U.S. patent number 3,667,469 [Application Number 04/884,842] was granted by the patent office on 1972-06-06 for post-surgical drainage pouch.
Invention is credited to Arthur E. Marsan.
United States Patent |
3,667,469 |
Marsan |
June 6, 1972 |
POST-SURGICAL DRAINAGE POUCH
Abstract
This invention is characterized by a drainage pouch having a bag
of plastic film and a gelatinous sealing member for providing a
seal between the pouch and the stoma of a patient when the pouch is
in use on the patient, and novel construction whereby a single
pouch and its sealing member (as an article of manufacture) serves
a wide range of stoma sizes, and also whereby the film bag entirely
encloses the sealing member before use and serves as the wrapper
for the pouch. The invention is further characterized by a method
of making the pouch wherein the sealing member is molded to shape
and is in operative position within the bag and in which a wall of
the film serves as a lining for the mold.
Inventors: |
Marsan; Arthur E. (Denver,
CO) |
Family
ID: |
25385537 |
Appl.
No.: |
04/884,842 |
Filed: |
December 15, 1969 |
Current U.S.
Class: |
604/336;
264/135 |
Current CPC
Class: |
A61F
5/445 (20130101); A61L 2400/14 (20130101) |
Current International
Class: |
A61F
5/445 (20060101); A61f 005/44 () |
Field of
Search: |
;128/283,294,295
;264/135,267,273 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Rosenbaum; Charles F.
Claims
I claim:
1. A post-surgical pouch for receiving discharge from the stoma of
a patient, comprising a pouch bag having an inner and an outer wall
with the inner wall having a stoma opening, and a sealing member
within the bag composed of a gelatinous adhesive material adhered
to said inner side of the inner wall covering the area surrounding
said stoma opening, the sealing member providing passage of the
stoma for discharge into the bag and having sealing engagement with
the stoma.
2. A post-surgical pouch as set forth in claim 1, in which the
gelatinous sealing member is molded to the inner side of the inner
side wall around the area of the stoma opening therein, and in
which a gasket member is embedded in the sealing member and has a
belt connector extending from each lateral side of the sealing
member.
3. A post-surgical pouch as set forth in claim 1, in which the
sealing member has an opening at its center in alignment with the
stoma opening in the inner side wall of the bag.
4. A post-surgical pouch as set forth in claim 1, in which the
outer side wall of the bag is provided at its inner side with a
release coating covering the adjacent side surface of the sealing
member.
5. A post-surgical pouch as set forth in claim 1, in which the
sealing member has a through opening in alignment with the stoma
opening in the inner wall of the bag, and the outer wall of the bag
has a release coating on its inner side covering the adjacent side
surface of the sealing member.
6. A post-surgical pouch as set forth in claim 1, in which the
sealing member has a central through opening of a given minimum
diameter in alignment with the stoma opening in the inner wall of
the bag, and in which the stoma opening in the outer wall of the
bag is of a given maximum diameter.
7. A post-surgical pouch as set forth in claim 1, in which the
sealing member has a through opening of a given minimum diameter in
alignment with the stoma opening in the inner wall of the bag and
said stoma opening in the bag is of a maximum diameter, the outer
wall of the bag having at its inner side a release coating covering
the adjacent side surface of the sealing member, and the inner side
wall of the bag having at its inner side a release coating covering
an area larger than said maximum diameter of the opening in said
inner side wall.
8. A pouch for receiving discharge from a stoma or the like of a
patient, comprising a pouch bag having an inner and an outer wall,
the inner wall having a stoma opening, a sealing member adhered to
the inner side of the inner wall covering the area around the stoma
opening, said sealing member consisting of ingredients which
provide a gelatinous member having adhesive, elastic, and resilient
properties, a reinforcing gasket embedded in the sealing member and
having extensions at opposite edges forming belt connectors, said
sealing member having a central through opening in alignment with
said stoma opening in the bag, the central opening in the sealing
member being of a given minimum diameter for entry of a small stoma
and the stoma opening in the bag being of a maximum diameter for
passage therethrough of larger stomas.
9. A post-surgical pouch for receiving discharge from the stoma of
a patient, comprising a pouch having spaced inner and outer walls
closed on all peripheral edges and imperforate so as to form an
enclosure sealed from the outer atmosphere, a ring member located
inside the pouch composed of gelatinous material having resilient,
adhesive properties, said member positioned against the inner side
of the inner wall at a stoma entrance location and adhering to said
inner side, a coating of release material at the inner side of the
outer wall covering the area of the ring member, the inner wall
adapted to be opened prior to use of the pouch to permit entrance
of the stoma into the pouch through the ring member and to expose a
portion of the ring member for sealing engagement with the skin of
the patient around the stoma.
10. A post-surgical pouch as set forth in claim 9, in which the
ring member has a central opening, whereby after the inner wall has
been opened to provide a stoma opening, an object may be inserted
through said stoma opening and through the central opening in the
ring member into contact with the release coating on the inner side
of the outer wall of the pouch, and whereby upon further pressure
of said object outwardly the outer wall will be moved away from the
ring member to provide internal enlargement of the pouch to receive
drainage from the stoma.
11. A pouch for receiving discharge from a stoma or the like of a
patient, comprising a pouch bag having an inner and an outer wall,
the inner wall having a stoma opening, the inner side of the inner
wall forming the cavity of a mold, a sealing member molded in said
cavity to the inner side of the inner wall covering the area around
the stoma opening therein, a reinforcing gasket embedded in the
molded sealing member and having extensions at opposite edges
forming belt connectors, said sealing member consisting of
ingredients which when heated can flow into said mold cavity and
embed said gasket therein and which when cooled will gel to provide
a gelatinous member having adhesive, elastic, and resilient
properties, said sealing member having a central through opening in
alignment with said stoma opening in the bag, the central opening
in the sealing member being of a given minimum diameter for entry
of a small stoma and said stoma opening in the bag being of a given
maximum diameter for passage therethrough of larger stomas, a
release coating on the inner side of the outer wall in an area
covering the adjacent side of the sealing member, and a belt having
means for connecting to the belt connectors of the gasket.
12. A post-surgical pouch for receiving discharge from the stoma of
a patient, comprising: a bag formed of an inner and an outer sheet
of plastic film, a sealing member of gelatinous, adhesive material
molded to the inner side of the inner sheet and having adhesive
engagement therewith, a gasket embedded in the molded sealing
member having belt-connector members projecting beyond its opposite
sides and terminating within the bag, the outer film sheet forming
the side of the bag opposite from the sealing member and having on
its inner side a coating of releasing material covering and
over-reaching the sealing member, the inner and outer film sheets
being connected by heat sealing along their marginal edges whereby
to completely close the interior of the bag from the outer
atmosphere and enclose the sealing member and its gasket extensions
within the bag, the inner sheet having means whereby a portion of
the sheet opposite the sealing member may be removed to provide a
stoma opening and to expose a portion of the sealing member so that
when the pouch is applied to a patient this portion of the sealing
member will be pressed into adhesive sealing engagement with the
skin of the patient around the stoma, and whereby an object may be
pushed through the sealing member before applying such member to
the patient sufficiently to contact the coated release area and
push the outer film sheet away from the sealing member to enlarge
the interior capacity of the bag.
13. As an article of manufacture, a drainage pouch having a bag
formed of plastic film with the interior of the bag closed to the
outer atmosphere, a sealing member of gelatinous adhesive material
positioned within the bag in sealing engagement against an inner
side thereof, the closed bag serving as the outer wrapper of the
article, and means providing a stoma opening through a wall of the
bag to the sealing member and through the sealing member to the
interior of the bag when the pouch is to be used on a patient.
14. As an article of manufacture, a drainage pouch of the character
described having inner and outer side walls of plastic film forming
a bag, the interior of the bag closed to the outer atmosphere, a
sealing member of gelatinous adhesive material located entirely
within the bag, the closed bag serving as the outer wrapper of the
article, means providing for forming a stoma opening in said inner
wall to expose an outer surface of the sealing member when the
pouch is to be used on a patient and whereby a stoma can be passed
through said opening and through the sealing member for discharge
into the bag and whereby said exposed surface of the sealing member
can be pressed into adhesive sealing engagement with the skin of a
patient around the stoma.
15. As an article of manufacture, a pouch for receiving drainage
from the stoma of a patient, comprising a pouch bag having inner
and outer walls of plastic film, a sealing member of gelatinous
adhesive material having sealing engagement with the inner side of
the inner wall, the walls of the bag completely closing the
interior of the bag and the sealing member from the outer
atmosphere, and means for subsequently providing a stoma opening in
the inner wall to expose an outer side surface of the sealing
member and to permit passage of the stoma through the sealing
member for discharge into the bag and whereby the exposed surface
of the sealing member can be pressed into sealing engagement with
the skin of the patient around the stoma.
16. As an article of manufacture, a post-surgical pouch for
receiving discharge from a stoma or the like, comprising a pouch
bag having a stoma opening, and a sealing member in coaction with
said opening comprising for a relatively small batch, one-half
ounce gelatine, 1 ounce corn starch, 1 ounce glycerine, and 8
ounces corn syrup, mixed with water heated and whipped to form a
foam gel (substantially as described) producing a sealing member
product having gelatinous, adhesive, elastic, resilient, and low
water solubility properties.
17. As an article of manufacture for use with a post-surgical pouch
having a stoma opening through which discharge is received from a
stoma or the like, a sealing member comprising a body having a
stoma opening therethrough, the body composed of a mixture of
starch ingredients and other ingredients producing a foamed gel
having properties of adhesiveness, elasticity, resiliency, and
relatively low water solubility.
18. A manufacture comprising a sealing member for use with a
post-surgical pouch having a stoma-receiving opening through which
discharge is received from any size stoma or the like, said sealing
member comprising a body having opposed spaced wall surfaces and a
stoma opening extending through the body connecting said spaced
wall surfaces, the body shaped to cover an area of skin surrounding
the patient's stoma for contact with said area when used on the
patient, the body composed entirely of a mixture of starch
ingredients and other ingredients to form a foamed gel having
adhesive, elastic, resilient, and low water solubility
properties.
19. A pouch for receiving discharge from a patient, and means
adapted to provide a seal between the pouch and the patient around
the discharge area, said means comprising a body of gelantinous
material heated for flowing to a predetermined form and whipped to
a foamed condition for gelling when cooled.
20. A post-surgical pouch for receiving discharge from the stoma of
a patient, the pouch having an opening of given maximum diameter to
receive stomas of relatively large sizes, and sealing means
associated with the pouch in the area of said opening comprising a
body of foamed gelatinous material having a stoma-receiving opening
of given minimum diameter to receive a stoma of relatively small
sizes, said gelatinous material having foamed gel properties of
elasticity and resiliency whereby the body is adapted to be
expanded at its stoma opening to receive larger stomas and the body
will contract around said larger stomas.
Description
This invention relates to drainage pouches for use in post-surgery
in draining the discharge from the stoma of a patient. The
invention is applicable generally in the medical field and
particularly in colostomy, cecostomy, ileostomy, ureterostomy,
ileal conduit, vesicotomy, fistula drainage, and other cases where
there is discharge from a patient for collection into a pouch which
is disposable after use.
Heretofore it has been the practice in this art to make drainage
pouches with the bag of the pouch made of sheet film materials such
as polyethylene, vinylidene chloride and laminates of the two
films. In view of the different sizes of the stomas on different
patients it is customary to provide as a separate article of
manufacture, a separate pouch for each stoma size, sometimes as
many as five to 10 different sizes. It is necessary, therefore, for
the hospitals and other places where these pouches are used, to
carry a large inventory of pouches to take care of the different
needs of the patients. This becomes costly and troublesome in
maintaining a sufficient stock of the various sizes.
One of the objects of my invention is to eliminate the need for
large inventories of pouches by providing a pouch as a single
article of manufacture constructed in such manner that the single
pouch may be used for a wide range of stoma sizes. This makes
unnecessary the manufacture of numerous sizes of pouches and also
eliminates troubles incident to the selection and use of such many
sizes of pouches. This object is attained particularly by a novel
construction in which the sealing member through which the stoma
passes into the pouch has what I have termed a universal stoma
opening, as will be described hereinafter.
Another object of my invention is to provide a drainage pouch of
novel construction, particularly with reference to the sealing
member and its coaction with the film bag of the pouch, whereby the
sealing member is completely enclosed within the bag. Thus the bag
becomes the outer wrapper for the product and, in effect, a single
package which does not require extraneous parts but is in itself a
complete article of manufacture and can be handled and marketed as
such. Furthermore, I have provided a pouch which is a water tight
package in which the interior is kept clean and sterile.
Another object of my invention is to provide an improved drainage
pouch with the view to economy in cost of product, considering the
merits of the product. In this connection I have provided a sealing
member having characteristics and functions new in this art. As
will be described more in detail hereinafter, the sealing member is
composed of gelatinous material having the properties of being
adhesive, elastic, and resilient, and also having relatively low
water solubility. In furtherence thereof, my invention contemplates
a sealing member the composition of which is starch granules,
together with other ingredients described hereinafter. This
produces what I term a foamed gel. In the preferred embodiment of
my invention and as one of its objects, I make a flowable mixture
of this composition and flow it into a mold which provides the
desired shape characterists of the ultimate sealing member. In this
preferred embodiment the sealing member is molded directly in an
operative position within the pouch bag. In this molding operation
a wall of the bag film serves as a mold lining. Another feature is
that because of the elasticity and resilience of the composition
after it is set, the central portion of the sealing member may be
expanded by finger action to admit passage of stomas of different
sizes, in contrast to prior practice of providing sealing members
having a large variety of stoma opening sizes. Further in this
phase, my invention contemplates a universal stoma opening which
provides a snug fit around the stoma of any size. This is
accomplished without causing strangulation of the stoma but
providing an effective seal to permit discharge from the stoma from
contacting the skin of the abdomen surrounding the stoma which
would cause excoriation of the skin.
Another object of my invention is to provide an improved belt means
for fastening the pouch to the patient, with the view to more
accurately and firmly holding the pouch in position without placing
the bag under too much tension. In one phase of my invention the
belt has a connector at each end which hooks into a gasket which is
part of the sealing member. The construction is such that the belt
connections are made without opening the pouch or admitting air to
the interior thereof.
Another object is to provide a low cost disposable belt for use
with the drainage pouch.
A further object is to provide a novel method of making a drainage
pouch of the character described. This method includes steps or
operations some of which are specific to the preferred
construction, that is, the construction here shown for molding the
sealing member in connection with the bag. It will be apparent,
however, that some of the steps or operations are useful beyond
this specific construction.
Referring to the drawings:
FIG. 1 is a face view of the outer side of a pouch, opposite from
the side attached to the patient, embodying one species of my
invention, with a cut-away to show a portion of the enclosed
gelatinous sealing member;
FIG. 2 is a face view of the inner side of this pouch, showing a
circular cut-out of the inner film sheet providing a stoma opening
in the pouch;
FIG. 3 is a section lengthwise of this pouch taken on the section
line 3--3 of FIG. 1;
FIG. 4 is a face view of a gasket which is to be molded in the
sealing member;
FIG. 5 is a perspective view of a mold box used in making the pouch
shown in FIG. 1;
FIG. 6 is a cross-section taken substantially on the section line
6--6 of FIG. 1, showing the mold box and the gasket in position for
molding;
FIG. 7 is a similar section showing the gelatinous material poured
into the mold with a center core in position;
FIG. 8 is a similar section showing the mold box and core removed
and the outer film sheet in position closing the sealing member
within the pouch;
FIG. 9 is a side view of a connector at each end of a belt for
hooking into one end of the gasket shown in FIGS. 1 and 4, or in
FIGS. 16 and 17 in the slits at the sides;
FIG. 10 is a top view of the belt connector shown in FIG. 9;
FIG. 11 is a face view of the outer side of a pouch embodying
another species of my invention, with a portion of the outer film
sheet cut away to show a portion of the gelatinous sealing
member;
FIG. 12 is a face view of a modified form of gasket used in the
pouch shown in FIG. 11;
FIG. 13 is a side view of the belt connector at each end of a belt
for hooking into the gasket shown in FIGS. 11 and 12;
FIG. 14 is a top view of the belt connector shown in FIG. 13;
FIG. 15 is a section on the section line 5--5 of FIG. 13;
FIG. 16 is a face view of a further modified form of pouch
embodying my invention;
FIG. 17 is a face view of a further modified form of a pouch
embodying my invention;
FIG. 18 is a section taken on the section line 18--18 of FIG.
17;
FIG. 19 is a perspective view of one end of a belt used with
pouches such as shown in FIGS. 16 and 17, or FIG. 1;
FIG. 20 is a similar view of the belt shown in FIG. 19 with a short
cover sheet (release paper) removed to expose a pressure sensitive
adhesive on the belt;
FIG. 21 is a face view of the outer film sheet used in the pouch
shown in FIG. 1, showing the sheet before it is used in making the
pouch;
FIGS. 22 to 29 inclusive show diagrammatically a series of steps in
the manufacture of a pouch in accordance with my invention, with
brief memoranda of the operation shown in each figure;
FIG. 30 is a perspective view of a modified form of mold used with
my invention;
FIG. 31 shows the mold of FIG. 30 in pouring position on the film
sheet;
FIG. 32 is a perspective view of a further modification of mold
construction used with my invention.
My invention also contemplates generic and specific constructions.
And, inasmuch as both article and method claims are involved, I
will for purpose of clarity, start with a description of the
article of manufacture shown in FIG. 1 together with the method of
making it. As is customary in this art I use plastic film such as
polyethylene, vinylidene chloride or laminations of the two films
for the pouch bag or body, but other materials may be used suitable
for the purposes of my invention. In this instance the bag is
formed of a single sheet of film designated by the reference
numeral 41 of uniform width (see FIG. 21) bent upon itself at 42
midway between its ends to provide an inner side wall 43 and an
outer side wall 44. The inner side wall 43 will be positioned
against the body, but other materials may be used suitable for the
purposes of my invention. In this instance the bag is formed of a
single sheet of film designated by the reference numeral 41 of
uniform width (see FIG. 21) bent upon itself at 42 midway between
its ends to provide an inner side wall 43 and an outer side wall
44. The inner side wall 43 will be positioned against the body of
the patient when the pouch is in use. Before the outer side wall is
moved to its bag-forming position shown in FIGS. 1 and 3 and is
flat as shown in FIG. 22, a gelatinous sealing member designated
generally by 45 is molded to the inner side of the inner wall 43 as
will be presently described. Following this, the outer wall 44 will
be folded over to the bag-forming position. While in this position
the bag will be closed by heat sealing at 46 along the entire
length of the bag at both sides and across the end 47, thus
completely closing the bag to the outer atmosphere. Returning now
to the molding of the sealing member, reference is made to FIGS. 1
to 8 inclusive and FIGS. 22 to 28 inclusive. However, prior to this
molding operation a coating of release material is applied to one
side of the film sheet at areas 48 and 49, the purpose of which
will be presently apparent. Also prior to the molding, means is
provided such as a marking by a circle 51 concentric with the
release area 49 but on the side of the film sheet opposite from
said release area for cutting out this circle portion of the film
to provide a stoma opening 52 therein. Continuing with the method,
a mold-box designated generally by 53 is positioned beneath the
filmsheet in registration with the marking 51, as shown in FIG. 23.
This mold-box defines the general depth and configuration of the
sealing member to be molded. In this embodiment it is rectangular;
in FIGS. 11, 16 and 17 it is circular. It may be varied. The film
overlying the mold-box is then pressed or drawn by any suitable
means into the cavity of the mold as shown in FIG. 24. By pressing
the film sheet into the mold the film becomes a lining for the mold
and the resulting sealing member will be adhered to the film and
the bag. It will now be noted that a locating notch 54 is provided
in each of the walls 55 of the mold. A gasket designated generally
by 56 provided with extensions 57 is placed into the mold with the
extensions 57 fitting into the notches 54, thereby positioning and
locating the gasket within the mold. In this position it will be
noted that the extensions 57 are pressed down over the film and the
film is pressed into the notches. The body of the gasket is
supported intermediate the top and bottom of the mold. The ring
body of the gasket is perforated as by openings 58 which receive
the gelatinous material when it is poured into the mold, as will be
presently described. A center core 59 circular in cross-section is
then positioned in the mold as shown in FIG. 26. This core forms a
stoma opening 60 in the center of the sealing member. However, as
described below, the sealing member may be used without this center
opening. The mold and coacting parts are now in position for
pouring in the gelatinous material. This material is prepared so
that when heated it can flow and when cooled it will set or gel
into shape. Thus, when the material is poured into the mold it will
flow into all cavities including the perforations 58, with the
result that the gasket 56 will be embedded in the mold as shown in
FIGS. 1, 2, 3, 7, 27, 28 and 29. It will be understood that the
drawings are somewhat diagrammatic in view of the difficulty of
showing the exact shape of the film around the molded member. When
the gelatinous material sets or gels, the core 59 will be removed,
leaving the parts as shown in FIG. 28. The end half of the film
sheet opposite from the molded end will now be folded over at 42 to
provide the outer wall 44 of the bag, as shown in FIGS. 3 and 29.
The bag will now be heat sealed along the edges 46 and 47 as
described, thereby entirely closing the interior of the bag to the
outer atmosphere. The pouch is now complete and ready for use. At
this point it will be noted that the sealing member 45, the belt
connector ends 57, and the interior of the bag are completely
enclosed, thus protecting and preserving the functioning parts of
the pouch. Also, this construction provides a water tight package
which prevents drying out of the gelatinous sealing member and
keeps the interior of the package clean and sterile. Also, the film
body which forms the bag becomes a wrapper for the article of
manufacture so that we now have a package which can be handled,
shipped, and stored without harm to the interior parts. When the
pouch is to be used, that is, applied to a patient, the circular
portion of the side wall 43 noted by the circle marking 51 will be
cut out, using a scalpel, razor blade, sissors, or suitable sharp
implement. This cut-out 51 is facilitated because its inner surface
has the release coating 49 which releases from the sealing member.
This now exposes the central opening 60 in the sealing member and
also the sealing surface of such member surrounding the opening 60.
This opening is intended for the smallest stoma and the opening
defined by the cut-out 51 the largest stoma needs. In applying the
pouch to the patient the attendant will first press an object (such
as the finger) through the opening 60 until it contacts the inner
surface of the outer wall and upon further pressure this outer wall
will be pushed outwardly, thus releasing the area 48 from adhesion
to the sealing member. This opens the bag for placing the stoma in
position to discharge into the bag. In practice it is suggested
that the attendant insert wet fingers into the opening 60 and
expand the sealing member to provide an opening slightly larger
than the stoma to which the pouch is to be applied. Because of the
expansible and resilient nature of the gelatinous material, this
material may be easily spread to receive the stoma. The gelatinous
material will contract and seal around the stoma. The attendant
gently presses the central portion of the pouch, particularly the
portion of the sealing member disposed within the circle cut-out
51, against the abdomen of the patient, thereby sealing the member
45 to the skin of the patient around the stoma. A belt is used to
insure better attachment of the pouch to the patient. In this
instance a belt 61, FIG. 9, is provided at each end with a
connector 62 in the form of a hook which is adapted to be hooked
into a slot opening 63 in one of the gasket extensions 57. Each
such slot opening is also through the inner and outer film sheets
and these sheets are heat sealed together at 64 surrounding the
area through which the slots pass. This seals the interior of the
bag from any air or water passage into or out of the bag in the
belt connector area. Suitable means (not shown) is provided for
tightening the belt, as is well known in the art.
Referring now to the composition of the sealing member 45: I refer
to this as foamed gel and in my work on the invention I have used
corn starch as the basic gelling ingredient and water as the
vehicle. Gelatine was used as the agent to permit mechanical
whipping or beating of the blended ingredients into a foam. Also,
corn syrup and glycerine were used as modifying agents. As an
example in making a small batch as distinguished from large batches
such as would be used in production manufacture, I have used the
ingredients by weight as follows: One-half ounce unflavored
gelatine; 1 ounce corn starch (thin boiling type); 1 ounce
glycerine; 8 ounces corn syrup; separate containers of water in
quantities presently noted; and several drops of food color dye. In
making this small batch I proceeded as follows: Pre soak in a first
beaker the one-half ounce of gelatine in 6 ounces of cold water for
one-half hour, then raise the temperature to 150.degree. F. to
insure that all the gelatine has gone into solution. In a second
beaker blend the 8 ounces of corn syrup, 1 ounce of glycerine, and
4 ounces of water and bring to a slow boil. In a third beaker blend
the 1 ounce of corn starch into the 4 ounces of cold water and
gradually stir into the second beaker. Heat this to a boil and
continue the heating and stirring until the mixture has turned from
a cloudy to a clear solution. This will take from 5 to 10 minutes.
Clarity is an indication that the starch particles have absorbed
adequate water. Remove second beaker mixture from the heat and
continue to stir until the starch solution temperature drops to
150.degree. F. Add the contents of the first beaker into the second
beaker plus a few drops of a suitable food color to provide a
yellow tan-like color. If food color is not added, the foam gel
will be white. Whip this mixture as with an electric kitchen egg
beater, using the highest speed, usually from 3 to 5 minutes. This
mixture is in condition for pouring into the mold. This foam
mixture required about 4 hours to gel or set at room temperature.
In production manufacture, suitable means may be used to reduce the
time for the mixture to gel. Also in production, to counteract
bacterial action on the starch gel, food perservatives can be added
to the mixture during the blending and whipping. Some of these
preservatives are sodium benzoate, ascorbic acid, lactic acid,
methylparaben soda propionate, etc. This description of
ingredients, volumes, times and temperatures is for purpose of
illustrating a single method such as what might be termed a
laboratory batch example. It should be understood, therefore, that
where industrial equipment is available, foam gels for my invention
may be produced on a continuous basis. Also, as to the steps in the
method illustrated in FIGS. 22 to 29 inclusive, this is subject to
variation according to the industrial equipment used and whether
the operations should be carried out automatically in sequence or
in several stages.
From the foregoing it will be apparent that my invention
contemplates the provision of a gelatinous member which has the
characteristics or properties of being flexible, resilient,
adhesive, and of relatively low water soluability. The foam gel
here described is somewhat sticky and will adhere to almost any
material surface. It will adhere well to the skin around the stoma
of a patient. Because of its resilient nature it may be easily
expanded at its center to accommodate different stoma sizes and it
will have contracting tension on the stoma without strangulation
effect. Also, it has relatively long life because of its water
insoluability.
It should be noted that my invention contemplates the use of
ingredients and proportions other than described herein, for
producing a sealing member having the characteristics described.
For example, there are many starches or starch-like ingredients
such as from potato, wheat, and rice starches, tapioca, and others.
Also, other agents may be used for cross linking the starch
molecules and the gelatin molecules which will make the molecules
less soluable in water. Some such agents are glyoxal and
formaldehyde.
Referring now to further pouch modifications:
FIGS. 11 and 12 show a pouch generally similar to that shown in
FIG. 1 except that the gelatinous sealing member here designated by
65 is circular and the gasket 66 is provided with belt connector
terminals 67 of different shape. That is, each terminal has
laterally projecting ears 68 making a T-shaped connector. The belt
69, FIGS. 13, 14 and 15, usually of fabric, is provided at each end
with a terminal hook 71 shaped to fit over one of the T-shaped
connectors 67. These connectors 67 are enclosed within the bag as
shown at the left in FIG. 11 to permit pushing the hook end 71
against film 43 and connector 67 and hooking it onto the terminal
connector 71. The T-connector and film 43 both lock into 72 or
connector 67 without piercing the film.
FIG. 16 shows a pouch generally similar to that of FIG. 1 except
that no gasket is used and the film sheet is shaped to provide side
extensions 74 having through slots 75 and heat seals 76 around the
belt slots 75. The plastic film in this modification is heavier so
that it better absorbs and carries the belt tension.
FIG. 17 is similar to FIG. 16 except that tabs 77 of heavier film
are applied to the side portions of the bag, straddling the bag,
and are united thereto by the heat sealing 46.
In FIGS. 18 and 19 I have shown a disposable belt which is used
with the described pouches in place of the belts 61 and 69. It is
common in prior practice to use belts of fabricated materials which
when soiled are washed and reused. This is time consuming and
objectionable. I have provided a disposable belt to be supplied
with each disposable pouch. As shown in these figures this belt is
laminated, composed of a paper or thin fabric tape 78 and a plastic
tape 79 suitably adhered one to the other. The side 78 is used
against the body because this side is porous to permit perspiration
absorption. To each end of the belt an adhesive coating 81 is
applied to the plastic side. This adhesive is of the pressure
sensitive type. A short strip of release paper 82 covers and is
adhered to the area 81. The belt can be attached at one end to the
pouch or to the gasket by stapling, riveting, heat sealing, or by
passing one end of the belt (such as that shown in FIG. 18) through
one of the slots 75; removing the strip 82, and folding the
adhesive end back on the plastic side of the belt and pressing it
into fixed adhesive connection therewith. When the pouch has been
applied to the patient as above described, the belt will be wrapped
around the patient and its free end will be passed through the
opposite slot in the pouch and drawn taught. This latter end can be
provided with the adhesive fastening shown in FIG. 18 and fastened
to the belt, as described, or the belt can be looped or tied in the
holding position.
In FIGS. 30, 31 and 32 I have shown several means for molding the
sealing member 45 in the bag without using a reusable mold-box such
as 53. In FIG. 29 I show a strip of paper 83 about nine-sixteenths
inch high, to be formed into a circle, square, oblong, or any
desired configuration, to serve as the outer wall of a mold. In
this figure the paper strip, wound around a gasket 66, is slotted
at 84 to receive the T-shaped belt connectors of the gasket. This
mold will be positioned on the film sheet at the same location as
the mold-box 53 in FIG. 22 except that the film sheet would be
inverted because the gel would be poured into the paper mold from
the top. This is shown in FIG. 31, diagrammatically. This paper
mold will remain in this position on the film sheet until the
gelatinous material has jelled and could remain in the bag. In FIG.
32 I have shown a modified plastic gasket and mold which remains in
the bag, similar to the paper mold in FIGS. 30 and 31. In FIG. 32
the gasket has formed integral therewith, thin lips 85 which extend
above and below the circular body of the gasket at the periphery
thereof. These lips provide the side wall of the mold.
It is believed that the foregoing conveys to those skilled in this
art the manner and process of making and using drainage pouches
contemplated by my invention. It will be understood also that my
invention contemplates various species and that modifications may
be made in the construction of the drainage pouch and in the method
of manufacture without departing from the spirit and scope of the
invention expressed in the appended claims, in which:
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