Note: Descriptions are shown in the official language in which they were submitted.
This invention relates generally to closed system
urinary drainage bags of the -type conventionally used in
hospitals and health care facilities when it is necessary
to collect urine from a patient over an extended period of
time. Such bags are routinely used by post-operative patients
as well as those with urological disorders Eor collection,
measuring and frequent testing o.E the urinary output. In
use, the patient is first cathe-teri2ed and the catheter is
then connected to the drainage bag -through a len~th of tubing.
The bag is normally supported below the pa-tient's level,
either from the bed rail or other support, and the urine
drains by gravity from the patient through the catheter,
the tubing, and then finally into the bag. Almost all such
bags are provided with drain ports through which measured
quantities of urine may be removed from time to time for
various testing procedures. More particularly, the instant
invention herein relates to a new system for aseptically
draining urine from the primary urine bag into a separate
sterile disposable transfer bag.
A typical urine drainage bag known in -the prior
art is shown in Charles E. Meisch et al, United States Patent
4,312,352, issued January 26, 1982.
One oE the drawbacks with prior art bags is the
possibility of contamination and infection to the patient
when the bags are opened for removal of all or part of the
contents thereof. During such opening, air is permitted
to enter into the outlet spout and bacteria can then migrate
up the spout into the bag and finally up through the connect-
ing tubing and the catheter into the bladder thereby causing
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infection. ~dditionally, -there is the problem of contamina-
tion of hospital personnel due to splattering of urine during
the collection process.
The principal advantage of the present sys-tem over
the known prior art is -the provision for the first time of
as~ptically draining urine from the principal bag into an
auxiliary drainage bag which is s-terile and disposable, thereby
obviating problems of infection.
It is a primary object of the present invention
to provide a simple, saEe and sterile transfer system or
removing urine from a primary drainage bag into a secondary
transfer bag.
The present invention provides a system for asep-
tically removing urine from a drainage bag connected to a
catheterized patient, the system comprises an outlet on -the
drainage bag adjacent the bo-ttom thereof, normally closed
valve means operatively connected to the outlet means pre~
venting flow through the outlet, a transfer bag for receiving
urine removed from the drainage bag, means on the transfer
bag which cooperate wi-th the outlet, the means adapted to
open the valve means -to initiate rem~val of urine from the
drainage bag.
The drainage bag may include a housing means secured
thereto and around the outlet and the transfer bag includes
means adapted to mate with the housing means, and preferably
the valve means is located within the said opening and the
transfer bag means cooperative with the outlet is a spout
mounted on the transfer bag.
The invention further provides a system for asep-
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tically removing urine from a drainage bag connected to acatheterized patient, the sys-tem comprises an outlet on the
drainage bag adjacent the bot-tom thereof, housing means secured
to the bag around the outlet, normally closed valve means
within the housing means preventing flow through the housing,
a transEer bag for receiving urine removed from the drainage
bag, rigid spout means on the transEer bag and projecting
outwardly therefrom, the spout means adapted to enter into
the housing means and to open the valve means to initiate
removal of urine from the drainage bag.
The invention will be more readily apparent from
the following detailed description taken in conjunction with
the drawings in which an exemplary embodiment of the invention
is shown.
Figure 1 is a perspective showing of a typical
prior art urine drainage bag showing removal of the contents
into a receptable.
Figure 2 is a similar perspective view showing an embodi-
ment of the present invention with the two bags in-terconnected.
Figure 3 is a vertical section through the primary
drainage bag and showing the interconnection of the transfer
bag spout thereto.
Figure 5 is a sectional view similar to Figure 3 but
prior -to full engagement of the spout.
Figure 5 is a sectional view of the lower portion
of the primary urine drainage bag showing the outlet and
valve assembly closed by the cap.
Figure 6 is a sectional view taken along the lines
6-6 of Figure 5 and specifically showing the slit valve face.
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Referring now to the drawings, a conventional urine
drainage bag is shown in Figure 1 a-t 10 which bag is
conventionally formed by peripherally heat sealing or otherwise
securing a pair of flat vinyl or polyvinyl chloride sheets
together. The bag is provlded with an inle-t opening adjacent
the top for reception of a drip chamber 11 which may alsa have
integral therewith a bacterial alr Eilter. The drip chamber ls
connected to a -tube 12 which in turn is connected at its end,
not shown, to a conventional Foley catheter or the like which is
in turn inserted in the urethral canal oE -the patient.
sag 10 is also provided with an outlet hose or drainage
tube 13 which may be permanen-tly secured to the bag by heat
sealing a flange member l4 thereon. A spring meta] pinch clamp
15 is provided on the tubing 13 for the purpose of opening and
closing the passage through the tube. As shown in Figure 1, a
receptacle R may be placed beneath the end of tube 13 and will
receive urine U from the tube and the bag 10 when the pinch clamp
15 is open as shown. When the clamp is in the closed position,
the free end of tube 13 is conventionally received in a housing
which is sealed to the face of the bag. This is not part of the
instant invention bu-t may be noted in the copending application
noted above.
The system for aseptically draining urine that
embodies the present invention is shown in Figure 2 and
includes a bag 10 virtually -the same as the bag in the prior art
also utili~ing the drip chamber 11 and the tube 12. Here it will
be seen however that the outlet port and flange assembly 13, 14,
and 15, has been replaced by a specific outlet construction shown
in Figures 3-6. A sterile disposable transfer bag 20 is provided
to receive urine from the primary drainage bag 10. The transfer
bag may be formed in a similar manner and from materials similar
to that of the principal bag but is totally closed at the top
and has provided adjacent -the upper wall thereof an inlet open-
ing provided with an outwardly extending spout 21. The spout
may be secured to the bag 20 by welding of a flange 22 all as is
common in the art. The distal end of the spout is straight as
shown at 23 and spaced rearwardly Erom the tip is a wide shoulder
24 which serves as an abutment as later described. There is a
gradual curve 25 extendin~ Erom the spout shaft to the shoulder.
This curved surface seats against the outer face of a slit valve
as will appear further herein. An annular groove 26 circum~
scribes the spout wide portion rearwardly of shoulder 24 and
acts in conjunction wi-th a circular rib on the main bag outlet
to lock the spout therein. A circular abutment flange 27 at the
rear of the wide portion further limits penetration of the spout
into the outlet as shown in Figure 1. An axial bore 28 extends
throughout the spout for conveying the urine between the two bags.
Primary urine drainage bag 10 is formed with a circular
opening 30 adjacent the lower end of its outer face. A capped
outlet assembly 31 is attached directly over this opening and
consists of a plastic housing 32 havin~ a peripheral mounting
flange 33 at one end which may be chemically or thermally welded
to the bag face. The opposite end of the housin~ 32 has an
annular lip 34 formed thereon Oll the e~terior barrel. Interiorly
of the housing and adjacent the mounting flange 33, a flap valve
abutmen-t 35 is formed.
A thin circular flap valve 36 engages against tle
abutment 35 and is basically a nearly full circle cut into a fla-t
circular disc so that it can be displaced inwardly as shown in
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E'igure 3. A pair of identical slit valves ~0 and 41 are mounted
internally of the housing barrel by a mounting collar 42. This
collar has peripheral flanges ~3 and 44 which engage behind
inwardly turned flanges 45 and 46 on the sli-t valve assemblies.
The face oE the sli~ valves 47 are slit as at 48 in Figure 6 to
provide a plurality of fingers. While three such fingers are
shown, it is to be understood that this is merely exemplary and
any number could be employed. Since the Eace ~7 is Eormed of an
elastomeric material, the slits ~ will seal when the valve is
undisturbed as in Figures 5 and 6 and will block fluid passage.
Note that slit valve 40 seals face to ~ace against the flap
valve 36 as in Figure 4.
A cover assembly for the outlet is provided at 50 and
has an opening 51 into which spout 21 may be inserted. The
cover assembly has an internal annular recess receiving the
annular lip 34 on the barrel and is re-tained thereon in a snap
fit. A cap 52 is tethered to cover assembly 50 by an integrally
formed retainer strap 53. A thumb tap 5~ extends opposite the
strap for ease in applying and removing the cap.
Cap 52 is annularly grooved as at 55 to cooperate as
shown in Figure 5 with ridge 56 formed interiorly of the cover
assembly. The ridge also cooperates in the same manner with
groove 26 of the spout to ensure a snap fit sealed connection.
It will be understood that cap 52 can be made as a
separate piece rather than formed integrally with the cover
assembly shown in the preferred embodiment shown.
Operation
In use, the primary urine drainage bag is connected to
the patient via a Foley catheter in the conventional manner and
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supported from a hanger or the like at a level below that of the
patient. During this procedure and while -the bag is in use, the
cap 52 is in place covering -the outle-t as shown in Figure 5. Here
the flap valve 36 and slit valves 40 and 41 prevent urine from
passing through the outlet. To empty the system without exposing
it to the bacteria in the air, cap 52 is removed from the outlet
and the outer ace of slit valve ~l is cleaned with a suitable
solution. Urine removal into the bag 20 is accomplished by
inserting the spout 21 of the se~condclry drainage bag through the
two slit valves ~0 and 4:L and displacing flap valve 36 as in
Figures 3 and 4. Spout 21 is inserted until it locks into
position with abutment Elange 27 engaging the Eace of cover
assembly 50 and groove 26 engaging rib 56.
This will then allow transfer of the urine from the
primary bag into the secondary bag. Flow will immediately cease
upon removal of spout 21 as the slit valves and flap valve will
automatically close.
During the transfer process all air replacing urine in
the primary drainage bag 10 will pass through the bacterial filter
keeping the bag interior free from contamination.
In the alternative, a valved spout could be mounted on
the primary bag. The transfer bag would then have a valved
opening which would cooperate with the valved spout so that mating
of the primary bag spout with the opening in the transfer bag
would cause the valve to open, thus effecting drainage of said
primary bag.
It must be reco~nized that the above is descriptive of
two embodiments for ef~ecting sterile drainage of the contents of
a valved drainage bag into a second transfer container without
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26
causing the interior oE the drainage bag to become nonsterile.
The specific s-truc-tural features of the two bags can be varied
within the scope of the basic concept and the produc-t or its
method of use is not limited to the embodiments disclosed above.
