Dispensing – With plural openings or discharge guides – Coterminous
Reexamination Certificate
1999-08-06
2001-01-09
Bomberg, Kenneth (Department: 3754)
Dispensing
With plural openings or discharge guides
Coterminous
C222S484000, C222S556000, C215S235000, C215S236000, C220S254800
Reexamination Certificate
active
06170719
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of Invention
The present invention relates to a medical safety closure for sealing an open top of a specimen collection tube. More particularly, the present invention relates to a medical specimen safety closure used during the collection and shipment of biological specimens, such as urine, to analytical laboratories.
2. Background Description
Biological specimen collections are frequently performed in physicians' offices, hospitals and clinics. It is then sent out to the laboratory for diagnostic testing. Urine collection is one of the most notable. The usual procedure to carry out a urine test is to have one's urine collected and then shipped to an analytical laboratory. The specimen is usually collected in a physician's office where the patient is asked to fill some type of container and then return it to the healthcare provider. The specimen is then transferred from the reservoir container into some shipping container and mailed out to an analytical laboratory for diagnostic analysis.
A problem with current devices that are utilized to carry out this specimen collection is that during the transfer of the specimen from the primary collection device to the transport device, the healthcare provider can be exposed to the specimen. There is a current need to provide safe transfer of the specimen from the reservoir to the shipping container. In addition, there is a need to provide a closure which has a liquid-tight seal so that the specimen does not leak out during transport to the analytical laboratory.
It is also important to provide a safety feature to the closure so that the laboratory technician cannot defeat the medical safety closure's lid and potentially become exposed to the specimen by splatter or spray when the lid is re-opened.
Furthermore, it is desirable to have these above features and advantages with a closure that provides passive filling of the specimen which also stops the liquid specimen from filling at a pre-determined volume. As those skilled in the field of specimen collection are aware, safety is becoming more important due to the exposure to the specimen and the possible infectious disease it may carry. Therefore, there is an ever-increasing need for a specimen closure that minimizes exposure of the specimen to the healthcare provider during collection and transfer of the specimen from a reservoir to a container. In addition, there is a need for a closure to be fluid-tight during shipping of the specimen and a feature to prevent tampering of the closure's lid that could lead to exposure of the specimen from spray or splatter caused by the re-opening of the lid. Currently, stoppers are used that must be pulled out of the containers which can cause splatter or spray of the specimen out of the container. Closures which have a permanent snap fit and only allow removal of the closure by twisting off of the container may be defeated if enough force is applied to the lid of the closure.
SUMMARY OF THE INVENTION
The present invention overcomes the problems identified in the background material. The preferred embodiment of the safety specimen closure comprises a base having an open upper portion, a lower portion and side walls therebetween. The side walls have at least one detent. The lower portion has an annular skirt and a barrier wall extending distally. The annular skirt is attached to the tube by having at least one internal protrusion and the tube having at least one external protrusion. The tube is secured between the annular skirt and barrier wall to provide leakage protection from the tube and closure connection. A transfer port for internally receiving the male reservoir outlet is attached to the lower portion and extends towards the open upper portion. The transfer port is offset from the center of the lower portion and has a hole that is oblong in shape for maximum filling speed. The oblong transfer port where a male reservoir outlet is received inside the transfer port assists in avoiding any spillage or leakage that may occur by having the specimen from the container directly poured into the transport container or tube, instead of having a male receptacle over the transfer port of the closure which may result in leakage of the specimen.
A vent tube is mounted on the lower portion between the transfer port and side walls. The vent tube extends adjacent to the annular skirt and has a conduit therethrough such that the diameter of the conduit is larger at the lower portion than at the distal end of the vent tube adjacent to the annular skirt.
The closure further includes a snap lid hingedly connected to the base. The snap lid has at least one coupler or annular ring and a portal mating plug such that when the snap lid is rotated onto the open upper portion of the closure, the portal mating plug securely attaches into the transfer port and the coupler permanently attaches to the detent on the side walls. This feature provides a liquid-tight seal suitable for shipment and prevents the snap lid from being re-opened. Further prevention of re-opening the snap lid is provided by a tab being frangibly and flexibly mounted on the snap lid which detaches when force is applied to re-open the snap lid. This frangible tab is strong enough to press the snap lid onto the open upper portion but breaks off making it unusable when attempts are made to re-open the lid. A plurality of vertical ribs mounted on the side walls of the closure further provide safety by allowing secure gripping of the closure.
The closure further includes a supporting disk attached to the distal end of the vent tube. The supporting disk has an aperture therethrough that has a diameter smaller than the diameter of the conduit of the vent tube adjacent to the annular skirt. The supporting disk provides for passive filling of the specimen into the specimen collection tube. The supporting disk also provides for the specimen to stop filling at a certain predetermined volume based on the height of the supporting disk from the bottom of the specimen collection tube.
These and other aspects, features and advantages of the present invention is apparent from the following detailed description taken in conjunction with the accompanying drawings and claims.
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Golabek, Jr. Robert S.
Wilkinson Bradley M.
Becton Dickinson and Company
Bomberg Kenneth
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