U.S. patent number 3,906,935 [Application Number 05/375,044] was granted by the patent office on 1975-09-23 for medical fluid drainage and sampling system.
This patent grant is currently assigned to G.A.R.D. Industries, Inc.. Invention is credited to David C. Raia, Brewster H. Staples.
United States Patent |
3,906,935 |
Raia , et al. |
September 23, 1975 |
Medical fluid drainage and sampling system
Abstract
An improvement in medical fluid drainage systems, for permitting
invasion of the system for sampling of the most recently collected
fluid while insuring against the entry of infectious agents. A
sample chamber is placed in a collection tube line between a
catheter and a drainage collection vessel. The chamber has a
self-sealing, elastomeric seal for entry of a sterile hypodermic
needle to allow sampling of fluids collected in the chamber without
contaminating the liquid in the chamber or the body of a patient to
whom the system is connected.
Inventors: |
Raia; David C. (Arlington,
MA), Staples; Brewster H. (Pownal, ME) |
Assignee: |
G.A.R.D. Industries, Inc.
(Boston, MA)
|
Family
ID: |
23479274 |
Appl.
No.: |
05/375,044 |
Filed: |
June 29, 1973 |
Current U.S.
Class: |
600/575;
128/DIG.24; 604/325; 604/323; 600/581 |
Current CPC
Class: |
A61F
5/4404 (20130101); A61B 5/20 (20130101); A61M
39/04 (20130101); A61B 5/208 (20130101); Y10S
128/24 (20130101) |
Current International
Class: |
A61F
5/44 (20060101); A61B 5/20 (20060101); A61M
39/02 (20060101); A61M 39/04 (20060101); A61B
010/00 () |
Field of
Search: |
;128/2F,295,DIG.24
;4/110 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Howell; Kyle L.
Attorney, Agent or Firm: Cohen, Esq.; Lawrence S.
Claims
What is claimed is:
1. In a medical fluid drainage system for conducting fluid from the
body of a patient, said drainage system comprising a fluid
collection vessel and a fluid collection tube, the tube being
connected at one end to a catheter insertable in the patient and to
the vessel at another end, the improvement comprising, a wall
defining a closed unitary sample chamber mounted intermediately in
said collection tube between the catheter and the collection
vessel, establishing an input section of the tube between the
catheter and the sample chamber, the input section being connected
to a first opening in the wall and the sample chamber also
establishing an output section of the tube between the collection
vessel and the sample chamber, the output section being connected
to an output tubular stem means extending through a second opening
in the wall for collecting a sample in the chamber and terminating
inside said chamber and spaced from said wall at its termination
within the chamber,
an elastomeric self-sealing seal means in the wall of said chamber
constructed and located to receive a sterile hypodermic needle
therethrough into communication with a collected sample and to
maintain its seal upon withdrawal of such hypodermic needle whereby
collection of the most recently drained fluid from a patient's body
is permitted by sterile invasion of the system.
2. The improvement of claim 1 and further comprising means for
preventing backflow of fluid from the sample chamber to the input
section of the tube.
3. The improvement of claim 1 wherein said sample chamber further
comprises an input tubular stem extending into said chamber and
spaced from said chamber wall at an orifice end.
Description
BACKGROUND OF THE INVENTION
Body fluid drainage systems such as urinary catheterization systems
are well-known for medical use. In such systems a Foley-type
catheter is inserted into the bladder in the body of a patient and
often connected through flexible tubing to a collection vessel. The
catheter is maintained in the body for long periods of time often
for days or even weeks. Samplings are taken from the collection
vessel periodically to perform desired urinalysis studies. It has
long been a problem that patients are susceptible to infection
traveling through the catheterization system up into the body.
Bacteria can invade the system as when samples are taken from the
collection vessel.
There have been a number of systems suggested to prevent bacterial
infection to the patient during urinary catheterization over long
time periods. However, most commonly used medical procedures and
systems still result in an undesirably high rate of infection to
patients.
SUMMARY OF THE INVENTION
It is a primary object of this invention to provide an improvement
in medical fluid drainage systems for permitting invasion of the
system for sampling of the most recently collected fluid while
insuring against the entry of infectious agents.
Still another object of this invention is to provide an improvement
in accordance with the preceding object which is inexpensive and
can readily be adopted to existing systems rapidly and
efficiently.
Still another object of this invention is to provide an improvement
in accordance with the preceding objects which can be used by
relatively untrained medical personnel without the need for
physician supervision.
Still another object of this invention is to provide an improved
means for permitting invasion of a medical fluid drainage system
and sampling of the most recently collected fluid while insuring
against entry of infectious agents to the system and thereby
lowering the danger of infection to the patient.
According to the invention, a sample chamber is provided in a
medical fluid drainage system for conducting fluid from the body of
the patient which system has a fluid collection vessel and a fluid
collection tube connected to a catheter in the patient's body. The
sample chamber comprises a self-sealing elastomeric seal in its
wall which seal permits entrance of a sterile hypodermic needle
while the remainder of the system is maintained sterile to withdraw
fluid samples for testing. Preferably the sample chamber has means
for preventing backflow of fluid from the chamber to the body and
means for holding a predetermined volume of body fluid while
allowing passage to the collection vessel of additional body fluid
passing from the body.
It is a feature of this invention that the sample chamber enables
sampling of the most recently collected fluid specimen since the
chamber can be placed close to the catheter leading from the body.
Because sterile invasion of the system for sampling can be carried
out, samples can be taken more frequently than is the case with
existing surgical drainage systems where each opening of a
collection device can lead to bacterial infection. This is
particularly useful in tests such as the Schilling test where
radioisotopes are injected into the body and the urine collected
for 24-hour periods. Often the urine is tested and the collection
vessel emptied only at the end of a 24 hour period to determine the
degree of absorption. With the system of this invention, it is
possible to sample every two or four hours or as desired without
leading to bacterial infection yet obtaining a rate of isotope
absorption as well as a total amount in any 24 hour period.
BRIEF DESCRIPTION OF THE DRAWINGS
The above and other features, objects and advantages of the present
invention will be better understood from the following
specification when read in conjunction with the accompanying
drawings in which:
FIG. 1 is a perspective view of a medical fluid drainage system of
this invention;
FIG. 2 is a side view of an element thereof;
FIG. 2a is a cross sectional view through line 2a--2a of FIG.
2;
FIG. 3 is a side view of an alternate embodiment of an element
thereof;
FIG. 4 is a side view of another alternate embodiment of a sample
chamber; and
FIG. 5 is a view through line 5--5 of FIG. 4.
DESCRIPTION OF PREFERRED EMBODIMENTS
With reference now to the drawings and more particularly FIGS. 1
and 2, the urinary catheterization system 10 is shown having a
preferred embodiment of a sample chamber 11 of this invention
incorporated therein.
The conventional parts of the system 10 as normally used in urinary
catheterization include a Foley or other drainage catheter 12 which
is inserted in a body of a patient diagrammatically indicated at 13
and has an end 15 attached to a plastic or rubber collection tube
14 forming an input portion and a lower output tube portion 16. The
output portion of the tube is attached to a conventional metering
vessel or chamber 17 which is in turn linked by a drainage tube 18
to a storage vessel or chamber 19.
In conventional practice, the plastic tube portions 14 and 16 are a
unitary collection tube leading directly to the metering chamber.
The metering chamber may be for example, a Curity urine-meter
produced by Kendall Corporation of New Jersey, having rigid
transparent plastic walls with calibrated volume markings to
determine the volume of fluid output from the patient. Preferably
the metering chamber has a drainage stopper 20 to allow sampling as
in conventional practice although it is preferred that this
drainage stopper not be used. The storage chamber 19 is preferably
a Curity bedside drainage bag produced by Kendall Corporation of
New Jersey formed of thin plastic walls and having a collection
tube 21 stoppered as at 22 by a clamp with a microporous filter 23
allowing equalizing of air pressure when fluid enters the system
but preventing bacterial invasion of the system. Thus the system is
closed to the atmosphere except at filter 23.
In accordance with this invention, the sample chamber 11 is
provided. The sample chamber 11 is preferably of a rigid plastic
such as polystyrene in the form of two joined conical portions 30
and 31 each having tubular stems 32 and 33 extending through the
apex ends. The stems extend into the space within the chamber.
Thus, fluid collected in the chamber does not pass down the tube 16
until a level is reached above the level of the orifice 34 of the
stem 32. This permits a fresh sample to always be present within
the chamber 11 while permitting over-flow to pass through the
collection tube 16 to a collection vessel. Similarly, the extension
of the stem 33 to an area within the chamber spaced from the side
walls of the chamber, prevents backflow of liquid to the patient.
When the chamber is inverted, since the stem 33 extends at least as
far into the chamber as the stem 32, no backflow is possible to the
patient.
The chamber 11 also carries an orifice 35 in which is mounted an
elastomeric self-sealing seal 36. This seal can be a rubber plug as
for example the type used in resealable pharmaceutical vials and
Vacutainers (a trademarked product of Becton, Dickinson &
Company of Columbus, Nebraska and Rutherford, New Jersey) and the
like. Thus, fluid specimens within the chamber can be sampled by
inserting a hypodermic needle through the plug 36 withdrawing a
sample of the fluid and then removing the hypodermic needle
whereupon the plug automatically reseals the chamber. Since all
parts of the system are sterilized initially before use, if a
sterile hypodermic needle is used, invasion of the system by the
hypodermic needles does not cause bacterial entrance into the
system. Thus, sterile invasion of the system is possible with
sampling at whatever time intervals desired. It is preferred that
the chamber 11 be as close to the catheter 12 as possible in order
to enable collection and sampling of the freshest fluids removed
from the body at all times.
In using the system 10, the Foley catheter is connected to the
patient and the apparatus set up as shown in FIG. 1. As fluid
drains from the patient, it is passed to the sample chamber 11
which is preferably located below the level of the patient and
preferably in a generally upright position. However, the system can
be near horizontal although the orifice 34 should always be
somewhat below the orifice of the stem 33 to allow drainage to the
collection vessel rather than passage back to the patient. Fluids
collect below the level of rim 34 and overflow passes to the
metering chamber 17 where volume can be measured at periodic
intervals. At such intervals, the storage chamber 19 can be lowered
with respect to the metering chamber to cause drainage of the
metering chamber into the storage chamber. Thus, large volumes of
fluids can be stored without the need for opening the system to the
atmosphere over short time periods. This prevents bacterial
invasion of the sterile system which could be caused by bacteria
carried in the atmosphere. At any time during drainage, a sterile
hypodermic needle can be inserted through the plug 36 to sample
fresh fluid collected below the level of rim 34. Preferably the
chamber 11 is transparent to allow visual access to the chamber
which is preferred. The chamber can be completely drained by the
sampling needle if desired.
Turning now to an alternate embodiment of a sample chamber 11, a
plastic thin wall rigid sampling chamber 40 is illustrated in FIG.
3 having a stem 32 as previously described with conical sections 30
and 31. A plug 36 as previously described is mounted in the conical
section 31. In this embodiment, the stem 33 is truncated at the
entrance to the chamber and a divider wall 41 extends across the
chamber having a central aperture 42. In this embodiment, fluid
collected passes through the aperture 42 when the chamber is
vertically held. Thus, the first portion of the chamber provides
one collection area when the chamber is other than vertical while
allowing drainage to the second chamber when the chamber is
vertically held. Sampling can be accomplished by inserting a needle
through plug 36 to either the first or second portion of the
chamber. If desired, additional plugs 36 can be used in the lower
portion of the chamber.
FIGS. 4 and 5 illustrate still another embodiment of a sample
chamber in accordance with this invention. As in the first
alternate embodiment, identical numbers indicate identical parts to
those shown in FIGS. 1 and 2. The sample chamber 50 has walls 30
and 31 with inwardly extending stem 32. In place of the stem 33, a
one-way valve 51 is positioned in the end of tube 15 to prevent
backflow to the patient. The valve is formed of a resilient nipple
having a slit 52 which allows flow to chamber 50 but prevents
backflow to the body of the patient. In this embodiment, stem 52
ends at the chamber wall 31.
While specific embodiments of the present invention have been shown
and described, many modifications are possible. The chamber 11 or
modifications thereof need not be made of plastic. Glass, or other
materials can be used. Although it is preferred that the sample
chambers be transparent, in some cases, opaque walls can be used.
Similarly, the size and number of self-sealing seals used can
vary.
The specific collection and metering chambers can be any of those
known in the art. While it is preferred that the system be closed
to the atmosphere, the sampling chamber has use even in open
systems to collect the freshest sample removed from the
patient.
It is preferred that the volume of the chamber 11 hold from 1 to
100 cc, and preferably 10 cc in urinary catheterization, before
additional fluids are passed to the collection or metering chamber.
Thus, normal urinary output of 1000 to 2000 cc per 24 hour period
passes to the metering chamber always leaving a sample which is a
fresh sample of a predetermined size in the sample chamber. For
example, when the total volume of the sample chamber is 200 cc,
approximately 10 cc is preferably left for sampling at all times by
proper dimensioning of the length of stem 32. If desired,
volumetric calibrations can be mounted directly on the wall of the
sample chamber to determine the volume held in the chamber.
The specific size and configuration of the sample chamber 11 can
vary greatly as desired. While conical-shaped portions are shown in
the preferred embodiment, the chamber can be circular or of
irregular configuration. While rigid walls are preferred, in some
cases, resilient or collapsible wall devices can be used although
it is preferred that the stem 32 always have its orifice 34 spaced
from the walls of the chamber.
While the stem extending into the chamber provides for collection
of a portion of fluid desired, in some cases, valves of various
types can be used in place of the inward extension of the stem 32.
Valves or other means can be used to provide for filling of the
chamber to a desired level with a preselected amount of fluid
drained, after which, excess fluid drains to the storage vessel. In
all cases, it is important that a self-sealing, seal be mounted on
the chamber in operative relationship to the fluid portion
collected for sampling, to allow sterile invasion of the system for
sampling purposes.
While urinary catheterization has been specifically described, the
method and apparatus of this invention can be used in connection
with other medical drainage systems. For example, use can be made
in nasal and gastric drainage.
The hypodermic needle used for sampling is preferably attached to a
sterile vacuum tube. However, sterile syringes and the like can be
used so long as the system is maintained free of the entrance of
bacteria during sampling.
* * * * *