CA1334645C - Drainage device - Google Patents

Drainage device

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Publication number
CA1334645C
CA1334645C CA000616709A CA616709A CA1334645C CA 1334645 C CA1334645 C CA 1334645C CA 000616709 A CA000616709 A CA 000616709A CA 616709 A CA616709 A CA 616709A CA 1334645 C CA1334645 C CA 1334645C
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CA
Canada
Prior art keywords
chamber
suction
collection chamber
inlet
ambient
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA000616709A
Other languages
French (fr)
Inventor
Frederick Alan Everett Jr.
Quinton James Farrar
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Genzyme Corp
Original Assignee
Deknatel Technology Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US06/916,342 external-priority patent/US4784642A/en
Priority claimed from CA000616055A external-priority patent/CA1324939C/en
Application filed by Deknatel Technology Corp filed Critical Deknatel Technology Corp
Priority to CA000616709A priority Critical patent/CA1334645C/en
Application granted granted Critical
Publication of CA1334645C publication Critical patent/CA1334645C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Abstract

An apparatus for draining fluids, for example, from a chest or pleural cavity, includes a collection chamber for col-lecting 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 pre-determined 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 immedi-ate confirmation of proper operation of suction in the collection chamber.

Description

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 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) ~, 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 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.

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.

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 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 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 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.

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.

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.

-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.

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.

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).

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.

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 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 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 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 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 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 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 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 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 1 3346~5 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 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.

-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.

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, 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.

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 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 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.

Claims (22)

1. Apparatus for draining bodily fluids comprising:
a. collection chamber for collecting fluids from a body cavity, said collection 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 arm compartment having a suction inlet at one end;
2) a small arm compartment at one end having an opening communicating with said collection chamber and communica-ting at its other end with the other end of said large arm, said small arm compartment having means adjacent its one end for pre-venting ambient from passing into said collection chamber when said collection chamber has a relatively high level of negative pressure.

2. The apparatus according to claim 1 wherein said ambient prevention means comprises a first chamber formed adjacent said opening and being dimensioned and configured so as to contain the entire volume of a predetermined amount of sealing fluid disposed in said seal chamber at the juncture of said large arm and small arm compartments.
3. The apparatus according to claim 2 further comprising a second chamber disposed so as to separate said first containment chamber from said opening into said collection chamber so that any sealing fluid passing from said first containment chamber will enter into said second separation chamber and thereafter return to said containment chamber instead of passing through said opening.
4. The apparatus according to claim 2 wherein said contain-ment chamber is configured so that any sealing fluid passing into said 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 said containment chamber.
5. The apparatus according to claim 4 further comprising a. wall member positioned within said small arm and separating said containment chamber from the remainder of said small arm, said wall member having an aperture; and b. valve means being dimensioned and configured for opening and substantially closing said aperture, said valve means being open when the collection chamber suction is at said preset level of suction and otherwise said valve means tending to sub-stantlally close said aperture in response to any fluid entering into said containment chamber from said juncture of said large arm and said small arm compartments.
6. The apparatus according to claim 5 wherein said valve means comprises a ball dimensioned and configured so as to be adapted for seating with and substantially closing said aperture.
7. The apparatus according to claim 6 wherein said aperture includes a notch so as to permit the sealing fluid to enter into said containment chamber when said ball valve seats upon and sub-stantially closes said opening whereupon the sealing fluid is diverted within said containment chamber generally transverse to the direction of normal suction flow.
8. The apparatus according to claim 7 wherein said remain-ing portion of said small arm is constricted so as to retain said ball valve movably between said constriction and said aperture.
9. The apparatus according to claim 8 wherein said remain-ing portion of said small arm is smaller in cross-sectional area than that of said containment chamber.
10. The apparatus according to claim 1 wherein said ambient prevention means comprises a one-way check valve disposed and oriented in said small arm compartment, said valve being open so as to permit the passage of suction flow from said collection chamber into said suction inlet, but being closed so as to prevent ambient from passing into said collection chamber.
11. The apparatus according to claim 10 wherein said one-way check valve is positioned adjacent said opening communicating said small arm compartment with said collection chamber.
12. The apparatus according to claim 1 further comprising an air flow meter disposed at the juncture of the other ends of said small arm and large arm, said air flow meter providing for measurement of the quantity of gases passing from the body cavity.
13. The apparatus according to claim 1 further comprising a check valve means disposed in said large arm compartment, said check valve means being normally closed and tending to open to permit ambient into said seal chamber in response to substantially increased pressure within said seal chamber.
14. Chest drainage device for draining fluids from a body cavity or portion comprising:
a. housing;
b. collection chamber formed within said housing for collecting fluids including an inlet for entry of the fluids and for fluid communication with the body cavity or portion;
c. seal chamber formed within said housing for preventing passage of ambient into the collection chamber and including:
1) a large arm compartment having a suction inlet at one end for coupling to a suction source;

2) a small arm compartment at one end having an opening communicating with said collection chamber and communica-ting at its other end with the other end of said large arm, said small arm compartment having means adjacent its one end for pre-venting ambient from passing into said collection chamber when said collection chamber has a relatively high level of negative pressure;
d. suction control chamber formed within said housing and being in fluid communication with said collection chamber for regulating the degree of vacuum imposed in the collection chamber and pleural cavity and including:
1) first inlet for coupling to said suction inlet of said seal chamber;
2) second inlet communicating with the ambient;
3) waterless means for regulating the degree of suction imposed in said collection chamber at a plurality of pre-determined preset levels of suction, said regulating means dis-posed between said first inlet and said ambient inlet; and 4) indicator means disposed between said regula-ting means and said first inlet for providing immediate confirma-tion of proper operation of suction in said collection chamber.
15. The apparatus according to claim 14 wherein said housing is formed of a front wall member and a back wall member sealed together along their peripheries by a plurality of side wall members.
16. The apparatus according to claim 15 wherein said front wall member includes an integrally formed handle.
17. The apparatus according to claim 16 wherein said suction inlet and collection chamber inlet are each disposed in a first side wall common to said seal chamber and said collection chamber.
18. The apparatus according to claim 17 wherein said ambient inlet to said suction control chamber is disposed in a second side wall adjacent to said first side wall.
19. The apparatus according to claim 18 further comprising an elongated support stand rotatably secured to a third side wall opposite said first side wall so that said support stand can be rotated from a stored position to a support position wherein said support stand is generally transverse to said third side wall so as to stably support said housing at a predetermined location.
20. The application according to claim 19 further comprising means for securing said support stand in said support position.
21. The apparatus according to claim 20 wherein at least portions of said housing are transparent to permit viewing of the operation or contents of underlying portions of each of said col-lection, seal and suction control chambers.
22. The apparatus according to claim 21 wherein at least selected portions of said front wall member are marked with graduations so as to identify the volume of the contents thereof and with predetermined indicia to provide instructional informa-tion.
CA000616709A 1986-10-07 1993-09-09 Drainage device Expired - Fee Related CA1334645C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA000616709A CA1334645C (en) 1986-10-07 1993-09-09 Drainage device

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US916,342 1986-10-07
US06/916,342 US4784642A (en) 1986-10-07 1986-10-07 Meterless drainage device with suction control
CA 548573 CA1292161C (en) 1986-10-07 1987-10-05 Drainage device with meterless suction control regulation
CA000616055A CA1324939C (en) 1986-10-07 1991-05-02 Drainage device
CA000616709A CA1334645C (en) 1986-10-07 1993-09-09 Drainage device

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA000616055A Division CA1324939C (en) 1986-10-07 1991-05-02 Drainage device

Publications (1)

Publication Number Publication Date
CA1334645C true CA1334645C (en) 1995-03-07

Family

ID=27167785

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000616709A Expired - Fee Related CA1334645C (en) 1986-10-07 1993-09-09 Drainage device

Country Status (1)

Country Link
CA (1) CA1334645C (en)

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