Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
1999-08-06
2001-05-22
Nguyen, Anhtuan T. (Department: 3763)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
C600S573000, C604S317000, C604S324000
Reexamination Certificate
active
06235010
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates generally to an apparatus for collecting and transferring biological fluids. More particularly, the present invention relates to an apparatus for collecting and transferring a urine specimen in conjunction with a collection tube.
2. Description of Prior Art
Biological fluids are collected periodically for laboratory analysis. Laboratory equipment that performs the analysis may only accept biological fluids stored in a test tube. However, a test tube is too small for the convenient collection of many biological fluids, such as urine. As a result, specimens often are collected in a fairly large container with a widely open top. After collection of the fluid in the container, the container is delivered to a medical technician. The medical technician then transfers a portion of the fluid into a test tube that is sealed and transported to a laboratory for analysis. The transfer of biological fluid from the collection container to the test tube is an unpleasant task that creates the risk of contaminating the specimen or exposing the medical technician to potentially harmful pathogens in the specimen.
Some biological fluids such as blood are collected with assemblies that include a vacuum tube and a double-ended needle cannula. One end of the needle cannula is placed in communication with the biological fluid. The opposite end of the needle cannula is urged through a vacuum seal into the vacuum tube. Low pressure within the vacuum tube generates a flow of the bodily fluid through the needle cannula and into the tube. Such vacuum tubes are very convenient and efficient for collecting blood samples. However, for urine specimen collection, vacuum tubes are not very useful because vacuum tubes only have a limited shelf life due to a gradual migration of gas molecules through the walls of the tube. Additionally, sharps or pointed cannula require careful shielding to avoid potential skin punctures.
In urine collection, some prior art collection containers have a test tube that is attached. In this prior art device, a portion of the urine specimen in the container is automatically transferred to the test tube. The test tube then may be separated from the container, sealed and shipped to a laboratory for analysis. However, these prior art assemblies can lead to leakage during the initial collection of the specimen or after the separation of the test tube from the collection container. Additionally, control of the volume of the specimen in the test tube may vary from sample to sample. A means for controlling the volume in each specimen sample taken is needed to assure accurate results in the subsequent laboratory analysis. Also, the use of a non-sharp or blunt cannula in the transfer of the specimen from the collection container to the test tube is preferred to avoid potential skin puncturing of the medical technician. Finally, a collection container designed to avoid contact with the user to prevent contamination of the specimen is desired. Prior art assemblies of collection containers can come into contact with the user's hands during collection which contaminate the specimen in the collection container. Finally, there is a need for a collection container to use a non-evacuated vacuum tube to avoid the potential limited shelf life of the vacuum tube.
SUMMARY OF THE INVENTION
The present invention alleviates in great part the drawbacks associated with prior art specimen collection containers. Provided is a container that allows transport of the specimen to a laboratory for analysis and minimizes the risk of spills or leaks. The present invention preserves non-contamination during collection and transfer between the collection container and collection tube. This transfer can be done either in the physician's office or at a laboratory.
The invention is directed to a closed system specimen collection container. The container has a bottom, an open top, and side walls extending from the bottom to the top. The bottom has a circular top surface and a bottom surface. The top surface is inclined and has an aperture located at the lowest gravitational point on the top surface. The aperture is non-eccentric to the top surface.
The container also includes an integrated valve that protrudes from the bottom surface. It is offset from the center point of the bottom. The valve is in fluid communication with the aperture and allows multiple sampling such that the valve is open when it is punctured by a piercing member and the valve is closed when the puncture is removed. A lid is also included in the collection container. The lid is disposed around the open top and has a recessed area containing a vent. The vent allows air to permeate the container. The vent further includes an air-permeable membrane that provides for the specimen to remain within the container. The vent on the lid is offset from the center point of the lid. This geometry allows maximum air permeation during collection.
The collection container further includes a circular extension portion connected to the bottom and extending approximately downward. The circular extension portion has a substantial planar bottom for the container to stand unassisted on a flat surface. The circular extension portion is further characterized by having a hemispherical recess that allows access to the valve. The bottom is further characterized by having an annular protective flap surrounding the valve for reducing splatter when the valve is pierced.
The side walls include at least one external protrusion and the lid includes at least one internal protrusion such that when the lid is connected by the internal protrusion to the external protrusion, a permanent and leak-resistant connection is formed between the lid and the side walls. A crimp area on the lid provides the permanent and leak-resistant connection.
The top surface of the bottom of the container has grooves symmetrically surrounding the aperture. The function of the grooves is to facilitate flow of the specimen toward the aperture. The valve includes a conical inlet for providing audible and tactile confirmation of the opening when the valve is pierced. The side walls and the lid are further characterized by comprising an array of ribs that allows gripping the lid during locking of the lid on the side walls.
The specimen collection container further includes a test tube. The test tube has a closed bottom, an open top and cylindrical side walls extending therebetween. A stopper is attached to the open top. The stopper has a piercing member for attaching the test tube to the valve such that the container is in fluid communication with the test tube. The valve is preferably made of an elastomeric material and the container and circular extension portion are preferably a unitary structure.
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Golabek, Jr. Robert S.
Wilkinson Bradley M.
Becton Dickinson and Company
McWha Keith J.
Nguyen Anhtuan T.
Thomas Nanette S.
Thompson Michael M.
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