Surgery – Means and methods for collecting body fluids or waste material – Aspiration collection container or trap
Reexamination Certificate
2002-08-05
2004-06-15
Calvert, John J. (Department: 3761)
Surgery
Means and methods for collecting body fluids or waste material
Aspiration collection container or trap
C604S317000
Reexamination Certificate
active
06749592
ABSTRACT:
FIELD OF 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 medical patients, such as from the pleural cavity, by means of a pressure differential.
BACKGROUND OF THE INVENTION
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 bottle also usually prevents the back flow of air into the chest cavity.
The suction pressure (vacuum) and pressure differentials must be precisely maintained with the “3-bottle set-up” because of the dangerous conditions that could result if unduly high or low pressure differentials should occur. Complications such as pneumothorax may result from the loss of the water seal in the water seal bottle if suction were temporarily disconnected, and undue build-ups of positive pressure could cause tension pneumothorax and possible mediastinal shift. To accomplish this precise control, however, results in increased maintenance and monitoring. For example, evaporation in the suction control chamber or bottle results in suction pressure variations which must be corrected by the addition of more water by a nurse, doctor or other authorized medical personnel.
The 3-bottle set-up lost favor with the introduction of an underwater seal drainage system sold under the name “PLEUR-EVAC”® in 1966 by Deknatel Inc. U.S. Pat. Nos. 3,363,626; 3,363,627; 3,559,647; 3,683,913; 3,782,497; 4,258,824; and Reissue 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 more detailed description of the need for and the proper use of chest drainage devices is presented in the Deknatel Inc. PLEUR-EVAC® publication entitled “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 features of the PLEUR-EVAC®) system which provide its improved performance is a single, pre-formed, self-contained unit that embodies the 3-bottle techniques. These PLEUR-EVAC® systems are sometimes referred to as wet or wet—wet chest drainage systems because they employ a fluid such as water both for suction control (i.e., a water manometer) and to establish the patient seal.
Despite the advantages of the PLEUR-EVAC® drainage system over the 3-bottle set-up and the general acceptance of this device in the medical community, improving the convenience and performance capabilities of chest drainage systems continues. One such improvement involved replacing the water filled manometer used for suction control with a dry or waterless suction control regulator, such as that described in U.S. Pat. Nos. 5,026,358; 5,300,050; 4,784,642 and 5,807,358. In these systems the dry suction control regulator includes a mechanism, such as a spring-loaded valve, to control the suction pressure and a water filled chamber is interposed between the suction source and the collection chamber, thereby forming the patient seal.
In these drainage devices or systems, the suction pressure actually being applied, however, could cause rapid modulation of the spring-loaded valve as a consequence of the suction pressure differentials or changes that occur during normal operation. For example, such suction pressure differentials can result from the cyclical pressure variations occurring in the suction source (e.g., suction pump). Such rapid modulation of the valve can cause the device or system to emanate a humming sound or other noise that would make the device or system unsuitable as a practical matter for the intended use (e.g. in a hospital). In order to reduce or attenuate this modulation, and thus also reduce or attenuate the unwanted sound, the drainage devices or systems are configured with a means or mechanism to dampen the rapid modulation of the valve.
In one exemplary case, such as that described in U.S. Pat. Nos. 5,026,358 and 4,784,642, attenuation of the rapid modulation of the valve in the suction control regulator is accomplished by means of a dashpot. The dashpot includes a plug that is interconnected to the plate valve member and which rides within a well. In the described embodiment, the plug is made from graphite and the well is formed of a glass annulus, which together provide non-binding surfaces so as to avoid the sticking of the component parts.
In order for the dashpot to function in the intended manner it is necessary for the plug and well to be manufactured with a high tolerance of perpendicularity. As a practical matter, this means that the plug and the member including the well must be manufactured to rather precise tolerances on the order of millionths of an inch. In addition, it is not uncommon for the plug and the member including the well to be further sorted and segregated so as to establish pairs of parts that can be used to make an acceptable dashpot, thereby minimizing wastage. Consequently, the dashpot and the components thereof are labor intensive and expensive to make.
Another type of drainage device, such as that described in U.S. Pat. Nos. 4,738,671; 4,715,856, 4,544,370; and 4,747,844, includes a modulation valve to control the suction flow, and correspondingly the suction pressure being developed, and a one way valve that forms the seal between the suction source and the collection chamber (e.g. the patient seal). These units are complex and involve a large number of parts.
It thus would be desirable to provide a waterless suction pressure regulator that includes a suction pressure control device that controls or regulates the suction pressure being applied to the waterless suction regulator. It would be particularly desirable to provide a suction pressure regulating device that would attenuate or control changes in suction pressure that could lead to rapid modulation while allowing the suction pressure regulator to be responsive to physiological induced suction pressure changes as well as long term suction source pressure changes. Such a suction pressure regulating device, and drainge devices and systems utilizing such a pressure regulating device preferably would be simple in construction and less costly than prior art devices and the methods related thereto would not require highly skilled users to utilize the device.
SUMMARY OF THE INVENTION
The present invention features a novel device, a suction pressure regulator for controlling the suction pressure being developed within the devices used for draining gases and/or liquid from the body cavity. The drainage of liquid, blood, and/or gas from the body cavity is accomplished by establishing a pressure differential between the device and the body cavity to be drained and maintaining or controlling this pressure differential at a desired value by means of the suction pressure regulator. Also featured is a pressure control regulator for use in combination with a medical device. Further featured are methods related to such a differential pressure control device and/or devices, apparatuses or systems using such differential pressure control device. Various aspects or features of the suction pressure regulator of the present invention, as well as the drainage devices using such a suction pressure regulator, provide a number of bene
Calvert John J.
John W. Ryan Dechert, LLP
Kidwell Michele
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