Surgery – Diagnostic testing – Liquid collection
Reexamination Certificate
1999-07-22
2002-03-19
Nasser, Robert L. (Department: 3736)
Surgery
Diagnostic testing
Liquid collection
C604S317000
Reexamination Certificate
active
06358218
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to apparatuses for draining fluid from a patient, and more particularly, to fluid recovery systems for draining blood from the thoracic cavity of the patient.
A number of fluid-recovery systems have been developed for drawing fluid, such as blood, from a patient. Such devices generally apply suction to a body cavity of the patient to remove blood or other fluid after trauma or surgery. For example, a chest drain is a relatively compact bedside fluid-recovery system that is employed to collect fluids post-operatively from a closed surgical site through a drain tube implanted in the patient's chest.
Conventional fluid-recovery systems typically include a housing and a number of components, such as valves and ports, that are manufactured separately from the housing, and subsequently attached to the housing. Such separate manufacturing of the components increases the number of steps in the manufacturing process, thereby increasing the manufacturing cost. Further, additional costs are incurred for assembling these components to the housing. Moreover, each separately manufactured component may need to be individually calibrated, further increasing the manufacturing cost of the system.
Accordingly, there is a need for a fluid-recovery system that requires fewer number of steps for its manufacturing, and further minimizes the need for calibration of its components.
SUMMARY OF THE INVENTION
The present invention provides a fluid-recovery system for collecting fluid from a patient which includes a housing having various integrally molded components and/or structures. The term integrally molded, as used herein, refers to forming a particular component and/or structure of the housing of the fluid-recovery system as a single unit with the remaining parts of the housing. In other words, an integrally molded component and/or structure is not added to a pre-formed housing, but rather is formed with other parts of the housing as a single unit. In particular, the integrally molded components and/or structures of the housing are not intended to be removed and/or replaced.
In one aspect, the present invention provides a fluid-recovery system having a housing and a valve for controlling fluid flow within the fluid-recovery system. The housing includes a collection chamber for collecting the fluid, and the valve includes a valve member that selectively engages a valve seat surrounding a fluid opening, to seal the opening. The valve seat is integrally molded to the housing of the fluid recovery system.
According to one aspect of the invention, the valve for controlling fluid flow within the fluid-recovery system is a vacuum protection valve that provides air flow communication with the collection chamber to permit air flow in one direction out of the collection chamber. In one preferred embodiment of the invention, the valve member of the vacuum protection valve is constructed of an elastomeric material and has a generally umbrella-like shape.
In another aspect, the present invention provides a fluid recovery system for collecting fluid from a patient that includes a housing having a collection chamber for collecting a volume of the fluid from the patient, and a vacuum protection valve for allowing air flow in one direction out of the collection chamber. The vacuum protection valve further includes an enclosure that is integrally molded within the housing.
In a preferred embodiment of the invention, the vacuum protection valve includes a flexible retaining member whose snap-action placement within the integrally molded enclosure secures the valve to the housing. The integrally molded enclosure can have a base extending to an opening that is sized and shaped to engage the flexible retaining member of the valve, thereby attaching the valve to the housing. The vacuum protection valve can include a valve body having an opening therein, and an umbrella valve member that is seated within the valve body to seal the opening. The umbrella valve member provides one way air flow through the opening when the pressure in the collection chamber exceeds a pre-defined threshold.
According to another aspect of the invention, the valve for controlling fluid flow within the fluid-recovery system is a negative pressure protection valve that opens to provide air flow between the collection chamber and the outside environment through the fluid opening when pressure in the collection chamber is lower than a predefined threshold.
In a preferred embodiment of the invention, the negative pressure protection valve can include a valve housing for seating a spring, and the valve member. The spring biases the valve member against the integrally molded valve seat to seal the fluid opening. A pressure in the collection chamber that is lower than the predefined threshold causes the spring to contract, thereby moving the valve member and providing air flow between the collection chamber and the outside environment. The negative pressure protection valve can optionally include a filter to filter the air before it enters the collection chamber. The valve housing can be integrally molded to the housing of the fluid recovery system. Alternatively, the valve housing can be a separate component that is seated within the integrally molded enclosure. The valve housing can include a first cylindrically tubular portion for receiving the spring and extending to a second portion for seating the valve member. The second portion of the valve housing can have at least one port therein for providing air flow between the valve housing and the collection chamber.
Accordingly to one aspect of the invention, an integrally molded raised structure protruding outwardly from the fluid opening of the negative pressure protection valve inhibits occlusion of the opening. The raised structure can include a hollow frusto-conical member that surrounds the fluid opening from the outside and has ports therein for providing air flow from the outside environment through the fluid opening.
According to yet another aspect of the present invention, a fluid-recovery system is provided that includes a collection chamber for collecting a volume of fluid from a patient, and a positive pressure relief valve for reducing pressure in the collection chamber when pressure in the chamber exceeds a pre-defined value. The pressure relief valve includes an integrally molded enclosure formed in the housing, and further includes an integrally molded ramped rib. The integrally molded enclosure of the pressure relief valve can include a first opening for providing air flow communication with the collection chamber, and a second opening for providing air flow communication with the outside environment. The first opening can have a tapered portion for seating a sealing ball that seals the first opening to provide a fluid-tight seal between the collection chamber and the integrally molded enclosure.
When pressure within the collection chamber exceeds a pre-defined value, it dislodges the ball from the first opening to allow air flow between the collection chamber and the outside environment. The integrally molded ramped rib provides a rolling surface for the sealing ball to bias the ball toward the first opening when the fluid recovery system is destabilized from a normal operating orientation. The term “destabilized” as used herein refers to situations or conditions in which the fluid recovery device is bumped, jarred, pushed, tipped or completely knocked-over, resulting in the device being positioned, temporarily or permanently, in an orientation other than its normal, preferred operating orientation, i.e., an orientation in which the fluid recovery system is upright. The pressure relief valve can include a raised surface surrounding the second opening to provide a seat for a sealing element that can seal the housing from the outside environment, for example when pressure testing the fluid-recovery system.
In another aspect, the fluid-recovery system of the invention can include a housing having a front face, a collection c
Autote David R.
Cochran Thomas S.
Corbeil Scott E.
Gillis Ralph L.
Herweck Steve A.
Atrium Medical Corporation
Lahive & Cockfield LLP
Nasser Robert L.
Wingood Pamela
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