Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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Background of the Invention
The present invention relates ko a ~rainage con~rol method
and valve especially adapted for use with drainage catheters to
dump the contents of a bladder upon a predetermined pressure
being reached in the valve and to close the valve once the con-
tents has been released into a drainage bag.
~ eretofore, it has been a common hospital procedure to
ob~ain continuous drainage of urine from ~he urinary bladder
by means of a catheter passed transurethrally and retained
in the bladder by a number of s~andard and conventional de-
vices. It is usual practice to attach a relative large bore~
plastic drainag tube to the distal proximal ènd of the uri-
nary catheter and lead this drainage tubi~g along a downhill
path over the side of the bed into a collection bottle or bag
which is placed below the level o~ the urinary bladdexO Such
an apparatus when functioning properly creates a syphon effect
in the catheter only to the level of the connection between the
catheter and the drainage tube. However, a syphon effect is
not obtained in the drainage tube as the bore of the latter
is large enough so that air bubbles pass up the drainage tube
preventing a syphon action therein~ With this arrangement, ~
generally continuous drainage is obtained in that the bladder
is always kept empty, there being no provision for automatic
and periodic filling and emptying of the bladder~
There are two basic objections to this system. First J
the urinary bladdér is a hollow distensible organ which de
pends upon alternate filling and emptying to maintain the tone
of its muscular walls. Also, periodic filling and emptying of
the bladder is one of the major methods or mechanisms by which
the concentration of bacteria in the bladder is kept at low
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levels. This mechanism depends on dilution of the bacteria _-
which may be existing in the bladder with sterile urine from
the ureters followed by periodic and complete emptying of the
bladder. It has been demons~rated that if bacteria are in~
troduced into a normal bladder in large concentrations, the
bladder is capable of clearing these organisms by this mech~
anism within approximately 24 to 48 hours. If the bladder
i5 kept from emptying completely, though still allowed to
expel portions of its contents periodically or continually,
the growth of bacteria in the bladder may be of such mayni-
tude that infection will ensue.
The second objection to the aforementioned conventional
method is that most of the catheters used as indwelling bladder
catheters do not conform to the contracted shape of the bladder
so that "foley tip necrosis" of the dome of the bladaer, a
syndrome well known to urologist~ and pathologists~ may re-
sult. It is elt by some that this pressure ische~ic ulcer
of the dome of the bladder is the portal by which bacteria
enter to infect the bladder. Such infections, common in
patients with indwelling catheters, are caused when the
dome of the bladder collapses and falls or is drawn down
over the indwelling cathe$er, particularly over the tip of
the catheter.
~ hexe are several pitfalls in the use of the aforemen-
tioned conventional drainage system which are very commonly
encountered in hospitals and which accentuate this situation.
For example, the drainage tube may be placed below the surface
level of urinein the collection bottle or ~ag. Under these
circumstances, the drainage tubing may ill with urine and
exert a strong and continuous syphon action in the bladderO
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This draws the dome of the bladder down over the indwelling
catheter and over the ~ip thereof very much enhancing the
formation of pressure ulcers in the dome of the bladder. Also,
it has been demonstra~ed many times that submerging ~he end
of the drainage tube in the urine will allow bacteria to swim
up the slowly draining ~luid in the drainage or connecting
tubing and infect the bladder by that route~
Another pitfall of the aforesaid conventional drainage
system is that if the drainage tubing is not led straight
from the indwelling catheter ~o the collectibn hottle, urine
will collect to form pockets in any loops which may be in
the tubing thereby causing a back pressuxe in the bladder
with a resulting residual stagnant pool of urine therein.
Such residual pooling is well known to hasten the onset of
infection.
It is an advantage of the present invention to avoid
the aforesaid dificul~ies of known prior art practices by
providing a method and apparatus for drainage of fluids from
the body with an indwelling bladder catheter, or the like,
which au~oma~ically and periodically collapses and drains
the cavity insllring its complete emptying and which then
allows the cavity to distend and collect the fluid once again
to a predetermined pressure ~efore recycling, while essentiall~
emptying ~nd clearing th$ drainage tubing of fluid at the end
of each cycle.
In the past, various attempts have been made to provide
a drainage system for the drainage of uxine from the urinary
bladder to overcome the ob~ections to a conventional drainage
catheter. In U.S. Patent~ 2,~02,448 and 2,860,636, a title
drainage and irrigating unit utilizes a syphon in combination
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with a reservoir to prsvide cycle drai-ning of ~he bladder.
~owever, this system like other syphon sy~tems, requires
that a loop be fed at a predetermined heigh~ above the pa-
tient's bladder to create two syphon legs which will create
the pressure at whlch the syphon will empty the bladder.
Pressure release is controlled by raising the height of the
device on a bedside tree and i$ very precise and subject
to variations by a shifting patient and prevents the pati~nt
from moving around while the catheter is in place.
In U.S. Patent 3,598,124, the syphon leg is controlled
by merely attaching the catheter to a bedside tree at pre~
determined adjusted height, which varies the pressure at
which the bladder will drain and providing a fiutter valve
near the patient to bxeak the syphon action of the system
once the bladder has drained. In U.S. Patent 4,230,102, a
device for the draining of a urine bladder is shown in
which a T-joint has been placed on a catheter and has a
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pressure membrane attached thereto in a large casing or
actuating a pressure s~itch which in turn actuates an elec~
tric motor driv~ing a gear train and cam~ A cam follow is
spriny loaded to clamp the catheter for two minute cycles
upon actuation by the pressure switch ~o drain the bladder.
This type of device, however, is expensive and bulky and
positions an electrical apparatus adjacent the catheter.
In U.S. Patent 3,768,102t an implantable artificial urethal
valve is shown, while in U.S. Patent 3,642,004 a urethal
valve having an electrically actuated solenoid in the tip
thereof is shown. In U.SO Patent 3/419,009, another vented
surgical drainage tube is an automatic reyulating device
for bladder irrigation devices utili~ing an electrical control
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system with a timing cam.
The present invention is directed towards a simplified
device to control the drainage of the bladder irrespective
of a patient's position and allows ~he patient mobility while
the catheter is attached. The pre~ent invention is designed
to be a single patient device which is sufficiently inexpen--
sive to be thrown away after use by the patient.
Summary of the Invention
A draining control valve apparatus is provided hav1ng a
pressure relief valve for opening upon a predetermined ~luid
pressure being applied thereto and a suction column for hold
ing the pressure relief valve open by the weight of a liquid
column escaping past the pressure relief valve. The arainage
control valve may include a housing having an inlet having a
tube attached thereto and an outlet having an outlet tube
attached thereto. ~he inlet tube can be connected to a uri-
nary bladder, while the outlet tube can be connected to a
drainage bag. A valve element located in the housing is
biased against a valve seat to open upon a predetermined
pressure thereagainst by liquid in the housing inletO An
outlet column is formed by the outlet and tube attached
thereto to create a suction with a liquid column formed from
the liquid passing by the valve elemenk to place a suction
on the back of the valve element to open the valve element
and to hold the valve element open until the drainage is
complete. The column suction relief opening relie~es the
negative pressure on the back oE the valve elemen~, thereby
allowing the valve element to close. The suction relief
can be either a small opening of predetermined size in the
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outlet or -~he outl~t tub~ which ma~ be covered wlth a filter,
or may be a small check valve. The valve element nlay be a
spring biased pis-ton held in positi.on within the housing and
may have a compression adjusting ~ember to vary the pressure
at which the pressu.re relief valve will open. The drainage
control valve may be providecl wi-th an arcuate base and a
flexible s-trap for at-tachlng to a patient's leg. A manual
valve release allows the valve to be manually actua~ed prior
to it reaching the predetermined pressure require~ to
automa-tically actuate the valve.
In accordance with a first aspect of the
- present invention there is provided a drainage control valve
for use in the drainage of a bladder comprising in combination:
a housing; pressure relief valve means 10cat2d in the
housing for opening upon a predetermined fluid pressure being
applied thereto and including a valve element ~ovably
mounted therein; suction means for holding the valve element
open by the weight of a liquid column escaping past the
pressure relieve valve means; and the housing having an
~0 offset outlet passageway whereby a suction column is formed
when the pressure relief valve means opens to allow the
passage of a liquid therethrough.
In accordance with a second aspect there is
pxovided a method of draining a bladder having the steps
of opening a pressure relief valve under hladder pressure
in a catheter; holding the pressure relief valve open with
a suction of a column of liquid passing the pressure relieE
valve; ana releasing the pressure relie-f valve when drainage
is substantially complete.
Brief Description of the Drawinys
Other objects, features and advan-tages of the
present invention will be apparent from the written
description and the d.rawings, in which:
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Figure 1 is a sectional v:iew of a preEerred
embodiment of -the present invention;
Figure 2 is a perspective view of a drainage
control valve in accordance with the present .inven-tion
attached to a patient's leg;
Figure 3 is a sectional view taken on the line
3 3 of Figure 2;
Figure 4 is a sectional view of an alternate
embo~iment of a drainaye control valve in accordance with
the present invention;
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Figure 5 is a sectional view taken on the line 5~5 of
Figure l;
Figure 6A is a b~ottom persp~ctive v.iew of a drainage
control valve in accordane ~Ji.th the present invention;
Figure 6B is a cutaway top perspective view of the
valve of Figure 6A;
Figure 7 is a partial sectional view showing the manual
valve actuation portion on an enlarged scale; and
Figure 8 is a sectional view taken on the line 8-8 of
Figure lo
Description of the Preferred Embodiments
Reerring to Figures 1 ~hrough 3 and 5 through 7, a
drainage control valve 10 is shown having a cylindrical
housing 11 with an arcuate base plate 12 which may be of a
flexible polymer material having a flexible strap 13 attached
thereto, along with a hook a~d loop fastener 14 for attaching
the strap and the drainage control valve 13 to a patien~'s
leg 15. A drainage catheter 16 may be connected to a patient's
bladder and to an inlet 17 on the valve 10, while a drainage
tube 18 is connected onto an outlet ZO of t~e valve 10 and ~o
a drainage bag which may be located beside a bed or which may
be attached to the bottom of a patient's leg~ The valve has.
a chamber 21 having a valve elemen~ or piston 22 slidably
positioned in the chamber 22 to slide along the interior
Jalls thereof. The piston 22 has a valve seal 23 which may
be made of a soft rubb~r, or the like, attached to one side
thereof and may have a plurality of slots 24 as rnore clearly
shown in Figure 5. The sliding valve element 22 is spring
biased with a spring 25 which may be a small stainless steel
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helical sprinq compressed to drive the valve element 22 a~ainst -~~
the valve seat 26 adjacent the inside of the inlet 17 to seal
the inlet against the valve seat 26. The spring 25 is held in
position by a supporting protruding surfac3 27 which protrudes
into the base of the springO It will, of course, be clear that
a cylindrical spring support could extend to the outside of the
spring if desired. The opposite ~nd of the spring ~8 is sup
ported in the piston ~2 by a cylindrical removed area 30 there-
in. The outlet 20 has a small opening 31 covered by a filter
32 on the outlet 20 inside of the ~ube 33. As a patient 3 S
bladder fills and the pressure increases in the drainage cath-
eter tube portion 16 and the inlet 17 of the valve 10, pressure
i5 applied agains~ a small portion of ~he surface of the valve
element 22 until the pressure overcomes the bias of the spring
25. At this time, the piston 22 is slid only slightly to
allow small amounts of fluid to drip through the valve around
the notches 24 and into the chamber 21. A small amount of
flow feeds into the outlet and ~ubes 33 towards a drainage .
back which is generally located on the side of the b~d.
As the urine accumulates in the tube 33, it forms a suc-
tion column and the weight of the column places a suction o~
the chamber 21 and against the back surface of the piston 22
which pulls the piston open further and allows the urine from
the bladder to substantially empty through the tube 16, inlet
17, through the valve 10 and into the drainage bag~ ~s ~he
bladder is draining through the tube 33 and through the out-
let 22, small amounts of air are pulled through the opening
31 and through the filter 32, which is carried with the
urine into the drainage bag. However, once the urine ceases
to flow, air will leak through the opening 31 to relieve the
suction or negative pressure in the chamber 21 being applied
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against the back of the valve element 22 to thereby allow
the back of the valve element 22 to close ayainst the valve
seal 26 to again seal the valve until sufficient pressurP
builds up in the bladder to again ac-tuate the valve 10.
The suction col~ also helps more fully drain the
bladder similar to a syphon device, but may not be a true
syphon which normally has a shor~ leg and a long leg and is
actuated b~ the suc~ion created by the fluid column in the
long leg. However, depending upon the position of the pa-
tient, there may not be a short leg in the present invention.
A manual release 34 ha~ a release stem 35 passing ~hrough an
opening 36 and connected to a head 37 to allow a patient to
push the relief stem 35 to push against a flexible elastomer
or rubber surface 38 and against the top of the valve ele-
men~ 22 ~o open the valve manually. The flexible elastomer
material 38 prevents any contact in the valve with the atmos-
phere and also acts as a spring to return the stem 35 when
released. ~n alternate opening 40 has a rubber cover or cap
41 sealing the opening in a manner to allow a needle to be
inserted through the rubber sealed cap 41 for feeding a solu-
tion into the patie~t's bladder. ~dvantageously, if too much
solution is fed to the bladder, the valve 10 will actuate and
drain the bladder. The drainage control unit capped opening
in the proximal housing allows bladder medication to be in
serted through this opening and periodically emptied by the
action of the va~ve. Antimicrobial solutions and antispas-
motic medications may be used in the bladder this way.
In Figure 3, the valve 10 is seen attaehed to the plate
12 and to the strap 13 and having a hook and loop fastener
for attaching the strap to different size legs of patient~.
It will, of course, be clear tha~ the present valve 10 can
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operate without the strap 13 by just laying the valve lO on . .
the bed beside the patient or even beside the bed and will
not be actu~ted in any,event until sufficient pres~ure from
the bladder is applied against the valve element 22.
Turning now to Figure 4, a slightly modified embodiment
has a drainage valve 42 having a housing 43 ~nd an arcuate
leg c~nforming mount 44 connected to a strap 45. The housing
43 has chamber 46 therein similar ~o the embodiment of Figure
1. This embodiment differs in that ~he drainage ~ube 33 i5
connected to an outlet 47 and ha~ a small check valve 48 whlch
may be a small ru~ber flap for closing ~he surface against the
escapement of-air or liquid, but to allow air ~o be sucked in
with the flow of liquid and to break the suction created in
the chamber 46 to release the valve elemtn. This embodiment
also has a filter 5G covering the opening. The embodiment of
Fi.gure 4 also differs in tha~ it has a threaded spring support
member 51 having a small spring supporting cup 52 mounted on
one end having a slip washer, such as a teflon washer 53,
therein supported against a sprin~ 54~ A small knurled han-
dle 55 is attached to the other end of the threaded shaft 51
and threaded through a threaded opèning 56 in the housing 4~.
Rotating the knob 55 will thread the threaded shaft 51 into
or out of the housing 43, increasing or reducing the compres-
sion of the spring 54~ The spring slides on a slip washer
S3 thereby preventing binding of the spring wh.ile mak.ing ad
justments. This embodiment allows the pressure by whioh the
valve 42 is open to be varied in accordance with the patient' 5
requirements; while the embodiments of Figure 1 may be made
in several different sizes requiring a different spring 25 in
size for different patients. The ability to vary the opening
pre-sure o~ the drainage control valve permits the apparatus
to increase bladder capacity. When used wi~h contracted or .
small bladders, the opening pressure of the device may be in-
creased at desired increments. This will dilate and distend
the bladder to an accep~ed capacity.
The shaft 51 and knurled knob 55 may be provided with
indicia to indicate a particular pressure of any particular
setting and may be provided with a click settlng for locking
the pre~sure in any particular position as desired without
depa~ting from the spirit and scope of the invention. The
embodiment of Figure 4 also has a protrudlng wall 57 forcing
the liquid to follow a circui~ous pa~h from the chamber 46
into the tube 33. If a large drainage tube 33 is utiliz~d,
a liquid path such as formed by the w~ll 57 in the offset
outlet 47 assist in creating a suction column in the outlet
47 in the tube 33. It has, however, been found that with
the small drainage tubes normally used, a suction column will
start without a ~articular sloped passageway to assure the
column is completely filled ilp~ This circuitous path can be
extended to form other bends or even a knot in the tube 33
to assure ~hat the tube fills at some poin~, if desired.
However, in the case as shown in Pigures 1 through 3~ the
catheter rises over the patient's leg and down again, assur-
ing the creation of a suction column even with a larger drain-
age tube.
It should be clear at thi6 point that a drainage control
valve may be inexpensively manufactured for use as a dispos-
able item and is actua~ed by pressure on the one hand, but is
drained by a liquid suction column holding the valve open;
~ut which the suction is relieved upon the completion of the
drainage. It should also be clear, howeverl that the large
siæe of the back of the piston area 22 allows the valve ele-
ment 22 to be easily held open by the negative pressure against
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the spxing ~5 and the size o~ the cha~bex 21 which is nor-
mally ~illed with air is under a negative pressure drainage
and allows enough compression and expansion to reduce the
suction placed on the bladder when the drainage is complete,
while the air opening 31 releas~s the suction in the chamber
21 as soon as the last liquid .is passed through the outlat
20. It is an~icipated that the housing and valve element
can be made of polymer ma~erials by injection molding~ or the
like, while the spring ~5 can be a stainl~ss steel compression
spring and other inexpensive ma~erials can ~e u~ilized for
the seal cover 41 and the elastic member 38. Accordingly,
the present invention is not to be construed as limited to
the forms sho~n, which are to be considered illustrative
rather than restrictive.
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