CA1324939C - Drainage device - Google Patents

Abstract

ABSTRACT OF THE DISCLOSURE
An apparatus for draining fluids, for example, from a chest or pleural cavity, includes a collection chamber for collecting fluids through an inlet port for entry of the fluids. Also included is a dry or waterless suction control chamber in fluid communication with the collection chamber for regulating the degree of vacuum imposed in the collection chamber. If desired, a seal chamber can also be provided between the dry suction control chamber and the collection chamber so as to prevent any ambient or atmospheric air from passing into the collection chamber. The suction control chamber has a first inlet which is coupled to a suction source and a second inlet communicates with the ambient. A
waterless regulator is provided for regulating the degree of suction imposed in the collection chamber at a plurality of predetermined preset levels of suction. This regulator is positioned between the suction inlet and the ambient inlet.
The suction control chamber also has at least a visual indicator disposed between the regulator and the suction inlet for providing immediate confirmation of proper operation of suction in the collection chamber.

The present invention also includes a device for retaining tubing under compression so as to provide self-sealing capability of the tubing during sampling or injection procedures.

Description

~ 132~939 - l - 6468~-425D

This is a division of our co-pending Canadian Patent Application No. 548,573 filed 5th October, 1987.
The present invention relates to drainage devices and in particular to suction drainage 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 ca~ity was a drainage system known as the "3-bottle set-up" which includes a collection bottle, a water seal bottle and a suction control bottle. A catheter runs from the patient's pleural cavity to the collection bottle, and the suction bottle is connected by a tube to a suction source.
The three bottles are connected in series by various tubes to apply suction to the pleural cavity to withdraw 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 establishing a pressure differential between the suction source and the internal pxessure in the patient. Such suction pressure and pressure differentials must be 132~939 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 degra~es the suction performance. Also, drainage systems incorporating water filled manometers in the suction control chamber whose - water level indicates fluid pressure are inconvenient because 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 sy~tems.

Also various inefficiencies have existed in the 3-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 ~ater 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 shor~coming of the 3-bottle set-up is the possibility of incorrect connection and the t~me necessary to set the system up to monitor its operation.

The 3-bottle set-up lost ~avor with the introduction of an underwatQr seal drainage system sold under the name ~Pleur-evac~ in 1966 by Deknatel Inc.l U.S. Patent l A ~ore detailed description of the need for and the proper us~ of chest drain~ge devices is presented in th~ Deknatel Inc. Pleur-ev~c publication entltled nPhysiology of the ~ (~ootnote continued) :

Nos. 3,363,626; 3,363,627; 3,559,647; 3,683,913: 3,782,497;
4,258,824; and Re. 29,877 are directed to various aspects of the Pleur-evae~ 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 tha Pleur-evac0 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 generally established 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 re~erred to as the ~High Ne~ativity Valve~ is included which i~ employed when the patient's negativity beco~e~ sufficient to threaten loss of the water seal. Also, a ~Positive Pressure Release Val~e~ in the large arm of the water seal cha~ber works to prevent a tension pneumothorax when pressure ~n the large ~rm o~ the water seal exceeds a ; ~5 prescribed value because of suction malfunction, accidental clamping or occlusion of the suction tube. The Pleur-evac~
system i~ disposable and helps in the battle to control cross-contamination.

(~ootnote continued from previous page) Chest and Thoracic Catheters; Chest Drainage Systems No. 1 of a ~eries from DeXnatelR ~1985) ~3249`39 Despite th2 advanta~e~ of the Pleur-evac~ sy~te~
over the 3-bo~tle 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 fil~ing could be performed at a manufacturing facility prior to shipment, as a practical matter ~his is undesira~le ~ecause ~xequent adjustments may be needed according to the different values of patient suction as dictated by the attending physic-an. 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 ~yst~ are somewhat limited by the size of the manometer tubes required to maintain ~uch suction levels.
For high level~ of suction, the size of manometers reguired would in ~o~e circumstances render the drainage system impractical. A reduction in size of the system would offer such benefitæ aæ ease of u~e, ease of storage, less expensive shipping cost~, and the reduction in the obstruction between the patient, and vicitors and the medical staff. In addition, accuracy o~ present underwater drainage systems is limited in that the various manometer6 employed must be constantly monitored visually by observing the liquid level in the respective chambers. Even when gauges are used, they likewise ml~st be constantly monitored. In either case, when the fluid in the manometer~ evaporates, suction variations ~\
13 2 ~ 9 3 9 64680-425D

occur which require the addition of more water to compensate for the loss. All such activity of course is time consuming.
We have invented an improved drainage device which provides additional improvements to presently availabe devices.

SUM~5ARY OF THE INVENTION
The present invention provides device for regulating the degree of vacuum imposed in a drainage system comprising:
1. housing defining a chamber adapted for fluid communication with the drainage system;
2. first inlet in said housing for coupling to a suction source;
3. second inlet in said housing communicating with the ambient;
4. waterless means for regulating the degree of suction at a plurality of predetermined preset levels of suction, said regulating means disposed between said suction inlet and said ambient inlet; and 5. indicator means disposed between said regulating means and said suction inlet for providing immediate confirmation of proper operation of suction.
The regulation suction means may comprise a wall member having an aperture and disposed within and separating the chamber into a first portion adjacent the ambient inlet and a remaining second portion adjacent the suction inlet, the second portlon adapted for fluid communication with the drainage system;
valve means dimensioned and configured for sealing the aperture;

132~93~

and means for tensioning the valve means to seal the aperture when the drainage system suction is at the pre~et level of suction and otherwlse unsealing the valve means so as to permit amblent to flow into the second portion and thereby return the suction in the drainage system to the present level.
There i~ also disclosed apparatus for draining bodily ~luids comprising:
a. collection chamber for collecting fluids from a body cavity, said collectlon chamber including an inlet for fluid communication with the body cavity;
b. suction control chamber for regulating the degree of vacuum imposed in the collection chamber; and c. seal chamber for preventing passage of ambient into the collection chamber and including:
1) a large ar~ compartment having a suction inlet at one end;
2) a small arm compartment at one end having an A

~ 7 ~ 13 2 4 9 3 964680-425D

opening communicating with said collection chamber and communi-cating at its other end with the other end of said large arm, said small arm compartment having means adjacent its one end for preventing ambient from passing into said collection chamber when said collection chamber has a relatively high level of negative pressure.
The ambient prevention means may comprise a first chamber formed adjacent the opening and being dimensioned and configured so as to contain the entire volume of a predetermined amount of sealing fluid disposed in the seal chamber at the juncture 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 first 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 configured 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 collected within the containment chamber.
The apparatus preferably further comprises a wall member positioned w1thin the small arm and separating the contain-ment chamber from the remainder of the small arm, the wall member having an aperture; and valve means being dimensioned and con-figured for opening and substantially closing the aperture, the valve means being normally open and tending to substantially - 8 - 13 2 ~ ~ 3 9 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 132~39 cavity. The apparatus also comprises a check ~alve means disposed in the lar~e arm compartment. The check valve means 5 is normally closed and tends to open to per~it ambient into the seal chamher in response to substantially increased r pressure within the seal chamber. Also, the present .~ invention is directed to.a chest drainage device for draining ~luids from a body cavity or portion comprising a housing;
collection cha~ber formed within the housing for collecting 10 fluids including an inlet for entry of the fluids and for fluid com.munication with the body.cavity or portion; seal chamber for~ed wit~in the housing for preventing passage of .ambient into the collection chamber and including a large arm compartmen~ having a suction inlet at one end for c~upling to 15 a suction source~ a small arm compartment at one end having : an opening communicating with the collection chamber and communicating at its other end with the other end of the large arm, the small arm compartment havin~ means adjacent its one end for preve~ting ambient from passing into the 20 collection chamber when the collection chamber has a relatively high level of negative pressure; suction control chamber for~ed within the housing and being in fluid c~mmunication with the collection chamber for regulating the : degree of vacuum imposed i~ the collection chamber and 25 pleural cavity and including a first inlet for coupling to the suction inlet of the ~eal chamber: second inlet communicating with the ambient; waterless means for regulat~ng the degree o~ suction imposed in the collection ~: chamber at ~ plurality of predetermined pxaset levels of 30 suction, the regulating means disposed between the first inlet and the ~mbient inlet; and indicator means disposed 132~93~

betwe~n the regulating means and the ~irst inlet ~or providing immediate confirmation of proper operation of suction in the collection cham~er.

Preferably, the housing is formed of a front wall member and a back wall membar s2aled together along their peripheries by a plurality o~ side wall members. The ~ront 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 se~l chamber and the collection chamber. Alss, the ambient inlet to the suction control chamber is disposed in a second side wall adiacent 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 ~tand can be rotated fro~ a stored position to a support position wherein the support stand is generally transverse to the third side wall 80 as to 6tably support the housing at a predeter~ined loca~ion. The support ~tand can be ~ecured in the support position.

: 25 Preferably, at least portions of the housing are transparent to permit viewing of the operation or contents of underlying portion~ o~ each o~ tho collection, seal and ~uction control chambers. Also, at least sel~cted portions of the ~ront wall ~ember are ~arked with graduations so as to idantify the volume o~ the contents thereof ~nd with predetermined ~ndicia to provide instructional in~ormation.

132~39 -- 11 -- ..

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 fluids including an inlet for entry of the fluids; tubing coupled a~
on~ end to the collection chamber inlet, the other end adapted for insertion into the ~ody 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 çxpose the tubing and to provide ac~ess to the interior of the tubing upon ~nsertion of a hypodermic needle; and suction control chamber in fluid communication with the collection cha~ber for regulating the degree of vacuum imposed in the collection chamber and including first inlet ~or 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 preset levels of suction, the regulating means disposed between the suction inlet and the a~bient inlet; and ; indicator means disposed between the regu'ating means and the suct~on inlet for providing immediate confirmation of proper operation o~ suction in the'collection chamber.

Preferably, the compression means is ~ormed of two like structured, elongated curved plate members having flanges extending along rsæpective correspond$ng 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.

~``\ ( l ~32~939 Preferably, the inn~r cross sectional diameter of tho curved plate mem~er~ is less than the cross sectional outer diameter of the tubing. According to one preferred embodiment, the inner cross section~l diameter of the curved plate members is about four fifths of that of the outer diameter of the tubing.

OF THE DRAWINGS

1 o The present inYentiOn is described in greater detail hereinbelow, 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 o~ the drainage device of FIG.
1 illustrating the inlet ports into the collection chamber 2~ and the suction control cha~ber.

~ IG~ 3 is an enlarged view of a portion of tAe botto~ of the drainage device of FIG. ~ before attach~ent of the floor stand~

~ IG. 4 is an exposed front view o~ the drainage device of FIG~

FIG. ~ is an exposed front view of an alternative embodiment of the drainage device of the present invention.

FIG. 6 is a ~rst cross-sectional side view in the collection chamber taken along the lines 6-6 o~ FIG. 4.

132~39 FIG. 7 is a second cross-sectional side view in the collection chamber taken along the lines 7-7 of ~I&. 4.

FIG. 8 is a first cross-sectional side view of the small arm of the seal chamber taken along the lines 8-B 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 checX
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.

~ IG. 10 i a cross-sectional sida view in the second compartment of the suction control chamber taken along :the line~ 10-10 of FI~. 4.

FIG. lI is a cross-sectional view taken along lines 11-11 o~ ~IG. 4.

FIG. 12 is a cross sectional view taken along lines 12-12 of FIG. 4.

: FIG. 13 is an enlar~ed ~iew illuætrating the poppet valve and dashpo~ in the suction control chamber taken along lines 13-13 of FI~. 10.

FIG. 14 is an exploded view of the in~ection~
sampling dev~ce according to the present invention.

1~2~939 FIG. 15 is a top view of the injection/sampling device of FIG. 14.

FIG. 16 is a cross-sectional side view taken along the lines 16-16 of FIG. 15 illustrating tubing under compression.

DESCRIPTION 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 c~est 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 ~arious chambers are generally described in U.S. Patent Nos.
3,363,626; 3,363,627; 3,5597647; 3,683,913; 3,782,497;

2~ 4,258,824; and Re. 29,877 to the extent that like or common elements are presented therein. In addition, the purpose and general operation of the various chambers of the chest drainage device 10 of the present ~nvention are also more fully described in the ~eknatel In~. Pleur-evac- publication 3Q entitled ~Understanding Chest Drainage Systems~ (1985).

~32~939 The collection chamber 12 is formed generally to the right of line ~A-A~ and preferably includes four separate collection compartments 18, 20, ~2 and 24 which are formed between respective pairs of walls 26, 28, 30, 32 and 34 as shown in FI~. 4. However, the collection chamber 12 of the present invention is not limited as to the number of separate collection compartments and any number as desired can be provide~. Likewise, the volumetric size of the varisus 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 collectio~ compartment 18. To provide for finer measurements of fluids collected, at least collection compartment 18 is dimensioned and configured to have the smallest volumetric size and the remaining compartme~ts are preferably larger ized to accommodate greater amounts of fluid collected. In .
addition, sloping wall member 19 as shown more clearly in FI~. 6 permits the lower portion of compartment 18 to be ~:: s~aller than thQ upper portion and thus provide yet even ~maller volumetric measurements. An opening 27 in wall 28 as shown more clearly in FIG. 6 permits over~l~w of fluid from compartm~nt 18 to pass ~ir~t into compart~ent 20. Likewise, any overflow from compartment 20 ~an~pass over upper edge of wall 30 into compartment 22 and from there o~er upper edge of wall 32 into compartm~nt 24. Accordingly~ the upper edges of walls 30 and 32 are ~pproximately at the same height to allow ~or ov~r~low-1324~39 . A high negativity valve 40 is positioned in topwall 38 in communicatio~ with collection chamber 12. ~he high negativity valve includes a button actuated valve which when depressed allows filtered air to enter the collection chamber 12. In this manner, undesired high degrees of negative pressure that may occur in the body cavity and thereby develop in the collection cha~ber 12 are relieved.

The seal chambe* 14 generally is formed between the lines ~-A~ and ~B-B" as shown in ~IG. 4. In particular, the seal chamber 1~ includes a small arm comp~rtment 42 formed between walls 34 and 44 and a large compartment 46 formed between walls 44 and 47. Although seal chambers are typically operated with a predetermined level of fluid such as water, the ~eal chamber 14 of the present invention can be operated in ~ither a ~dry~ or a ~wet" mode of operation in the mannar to be more fully described hereinbelow. An air flow meter 48, if desired, can ba positioned as shown in ~IGS. 1 and 4 at the juncture o~ the lower ends of the small and largæ arm compartments 42, 46. ~he air flow meter 48 is intended for use in the ~wet~ mode and is of the type : illustrated and described in aforementioned U.S. Patent No.
3,683,913.
However, even if operated in the n~ry~ mode, the air flow meter 48 if present will have no deleterious e~ect.

The seal chamber 14 preferably also include~ a valve mechanism in the small arm co~partment 42 which includes a plate membar 48 and a ball float valve 50 that is free to travel between plate member 48 and a constr~cted port$on of small arm compartment 42 as æho~n ~n FIG. 4.
However, the co~stricted portion a~ shown ~ore clearly in 132~39 FIG. 8 is conflgured so that in operation under suctlon, the float ball valve 50 wlll not block off the lower portion of the small air compartment 42.
Plate member 48 as shown more clearly in FIG. 8 lncludes a clrcular openlng 52 whlch is conflgured and dlmensloned so as to permlt ball float valve 50 to seat within openlng 52 when fluld such as water whlch ls typlcally contalned wlthln the water seal chamber 14 ls drawn by unduly hlgh negatlve pressure toward the collectlon chamber 12 through openlng 54 in the upper end of the small arm compartment 42. A slmllar valve arrangement ls also descrlbed as a cyllndrlcal valve member ln U.S. Patent No.
3,683,913 whlch also serves to retaln water or fluld ln the water seal chamber. However, plate number 48 accordlng to the present lnventlon lncludes a notch or keyway slot 56 whlch stlll permits fluld or water from the water seal chamber to bypass ball valve 50 and enter lnto the upper end 58 of small arm compartment 42.
Wlthln the upper end compartment 58, the fluld bypasses ball valve 50 and clrculates in a dlrection transverse to the flow of suction or normal flow and is diverted upon the walls forming upper end compartment 58.
Preferably, the upper end compartment 58 is conflgured and dlmensloned so as to accommodate the entlre fluld volume ln the water seal chamber to be contained therein. In thls manner, water ln the water seal chamber ls prevented from being drawn lnto the collectlon chamber through openlng 54 in the event of a high negatlvlty developed ln the collectlon chamber 12. Such hlgh negatlvlty occurrences can result from a deep breath, coughlng or choklng by the patlent. It can also occur when suction ls turned off whlch ~ 17 132~39 happens either when the suction tu~e is occluded or the hospital suction ~ails. High negativity can likewise occur when the patient is on a ventilator. Alternati~ely high negativity results when medical person~el 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 compartmènt 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 preve~tion 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 sa~eguard 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 fro~ op~ning 54 80 as to aid in pre~enting ; ~luid from passing-into the collection chamber 12.
Preferably the separation chamber 5~ 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 reguired to maintain a seal. In such instance, the ball float valve 50 can be replaced with ~ check valve 51 which seats in compartment 58 and about opening 52 as shown in FIG. 8A. The 1324~3~

check valve 51 is a one way valve that permits suction flow in the direction of arrow ~c~ 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 s~al chamber 14 is in fluid communication with suction inlet port 60 and a posi~ive pressure relief valve 62 as shown in ~IG. 4. Alternatively, this ~alve 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 ~onfiguration which is normally closed and includes valve member 6~. it opens to permit excessive pressure in the seal cham~ar 14 to be vented to th~ ambient 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 insludes a suction control chamber 16 :: which includes a first co~partment 64 formed between walls 47 and 66 and a second compartment 67 ~rmed between walls 66 and 68. The u~per end o~ first compartment 64 is fluidly coupled to the -~uction inlet port 60 together with the upper end of the large arm 46 of the water seal cha~ber 14. The :: upper end of the second compartment 67 which is formed be-tw en walls 66 and 68 includes a waterless suction regulator : ; 72 which ~s hQused in the upper portion o~ second compartment 7 .. as shown in FIG. 4. The upper end of compartment 67 has 3Q an opening 74 which communicates with the atmosphere or the ' ambient about the chest drainage device 10. The suction ; regulator 7~ in51udes a valve 76 which is configured and dimens~oned to 5eat against opening 78 in a plate mem~er 80 wbich separates the second compart~ent 67 as shown in ~IG. 5 35 into an upper ~nd ~ lower portion. As evident from the ~324939 drawings, the plate valve 76 is po$itioned 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 in the upper wall 38 in a rotatable joint 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 ~ereinbelow. 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 is of the type manufactured under the trademark Airpot which is manufactured by Airpot Corporation, 27 Lois Street, , Norwalk~ Connecticut. The dashpot 86 attenuates the rapid modulation of the valve 76 which may occur during the operation of the chest drainage device 10. Praferably the dashport 86 includes a gr~phite plug 90 attached to a stem 92 of plate valve 7~. Th~ graphite plug 90 rides within a well formed of a glass annulus ~4 which together with the graphite plug 90 proYide 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 msmber 80 and about opening ~8. In this manner, tha plate valve 76 in cross section generally provides a single point of contact between the bead 96 and plate member 80. This eliminates large contacting surface ~32~939 areas and thereby prevents any sticking 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 con~orm 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 positionad disk 104 having lever arm 106. Accordingly, as gear 100 is rotated upon movement of lever 106, the worm gear 9~ and rod 84 are advanced upwardly or downwardly while . collar 86 remains fixed or non-rotating and thereby changes the tension o~ the spring 82 that provides the amount of force for seating valve plate 76 against opening 78. Such tension corre~ponds to the amount of suction imposed in the collection chamber 12 and likewise the patient's pleuxal ~:~ cavity and can thereby be calibrated so as to provide for a plurality of predetermined, preset values that can thereby be marked on th~ disk 104. To provide for accurate positioning of the disk 104, a correspo~ding series of detent~ 106 are provided along prescribed portions of the circumference of : disk 104 and cooperat~ with a stop arm 108 that seats at its outer end within any one of the predeter~ined preset detents 106 that correspond to a pre-set level o~ suction. The stop : ar~ 108 is supported from outer wall 68 that includes opening : 30 ~4 that permits a~bient or atmosphere to enter the suction control chamber 16. As noted above, rotation o~ collar 86 simul~aneously allow~ the rod 84 to be advanced upwardly or 132~939 downwardly w~ile the disk 104 is in a given position in order to provide for propar calibration of the suction level settings- .

The suction control ~hamber 16 includes a visual indicator that provides immediate confirmation o proper operation of suction in the collection cham~er 12. This visual indicator will be described in greater detail below.

As shown in PIG. 1, the drainage device 10 is generally formed o~ a housing that includes a ~ront wall llo .that is secured to a back wall 1~2. The front wall 110 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 diffexent walls and sides can have different contours in order to accommoda~e the ;~ different chambers defined therebetween. In one pre$erred embodiment, the housing can be ~or~ed integrally with all the walls ~oined along their peripherles. Alternatively, the separate side walls and front and back walls can be secured to one another by suitable ~eans wAich are well known to : those skilled in the art. ~ccording to the preferred ~: 25 .embodiment illu~trated in ~IG. 1, th~ housing 10 includes :~ side brackets 116 shown more clearly in FIG. 2 ~rom which hanqers 118 extend in ord~r 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 devlce 10 includes a f}oor ~upport stand 122 which ~ s secured rotatably to the bottom wall 114 as shown in FIG. 4. The floor stand 122 comprises a generally rectangular or elongated bar whi~h ;~ has an aperture centrally positioned 80 as to be able to pass . .

132~939 over the split collar 124 as shown-in FIG. 3. In this manner the floor stand 122 once assembled over the split collar 124 is able to rotate about its opening and can be positioned 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 ~arrying 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 smalle~ volumetric size of the first collection compartment permits finer measurements, for examplej from 0 -: 200 cc of fluid while the other compar~ments accommodate still larger volumetric a~ounts. In this manner, the med;cal 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 ~luid evacuation procedure by a single reading of the height of the fluid in the most recently filled collection compartment~

Other portions o~ front wall 110 are also ; 30 transparent to permit the vi~wing o~ additional operational features of the devicQ 10. In this respect, the ~mall arm compartment 42 of the ~ealed chamber 14 is transparent 132 in order to permit viewing of the height o~ the fluid contained within the seal chamber 14. Accordingly, the length of the small arm compartment 42 i5 also calibrated with graduations 134 in order to permit ready measurement of the height of the fluid. Similarly the air~low meter 48 has a transparent portion 136 which allows viewing of any air bubbles passing therethrough.

In ord~r to allow for filling of the fluid into the ~eal 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 ~38 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 ~hown in FIG. 1, the device ~0 is coupled to a suction Eource 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 ~luids therefrom.

Also, the suction control chamber 16 underlies a transparent portion 148 that permits viewing o~ the optional bubbling operation, i~ utilized as desired, in that cha~ber portion and thereby pro~ides both a visual and aud~ble confirmation of operation o~ suction. Similarly, a - 25 - 132~939 transparent p~rtion 150 permits visual confirmation of operation in the first compartment 64 of tA~ suction control 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 1~0 that the device lo is properly operating. In ordar to permit visual d.etermination 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 ~xtending through opening 74 of :left side wall 68. Instructional information can be provided on the face of front wall ~10 as shown at different locations 156, 158 and 159.

An alternative embodiment 10' of the chest drainage device lO according to the present invention is illustrated in FIG. 5. ~or ease of convenience elements of chest drainage device lO' that are common to lika elements in the embodiment lO of FIG. 4 are identified by like numerals.
~owever, 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 seal chamber as shown in the embodimenS depicted in FIG. 4. Acordin~ly, in FI~. 5, the collection chamber 12 is formed to the right of lines nA-A"
and suction control cham~er 16 to the left thereof.

During the drainage procedure, it is at times advantageous or desira~le to draw a fresh sample of ~luid drainage ~ro~ the patient for culture purposes or other testing procedures. It is also advantageous or desirable to !

- 26 - 1~24~39 provide for introduction of antibiotics as well as other drugs back to the patient in the event infection is detected.
Ac~ording to currently available methods for obtaining drainage samples, some chest drainage devices include a resealable site in the collection chamber 12. However, with this method the clinician or medical personnel cannot obtain a fresh sample since the collection chamber 12 invariably would contain fluids that have c~llected 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 sel~-sealing, tests have indicated that leakage occuxs under normal operating conditions. Another disadvantage with such sampling/injection methods is the possibility that the needle of a hypodermip needle, for example, may pass through both walls of the tubing and possibly stick and injure the clinician'~ 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 IS9 for co~presaing tubing 146 preferably formed of latex which extends from suction inlet 36 and whose other end i5 adapted for insertion into the body cavity or portion whi~h i~ to b~ dr~ined o~ ~luids and gases. According to the compression device 159 o~ the present invention as shown in FIG. 14, fresh dr~inage samples or infusion of ~rugs can be provided through th~ latex tubing 146 without any danger of leaXage or cont~mination of the clinician due to possible stick~ with the hypodermic. The compression device 159 of ~35 ;~

- 27 - 132~939 the present invPntion m~intains at least a portion of the wall of the tubing 146 in compression and thereby provides -5 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 th~t i8 smaller than the cross-sectional outer diameter of the tubing 146. The plates 160 and 162 are liXe 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 w~ndow 166 that allows the tu~ing 146 to be exposed.
Since the inner cross-sectional diameter of assem~led plates 160, 162 is less than the cross-sectional outer diameter of the tubing 146--pre~erably 20% less--the tubing 146 extends outwardly of the window 166 portion of upper plate 160 as shown more clearly in FIG. ~6. In this manner, the tubing 146 at ieast within the portion of the window 166 is m~in~ained under compression so that when a hypodermic needle is injected throu~h thQ 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. 15, the tubing 146 is also glued with a suitable solvent at portions 168, 170 which are a~acent the window portion 166. ~his permits the retention of the tubing 146 and partlcularly that portion about the window 166 even if the tubing is h~ndled or pulled at portions outsid~ o~ tha compression device t59 Such handling 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 drainage line. By means of the glued portions 168 and 170 the tu~ing is assured of baing retained in its position within the device 159. At least the back plate member is relative~y rigid so as to prevent a hypodermic needle from penetrating into the clinician's ~kin i.n the manner as described above.

Referring to PIG. 4, the visual indicator as noted above includes a float member 172 which i$ positioned in the :first compartment 64 of the suction control chamber 16 and in particular in the upper portion thereof adjacent the juncture of the first compartment 64 and the large arm 46 of the seal chamber 14. The float member 1~2 is dimensioned and configured so as to be capable of moving within a c~nfined region 174 which is determined between a pair of post members 176, 178 that serve as stops to limit the movement of the 2~ float member 172 within the confined region 174. The float member 172 is critically sized as is also the confined region 174 so that the float member will move upwardly within the confined region 174 when the pxedetermined preset level of suction as controlled ~y regulator 72 is obtained in the collection chamber 12. Acc~ordingly, ~ such circumstance, the flo~t member 172 will rise ~ . stop 175 when the proper predetermined level of suction is achieved~ In order to par~it viewing o~ the float member 172, the front wall 110 has a viRible portion 150 which permits viewing o~ the float member 172 as it moves upwardly towards stop member 176.
This provide~ to the medical personnol immediate visual confirmation that the chest drainage device 10 has a proper operation of suction in the collection chamber 12.

- 29 - ~3~4939 Pre~erably, the float member 172 is colorPd 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 raduced light or night conditions.

Notably, the dry or waterless uction control chamber i6 is independent of any ~luid which in typical drainage devices provides the degree of suction. However, the evaporation of the ~luid 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 o~ the setting of the suction level will be accomplished by turning the dial 104. ~he position of the dial 104 will cause spring 82 to be elongated accordingly.
:~ Elongation of the spring 82 causes a foroe to be exerted on the valve plate 76 which seats against opening 78. The exerted force is a function of the de~ree of spring elongation and the spring's phy~ical properties. Once suction is appled to the collection cha~ber 12 and thereby the chest cavity or body portion of the patient, a force will be appli~d to the valve pl~te 76. If the force applied to the valve plate 76 result~n~ from the applied suction exceeds the force supplied ~rom elongation of the spring 82, the plate valve 76 will be dixplaced allowin~ ambient or atmospheric air to enter the chest drainage device chambers.
In particular, at~ospheric air enters in through opening 74, _ 30 _ ~32~939 through opening 78 in wall 80, around smaller sized wall 88, through opQning 79 in wall 81 and thus through the second compartment 67 and thro~gh 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 regulation of imposed suction as described above, however, will provide rapid modulation of the plate seat 76 as those differen~ials occur. In order to reduce or attenuate this modulation, the dashpot 86 is included whqse stxucture has ~een described hereinabove.

According to the configuration of the regulator 72 and its location in the chest drainage device 10, pre~erential air flow is provided which permits evacuation of air preferentially from the patient rather than from the regulator 72. This is assur d 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 devica 10 according to the present invention is insensitiVe to pressure variations regardless of their source ~nd 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.

.

132~9:39 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 ~esired imposed suction pressure level and rather restrict volume flow of air through such systems.

In an alternative embodiment of the present invention, the float memb~r ~72 can be optiQnally replaced by means of a bubbler indicator which will provide not only visible but also audible immediate confirmation of the proper level of ~uction 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 64 and the second compartment 67 of the suction control chamber 16.
A predetermined amount of fluid is a~mitted into the bubbler zone so that under operational conditions, any ambient or atmospheric air entering through the regulator 72 will pass through the bubbler zone and will bubble ther~through tow2rd the suction inlet 60 and thus provide audible con~irmation of proper operation of suct;on in the collection chamber 12. By providing a transparent portion 148 on front wall 110 as shown in FIG. 1, visual con~irmation is also provided. Thus, - medical personnel upon passing the chest drainage device lo as illustrated in FIGS. 1 and 4 will be able to both hear and ee that the chest drainage device 10 is operating properly.

~ owever, since the plate valve 76 i8 not a perfe~t seal ~nd in mo-~t instances will permit some air or ambient to pass through toward the suctiun inlet 60, a critically s~zed passageway 180 is provided ~n wall ~ember 182 ~eparating the ~irst compartment 64 and second compartment 67 and is positioned at a point above the level o~ the predetermined .
~ 35 ~ 32 - 1324~39 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 described is provided through which the fluid may be admitted. Alternatively, a suitably sized flexible injection tubing (not shown~ can be inserted through the suction inlet 60 and positioned down to the lower portion of compartment and thereupon provide for admission o~ ~luids. Similarly, the inje~tion flexible .~ubing can also be passed into the large arm 46 of the seal chamber 14 and thereby provide for admission uf fluid t5 ~n these alternative operations, there will be no need for the grommets 140 and 138 as illustra~ed in FIG~ 1. Thus, after a predetermined amount of fluid is injected into the bubbler zone, any atmospheric air ~ - passing therethrouqh will cause bubbling in the suction ;~ 20 control chamber 1~ when the applied suction exceeds the preset impased value. The bubbler zone and regulator 72 are designed so that the addition or deletion of water in the bubbler zone will have no ef~ect whatsoever upon the imposed suction level. The bubbler zona and ~irst compartment 64 and 25 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 ~eal chamber 14. In addition, the height of th~ second compartment 64 is chosen : 80 as to further aid in preventing such spillover. Notably, the amoun~ of predetermined fluid in the bubbler zone is below that level re~uired to open the valve plate 76. In ~5 132~939 comparison with the ~loat ~ember 172, the am3unt of predetermined fluid corresponds to the inertial mass of float member 172.

Although the suction regulator 72 of the present invention has bPen 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 ~IG. 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 sXilled in the art to which the invention pertains.

:

.

Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. Device for regulating the degree of vacuum imposed in a drainage system comprising:
1. housing defining a chamber adapted for fluid communication with the drainage system;
2. first inlet in said housing for coupling to a suction source;
3. second inlet in said housing communicating with the ambient;
4. waterless means for regulating the degree of suc-tion at a plurality of predetermined preset levels of suction, said regulating means disposed between said suction inlet and said ambient inlet; and 5. indicator means disposed between said regulating means and said suction inlet for providing immediate confirmation of proper operation of suction.

2. The device according to claim 1 wherein said regulation suction means comprises:
a. wall member having an aperture and being disposed within and separating said chamber into a first portion adjacent said ambient inlet and a remaining second portion adjacent said suction inlet, said second portion adapted for fluid communication with the drainage system;
b. valve means dimensioned and configured for sealing said aperture; and c. means for tensioning said valve means to seal said aperture when the drainage system suction is at said preset level of suction and otherwise unsealing said valve means so as to permit ambient to flow into said second portion and thereby return the suction in the drainage system to said preset level.

3. The device according to claim 2 wherein said tensioning means comprises a spring under tension and coupled at one end to said valve means and at its other end to a support member within said first portion, so as to maintain said valve means in a closed sealing relationship with said aperture in accordance with said predetermined preset level of suction.

4. The device according to claim 3 further comprising means for adjusting said spring tension in predetermined preset discrete steps so as to selectively provide one of said predetermined preset levels of suction.

5. The device according to claim 4 wherein said adjusting means comprises:
a. worm gear disposed on at least a portion of said support member;
b. pinion gear being rotatably supported and coopera-tively engaging said worm gear;
c. dial coupled to said pinion gear and having a plurality of predetermined preset grooves along its periphery;
d. detent member secured to said housing and resilient-ly disposed against said periphery and configured and dimensioned for seating within one of said grooves and such that upon rotating said dial, said detent member rides along said periphery until seating within next one of said grooves.

6. The device according to claim 5 further comprising means for variably calibrating the tension of said spring while said detent member is seated within one of said predetermined preset grooves of said dial so that said spring tension can be selectively varied without any rotation of said dial.

7. The device according to claim 6 wherein said tension calibration means comprises a collar rotatably disposed in said housing, said other end of said support member being secured to said collar for rotation therewith so that upon rotation of said collar together with said support member, the tension of said spring can be selectively varied while said dial is stationary.

8. The device according to claim 7 wherein at least a portion of said dial extends out of said ambient inlet so that said dial can be rotated from outside of said chamber.

9. The device according to claim 8 wherein said dial has graduations thereon to indicate the suction pressure imposed in said drainage system while said detent member is seated in one of said grooves.

10. The device according to claim 2 wherein said valve means is a generally flat plate having a circular bead on one side thereof for seating against said separation member and about said aperture so as to provide in cross section a generally single point of contact between said bead and said separation plate.

11. The device according to claim 2 wherein said aperture in area is greater than the smallest cross sectional area of any passage in said chamber or the drainage system.

12. The device according to claim 2 further comprising damping means coupled to said valve means for attenuating any rapid movement of said valve means during opening and closing of said aperture in response to any suction variations from said predetermined preset level of suction.

13. The device according to claim 12 wherein said damping means comprises a dashpot operatively connected to said valve means.

14. The device according to claim 13 wherein said spring is disposed in said first portion adjacent said ambient inlet and said valve means and said dashpot are each disposed in said second portion.