Urinary drainage container comprising external source of biocide

A patient-care apparatus comprising a container for receiving a biological fluid, and a delivery device on the outside of the container, which device comprises a biocide that is released to the container for preventing the multiplication of and/or eliminating the presence of unwanted pathogens in the container.

FIELD OF THE INVENTION 
This invention pertains to a patient-care apparatus comprising, in 
combination, a container comprising an external biocidal means releasably 
positioned on the outside wall of the container for delivering a biocide 
through the wall into the container. More specifically, the invention 
relates to an urinary drainage container comprising an external source of 
biocide. The biocide is delivered into the container for preventing and 
eliminating the presence of unwanted pathogens present inside the 
container. 
BACKGROUND OF THE INVENTION 
It is now generally acknowledged that indwelling catheterization in 
medical, surgical, gynecological, urological and other patients leads to 
serious infection of the urogenital tract. The process of indwelling 
catheterization is performed in approximately 10 to 15 percent of 
hospitalized patients. Despite the use of the most careful aseptic 
techniques undertaken while the catheter is in the patient, approximately 
fifty percent of the patients develop an infection when a catheter is in 
place for twenty-four hours or longer. This is harmful to the patient 
because they are subjected to the risk of cystitis, acute pyelonephrititis 
and life-threatening septicema, which carries a risk of mortality, as 
reported in Arch. Internal Med., Vol. 110, pp 703-11, (1962); Antimicrob. 
Agents Chemother., pp 617-23, (1963); and Lancet. Vol. 1, pp 310-12, 
(1960). 
The occurrence of the above-mentioned infections is encouraged by many 
circumstances. These circumstances include prolonged use of indwelling 
Foley catheters often accompanied by the absence of a sterile insertion 
and maintenance techniques, and by having the catheter connected to a 
clean, but not sterile drainage collection container placed in the 
immediate vicinity of the patient's bed. These and other circumstances 
that predispose a patient to infection are reported in Urinary Tract 
Infection And Its Management, edited by Kaye, D., Chapter 15, "Care of the 
Indwelling Catheter," pp 256-66, (1972), published by the C. V. Mosby 
Company, St. Louis, Mo.; and in "Factors Predisposing To Bacteriuria 
During Indwelling Urethral Catheterization," New Eng. J. Med., Vol. 291, 
pp 215-23, (1974). 
Attempts have been made to reduce the incidence of catheter acquired 
infection and to reduce the presence of unwanted organisms in drainage 
containers, but these attempts have not met with general acceptance. For 
example, one attempt consists in systemic chemoprophylaxis achieved by 
orally administering an antibiotic such as chloramphenicol, penicillin or 
streptomycin. This attempt, however, affords no significant protection 
against the acquisition of infection after indwelling catheterization, as 
reported in Arch. Internal Med., Vol. 110, pp 703-11, (1962); Acta Chiv. 
Scand., Vol. 118, pp 45-52, (1959); and Dis. Mon., pp 1-36, (Sept. 1960). 
The attempts for preventing or eliminating unwanted organisms also include 
adding a biocide to the inside of a drainage container, or placing a 
device inside the container wherein the device releases a biocide. For 
example, formalin is added to the fluid collection container for 
controlling, that is, killing pathogens. This method, however, does not 
enjoy general use because there is a risk of siphoning formalin into the 
urinary tract, as reported in British Med. J., Vol. 2, pp 4233-25, (1964). 
In U.S. Pat. No. 4,233,263 the patentee Shaeffer disclosed adding 3% 
hydrogen peroxide solution to a urine bag for reducing the risk of urinary 
tract infection. This method is inherently subjected to poor results 
because of a lack of compliance. This is, each time urine is drained from 
the urinary drainage bag the hydrogen peroxide is drained and it must be 
reintroduced into the bag. This requires mixing and agitation, and it is 
often accompanied by spilling of the solution. Also, hydrogen peroxide 
loses its strength over time. In U.S. Pat. Nos. 4,193,403 and 4,241,733 
Langston et al discloses a device inside a urinary drainage bag. The 
device contains paraformaldehyde that depolymerizes to formaldehyde in the 
presence of moisture inside the drainage bag. While formaldehyde is an 
antimicrobial, it is not used because it may be injurious to an animal 
host. 
It will be appreciated by those versed in the urinary drainage art that, in 
view of the above presentation, a critical need exists for a novel and 
unique means for introducing a biocidal agent into a urinary container. 
The need exists for overcoming the difficulties associated with the prior 
art use of an internal biocide and an internal delivery device. It will be 
further appreciated that a pressing need exists for a means that is not 
introduced into the container, but can provide a biocidal agent from an 
external delivery source in contact with the outside of the drainage 
container. 
OBJECTS OF THE INVENTION 
Accordingly, it is an immediate object of the invention to provide an 
improvement in urinary drainage collection, which improvement overcomes 
the disadvantages associated with the prior art. 
It is a further object of the invention to provide a drainage collection 
system comprising, in combination, a urine receiving container and means 
for positioning on the exterior of the container for delivering a biocide 
that enters the container for preventing the multiplication of and/or the 
elimination of pathogens in the container. 
Another object of the invention is to provide a delivery device that is 
releasably mounted on the exterior of the urine receiving container for 
delivering a biocidal agent into the container. 
Another object of the invention is to provide an urinary drainage container 
with an external detachable dispensing device that releases an 
antipathogenic agent, and which detachable dispensing device embraces 
inventive simplicity, is inexpensive to make, and is disposable. 
Another object of the invention is to provide a delivery device for 
positioning on the external surface of a drainage container, wherein the 
delivery device comprises a shape that corresponds to the shape of the 
external surface of the container. 
Another object of the invention is to provide a detachable pouch for 
positioning on the outside wall of an urinary drainage container, and 
which pouch contains a biocide that passes through the wall into the 
container for preventing bacterial contamination within the container. 
These and other objects of the present invention will become more apparent 
upon a consideration of the drawings, the specification and the 
accompanying claims.

DETAILED DESCRIPTION OF THE DRAWINGS 
Turning now to the drawings in detail, which are examples of various 
embodiments of the invention, and which examples are not to be construed 
as limiting the invention, one embodiment of an urinary drainage container 
is indicated in FIG. 1 by the number 10. In FIG. 1, there is illustrated 
one embodiment of a bedside drainage container 10 designed for use in a 
closed catheter system. In one preferred manufacture bedside drainage bag 
10 is made from two films of polyvinyl chloride plastic 11 and 12. The two 
films are sealed to each other around their peripheral edges, for example 
by an electronic welding procedure or heat sealed to each other to provide 
sealed container 10. Optionally one wall comprising the container may be 
transparent or translucent for exposing the contents of the container. In 
a preferred embodiment, the other wall is opaque. The wall is made opaque 
by the addition of TiO.sub.2. Drainage container 10 preferably is 
manufactured as a bag, and it is provided with an inlet fitting 13 for 
receiving a catheter for letting fluid flow into the container. Drainage 
container 10 also is provided with a drainage assembly 14 for periodically 
draining the contents of the container. A hook 15 is fixed to the top of 
container 10 for hanging the container on a bedside stand. 
In FIG. 1, container 10 is illustrated in an essentially closed or flat 
state. Container 10, when put into use, generally is free of air at the 
beginning of receiving fluid from a patient. Over time, as fluid drains 
into container 10, flexible walls 11 and 12 bulge outward, thereby 
increasing the space inside the container for receiving an increasing 
volume of urine. 
In another embodiment container 10 may be manufactured as a bag comprising 
a flexible polymeric composition. Container 10, when made as a bag, can be 
produced by blowing an extruded tube of the polymeric composition to 
conform to the interior of a mold cavity having the desired configuration. 
In a presently preferred embodiment at least one of wall 11, or wall 12, or 
both wall 11 and wall 12, is made from a polymeric composition that 
permits the passage of a biocidal agent from an outside delivery source 
through wall 11 or wall 12 into the inside of container 10. Representative 
polymeric composition for forming walls 11 and 12 comprise olefin 
polymers, vinyl polymers, condensation polymers, addition polymers, rubber 
polymers and silicon polymers. More specific polymers comprise a member 
selected from the group consisting of polyethylene, polypropylene, 
polyvinyl acetate, polyvinyl acetal, polyvinyl chloride, polyamide, 
polyester, butadiene rubber and organosilicon polymers. Walls 11 and 12 
optionally comprise a plasticizer such as a member selected from the group 
consisting of phthalate ester, adipate ester, sebacate ester, azelate 
ester, di-2-ethylhexyl phthalate, butyl phthalyl butyl glycolate, diamyl 
phthalate, dibutyl succinate, diethylene glycol dipropionate, 
ethylphthalyl, ethylglycolate, tributyl citrate, tributyl phosphate, 
triethylene glycol dibutyrate, glycol monoleate, polyethylene glycol 200; 
polyethylene glycol 400-ML, diethyl lauramide, oleic and mineral oil, and 
the like. The amount of plasticizer in a wall is from 0.01 weight percent 
(wt %) to 10 wt %, or more. 
FIG. 2 illustrates an urinary drainage container 10 comprising a wall 11, a 
wall 12, an inlet 13, an outlet port 14, a hook 15, and a biocidal 
delivery device 16 releasably positioned on the outside wall 12 of 
container 10. Delivery device 16 can be placed at any position on the 
outside of the container, usually near the bottom. Also, delivery device 
16 can be positioned vertically on the outside wall of container 10. 
FIG. 3 depicts the urinary drainage container 10 of FIG. 2 comprising wall 
11, wall 12, inlet port 13, outlet port 14, hanging hook 15 and biocidal 
delivery device 16 releasably mounted onto an external surface of wall 12 
of container 10. In FIG. 3, delivery device 16 is peeled-open at 17 for 
illustrating delivery device 16 in biocide 18 delivery position on wall 
12. Delivery device 16, in one embodiment, is a reservoir formed of a 
polymeric composition comprising a biocide agent 18. The polymer 
composition stores and releases a biocide 18 by diffusion or by osmotic 
action to wall 12. Representative polymers for forming delivery device 16 
comprise a homopolymer, copolymer, cross-linked polymer, diffusion polymer 
or a microporous polymer. Examples of polymers include acrylic polymers 
and copolymers of methacrylate, ethylacrylate, ethylmethacrylate, and 
methylmethacrylate; homopolymers and copolymers including 
vinylchloride-vinylacetate copolymer; chlorinated vinyl chloride; 
polyethylene; polypropylene; ethylene-propylene copolymer; chlorinated 
polyethylene; ethylene-vinyl acetate copolymer; styrene-butadiene 
copolymer; acrylonitrile-styrene-butadiene terepolymer; polyvinylidene 
chloride; vinylchloride-acrylonitrile copolymer; vinylchloride-vinylidene 
chloride copolymer; vinylidenechloride-acrylate ester copolymer; 
polybutylene terephthalate; vinylchloride-acrylate ester copolymer; 
cross-linked polyvinyl acetals such as cross-linked polyvinyl formal; 
cross-linked polyvinyl acetal and cross-linked polyvinyl butyral; 
polyethers; polyesters; sparingly cross-linked polyesters; polyurethane; 
polyamide; chlorosulfonated polyolefins; polyolefins; polybutadiene; 
polyisoprene; polysilicone; and the like. The polymers are known in The 
Handbook of Common Polymers, by Scott et al., (1971), published by CRC 
Press, Cleveland, Ohio; in Modern Plastics Encyclopedia, (1979), published 
by McGraw-Hill Inc., New York, N.Y.; and in Handbook of Plastics and 
Elastomers, by Harper, (1976), published by McGraw-Hill Inc., San 
Francisco, Calif. 
The biocides useful for the purpose of the invention include a member 
selected from the group consisting essentially of a phenol, quaternary 
ammonium biocides, surfactant biocides, chlorine-containing biocides, 
quinoline, quinaldinium, lactone, antibiotics, dye, thiosemicarbazone, 
quinone, sulfa, carbamates, urea, salicylamide, carbanilide, amide, 
guanide, amidine, chelate and imidazoline biocides. 
Exemplary biocidal dyes include acridine, acriflavine, aminacrine 
hydrochloride, proflavin hemisulfate, triphenylmethane, magenta, crystal 
violet, scarlet red, pararosaniline, and rosaniline. Exemplary chlorine 
releasing biocides include sodium hypochlorite, oxychlorosene, chloramine, 
dichlorodimethylhydantoin, halazone, dichloramine, chlorasine, 
succinchlorimide, trichloroisocyanuric acid, dichloroisocyanurate, 
trichloromelamine, dichloroglycoluril, halogenated dialkyl-hydantoin, and 
halane. 
Exemplary biocidal quinaldinium and quinoline biocides are dequalinium, 
laurolinium, hydroxyquinoline, lioquinol, chlorquinaldol and halquinol. 
Exemplary quaternary ammonium biocides include pyridinium biocides, 
benzalkonium chloride, cetrimide, benzethonium chloride, cetylpyridinium 
chloride, chlorphenoctium amsonate, dequalinium acetate, dequalinium 
chloride, domiphen bromide, laurolinium acetate, methylbenzethonium 
chloride, myristyl-gamma-picolinium chloride, ortaphonium chloride, and 
triclobisonium chloride. Exemplary furans include greseofulvin, 
nitrofurfural, nitrofurazone, nitrofurantoin, furazolidone, and 
furaltadone. 
Exemplary phenol biocides include a member selected from the group 
consisting essentially of chlorinated phenol, cresol phenol, thymol, 
chlorocresol, chloroxylenol, hexachlorophane, bisphenols, amylmetacresol, 
bithionol, chlorothymol, dichloroxylenol, chiorophene, p-chlorophenol, 
p-phenylphenol, trinitrophenol, dichlorobisphenol, and 
bromochlorobisphenol. Exemplary antibiotics include penicillins, 
gentemyctin, aminoglycosides, benzylpenicillin, ampicillin, tetracylines, 
cephalosporins, neomycin, chloramphenicol, vancomycin, fudicin, 
rifampicin, cephaloridine, erythromycin, actinomycin, neomycin, polymyxin, 
colistin, gentamicin, bactriun, carbenicillin and streptomycin. Exemplary 
lactones include propiolactone. Exemplary urea biocides include 
noxytiolin, polynoxylen and triclocarbon. 
Examples of other biocides useful for the purpose of the invention are 
chlorhexidine gluconate, chlorhexidine, chlorhexidine acetate, 
chlorhexidine hydrochloride, dibromopropamide, halogenated 
diphenylalkanes, cibromsalan, metabromsalan, tribromsalan, carbanilide, 
salicylanilide, tetrachlorosalicylanilide, trichlorocarbanilide, propamide 
isethionate, pentamidine, picloxydine, mendalamine, methenamine salts, the 
acid addition and quarternary, methenamine mandelate, polyoxmethylene 
esters such as polyoxmethylene diester, polyoxmethylene diacitate, and the 
like, and mixtures thereof. 
The amount of biocide in device 16 generally will be about 0.1% to 80% by 
weight, with a more preferred amount of 5% to 50% by weight. The device 
can be manufactured for releasing anti-infective amounts of biocide over a 
prolonged period from several hours to 30 days or longer, with a more 
preferred period of 1 to 14 days. The devices of the invention release 
from 10 ng to 750 mg per hour, or higher. One device can be used at a 
time, or two or more devices can be used at a time. The devices can be 
used in succession, and more than one device can be used simultaneously. 
The biocides kill, prevent or retard the presence of harmful or unwanted 
microorganisms inside a urine container. Typical microorganisms include 
the fungi Aspergillus niger, Aspergillus flavus, Rhizopus nigricans, 
Cladosporium herbarium, Epidermophyton floccosum, Trichophyton 
mentagrophytes, Histoplasma capsulatum, and the like. The term, 
"micro-organisms," also includes Pseudomonas aeruginosa, Escherichia coli, 
Proteus vulgaris, Staphyloccus aureau Streptococcus faecalis, Klebsiella, 
Enterobacter aerogenes, Proteus mirabilis, other gram-negative bacteria 
and other gram-positive bacteria, mycobactin, and the like. The term also 
embraces yeast such as Saccharomyces derevisiae, Canndida Albicans. and 
the like. Additionally, spores of micro-organisms, viruses and the like, 
are within the intent of the invention. 
The biocides are disclosed in Disinfection, Sterilization and Preservation, 
by Block, (1977), published by Lea & Febiger, Philadelphia, Pa.; in 
Inhibition and Destruction of Microbial Cells, by Hugo, (1971), published 
by Academic Press, New York, N.Y.; in Martindale, The Extra Pharmacopoeia, 
edited by Blacow, published by The London Pharmaceutical Press, London; 
and in U.S. Pat. No. 4,445,889. 
Delivery device 16 can be releasably held on the outside wall of a drainage 
container by an adhesive. Representative adhesives include a mixtures of 
2-cyanoacrylate and dimethyl methylenemalonate, monomeric ester of 
alpha-cyanoacrylic acid, cross-linked copolymer of 
dimethylaminoethylmethacrylate and an alkyl acrylate, adhesive composition 
comprising a hydrocolloid gum, polyisobutylene and cross-linked dextran, 
silicone medical adhesive, mineral oil-polyisobutylene adhesive, and the 
like. The adhesive optionally can contain a rheological agent that imparts 
thixotropic characteristics to the adhesive, aids in increasing its 
cohesiveness and bond strength, imparts slump control, maintains the 
delivery device on the container, and lets it be easily removed therefrom 
at the end of the delivery period. The rheological agents useful for this 
purpose are silicone compounds such as fumed silica. 
FIG. 4 is a sectional view through 4-4 of FIG. 2. In FIG. 4, there is 
illustrated urinary drainage container 10, comprising two walls, wall 11, 
and wall 12, delivery device 16 positioned on outside of wall 12, for 
supplying a biocide to the lumen or inside 19, of drainage container 10. 
FIG. 5 is a sectional view through 4--4 of FIG. 2. In FIG. 5, there is 
illustrated urinary drainage container 10 comprising wall 11, wall 12, 
lumen 19, and delivery device 16. In FIG. 5, delivery device 16 is covered 
or laminated with a membrane 20 impermeable to the passage of biocide 21 
in device 16. The presence of impermeable membrane 20 insures 
unidirectional passage of biocide 21 through wall 12 into lumen 19. 
Backing member 20 comprises occlusive, nonoclusive, flexible and 
non-flexible materials. Examples of materials that can be used for backing 
member 20 include high density polyethylene, metal foil used alone, such 
as aluminum, or metal foil laminated to a polymeric substrate for added 
strength and toughness. In one preferred embodiment backing member 20 is a 
composite designed for strength and as a barrier for preventing loss of 
biocide 21. Multilaminated films also can serve as a backing member 
comprising a lamina of medium density polyethylene in laminar arrangement 
with a lamina formed of polyethylene terephthalate on which a thin layer 
of aluminum was vapor deposited. Siliconized polymers, such as siliconized 
polyalkylene terephthalate also can be used alone, or in a laminate. In an 
optional embodiment, not shown, external delivery device 16 can comprise a 
multilaminate, or a form fill and seal delivery system. 
FIG. 6 is a sectional view through 4--4 of FIG. 2. In FIG. 6, there is seen 
urinary drainage container 10 comprising a single film comprising with a 
first wall 11, and a second wall 12, an internal lumen 19 and an external 
delivery device 22 positioned on the outside of container 10. Delivery 
device 22 is sized, shaped and adapted as an external pouch. External 
pouch device 22 comprises a wall 23 that defines an internal space 24 in 
cooperation with the outer surface of wall 12 of container 10. Wall 23 of 
pouch device 22 comprises a composition that is substantially impermeable 
to the passage of a biocide 25 in space 24. The pouch 22 is comprises 
internally at least in part a biocide 25, or the pouch is filled with 
biocide 25, which is available for passage through wall 12. Pouch 22 
comprises an injection port 26 for filling and refilling reservoir space 
24. The biocide 25 can be present in any form that readily makes available 
biocide 25 to wall 12. Exemplary biocide 25 releasing forms comprise a 
member selected from the group consisting of solid, crystalline, 
microcrystalline, particle, pellet, granule, powder, tablet, spray-dried, 
lyophilized, or compressed forms that release the biocide, such as a 
compressed powder, compressed granules, and the like. The biocide can be 
mixed with a carrier such as silicone oil, mineral oil, rapseed oil, palm 
oil, agaragar, sodium alginate, gum Arabic, methyl cellulose, silica gel, 
and the like. External pouch 22 can also comprise a biocidal emulsion, a 
biocidal suspension, an optional permeation enhancer such as glyceryl 
monoleate, dimethyl sulfoxide, ethanol, and the like, for transporting a 
biocide through the wall of the container, and the like. The amount of 
biocide 25 housed in internal space 24 is about 1 milligram to 25 grams, 
and the like. 
Selection of polymers for forming wall 11, or wall 12, for the passage of 
biocide from the external delivery device, or selection of a polymer for 
forming an impermeable backing member can be determined by measuring the 
rate of diffusion through a polymeric material. Various techniques can be 
used to determine the permeability of a homopolymer, copolymer, or 
terepolymer to the passage of a biocide. One method that can be used is to 
position a film of the polymer, of known thickness, as a barrier between a 
rapidly stirred, saturated solution of the biocide and a rapidly stirred 
solvent bath, at a constant temperature, typically 25.degree. C., and 
periodically measuring the concentration in the biocide solution and in 
the solvent bath. Then, by plotting the biocide concentration in the 
solvent bath versus time, the absence of the degree of permeability, P, of 
the polymeric film is determined by Fick's Law of Diffusion. Fick's Law of 
Diffusion is expressed by the following equation (1): 
EQU Slope of plot=(Q.sub.1 -Q.sub.2 /t.sub.1 -t.sub.2)=P AC/h 
wherein 
Q.sub.1 =cumulative amount of drug in solvent in micrograms at t.sub.1 
Q.sub.2 =cumulative amount of drug in solvent in micrograms at t.sub.2 
t.sub.1 =elapsed time to first sample, i.e., Q.sub.1 
t.sub.2 =elapsed time to second sample, i.e., Q.sub.2 
A=area of film in cm.sup.2 
C=concentration of drug in saturated solution 
h=thickness of film in cm 
By determining the slope of the plot, i.e., [Q.sub.1 -Q.sub.2 /t.sub.1 
-t.sub.2 ] and solving the equation using the known or measured values of 
A, C and h, the permeability P constant in cm.sup.2 /time of the film for 
a given biocide is readily determined. The procedures used to determine 
the rate of release through the polymer can be ascertained easily by 
standard techniques known to the art as recorded in J. Pharm. Sci., Vol. 
52, pp 1145-49, (1963); ibid, Vol. 53, pp 798-802, (1964); ibid, Vol. 54, 
pp 1459-64, (1965); ibid, Vol, 55, pp 840-43 and 1224-39, (1966); Encyl. 
Polymer Sci. Technol., Vol. 5 and 9, pp 65-82 and 794-807, (1986); the 
references cited therein, and the like. 
For the purposes of this invention the delivery of the biocide bronopol 
from an external delivery pouch is seen from the following study: first, 
40 mg per ml of bronopol was blended with 5 ml of a biocidal carrier 
comprising 2.5 ml of tributyl citrate and 2.5 ml of mineral oil and the 
blend charged into an external, adhesively positioned device on the 
outside surface of a urinary drainage bag. The bag was made of opaque 
polyvinyl chloride with a wall thickness of 10 mils, and the bag had an 
internal lumen of 25 ml. The bronopol delivery rate through the wall of 
the bag is seen in FIG. 7. In FIG. 7, the clear circle and the darkened 
circle represent the results of two separate studies. In FIG. 8 the 
delivery rate of bronopol is depicted through a 9 mil thick opaque or 
white polyvinyl chloride wall into a bag having a fluid receiving volume 
of 25 ml. The bronopol was in a carrier as a concentration of 40 mg/ml, 
which carrier comprised 2.5 ml of tributyl citrate and 2.5 ml of mineral 
oil, and the area of the wall through which the bronopol passed was 7.07 
cm.sup.2. The clear circles and the darkened circles represent the results 
of the two studies. 
In a separate experiment, both the minimum inhibitory, MIC, and 
bactericidal concentrations MBC of bronopol were determined against E. 
Coli, P. Aeruginosa, S. Aereus and C. Albicans at 37.degree. C. The 
initial colony forming unit per test tube ranged from 30 to 450, which was 
inoculated in the actual human urine whose pH was approximately 6. The MIC 
values were from 12.5-25 .mu.g/ml, and the MBC ranged from 25-50 .mu.g/ml 
irrespective of the microorganisms tested. 
From this microbiological potency data, average daily urinal output (2000 
ml), and the size of a bronopol release system (50-100 cm.sup.2), an 
estimate was made of the required bronopol flux for biocidal control 
through the walls of urine bag made of poly(vinyl chloride), (PVC). The 
minimum bactericidal flux presently preferred is about 20-40 
.mu.g/cm.sup.2 hr, which can be accomplished with the bronopol formulation 
used for the data shown in FIG. 7 and 8. The required, minimum inhibitory 
flux is approximately 10-20 .mu.g/cm.sup.2 hr. According to FIGS. 7 and 8, 
the required bronopol flux was continuously maintained for 7 to 14 days, 
or longer. 
Another device is prepared by casting a film from a solution comprising 20 
parts of polyisobutene having a 1,200,000 viscosity average molecular 
weight; 30 parts of polyisobutene having a 35,000 viscosity average 
molecular weight; 40 parts of mineral oil and 10 parts of bronopol in 
chloroform solvent cast onto an biocidal impermeable film of aluminized 
polyethylene terephthalate. A contact adhesive is applied around the edges 
of the film comprising the bronopol. The reservoir-backing member is 
applied to the opaque, outer surface of a urinary drainage bag for 
delivering the biocide to the inside of the bag over a prolonged period of 
18 hours. 
It will be understood by those versed in the medical, surgical and 
patient-care arts that in the light of the present specification, drawings 
and the accompanying claims, this invention makes available to the art 
both a novel and useful delivery device and a combination dispensing 
device and container endowed with beneficial properties. It will be 
further understood by those versed in the art that many embodiments of 
this invention can be made without departing from the scope of the 
invention. Accordingly, it is to be understood the invention is not to be 
construed as limited, but it embraces all equivalents inherent therein.