Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-05-02
2003-03-18
Walberg, Teresa (Department: 3742)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C600S578000
Reexamination Certificate
active
06533760
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a device for collecting blood samples by performing venipuncture on a patient. More particularly, the present invention relates to a needle assembly for multiple sample blood collection that allows a phlebotomist to determine whether vein entry has occurred when collecting a blood sample from a patient into an evacuated blood collection tube.
2. Description of Related Art
Venipuncture is the primary method used for acquiring blood samples for laboratory testing. In performing venipuncture procedures, a phlebotomist must follow several steps simultaneously. Such steps include assessing the patient's overall physical and psychological condition so as to properly select a venipuncture site and technique. The phlebotomist must also select the proper corresponding equipment and perform the technique so as to not only control bleeding, but also to properly collect and identify fluid specimens for testing. The phlebotomist must ascertain all of these coinciding factors, as such factors may adversely affect the distension of the vein and the length of the venipuncture procedure.
Various venipuncture devices have been developed which address the above-described problems. These devices incorporate a needle assembly having a housing defining a chamber therewithin, wherein a single cannula pointed at both ends, is affixed to the housing. The intravenous end of the cannula is adapted for penetration of a patient's vein, and the non-patient end of the cannula has a sealable sleeve and adapted for penetration of a penetrable stop positioned within an evacuated container.
Upon vein entry with the intravenous end of the cannula, blood will flow through the cannula, into the sealable sleeve and into the housing chamber which is clear or translucent for visualization (“flashback”). Once air is vented from the housing chamber, the blood therewithin is pressurized each time the sealable sleeve is pushed toward the housing chamber upon activation of an evacuation container.
Due to the length of time between vein entry and flashback, the phlebotomist erroneously believes that satisfactory vein entry has not been achieved since there is no immediate indication thereof in the see-through chamber. Often the phlebotomist unnecessarily repeats the venipuncture procedure, requiring replacement of the evacuated container and/or the needle assembly itself. Such a repetitive process prolongs the physical and emotional discomfort endured by the patient.
It is therefore desirable to provide a fast, accurate and cost effective solution to conventional blood collection procedures upon which the phlebotomist may consistently rely on flashback to provide satisfactory venous entry. Moreover, it is particularly desirable to provide a blood collection device that permits blood flow through a relatively short needle directly into a flashback chamber, thereby providing immediate indication of successful vein entry.
SUMMARY OF THE INVENTION
The present invention provides a needle assembly for the extraction of at least one fluid sample into an evacuated container for laboratory testing, which needle assembly obviates the need for venting by providing a clear or translucent housing chamber with sufficient dead space for blood to flow into the chamber for visualization by the user to confirm successful vein entry.
A needle assembly is provided for collecting at least one fluid sample from a patient for subsequent discharge into at least one evacuated container. The needle assembly of the present invention includes a transparent or translucent housing having a fluid inlet end defined by a cylindrical exterior wall. The wall delineates an annular flashback chamber within the housing for retention of a blood sample therein. The housing further includes a fluid outlet end in communication with said fluid inlet end. A first cannula in fluid communication with the blood inlet end extends outwardly therefrom. The first cannula has an interior extremity positioned proximate the chamber and an exterior extremity opposed thereto that is adapted for puncture of a patient's vein. Similarly, a second cannula is provided in fluid communication with the fluid outlet end and extends outwardly therefrom. The second cannula has an interior extremity positioned proximate the first interior extremity and further includes an exterior extremity opposed to said second interior extremity. The second exterior extremity is adapted for puncture of a penetrable stopper in an evacuated container. The first and second cannulae are preferably in axial alignment with one another so as to provide an axial fluid flow path therebetween along a length of the housing. The second cannula further includes a sealable sleeve.
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Becton Dickinson and Company
Campbell Thor
Rittman, Esq. Scott J.
Thomas, Esq. Nanette S.
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