Urine drainage bag outlet with barrier against microbial infection

A urine drainage bag having an outlet tube housing a microcidal tube is disclosed. The microcidal tube is manufactured from polymeric materials capable of absorbing and releasing antimicrobial substances in a controllable sustained time release mechanism, activated upon contact with droplets of urine, thereby preventing the retrograde migration of infectious organisms into the drainage bag.

BACKGROUND OF THE INVENTION 
1. Field of the Invention 
The invention relates to closed system urinary drainage bags. More 
specifically, the invention relates to a device placed in the outlet tube 
for dispensing an agent for controlling and preventing the retrograde 
migration of pathogenic microorganisms into the urinary drainage bag. 
2. Brief Description of the Prior Art 
Urine drainage bags are routinely used by post-operative patients as well 
as those with urological disorders. Because of injury to the spinal cord, 
paraplegic patients are unable to control bladder activity and 
consequently must continuously use a catheter. 
In practice, the patient is catheterized and the catheter then connected to 
the drainage bag through a length of plastic tubing. The bag is normally 
supported below the level of the patient either from a bed rail or other 
support and the urine drains by gravity from the patient through the 
catheter, the tubing and then into a bag via a drip chamber. The bag may 
be emptied from time to time by means of an outlet tube which is normally 
closed to prevent leakage. The tube may discharge its contents into any 
convenient receptacle and then the outlet tube is clamped and the bag 
reused for the same patient. 
The characterized urinary track is one of the most common sites of 
hospital-acquired infection and in fact accounts for almost thirty percent 
of such infections. Significant improvements in the prevention of catheter 
associated infection has been by use of what are known as closed sterile 
drainage systems. Despite these advances, still over twenty percent of 
patients with indwelling catheters continue to acquire urinary infections. 
See Garibaldi et al, New England J. Med., 291: 215-219, 1974. Urine 
collection bags must be emptied at frequent intervals usually at least 
once every shift and the removal of bacterially contaminated urine can 
lead to the spread of urine infection. It is even possible for a patient 
in the same ward or room shared with a catheterized patient to acquire the 
infection. In order to minimize cross-contamination, the collected urine 
must be maintained in sterile condition during the collection period, even 
when the urine has a high bacterial count when it enters the drainage bag. 
Despite the use of the most careful aseptic techniques almost fifty percent 
of catheterized patients develop an infection when the catheter is in 
place for twenty-four hours and approximately ninety-eight percent or even 
more develop an infection of after four days of use of such catheters. 
This of course is quite harmful to the patient and subjects them to the 
risk of cystitis and life threatening septicemia. Arch. Internal Med., 
Vol. 110: 703-711 (1962) and Lancet, Vol. 1,310-312 (1960). The 
above-noted infections occur due to many circumstances. These include 
prolonged use of indwelling Foley-type catheters which are often 
accompanied by absence of sterile insertion and maintenance techniques; 
having the catheter connected to clean but not sterilized drainage 
collection containers; and others. The presence of urinary pathogens in 
the container which multiply and enter the urinary track through the 
ascending catheter which is a major pathway of infection is quite 
important. Various attempts have been made to reduce the migration of 
bacteria through the closed system including the bag, the drip chamber and 
the tubing connected to the catheter. 
The patent to Jinkens et al, U.S. Pat. No. 3,332,442 employs a connector 
between a catheter and a urine drainage bag for preventing movement of 
bacteria from the bag to the patient. The three patents of Langston et al, 
U.S. Pat. Nos. 4,236,517; 4,193,403; and 4,241,733 show a dispensing 
device which releases paraformaldehyde to control the multiplication of 
pathogens and prevent migration in catheters. Shaffer U.S. Pat. No. 
4,233,263, teaches adding of hydrogen peroxide solution periodically to a 
urine bag for prevention of bacterial growth. Attempts have been made to 
provide a one way inlet valve into the urine bag to prevent upward 
migration. See, for example, U.S. Pat. Nos. 3,312,221 and 4,232,677. 
Other attempts have been made to treat the catheter itself with an 
microbicidal substance. Note U.S. Pat. No. 3,598,127 and the Shepard et al 
U.S. Pat. Nos. 3,566,874 and 3,695,921 which relate to an antibiotic 
material in a hydrophilic catheter coating. 
U.S. Pat. No. 4,417,892 describes a method of releasing an microbicidal 
substance by means of a frangible capsule which is inserted into the 
outlet drainage tube. The capsule must be broken by a nurse or other 
medical personnel in order to release the active agent. 
SUMMARY OF THE INVENTION 
It is well known that indwelling catherization of patients, can lead to 
serious infections. In normal use of the conventional urinary drainage 
bag, transmission of infection via the outlet drainage tube is of major 
concern. 
In this invention, a microbicidal tube or plug is inserted into a section 
of the outlet tube. The microbicidal tube is usually made by one of three 
process. (1) A porous material, such as polypropylene is impregnated with 
at least one microbicidal agent. It is then coated with a hydrophilic 
polymer which in response to contact with urine swells, causing the 
leaching out of the microbicidal substance. (2) A porous material, such as 
high density polyethylene is impregnated with a hydrophilic polymer and at 
least one microbicidal agent. (3) The microbicidal tube is made by 
compounding and co-extruding a polymer, such as silicone, with at least 
one microbicidal agent, and then coated with a hydrophilic polymer. By 
appropriate combination of active agents, virtually all pathogens can be 
effectively eliminated and prevented from entering the urinary bag and 
further into the catheter. 
The present invention is superior in many ways to the methods of prior art. 
It is a passive dispensing system, thus eliminating the need for human 
participation, such as is necessary, for example, in the breaking of an 
antibiotic containing capsule. It is a self-activating system which 
responds to the presence of body fluids, in this case, urine. The 
microbicidal substances are released in a timed sequence for an extended 
period of time, thus creating an effective barrier against migration of 
infectious organisms into the catheter. 
The microcidal tube is easy to prepare using readily available materials 
and microbicidal substances. The prolonged effectiveness of the invention 
obviates the need for frequent draining of bags, thus saving on nurse's 
time. The passive, self-actuating release, likewise is a labor-saving 
aspect of the present invention. Since the need for human handling is 
substantially reduced, there is less of a chance for infection due to such 
contact.

DETAILED DESCRIPTION OF THE INVENTION 
Referring now to the drawings, a conventional closed system urine drainage 
bag is shown generally at 10 and is formed by peripherally heat sealing or 
otherwise securing a pair of flat vinyl or PVC sheets. The bag is provided 
with an inlet 11 adjacent the top thereof for reception of a conventional 
drip chamber 12 and its associated tubing 13 which connects to a catheter 
which in turn is inserted in the urethral canal of the patient. An air 
vent and bacterial filter 14 is conventionally provided on one face of the 
bag. 
The bag also includes a drain 15 terminating in an outlet tube or conduit 
16 which may be formed of latex or any other suitable material, and which 
may be clamped off when not in use in a well known manner by means of the 
spring pinch clamp or valve 17 which is received about the outlet tube. 
The free end of the outlet is received in a protective housing 18 heat 
sealed to one face of the urine drainage bag. 
Part of the outlet tube 16 houses a microcidal tube 25. The microcidal tube 
is typically 11/2 inches in length, 5.5 mm in internal diameter (I.D.), 
8.5 mm in outer diameter (O.D.) and is 70% void. It is hollow inside in 
order to permit unimpided urine flow. Obviously, the geometry and 
dimension of the microcidal tube may be varied over wide limits yet still 
function as a microbial barrier while permitting urine flow. 
In general, the microbicidal tube is prepared by impregnating porous 
polymeric material with at least one microbicidal agent. Various kinds of 
polymeric materials can be used, but they must be crystalline and have a 
high melting point which will allow them to withstand exposure to body 
fluid temperatures without softening. Usually the tube is made by one of 
three methods. (1) A porous material, such as polypropylene is impregnated 
with at least one microbicidal agent. It is then coated with a hydrophilic 
polymer which in response to contact with urine swells, causing the 
leaching out of the microbicidal substance. (2) A porous material, such as 
high density polyethylene is impregnated with a hydropholic polymer and at 
least one microbicidal agent. (3) The microbicidal tube is made by 
compounding and co-extruding a polymer, such as silicone, with at least 
one microbicidal agent, and then coated with a hydrophilic polymer. 
The solution of the additives and the polymeric material is allowed to 
react for a suitable length of time in the presence of solvent or 
solvents. The usual solvents in the preparation of the microcidal tube are 
ethanol and dimethyl sulfoxide. At the end of the reaction time, the 
microbicidal tube is dried by conventional methods and sterilized with 
ethylene oxide (ETO). 
The specific antimicrobial substance to be used is left to the choice of 
the manufacturer, however such substance must readily be compounded into 
polymers or adhere to the porous polymeric material which in turn will 
absorb the substance. The biocidal additives can be selected from a very 
large group of commercially available antibiotics, drugs, antiseptics, 
etc. Some examples of the common active agents that can be incorporated 
into the microcidal tube are: penicillin, tetracycline, triclosan, 
nalidixic acid, sulfamylon, amphotericin B, nonfloxacin, haloprogin, 
gentamicin, chlorhexidine, clotrimazol, tolnaftate, polymyxin, 
parachlorometaxylenol, pyrithione, hexachlorophene, nitrofurazone, 
nitrofurantoin, chlorixin and many others. Microbicidal agents may be 
incorporated either singly or in various combinations. 
The microcidal tube may be inserted inside the outlet tube during normal 
manufacturing conditions and there will be no loss of the biocidal 
activity since the substance does not become released until it comes in 
contact with urine. The microcidal tube is effective for at least two 
weeks. During this time, it continues to release in a timed sequence, the 
microbicidal agents, thus creating an effective barrier against upward 
movement and multiplication of organisms and the subsequent infection of 
the urinary tract. 
The amount of drug released will depend on a number of factors, such as for 
example, the specific biocidal agent used, the length of time it is 
desired to release the drug, the dosage that is to be administered in a 
specific time, etc. The dosage can be controlled by varying the 
concentrations (or amounts) of the drug(s) and hydrophilic polymer and 
physical parameters such as pore size and shape of the support polymer 
used. 
There are a number of important advantages that the microbicidal tube 
offers over the apparatus and methods of prior art. 
Thus, the prolonged effectiveness of the microbicidal tube (two weeks at 
least) saves on nurses' time, for the bag need not be drained as often as 
it has to be, using prior art apparatus. The passive nature of the 
sustained drug release, activated upon contact with urine, likewise saves 
on the nurse's time, for there is no necessity for human participation. 
Moreover, this is likewise a more reliable and certain method of 
controlling and preventing infections than methods requiring periodic 
handling of apparatus. Such periodic manipulation is frequently delayed or 
entirely disregarded. Additionally, the less human handling that is 
involved, the less is there a chance for contamination from the outside, 
hence the decrease in an opportunity for an infection. 
The following examples describe the manner and process of making and using 
the invention and represent the best mode contemplated by the inventor, 
but are not to be construed as limiting. 
The examples and procedures are to be regarded as illustrative rather than 
restrictive. Variations and changes may be made by those skilled in the 
art without departing from the spirit of the present investion. 
PREATION OF MICROCIDAL TUBE 
EXAMPLE 1 
Batchwise compound 85% polypropylene, 10% hexachlorophene, 4% gentamicin A 
HCl and 1% clotrimazole at 196.degree. C. and, then, extrude in into a 
tude. A 1.0 inch segment of the tube is dipped into a solution of 96% 
ethanol and 4% D-3 polyethylene glycol polyurethane (D-3) for 5 seconds, 
air-dired at RT for 10 minues and oven dried at 85.degree. C. for 10 
minutes. 
EXAMPLE 2 
Batchwise compound 88% polypropylene, 6% triclosan, 4% chloroxin, and 2% 
tolnaftate at 198.degree. C. and then extrude it into a tube (5.5 mm 
ID/8.5 mm OD). A 1.5 inch segment of the tube is dipped into a solution 
containing 96.5% ethanol and 3.5% D-3 for 5 seconds, air-dried at RT for 
10 minutes and oven-dried at 52.degree. C. for 30 minutes. 
EXAMPLE 3 
Batchwise compound 91% polythylene, 6% nalidixic acid and 3% 
parachlorometaxylenol at 150.degree. C. to a homogenous dispersion and 
extrude it into a tude (6.5 mm ID/8.5 mm OD). A 1.0 inch segment of the 
tube is dipped in a solution containing 97% ethanol and 3% D-3 for 5 
seconds, air-dried at RT for 10 minutes and oven-dried at 78.degree. C. 
for 10 minutes. 
EXAMPLE 4 
Batchwide compound 89.8% polyethylene, 8% zinc pyrithione and 2.2% 
tetracycline HCl at 152.degree. C. to a homogenous dispersion and extrude 
it into a tube (6.5 mm ID/8.5 mm OD). A 1.5 inch segment of it is dipped 
in a solution of 95% ethanol and 5% D-3 for 5 seconds, air-dried at RT for 
10 minutes and oven-dried at 65.degree. C. for 10 minutes. 
EXAMPLE 5 
A segment of microporous polysulfone tube is immersed in a solution of 
88.8% ethanol, 7% gentamicin A HCl, 4% D-3 polyethylene glycol 
polyurethane and 0.2% zinc pyrithione for 10 minutes. It is then air-dried 
at room temperature (RT) for 10 minutes and oven-dried at 70.degree. C. 
for 15 minutes. The concentration of gentamicin A HCl is below its 
saturation point and could be raised if wanted. Zinc pyrithione, an 
antifugal agent, is approximately at its optimum concentration. It could 
be replaced bythe more soluble sodium pyrithione. 
EXAMPLE 6 
A segment of microporous polysufone tube is immersed in a solution of 79.5% 
ethanol, 11% tetracycline HCl, 5.3% polymyxin B HCl, 3.5% D-3 polyethylene 
glycol polyurethane and 0.2% zinc pyrithione for 10 minutes. It is 
air-dried at RT for 10 minutes and oven-dried at 68.degree. C. for 20 
minutes. Both tetracycline and polymyxin are below their saturation 
points. 
EXAMPLE 7 
A segment of microporous high density polyethylene tube (HDPE; pore size: 
50 microns) is immersed in a solution of 50% anhydrous acetone, 40% 
anyhydrous ethanol, 5% gentamicine HCl, and 5% parachlorometaxylenol for 5 
minutes. It is air-dried at RT for 15 minutes, dipped in 96.5% ethanol, 
3.5% D-3 polyethylene glycol polyurethane for 5 seconds, air-dired at RT 
for 10 minutes and oven-dried at 70.degree. C. for 15 minutes. 
Concentrations of D-3, gentamicine and parachlorometaxylenol could be 
increased if needed. 
EXAMPLE 8 
A segment of microporous HDPE is immersed in a solution of 73% ethanol, 10% 
tetracycline HCl, 10% parachlorometaxylenol, 3.8% D-3, 2% dimethyl 
sufoxide (DMSO), 0.6% clotrimazol and 0.6% tolnaftate for 5 minutes. It is 
then air-dried at RT for 10 minutes, oven-dried at 55.degree. C. for 20 
minutes, and air-dried at RT for 18 hours. 
EXAMPLE 9 
A segment of HDPE tube is immersed in a solution of 41.4% DMSO, 44.6% 
acetone, 10% triclosano and 4.3% chloroxine for 10 minutes. It is 
air-dried at RT for 15 minutes, dipped into 96.5% ethanol and 3.5% D-3 for 
5 seconds, air-dried at RT for 10 minutes and oven-dried at 55.degree. C. 
for 30 minutes. Concentrations of triclosan and chloroxine could be raised 
substantially if needed. 
EXAMPLE 10 
A segment of microporous polypropylene tube (5.5 mm ID/8.5 mm OD; 70% void) 
is immersed in a solution of 83.5% anhydrous acetone, 8% chlorhexidine 
acetate, 5.5% triclosan and 3% Hypol 3000 polyurethane for 5 minutes. It 
is air-dried at RT for 5 minutes, oven-dried at 52.degree. C. for 10 
minutes and air-dried at RT for 18 hours. Concentrations of chlorhexidine 
and triclosan can be increased if needed. 
EXAMPLE 11 
A segment of microporous polypropylene tube is immersed in a solution 
containing 50% ehtanol, 33% chloroform, 11% hexachlorophene, 3.8% D-3, 1% 
nalidixic acid, 0.6% clotrimazole and 0.6% tolnaftate for 10 minutes. It 
is air-dried at RT for 10 minutes and oven-dried at 72.degree. C. for 25 
minutes. Concentrations of clotrimazole and tolnaftate are substantially 
below their saturation points in the solvent system. 
EXAMPLE 12 
A segment of microporous polypropylene tube is immersed in a solution of 
46.2% ethanol, 22% DMSO, 11% parachlorometa xylenol, 11% dchlorhexidine 
diacetate, 4.8% water, 4.0% D-3 and 1.0% nitrofarazone for 10 minutes. It 
is air-dried at RT for 10 minutes, oven-dried at 68.degree. C. for 10 
minutes and air-dried at RT for 18 hours. The concentration of 
parachlorometaxylenol could be increased if needed. 
EXAMPLE 13 
A segment of microporous polypropylene tube is immersed in a solution 
containing 84% ethanol, 7.5% hexachlorophane, 5% D-3, 2.5% DMSO, 0.7% 
H.sub.2 O, 0.25% clotrimazole and 0.05% aminacrine for 10 minutes. It is 
air-dried at RT for 10 minutes, oven-dried at 78.degree. C. for 20 minutes 
and air-dried at RT for 18 hours. 
EXAMPLE 14 
A segment of microporous polypropylene tube is immersed in a solution of 
50.5% ethanol, 31% acetone, 10% hexachlorophene, 4.3% D-3, 2.5% DMSO, 1% 
clotrimazole an d0.5% H.sub.2 O for 10 minutes. It is air-dried at RT for 
10 minutes, oven-dried at 78.degree. C. for 20 minues, and air-dried at RT 
for 18 hours. 
EXAMPLE 15 
A segment of microporous polypropylene tube is immersed in a solution 
containing 44.1% ehtanol, 31% DMSO, 11% triclosan, 9% hexachlorophene, 
3.4% D-3, 1.0% clotrimazole, and 0.5% nitrofuragon for 10 minutes. It is 
air-dried at RT for 15 minutes, oven-dried at 52.degree. C. for 30 minutes 
and air-dried at RT for 18 hours. Concentrations of triclosan, 
hexachlorophene and clotrimazole could be increased if needed. 
The foregoing preparations of microbicidal tubes were effective in 
maintaining sterility for 17 to 21 days upon exposure to urine.