U.S. patent number 3,601,119 [Application Number 04/786,161] was granted by the patent office on 1971-08-24 for body fluid drainage apparatus.
This patent grant is currently assigned to Horizon Industries. Invention is credited to Harvey J. Engelsher.
United States Patent |
3,601,119 |
Engelsher |
August 24, 1971 |
BODY FLUID DRAINAGE APPARATUS
Abstract
A container for the drainage of body fluids such as urine has a
partition defining and separating inlet and storage chambers for
measuring and then storing the fluid, with the partition being open
at its upper part to provide an interconnecting passage between the
chambers. An inlet tube extends downward, slightly into the inlet
chamber where its discharge end terminates with a one-way valve
which is spaced below the chamber's upper surface and generally
above the passage for preventing backflow of fluid and bacteria.
Fluid draining through the inlet tube drips first into the inlet
chamber which is calibrated for accurate measurements, and can
later be transferred to the storage chamber via the passage.
Inventors: |
Engelsher; Harvey J. (N/A,
NY) |
Assignee: |
Industries; Horizon
(NY)
|
Family
ID: |
25137766 |
Appl.
No.: |
04/786,161 |
Filed: |
December 23, 1968 |
Current U.S.
Class: |
600/575; 604/323;
604/325; 600/580; 600/581 |
Current CPC
Class: |
A61M
1/0001 (20130101); A61F 5/44 (20130101); A61M
1/602 (20210501) |
Current International
Class: |
A61F
5/44 (20060101); A61M 1/00 (20060101); A61B
005/10 (); A61F 005/44 () |
Field of
Search: |
;128/275-276,294-295,348-350,2 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Rosenbaum; Charles F.
Claims
I claim:
1. A body fluid drainage apparatus comprising:
a. a storage chamber;
b. a sampling chamber mounted on the storage chamber;
c. common partition means separating said chambers from each
other;
d. inlet means extending through an upper portion of the sampling
chamber and outlet means projecting from a lower portion
thereof;
e. passage means between the chambers for establishing fluid
communication therebetween, said passage means including an opening
provided in said partition means; and
f. said inlet means including an inlet tube having a terminal end
portion located above the bottom edge of said passage means and
below the top edge thereof for discharging body fluid into said
sampling chamber;
whereby at least a sample portion of body fluid may be withdrawn
from said sampling chamber via the outlet means thereof and any
residual portion of body fluid may be transferred between the
chambers via said passage means upon movement of said body fluid
over the bottom edge of said passage means.
2. The body fluid drainage apparatus as recited in claim 10,
further including one-way valve means on said inlet means for
permitting unidirectional fluid flow from the inlet tube to the
sampling chamber.
3. The body fluid drainage apparatus as recited in claim 1, wherein
said passage means extends between the upper portions of said
chambers.
4. The body fluid drainage apparatus as recited in claim 1, wherein
the lower portion of said sampling chamber has smaller
cross-sectional dimensions than that of the upper portion, and
fluid volume indicia provided on the lower portion of the sampling
chamber.
5. The body fluid drainage apparatus as recited in claim 1, further
comprising nonwetting filter means secured to the storage chamber
for permitting passage of air and other gas from within said
chamber to the atmosphere while barring passage of liquid and
bacteria.
Description
BACKGROUND OF THE INVENTION AND DESCRIPTION OF THE PRIOR ART
This invention relates to portable and disposable apparatus for use
in draining and temporarily storing various body fluids. Drainage
of these fluids by either natural or suction means is a very common
and important medical procedure utilized for numerous conditions
and treatments, of which urinary catheterization is one of the most
significant. Samples of the urine accumulated by this procedure are
generally subjected to standard urinalysis, culture tests, and
specific gravity determination in the case of renal shutdown,
whereby indications of numerous physical conditions and changes are
monitored; and the remaining urine is then discarded.
The basic form of the apparatus for providing this drainage
function is quite simple, comprising a catheter tube having one end
inserted through the human urethra to the bladder and a discharge
end which is directed into a container. One development in this
field has been the use of flexible, plastic containers which are
relatively easy to handle and are also readily disposable.
In using such drainage equipment there is a constant and very
serious danger to the patient of infection caused by bacteria
entering the drainage system, traveling upward to the bladder,
ureters and kidneys, and causing problems such as urinary sepsis,
cystitis, and pyelonephritis. The specific areas of bacterial
intrusion are the junctions between the adjacent ends of a catheter
and the connection tube, and at the container's inlet and
outlet.
A closely related problem in existing draining systems is backflow
of urine from the container into the patient's bladder, which may
occur if a careless or uninformed attendant drops or causes
inversion of a filled and still connected container. The
construction of existing equipment permits or dictates certain
other procedures which are not foolproof against typical
mishandling and the corresponding inadequate patient care, these
procedures including: (a) placing a container on a patient's bed
with a portion of the connector tube being pinched or bent, thus
interferring with normal drainage, (b) removing a urine sample from
the base of a container, which contains both fresh and stale fluid,
and (c) obtaining a rough measure of the fluid accumulated in a
flexible container by observing the fluid level with respect to
unit marking on the container's surface.
Despite various developments in the prior art systems, the
above-described problems have persisted, particularly in the area
of contamination, backflow, and obtaining fresh and accurately
measured samples from a basically closed system.
SUMMARY OF THE INVENTION
The new invention provides a closed system for the drainage of body
fluids, with a substantial reduction in the dangers to a patient
commonly caused by inherent imperfections or common misuse of the
prior art apparatus. More specifically according to the new
invention, a container has its interior divided by a partition into
an inlet chamber and a storage chamber, and through the upper part
of the partition is an aperture providing a passage interconnecting
these chambers. An inlet tube has one end connected to a drainage
tube such as a catheter, and has its discharge end extending
through an upper part of the container into the inlet chamber. This
discharge end is spaced above the passage in the partition for
maintaining an airgap between this end and the fluid that may flow
in the passage. By preventing the fluid from contacting the inlet
tube, there will be no continuous path of liquid upward to the
discharge end, which substantially precludes corresponding movement
of bacteria from the accumulated fluid into the inlet tube.
By this structural arrangement fresh fluid is directed to the inlet
chamber where its quantity and rate of accumulation can be visually
determined, and subsequently this fluid is transferred via the
passage to the storage chamber with the inlet chamber again ready
to receive a fresh flow.
Attached to the inlet tube's discharge end is a one-way valve for
preventing any backflow of liquid in the event that the container
becomes totally filled or inverted. In one preferred embodiment of
this invention stiffness is added either to the partition, to the
material of the inlet chamber, or to the entire container such that
the inlet chamber walls are less deformable and the volume markings
on one of these walls provide a more accurate determination of the
fluid within. As a further refinement the inlet chamber may have
its lower portion reduced in diameter; the fluid drips to this
portion first, where measurement is more accurate. A separate drain
for the inlet chamber is another preferred feature for removing the
fresh fluid from this chamber for testing before it becomes mixed
with the stale fluid in the storage chamber. With regard to some of
the tests mentioned above that are conducted on a urine sample, the
value and reliability of the results will be greatly reduced if the
fluid is not fresh.
The invention is further disclosed by way of example as a preferred
embodiment presented in the drawings and description below.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a front perspective view of a preferred embodiment of the
apparatus according to the present invention;
FIG. 2 is a sectional view taken along lines 2--2 of FIG. 1;
FIG. 3 is another sectional view taken along lines 3--3 of FIG. 1,
showing the relationship of the partition and the inlet and drain
tubes in container; and
FIG. 4 is a front view of another embodiment.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring to FIGS. 1-3, the apparatus has the basic components of a
storage chamber 11, the inlet chamber 12, inlet tube 13, and first
and second drain tubes 14 and 15. The storage chamber is formed
from a sheet of flexible, waterproof or water-impermeable plastic,
such as polyvinyl, which is heat sealed along its edges 16 to form
a closed container. This chamber defines an expandable internal
space bounded by front and rear walls 17 and 18, and top and bottom
parts 19 and 20 which are also reference levels for orienting
components within the container. FIG. 4 shows another embodiment in
which a single sheet of plastic is folded along its top edge and
sealed along its side and bottom edges. A partition is formed by
sealing along line 17A which divides the container into chambers
11A and 12A.
Referring again to FIGS. 1-3, the inlet chamber 12 is formed by a
process such as molding of a semirigid plastic of any appropriate
type that can be economically and securely heat sealed or adhesive
sealed to the flexible plastic storage chamber 11. As best seen in
FIG. 3, between the two chambers is a partition 21 which may be a
single layer serving as both front wall 17 of chamber 11 and the
rear wall of chamber 12, or may be a double layer wall if the two
chambers are initially separate units. In either case this
partition must have an aperture or a complete break 22 to provide a
passage interconnecting the chambers near the top level of the
apparatus.
The inlet tube 13 has a discharge end 23 within the chamber 12 and
a remote end not shown into which a catheter is emptied. one
important feature of this discharge end is a one-way valve 24 that
permits fluid flow only in one direction from the catheter 13 to
the inlet chamber 12. A particularly economical, simple and also
highly effective valve is a fish-mouth type, in which the end of
the tube is flattened to form two, very thin, flexible and closely
adjacent tabs. Fluid flowing downward easily separates the tabs
which thus do not interfere with normal drainage; however, the
slightest contact of reverse flowing fluid with the tabs causes
them to become pressed together preventing any backflow.
Another and equally important feature of this invention is that the
discharge end 23 and its valve 24 are positioned below wall 26 but
above edge 25 of the partition 21, with the semirigid quality of
chamber 12 maintaining this spacing. By this construction fluid can
drip from the valve through air space without flowing down a wall
which would form a fluid path for bacteria; also the fluid can flow
from chambers 12 to 11 across edge 25 without much likelihood of
its contacting the valve spaced above.
In operation, fluid such as urine flows in tube 13, drips out of
valve 24 and falls to space 27 which has a small diameter and fine
calibration marks as compared to the diameter and calibrations of
the larger space 28 immediately above; accordingly as the fluid
flows initially into space 27, its quantity and rate of flow can be
measured very accurately without having to drain any fluid from
either chamber and without having to tip the container or in some
prior art apparatus. If and when the fluid reaches the level of
edge 25, it will spill over the partition into storage space 29.
Alternatively, if the space 27 had become only partially filled
during a given time period, and an attendant wished to check the
rate of flow for a subsequent time period, the container could be
tipped in the direction of arrow A in FIG. 3, thus emptying space
27 for a fresh accumulation. Because of the relative positions of
partition edge 25 and the tube's discharge end 23, the fluid
spilled to space 29 will not contact the valve 24, and thus will
avoid a backflow of either fluid or bacteria. As another
alternative, drain tube 14 can be opened to deliver a sample of
fresh fluid, in contrast to the stale fluid stored in space 29. As
described earlier, in some circumstances it is essential that the
urine sample be fresh, and this was previously obtained directly
from the catheter by temporarily disconnecting it from the drainage
container. The obvious drawbacks with this procedure are the high
susceptibility of new infection, inconvenience, and loss of
time.
It is intended that before the fluid level in chamber 11 ever
reaches the level of valve 24, an attendant would either drain this
chamber via tube 15, or discard the whole container. By maintaining
this procedure, valve 24 will always be spaced from the upper
surface of the fluid, and in fact separated from contact with any
other part of the apparatus, thereby providing the above described
air gap for impending bacteria movement. Should an attendant fail
to follow this procedure and the container become completely filled
with urine, the one-way valve 24 would close in response to the
slightest backflow of the fluid.
Referring again to FIG. 1, there is provided a breather valve 30
located at an upper portion of the chamber 11 to permit air but not
liquid to escape from the chamber, and also to bar any passage of
bacteria. This valve is made of a microporous filter material,
which is secured to the wall material of the container. A preferred
filter material has nonwetting characteristics so that the outer
surface will not become moist despite the close proximity of liquid
touching the inner surface.
Also shown in FIG. 1 is a cord 31 for suspending the apparatus from
a patient's bed frame or other support; and it is intended that
spring clips (not shown) be used to secure an upper portion of
inlet tube 13 to the bed. Other clamps or valve 32 releasably close
and seal drain tubes 14 and 15. Alternatively, a single valve may
selectively drain tube 14 or 15.
* * * * *