US 3601119 A
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United States Patent Primary Examiner-Charles F. Rosenbaum Attorney- Irving Seidman 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.
PATENTEI] M1824 mm Fig. 3'
INVENTOR. HARVEY J. ENGELSHER BODY FLUID DRAINAGE APPARATUS 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 humanurethra 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 containers inlet and outlet.
A closely related problem in existing draining systems is backflow of urine from the container into the patients 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 patients 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 onthe containers 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 tubes 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 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 "of the p'artition 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; ac-
cordingly 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'g'iven 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 tubes 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, arid 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 oneway 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 patients 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.
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 ed e of said passage means and below the top edge t ereof 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. I
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.