Patent Application
20070219535
The present invention relates generally to medical devices. More particularly, the present invention relates to chest drainage units having blood collection chambers and suction and control elements for drawing fluids from a body.
Chest drainage devices and systems and more particularly suction drainage systems and devices for removing gases and/or liquids from medical patients, such as from the pleural cavity, by means of a pressure differential, are well known in the art. For many years, the standard apparatus for performing the evacuation of the pleural cavity was a drainage system known as the “3-bottle set-up” which includes a collection bottle, a water seal bottle, and a suction control bottle. A catheter runs from the patient's pleural cavity to the collection bottle, and the suction bottle is connected by a tube to a suction source. The three bottles are connected in series by various tubes to apply suction to the pleural cavity to withdraw fluid and air and thereafter discharge the same into the collection bottle. Gases entering the collection bottle bubble through water in the water seal bottle. The water in the water seal also usually prevents the back flow of air into the chest cavity. Suction or “negative” pressure is usually provided by a central vacuum supply in a hospital so as to permit withdrawal of fluids such as blood, water and gas from a patient's pleural cavity by establishing a pressure differential between the suction source and the internal pressure in the patient.
The 3-bottle set-up lost favor with the introduction of an underwater seal drainage system first sold under the name “Pleur-evac”® in 1966 by Deknatel Inc. U.S. Pat. Nos. 3,363,626; 3,363,627; 3,559,647; 3,683,913; 3,782,497; 4,258,824; and U.S. Pat. No. Re. 29,877 are directed to various aspects of the Pleur-evac® system, which over the years has provided improvements that eliminated various shortcomings of the 3-bottle set-up. These improvements have included the elimination of variations in the 3-bottle set-up that existed between different manufacturers, hospitals and hospital laboratories. A principal feature of the Pleur-evac® system is the use of a single, unitary, pre-formed, self-contained unit that embodies the 3-bottle techniques. Each unit generally includes a collection chamber for collecting body fluids drained from the pleural cavity of a patient. Such fluids can contain liquids such as blood or water. These liquids are meant to remain inside the collection chamber while a suction flow of gases travels from the collection chamber throughout the rest of the device and out through an attached suction line.
A common problem in known chest drainage devices occurs when the device is tipped over, causing fluids collected in the collection chamber to leak into the rest of the flow passageways in the device. This can occur fairly often when the unit is placed on the floor of a surgical room and similar such situations. The unit commonly also includes a water seal element as is well known in the art. When the unit is tipped over the fluids in the collection chamber and water seal chamber can mix, therein hampering further proper use of the device.
It is desirable therefore to provide for a way of preventing the spilling of collected fluids into other parts of a chest drainage device when such a device is tipped over. It is further desirable to maintain a proper flow passageway between various flow chambers inside a chest drainage device, while preventing the intermixing and flow of undesirable liquids such as water or blood, while allowing for the passage of suction gas flows and the transmission of suction pressures.
In accordance with one embodiment of the present invention, an anti-spillover flow coupling is provided for a chest drainage assembly having an upright axis through an upright plane of orientation for the assembly. The assembly defines at least a first and a second flow chamber. The anti-spillover flow coupling includes an intake port adapted to couple to the first flow chamber and an exit port adapted to couple to the second flow chamber. The anti-spillover flow coupling includes a valve axis aligned in the direction of the upright axis of the chest drainage assembly when said intake port and exit port are coupled to the chest drainage assembly. A valve element is disposed in an interior space of the flow coupling between the intake port and exit port. The valve element has a ball member and defines a valve seat disposed above the ball member along the valve axis. The valve element defines, in an open position, a free flow passageway between the intake port and exit port to place the first and second flow chambers in fluid communication. The valve element is in the open position when the valve axis is aligned substantially opposite to the direction of gravity.
In accordance with another embodiment of the present invention, an anti-spillover flow coupling for a chest drainage assembly is provided, the assembly defining at least a first and a second flow chamber. The flow coupling includes an intake port adapted to couple to the first flow chamber, a first hydrophobic filter disposed over the intake port, an exit port adapted to couple to the second flow chamber, and a second hydrophobic filter disposed over the exit port. The flow coupling defines a gas flow passageway between the intake port and exit port to place the first and second flow chambers in fluid communication, the first hydrophobic filter impeding liquid flow from the first flow chamber into the gas flow passageway and the second hydrophobic filter impeding liquid flow from the second flow chamber into the gas flow passageway.
In accordance with yet another aspect of the present invention, an anti-spillover flow coupling for a chest drainage assembly is provided, the assembly defining at least a first and a second flow chamber. The anti-spillover flow coupling includes an intake port adapted to couple to the first flow chamber, and an exit port adapted to couple to the second flow chamber. The flow coupling defines a gas flow passageway between the intake port and exit port to place the first and second flow chambers in fluid communication, and includes an anti-spill means for preventing the flow of liquid between the first flow chamber and second flow chamber.
In accordance with still embodiment of the present invention, a modular chest drainage assembly with an upright axis is provided. The assembly includes a collection module which defines a collection chamber. The assembly further includes a flow control module defining at least one fluid flow pathway. An anti-spillover flow coupling is attachable to the collection module and flow control module to place the collection chamber and at least one fluid flow pathway in fluid communication. The anti-spillover flow coupling includes an anti-spill means for preventing the flow of liquid between the collection chamber and at least one fluid flow pathway.
There has thus been outlined, rather broadly, certain embodiments of the invention in order that the detailed description thereof herein may be better understood, and in order that the present contribution to the art may be better appreciated. There are, of course, additional embodiments of the invention that will be described below and which will form the subject matter of the claims appended hereto.
In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of embodiments in addition to those described and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein, as well as the abstract, are for the purpose of description and should not be regarded as limiting.
As such, those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention.
The invention will now be described with reference to the drawing figures, in which like reference numerals refer to like parts throughout. An embodiment in accordance with the present invention provides a flow coupling with an anti-spill mechanism therein, configured to be coupled to a chest drainage assembly having an upright axis disposed through an upright plane of orientation for the assembly, where the assembly includes at least a first and a second flow chamber. The flow coupling provides a fluid flow pathway between the two chambers, where one chamber can be a collection chamber in a body fluid collection module and the second chamber can be a flow pathway in a flow control module. The anti-spillover flow coupling includes a valve element therein which is closed when the assembly unit is tipped over such that the upright plane forms an angle relative to gravity. Thus any fluid collected in the collection chamber is prevented from mixing with the pathways in the flow control module.
The collection module includes a fluid intake port 28 for receiving fluids from a patient. A catheter, tube, or similar device (not shown) can be coupled to the fluid intake port 28 in a variety of ways as is well known in the art. An ambient air port 30 is included on the flow control module 16 as part of a positive pressure relief valve element therein. A filling valve 32, such as a grommet or needle-less fill valve with a luer type fitting, is provided on the flow control module 16 for injecting fluids into the module for filling a manometer chamber or water seal chamber that is needed to control the backflow of gases and to indicate pressure, flow, or breathing, as further explained below. A re-infusion port 34 is provided on the collection module 12 for allowing collected body fluids to be returned to a patient by a re-infusion line. A high negativity pressure relief valve 36 is also provided on the flow control module 16 to prevent excessive negative pressures from building in the device.
Fluid entering the device 10 from a patient first passes through the fluid intake port 28 and enters a collection chamber defined inside the walls of the collection module 12. The collection chamber can be made up of any number of compartments or sub-compartments, as is well known in the art, and can vary in size depending on the nature of the patient body to which the chest drainage device is attached: i.e. adult vs. pediatric sizes. Suction pressures established throughout the device 10 are also present in the collection chamber such that gases entering the collection chamber are passed out of the chamber through exit port 14, while the liquid matter in the fluids captured inside of the collection chamber remains trapped inside the chamber. Suction pressure is thereby ‘transmitted’ such that a ‘suction flow’ is established between the intake port 28 and exit port 14, and further, via flow coupling 22, through the flow control module 16 and out through suction port 20. As used herein, the term ‘suction flow’ shall mean either a flow of gases or fluids from one point to another driven by a source of suction, or a flow in the direction of a negative pressure gradient, or an actual negative pressure gradient itself.
The overall assembly 10 is configured to be placed on a surface or attached or hung from a point such that an upright axis “U” as shown is substantially aligned with a gravity vector ‘g’, the direction of axis U pointing to the upwards or ‘upright’ orientation of the device 10. Upright axis U is coincident with an upright plane “P” which is coplanar with the span of face plate 26. Upright plane P thus generally denotes the plane of orientation of the major dimensional axes of the assembly, and is parallel to face plate 26.
The flow coupling 22 in
The flow coupling 22 includes a ‘bottom’ portion or edge 120 and a ‘top’ portion or edge 130, as oriented relative to the valve axis V. The valve element 110 functions to be in the open position when the valve axis vector V is aligned substantially opposite to the vector of the direction of gravity g as shown in
In addition, the sloping surfaces 134 and 136 that are perpendicular to diverging surface 132 are sloped to converge towards the valve axis V as they extend towards the valve seat 116, thereby guiding or urging the ball member 114 to abut against the valve seat 116 when the assembly is tipped over on its face plate 26 or against its back. Thus, the plurality of sloping surfaces around the ball member 114 cause the ball member 114 to be biased by to rest against the valve seat to block the free flow passageway. This prevents blood, water, or other fluids from being transferred between the two ports 100 and 102 when the chest drainage assembly is knocked over.
In addition to the gravity-driven anti spillover mechanism discussed and shown in
The many features and advantages of the invention are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the invention which fall within the true spirit and scope of the invention. Further, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.
