U.S. patent number 3,661,143 [Application Number 04/835,619] was granted by the patent office on 1972-05-09 for medical apparatus for drainage, collection and monitoring of body fluids.
Invention is credited to Melvyn L. Henkin.
United States Patent |
3,661,143 |
Henkin |
May 9, 1972 |
**Please see images for:
( Certificate of Correction ) ** |
MEDICAL APPARATUS FOR DRAINAGE, COLLECTION AND MONITORING OF BODY
FLUIDS
Abstract
A sealed fluid drainage system, particularly well adapted for
urine drainage, collection and monitoring, including parallel
drainage tubes in fluid communication via a venting passage, the
tubes and associated drip chambers being physically arranged to
provide a difference in hydrostatic pressure for initiating liquid
flow and completely draining liquid from the tubes and chambers.
Highly reliable valving and flexible drip chamber configurations
enable further enhancement of unidirectional flow and system line
clearing capabilities. An effective gas gap is also provided to
minimize the possibility of ascending infections in the system.
Fluid collection is accomplished in a sealed, multi-chamber,
flexible, calibrated container, with fluid being first directed
into the smallest chamber and overflowing successively or being
deliberately emptied into larger capacity chambers. Suitably
located drain tubes permit selective sampling of liquid from the
smallest chamber or complete emptying of the container from the
largest chamber.
Inventors: |
Henkin; Melvyn L. (Tarzana,
CA) |
Family
ID: |
25269991 |
Appl.
No.: |
04/835,619 |
Filed: |
June 23, 1969 |
Current U.S.
Class: |
600/575; 600/580;
600/584; 604/129; 604/324; 604/325 |
Current CPC
Class: |
A61F
5/441 (20130101); A61M 1/69 (20210501) |
Current International
Class: |
A61F
5/441 (20060101); A61M 1/00 (20060101); A61b
005/10 () |
Field of
Search: |
;128/2,275-276,294-295 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Rosenbaum; Charles F.
Claims
I claim:
1. Fluid drainage apparatus, comprising:
first means defining a first conduit, adapted for use in a
substantially vertical position, both upper and lower ends of said
conduit being open, said upper end being adapted for connection to
a liquid source to be drained;
second means defining a second conduit, adapted for use in a
substantially vertical position and substantially adjacent said
first conduit, said second conduit being in fluid communication
with said first conduit at substantially the upper end of said
first conduit;
closed collection means for receiving liquid drained from said
source;
means connecting the lower ends of said first and second conduits
to said collection means, said second conduit being open at its
lower end and remaining open to gas flow only from said collection
means in normal use, said lower end of said second conduit being
located above said lower end of said first conduit in normal use to
establish a hydrostatic pressure differential between said first
and said second conduits, whereby said conduits will carry liquid
from said source to said collection means even when said source is
closed to the atmosphere.
2. Apparatus as set forth in claim 1, and further including:
manual pump means in fluid communication with said second conduit
for selectively increasing the pressure differential between said
first and said second conduits so that fluid is pumped up said
second conduit and liquid is pumped down said first conduit.
3. Fluid drainage apparatus, comprising:
first means defining a first conduit, adapted for use in
substantially vertical position, both upper and lower ends of said
conduit being open, said upper end being adapted for connection to
a liquid source to be drained;
second means defining a second conduit, adapted for use in a
substantially vertical position and in substantially close
proximity to said first conduit;
closed collection means for receiving liquid drained from said
source;
means connecting the lower ends of said first and second conduits
to said collection means, said second conduit being open at its
lower end and remaining open to gas flow only from said collection
means in normal use; and
a fluid passage defined between said first and said second conduits
remote from both of said lower ends whereby at least one of said
conduits will carry liquid from said source to said collection
means even when said source and said collection means are closed to
the atmosphere.
4. Apparatus as set forth in claim 3, wherein said first and said
second means are in abutment and said fluid passage is defined by
said first and said second means.
5. Apparatus as set forth in claim 3, and further including:
selectively actuable pump means in fluid communication with said
second conduit for pumping fluid up said second conduit.
6. Apparatus as set forth in claim 3, and further including:
one-way check valve means in said second conduit for limiting fluid
flow therein to an upward direction.
7. Apparatus as set forth in claim 6, and further including:
selectively actuable pump means in fluid communication with said
second conduit.
8. Fluid drainage apparatus, comprising:
first means defining a first conduit, adapted for use in
substantially vertical position, both upper and lower ends or said
conduit being open, said upper end being adapted for connection to
a liquid source to be drained;
second means defining a second conduit, adapted for use in a
substantially vertical position and in substantially close
proximity to said first conduit, said second conduit being open at
its lower end, and remaining open to gas flow in normal use;
a fluid passage defined between said first and said second conduits
remote from both of said lower ends;
drip chamber means for receiving the lower ends of said first and
said second conduits; and
additional means defining a plurality of conduits communicating
with said chamber means for draining a first fluid therefrom and
simultaneously replacing said first fluid with a second fluid.
9. Apparatus as set forth in claim 8, and further including:
one-way check valve means in said second conduit, below said fluid
passage.
10. Apparatus as set forth in claim 8, and further including:
a substantially sealed collection container in fluid communication
with said drip chamber means via said conduits defined by said
additional means.
11. Apparatus as set forth in claim 10, and further including:
means for dividing said collection container into a plurality of
different size volumetric capacity compartments.
12. Apparatus as set forth in claim 11, and further including:
drain means at the bottom of said container for selectively
draining fluid from the smallest of said compartments.
13. Apparatus as set forth in claim 12, and further including:
additional drain means at the bottom of said container for
selectively draining fluid from the largest of said
compartments.
14. For use in a liquid drainage medical apparatus, the combination
comprising:
a first, substantially vertically oriented tube, said tube being
open at its upper end and at its lower end, said upper end being
adapted for connection to a liquid source to be drained;
a second, substantially vertically oriented tube, said second tube
being closed at its upper end and open at its lower end, said lower
end remaining open to gas flow in normal use;
means defining a fluid passage between said first tube and said
second tube; and
valve means in said second tube, below said fluid passage, for
enabling fluid flow up said second tube while substantially
preventing liquid flow down said second tube.
15. Apparatus as set forth in claim 14, and further including:
selectively actuable pump means in fluid communication with said
second tube for pumping fluid up said second tube.
16. Apparatus as set forth in claim 14, wherein said second tube is
in abutment with said first tube substantially along the entire
length of said second tube, and said fluid passage is located
adjacent the upper end of said second tube.
17. Apparatus as set forth in claim 14, wherein both of said first
and said second tubes terminate at their lower ends in a drip
chamber.
18. Apparatus as set forth in claim 14, and further including:
drip chamber means for receiving both lower ends of said first and
said second tubes; and
conduit means communicating with said chamber means for draining
liquid therefrom and simultaneously replacing said liquid with
gas.
19. Apparatus as set forth in claim 16, wherein both of said first
and said second tubes are co-extruded as an integral tube pair.
20. Apparatus as set forth in claim 18, wherein said conduit means
comprises:
a pair of drain and vent tubes each open at both ends and passing
through the bottom of said chamber means, the relative elevations
of said drain and said vent tubes providing a hydrostatic pressure
differential promoting substantially unidirectional fluid flow.
21. Apparatus as set forth in claim 18, and further including:
a substantially sealed liquid collection bag in fluid communication
with said drip chamber means via said conduit means.
22. Apparatus as set forth in claim 21, wherein said conduit means
comprises:
a pair of drain and vent tubes each open at both ends and passing
through the bottom of said chamber means into said collection bag,
the relative elevations of said drain and said vent tubes providing
a hydrostatic pressure differential promoting substantially
unidirectional fluid flow for both liquid an gas.
23. Apparatus as set forth in claim 22, wherein said second tube is
in abutment with said first tube substantially along the entire
length of said second tube, and said fluid passage is located
closely adjacent the upper end of said second tube.
24. Apparatus as set forth in claim 23, and further including:
one-way check valve means in said second tube, below said fluid
passage, for enabling gas flow up said second tube while
substantially preventing liquid flow down said second tube.
25. Apparatus as set forth in claim 22, and further including:
divider means for dividing said collection bag into a plurality of
different size volumetric capacity compartments.
26. Apparatus as set forth in claim 25, and further including:
flow director means for directing liquid flow from said drain tube
into the smallest of said compartments.
27. Apparatus as set forth in claim 25, wherein said divider means
includes at least one integral seam separating said
compartments.
28. Apparatus as set forth in claim 25, wherein said divider means
includes at least one substantially rigid container.
29. Apparatus as set forth in claim 25, wherein said compartments
are calibrated.
30. Apparatus as set forth in claim 26, and further including:
first drain means for selectively draining liquid from the smallest
of said compartments; and
second drain means for selectively draining liquid from the largest
of said compartments.
31. Apparatus as set forth in claim 26, wherein said flow director
means includes a tapered lower open end of said drain tube
extending into said smallest compartment.
32. Apparatus as set forth in claim 26, wherein said flow director
means includes a tapered lower open end of said vent tube extending
into said smallest compartment, the beginning of said tapered end
of said vent tube initiating at a higher elevation than said
tapered end of said drain tube.
33. Apparatus as set forth in claim 26, wherein said flow director
means includes a web secured to the lower open end of said drain
tube and extending down into said smallest compartment.
34. Apparatus as set forth in claim 33, wherein said web is also
secured to the lower open end of said vent tube.
35. For use in a liquid drainage medical apparatus, the combination
comprising:
a first, substantially vertically oriented tube, said tube being
open at its upper end and at its lower end, said upper end being
adapted for connection to a liquid source to be drained;
a second, substantially vertically oriented tube, said second tube
being closed at its upper end and open at its lower end, said lower
end remaining open to gas flow in normal use;
means defining a fluid passage between said first tube and said
second tube;
a first chamber receiving and locating said lower open end of said
second tube above the bottom of said chamber;
a venting conduit having its upper open end in fluid communication
with said first chamber, said venting conduit having a lower open
end;
a second chamber, said lower open end of said first tube being
received within said second chamber; and
a drainage conduit in fluid communication with said second chamber
at substantially the bottom of said second chamber, the lower open
end of said drainage conduit being lower than the lower open end of
said venting conduit.
36. Apparatus as set forth in claim 35, wherein said second chamber
is located below said first chamber.
37. Apparatus as set forth in claim 35, wherein said first chamber
includes a flexible wall.
38. Apparatus as set forth in claim 36, wherein said first tube
passes through said first chamber to enter said second chamber, and
said venting conduit passes through said second chamber to enter
said first chamber.
39. Apparatus as set forth in claim 35, wherein said upper open end
of said venting conduit is located substantially no higher than the
bottom of said first chamber.
40. Apparatus as set forth in claim 39, and further including:
a one-way valve means located in said venting conduit for normally
allowing fluid flow only up said venting conduit, said valve having
an occluding member with a specific gravity less than the specific
gravity of any liquid to be drained, whereby said valve is disabled
in the presence of said liquid to permit fluid flow down said
venting conduit.
41. Apparatus as set forth in claim 40, wherein the bottom of said
first chamber is shaped to favor liquid drainage towards said
venting conduit.
42. For use in a liquid drainage medical apparatus, the combination
comprising:
a first, substantially vertically oriented tube, said tube being
open at its upper end and at its lower end, said upper end being
adapted for connection to a liquid source to be drained;
a second, substantially vertically oriented tube, said second tube
being closed at its upper end and open at its lower end, said lower
end remaining open to gas flow in normal use;
means defining a fluid passage between said first tube and said
second tube;
a first sealed drip chamber, at least a portion of the walls
defining said drip chamber being flexible, said lower end of said
second tube being received by one of said walls to space said lower
end of said second tube above the bottom of said chamber;
a venting conduit entering said drip chamber through said bottom
wall, the upper open end of said venting conduit being
substantially no higher than the bottom of said chamber;
one-way valve means located in said venting conduit for normally
allowing fluid flow only up said venting conduit, said valve means
having an occluding member with a specific gravity less than the
specific gravity of any liquid to be drained, whereby said valve
means is disabled in the presence of said liquid to permit fluid
flow down said venting conduit;
a second drip chamber below said first chamber, the lower end of
said first tube being received within said second drip chamber;
and
a drainage conduit in fluid communication with said second drip
chamber through the bottom of said second chamber, the lower open
end of said drainage conduit being lower than the lower open end of
said venting conduit.
43. Apparatus as set forth in claim 42, and further including:
valve means in said second tube, below said fluid passage, for
enabling gas flow up said second tube while substantially
preventing liquid flow down said second tube.
44. For use in a liquid drainage medical apparatus, the combination
comprising:
a substantially sealed liquid collection bag; and
divider means for dividing said collection bag into a plurality of
different size volumetric capacity compartments, said divider means
including a substantially rigid baffle member separating said
compartments, the tops of said compartments being in open
communication with each other within said bag.
45. For use in a liquid drainage medical apparatus, the combination
comprising:
a substantially sealed liquid collection bag;
divider means for dividing said collection bag into a plurality of
different size volumetric capacity compartments, said divider means
including at least one substantially rigid container defining at
least one of said compartments, the tops of said compartments being
in open communication with each other within said bag;
a spout in fluid communication with said container at the bottom of
said container; and
selectively operable drain means at the bottom of said bag in fluid
communication with said spout.
46. For use in a closed liquid drainage system, medical apparatus
comprising, in combination:
a drainage tube having an open upper end for connection to a liquid
source to be drained, said liquid source being effectively closed
to the atmosphere;
a vent tube adjacent and generally parallel to said drainage tube,
and having its upper end closed to atmosphere and in fluid
communication with said drainage tube at substantially the upper
end of the drainage tube; and
closed collection means for receiving liquid drained from said
source, the lower ends of said drainage and vent tubes being
connected to said collection means and in fluid communication with
the interior thereof, whereby liquid from said closed source will
flow down one of said tubes to said closed collection means and
fluid from said closed collection means will flow up the other of
said tubes.
47. The system of claim 46, wherein the lower end of said vent tube
is located above the lower end of said drainage tube within said
closed collection means in normal use to establish a hydrostatic
pressure differential between said vent and drainage tubes.
48. The system of claim 47, further including pump means in fluid
communication with said vent tube for selectively increasing the
pressure differential therebetween so that fluid may be pumped up
said vent tube and down said drainage tube when the upper end of
said drainage tube is connected to said liquid source.
49. The system of claim 46, further including one-way valve means
in said vent tube for limiting fluid flow therein to a direction
away from said collection means.
50. The system of claim 49, further including selectively actuable
pump means in fluid communication with said vent tube for pumping
fluid from said collection means and up said vent tube, thereby
pumping liquid down said drainage tube when the upper end of said
drainage tube is connected to said liquid source.
51. The system of claim 50, wherein said collection means is a drip
chamber.
52. The system of claim 50, wherein said collection means is a
liquid collection bag having a flexible wall.
53. The system of claim 50, wherein said vent and drainage tubes
form an integral unit.
54. The system of claim 46, further including selectively actuable
pump means in fluid communication with at least one of said tubes
for pumping fluid from said collection means up said vent tube and
for pumping liquid down said drainage tube when the upper end of
said drainage tube is connected to said liquid source.
55. For use in a liquid drainage medical apparatus, the combination
comprising:
a first substantially vertically oriented tube, said tube being
open at its upper end and at its lower end, said upper end being
adapted for connection to a liquid source to be drained;
a second, substantially vertically oriented tube, said second tube
being closed at its upper end and open at its lower end, said lower
end remaining open to gas flow in normal use;
means defining a fluid passage between said first tube and said
second tube; and
selectively actuable unidirectional pump means in fluid
communication with at least one of said first and second tubes for
pumping fluid up said second tube, through said fluid passage, and
down said first tube.
56. The apparatus of claim 55, further including valve means in
said second tube, below said fluid passage, for enabling fluid flow
up said second tube while substantially preventing liquid flow down
said second tube.
57. The apparatus of claim 55, wherein said pump means comprises a
gas barrier chamber for receiving the lower open end of said second
tube, said chamber having a flexible wall.
58. The apparatus of claim 57, further including one-way check
valve means in said chamber limiting the direction of fluid flow
therethrough.
59. The apparatus of claim 55, further including one-way check
valve means in at least one of said tubes for limiting the
direction of flow therein.
Description
BACKGROUND OF THE INVENTION
This invention relates generally to improvements in medical
apparatus for drainage, collection and monitoring of body fluids
and, more particularly, to a new and improved urine drainage,
collection and monitoring system characterized by relatively simple
and economical construction, higher reliability, versatility and
accuracy, substantially reduced possibilities of spillage,
contamination or infection and enhanced physical tolerance by the
patient.
Those concerned with the design, development and clinical use of
various types of medical apparatus for drainage, collection and
monitoring of body fluids, and particularly urinary drainage
systems and the like, have long been concerned with the problems of
providing reliable and accurate devices free from the commonly
encountered difficulties of delayed flow, gross fluid retention,
fluid contamination, patient infection, poor patient tolerance, and
the lack of simple, economical means for obtaining short term, low
volume fluid samples.
Typical of the various approaches for accomplishing urinary
drainage, collection and monitoring in hospitalized patients on
medical or surgical wards and the like is the use of a single,
vertically oriented drainage tube, communicating at its upper end
with an implanted patient catheter and terminating at its lower end
in a drip chamber. The lower end of the drip chamber communicates
with a flexible, plastic urine collection bag which includes an air
vent at or near the top of the bag and a drain tube at the bottom
of the bag. The air vent passage usually includes a filter of
cotton wadding or the like.
The aforedescribed system of the prior art is in wide use, despite
the presence of a number of problems involving mechanical
operation, patient safety and tolerance, thus indicating a very
substantial need for improved apparatus in this area. In this
regard, the systems of the prior art have been prone to delayed
urine flow and gross retention of urine in the drain tube between
the patient and the collection bag, frequently requiring jiggling
or squeezing of various portions of the apparatus, with unreliable
results. Retention of urine also makes quantitative urine output
determinations extremely difficult, particularly in the case of
short term, low volume measurements. The devices of the prior art
have also been prone to urine spillage, urine contamination through
the air vent, and clogging of the air vent. In addition, the prior
art devices have posed a substantial risk of ascending infection to
the patient, particularly when used over relatively long periods of
time. Moreover, vented collection bags often result in unduly high
negative pressures which are transmitted to the patient and
frequently result in bladder lesions or system clogging due to the
sucking of mucosa from the patient into the drainage system. While
attempts have been made to eliminate the negative pressure
phenomenon and its deleterious consequences by air venting the
catheter end of the drain tube to room pressure, such approaches
have generally proved cumbersome or unreliable, particularly where
valving is employed.
Further difficulties encountered with the devices of the prior art
include inaccuracy in the measurement of low volumes of urine in
the collection bag, together with relatively high cost and
complexity of separate or combined specialized devices for short
term, low volume urine output measurements or for obtaining recent
urine specimens for testing. Unfortunately, such specialized
devices are often even more prone to trapping or retention of
fluid, contamination and spillage.
It will be apparent, therefore, that there has been a long existing
need in the medical art, and particularly in the area of fluid
drainage, collection and monitoring, for a relatively simple,
compact, low cost, yet safe, accurate and reliable drainage,
collection and monitoring system, without the usual problems of
spillage, contamination, poor flow, infection, complicated sampling
and poor patient tolerance which has so plagued the prior art. The
present invention clearly fulfills these requirements.
SUMMARY OF THE INVENTION
Briefly, and in general terms, the present invention provides a new
and improved system for draining, collecting and monitoring a
selected body fluid, e.g., urine, and includes a pair of
substantially vertically oriented drain tubes in fluid
communication with each other via an upper venting passage, the
relative elevations of the lower terminal ends of the tubes
producing a hydrostatic pressure differential, whereby one of the
tubes functions as a liquid drain while the other tube functions as
a positive pressure air vent for initiating liquid drainage flow
and insuring both complete drainage and unidirectional flow. The
pair of tubes communicate with various drip chamber configurations,
including drip chambers embodying flexible walls, to increase the
magnitude of the hydrostatic pressure differential and facilitate
hand pumping wherever necessary or desirable. Valves in the air
vent tube and drip chamber further enchance the unidirectional flow
and total drainage characteristics of the system. In addition, the
dual tube drip chamber functions as a very effective gas barrier to
ascending infection.
Fluid collection and monitoring is accomplished in a completely
sealed, flexible, calibrated bag which is suitably divided into a
plurality of different volumetric capacity chambers, with the tops
of the chambers in direct communication. Novel flow directing means
are utilized to direct fluid being collected into the smallest
chamber first, thus facilitating accurate low volume measurement,
with overflow occurring successively into the larger chambers or,
alternatively, deliberate emptying into the larger chambers by
rotation of the collection bag. Appropriately located drain tubes
permit selective sampling of the collected liquid from the smallest
chamber, to obtain a recent fluid specimen, or complete emptying of
the collection bag from the largest chamber. The sealed collection
bag usually develops a low positive pressure as it is filled, and
this pressure is transmitted in use to the dual drain tube system
and to the patient.
In a presently preferred embodiment of the present invention, by
way of example and not necessarily by way of limitation, the dual
drain tubes may be extruded as a siamese pair with a one-way check
valve just below the venting passage between the tubes, to further
prevent liquid from flowing down the air vent line. In addition, an
air pump chamber may include a one-way check valve having an
occluding member with a specific gravity less than unity, so that
any liquid which may inadvertently drain into the chamber will
drain from the chamber rather than being trapped.
The enhanced drainage efficiency of the present invention
facilitates the use of much smaller diameter tubing than that used
with prior art devices, thereby reducing the size and cost of the
apparatus. In addition, the low pressure within the system of the
present invention is generally well tolerated by the patient.
Hence, the fluid drainage, collection and monitoring system of the
present invention is of relatively compact and economical
construction, and is characterized by trouble-free, complete
drainage, while substantially obviating problems of spillage,
contamination, ascending infection and patient injury. The present
invention also provides relatively simple, compact, reliable, low
cost means for making accurate, low volume measurements and
obtaining recent flow fluid specimens for testing.
The above and other objects and advantages of the invention will be
better understood by reference to the following more detailed
description, when considered in connection with the accompanying
drawings of illustrative embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a partial, elevational view of a first embodiment of a
drainage system constructed in accordance with the present
invention, portions being shown in section;
FIG. 2 is an enlarged, fragmentary sectional view of the area "2"
in FIG. 1, illustrating the venting passage between the drain
tubes;
FIG. 3 is a view similar to FIG. 2, but taken at an earlier stage
in the manufacture of the dual tube configuration;
FIG. 4 is a sectional view, taken substantially along the line 4--4
in FIG. 3;
FIG. 5 is a partial, elevational view of a second embodiment of a
drainage system constructed in accordance with the present
invention, portions being shown in section;
FIG. 6 is an enlarged, fragmentary view of portions of a third
embodiment of a drainage system in accordance with the
invention;
FIG. 7 is an enlarged, fragmentary view of a modified drip chamber
construction in accordance with the present invention;
FIG. 8 is an elevational view, with portions broken away, of a new
and improved liquid collection and measurement bag constructed in
accordance with the invention;
FIG. 9 is a sectional view, taken substantially along the line 9--9
in FIG. 8;
FIG. 10 is an elevational view, similar to FIG. 8, of another
embodiment of a liquid collection and measurement bag constructed
in accordance with the present invention;
FIG. 11 is a perspective view of a further embodiment of a fluid
collection and measurement bag constructed in accordance with the
invention;
FIG. 12 is a perspective view of the chamber divider used with the
bag of FIG. 11;
FIG. 13 is a sectional view, taken substantially along the line
13--13 in FIG. 11;
FIG. 14 is an elevational view of still another embodiment of a
liquid collection and measurement bag constructed in accordance
with the invention; and
FIG. 15 is a sectional view, taken substantially along the line
15--15 in FIG. 14.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to the drawings, and particularly to FIG. 1 thereof,
there is shown a urinary drainage system, constructed in accordance
with the present invention, and designated generally by the
reference numeral 20. Although the invention is particularly
described in connection with urine drainage, collection and
monitoring systems, it is to be understood that its use is not so
limited, and it may also be used in other medical procedures and
for draining, collecting and monitoring other body fluids.
The drainage system 20 includes a pair of parallel, vertically
oriented, flexible tubes 21 and 22, the tube 21 performing the
function of liquid drainage, while the tube 22 functions as an air
vent.
As best observed in FIG. 2, the air vent tube 22 is sealed at its
upper end 22a after first providing an air vent port 23 to
establish fluid communication between the vent tube and the drain
tube 21.
The upper end of the drain tube 21 is connected by a conventional
tubing connector 29 to an appropriate catheter 31 (such as a Foley
catheter) dwelling within the bladder of a patient (not shown). An
occlusive clamp 33, of any appropriate design, is located between
the upper end of the drain tube 21 and the junction of the tubes
21, 22, the clamp being used to selectively seal the drain tube and
prevent urine flow whenever desired. The catheter 31 and clamp 33
are preferably physically located as close as is practically
feasible to the junction of the tubes 21, 22 for best system
performance.
The lower distal ends 24 and 25 of the tubes 21 and 22,
respectively, terminate in a drip chamber 27 which should be
maintained in the substantially vertical position shown in FIG. 1
for proper operation of the drainage system. The open end 24 of the
drain tube 21 is at a lower elevation than the open end 25 of the
vent tube 22, thus providing a hydrostatic head when both tubes are
filled with liquid, the resulting pressure differential forcing
urine to flow down the tube 21 and into the drip chamber 27 while
air rises up the vent tube 22, passes through the port 23 between
the tubes, and then moves down the drain tube 21.
The dual tube arrangement shown favors unidirectional flow, with
substantially no retention of liquid within the tubes 21, 22. Thus,
the drainage system of the present invention is essentially
self-clearing, and the lack of liquid retention by the system makes
accurate short term low volume urine output measurements
feasible.
The lower end of the drip chamber 27 is provided with two openings
in which a pair of tubes 35 and 36 are mounted. The upper open end
of the tube 35 is flush with the bottom wall 27a of the chamber 27,
to enable liquid to drain therethrough, whereas the upper open end
of the tube 36 is located above the bottom wall 27a. Similarly, the
lower open end of the tube 35 is below the lower open end of the
tube 36.
Tube 35 drains the urine in the drip chamber 27 into a urine
collection bag 38, while the tube 36 allows air from the bag 38 to
enter the drip chamber and replace the liquid leaving the chamber.
Hence, tube 35 functions as a liquid drain tube, while tube 36
functions as a vent tube. In this regard, the relative elevations
of the upper and lower ends of the tubes 35, 36 insure
substantially unidirectional flow of both gas and liquid. Moreover,
the dual tube drip chamber 27 serves as a very effective gas
barrier to ascending infection and is, therefore, safer to use than
conventional drainage devices. It will be understood that by the
term drip chamber is meant any arrangement that will provide a
break in the liquid path of the drain tube, and such breaks may
take numerous forms other than that illustrated herein.
The collection bag 38 is typically fabricated of any pliable
material, typically a transparent or translucent flexible plastic,
which is heat-sealed along its periphery to exclude entry of any
contaminating gas from outside the system. The tubes 35, 36 are
sealed in position, by any appropriate conventional means, where
the tubes enter at the top of the bag 38. The bag 38 is also
provided with an output drain tube 40 and an associated occlusive
clamp 41, to permit selective drainage of collected urine from the
bag.
If desired, the collection bag 38 may be provided with appropriate
calibrations 42, typically in milliliters, to indicate the volume
of liquid collected within the distended bag.
The drainage system 20 and collection bag 38 are typically supplied
with all clamps closed and with the small residual volume of tubing
and chambers filled with sterile gas. In actual use, the clamps 33
and 41 are selectively unclamped for drainage of urine through the
tube 21, drip chamber 27, tube 35, into the bag 38, and for
drainage of collected urine from the bag 38 via the tube 40. At
these times, substantially no additional gas enters the system
since the relatively small diameter drainage tubes essentially
provide their own water seal. The collected urine distends the
pliable plastic urine collection bag 38, and the small supplied
volume of sterile gas is then displaced above the liquid in the
bag, tubes and drip chamber.
The sealed collection bag 38 usually develops a small positive
pressure as it is filled with liquid, and this latter pressure is
transmitted through the dual tube drainage system and the catheter
to the patient. Such small positive pressures are well tolerated by
the patient and are generally desirable to minimize the occurrence
of bladder lesions.
Referring now more particularly to FIGS. 3 and 4, it will be
observed that the drain tube 21 and vent tube 22 can be
economically manufactured by simultaneous co-extrusion as a siamese
tubing pair. After punching the vent port 23 through the common
wall between the tubes 21, 22, the upper open end of the vent tube
22 is heat-sealed at 22a as shown in FIG. 2.
Referring now to FIG. 5, there is shown a second embodiment of a
urinary drainage system, constructed in accordance with the present
invention, and designated generally by the reference numeral 50.
Like reference numerals designate like or corresponding parts in
the drainage systems of FIGS. 1 and 5.
The drainage system of FIG. 1 differs from the drainage system of
FIG. 5 primarily in the addition of a separate drip chamber 52
located above the urine drainage drip chamber 27. Although the
chambers 27 and 52 are described as being separate, it is
understood that this is meant in terms of separate compartments
only, and the two chambers may preferably be provided as a single,
integrally formed unit as shown in FIG. 5.
The lower open end 25 of the vent tube 22 in FIG. 5 terminates
within the chamber 52 adjacent the top of the latter chamber,
whereas the drain tube 21 passes through the chamber 52 and its
lower open end 24 terminates within the lower chamber 27.
It will also be noted in FIG. 5 that the vent tube 36 passes
through the lower chamber 27 and enters the upper chamber 52.
Locating the upper end of the vent tube 36 in the chamber 52, while
locating the lower end of the drain tube 21 in the chamber 27,
results in complete separation of the liquid drainage system from
the gas venting system, i.e., chamber 27 is confined substantially
to liquid drainage while chamber 52 is essentially limited to gas
venting functions, thus simplifying the fluid flow paths, further
decreasing the chance of any fluid retention in the tubes or
chambers, and providing a more efficient gas barrier to ascending
infection.
It will be appreciated that the drain tube 21 and vent tube 36 need
not pass directly through the chambers 52 and 27, respectively, as
shown in the preferred embodiment of FIG. 5, but may also travel
outside of the drip chambers as long as they ultimately terminate
at proper elevation and in the appropriately designated chambers
shown, without in any way departing from the spirit and scope of
the present invention.
The embodiment of the drainage system shown in FIG. 6 essentially
duplicates the systems of FIGS. 1 and 5 previously discussed, with
the additional modification of providing a one-way check valve 54,
typically a simple ball valve, in the vent tube 22 just below the
venting port 23.
The valve 54 prevents any substantial amount of liquid from flowing
into the vent tube 22 through the port 23, thus further assuring a
relatively high hydrostatic pressure differential between the tube
22 and the drain tube 21. Hence, unidirectional flow is further
enhanced, since liquid must always flow down the tube 21, while air
must always go up the tube 22 past the valve 54.
An additional advantage of locating the valve 54 adjacent the port
23 is that the relatively close proximity to the exit of the Foley
catheter assures a substantially moist state, with consequent
reduced probability of valve failure due to inspissated
material.
Referring now to FIG. 7, there is shown a modified drip chamber
construction which is particularly well suited for application in
the drainage systems of FIGS. 5 and 6. The primary differences
between the embodiment of the invention snown in FIG. 7 and the
embodiment shown in FIG. 5 resides in the provision of a flexible
outer wall 52a for the upper chamber 52, and the location of a
one-way check valve 56 at the lower end of the vent tube 36.
The check valve 56 includes an occlusive member 56a, e.g., a small
ball, with a specific gravity (typically less than unity) below
that of the liquid drained through the system. Therefore, if liquid
should inadvertently enter the upper chamber 52 (a condition which
is unlikely to occur with the system of the present invention), the
liquid will enter the tube 36, and the member 56a will then rise to
open the valve 56 and permit the liquid to exit from the vent tube.
In this connection, the lower wall surface 52b of the chamber 52 is
appropriately sloped to favor drainage of liquid within the chamber
towards the side of the chamber where the tube 36 and valve 56 are
located.
The flexible wall 52a of the chamber 52 enables the chamber 52 to
be used as a hand operated air pump to assure immediate clearing of
all tubes and chambers when desired. In this regard, upon squeezing
the wall 52a, any liquid that might be present in the chamber 52 is
rapidly forced through the tube 36 and the open valve 56 into the
collection bag 38. When the chamber 52 is substantially empty, the
valve 56 closes and the entire fluid pressure generated by the
pumping action is directed through the upper vent tube 22 and port
23 to clear the remaining tubes and chambers.
In view of the very high relative humidity in the sealed system of
the present invention, normally at or near 100%, the likelihood of
failure of the valve 56 due to inspissated material is very
remote.
Application of the modified drip chamber and valve construction of
FIG. 7 to the drainage system 50 of FIG. 5, with the addition of
the valve 54 in the vent tube 22 as shown in FIG. 6, results in an
extremely trouble-free, consistently reliable system with an
inherently high hydrostatic pressure differential and a hand pump
backup. The drainage efficiency of such an arrangement is
sufficiently high that it will function extremely well, even with
very small diameter tubing, typically 3/32 inch I.D. and less, with
obvious advantages in terms of cost and compactness.
FIGS. 8 through 15 of the drawings illustrate several embodiments
of a new and improved liquid collection and measurement bag
particularly well adapted for use with the drainage systems of
FIGS. 1 through 7 in lieu of the simplified collection bag 38
previously described. However, while the collection and measurement
bags of FIGS. 8 through 15 are well suited for use with such
drainage systems, it is to be understood that the bags may also be
used with other drainage systems and for collecting liquids other
than urine.
Referring now to FIG. 8, there is shown a urine collection and
measurement bag 138 fabricated of pliable translucent or
transparent material, preferably plastic, which has been first
vacuum-heat formed to define three slightly distended chambers 143,
144,145, and then heat-sealed along the bag periphery 139 and the
pair of inner seams 140, 141. The result is a completely sealed bag
capable of excluding contaminating gas from the external
environment. In addition, as best observed in FIG. 8, the seams
140, 141 extend considerably less than the full height of the bag
138, and the seam 140 is shorter than the seam 141, thus defining
the three liquid collection chambers 143, 144, 145 of progressively
increasing volumetric capacity, respectively, with all three
chambers communicating with each other at their upper open
ends.
The collection chamber 143 is the smallest chamber and is ideally
suited for accurate, short term, low volume measurements,
particularly when used in conjunction with any of the previously
described drainage systems of the present invention which avoid
liquid retention that would otherwise introduce inaccuracies into
such measurements.
The bag 138 and each of the chambers 143, 144, 145 become further
distended when filled with the weight of the urine collected. In
this regard, appropriate vertically spaced series of calibration
marks 143a, 144a, 145a, typically in milliliters, are printed or
otherwise appropriately defined in the bag 138 along the edge of
each of the chambers 143, 144, 145, respectively, to indicate the
distended volumes of liquid collected.
The bag 138 is either pierced and subsequently heat-sealed, or
provided with any other appropriate gas tight mounting, at 139a for
receiving a drain tube 135 and vent tube 136 equivalent to the
tubes 35, 36, respectively, previously described in connection with
the drainage systems of FIGS. 1-7.
The drain tube 135 is slashed diagonally at 135a from a point a few
centimeters below its point of entry into the bag 138 to its tip
135b near the bottom of the bag and well within the smallest
collection chamber 143. Similarly, the vent tube 136 is slashed
diagonally at 136a from a point above the beginning of the diagonal
slash for drain tube 135 to the tip of the tube 136 at point 136b
within the chamber 143.
The slashed tube construction serves as a liquid flow director to
make sure that liquid entering the bag 138 enters the smallest
collection chamber 143 first. As for the tube 136, if liquid flow
should inadvertently reverse in direction, the liquid will still
enter the chamber 143 first in the embodiment of the system shown
in FIG. 8. Normally, however, the tube 136 performs its primary
designated function of venting gas, displaced above the liquid
entering bag 138, to the remainder of the drainage system.
When collection chamber 143 is filled with urine or the like, the
liquid will overflow into the chamber 144. When both of the
chambers 143 and 144 are full, urine then overflows into the
largest chamber 145. After a prescribed interval of liquid
collection, the urine from chambers 143 and 144 may be emptied into
the chamber 145 by tipping the bag 138 so that it rotates clockwise
90 degrees or more.
The bag 138 is also provided with a pair of drain tubes 147, 148
located at the bottoms of collection chambers 143, 145,
respectively. The drain tubes 147, 148 are typically 1/4 inch I.D.
in size and are provided with conventional occlusive clamps 149,
150, respectively, located close to the bottom of the bag 138.
Short term, relatively low volume liquid specimens from a given
collection period may be selectively drained from the small chamber
143 through the drain tube 147 for any type of subsequent testing.
If desired, a relatively inexpensive, disposable urinometer (not
shown), for measuring urine specific gravity, may also be
incorporated into the chamber 143. At the end of each day or
nursing shift, the entire bag 138 may be emptied through the drain
tube 148.
The collection and measurement bag 138 completely avoids the
problems of the prior art involving urine spillage through the air
vent, urine contamination by gas entering the system through the
air vent, and vent clogging. In addition, the bag 138 provides a
relatively simple, low cost, accurate collection and monitoring
apparatus as an ideal solution to the problem of making precise,
low volume urine measurements and obtaining recent urine specimens
for testing.
Referring now to FIG. 10, there is shown another embodiment of a
liquid collection and measurement bag 238, constructed in
accordance with the present invention. In this connection,
reference numerals 235-249 in the embodiment of FIG. 10 designate
like or corresponding parts as the reference numerals 135-149 in
the embodiment of FIG. 8.
The primary distinction between the bag 238 of FIG. 10 and the bag
138 of FIG. 8 is that, in lieu of the pair of heat-sealed seams
140, 141, the bag 238 is provided with a single curved seam 240
which divides the bag into two chambers 243 and 245. Since the seam
240 curves closer to the side of the bag 238 as it approaches the
bottom of the bag, smaller urine output volumes are measured more
accurately, while the ability to measure relatively large hourly
volumes is preserved at the wider, upper end of the chamber 243 and
the much larger chamber 245 into which urine overflow occurs.
FIG. 10 also shows a different form of a liquid flow director than
the diagonally slashed tubes shown in FIG. 8. In this regard, the
bag 238 includes an additional layer or flap 251 of flexible
plastic material which is heat-sealed into the adjacent peripheral
joint 239 of the bag. The flap 251 defines a flow directing web
which is secured at its upper end to the lower ends of the tubes
235, 236 and extends down into the chamber 243, to assure that
urine entering the bag enters the latter chamber first.
FIGS. 11-13 illustrate another embodiment of a liquid collection
and measurement bag 338, constructed in accordance with the present
invention. In this connection, reference numerals 335-348 in the
embodiment of FIGS. 11-13 designate like or corresponding parts as
the reference numerals 135-148 in the embodiment of FIG. 8.
The primary difference between the bag 338 of FIGS. 11-13 and the
bag 138 of FIG. 8 resides in the provision of a rigid baffle 353 as
a divider defining collection chambers 343, 345, rather than using
the seams 140, 141 shown in FIG. 8. The baffle 353 is typically
fabricated of relatively rigid plastic material and includes a base
member 353a secured to or integrally formed with an upwardly
extending compartment dividing member 353b.
The vertical edges of the member 353b are heat-sealed to the outer
walls of the bag 338 after the baffle 353 is installed within the
bag. The opening 347a of the drain 347 overlaps with the upper
surface of the member 353a within the bag 338 to permit selective
drainage from the compartment 343. Drainage from the compartment
345 by the drain tube 348 is accomplished through a hole 355
provided in the base member 353a directly above the tube 348.
FIGS. 14 and 15 illustrate a further embodiment of a novel liquid
collection and measurement bag 438, constructed in accordance with
the present invention. In this connection, reference numerals
435-448 in the embodiment of FIGS. 14, 15 designate like or
corresponding parts as the reference numerals 135-148 in the
embodiment of FIG. 8.
The primary difference between the bag 438 of FIGS. 14, 15 and the
bag 138 of FIG. 8 resides in the provision of a separate,
relatively rigid walled, graduated container 450 within the bag 438
and defining the small volume collection chamber 443. The container
450 includes a spout 450a at the lower edge thereof adapted to
enter the mouth 447a of the drain tube 447 when the container is
installed within the bag 438.
It will be appreciated that, while the container 450 is shown in
FIGS. 14, 15 as defining only the single chamber 443, it is within
the ordinary skill of the art to provide a similar container
defining two or more collection chambers, without in any way
departing from the present invention.
Except for the structural differences noted, the intended use,
operational performance and advantages of the bag embodiments shown
in FIGS. 10 through 15 of the drawings substantially duplicate
those for the bag 138 shown in FIGS. 8 and 9 of the drawings.
The new and improved fluid drainage, collection and monitoring
systems of the present invention are characterized by relatively
simple, compact and economical construction, while substantially
obviating or minimizing the prior art problems of spillage,
contamination, ascending infection to the patient and poor patient
tolerance. In addition, the present invention satisfies a long
existing need in the medical arts for a system capable of
trouble-free, complete drainage and capable of making accurate, low
volume urine output measurements and obtaining recently collected
urine specimens.
It will be apparent from the foregoing that, while particular forms
of the invention have been illustrated and described, various
modifications can be made without departing from the spirit and
scope of the invention.
* * * * *