Surgery – Diagnostic testing – Liquid collection
Reexamination Certificate
2000-08-16
2003-08-05
Hindenburg, Max F. (Department: 3736)
Surgery
Diagnostic testing
Liquid collection
Reexamination Certificate
active
06602206
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a stopper and shield closure for fluid collection tubes and more particularly to a stopper and shield closure assembly for 16 millimeters (mm) fluid collection tubes.
2. Description of Related Art
An evacuated blood collection tube is commonly used by a doctor, phlebotomist or nurse to draw a sample of body fluids from a patient in a hospital or doctor's office for diagnostic testing. During the use of such a tube, a double-ended needle that is attached to a needle holder, is inserted in a vein of the patient, and the closure end of the evacuated tube is inserted into the open end of the holder until the needle in the holder pierces the tube's closure. The blood collection tube contains a vacuum that then draws a body fluid sample from the patient into the tube. Therefore, it is important for the closure on the tube to fit securely on the open end of the tube and maintain the vacuum in the tube before, during and after the blood collection procedure.
Currently, closures for 13 millimeter or less evacuated blood collection tubes may include plastic shields containing a rubber stopper, wherein the stopper is thick or has an enlarged head to fit snugly within and remain attached to the shield and a plug portion that fits in the open end of the tube. Retention of the stopper in the shield is important when the shield and stopper are being removed from the open end of the tube so that blood within the tube can be tested and when the tube is mated with the end of a double ended needle in a needle holder and body fluid is being obtained from a patient.
Standard needle holders, have a fixed internal diameter and accept 13 millimeter or less evacuated blood collection tubes that have a plastic shield containing a rubber stopper. Standard needle holders will also accept 16 millimeter evacuated blood collection tubes that have a rubber stopper and not a plastic shield. Standard needle holders are not compatible with 16 millimeter evacuated blood collection tubes that have a plastic shield that is scaled up from a 13 millimeter tube because the outside diameter of the plastic shield is greater than the internal diameter of the standard needle holder.
Therefore, there exists a need to provide a stopper and shield closure on a 16 millimeter tube that is compatible with standard needle holders.
SUMMARY OF THE INVENTION
The present invention is a specific stopper-shield assembly comprising a plastic shield that is mounted over a rubber stopper for use with a 16 millimeter evacuated tube and that would be compatible with standard needle holders.
The present invention provides a stopper and shield closure assembly having an overall diameter the same or similar to that of stopper and shield closure used with 13 millimeter tubes.
Most preferably, the stopper-shield assembly of the present invention comprises dimensions whereby use of the stopper-shield assembly with a 16 millimeter plastic tube may be used with a conventional needle holder. The dimensions of the stopper-shield assembly have been minimized to be compatible with conventional needle holders while maintaining the aspects, features and advantages of a stopper-shield assembly that is currently used with 13 millimeter plastic tubes.
Most preferably, the two-piece composite closure of the present invention is for use with 16 millimeter plastic tubes. The two-piece composite closure preferably comprises a plastic shield and a rubber stopper.
Most notably is that the two-piece composite closure of the present invention comprises an outside diameter that is not proportional to the scale up of the stopper and shield closure assembly that is used with a 13 millimeter tube.
An important feature of the stopper and shield closure assembly of the present invention is that the diameter of the assembly allows the closure to fit in conventional needle holders.
Another important feature is that the shield material is more rigid than shields commonly used with tubes of 13 millimeters or less.
A further notable advantage is that the two-piece composite provides a 16 millimeter tube with a closure that can be used with conventional needle holders.
REFERENCES:
patent: 4441951 (1984-04-01), Christinger
patent: 4741446 (1988-05-01), Miller
patent: 4967919 (1990-11-01), Earhart
patent: 5060659 (1991-10-01), Cook et al.
patent: 5361921 (1994-11-01), Burns
patent: 5779074 (1998-07-01), Burns
patent: 2001/0020607 (2001-09-01), Chiarin
Iskra Michael J.
Niermann Volker
Becton Dickinson and Company
Hindenburg Max F.
Rittman, Esq. Scott J.
Thomas, Esq. Nanette S.
Wingood Pamela L.
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