128/283 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Rosenbaum; Charles F.
Claims
I claim:
1. An ostomy bag comprising:
1. a receptacle pouch containing an inlet aperture;
2. means for providing communication between the interior of said
pouch and an ostomy orifice on the surface of the body, said means
comprising a unitary, flexible, essentially planar member having an
inner and outer surface, said inner surface being adjacent the body
surface in proximity to the ostomy orifice, said planar member
containing:
i. a conduit adapted to provide communication between the ostomy
orifice and the inlet aperture of the receptacle pouch;
ii. an unflanged rim integral with said planar member projecting
upwardly from said outer surface and surrounding said conduit, said
inlet aperture of said receptacle pouch fitting over said unflanged
rim;
iii. a continuous groove formed in said outer surface, said groove
surrounding the base of said rim and having positioned therein, in
attached relationship, a portion of the receptacle pouch
surrounding said inlet aperture;
iv. a recess in said inner surface surrounding said conduit adapted
to receive gasket sealing means, therein; and
v. means for connecting support belt means to said planar member,
said means being integral with said planar member.
2. The ostomy bag of claim 1 wherein the inner walls of said rim
taper inwardly towards said conduit to provide divergence at one
end of said conduit.
3. The ostomy bag of claim 2 wherein said conduit is of a circular
configuration and wherein said rim, groove, and recess are of an
annular configuration.
4. The ostomy bag of claim 3 further including gasket means
disposed in said annular recess.
5. The ostomy bag of claim 4 wherein said gasket means is an O-ring
fabricated from karaya gum.
6. The ostomy bag of claim 4 wherein said gasket means is an O-ring
fabricated from a polyurethane sponge which is impregnated with
karaya gum.
7. The ostomy bag of claim 4 wherein the inner surface of said
planar member contains a centrally located annular taper
surrounding said conduit, said taper rising upwardly from said
inner surface and terminating upon reaching said annular
recess.
8. The ostomy bag of claim 1 wherein said pouch contains therein a
portion which is gas permeable and liquid impermeable, said portion
providing communication between the interior and exterior of the
pouch to provide for automatic release of gas to the exterior of
the pouch.
9. The ostomy bag of claim 1 wherein said bag has affixed to the
inner surface of said pouch a deodorizing packet comprising:
1. an inner sealed envelope containing therein a composition
comprising a volatile deodorizing agent, said inner envelope having
a rupturable seal and being fabricated from a material which is
substantially gas impermeable, and
2. an outer sealed envelope containing therein said inner sealed
envelope, said outer sealed envelope being fabricated from a
material which is permeable to gas, whereby, upon rupture of the
inner envelope seal, the volatile deodorizing agent released from
the inner envelope permeates the outer envelope into the
environment surrounding said packet.
10. The ostomy bag of claim 9 wherein the outer envelope of the
deodorizing packet is fabricated from a material also having
microbial barrier properties.
11. The ostomy bag of claim 10 wherein said composition comprises a
gel adapted for introducing into air a uniform quality vapor
mixture, said gel comprising from about 96 to 99 percent of an
aqueous medium, said aqueous medium containing from about 1 to 10
percent of a plurality of volatile deodorizing agents which are
compatible and uniformly dispersible in water, and which normally
volatilize at different rates at room temperature, and from about 1
to 4 percent of an aqueous gelling agent, the amount of gelling
agent present in proportion to the aqueous medium being such that
the gel is firm and substantially devoid of syneresis.
12. The ostomy bag of claim 1 further including an opening in the
bottom of said pouch, and means for opening and closing said
opening.
13. An ostomy bag comprising:
1. a receptacle pouch containing an inlet aperture;
2. means for providing communication between the interior of the
pouch and an ostomy orifice on the surface of the body;
3. a gas permeable but liquid impermeable portion in the surface of
said pouch; and
4. a deodorizing packet attached to the inner surface of said
pouch, said packet comprising:
i. an inner sealed envelope containing therein a composition
comprising a volatile deodorizing agent, said inner envelope having
a rupturable seal and being fabricated from a material which is
substantially gas impermeable, and
ii. an outer sealed envelope containing therein said inner sealed
envelope, said outer sealed envelope being fabricated from a
material which is permable to gas whereby, upon rupture of the
inner envelope seal, the volatile deodorizing agent released from
the inner envelope permeates the outer envelope into the
environment surrounding said packet.
14. The ostomy bag of claim 13 wherein the outer envelope of the
deodorizing packet is fabricated from a material also having
microbial barrier properties.
15. The ostomy bag of claim 13 wherein said means for providing
communication between the interior of the pouch and the ostomy
orifice comprises an essentially planar flexible member having an
inner and outer surface said inner surface being adjacent the body
surface in proximity to the ostomy orifice, said planar member
containing:
1. a conduit adapted to provide communication between the ostomy
orifice and the inlet aperture of said receptacle pouch;
2. a rim projecting upwardly from said outer surface and
surrounding said conduit, said inlet aperture of said receptacle
pouch fitting over said rim;
3. a continuous groove in said outer surface, said groove
surrounding said rim and having affixed therein a portion of said
receptacle pouch surrounding said inlet aperture;
4. a recess in said inner surface surrounding said conduit and
adapted to receive gasket sealing means therein, and
5. means for connecting support belt means to said planar
member.
16. The ostomy bag of claim 15 wherein said composition comprises a
gel adapted for introducing into air a uniform quality vapor
mixture, said gel comprising from about 96 to 99 percent of an
aqueous medium, said aqueous medium containing from about 1 to 10
percent of a plurality of volatile deodorizing agents which are
compatible and uniformly dispersible in water, and which normally
volatilize at different rates at room temperature, and from about 1
to 4 percent of an aqueous gelling agent, the amount of gelling
agent present in proportion to the aqueous medium being such that
the gel is firm and substantially devoid of syneresis.
17. The ostomy bag of claim 15 wherein said inner envelope is
fabricated from a laminate, said laminate comprising an outer layer
of pouch paper, a first inner layer of polyethylene, a second inner
layer of aluminum foil, and a third innermost layer of
polyethylene.
18. The ostomy bag of claim 17 wherein said outer envelope is
fabricated from a polyvinyl chloride film.
19. The ostomy bag of claim 18 wherein the liquid medium is an
aqueous-alcoholic medium.
20. The ostomy bag of claim 19 wherein the amount of volatile
deodorizing agents ranges from about 0.1 to about 0.25 percent.
21. The ostomy bag of claim 16 further including an opening in the
bottom of said pouch, and means for opening and closing said
opening.
22. The ostomy bag of claim 16 further including gasket means
disposed in said recess, said gasket means being non-irritating to
skin.
23. The ostomy bag of claim 22 wherein said gasket means is an
O-ring fabricated from karaya gum.
24. The ostomy bag of claim 20 wherein said conduit is of circular
configuration and wherein the inner surface of said planar member
contains a centrally located annular taper surrounding said
conduit, said taper rising upwardly from said inner surface and
terminating upon reaching said annular recess.
Description
BACKGROUND OF THE INVENTION
This invention relates to ostomy bags and to deodorizing devices
which are eminently suitable for inclusion within the interior of
such bags. The term "ostomy" refers to a surgical procedure whereby
substantial portions of the intestine are removed and the intestine
then re-routed to exit the body by means of an orifice located on
the surface of the body, usually in the abdominal portion of the
body. Provision must be made for the collection of the fecal matter
discharged through this orifice. The common procedure is to affix
an ostomy bag to the body in proximity to this orifice so that the
fecal matter discharged from the orifice is discharged into the
interior of such a bag. Numerous such devices have been heretofore
described.
When a substantial portion of the large intestine or colon is
removed, the surgical procedure is referred to as a "colostomy."
When a substantial portion of the small intestine is removed, the
surgical procedure is referred to as an "ileostomy." Both types of
surgical procedures require the use of ostomy bags except that, in
the case of ileostomies, the fecal matter ordinarily contains a
greater quantity of liquid than in the case of a colostomy.
Accordingly, an ostomy bag for this usage must be equipped to
handle this type of fecal discharge.
One problem encountered by the wearer of an ostomy bag is the
undesirable odor emanating from the fecal matter discharged into
the bag. At the present time, the most common remedy is to either
replace the bag or to remove it and empty its contents. These
procedures can greatly inconvenience the wearer. This odor problem
is prevalent in other medical devices such as, for example, closed
urinary collection systems. There exists therefore, a need for a
means of effectively and conveniently removing such odors.
If such a deodorizing means were to be inserted within a receptacle
for urinary or fecal matter, it would be desirable that the
migration of microbes into or out of the deodorizing device be
substantially eliminated so as to not interfere with analyses of
the urinary or fecal matter which seek to determine the presence of
infection in the body wastes. This is particularly true in urinary
collection systems wherein the microbial count is a most effective
technique for determining the presence of infection in the
urine.
Another problem encountered by the wearer of an ostomy bag is the
undesirable inflation of the bag produced by discharge of
intestinal gas into the bag. In most presently used ostomy bags,
this problem is remedied by puncturing the bag to release the gas.
The inconvenience of such a procedure is apparent.
It is an object of this invention, therefore, to provide an ostomy
bag which is internally furnished with a deodorizing packet which
is conveniently ruptured by the wearer whenever the need for
deodorization of the bag contents occurs; the packet remains intact
until needed for use.
It is another object of this invention to provide an ostomy bag
which automatically releases gas discharged from the intenstine to
the environment thereby eliminating undesirable inflation of the
bag.
It is another object of this invention to provide a novel, reusable
and/or disposable ostomy bag with an improved means for affixing
the bag to the body of the wearer.
It is another object of this invention to provide a novel type of
deodorizing device which is eminently suitable for inclusion within
the interior of the pouch of an ostomy bag and for use in other
deodorizing applications such, as for example, in closed urinary
collection systems.
It is another object of this invention to provide such a
deodorizing device wherein the migration of microbes into or out of
the device is substantially eliminated thereby permitting the
device to be disposed in close proximity to the odor source without
interfering with various medical analyses of the odor source
material.
These and other objects of this invention will be apparent to one
skilled in the art from a consideration of this disclosure.
SUMMARY OF THE INVENTION
This invention relates to a novel type of ostomy bag which
comprises a receptacle pouch containing an inlet aperture and means
for providing communication between the pouch interior and the
ostomy orifice on the surface of the body of an ostomy patient.
This communication is achieved by providing a thin, flexible,
essentially planar member having an "inner" and "outer" surface,
the "inner" surface being defined as that surface which is in
contact with or adjacent to the body surface of the bag wearer when
the bag is in use and the "outer" surface being defined as that
surface which is in contact with or adjacent to the receptacle
pouch.
The thin planar member contains a conduit which is adapted to
communicate at one end with the ostomy orifice of the wearer and,
at the other end, with the inlet aperture and interior of the
receptacle pouch. A rim surrounds this conduit and projects
upwardly a small distance from the outer surface. The outer surface
also contains a continuous groove which surrounds this rim. The
receptacle pouch contains an inlet aperture in one of its surfaces
of a slightly larger dimension than that of the rim. This inlet
aperture is fitted over the rim, with a portion of the surfaces of
the pouch surrounding the aperture being seated within the
adjoining continuous groove of the outer surface. The pouch
surfaces are attached to the groove by heat-sealing or other
suitable adhesive means whereby the flexible planar member is
affixed to the receptacle pouch to form the ostomy bag.
The planar member also contains a recess in its inner surface which
surrounds the conduit and is adapted to receive therein a gasket or
other suitable sealing means for effecting a tight and effective
seal between the surface of the body of the wearer and the flexible
planar member. A gasket, fabricated from a non-toxic,
non-irritating material is inserted into the recess and affixed
therein. The outer surface of the planar member is further provided
with lugs or other suitable means for affixing a belt to the member
in order to support the ostomy bag against the wearers body.
Automatic release of gas discharged from the intestine into the
interior of the receptacle pouch is achieved by providing in a wall
of the receptacle pouch, a gas permeable but liquid impermeable
portion which provides communication between the exterior and
interior of the pouch and allows any build-up of gas pressure
within the interior of the pouch to be immediately released to the
exterior. This feature eliminates inflation of the pouch resulting
from gas pressure. Since the gas permeable portion is not permeable
to liquid, there is no danger of discharging contents of the pouch
to the exterior through this portion.
To minimize the odors within the receptacle pouch, or the odors of
the gas discharged to the exterior through the gas permeable
portion of the wall of the pouch, there is provided within the
pouch a packet containing a suitable volatile deodorizing
composition.
The term "deodorizing" as used herein refers to the removal of
unpleasant or offensive odors from air or other gaseous
environments by any suitable technique such as, for example,
masking, balancing, etc. and is not intended to limit odor removal
to any specific mechanism whereby odor causing molecules are
rendered undetectable to the sense of smell.
In one such packet, a deodorizing composition, preferably in gel
form, is sealed within an inner envelope which has an easily
rupturable seal and which is fabricated from a material which is
substantially impervious to gas. This inner envelope therefore,
prevents the escape of the volatile deodorizing constituents of the
deodorizing composition until they are needed. Moreover, the
deodorizing contents of the inner envelope are protected from
degradation and chemical reaction with reactive gases, such as, for
example, oxygen, the moisture found in air, or ethylene oxide in
cases where it is desirable to sterilize the deodorizing packet or
ostomy bag.
This inner envelope is contained within an outer sealed envelope
which is fabricated from a material which is permable to gas and
which possesses microbial barrier properties. The deodorizing
effect of the packet does not occur until the inner envelope is
ruptured to discharge the deodorizing composition into the inner
space between the two envelopes. The vapors emanating from the
discharged deodorizing composition pass through the gas permeable
outer envelope material and into the environment surrounding the
outer envelope.
The deodorizing packet can be used in conjunction with a variety of
devices wherein offensive odors occur such as, for example, closed
urinary collection systems, incontinent devices, and diaper pails.
When used in conjunction with an ostomy bag, it is conveniently
affixed to the inner surface of the receptacle pouch, preferably in
proximity to the zone where the fecal matter enters the pouch. When
deodorizing action is needed, the wearer of the ostomy bag simply
exerts mild pressure against the deodorizing packet to rupture the
inner envelope seal thereby deodorizing the contents of the
receptacle pouch. Since the outer envelope material of the
deodorizing packet has microbial barrier properties, the packet can
be placed in close proximity with the odorous material without the
migration of microbes from the odorous material into the packet or
from the interior of the packet into the odorous material. The
result is that the presence of the deodorizing packet will not
alter microbial counts of the odorous material which are widely
used to detect the presence of infection in the odorous material
discharged from the body.
The ostomy bag, deodorizing packet, and combination of deodorizing
packet and ostomy bag of this invention are more fully described
hereinbelow in conjunction with the attached drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side elevational view of a preferred embodiment of an
ostomy bag of this invention, said ostomy bag being provided with a
deodorizing packet and ventilating aperture for releasing gas from
the interior to the exterior of the ostomy bag pouch.
FIG. 2a is a sectional view taken along the line 2a--2a of FIG. 1
and illustrates the ostomy bag with its bottom in the open position
for discharge of the contents of the bag.
FIGS. 2b and 2c show sequentially the closing of the opening at the
bottom of the ostomy bag to retain fecal matter within the pouch
during use of the bag.
FIG. 3 is a sectional view taken along the line 3--3 of FIG. 1,
with the bag in a slightly expanded position.
FIG. 4 is a sectional view taken along the line 4--4 of FIG. 1,
with the bag in a slightly expanded position.
FIG. 5 is a schematic diagram showing the mounting of the ostomy
bag of FIG. 1 onto the wearer's body by means of a support
belt.
FIG. 6 is a sectional view taken along the line 6--6 of FIG. 5 and
serves to illustrate the connection of the ostomy bag to the ostomy
orifice on the surface of the wearer's body.
FIG. 7 is a plan view of a preferred embodiment of a deodorizing
packet of this invention.
FIG. 8 is a sectional view taken along the line 8--8 of FIG. 7.
FIG. 9 is a schematic view illustrating the rupturing of the seal
of the inner envelope under the exertion of mild thumb pressure to
thereby discharge the contents of the inner envelope into the inner
space between the inner and outer envelope.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The Ostomy Bag
Referring to FIG. 1, it is seen that the ostomy bag 10 of this
invention comprises a receptacle pouch 11 which contains in its
upper portion a circular inlet aperture 12. Affixed to pouch 11 is
a thin, flexible, essentially planar, unitary member 13 containing
therein a circular conduit 34 which provides communication between
the interior of pouch 11 and the ostomy orifice on the surface of
the body of the wearer.
Pouch 11 can be fabricated from a variety of suitable materials
such as, for example, vinyl type plastics, polyethylene, and
polypropylene. The thickness of pouch 11 is not significant but
preferably is sufficiently thin to allow the pouch to adopt the
contour of the wearer's body. The pouch material is preferably
non-irritating to the skin and should, of course, possess
sufficient strength and impermeability to hold the fecal matter
deposited therein. A pouch prepared from 8-mil thick vinyl plastic
has been found quite suitable. Pouch 11 is conveniently fabricated
from two sheets of vinyl plastic which are joined together about
their periphery by heat seal 11a.
The planar connecting member 13 can be fabricated from any one of a
number of suitable materials such as, for example, Delrin resin,
polyethylene, polypropylene, or other plastics. The material
selected is preferably of a smooth texture and is non-irritating to
the skin. Resins of the Delrin type are preferred. These materials
are generally linear polyoxymethylene type acetal resins made by
the polymerization of formaldehyde and are characterized by high
strength and solvent resistance.
The ostomy bags of this invention can be used as disposable items
or they can be reused as discussed in greater detail
hereinbelow.
Bag 10 can optionally be provided with a gas permeable portion 63
in one of the surfaces of pouch 11 whereby gas can escape from the
interior to the exterior of bag 10. Bag 10 can also optionally be
provided with a deodorizing packet 16 which is contained within the
interior of the pouch 11 and is preferably affixed to an inner
surface of pouch 11 as discussed in greater detail hereinbelow.
The lower constricted portion 17 of pouch 11 is provided with a
slit 18 which provides communication between the interior and
exterior of pouch 11. Slit 18 makes it extremely convenient to
clean out the interior of pouch 11 when it becomes desirable to
reuse the ostomy bag. In such a case, the bag is simply
disconnected from the wearer and flushed out through slit 18
preferably with the aid of a water or other fluid rinse injected
through aperture 12.
The bag shown in FIG. 1 will have slit 18 closed prior to its being
used. One means for quickly opening and closing slit 18 is depicted
in FIGS. 2a through 2c. A closure of the Velcro type, such as for
example, that described in U.S. Pat. No. 3,203,551, said patent
incorporated herein by reference, is very suitable for this
purpose. The constricted portion of pouch 17 is conveniently broken
down into three separate portions 17a, 17b and 17c, said portions
separated from each other by folds 19 and 20. Portion 17c has
affixed thereto on one side a strip 21 of a pile portion of a
typical Velcro closure. Portion 17a has affixed thereto a strip 22
of the mating hooked portion of a typical Velcro closure, strip 22
being affixed to a surface of portion 17a opposed to that surface
of portion 17c to which strip 21 is affixed. To effectively close
slit 18, portion 17c is folded upwardly against the surface of
portion 17b along fold 20 as shown most clearly in FIG. 2b.
Portions 17b and 17c are next folded upwardly against the surface
of portion 17a along fold 19 causing the hooks of strip 22 to
engage the pile of strip 21 to effect a secure closure of slit 18.
To open the bag, the reverse sequence to that shown in FIGS. 2a
through 2b is followed.
FIGS. 3 and 4 provide detailed views of the thin, essentially
planar connecting member 13 which provides communication between
the interior of pouch 11 and the ostomy orifice on the surface of
the wearer's body. Referring to these Figures, it is seen that
member 13 comprises a thin, essentially planar portion 30 having an
outer surface 31 which is adjacent to pouch 11 and an inner surface
33 which is adjacent to the surface 33a of the body of the wearer,
surface 33a being shown by a dotted line in FIGS. 3 and 4.
Member 13 contains a circular conduit 34 which provides
communication between the interior 32 of pouch 11 and the ostomy
orifice 160 (see FIG. 6) on the surface of the wearer's body. The
outer surface 31 of member 13 is provided with an annular groove 35
which circumscribes the base of an unflanged rim integral with
member 13 36 which, in turn, projects upwardly from outer surface
31 to surround circular conduit 34. Surface 40 of pouch 11 is
provided with a circular aperture 12. Rim 36 of member 13 is
inserted within aperture 12 with those portions 40a of pouch
surfaces 40 which are adjacent to aperture 12 coming to rest on
outer surface 31 of member 13 and, more particularly, on top of
continuous annular groove 35 in the outer surface 31 of member 13.
Member 13 is affixed to surface 40 of pouch 11 by heat-sealing
surfaces 40a to member 13 in groove 35. Member 40 may be similarly
affixed to member 13 in groove 35 by means of any suitable
adhesive.
The inner surface 33 of member 13 is provided with an annular
recess 42 which surrounds conduit 34 at one end and is adapted to
receive a gasket 43 which provides an effective seal between member
13 and surface 33a of the wearer's body. Gasket 43 can be
fabricated from any of numerous suitable materials and is
preferably fabricated from a non-toxic, non-irritating,
non-allergenic material whose properties are not adversely effected
by contact with the fecal matter, such as, for example, karaya gum,
flexible polyurethane sponge, or flexible polyurethane sponge which
is impregnated with karaya gum. The geometric configuration of the
gasket is selected to conform with that of recess 42 and is an
O-ring in the case where recess 42 is circular.
The inner walls 44 of rim 36 preferably taper inwardly towards
conduit 34 to create a diverging portion 48 of conduit 34 for the
fecal matter entering the interior 32 of pouch 11.
The outer surface 33 of member 13 is preferably provided with a
centrally located annular tapered portion 50 which rises upwardly
from inner surface 33 and terminates upon reaching annular recess
42. This taper aids in providing an effective seal between member
13 and the wearer's body.
Referring to FIG. 4, it is seen that member 13 is provided at each
end with lugs 52 which are integral with member 13 and which are
adapted to engage a belt 53 whereby the ostomy bag can be
appropriately positioned against the wearer's body and firmly
retained in that position. The pressure exerted by belt 53 causes a
slight compression of gasket 43 to thereby effect a good seal
between member 13 and the outer surface 33a of the wearer's
body.
Referring particularly to FIG. 3, it is seen that surface 40 of
pouch 11 is provided with a small aperture 60 of a generally
rectangular configuration (see FIG. 1). Mounted across aperture 60
and secured to the interior of inner surface 40 at points 61 and 62
is a gas permeable member 63, the function of which is to permit
the automatic release of gas discharged from the ostomy orifice
into the interior 32 of pouch 11 to the exterior of the pouch. This
prevents undesirable build-up of gas within the interior 32 of
pouch 11.
The material from which member 63 is fabricated must, of course, be
permable to gases and additionally should provide a microbial
barrier to retain germs and undesirable organisms within the
interior 32 of pouch 11. Moreover, it is preferable that the
material of member 63 have substantial hydrophobic properties in
order to maintain the ventilation properties of member 63 intact if
member 63 should be contacted with liquid as can occur, for
example, in the case of an ileostomy wherein the fecal matter
discharged into pouch 11 can contain substantial amounts of liquid
matter. Member 63 is fabricated from a substantially liquid
permeable material in order to retain such liquid matter within
pouch 11. One preferably material out of numerous suitable
materials for fabricating member 63 is a laminate comprising a
first layer of gas permeable Teflon 63a which is affixed to a
second backing layer 63b of a spun fiber, with the spun fiber layer
63b preferably being in contact with the interior of inner surfaces
40 of pouch 11 and affixed thereto. Such a material is available
commercially from the Pall Corporation under the designation
TV-20A40. Member 63 is preferably positioned away from the
receptacle area of pouch 11 to prevent its becoming blocked with
fecal matter and thereby destroying its ventilation properties.
The Deodorizing Packet
To provide effective deodorization within the interior 32 of pouch
11 and to deodorize the gases released through permeable member 63
prior to their leaving the interior 32 of pouch 11, it is desirable
to position a disinfecting packet 100 within the interior 32 of
pouch 11. A particularly suitable disinfecting packet is shown in
FIGS. 7 through 9, wherein the packet 100 is shown in isolation
from the ostomy bag for purposes of clarity. Referring to FIG. 7,
it is seen that packet 100 comprises a sealed inner envelope 101
which contains therein a deodorizing composition 102 having as its
active ingredient one or more volatile deodorizing constituents.
Inner envelope 101 is sealed within an outer envelope 103.
In general, any of a number of suitable deodorizing compositions
can be packaged within inner envelope 101. For example, various
solid or pelletized compositions, liquid compositions, and gel
compositions can be employed. Numerous such compositions have been
heretofore described. A preferred deodorizing formulation comprises
the various air-treating gels described in detail in U.S. Pat. No.
2,691,615, said patent incorporated herein by reference. These gels
generally comprise from about 96 to 99 percent by weight of an
aqueous medium, with from about 1 to 10 percent by weight of this
aqueous medium comprising a plurality of volatile deodorizing
components which are compatible and uniformly disperable with water
and which normally volatize at different rates at room temperature.
These gels introduce a uniform quality vapor mixture into the air.
The gel further comprises from about 1 to 4 percent of an aqueous
gelling agent, the amount of which is present in proportion to the
aqueous medium being such that the gel is firm and substantially
devoid of syneresis.
Typical liquid mediums include aqueous-alcoholic mediums and
aqueous-aldehyde mediums and especially liquid mediums wherein the
alcohols are aliphatic monohydric alcohols and the aldehydes are
aliphatic aldehydes containing from two to 20 carbon atoms. Among
the volatile substances which may be employed are compounds such as
acetaldehyde, paraldehyde, betahexyl acrolein, caproaldehyde,
acetals, halogenated acetals and phenylacetaldehyde. Alcohols such
as ethyl alcohol can also be employed. A preferred deodorizing gel
is available commercially from Air-Kem, Inc. (Carlstadt, N.J.)
under the tradename "Solidaire." Different formulations can be
employed to counteract different types of odors, as is known in the
art. One suitable formulation includes pine oil, acetaldehyde and
chlorophyll.
The volatile deodorizing constituents of the gel are generally
present in amounts ranging from about 0.03 to 0.5 percent by weight
and preferably from about 0.1 to about 0.25 percent by weight.
Chlorophyll can also be added to the gel, preferably in amounts
ranging from about 0.1 to 0.4 percent by weight, and typically
about 0.2 percent by weight.
A variety of gelling agents can be employed, such as, for example,
gelatin, pectin, agar-agar, gums such as karaya and gum tragacanth,
starch, and calcium alginate. The gelling agent is typically
present in an amount of about 1.5 percent.
The deodorizing gel compositions can be dyed with anyone of a
variety of suitable colors to create a pleasing aesthetic
effect.
Inner envelope 101 is fabricated from a material which is
substantially impermeable to gas. This effectively prevents
degradation of the deodorizing composition contained within the
envelope resulting from exposure to reactive gases such as air,
moisture, or in the case where the packet is to be sterilized,
ethylene oxide. Moreover, it retains the volatile deodorizing
constituents of the composition within envelope 101 until needed
for use.
A particularly suitable material for the fabrication of envelope
101 is the four-layered laminate shown most clearly in FIG. 8. This
laminate comprises an outer layer 105 of pouch paper, a first inner
layer 106 of polyethylene, a second inner layer 107 of aluminum
foil, and an innermost layer 108 of polyethylene. Such a laminate
is available commercially from several sources. For example, it is
available from the St. Regis Paper Co. under the name "Dreamwhip
Pouch Stock."
The function of polyethylene layer 106 is to bind paper layer 105
to aluminum foil layer 107. Gas impermeability is imparted to
envelope 101 by the aluminum foil layer 107. The function of
innermost polyethylene layer 108 is to provide a means for joining
the two layers 110 and 111 of the laminate together about their
periphery by heat seal 112. Seal 112 is prepared in accordance with
known techniques so that it will easily rupture when pressure is
exerted upon the contents 102 of envelope 101.
Outer envelope 103 is fabricated from a material which is permeable
to gas such as, for example, films of polyvinyl chloride,
polyethylene, polypropylene. Moreover, envelope 103 is preferably
fabricated from a material having microbial barrier properties.
Such a material substantially prevents migration of microbes either
into or out of the deodorizing packet. This feature is important in
applications where it becomes important to make a microbial count
on the urinary or fecal matter in order to determine the presence
of infection. If microbes could escape into the deodorizing packet
or if foreign microbes were introduced from the deodorizing packet,
the true microbial count of the urinary or fecal matter could be
substantially altered.
Outer envelope 103 is typically prepared from two layers of a
suitable material which are joined together along their peripheries
by heat seal 115. As can be seen in FIG. 7, both inner envelope 101
and outer envelope 103 are only heat-sealed about three of the four
edges. The remaining edge is simply a fold in the sheet material
used to fabricate the envelopes. A preferred material is
commercially available polyvinyl chloride film having a thickness
of three-fourths to 1 inch.
To activate the deodorizing packet, it is only necessary to exert a
mild pressure with the thumb, as seen in FIG. 9, upon the contents
102 of inner envelope 101. This causes seal 112 to readily rupture
and discharge the contents 102 of envelope 101 into the inner space
120 (see FIG. 8) between envelopes 101 and 103. The vapors from the
deodorizing composition 102 fill inner space 120 and pass through
gas permeable outer envelope 103 and into the environment
surrounding envelope 103 to thereby deodorize the environment.
Referring again to FIG. 3, the deodorizing packet 100 illustrated
in FIGS. 7 through 9 is shown attached to the interior of surface
130 of pouch 11 by means of a heat-seal 131 or other suitable
adhesive. When deodorizing action is required within the interior
32 of pouch 11, it becomes a simple expedient for the wearer of
ostomy bag 10 to exert a slight pressure against the contents 102
of inner envelope 101 to rupture the seal 112 of envelope 101,
discharging the deodorizing composition into the inner space 120 of
packet 100. The volatile deodorizing vapors then pass through gas
permeable outer envelope 103 and fill up the interior 32 of pouch
11 to thereby deodorize the contents of the pouch. Packet 100 is
preferably positioned in close proximity to the zone of entrance of
the fecal matter into pouch 11.
The use of the ostomy bag of this invention is best seen in FIGS. 5
and 6 wherein it is shown attached to the wearer's body. Referring
to FIG. 6, it is seen that the ostomy orifice 160 on the surface
33a of the wearer's body 161 communicates with conduit 34 of member
13 so that the fecal matter discharged from orifice 160 passes
through conduit 34 and into the interior 32 of pouch 11. One end of
conduit 34 circumscribes the stoma 162 which defines the periphery
of ostomy orifice 160. The spilling of fecal matter against
adjoining surface 33a of the body is prevented by sealing gaskets
43 which are mounted in recess 42 and which are compressed slightly
by the force exerted against connecting member 13 by belt 53.
Gas discharged into the interior 32 of pouch 11 from orifice 160 is
automatically vented to the exterior of pouch 11 through gas
permeable member 63. Deodorizing packet 100 which is affixed to
interior surface of pouch 11 can be activated at any time by the
wearer simply exerting a sufficient force against the contents 102
of inner envelope 101 to rupture seal 112.
The bag can be cleaned and reused by simply disconnecting it from
the body and opening slit 18 at the bottom thereof in a manner
directly opposite to that shown in FIGS. 2a through 2c for closing
slit 18. The fecal matter can be flushed out through slit 18 with
the aid of a water flush. If desired, ostomy bag 10 can then be
sterilized prior to reuse by the use of ethylene oxide gas or other
suitable sterilization techniques.
The specific structure described hereinabove and in the attached
drawings is illustrative only and such modifications and
alterations thereof as would be apparent to one skilled in the art
are contemplated to fall within the scope and spirit of the claims
appended hereto.
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