MXPA99006539A - Device and system for draining a body cavity and methods related thereto - Google Patents

Abstract

Featured is a device for draining fluids and/or gas from body cavities, including at least a pressure control chamber and a collection chamber being fluidly coupled by a one-way valve thereby establishing a waterlessseal between the collection chamber, including the patient, and the suction source. The pressure control chamber also includes a waterless suction pressure control regulator that controls and maintains the suction pressure at or about a selected value. Preferably, the regulator includes a spring operated valve. The device also includes a vent path arrangement having an intermediate chamber and at least two passages that are perpendicular to two adjacent surfaces within the intermediate chamber. The two passages and intermediate chamber are arranged so liquid in the collection chamber does not flow and contaminate the upstream portions of the device when the device is resting on its front side or backside. Also featured is an autotransfusion system including a drainage device and a bag assembly attached thereto. The device and bag assembly are fluidly coupled so the differential pressure established by the device causes the blood from the patient to drain into the bag assembly. In an alternate embodiment, the drainage device is configured to continuously collect and filter a patient's blood and continuously output it for re-infusion back into the patient.

Description

DEVICE AND SYSTEM FOR DRAINING A CAVITY OF THE BODY AND METHODS RELATED TO THE SAME FIELD OF THE INVENTION The present invention relates to drainage devices and systems and more particularly to suction drainage systems and devices for removing gases and / or liquids from patients, such as from the pleural cavity, by means of a pressure differential.

BACKGROUND OF THE INVENTION For many years, the standard apparatus to perform the evacuation of the pleura cavity was a drainage system known as the "3-bottle installation" that includes a collection bottle, a water-sealed bottle and a bottle of water control. suction. A catheter is moved 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 means of several tubes to apply suction to the cavity of the pleura to remove fluid and air and then discharge them into the collection bottle. The gases that enter the collection bottle bubble through the water in the bottle with water seal. Water in the water seal they usually prevent the reflux of air inside the chest cavity. Suction pressure is usually provided by a central vacuum supply in a hospital to thereby allow the removal of fluids such as blood, water and gas from the patient's pleural cavity by establishing a pressure differential between the suction source and the internal pressure in the patient. Such suction pressure (vacuum) and pressure differentials must be maintained precisely because dangerous conditions could result if unduly high or low pressure differentials occur. However, the hospital suction source can typically vary over time which degrades the suction performance. Also, drainage systems that incorporate pressure gauges in the suction control chamber are inconvenient due to the need to add water before use, and also due to their size and weight. In addition, evaporation in the suction control chamber results in variations in suction pressure that must be corrected by the addition of more water thereby increasing the maintenance and monitoring time required in the use of such drainage systems. There have also been several inefficiencies in the installation of 3-bottles that result from many separate components and the large number of connections (usually 16 or 17). Complications such as pneumothorax can result from the loss of the water seal on the water seal bottle if the suction was temporarily disconnected, and undue accumulations of positive pressure could cause pneumothorax tension and possible mediastinal shift. Another important disadvantage of the installation of 3 bottles is the possibility of incorrect connection and the time necessary to install the system to monitor its operation. The installation of 3 bottles lost ground with the introduction of an underwater drainage system sold under the name "Pleur-evac" ® in 1966 by Deknatel Inc. United States Patent Nos. 3,363,626; 3,363,627; 3,559,647; 3,683,913; 3,782,497; 4,258, 824; and Re 29,8777 are directed to different aspects of the Pleur-evac® system that has shown improvements over the years that eliminated several disadvantages of installing 3 bottles. These improvements have included the elimination of variations in the installation of 3 bottles that existed between different manufacturers, hospitals and hospital laboratories. A more detailed description of the need for and proper use of chest drainage devices is presented in Deknatel Inc.'s publication Pleur-evac® entitled "Physiology of the Chest and Thoracic Catheters; Chest Drainage Systems No. 1 of a series from Deknatel "(1985) which is incorporated herein by reference. Among the characteristics of the Pleur-evac® system that provides its improved performance is a self-contained, preformed, individual unit that presents the techniques of three bottles.

The desired suction values are generally established by the water levels in the suction control chamber. These levels are filled according to specified values before the application of the system to the patient. This includes a special value referred to as "High Negativity Value" that is used when the patient's negativity becomes sufficient to threaten the loss of the water seal. Likewise, a "Positive Pressure Release Value" in the large arm of the seal chamber works to avoid a pneumothorax tension when the pressure in the large arm of the water seal exceeds a prescribed value due to suction malfunction, clamping accidental or occlusion of the suction tube. The Pleur-evac® system is disposable and helps in the effort to control cross-contamination. Despite the advantages of the system over the installation of 3 bottles and the general acceptance of the device in the medical community, there is still a need to improve the convenience and performance of the chest drainage system and to make these systems compact. As noted above, the suction control chambers filled with fluid are filled to levels specified by the physician before being connected to the patient and the hospital suction system. The suction levels obtained by such a chest drainage system are somewhat limited by the size (eg, height) of the chamber required to maintain such suction levels). For such suction levels, the height of the required chamber would render the pectoral drainage system impractical in some circumstances. Furthermore, the accuracy of such underwater drainage systems is limited in that the fluid chamber used therein must be constantly monitored by observing the level of the liquid in the respective chambers. Even when calibrators are used, they must be monitored constantly. In any case, when the fluid in the chambers evaporates, suction variations may occur that require the addition of more water to compensate for the loss of water. Of course all that activity is time consuming and laborious. Due to the size of these devices, they usually present an obstruction between the patient and the visitors and the medical staff. As such, it is not common for the device to be struck thereby creating the potential for cross-contamination of fluids with the device. These devices may include some mechanism to minimize cross contamination if the device falls on its back, although there is no protection available if the device falls to the front. It is also possible that these units, when hit, will be damaged or broken. Because these devices are usually close to the floor when patients are moved, for example, between the floors of a hospital, it is common to see that a device is broken because they hit the floor, obstructions or when entering / leaving elevators.

As a result, medical personnel should be more careful when using such devices so that such devices are not hit or damaged during transport. If a device is damaged, medical personnel should stabilize the patient, replace the device, and clean up fluids collected that have spilled. This can become even more problematic if the device is used to collect blood in a process of autotransfusion. In addition, medical personnel who must deal with the patient's undesirable anxiety that may arise, dealing with damaged or broken drainage devices is costly, laborious and time consuming. The above also applies to devices that have been cross-contaminated because they are typically replaced by medical personnel. Other drainage systems or devices have been developed since the introduction of the above-described underwater systems to address their noted disadvantages. A type of drainage device already developed, as described in U.S. Patent No. 5,300,050, uses a waterless pressure regulator as a means to control the suction pressure and a chamber filled with water to establish a seal, the patient's seal, between the fluid collection chamber and suction source. These devices, like the aforementioned underwater drainage systems, can be damaged during the transportation of patients, create an obstruction, and can be struck. Also, although these devices may include some protection for minimize cross-contamination if they are hit in the back, there is no protection if they fall forward. Another type of drainage device, such as those described in U.S. Patent Nos. 4,738,671; 4,715,856; 4,544,370; 4,747,844, includes a modulating valve to control the suction flow and, correspondingly, the suction pressure that develops, and a unidirectional valve that forms the seal between the suction source and the collection chamber (for example, the seal of the patient). In these devices the collection chamber is placed under the mechanisms to regulate the flow of suction and pressure, the mechanism to establish the patient's seal, flow meters and internal drainage and suction lines. These units are complex and involve a large number of parts. Also, due to direct communication between the seal valve and the collection chamber, the seal valve may come into contact with the collected fluid if the device spills. These devices, like those described, create an obstruction, can be damaged during the transportation of patients and can be hit. Even another type of device as shown in U.S. Patent No. 4,605,400, uses a plurality of unidirectional valves to control the suction pressure and one, or two unidirectional valves in series, as a unidirectional seal between the suction source and the collection chamber. The collection chamber is located below other control parts of the device. A siphon is provided between the seal valve (s) and the collection chamber to collect any liquids inadvertently withdrawn through the suction line between them. However, there is no barrier between the unidirectional seal and the suction source and the other parts of the device. Therefore, if the device is struck, the collected fluid can flow and contaminate various parts of the device. In addition, there is the potential for the collected fluid to be extracted into the suction system. As with the devices described above, this device can be damaged during the transfer of the patient and create an obstruction that can lead to the unit being hit. In sum, it is common in the prior art devices that they are hit, that they can have adverse consequences, and that they are damaged during the transfer of the patient. This creates an environment where medical staff must take extra care to avoid undue consequences. It also creates a laborious, time-consuming and expensive environment. Accordingly, there is a need for an improved device or system as well as the methods related thereto to remove gases and liquids from patients when the suction pressure control and the seal of the collection chamber do not involve the use of liquids. . In addition, there is a need for an improved mechanism for venting the collection chamber that is more resistant to cross contamination than the devices and systems of the prior art. Additionally, there is a need that they are compact in size and are resistant to overturning compared to prior art devices.

BRIEF DESCRIPTION OF THE INVENTION The present invention presents a novel device for draining gases and / or liquids from a body cavity of a patient. Draining the liquid, blood and / or gas from the body cavity is achieved by establishing a pressure differential between the device and the body cavity to be drained. Various aspects or characteristics of the draining device of the present invention provide a number of benefits compared to prior art devices. In particular, these features produce a device that is compact compared to the devices of the prior art and that is more resistant to being overturned compared to the devices of the current art. This reduces the likelihood of device damage during the patient's movement and also makes it less uncomfortable for the use of medical personnel (eg, minimizes the potential for clogging). These features also reduce or minimize the potential for cross-contamination within the device if it is inadvertently hit on its back or front. Other features provide additional safety, providing multiple indications of the suction pressure that is being developing on the device, and producing a device hanger that can be easily adjusted to suit a given support arrangement. In a first aspect, a device according to the present invention includes a novel ventilation or flow path arrangement interposed between a collection chamber, in which fluid (for example blood) accumulates and a unidirectional valve that forms the seal of the patient The flow path is positioned to prevent fluids accumulating in the collection chamber from communicating upstream to other parts of the device in the event that the device falls forward or backward. In particular embodiments, the ventilation arrangement includes an intermediate chamber positioned close to the rear of the device and at least two passage flows. A passage flow is fluidly coupled to the intermediate chamber and the collection chamber and another flow passage that fluidly couples the intermediate chamber to the flow path that goes toward the patient's seal. In a preferred embodiment, two separate flow passages fluidly couple the intermediate chambers and the collection chamber. These flow passages are also positioned to be essentially perpendicular to the front surface of the device, in a type of front-to-back relationship. The intermediate chamber is configured with two compartments that are fluidly coupled by means of an opening staggered between them forming a stepped surface. Each flow passage of the collection chamber forms an opening in a surface of a compartment and the flow passage to / from the patient's seal ventilation path forms an opening in one surface of the other compartments. The surface having the opening of the flow passage of the collection chamber is configured so that it is smaller than the surface of the other compartment, when the device is on its front or face. An opening is provided in each flow passage of collection chamber that is in fluid communication with the collection chamber opening is preferably positioned so that it is located above the maximum height of the fluid accumulated in the collection chamber, when the device It's on its back. Correspondingly, the length of each collection chamber flow passage and the height of the step, in the stepped intermediate chamber surface, are set so that the high point of the stepped surface is located above the fluid level in the chamber. Collection camera when the device is on your forehead or face. In this way, the fluid accumulated from the collection chamber is not in cross communication upstream with other parts of the device, if the device is inadvertently hit on its front or back. In a second aspect, a device of the present invention includes at least two chambers, a pressure regulation chamber and a collection chamber that are interconnected in Fluid form for a unidirectional valve that represents the patient seal. The unidirectional valve allows the flow of gases from the collection chamber to the pressure regulation chamber and blocks the flow of gases from the pressure regulation chamber to the collection chamber. The collection chamber also includes a port in fluid communication with the region to be drained. The pressure regulation chamber includes two ports, both positioned upstream from the unidirectional valve, where one port is fluidly interconnected to a source of negative pressure (i.e., a suction source) and the other port is open to the atmosphere. The draining device further includes a pressure control mechanism that selectively adjusts the negative pressure that is applied to the collection chamber and maintains the negative pressure that is applied at or around the selected value. In particular modalities, the suction pressure control mechanism includes a suction pressure control valve which is a spring loaded and operated valve positioned between the atmospheric and suction source ports. The spring is biased or loaded (eg tensioned) to any of a number of predetermined values, each value that is representative of a suction or negative pressure that is applied to the collection chamber. The spring also bypasses the valve to be in a closed position until the suction source pressure exceeds the selected applied suction pressure, in which point the suction pressure control valve opens to maintain the suction pressure applied at the selected value. In a preferred embodiment, the unidirectional valve that fluidly interconnects the pressure regulating chamber and the collection chamber is a precision vane-type check valve. Such a check valve opens at relatively low differential pressures and operates completely independent of any fluid present in the collection chamber. In a particular embodiment, the check valve opens at a pressure differential of approximately 0.5 cm H2O.

More particularly, the check valve includes a disk-shaped elastic valve member mounted along the flow path of the valve to allow flow in only one direction. The disc is normally held in a plate shape, with the plate disc being deflected towards and against the valve inlet to normally deflect the valve in a closed configuration. The operating characteristics of the valve, such as the opening pressure and the minimum flow velocity, are adjustable by means of a disk assembly. The valve also includes an outlet that minimizes back pressure to allow the valve to respond quickly even at low pressure differentials. In this way, a dry pressure seal is established between the pressure regulating chamber, the suction chamber and the collection chamber, which also allows the gases to be drained from a patient to be ventilated towards the patient. source of suction while preventing gases from flowing into the collection chamber and correspondingly within the patient. The waterless suction pressure control mechanism and unidirectional valve cooperate so that high differential suction pressures and a patient seal can be established in a highly compact and rugged device. The compact feature results in a device less prone to being damaged during patient transfer. The compact feature of the shape also produces a device less susceptible to being knocked over or overturned while in use (for example, when placed on the floor under a patient's bed). In a third aspect, a device of the present invention further includes an air escape measuring chamber interposed fluidly between the unidirectional valve and the collection chamber. The air exhaust metering chamber includes a cavity filled with fluid and media, which responds to gases flowing from the collection chamber to the suction source, which provides a relative indication of the flow velocity of the flowing gases. In a particular embodiment, the indicating means includes a downward inclined member having a plurality of spaced holes. The sliding member is in fluid communication with the collection chamber so that gases flowing into the collection chamber can also flow through the orifices.

The holes and the downwardly inclined member cooperate so that the gas flowing through each orifice is representative of a relative exhaust velocity. The inclined member also includes a plurality of vertical partitions separating each of the spaced holes. The entries provide a mechanism for clearly identifying the orifices through which the gas is flowing and correspondingly an indication of the relative flow velocity. Preferably, the front panel of the device includes a transparent window for viewing the inclined member and the vertical partitions. In a fourth aspect, a device of the present invention includes a negative pressure indicator for detecting the negative pressure that is developing in the collection chamber. The negative pressure indicator includes a message station or board covered by a flexible membrane. The interior of the flexible membrane is fluidly coupled to the collection chamber to respond to pressure changes in the collection chamber. So, when a negative pressure is established in the collection chamber, the flexible membrane is folded around the board or message post. When this occurs, the message and / or symbol on the message board becomes visible. A separate indication of the collection chamber pressure can identify potential problems not otherwise indicated by a suction pressure gauge.

A fifth aspect of the invention features a novel hanger rotatably secured to the sides of the device so that the device can be hung from the side rails of a hospital bed or other support mechanisms or structures (for example wheelchairs). Each hanger includes a hook-shaped joint member having a point of flexure around which the hanger attachment member can flex. The medical personnel, for example the nurse, can make local adjustments, for example from side to side, to the hook-shaped joint member so that it can accommodate variations in the support mechanism. However, a union for a support mechanism is not required because the device is also configured to be self-sustaining. In addition, the shape of the device and the relative dimensions were set to reduce the center of gravity compared to drainage devices of the prior art so that the resistance of the device to roll over is improved. In a sixth aspect of the present invention, the device is configured to continuously collect the patient's blood and re-pour the collected blood back into the patient. More particularly, the collection chamber is configured to filter the blood and collect the filtered blood in a portion of the chamber. In addition, the portion of the chamber in which the blood is being collected includes inferior surfaces inclined to create a collector in which a drainage port is located. This device is connected to a patient as described below so that the blood can be reintroduced into the patient. There is also presented an autotransfusion drainage system using the drainage device described above, a joint interface member and an external bag having a support structure. The interface member is configured to engage releasable with connections or assemblies in the device and the structure of the outer bag. Alternatively, the outer bag can be configured to releasably couple the connections or assemblies of the device. The outer bag also includes two ports / lines that communicate with the inside of the bag. One of the ports is connected to the drainage line from the patient's body cavity and the second port is connected to the drain port of the device. In this way, the discharge of fluid from the patient is collected in the external bag. The external bag also includes a connection used for a drip line I .V. or an infusion pump I .V. so that a patient can be infiltrated with the blood collected in the external bag. The system further includes a filter means that is preferably positioned so that blood that is drained from the patient is filtered before being collected in the external bag. Alternatively, the blood is collected and then filtered before being introduced to the patient. In another modality more, The blood that is collected is filtered before collection and before transfusion to the patient. Similarly, the modality of the aforementioned alternative device can be configured with a filter means so that the blood is filtered before collection, before transfusion or both. The present invention also presents the methods related to the use of the devices and systems described above including use in postoperative environments.

DEFINITIONS The present invention is more fully understood with reference to the following definitions: Autotransfusion should be understood as the collection and infusion of the patient's blood collected back into the patient.

BRIEF DESCRIPTION OF THE DRAWING For a more complete understanding of the nature of the invention and the desired objects of the present invention, reference is made to the following detailed description taken in conjunction with the accompanying drawings in which like reference numerals denote corresponding parts through the different views and where: Fig. 1 is an axionometric view of a draining device of the present invention; Fig. 2 is a top view of the device of Fig. 1; Fig. 3 is a cross-sectional front view of the drainage device taken along section line 3-3 'of Fig. 2; Fig. 4A is a side view of the device of Fig. 1 with the hangers removed; FIG. 4B is a front elongated view of the device hanger connection of FIG. 4A; Fig. 4C is a cross-sectional side view of the hanger joint of the device of Fig. 4B; Fig. 5A is section 5-5 'of Fig. 3; Figs. 5B-D are different views of the air flow meter; Fig. 6 is section 6-6 'of Fig. 3; Fig. 7 is section 7-7 'of Fig. 6; Fig. 8 is a cross-sectional side view of a high pressure negativity release valve; Fig. 9 is an elevation view taken along line 9-9 'of Fig. 3 with the front panel in the body portion; Fig. 10 is an elevation view of the rear part of the device with the cover over the intermediate chamber removed; Fig. 11 is an elevation view in cross section of the intermediate chamber, with the cover, when taken along the section line 1 1 - 1 1 'of Fig. 10 with the angled members excluded for clarity; Figs. 12A-D are different views of a device hanger according to the present invention; Fig. 12E is a cross-sectional view of the hanger hub taken along the section line of Fig. 12B. Fig. 12F is a cross-sectional view of the hanger hub taken along the section line in Fig. 12E; Fig. 12G is a cross-sectional view of the hanger attachment member taken along the section line in Fig. 12C; Fig. 13A is a cross-sectional front view of an alternative drainage device embodiment; Fig. 13B is a side view with a partial and cross sectional view of the draining device of Fig. 13A; FIG. 13C is an elevation view in partial cross section of the device of FIG. 13B taken through the drain ports of the patient; Fig. 13D is an elevation view in partial cross section of an alternative embodiment of the device of Fig. 13; and Figs. 14A-B are schematic views in accordance with the present invention. Figs. 15A-E are different views of the interface member of FIGS. 14A-14B.

DESCRIPTION OF THE PREFERRED MODALITY Referring now to the different figures in which similar reference numbers refer to similar parts, it is shown in Figs. 1-3 and Fig. 4A a drainage device 10 that can be used to drain gases and liquids from the body cavity of a patient (not shown). In one arrangement, the drainage device is hung from a support, such as the side rail 2 of a hospital chamber, by means of two hangers 200 rotatably attached to the sides 18 of the device housing 12. The drainage device housing 12 is also formed so that the device 10 is self-supporting or self-stable without the need for means to increase the footprint of the device to improve the overturning moment of the device. In an illustrative embodiment, a device 10 according to the present invention includes a length or width of approximately 30.48 cm, and a depth of approximately 10.16 cm, and a height of approximately 25.4 cm. The result is a drainage device 10 that is smaller and less bulky than drainage devices of the prior art although they may contain approximately 2 liters (2000 cubic centimeters) of liquid.

In use, the drain line 6 from the patient is connected to the patient port 26 of the device housing 12 and the thoracic catheter of the patient. The suction line 4 from the negative pressure source, the suction source is connected to the suction port 24. The drainage and suction lines 4, 6 are flexible medical grade plastic tubes as are known in the art. The suction and patient ports 24, 26 are commonly about 0.95 cm in diameter and are located in the device housing 12 so that the suction port is in fluid communication with the suction pressure regulating chamber 46 of the device 10 and so that the port of the patient is in fluid communication with the collection chamber 50. A high negativity release valve 30 is placed on the wall or surface defining the upper part 16 of the housing 12 and is in fluid communication with the collection chamber 50. The negativity can release valve 30 includes a push-button valve which, when depressed, allows filtered air to enter the collection chamber 50. In this way, high degrees Undesirable negative pressure that may occur in the body cavity and / or the collection chamber 50 can be solved. For example, conditions of high negativity in the collection chamber 50 can result from separation or uptake of the tubing from the body cavity as well as by the patient in certain circumstances.

In addition to the high negativity release valve 30, a negative high pressure release valve 34 is located in the air exhaust measuring chamber 48. The automatic release valve 34 is also positioned such that it is fluidly coupled to the atmosphere through the rear portion 17 of the device housing 12. The automatic release valve 34 is configured to limit the negative pressure to a predetermined value, and in a specific embodiment the set pressure of the valve is approximately 50 cm. H2O. The automatic release valve 34 is also configured to allow filtered air to enter the air exhaust chamber 48 when it is actuated. In an illustrative embodiment, the automatic release valve 34 is an adjustable diaphragm check valve as described in U.S. Patent No. 4,550,749 the teachings of which are incorporated herein by reference. A releasable rope ring 32 and a positive pressure relief valve 24 are also placed in the housing 12. The rope ring 321 is provided so that the required volume of liquid of a liquid, eg, sterile water solution, is provided. it can be injected into the air exhaust measuring chamber 32 by the user. The positive release valve 24 opens with the increased positive pressure in the suction pressure regulating chamber 46. For example, the patient's cough may create momentary positive high pressure conditions in the device.

Preferably, the positive release valve 24 includes an opening 52 in the upper portion of the housing 16, an angled wall 53 having an opening 54 therethrough, and a ball 55. When negative pressure conditions are established in the Suction pressure regulating chamber 46, the ball 55 is withdrawn into the sealed coupling with the wall opening 54 thereby isolating the suction pressure regulating chamber from the atmosphere. However, if a high pressure condition occurs in the suction pressure control chamber 46, the ball 55 is forced out of the sealed coupling and therefore does not block the wall opening 54. In this way, the air High pressure can escape into the atmosphere through the opening 52 in the upper part of the housing 16. The device housing 12 is a unitary housing formed from two portions, a rear portion or body portion 14a and a front panel 14b. The body portion 14a is preferably molded using a light colored opaque plastic material and constructed with a number of generally extending walls, posts and other similar structures 14b to define a plurality of chambers, ribs, compartments and elements of support. The front panel 14b is formed from a transparent sheet of plastic material having a substantially uniform thickness. The front panel 14b and the body portion are preferably assembled to form the housing 12 by means of linear vibration welding.

As illustrated more clearly in FIG. 1, a graphic mask is printed on the front panel 14b and includes a plurality of windows, status indicators, and calibration or measurement indications, as well as other information provided by the user. Alternatively, a label or mask can be applied using any of a number of techniques known to those of skill in the art. Among the so-called windows defined by the mask, there is the suction status window 38, a window of the air exhaust meter 40 and a negative pressure indicator window 42 which are aligned on the corresponding chamber or compartment in the device 10. It is also defined a plurality of windows 44a-c, where a window is aligned with each compartment 1 16a-c of the collection chamber 50. In addition to defining the windows, the mask includes opaque regions that cover large portions of the front panel. Preferably the selected areas of the opaque portions include the marks provided for the calibration or measurement activities. For example, markings are provided together with each window 44a-c that correspond to a collection chamber compartment so that a user can easily and quickly determine the amount of fluid that has been collected (i.e., a total actuation of the amount of the collected fluid). The markings provided for the air exhaust gauge window 40 also preferably include a fill line to indicate the Level of water suitable for monitoring air leaks. As described hereinbefore, the marks representative of the desired suction pressure to be applied are provided close to the dry suction control knob 36. As indicated above, the walls, cost and internal partitions to the housing of 12 define three internal chambers: a suction pressure regulating chamber 46, an air exhaust measuring chamber 48 and a collection chamber 50. As shown in FIG. 3 and Figs. 6-7, the suction pressure regulating chamber 46 includes a number of walls and partitions defining a first compartment 56 and a second compartment 58. The upper end of the first compartment 56 has an opening 22 communicating with the atmosphere and the second compartment 58 is fluidly coupled with the suction port 24. Positioned in the first and second compartments 56, 58 is a pressure regulator 60, which includes a valve 62. The valve 62 is dimensioned and configured to seat against the aperture 64 in plate board 63 which separates the first and second compartments. The valve 62 is a plate-type valve that is biased in a closed position by means of a helical spring 66. The coil spring 66 is secured to one end of a rod 68 whose other end is placed inside an annular collar of the valve. rotary union 70 or coupling which is secured to the upper part of the housing 1 6. The annular collar 70 also includes a a keyway ridge which is received within a slot along an upper end of the bar 68. In this way, the bar 68 can be rotated together with the collar 70 and simultaneously move up or down to calibrate the regulator pressure 60 as described in greater detail in U.S. Patent No. 5,707,734 the teachings of which are incorporated herein by reference. The valve 62, as more clearly shown in Fig. 7, is formed at the end of a damper 72 which is secured in a slotted opening in the plate member 71 defining the lower end of the second compartment 58. The damper 72 attenuates the rapid modulation of the valve 62 that may occur during the operation of the draining device 10. Preferably, the valve 62 is formed of a material, such as a high density polyethylene, which is more collapsible than the plate member 63 that separates the two compartments 56, 58 so that the valve molds more easily to any irregularities in the plate member 63 and to ensure proper sealing of the opening 64. As shown more clearly in Fig. 6 the bar 68 includes a portion having a helical gear cooperating with a gear placed on an arrow holding the suction control knob rotatably mounted 36. Conform knob 3 6 is rotated, the gear is also rotated to cause the bar 68 to move up or down while the collar 70 it remains fixed or without rotation. In this way the tension in the spring 66 is changed. Because the tension of the spring 66 provides the force to seat the valve 62 against the plate member 63, as described above, it also changes the seating forces. The tension also corresponds to the suction pressure that is applied to the collection chamber 46 and correspondingly the body cavity of the patient to be drained. A series of detents 74 are provided along specific portions of the circumference of a portion of the control knob 36 which engages a stop arm 73 mounted to the housing 12. The detents 74 correspond to any one of a number of predetermined levels of suction or negative pressure. Therefore, in the operation a user rotates the knob 36 and engages a detent 74 corresponding to one of the suction levels indicated in the mask applied to the front panel and the tension in the spring 66 is adjusted, therefore, so that the selected suction pressure is developed. For further details regarding the construction and operation of the pressure regulator 60 of the present invention, reference should be made to U.S. Patent Nos. 5,507, 734 and 5, 300, 050, the teachings of which are incorporated herein by reference. the present by reference. The suction pressure regulating chamber 46 includes a visual indication to confirm the establishment of a condition of suction pressure in the collection chamber. Preferably, the visual indication is provided by a floating member 76 which is slidably placed in a portion of the second compartment 58. The floating member 76 is dimensioned so that it moves up against an upper stop member 75a, eg, a post , when the suction pressure develops. The floating member 76 is visible to the user through the suction pressure indicating window 38 when it is against the upper stop member 75a. As an additional aid to the user, the floating member 76 is colored in contrast to its surroundings to make it easily visible to the user. In a specific embodiment, the floating member 76 is fluorescent to make it easier to see in conditions of reduced light or night hours. When there is no suction pressure, the floating member 76 rests against the lower support member 75b. Another compartment 78 is provided in the draining device 10 in which a negative pressure indicator 80 is mounted. By means of an opening 79 in the intermediate chamber 100 (see Fig. 10), the pressure indicator 80 responds to the pressure conditions in the collection chamber. In this way, the indicator 80 can provide an indication that there is a negative pressure condition within the collection chamber 50. This indication is easily visible to the user in the negative pressure indicating window 42.

In an exemplary embodiment, the pressure indicator 80 is a message site or message board covered with a flexible material. When there is a condition of negative pressure in the collection chamber 50, the flexible material, by means of the opening 79, is folded into place and the message or symbol therein becomes visible. In case of no negative pressure, the flexible material moves away from the message site or message board so that the message or symbol is not visible. Referring to FIG. 3, a plate member 82, having an opening 83 therein for receiving one end of a unidirectional valve 84, extends between two plate members 82 in conjunction with the unidirectional valve 84 defines a limit of pressure between the suction pressure regulating chamber 46 and the air exhaust measuring chamber 48 and correspondingly the collection chamber 50. As provided below, a user can not use the air exhaust measuring chamber 48 and not introduce any water in it. As such, the plate member 82 in conjunction with the unidirectional valve 84 also defines a pressure limit between the suction pressure regulating chamber 46 and the collection chamber 50. Accordingly, and in an alternative embodiment, a drained 10 can be configured only with a suction pressure regulating chamber 46 and a collection chamber 50.

Preferably, the unidirectional valve member 84 is a high precision or diaphragm type check valve as described in U.S. Patent No. 4,715,856, 4,747,844 the teachings of which are incorporated herein by reference. Such a check valve opens at relatively low differential pressures and operates completely independently of any fluid present in the collection chamber 50 and / or in the air exhaust measuring chamber 48. In a particular embodiment, the check valve opens to a differential. pressure of approximately 0.5 cm H2O. More particularly, and as shown in Fig. 8, the check valve or unidirectional valve 84 includes a disc-shaped elastic valve member along the flow path of the valve to allow the flow only in one direction. address . The disc is normally held in a plate shape, with the plate disc that is biased towards and against the valve inlet to normally deflect the check valve in a closed configuration. The operating characteristics of the check valve, such as the opening pressure and the minimum flow velocity, are adjustable by a disc assembly. The check valve also includes an outlet that minimizes back pressure to allow it to respond quickly even at low pressure differentials. In this way, a seal without water is established between the pressure regulating chamber 46, the source of suction and collection chamber 50, which allows gases to leave the patient's body cavity to be ventilated to the suction source while preventing gas from flowing into the collection chamber and correspondingly within the patient . The draining device 10 of the present invention does not use a manometer to control the suction pressure or to establish a seal between the suction pressure regulating chamber 46 and the collection chamber 50, and correspondingly, the patient. As such, the draining device 10 of the present invention is shorter compared to the prior art devices that use such manometers for suction control or for the patient seal. This advantageously reduces the center of gravity of the draining device 10 compared to drainage devices of the prior art which in turn improves the resistance of the present invention to overturning. Also, by using a suction pressure control without water, the suction pressure can be maintained without requiring the constant attention of medical personnel. Referring now to Fig. 3 and Figs. 5A-D, at the lower end of the air exhaust measuring chamber 48 which is provided in an elongated cavity 86 in which an air exhaust meter or air flow meter 88 is placed. The air flow meter 88 measures the amount of gas or air that passes through the collection chamber 50 to the vacuum pump or vacuum source. Under normal operating conditions, the flow meter air 88 provides an indication of the amount of air or gas that is evacuated from the body cavity, e.g., a cavity of the pleura, of the patient. By monitoring the air flow meter 88, a user or clinical employee can easily determine if the flow increases or decreases. The air flow meter 88 also provides an indication of the presence of an air leak somewhere between the body cavity and the flow meter which could be hazardous to a patient's condition if left uncorrected. For example, an air leak could create conditions in the cavity of the pleura that would make it difficult for the patient to breathe, which would lead to death. The construction of an air flow meter 88 is shown in greater detail in Figs. 5A-D and 5A showing the relationship of the air flow meter with the draining device 10 of the present invention. The air flow meter 88 is provided with a rear wall 90 and a front wall 92, which includes a direct duct or passage 94 formed therein. The front wall 92 and the rear wall 90 have an interconnection portion 91 that forms the upper wall of the passage. The interconnection portion 91 includes a series of openings 96 behind each of which a plenum chamber 97 is formed which is fluidly coupled to the common passage 94. Positioned on and separating each of the openings 96 is a limb member. partition 98. The partition members 98 provide a mechanism for separating the bubbles that pass through each of the openings 96 so that the number of openings through which the gas is passing can be easily determined. The air flow meter 88 is placed in the elongated cavity 86 at a slight angle towards the horizontal. One end of the common passage 94 is fluidly coupled to a short arm 99 of the air exhaust measuring chamber 48 which is fluidly coupled to the novel ventilation path arrangement, described below, which in turn is coupled fluidly to the collection chamber 50. In this manner, the gases flowing downward in the short arm 99 will flow in the common passage 94 in one or more of the plenum chambers 97 and from there to one or more of the openings 96. Inclining the common passage 94, larger volumes of gas will flow through successive openings 96 in sequence. As such, each of the openings 96 is representative of a given gas flow. For example, the flow through the first opening would be representative of a gas flow of approximately 0 to 2 liters per minute and the flow through the last and all the openings would be representative of a gas flow exceeding 28 liters per minute. For further details regarding the air flow meter 88, reference should be made to U.S. Patent No. 3,683,913, the teachings of which are incorporated herein by reference. In use, a liquid is introduced into the air exhaust measuring chamber 48 by injecting it through the releasable rope ring 32. Preferably, a dye or coloring agent it is also provided in the elongate cavity 86 so that the fluid is easily observable to the user. Thereafter, the user monitors the air exhaust meter 88 through an air exhaust gauge window 40 in the front panel 14b to determine if gas is passing to the suction source and, if so, the flow velocity. relative. Referring now to the Fígs. 2-3 and Figs. 9-11, the draining device 10 preferably includes a novel vent path arrangement that fluidly couples the air exhaust measuring chamber 48 and correspondingly the suction pressure regulating chamber 46 to the collection chamber 50. Preferably , the ventilation path arrangement includes an intermediate chamber 100 and three passages 102, 103, 104 fluidly coupled thereto. As shown in Fig. 2 and Fig. 11, the intermediate chamber 100 is sealed with a cover member 101 to prevent the inflow of air into the collection chamber 50. The cover member 101 is preferably constructed from the same materials as the body portion 14a. A passageway, the first passageway 102 fluidly couples the air leakage measuring chamber 48 to the intermediate chamber 100 and the second and third passageway 103, 104 fluidly couples the intermediate chamber and the collection chamber 50. Those three passages 102, 103, 104 are placed essentially perpendicular to the surface of the front panel 14b so that the passages extend in a front-to-back relationship. Preferably, the body portion 14a is molded so that the ports, walls, ribs and partitions, internal to the body portion, the first, second and third passages 102, 103, 104, the intermediate chamber 100, which includes the Stepped opening 106, angled members 108a, 108b and internal partitions 107 are all formed at the same time. This minimizes the assembly time and also reduces the possibility of leakage that would be present if the intermediate chamber 100 was a separate part secured to the device housing 12. However, it is within the scope of the present invention for the housing 12 that be constructed using any of a number of techniques known to those skilled in the art. As shown in Fig. 3 and Fig. 9, the three passages 102, 103, 104 are generally rectilinear in cross section, where three sides of each passage extend and are sealed to the front panel 14b. The fourth side 1 10a, 1 10b, 1 10c, respectively of the first, second and third passage 102, 103, 104 are stepped walls separated from the front panel 14b, so as to form a through opening 1 12a, 1 12b, 1 12c for each passage. The openings 1 12b, 1 12c in the second and third passages 103, 104 create a flow path for the gases flowing out of the collection chamber 50 so that the source of suction by means of the intermediate chamber 100. The primary ventilation path from the collection chamber 50 is the third passage 104 and the secondary ventilation path is the second passage 103. During the normal operating conditions, the fluid level in the collection chamber 50 is located below the openings 112b, 112c in the second and third passages 103, 104. However, if the draining device 10 is inadvertently hit on its rear surface 17, then the level of the liquid in the collection chamber is readjust As such, the fourth sides 110b, 110c of the second and third passages 103, 104 are also spaced apart at a preset distance from the front panel 14b so that the liquid level in the collection chamber 50 should be located below the openings 112b, 112c when the device is on its rear surface. This minimizes the cross contamination potential of the air exhaust measuring chamber 48 as well as other parts of the device 10 with liquid from the collection chamber 50. This also allows the draining device to continue to operate or operate without interruption. If the draining device 10 is inadvertently struck on the front panel 14b, the level of liquid in the collection chamber will also be readjusted although the openings 112b, 112c in the second and third passages 103, 104 could be submerged below the liquid level. As such, a liquid level will rise within the second and third passages 103, 104 as the level is readjusted within the collection chamber 50. The level of fluid within the second and third passages 103, 104 will continue to rise until the liquid from the passages spills into the intermediate chamber 100 or until it stabilizes in the collection chamber 50. As illustrated in Figs. 10-1 1, the intermediate chamber 100 includes a stepped opening 106 so that an overflow condition does not immediately result in cross contamination or cross communication with the first passage 102 and the chamber 48 fluidly connected therewith. In a preferred embodiment, the length of the second and third passages 103, 104 and the height of the step in the intermediate chamber opening 106 are selected such that the amount of fluid typically accumulated in the draining device 10, before being replaced, It does not create a fluid level in the collection chamber that will result in cross-contamination. This also allows a handle 13 and the access required for a hand to be formed directly within the body portion 14a so that it does not project over the top 16. However, it is within the present invention for the length of the second. and third passages 103, 104 and / or the step height is increased or decreased to handle any amount of liquid, including the maximum volume content of the collection chamber 50. Although FIGS. 9-1 1 illustrate two flat surfaces on either side of the partitions 107 as they are separated differently from the cover member 101, this is not a limitation. In an alternative embodiment, the two flat surfaces are equidistanced from the cover member 101 and a stepped wall or partition is provided to establish the intermediate chamber stepped opening 106, for example, see the stepped partition 14 in the collection chamber 50. It is also within the scope of the present invention for the two flat surfaces that are equidistanced from the cover member 101 and there is no staggered opening therebetween, but only an opening. In this case, the lengths of the second passage 103 and the third passage 104 are selected so that the liquid rises in those passages when the device 10 is in its front panel 14b does not spill over the intermediate chamber 100. When the device drained 10 is straightened, any liquid in the third passage 104, flows into the intermediate chamber 100 and after this fluid, any fluid in the intermediate chamber and any fluid in the second passage 103 flows into the collection chamber 50 by means of of the second passage. The spatial separation of the second and third passages 103, 104 prevent siphoning of the fluid in the passages and / or the intermediate chamber 100 within the air exhaust measuring chamber 48 after the device is straightened. The intermediate chamber also includes two angled members 108a, 108b directing the fluid flowing in the intermediate chamber 100 to the second passage 103 and away from the first passage 102. For example, one of the angled members, member 108a, is angled so that the fluid exiting the third passage 104, hits the angled member and is directed outwardly from the first passage 102. As indicated above three sides of the first passage 102 extend and are sealed to the front panel 14b and the fourth side 1 10a is separated therefrom to create an opening 1 12a or flow path for gases passing through the collection chamber 50. The fourth side of the first passage 1 10a is also separated from the front panel so that the fluid, if any, in the air exhaust measuring chamber 48 is not communicated to the collection chamber 50 if the draining device 10 inadvertently falls on its rear surface 17. In addition, the short arm 99 of the chamber of Air exhaust 48 is configured to retain fluid therein. As with the second and third passages 103, 104, the opening 1 12a formed at the end of the first passage 102 could be submerged below the fluid level if the device 10 falls inside its front panel 14b. However, the volume of the short arm 99 in conjunction with the volume of the first passage 102 is set so that the volume of fluid used for exhaust detection and monitoring is not spilled and mixed with the fluids in the collection chamber 50. It is It is possible that a patient or user can create a condition of high negative pressure inside the collection chamber 50, which in turn siphons the fluid out of the cavity 86 in the exhaust measuring chamber 48 and upwards in the short arm 99 from the same. One of the partitions 107 defining the stepped opening 106 in the intermediate chamber 100 and an angled member 108b establishes a compartment 109 in the intermediate chamber that can receive the fluid from the air exhaust measuring chamber 48. The fluid is retained in this chamber. compartment 109 and is not communicated by way of the intermediate chamber 100 and the second passage 103 to the collection chamber 50. When the high negative pressure condition is removed, for example by a user operating the manual negative high pressure valve 30. , the fluid is returned by gravity to the air exhaust measuring chamber 48. The long arm 95 of the air exhaust measuring chamber 48 also includes a stepped wall member 87 extending between two side walls to form a barrier. This barrier is provided primarily to prevent the fluid or bubbling fluid from contacting the unidirectional valve 84 and the automatic high negativity release valve 34 while still providing a flow path for the gases. The collection chamber 50 includes two partitions 1 14, 1 15 defining three compartments 1 16a-c. The first compartment 1 16a communicates with the drainage line port 26 and receives the gas and liquid discharges from the drainage line 6. Each partition 1 14, 1 15 includes an opening 118 so that the gas discharges are communicated by means of of the first, second and third passages 102, 103, 104 towards the suction source.

Each opening 1 18 also provides a mechanism for directing liquids over the next compartment after the upstream compartment has been filled. Each opening 1 18 is also staggered or spaced a predetermined distance from the front panel 14b according to a mechanism for limiting the flow of liquids between the compartments 1 16a, 1 16b, 1 16c when the draining device 10 is on its rear surface 17. As indicated above, a window 44a, 44b, 44c is provided for each of the compartments 1 16a, 1 16b, 1 16c so that a user can easily determine the amount of fluid that has accumulated in a given compartment as well as in the collection chamber 50. Such information may be used to determine the presence of, for example, a problem or subsequent operational condition. The housing 12 can also be configured with resealable inner rings, for example as the inner ring 32 for introducing the fluid into the air exhaust measuring chamber 48, which communicates with the compartments 1 16a, 1 16b, 1 16c. This allows a user to insert a needle into any one of the compartments for the purposes of obtaining a sample of the fluid that is accumulated for analysis. As shown in Fig. 2 and Figs. 4A-C a hanger joint 120 or assembly is provided on each side 18 of the housing 12 to which a hanger 200 is rotatably secured as shown in Figs. 12A-G. Each hanger joint 120 includes two flexible arched arms 122 about a common axis that each Subscribe a portion of a circumference. Also included is a central portion 124 that provides a radial support area for the hanger for a portion of the circumference not subtended by the flexible arms. As seen more clearly in Fig. 4C, the front edge of the front portion 124 is positioned behind the front edge of the flexible arms 122. This allows the flexible arms 122 to flex into the common axis around the point of attachment to the housing 12 and so that the hub 200 can be rotatably secured therein. Each flexible arm 122 includes an inclined nozzle 126 and a recess 128. In use, the hanger hub 202 is pushed axially against the inclined nozzle 126 so that the raised region 206 in the opening 208 in the hub 202 contacts the inclined nozzle. The sliding coupling of the raised region of hub 206 and the inclined nozzle 126 as the hub moves axially causes each flexible arm 122 to flex. When the raised region of the hub 206 moves within the recess 128 of a flexible arm 122, the flexible arm is snap-fitted and the leading edge of the recess engages the raised region of the hub 206, thereby securing the hanger 200 to the hanger joint 120. Such an arrangement allows a single hanger style 200 to be mounted to the hanger joint 120 on either the right or left side of the device housing 12. The central hanger attachment portion 124 preferably includes an inclined nozzle 130 and a recess 132 for Fitting retainers provided on legs extending axially from a lid. In use the axially extending legs are inserted in the area 134 between the flexible arms 122 and the central portion 124 until the leg retainers of the lid engage the leading edge of the center portion recess 132. The lid has a shape generally circular and sized to cover at least the interior of the region exposed to the hanger hub 202. More particularly, the outer diameter of the lid corresponds to the external diameter of the hanger hub 202. As shown in Figs. 12A-G, each hanger 200 of the present invention is configured with a junction member 204 extending from the hub 202 and can be used to attach or hang the device 10 from a support structure such as the side rail of a bed. hospital, a pole I .V. , a wheelchair or the side rails of a "gurney". The hanger attachment member 204 is formed as an integral structure with an angled region 210, a straight region 212 and a hook region 214, wherein the angled region 210 interconnects the hanger attachment member 204 and the hub 202. Preferably , the hanger attachment member 204 is formed together with the hub 202, from plastic material such as ABS, so that the hanger 200 is an integral structure.

In an illustrative mode, the straight and hook regions 212, 214 are formed with raised members 216 or webs extending outwardly from faces 218 on each side, as illustrated in Fig. 12C, to form a beam-like structure.

I. The ends 220 of the raised members 216 are also preferably interconnected by an arcuate section traversing each face 218. It should be recognized that any of a number of techniques or structures may be used to produce a joining member 204 having the desired stiffness and shape for the intended use. In use, it is typically necessary to flex the hanger attachment member 204 to mold the space available in the support structure. As such, the angled region 210 preferably includes a point of flexure 222 around which the hanger attachment member 204 can be reasonably flexed without structural failure. Likewise, hanger attachment member 204 can be flexed about the flexure point 222 without adjusting the hanger 200 outside the housing joint 120. In the illustrated embodiment, the flexure point 222 is established by stopping the raised members 216 on both sides 218 in the same area in the angled region 1 10. The spacing of the raised members 216 to create a bending point 222 depends on a number of factors such as the thickness and width and the materials used for the member of base (ie, the member without elevated region), the forces that can be applied during the intended use and manufacturing limitations. In a particular embodiment, the flexure point 222 was established by providing a straight length of approximately 0.520 cm along an edge of a plastic member of 0.317 cm by 0.793 cm without the raised members 216 (ie, the surface is flat). In addition, the arcuate region portions of the raised members traversing the faces 218 are about 0.317 cm apart. In some cases, the fluid that is drained from a body cavity is essentially the patient's blood, which may include some products, such as bone fragments or clots that can easily leak. Given the current concern with diseases communicated by blood transfusions as well as the rarity of some types of blood, it is advantageous to be able to drain, collect and reintroduce a patient's own blood (ie, autotransfusion). In Fig. 13A a cross-sectional front view of an alternate draining device 10 'is shown which can continuously collect and filter the blood from a body cavity and provide a continuous output to a device or apparatus such as an I.V. infusion pump. (not shown) to reinfiltrate the patient with his own blood. The figures and description above for the pressure regulation chamber 46, the suction pressure measuring chamber 48 and the improved ventilation path arrangement as well as other characteristics of the aforementioned drainage device 10, can be applied in the same way to the corresponding characteristics of the modality of the alternate draining device 10 '. As such, they are not specifically described herein.

As shown in Fig. 13A, the wall and the internal partitions to the device housing 12 'are positioned so that the collection chamber 350 includes three compartments 30, 302, 304 and a filter element 306. The first compartment is fluidly coupled to the two patient line ports 326a, 326b, to receive the blood to be filtered. It is not common to see a patient with two or more postoperative drainage lines. As such, in the present embodiment the device 10i includes two drain ports 326a, 326b so that an individual device can be used for multiple drain line applications. Alternatively, a device 10 'may be configured with a single drain port 326 as shown in Fig. 13D. The first compartment 300 is also configured so that blood flows into the second compartment by means of a filter element 306. In an illustrative embodiment, the filter element 306 includes a filter medium of 200 micron mesh 308 which is welded ultrasonically to a filter shelf v 310. The filter medium 308 can be any of a number of mesh sizes that can filter bone fragments, blood clots, tissue and the like while allowing gases and red blood cells the blood flows unimpeded through it. Although a filter means 308 is illustrated, the filter element can be any of a number of filter media known to those skilled in the art such as a flat filter medium. The filter shelf 310 is slid on two side brackets 312 until it contacts and engages a rear shelf bracket 314. The rear shelf bracket 314 is preferably tilted forward so as to direct any blood from the second port of the shelf. Drain line 326b towards filter medium 308. Coupling of filter shelf 310 with side brackets 312, rear bracket 314 and front panel 14b establishes first compartment 300. Second compartment 302 is designed to create a collector 316 which is in fluid communication with the outlet port 318. The inclined surfaces, as seen in Figs. 13A, B are generally inclined from side to side and from front to back to direct blood to the exit port 318. The collector 316 is generally configured to ensure that the exit port 318 is submerged while supplying the blood in the line of exit 8 for reinfiltración. The reinfiltration line 8 is a PVC tube which is inclined within the annular ring 320 at the outlet port 306. The reinfiltration line 8 also preferably includes a tip port 9 to facilitate the connection of the line 8 to the dispensing device. The third compartment 304 essentially corresponds to the third compartment 1 16c described above and shown in Fig. 3. In the present embodiment, the third compartment 304 is configured to handle overflows that can occur due to a blockage in the lines of exit or other situations that can develop when the blood is not re-infiltrated at the same speed that is collected. Although the embodiment illustrated shows the third compartment 304 that is not in fluid communication to the second compartment 302, it is also within the scope of the present invention that the second and third compartments 302, 304 are configured so as to be fluidly coupled. In the operation, a user connects the drainage line ports 326a, to the appropriate drain lines 6 from a body cavity and sets the suction pressure conditions in the collection chamber 350. After a sufficient amount of accumulation of filtered blood in the collection chamber 350, the user begins to reinfiltrate the patient's collected blood inside the patient. The collection autotransfusion process, filtering and reinfiltration continues automatically until the user finishes the process. While this process is in progress, the fluid levels in the second compartment 302 are checked periodically, for example, by means of the window with annotated marks, to determine if there is enough blood in the first compartment to continue the autotransfusion or , finish the process. However, there are several other reasons that can lead to the termination of the process. Alternatively, a system 400 including the draining device 10, an external autotransfusion bag assembly 402, and a member of interface 404 may be used for the purposes of collecting and re-filtering a patient's blood back into the patient. In this process, the blood can be filtered along with the collection of the blood, when the blood is reinfiltrated or a combination of the two. The schematic views of such an autotransfusion system in a disassembled and assembled condition are shown in Figs. 14A-b, respectively. Various views of the interface member 404 are also shown in FIGS. 15A-E. The autotransfusion bag assembly 402 includes a plastic bag 420 placed in a support structure 422, for example a type of metal wire structure. The plastic bag 420 includes a connecting tube 424 and a collection tube 426. The bag also includes a tip port, as is known in the art, for purposes of reinfiltration of the collected blood. The connecting tube 424 is fluidly connected to the drainage line port 26 of the draining device 10 and the collection tube 426 is coupled to the draining line from the patient's body cavity. Therefore, when a condition of negative pressure or suction is established in the collection chamber 50, the gas and the liquid, i.e., the blood, is drawn into the plastic bag 420. The blood remains in the plastic bag 420 and the gas, if any, passes through the connection pipe 424 and any interconnecting pipe to the collection chamber 50. Subsequently, the gas is extracted through the device 10 as described hereinabove.

The autotransfusion bag assembly 402 is mounted to the draining device 10 by means of an interface member 404. The interface member removably couples the support structure 422 of the bag assembly 402 using any of a number of methods known to those skilled in the art. experience in the technique. In an illustrative embodiment, the interface member 404 includes a plate member 412 at one end that slides behind a horizontal member of the support structure 422 and a fastening member 414 near the other end that holds another horizontal member 414 of the support structure. The interface member 404 also includes a lever-actuated member 405 at one end thereof for removably engaging the horizontal support member 136 (see Figs 2, 3, 4A) which is provided on a side 18 of the device housing 12. The lever-operated member 405 includes a retainer 406 at one end for engaging the lower surface 140 of the support member 136. A fixed member 407 is secured to the other end of the interface member for slidably engaging the lower support member 138 in the housing of device. As shown in Figs. 2, 4A, the lower support member 138 is a T-shaped projection from the side 18 of the device housing 12. The fixed member 407 is configured to slidably and removably receive this formed member.

In an exemplary embodiment, the fixed member 407 includes downwardly extending end portions 408 that are spaced apart from each other so that the fixed portion can be centered on the vertical portion of the T-shaped support member. 1 38. As an interface member 404 is slid down, the flat / horizontal portion of the T-shaped support member 38 is received in a bag 409 in the fixed member 407 and is retained in the bag. by a member 41 0 projecting over at least a portion of the bag. This projection member 41 0 may also include a notch to receive the vertical portion of the T-shaped support member. In use, a user releasably secures the autotransfusion bag assembly 400 to the interface member 404. The fixed member 407 and a lever-operated member 405 are positioned so that they can be received slidably by the corresponding support member 136., 138 of the drainage device housing 12. the bag assembly 40 is moved downward with respect to the device housing until the retainer 406 of the lever-driven member 405 engages the bottom surface 140. The user then interconnects the tubes of connection and collection 424, 426 to the drain line 6 from the body cavity and the drainage line port 26 of the device 1 0 respectively. Negative pressure or suction conditions were established within the 1 0 drainage device so blood and any gases are extracted from the body cavity and the blood is collected in the plastic bag 420. This continues until the outer bag is filled or is otherwise needed for blood re-infiltration. Subsequently, a user stops the draining device 10 and reduces the negativity in the collection chamber 50 using the high negativity release valve 30. The connection and collection tubes 424, 426 are disconnected from the drainage line of body cavity and the draining device 10. The user presses on the lever portion of the lever-operated member 405 so that it can be disconnected from the corresponding coupling receptacle 136 and the user raises the bag assembly 400 upwards to release it from the draining device. 10. The plastic bag 420 is removed from the support structure 422 and prepared for reinfiltration by inserting a microaggregate filter into the tip port, attaching an infiltration assembly thereto, evacuating the residual air from the bag, initiating the filter and the drip chamber and suspending the bag from a pole I .V. if the user wishes to continue to collect blood from the patient's body cavity, then a new autotransfusion bag assembly 400 is attached and connected to the drainage device 10 and is also connected to the patient's body cavity. The draining device 10 restores the suction conditions and the draining process is restarted. Although the features of the present invention are described herein in combination with a device having a pressure regulator and a waterless seal, this is not a limitation for the application or use of the features in other devices known to those skilled in the art. As such, it is within the scope of the present invention for the novel vent path arrangement described above to be used in combination with a device where the suction control and / or the patient seal is established using any of a number of techniques including those that use manometers. Similarly, the negative pressure and hanger indicator system described above can be used with other devices. Although a preferred embodiment of the invention has been described using specific terms, such a description is for illustrative purposes only, and it should be understood that changes and modifications may be made without departing from the spirit and scope of the following claims.

Claims (35)

1. CLAIMS 1 . A draining device comprising: at least two chambers, a pressure regulating chamber and a collection chamber, which are fluidly coupled by means of a ventilation path; wherein the ventilation path includes an intermediate chamber and at least one first and second passages, each passage that is in fluid communication with the interior of the intermediate chamber; wherein an opening is provided in the first passage, remote from the intermediate chamber, for fluidly coupling the first passage and the pressure regulating chamber, where the opening of the first passage defines a plane that is essentially parallel to a long axis of the first passage; and wherein an opening is provided in the second passage, remote from the intermediate chamber, for fluidly coupling the second passage and the collection chamber, where the opening of the second passage defines a plane that is essentially parallel to a long axis of the second passage. second passage. The drainage device of claim 1, further comprising a third passage that is separate from the first and second passages and communicating with the interior of the intermediate chamber and wherein an opening is provided in the third passage, distant of the intermediate chamber, to fluidly couple the third passage and the collection chamber, where the opening of the third passage defines a plane that is essentially parallel to a long axis of the third passage. The drainage device of claim 2, wherein the openings of the second and third passageways are positioned with respect to the collection chamber so that each opening is above the fluid level in the collection chamber when the device is in place. an upright position and when the device is located on a back surface. The drainage device of claim 3, wherein the opening of the first passage is positioned so that the fluid level in the flow path upstream of the first passage is below the opening of the first passage when the device is in place. an upright position and when the device is located on a back surface. The draining device of claim 3, wherein the long axis of each of the first, second and third passages are essentially parallel to each other. The drainage device of claim 3, wherein the first passage communicates with an opening in a first internal surface of the intermediate chamber, wherein the openings of the second and third passage communicate with openings in a second internal surface of the chamber intermediate, and wherein the first and second internal surfaces are parallel adjacent surfaces. 7. The draining device of claim 6, wherein the first and second inner surfaces are positioned so that the first surface is above the fluid level in the collection chamber when the drainage device is located on the surface. frontal . 8. The doffing device of claim 6, wherein the long axis of the first passage is perpendicular to the first inner surface thereof and wherein the long axis of each of the second and third passages is perpendicular to the second inner surface. . 9. The draining device of claim 1, wherein the pressure regulating chamber is fluidly interconnected to a port to the atmosphere and a suction line port interconnected to a suction source and wherein the device Drainage also includes: a pressure regulating valve that selectively controls the suction pressure, which develops within the pressure regulation chamber and which is applied to the collection chamber, to a selected one of a number of levels of predetermined suction pressure; wherein the pressure regulating valve includes a mechanism for bypassing the closed regulating valve when the suction pressure of the suction source is less than the predetermined predetermined suction pressure level, thus isolating the line port from the suction source. suction of the atmospheric port, and to open the valve when the suction pressure of the suction source exceeds the selected predetermined suction pressure level, whereby the atmospheric port is fluidly interconnected to the drainage line port to maintain the suction pressure that is applied at approximately the same selected predetermined suction pressure level; and wherein the pressure regulation chamber and the collection chamber are in selective fluid communication with each other by means of a unidirectional valve placed between them, when in a position the unidirectional valve isolates the regulation and collection chambers from one of the another so that the gas does not flow into the collection chamber and where, in another position the unidirectional valve places the chambers in fluid communication with each other so that the suction pressure from the pressure regulating chamber is applied to the collection chamber to cause in this way the draining of fluids from a body cavity. The drainage device of claim 9, further comprising an air leakage measuring chamber that is fluidly coupled to the collection chamber and the unidirectional valve, the air exhaust chamber that includes a flow meter that it responds to the gas flow from the collection chamber and provides an indication of a relative flow velocity of the gas flowing from the collection chamber to the pressure regulation chamber. The drainage device of claim 9, further comprising a negative pressure indicator fluidly coupled to the collection chamber so that the indicator provides an indication of the presence of negative pressure conditions within the chamber harvest. The drainage device of claim 9, further comprising a drain port fluidly coupled to the collection chamber for draining the fluid from the collection chamber. The drain device of claim 12, wherein the collection chamber is divided into first and second compartments, each compartment being fluidly coupled, wherein the draining port is fluidly coupled to the second compartment and wherein the draining device further includes: a port connected to a patient drainage line that is fluidly coupled to the first compartment; a drainage port of filter element placed in an opening between the first and second compartments for filtering the liquid that is collected and drained from the second compartment. The drainage device of claim 9, further including at least one hanger assembly in the draining device and at least one hanger, each hanger being removably and rotatably secured in the hanger assembly, in where each hanger includes a hub and a binding member secured to the hub, the joining member includes a flexure area proximate the hub so that the link member can flex at least in one direction with respect to the mounting of the hub. hanger 15. A drainage device comprising: at least two chambers, a regulation chamber and a collection chamber, and three ports, where one of the ports, the drainage line port is in fluid communication with the chamber harvest; a suction pressure regulating valve which selectively controls the suction pressure, which develops within the pressure regulating chamber and which is applied to the collection chamber, to one selected from a number of predetermined suction pressure levels; wherein the pressure regulating chamber includes two compartments that are selectively and fluidly interconnected with each other by means of the pressure regulating valve, where one of the ports, the atmospheric port, is in fluid communication with a compartment and another of the ports, the suction port, is in fluid communication with the other of the compartments of the regulation chamber and a suction source; wherein the pressure regulating valve includes a mechanism for bypassing the closed regulating valve when the suction pressure of the suction source is less than the selected predetermined suction pressure level, thus isolating the suction port port of the atmospheric port, and to open the valve when the suction pressure of the suction source exceeds the selected predetermined suction pressure level, whereby the atmospheric port is fluidly connected to the second compartment to maintain the suction pressure that is applied at approximately the selected predetermined suction pressure level; and wherein the pressure regulation chamber and the collection chamber are in selective fluid communication with each other by means of a unidirectional valve placed between them, where in a position the unidirectional valve isolates the regulation and collection chambers from one another so that the gas does not flow into the collection chamber and where, in another position, the unidirectional valve places the chambers in fluid communication with each other so that the suction pressure from the pressure regulating chamber is applied to the collection chamber to cause in this way the draining of fluids from a body cavity. The drainage device of claim 15, further comprising an air leakage measuring chamber that is fluidly coupled to the collection chamber and the unidirectional valve, the air exhaust chamber that includes a flow meter that responds to the flow of gas from the collection chamber and which provides an indication of a relative flow velocity of the gas flowing from the collection chamber to the pressure regulating chamber. The drainage device of claim 16, wherein the air flow meter includes a downwardly sloping member having a passage therethrough and a plurality of openings communicating with the passageway, wherein the member is biased towards the passageway. down cooperates with the openings so that the gas from the collection chamber flows through successively lower openings as the flow velocity of the gas from the collection chamber increases. The drainage device of claim 15, further comprising a negative pressure indicator fluidly coupled to the collection chamber so that the indicator provides an indication of the presence of negative pressure conditions within the collection chamber . The drainage device of claim 18, wherein the negative pressure indicator includes a message station enclosed by a flexible membrane, wherein the interior of the flexible membrane is fluidly coupled to the collection chamber so that the Flexible material is folded over the message post and the message in it becomes visible. 20. The drainage device of claim 15, further comprising a drainage port fluidly coupled to the collection chamber to drain the fluid from the collection chamber. twenty-one . The draining device of claim 20, wherein the collection chamber is divided into at least first and second compartments, each compartment being fluidly coupled, wherein the draining port is fluidly coupled to the second compartment and wherein the draining device further includes: a port connected to a patient drain line that is fluidly coupled to the first compartment; a drain port of filter element placed in an opening between the first and second compartments for filtering the collected liquid and draining it from the second compartment. 22. The draining device of claim 15, further including at least one hanger assembly in the draining device and at least one hanger, each hanger being removably and rotatably secured in the hanger assembly, wherein each hanger includes a hanger. hub and a binding member secured to the hub, the connecting member including a flex area proximate the hub so that the link member can be flexed at least in one direction with respect to the hanger assembly. 23. A hanger system for a drainage device comprising at least one hanger assembly in the device and at least one hanger, each hanger being removable and rotatably secured in the hanger assembly, wherein each hanger includes a hub and a tie member secured to the hub, the tie member including a flex area proximate the hub so that the link member can flex around the hub. flexure point in at least one direction with respect to the hanger assembly. The hanger system of claim 23, wherein the flexure area comprises a reduced stiffness area along an axis, wherein the axis is parallel to a long axis of the hanger assembly extending outwardly from the device . The hanger system of claim 23, wherein the joining member on each side of the flexing area includes a projection running along the edge of two opposite faces of the joining member to form a beam-like structure I. 26. An autotransfusion system comprising a drainage device and a bag assembly removably secured thereto, wherein the draining device includes: at least two chambers a regulating chamber and a collection chamber, and three ports, where one of the ports, the drainage line port is in fluid communication with the collection chamber; a suction pressure regulating valve that selectively controls the suction pressure, which develops inside the pressure regulation chamber and which is applied to the chamber collection, to one selected from a number of predetermined suction pressure levels; wherein the pressure regulating chamber includes two compartments that are selectively and fluidly interconnected with each other by means of the pressure regulating valve, where one of the ports, the atmospheric port, is in fluid communication with a compartment and another of the ports, the suction port, is in fluid communication with the other of the compartments of the regulation chamber and a suction source; wherein the pressure regulating valve includes a mechanism for bypassing the closed regulating valve when the suction pressure of the suction source is less than the selected predetermined suction pressure level, thus isolating the suction line port of the atmospheric port, and to open the valve when the suction pressure of the suction source exceeds the selected predetermined suction pressure level, so that the atmospheric port is interconnected fluidly to the second compartment to maintain the suction pressure that applies to approximately the selected predetermined suction pressure level; and wherein the pressure regulating chamber and the collection chamber are in selective fluid communication with each other by means of a unidirectional valve placed between them, where in one position the unidirectional valve isolates the chambers of regulation and collection one from the other so that the gas does not flow into the collection chamber and where, in another position, the unidirectional valve places the chambers in fluid communication with each other so that the suction pressure from the chamber Pressure regulation is applied to the collection chamber to thereby cause the draining of fluids from a body cavity to the bag assembly. 27. The autotransfusion system of claim 26, wherein the draining device further includes: a venting path that fluidly couples the collection chamber and the unidirectional valve; wherein the ventilation path includes an intermediate chamber and at least one first and second passages, each passage that is in fluid communication with the interior of the intermediate chamber; wherein an opening is provided in the first passage, remote from the intermediate chamber, for fluidly coupling the first passage and the unidirectional valve, where the opening of the first passage defines a plane that is essentially parallel to a long axis of the first passage; and wherein an opening is provided in the second passage, remote from the intermediate chamber, for fluidly coupling the second passage and the collection chamber, where the opening of the second passage defines a plane that is essentially parallel to a long axis of the second passage. second passage. 28. The autotransfusion system of claim 27, further comprising a third passage that is separate from the first and second passages and communicating with the interior of the intermediate chamber and wherein an opening is provided in the third passage, distant from the intermediate chamber , to fluidly couple the third passage and the collection chamber, where the opening of the third passage defines a plane that is essentially parallel to a long axis of the third passage. 29. The autotransfusion system of claim 28, wherein the second and third passage openings are positioned with respect to the collection chamber so that each opening is above the fluid level in the collection chamber when the device is in place. an upright position and when the device is located on a back surface. 30. The autotransfusion system of claim 29, wherein the first passage opening is positioned such that the fluid level in the flow path upstream of the first passage is below the first passage opening when the device is in place. an upright position and when the device is located on a back surface. 31. The autotransfusion system of claim 29, wherein the first passage communicates with a first opening in a first internal surface of the intermediate chamber and wherein the openings of the second and third passages communicate with openings in the intermediate chamber, wherein the first and second surfaces internal ones are parallel adjacent surfaces, and wherein the first internal surface is on the second internal surface when the draining device is located on a front surface. 32. The autotransfusion system of claim 31, wherein the first and second internal surfaces are positioned such that the first surface is above the fluid level in the collection chamber when the draining device is located on the front surface. 33. The autotransfusion system of claim 26, wherein the draining device further includes at least one hanger assembly positioned on the draining device and at least one hanger, each hanger being removably and rotatably secured in the assembly. of hanger, wherein each hanger includes a hub and a binding member secured to the hub, the joining member including a flex area proximate the hub so that the link member can flex in at least one direction with regarding the hanger assembly. 34. The draining device of claim 6, wherein the first internal surface is on the second internal surface when the draining device is located on a front surface. 35. The drainage device of claim 6, wherein a stepped wall is positioned between the first internal surface and the second internal surface and wherein the stepped wall projects onto the internal surfaces so that The upper part of the wall is above the fluid level in the collection chamber when the drainage device is located on the front surface. SUMMARY A device for draining fluids and / or gas from body cavities is provided, including at least one pressure control chamber and a collection chamber that is fluidly coupled by a unidirectional valve thereby establishing a seal without water between the collection chamber, including the patient and the source of suction. The pressure control chamber also includes a waterless suction pressure control regulator that controls and maintains the suction pressure in or around a selected valve. Preferably, the regulator includes a spring operated valve. The device also includes a ventilation path that has an intermediate chamber and at least two passages that are perpendicular to two adjacent surfaces within the intermediate chamber. The two passages and the intermediate chamber are positioned so that the liquid in the collection chamber does not flow and contaminates the portions upstream of the device when the device is supported on its front or rear side. There is also an autotransfusion system that includes a drainage device and a bag assembly attached thereto. The device and the bag assembly are fluidly coupled so that the differential pressure established by the device causes blood from the patient to drain into the bag assembly. In an alternate mode, the drainage device is configured to collect continuously and filter the blood of a patient and continuously gives it out to reinfiltrate it back into the patient.