Needle holder assembly

Details Needle holder assembly Needle holder assembly

1999-03-10

2001-10-23

Kennedy, Sharon (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C600S577000

Reexamination Certificate

active

06306118

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to needle holder assemblies for use during a blood collection procedure and more particularly to a blood collection tube holder with means for easily engaging and disengaging a blood collecting needle from the holder.
2. Description of Related Art
Conventional blood collection systems typically employ some form of a reusable holder on which detachable and disposable needles and fluid collection tubes may be mounted. A blood collection system of this nature can be assembled prior to use and then disassembled after use. Thus, these blood collection systems allow repeated use of the holder upon replacement of the disposable needle and/or fluid collection tube.
Conventional blood collection procedures involve venipuncture to draw blood into a blood collection tube using a doubled ended needle assembly and a holder for maintaining the needle assembly and the collection tube in a fixed relation. The conventional double ended needle assembly includes a hub having an intravenous needle extending in one direction and a non-patient needle extending in the other direction. The hub is threadedly engaged with the holder wherein the non-patient needle is located within the housing of the holder and the intravenous end of the needle extends forwardly from the holder for puncturing the vein of a patient. The housing of the holder is open to receive an evacuated blood collection tube having a stopper to penetrably receive the non-patient needle. To draw a blood sample from a patient using this assembly, the blood collection tube is fully inserted into the housing of the holder such that blood will be drawn through the needle and into the collection tube.
On completion of the procedure, the intravenous needle is withdrawn from the patient and the needle assembly is detached from the holder. The manner of the disposal of the needle assembly varies, depending upon the phlibotomist, the procedures to be followed and other considerations.
Many incurable or fatal diseases are transmissible through contact with the blood of an infected person. A needle used during a blood collection procedure obviously contains a quantity of blood. In the event of needle stick, infection from infected blood is possible. Considering that inadvertent needle stick occurs frequently, the degree of exposure of medical personnel to incurable or fatal diseases is possible.
Particularly in recent years, various devices have been developed to assist with safely engaging and disengaging the needle from a needle holder to minimize instances of needle stick and exposure to blood.
However, these holders are concerned with custom designed blood collecting needles that have a depression or raised part on the hub, unlike a conventional blood collecting needle. Therefore these holders are not compatible with conventional blood collecting needles. In addition the needle is not fixed in the holder by screw-meshing as a conventional blood collecting needle is, so they have the drawback that the fixing of the blood collecting needle in the holder becomes loose.
Other holders have been developed that have a needle fixed in the holder with a one touch type for engaging and disengaging the needle. However, these devices have the drawback whereby needles may be prematurely released from the holder while the needle is in the patient.
Therefore, there exists a need to provide a blood collecting needle holder: (i) that is compatible with conventional blood collecting needles; (ii) whereby the user can disengage the blood collecting needle from the holder without touching the needle; (iii) whereby the blood collecting needle maybe securely engaged with the needle holder without the possibility of premature release from the holder; (iv) that has tactile features whereby the user may be deterred from touching the needle, assist the user in orienting the needle with the patient and triggering the appropriate disengaging mechanisms; (v) that has visual features whereby the user may be deterred from touching the needle, assist the user in orienting the needle with the patient and triggering the appropriate disengaging mechanisms; and (vi) that holder is capable of operating effectively without the need for any additional components.
SUMMARY OF THE INVENTION
The present invention is a needle holder assembly comprising a holder, means for disengaging a conventional blood collecting needle from the holder, means for engaging a conventional blood collecting needle to the holder, and means for deterring the user from touching the needle, assisting the user in orienting the needle with the patient and preventing premature release of the needle from the holder.
Preferably, the holder comprises a tubular body comprising a top end, an open bottom end and a sidewall extending between the top end and the bottom end.
Preferably, the means for disengaging a conventional blood collection needle from the holder is a needle actuation mechanism located at the top end of the holder.
Preferably, the means for engaging a conventional blood collection needle to the holder is a threaded passageway in the needle actuation mechanism.
Preferably, the actuation mechanism comprises a disengaging trigger, an engaging trigger, a threaded passageway and a finger recess indicator. Most preferably, the triggers and indicator have distinct features that provide the user with visual and tactile means for distinguishing between them.
Most preferably, the needle actuation mechanism comprises first and second half female members or jaws with surfaces that cooperate to define the threaded passageway therebetween, an engaging trigger for cooperating the female members and a disengaging trigger for separating the female members and a finger recess indicator.
When the engaging trigger is activated, the jaws cooperate to a closed position to define a threaded passageway. A conventional needle assembly comprising a non-patient end, an intravenous end and a hub, is then screwed into the threaded passageway by the user whereby the non-patient end of the needle extends into the body of the holder and the intravenous end of the needle extends outwardly from the top end of the holder. To release and dispose of the needle from the holder, the holder is held over a sharps disposal container such that the intravenous end of the needle extends vertically from the holder, then the disengaging trigger is activated, whereby the female members are separated to an open or retracted position and so that the threaded passageway is interrupted and there is a gap which is greater than the cross section of the hub of the conventional needle assembly so that the needle assembly is released from the holder and into the sharps disposal container.
In use, a user will use one finger of one hand to close the actuation mechanism whereby the threaded passageway is available for engaging a conventional needle assembly. The user then screws into the threaded passageway a conventional needle assembly whereby the hub of the needle assembly is screwed into the threaded passageway and the intravenous end of the needle extends from the top end of holder and the non-patient end of the needle extends into the housing of the holder.
The intravenous end of the needle is then inserted into the patient's skin as guided by the finger recess indicator to the user. A fluid collection tube is then inserted into the holder in communication with the non-patient end of the needle.
In addition to guiding the user for proper orientation of the holder assembly relative to the user, the needle is prevented from being prematurely released from the actuation mechanism due to the finger recess indicator. The finger recess indicator prevents the patient's skin from activating the disengaging trigger or the actuation mechanism.
After use, the fluid collection tube is removed from the holder, the holder is positioned over a sharps disposal container and the disengaging trigger is depressed with one finger of the user whereby the threaded passageway is int

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