Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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60950-189E
This is a division of our co-pending Canadlan Patent
Application No. 616,055 filed 2nd May, 1991, which in turn is a
divlsion of Application No. 548,573 flled 5th October, 1987.
The present invention relates to drainage devices and in
particular to suction dralnage systems for removal of gases or
fluids from medical patients, such as from the chest cavity, by
means of pressure differentials.
BACKGROUND ART
For many years, the standard apparatus for performing
the evacuation of the pleural cavity was a drainage system known
as the "3-bottle set-up" whlch includes a collection bottle, a
water seal bottle and a suctlon control bottle. A catheter runs
from the patlent's pleural cavity to the collection bottle, and
the suction bottle is connected by a tube to a suctlon source.
The three bottles are connected ln series by various tubes to
apply suctlon to the pleural cavity to wlthdraw fluid and air and
thereafter discharge the same into the collection bottle. Gases
entering the collection bottle bubble through water in the water
seal bottle. The water in the water seal also usually prevents
the back flow of air into the chest cavity.
Suction pressure is usually provided by a central vacuum
supply in a hospital so as to permit withdrawal of fluids such as
blood, water and gas from a patient's pleural cavity by estab-
lishing a pressure differentlal between the suction source and the
internal pressure in the patient. Such suction pressure and pres-
sure differentlals must be
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precisely maintained because of the dangerous conditions
which could result if unduly high or low pressure
differentials should occur. However, the hospital suction
source typically can vary over time which degrades the
suction performance. Also, drainage systems incorporating
water filled manometers in the suction control chamber whose
water level indicates fluid pressure are inconvenient because
0 of the need to add water prior to use, as well as because of
their size and weight. In addition, evaporation in the
suction control chamber results in suction pressure
variations which must be corrected by the addition of more
water thereby increasing the maintenance and monitoring time
required in the use of such drainage systems.
Also various inefficiencies have existed in the ~-
bottle set-up resulting from the many separate components and
the large number (usually 16 or 17) of connections, such as
pneumothorax which may result from the loss of the water seal
in the water seal bottle if suction were temporarily
disconnected, and possible build-ups of positive pressure
which could cause tension pneumothorax and possible
mediastanal shift. Another serious shortcoming of the 3-
bottle set-up is the possibility of incorrect connection and
the time necessary to set the system up to monitor its
operation.
The 3-bottle set-up lost favor with the
introduction of an underwater seal drainage system sold under
the name ~Pleur-evac~ in 1966 by Deknatel Inc.l U.S. Patent
l A more detailed description of the need for and the proper
use of chest drainage devices is presented in the Deknatel
Inc. Pleur-evac~ publication entitled nPhysiology of the
(footnote continued)
`- 1 334645
No~. 3,363,626; 3,363,627; 3,559,6~7; 3,6~3,913; 3,7~2,497;
4,258,824; and Re. 29,877 are directed to various aspects of
the Pleur-evac~ system which over the years has provided
improvements that eliminated various shortcomings of the 3-
bottle set-up. These improvements have includ~d the
elimination of variations in the 3-bottle set-up that existed
between different manufacturers, hospitals and hospital
laboratories. Such variations include bottle size, tube
length and diameter, stopper material and the like.
Among the features of the Pleur-evac~ system which
provide its improved performance are employment of 3-bottle
techniques in a single, pre-formed, self-contained unit. The
desired values of suction are ~enerally esta~lished by the
levels of water in the suction control bottle and the water
seal bottle. These levels are filled according to specified
values prior to the application of the system to the patient.
A special valve referred to as the ~High Negativity Valve" is
included which is employed when the patient's negativity
becomes sufficient to threaten loss of the water seal. Also,
a nPositive Pressure Release Valven in the large arm of the
water seal chamber works to prevent a tension pneumothorax
when pressure in the large ~rm of the water seal exceeds a
prescribed value because of suct~on malfunction, accidental
clamping or occlusion of the suction tube. The Pleur-evac~
system is disposable and helps in the battle to control
cross-contamination.
(footnote continued from previous page)
Chest and Thoracic Catheters; Ch~st Drainage Systems No. 1 of
a series from Deknatel~ (1985)
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~,
Despite the advantagea of the Pleur-evzc~ syste~
over the 3-bottle set-up and the general acceptance of the
device in the medical community, there remains a continuing
need to improve the convenience and performance of chest
drainage systems and to render such systems compact. As
noted above, fluid filled suction control chambers require
the filling of manometer tubes to levels specified by the
physician prior to being connected to the patient and the
hospital suction system. Although it is conceivable that
such filling could be performed at a manufacturing facility
prior to shipment, as a practical matter ~his is undesirable
because frequent adjustments may be needed according to the
different values of patient suction as dictated by the
attending physician. Moreover, the presence of fluid in the
various tubes could result in damage to the system during
shipment due to freezing temperatures or because of leakage.
Furthermore, the levels of suction obtained by a chest
drainage system are somewhat limited by the size of the
manometer tubes required to maintain such suction levels.
For high levels of suction, the size of manometers required
would in some circumstances render the drainage system
impractical. A reduction in size of the system would offer
such benefits as ease of u~e, ease of storage, less expensive
shipping costs, and the reduction in the obstruction between
the patient, and visitors and the medical staff. In
addition, accuracy of present underwater drainage systems is
limited in that the various manometers employed must be
constantly monitored visually by observing the liquid level
in the respective chambers. Even when gauges are used, they
likewise must be constantly monitored. In either case, when
the fluid in the manometers evaporates, suction variations
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60950-189E
occur whlch require the addltion of more water to compensate for
the loss. All such activlty of course ls tlme consumlng.
We have lnvented an improved dralnage devlce whlch
provides addltlonal lmprovements to presently avallable devlces.
SUMMARY OF THE INVENTION
The present lnventlon provldes an apparatus for dralnlng
bodlly fluids comprlslng: a. collectlon chamber for collectlng
flulds from a body cavlty, sald collectlon chamber including an
inlet for fluld communlcation with the body cavity; b. suction
control chamber for regulatlng the degree of vacuum imposed in the
collection chamber; and c. seal chamber for preventing passage of
ambient into the collectlon chamber and lncludlng: l) a large arm
compartment havlng a suctlon lnlet at one end; 2) a small arm
compartment at one end havlng an openlng communlcatlng wlth said
collectlon chamber and communicating at its other end with the
other end of said large arm, said small arm compartment having
means adjacent its one end for preventing amblent from passing
into said collectlon chamber when sald collectlon chamber has a
relatively hlgh level of negatlve pressure.
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60950-189E
The ambient prevention means may comprise a first
chamber formed adiacent the opening and being dimensioned and
conflgured so as to contain the entire volume of a predetermlned
amount of sealing fluid disposed in the seal chamber at the
~uncture of the large arm and the small arm compartments. The
apparatus may further comprise a second chamber disposed so as to
separate the first containment chamber from the opening into the
collection chamber so that any sealing fluid passing from the
flrst containment chamber will enter into said second separation
chamber and thereafter return to the containment chamber instead
of passing through the opening. The containment chamber is con-
figured so that any sealing fluid passing into the containment
chamber is diverted in a direction other than the direction of
normal flow so that entering fluid will circulate in and be col-
lected within the containment chamber.
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60950-189E
The apparatus preferably further comprlses a wall member
posltloned wlthln the small arm and separatlng the contalnment
chamber from the remalnder of the small arm, the wall member hav-
lng an aperture; and valve means belng dlmensloned and conflgured
for openlng and substantlally closlng the aperture, the valve
means belng normally open and tendlng to substantlally
- 8 - 1 3 3 4 6 4 5 64680-425D
close the aperture in response to any fluid entering into the
containment chamber from the juncture of the large arm and the
small arm compartments. The valve means comprises a ball
dimensioned and configured so as to be adapted for seating with
and substantially closing the aperture. This aperture includes a
notch so as to permit the sealing fluid to enter into the contain-
ment chamber when the ball valve seats upon and substantially
' closes the opening whereupon the sealing fluid is diverted within
the containment chamber generally transverse to the direction of
normal flow. The remaining portion of the small arm is constricted
so as to retain the ball valve movably between the constriction and
the aperture. This remaining portion of the small arm is smaller
in cross sectional area than that of the containment chamber. In
one preferred embodiment, the ambient prevention means comprises
a one-way check valve disposed and oriented in the small arm
compartment. The valve when open permits the passage of suction
flow from the collection chamber into the suction inlet, but when
closed prevents ambient from passing into the collection chamber.
The one-way check valve is positioned adjacent the opening
communicating the small arm compartment with the collection
chamber.
Preferably, the apparatus further comprises an air flow
meter disposed at the juncture of the other ends of the small arm
and large arm. The air flow meter provides for measurment of the
quantity of gases passing from the body
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cavity. The apparatus also comprises a check valve means
disposed in the large arm compartment. The check valve m~ans
is normally closed and tends to open to per~it ambient into
the seal chamber in response to substantially increased
pressure within the seal chamber. Also, the present
invention is directed to a chest drainage device for draining
fluids from a body cavity or portion comprising a housing;
collection chamber formed within the housing for collecting
fluids including an inlet for entry of the fluids and for
fluid communication with the body cavity or portion; seal
chamber formed within the housing for preventing passage of
ambient into the collection chamber and including a large arm
compartment having a suction inlet at one end for coupling to
a suction source; a small arm compartment at one end having
an opening communicating with the collection cha~ber and
communicating at its other end with the other end of the
large arm, the small arm compartment having means adjacent
its one end for preventing ambient from passing into the
collection chamber when the collection chamber has a
relatively high level of negative pressure; suction control
chamber formed within the housing and being in fluid
communication with the collection chamber for regulating the
degree of vacuum imposed in the collection chamber and
pleural cavity and including a first inlet for coupling to
the suction inlet of-the seal chamber; second inlet
communicating with the ambient; waterless means for
regulating the degree of suction imposed in the collection
chamber at a plurality of predetermined preset levels of
suction, the regulating means disposed between the first
inlet and the ambient inlet; and indicator ~eans disposed
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bet-~een the regulating means and the first inlet for
providing immediate confirmation of proper op~ration of
suction in the collection chamber.
Preferably, the housing is formed of a fron' wall
member and a back wall member sealed together along their
peripheries by a plurality of side wall members. The front
wall member includes an integrally formed handle and the
suction inlet and collection chamber inlet are each disposed
in a first side wall common to the seal chamber and the
collection chamber. Also, the a~bient inlet to the suction
control chamber is disposed in a second side wall adjacent to
the first side wall.
The apparatus further comprises an elongated
support stand rotatably secured to a third side wall opposite
the first side wall so that the support stand can be rotated
from a stored position to a support position wherein the
support stand is generally transverse to the third side wall
so as to stably support the housing at a predetermined
location. The support stand can be secured in the support
position.
Preferably, at least portions of the housing are
transparent to permit viewing of the operation or contents of
underlying portions of each of the collection, seal and
suction control chambers. Also, at least selected portions
of the front wall member are marked with graduations so as to
identify the volume of the contents thereof and with
predetermined indicia to provide instructional information.
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In addition, the present invention is directed to
an apparatus for draining fluids from a body cavity or
portion comprising a collection chamber for collecting flui~s
including an inlet for entry of the fluids; tubing coupled a~
one end to the collection chamber inlet, the other end
adapted for insertion into the body cavity or portion;
compression means configured and dimensioned for snugly
retaining a portion of the tubing under compression so as to
provide self sealing capability of the tubing portion, the
compression means having a port so as to ~xpose the tubing
and to pro~ide access to the interior of the tubing upon
insertion of a hypodermic needle; and suction control chamber
in fluid communication with the collection chamber for
regulating the degree of vacuum imposed in the collection
chamber and including first inlet for coupling to a suction
source; second inlet communicating with the ambient;
waterless means for regulating the degree of suction imposed
in the collection chamber at a plurality of predetermined
2Q preset levels of suction, the regulating means disposed
between the cuction inlet and the ambient inlet; and
indicator means disposed between the regulating means and the
suction inlet for providing immediate confirmation of proper
operation of suction in the'collection chamber.
Preferably, the compression means is formed of two
like structured, elongated curved plate members ha~ir.g
flanges extending along respective corresponding edges. The
plate members are secured to each other along the flanges and
the plate member opposite the port is relatively rigid so as
to protect against penetration of a hypodermic needle.
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Preferably, the inn~r cross sectional diameter of
the curved plate mem~ers is less than th~ cross sectional
outer diameter of the tubing. According to one preferred
embodiment, the inner cross sectional diameter of the curved
plate members is about four-fifths of that of the outer
diameter of the tubing.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention is described in greater
detail herein~elow, with reference to the drawings wherein:
FIG. 1 is a perspective view of a chest drainage
device according to the present invention supported in a
hanging position.
FIG. 2 is a top view of the drainage device of FIG.
1 illustrating the inlet ports into the collection chamber
and the suction control chamber.
FIG. 3 is an enlarged view of a portion of the
bottom of the drainage device of FIG. 1 before attachment of
the floor stand.
FIG. 4 is an exposed front view of the drainage
device of FIG. 1.
FIG. 5 is an exposed front view of an alternative
embodiment of the drainage device of the present invention.
FIG. 6 is a first cross-sectional side view in the
collection chamber taken along the lines 6-6 of FIG. 4.
-
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FIG. 7 is a second cross-sectional side view in th~
collection chamb~r taken along the lines 7-7 of FIG. 4.
FIG. 8 is a first cross-sectional side view of the
small arm of the seal chamber taken along the lines 8-~ of
FIG. 4.
FIG. 8a is an enlarged cross-sectional side view of
the small arm of the seal chamber taken along the lines 8-8
of FIG. 4 illustrating an alternative embodiment of a check
valve for dry operation of the seal chamber.
FIG. 9 is a cross-sectional side view in one
compartment of the suction control chamber taken along the
lines 9-9 of FIG. 4.
FIG. 10 is a cross-sectional side view in the
second compartment of the suction control cha~ber taken along
the lines 10-10 of FIG. 4.
FIG. 11 is a cross-sectional view taken along lines
11-11 of FIG. 4.
FIG. 12 is a cross-sectional view taken along lines
12-12 of FIG. 4.
FIG. 13 is an enlarged view illustrating the poppet
valve and dashpot in the suction control chamber taken along
lines 13-13 of FIG. 10.
FIG. 14 is an exploded view of the in;ection/
sampling device according to the present invention.
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- 14 -
FIG. 15 is a top view of the injection/sampling
devic~ of FIG. 14.
FIG. 16 is a cross-sectional side view taken along
the lines 16-16 of FIG. 15 illustrating tubing under
compression.
DE5CRIPTION OF THE PREFERRED EMBODIMENTS
In the description which follows, any reference to
either orientation or direction is intended primarily for the
-purpose of illustration and is not intended in any way as a
limitation of the scope of the present invention.
Referring to FIGS. 1 and 4, a chest drainage device
10 is illustrated with three chambers -- a collection chamber
12 for retaining and storing fluids collected from a body
cavity, a water seal chamber 14 for preventing any fluid from
entering into the collection chamber 12 during high levels of
negative pressure in the body cavity and a dry suction
control chamber 16. The function and operation of these
various chambers are generally described in U.S. Patent Nos.
3,363,626; 3,363,627; 3,559~647; 3,683,913; 3,782,497;
4,258,824; and Re. 29,877 to the extent that like or common
elements are presented therein. In addition, the purpose and
qeneral operation of the various chambers of the chest
drainaqe device 10 of the present invention are also more
fully described in the Deknatel Inc. Pleur-evac2 publication
entitled ~Understanding Chest Drainage Systemsn (1985).
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The coilection chamber 12 is formed generally to
the right of line nA-A~ and preferably includPs four separate
collection compartments 18, 20, 22 and 24 which are forme~
between respective pairs of walls 26, 28, 30, 32 and 34 as
shown in FIG. 4. However, the collection chamber 12 of t~e
present invention is not limited as to the number of separate
collection compartments and any number as desired can be
provided. Likewise, the volumetric size of the various
collection compartments can be uniform or varied as
preferred.
An inlet port 36 is positioned in top wall 38 so
that fluid and gases from a body cavity pass directly into
collection compartment 18. To provide for finer measurements
of fluids collected, at least collection compartment 18 is
dimensioned and configured to have the smallest volu~etric
size and the remaining compartments are preferably larger
sized to accom~oAate greater amounts of fluid collected. In
addition, sloping wall member 19 as shown more clearly in
FIG. 6 permits the lower portion of comr~tment 18 to be
smaller than the upper portion and thus provide yet even
smaller volumetric measurements. An opening 27 in wall 28 as
shown more clearly in FIG. 6 permits overflow of fluid from
compartment 18 to pass first into compartment 20. Likewise,
any overflow from compartment 20 can pass over upper edge of
wall 30 into compartment 22 and from there over upper edge of
wall 32 into compartment 24. Accordingly, the upper edges of
walls 30 and 32 are approximately at the same height to allow
for overflow.
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A high negativity valve 40 is posit~oned in top
wall 38 in communication with collection chamber 12. The
high negativity valve includes a button actuated valve which
when depressed allows filtered air to enter the collectior.
chamber 12. In this manner, undesired high degrees of
negative pressure that may occur in the body cavity and
thereby develop in the collection chamber 12 are relieved.
The seal chamber 14 generally is formed between the
lines ~A-An and nB-B" as shown in FIG. 4. In particular, the
seal chamber 14 includes a small arm compàrtment 42 formed
between walls 34 and 44 and a large compartment 46 formed
between walls 44 and 47. Although seal chambers are
typica]ly operated with a predetermined level of fluid such
as water, the seal chamber 14 of the present invention can be
operated in either a ~dry~ or a nwetD mode of operation in
the manner to be more fully described hereinbelow. An air
flow meter 48, if desired, can be positioned as shown in
FIGS. 1 and 4 at the juncture of the lower ends of the small
and large arm compartments 42, 46. The air flow meter 48 is
intended for use in the nwet~ mode and is of the type
illustrated and described in aforementioned U.S. Patent No.
3,683,913.
However, even if operated in the nd ryn mode, the
air flow meter 48 if present will have no deleterious effect.
The seal chamber 14 preferably also includes a
valve mechanism in the small arm compartment 42 which
includes a plate member 48 and a ball ~loat valve 50 that is
free to travel between plate member 48 and a constricted
portion of small arm compartment 42 as shown in FIG. 4.
However, the constricted portion as shown more clearly in
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60950-189E
FIG. 8 is configured so that in operation under suction, the float
ball valve 50 will not block off the lower portion of the small
air compartment 42.
Plate member 48 as shown more clearly in FIG. 8 includes
a circular opening 52 which is configured and dimensioned so as to
permit ball float valve 50 to seat within opening 52 when fluid
such as water which is typically contained within the water seal
chamber 14 is drawn by unduly high negative pressure toward the
collection chamber 12 through opening 54 in the upper end of the
small arm compartment 42. A similar valve arrangement is also
described as a cylindrical valve member in U.S. Patent No.
3,683,913 which also serves to retain water or fluid in the water
seal chamber. However, plate number 48 according to the present
invention includes a notch or keyway slot 56 which still permits
fluid or water from the water seal chamber to bypass ball valve 50
and enter into the upper end 58 of small arm compartment 42.
Within the upper end compartment 58, the fluid bypasses ball valve
50 and circulates in a direction transverse to the flow of suction
or normal flow and is dlverted upon the walls forming upper end
compartment 58.
Preferably, the upper end compartment 58 is configured
and dimensioned so as to accommodate the entire fluid volume in
the water seal chamber to be contalned thereln. In this manner,
water in the water seal chamber is prevented from being drawn into
the collection chamber through opening 54 in the event of a high
negativity developed in the collection chamber 12. Such high
negativity occurrences can result from a deep breath, coughing or
choking by the patient. It can also occur when suction is turned
off which
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hap~ens eithe~ when thP suction t~be is occluded or the
hospital suction fails. High negativity can likewise occur
when the patient is on a ventilator. Alternatively high
negativity results when medical personnel milk ~he tubing
from the drainage device to the patient. In the latter case,
milking is the process whereby clots in the tubing are pushed
into the collection chamber 12 by grasping the tubing with
one hand behind the clot and squeezing the tubing toward the
collection chamber 12 so as to advance the clot thereto.
Although the small end compartment 42 is
.-illustrated with a ball float valve 50 in the small arm
compartment, the configuration of upper end compartment 58 is
suitable to provide for prevention of any fluid from the
water seal chamber 14 passing into the collection chamber 12.
Thus the ball float valve 50 is but an additional safeguard
which can be optionally incorporated and used with the
structure of the upper end compartment 58. An additional
chamber 59 separates the containment chamber or upper end
compartment 58 from opening 54 so as to aid in preventing
fluid from passing into the collection chamber 12.
Preferably the separation chamber S9 has a sloping lower
surface 61 as shown in FIG.,4 and opening 54 is positioned
uppermost in wall 63.
In an alternative embodiment, the seal chamber 14
can be operated in a dry mode without any fluid required to
maintain a seal. In such instance, the ball float valve 50
can be replaced with a check valve 51 which seats in
compartment 58 and about opening 52 as shown in FIG. 8A. The
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check valve 51 is a one way valve that permits suction flo~
in the direction of arrow nc~ but closes and prevents any
flow of ambient or atmospheric air into collection cham~er 12
in the direction of arrow ~D. n
The upper end of the large arm compartment 46 of
the water seal chamber 14 is in fluid communication with
suction inlet port 60 and a positive pressure relief valve 62
as shown in FIG. 4. Alternatively, this valve 62 can be
positioned, if desired, in the large arm 46 of the seal
chamber 14 or in the suction line itself. The valve 62 is of
-the check type configuration which is normally closed and
includes valve member 63. it opens to permit excessive
pressure in the seal chamber 14 to be vented to the a~bient
or atmosphere in response to any substantially increased
pressure within the seal chamber 14.
The chest drainage device 10 according to the
present invention also includes a suction control chamber 16
which includes a first compartment 64 formed between walls 47
and 66 and a second compartment 67 formed between walls 66
and 68. The u~per end of first compartment 64 is fluidly
coupled to the suction inlet port 60 together with the upper
end of the large arm 46 of the water seal chamber 14. The
upper end of the second compartment 67 which is formed be-
tween walls 66 and 68 includes a waterless suction regulator
72 which is housed in the upper portion of second compartment
7-~ as shown in FIG. 4. The upper end of compartment 67 has
an opening 74 which communicates with the atmosphere or the
ambient about the chest drainage device lO. The suction
regulator 72 in_ludes a valve 76 which is configured and
dimensioned to seat against opening 78 in a plate member 80
which separates the second compartment 67 as shown in FIG. 5
into an upper and a lower portion. As evident from the
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60950-189E
drawlngs, the plate valve 76 is positioned in the lower portion
and is biased in a closed position by means of a coil spring 82
which is secured to the hook end of rod 84 and whose other end is
secured ln the upper wall 38 in a rotatable ~oint coupling or
collar 86 which is annular in configuration. The other end of rod
84 is positioned within the hollow portion of annular collar 86.
The collar 86 also has a keyway ridge that is received within a
groove along the upper end of rod 84. In this fashion, the rod 84
can be rotated together with the collar 86 and simultaneously
advanced upwardly or downwardly as will be described hereinbelow.
The plate valve 76 as shown more clearly in FIG. 13 is formed on
the end of a dashpot 86 which is secured in plate member 88 that
is smaller sized than plate member 80 to permit atmospheric air to
pass thereby. The dashpot is of the type manufactured under the
trademark Airpot which is manufactured by Airpot Corporation, 27
Lois Street, Norwalk, ~onnecticut. The dashpot 86 attenuates the
rapid modulation of the valve 76 which may occur during the opera-
tion of the chest drainage device 10. Preferably the dashpot 86
includes a graphite plug 90 attached to a stem g2 of plate valve
76. The graphite plug 90 rides within a well formed of a glass
annulus g4 which together with the graphite plug 90 provide non
binding surfaces to avoid sticking of component parts.
As shown more clearly in FIG. 13, the plate valve 76 is
a generally flat plate with a circular bead 96 for seating against
plate member 80 and about opening 78. In this manner, the plate
valve 76 in cross section generally provides a single point of
contact between the bead 96 and plate member 80. This eliminates
lar-ge contacting surface
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areas and thereby prevents any sticXing of the plate valve 76
that may occur due to moisture. Preferably the plate valve
76 is formed of a high density polyethylene which is more
pliable than the plate member ~ . In this fashion, the plate
valve 76 will more easily conform to any irregularities in
~ the plate member and assure proper sealing of the opening
78.
The rod 84 includes as shown more clearly in FIG.
10 a portion having a worm gear 98 that c~operates with a
gear 100 positioned on a shaft 102 that supports rotatably
-positioned disk 104 having lever arm 106. Accordingly, as
gear 100 is rotated upon movement of lever 106, the worm gear
98 and rod 84 are advanced upwardly or downwardly while
collar 86 remains fixed or non-rotating and thereby changes
the tension of the spring 82 that provides the amount of
force for seating valve plate 76 against opening 78. Such
tension corresponds to the amount of suction imposed in the
collection chamber 12 and likewise the patient's pleural
cavity and can thereby be calibrated so as to provide for a
plurality of predetermined, preset value~ that can thereby be
marked on the disk 104. To provide for accurate positioning
of the disk 104, a correspo~ding series of detents 106 are
provided along prescribed portions of the circumference of
disk 104 and cooperate with a stop arm 108 that seats at its
outer end within any one of the predetermined preset detents
106 that correspond to a pre-set level of suction. The stop
arm 108 is supported from outer wall 68 that includes opening
74 that permits ambient or atmosphere to enter the suction
control chamber 16. As noted above, rotation of collar 86
simultaneously allows the rod 84 to be advanced upwardly or
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downwardly whil~ the disk 104 is in a given position in orier
to provide for prop2r calibration of the suction level
settings.
The suction control chamber 16 includes a visual
indicator that provides immediate confirmation of proper
operation of suction in the collection chamber 12. This
visual indicator will be described in greater detail below.
As shown in FIG. 1, the drainage device 10 is
generally formed of a housing that inclu~es a front wall llo
that is secured to a back wall 112. The front wall llo and
the back wall 112 are joined by means of four side walls
which includes a top wall 38 as shown more clearly in FIG. 2,
right side wall 26 and left side wall 68 and a bottom wall
114. As shown in FIGS. 6 through 10, the different walls and
sides can have different contours in order to accommodate the
different chambers defined therebetween. In one preferred
embodiment, the housing can be formed integrally with all the
walls joined along their peripheries. Alternatively, the
separate side walls and front and ba~k walls can be secured
to one another by suitable means which are well known to
those skilled in the art. ~ccording to the preferred
embodiment illustrated in FIG. 1, the housing 10 includes
side brackets 116 shown more clearly in FIG. 2 from which
hangers 118 extend in order to permit the device 10 to be
supported from a support rod 120 such as a hospital bedpost
or the like. In an alternative embodiment, the device 10
includes a floor support stand 122 which is secured rotatably
to the bottom wall 114 as shown in FIG. 4. The floor stand
122 comprises a genarally rectangular or elongated bar whi~h
has an aperture centrally positioned so as to be able to pass
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over the split collar 124 as shown-in FIG. 3. In this ~anner
the floor stand 122 once assembled over the split collar 12~
is able to rotate about its opening and can be posi~ioned in
a support fashion transversely to the longitudal axis of
bottom wall 114 as shown in phantom lines in FIGS. 1 and 7
indicated as element 126. If desired, the floor stand 122
can be secured after being placed in the support position.
Also, the housing front wall 110 preferably includes an
integrally formed handle 125 for ease in carrying and
handling.
.
In order to permit viewing of the contents of the
collection chambers, the front wall 110 as shown in FIG. 1 is
at least transparent at certain portions 128 thereof which
overlay the heights of the various collection compartments.
Also, the heights are calibrated with graduations 130 which
indicate the amount of fluid collected therein. As noted
- above, the smaller volumetric size of the first collection
compartment permits finer measurements, for example, from 0 -
200 cc of fluid while the other compartments accommodatestill larger volumetric amounts. In this manner, the medical
personnel can readily evaluate the performance of the chest
drainage device 10 as the a~ount of fluid collected over time
and during a complete fluid evacuation procedure by a single
reading of the height of the fluid in the most recently
filled collection compartment.
Other portions of front wall 110 are also
transparent to permit the viewing of additional operational
features of the device 10. In this respect, the small arm
compartment 42 of the sealed chamber 14 is transparent 132 in
order to permit viewing of the height of the fluid contained
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within the seal chamber 14. Accordingl~l, the length of the
small arm compartment 42 is also calibrated with graduations
134 in order to permit ready measurement of the height of the
fluid. Similarly the airflow meter 48 has a transparent
portion 136 which allows viewing of any air bubbles passin~
therethrough.
In order to allow for filling of the fluid into the
seal chamber 14, a grommet 138 is provided as shown in FIG.
1. Similarly a grommet 140 is provided in front wall 110 so
as to permit injection of fluid if desire~ into the juncture
.of the first and second compartments 64, 67 in the suction
control chamber 16. These grommets 138 and 140 include a
central rubber portion 142 which permits injection of fluid
by means of a hypodermic needle which will penetrate but not
damage the rubber seal that thereafter self-seals and retains
the integrity of the respective chambers or portions thereof.
As shown in FIG. 1, the device ~0 is coupled to a
suction source by means of a suitable tubing 144 that is
connected over the suction inlet 60. In a similar fashion a
tubing 146 is employed for connection to the collection
chamber inlet 36 and has it's other end adapted for insertion
into the body cavity or portion if desired so as to permit
evacuation of gases and fluids therefrom.
Also, the suction control chamber 16 underlies a
transparent portion 148 that permits viewing of the optional
bubbling operation, if utilized as desired, in that chamber
portion and thereby provides both a visual and audible
confirmation of operation of suction. Similarly, a
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transparent portion 150 permits visual con.irmation of
operation in the first compartment 64 of tA~ suction cont~ol
chamber 16 in a manner to be described in greater detail
below. In this manner, medical personnel can easily
determine upon viewing through either portions 148 or l~0
that the device 10 is properly operating. In order to permit
visual determination of the proper level of suction setting
desired, the disk 104 is viewable through transparent portion
152 which is calibrated with indicia 154 that indicate
readily the degree of suction which is selected by means of
movement of lever arm 106 extending through opening 74 of
:left side wall 68. Instructional information can be provided
on the face of front wall 110 as shown at different locations
156, 158 and 159.
An alternative embodiment 10' of the chest drainage
device 10 according to the present invention is illustrated
in FIG. 5. For ease of convenience elements of chest
drainage device 10' that are common to like elements in the
embodiment 10 of FIG. 4 are identified hy like numerals.
However, the embodiment of the chest drainage device lO' of
FIG. 5 has a collection chamber 12 which is in direct fluid
communication with suction control chamber 16 through opening
54 in wall 63 without a sea; chamber as shown in the
embodiment depicted in FIG. 4. Acordingly, in FIG. 5, the
collection chamber 12 is formed to the right of lines nA-A"
and suction control cha~ber 16 to the left thereof.
During the drainage procedure, it is at times
advantageous or desirable to draw a frPsh sample of fluid
drainage from the patient for culture purposes or other
testing procedures. It is also advantageous or desirable to
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provide for introduction of antibiotics as well as other
drugs back to tne patient in the event inrection is detected
According to currently available methods for obtaining
drainage samples, some chest drainage devices include a
resealable site in the collection chamber 12. However, wi~h
this method the clinician or medical personnel cannot obtain
a fresh sample since the collection chamber 12 invariably
would contain fluids that have collected over a period of
time. Nor does such resealable site allow for the infusion
of any drugs to the patient. Another common method is to
sample directly through the patient tubing which is typically
formed of latex. Although manufacturers of latex tubing
claim that the latex tubing is self-sealing, tests have
indicated that leakage occurs under normal operating
conditions. Another disadvantage with such
sampling/injection methods is the possibility that the needle
of a hypodermic needle, for example, may pass through both
walls of the tubing and possibly stick and injure the
clinician's skin. The risk of blood contact by the clinician
would therefore exist every time a sample is withdrawn or
injected into the latex tubing.
Therefore, the present invention also includes a
device 159 for compressing tubing 146 preferably formed of
latex which extends from suction inlet 36 and whose other end
is adapted for insertion into the body cavity or portion
which is to be drained of fluids and gases. According to the
compression device 159 of the present invention as shown in
FIG. 14, fresh drainage samples or infusion of drugs can be
provided through the latex tubing 146 without any danger of
leakage or contamination of the clinician due to possible
sticks with the hypodermic. The compression device 159 of
- 27 _ 1 334645
the prPsent invention maintains at least a portion of the
wall of the tubing 146 i~ compression an~ there~y provides
for self-sealing of the tubing wall while additionally
providing access with a hypodermic needle.
The device 159 includes a pair of compression
plates--upper compression plate 160 and a lower compression
plate 162--which have, when assembled, an inner cross-
sectional diameter that is smaller than the cross-sectional
outer diameter of the tubing 146. The plates 160 and 162 are
like structured and curved as illustrated`in FIG. 14.
.~langes 164 along their respective longitudinal edges as
shown in FIG. 14 permit securing along the respective edges
of plates 160, 162 by suitable means such as gluing, welding
or the like as well as other means well known to those
skilled in the art. The upper plate 160 includes a central
port or window 166 that allows the tubing 146 to be exposed.
Since the inner cross-sectional diameter of assembled plates
160, 162 is less than the cross-sectional outer diameter of
the tubing 146--preferably 20~ less--the tubing 146 extends
outwardly of the window 166 portion of upper plate 160 as
shown more clearly in FIG. 16. In this manner, the tubing
146 at least within the portion of the window 166 is
maintained under compression so that when a hypodermic needle
is injected through the tubing 146 through window 166 and
thereafter removed, the tubing 146 will self-seal and prevent
any escape of fluid. Preferably, as shown in FIG. lS, the
tubing 146 is also glued with a suitable solvent at portions
168, 170 which are adjacent the window portion 166. This
permits the retention of the tubing 146 and particularly that
portion about the window 166 even if the tubing is handled or
pulled at portions outside of the compression device 159.
-
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Such handllng of the tubing occurs when medical personnel milk the
tubing 146 in the fashion as noted above in order to remove any
clots for example from the dralnage line. By means of the glued
portions 168 and 170 the tubing is assured of being retained in
its position wlthin the devlce 159. At least the back plate
member ls relatlvely rigld so as to prevent a hypodermic needle
from penetrating into the clinician's skin in the manner as
described above.
Referring to FIG. 4, the visual indicator as noted above
includes a float member 172 which is positioned in the first com-
partment 64 of the suction control chamber 16 and in particular in
the upper portion thereof ad~acent the iuncture of the first com-
partment 64 and the large arm 46 of the seal chamber 14. The
float member 172 is dimensioned and configured so as to be capable
of moving within a confined region 174 which is determined between
a pair of post members 176, 178 that serve as stops to limit the
movement of the float member 172 within the confined region 174.
The float member 172 ls critlcally slzed as ls also the conflned
reglon 174 so that the float member will move upwardly within the
confined region 174 when the predetermlned preset level of suctlon
as controlled by regulator 72 is obtained in the collection cham-
ber 12. Accordingly, in such clrcumstance, the float member 172
wlll rlse toward stop 176 when the proper predetermlned level of
suctlon ls achleved and overcome. In order to permlt vlewing of
the float member 172, the front wall 110 has a visible portlon 150
which permlts vlewlng of the float member 172 as it moves upwardly
towards stop member 176. This provides to the medical personnel
immediate visual confirmatlon that the chest dralnage device 10
has a proper operation of suction in the collection chamber 12.
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PreferaD~y, the float m2~ber 172 is colo_ed in contrast to
its surrounding so as to be readily visible. In a preferred
embodiment, the float member 172 is fluorescent so as to
provide immediate visual confirmation of proper suction
operation even in reduced light or night conditions.
Notably, the dry or waterless suction control
chamber 16 is independent of any fluid which in typical
drainage devices provides the degree of suction. However,
the evaporation of the fluid in those typical drainage
devices results in variations in the suction pressure. This
variation is avoided by means of the dry suction control
chamber 16 of the present invention which is not dependent o~
any fluid to control or regulate suction.
Thus, the regulator 72 of the present invention
does not employ water to control suction. In operation, the
positioning of the setting of the suction level will be
accomplished by turning the dial 104. The position of the
dial 104 will cause spring 82 to be elongated accordingly.
Elongation of the spring 82 causes a force to be exerted on
the valve plate 76 which seats against opening 78. The
exerted force is a function of the degree of spring
elongation and the spring's physical properties. Once
suction is appled to the collection chamber 12 and thereby
the chest cavity or body portion of the patient, a force will
be applied to the valve plate 76. If the force applied to
the valve plate 76 resulting from the applied suction exceeds
the force supplied from elongation of the spring 82, the
plate valve 76 will be displaced allowing ambient or
atmospheric air to enter the chest drainage device chambers.
In particular, atmospheric air enters in through opening 74,
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th~ough openirg 78 in wall 80, around smaller sized wall 83,
through op~ning 79 in wall 81 and thus through the second
co-.partment 67 and through first compartment 64 of the
suction control chamber 16 and up out of the suction inlet
60. The plate valve 76 will remain displaced until the point
where the force balance is achieved and thereupon the plate
valve 76 will once again seat and seal the opening 78. The
0 regulation of imposed suction as described above, however,
will provide rapid modulation of the plate seat 76 as those
differentials occur. In order to reduce or attenuate this
modulation, the dashpot 86 is included whqse structure has
been described hereinabove.
According to the configuration of the regulator 72
and its location in the chest drainage device 10,
preferential air flow is provided which permits evacuation of
air preferentially from the patient rather than from the
regulator 72. This is assured by the area of opening 78
being larger than the smallest cross-sectional area of any
passage in any of the chambers. Thus, the system allows
variations in patient air leaks and also source suction
levels while maintaining a predetermined preset imposed level
of suction in the collection chamber 12. Accordingly, the
chest drainage device 10 according to the present invention
is insensitive to pressure variations regardless of their
source and provides a generally steady level of suction in
accordance with the predetermined preset level of suction as
regulated by the suction control regulator 72 and as
indicated by the dial 104 setting.
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In comparison, typical dry chest drainage device
regulator systems employ a restricted oriface located in the
suction application line. These systems are ineffective in
maintaining a desired imposed suction pressure level and
rather restrict volume flow of air throug~ such systems.
In an alternative embodimsnt of the present
invention, the float member 172 can be optionally replaced ky
means of a bubbler indicator which will provide not only
visible but also audible immediate confirmation of the proper
- level of suction in the collection chamber 12. The bubbler
:indicator includes a bubbler zone which is formed at the
juncture of the lower ends of the first compartment ~4 and
the second compartment 67 of the suction control chamber 16.
A predetermined amount of fluid is admitted into the bubbler
zone so that under operational conditions, any a~bient or
atmospheric air entering through the regulator 72 will pass
through the bubbler zone and will bubble therothrough tow~rd
2~ the suction inlet 60 and thus provide audible confirmation of
proper operation of suction in the collection chamber 12. By
providing a transparent portion 148 on front wall 110 as
shown in FIG. 1, visual confirmation is also provided. Thus,
medical personnel upon passing the chest drainage device 10
as illustrated in FIGS. 1 and 4 will be able to both hear and
see that the chest drainage device 10 is operating properly.
However, since the plate valve 76 is not a perfect
seal and in most instances will permit some air or ambient to
pass through toward the suction inlet 60, a critically sized
passageway 180 is provided in wall member 182 separating the
first compartment 64 and second compartment 67 and is
positioned at a point above the level of the predetermined
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60g50-189E
amount of fluid admitted into the bubbler zone. In this fashion,
any leakage air will bypass the bubbler zone and travel directly
into the suction line without providing a false alarm of operation
which is not yet achieved since the predetermined preset level of
suction is yet to be obtained. A grommet 140 as previously
descr-ibed is provided through which the fluid may be admitted.
Alternatively, a suitably sized flexible lnjection tubing (not
shown) can be inserted through the suction inlet 60 and positioned
down to the lower portion of first compartment 64 and thereupon
provide for admission of fluids. Similarly, the iniectlon
flexible tubing can also be passed into the large arm 46 of the
seal chamber 14 and thereby provide for admission of fluid.
In these alternative operations, there will be no need
for the grommets 140 and 138 as illustrated in FIG. 1. Thus,
after a predetermined amount of fluid is iniected into the bubbler
zone, any atmospheric air passing therethrough will cause bubbling
in the suction control chamber 16 when the applied suction exceeds
the preset imposed value. The bubbler zone and regulator 7~ are
designed so that the addition or deletion of water in the bubbler
zone will have no effect whatsoever upon the imposed suction
level. The bubbler zone and first compartment 64 and second
compartment 67 include deflectors 182, 184 and 186 which aid in
preventing any fluid in the bubbler zone from rising and spilling
over into the seal chamber 14. In addition, the height of the
second compartment 64 is chosen so as to further aid in preventing
such spillover. Notably, the amount of predetermined fluid in the
bubbler zone is below that level required to open the valve plate
76. In
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cc~arison with the float riember 172, the amount of
predetermined fluid corresponds to the inertial mass of float
member 172.
Although the suction regulator 72 of the present
invention has been described in connection with a chest
drainage device 10, it can also be applied to control suction
of other drainage devices as well. As shown in FIG. 4, wall
member portions 190, 192 and 194 are provided for added
support.
The present invention has been described in detail
with particular emphasis on the preferred embodiments
thereof. However, it should be understood that variations
and modifications within the spirit and scope of the
invention may occur to those skilled in the art to which the
invention pertains.
