Needle shielding assembly

Details Needle shielding assembly Needle shielding assembly

2002-07-22

2004-11-02

Casler, Brian L. (Department: 3763)

Surgery

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

Treating material introduced into or removed from body...

C604S263000, CD24S130000

Reexamination Certificate

active

06811547

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a needle shielding assembly for use with double-ended needle assemblies commonly used in blood collection procedures. More particularly, the present invention relates to a needle holder which includes a safety shield for use with a double-ended needle for blood collection from a patient.
2. Description of Related Art
Disposable medical devices having piercing elements are typically used for administering a medication or withdrawing a fluid, such as blood collecting needles, fluid handling needles and assemblies thereof. Current medical practice requires that the fluid containers and needle assemblies used in such systems be inexpensive and readily disposable. Consequently, existing blood collection systems, for example, typically employ some form of durable, 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 usage.
A popular design configuration of previously available blood collection systems includes a double-ended needle assembly, an evacuated collection tube, and a holder for maintaining the needle assembly and the collection tube in fixed relation. The double-ended needle assembly, which is also referred to as a cannula, has a bore extending therethrough and a hub near a central region thereof. The evacuated fluid collection tube includes a puncturable stopper at one end thereof. In this type of blood collection system, the holder typically has a housing at one end thereof for receiving the needle assembly. Likewise, the holder also has a hollow body with an opening at an opposite end thereof for receiving the collection tube. The needle assembly is rigidly received within the housing of the holder such that a first end of the needle extends forwardly of the holder for puncturing the vein of a patient. The opposite, second end of the needle extends into the hollow body of the holder. Upon assembly of the blood collection system, the needle assembly is inserted into the housing and the collection tube is inserted through the open end of the hollow body until the second end of the needle pierces the puncturable stopper of the collection tube, thereby allowing fluid communication between the interior of the collection tube and the bore which extends through the needle assembly. To draw a blood specimen from a patient using one of these blood collection systems, the evacuated collection tube is partially inserted into one end of the holder, the first end of the needle is inserted into a patient's vein and the collection tube is fully inserted into the holder such that blood will be drawn through the bore of the needle assembly and into the fluid collection tube. After drawing the specimen, the collection tube is removed so that the blood contained therein can be analyzed and the needle assembly is detached for disposal.
In addition to being capable of accommodating blood collection tubes, the holders of some fluid transfer systems are compatible with fluid containers having a fluid to be injected into a patient. Thus, such holders can be used to inject fluid into, as well as draw blood specimens from, a patient.
In order to reduce the risk of incurring an accidental needle-stick wound, protection of the used needle tip becomes important. With concern about infection and diseases of the blood, methods and devices to enclose the used disposable needle have become very important and in great demand. Many developments have taken place for protecting used needle tips. For example, U.S. Pat. Nos. 5,139,489, 5,154,285 and 5,423,765 disclose needle holders for use with needle assemblies, with the needle holders including pivoting safety shields attached or mounted thereto which can be pivoted about the used needle for protection after use. The entire including the needle holder with the needle assembled therewith and shielded, can then be appropriately discarded.
Such needle holders are readily disposable after use, and therefore large inventories must oftentimes be maintained. This requires the needle holders to be sold in bulk packaging and maintained in large quantities, which increases storage costs.
Accordingly, a need exists for a needle holder which can be used with a needle assembly which can be activated for safety shielding of the needle, which is simple to manufacture, easy to operate, and which is easy to package and store.
SUMMARY OF THE INVENTION
The present invention is directed to a needle holder for use in combination with a needle assembly having a needle cannula with a puncture tip designed for penetration of the body. The needle holder includes a hollow housing having a forward end and a rearward end, and a generally tubular wall extending therebetween. The forward end is adapted to accommodate a needle assembly with a puncture tip extending from the forward end of the housing. The rearward end of the housing is adapted for the insertion of a fluid collection container, such as an evacuated blood collection container. The tubular wall of the housing includes at least one cutaway portion, such as a slot or notch, which extends from the rearward end along a portion of the tubular wall. The needle holder also includes a needle shield which is capable of protectively surrounding the needle cannula of the needle assembly when it is assembled with the housing. The needle holder is designed such that the forward end of a first needle holder is capable of nesting within the rearward end of a second needle holder, with the cutaway portion of the second needle holder accommodating the needle shield of the first needle holder. As such, a plurality of needle holders can be nestably stacked prior to assembly with a needle assembly for use.
Desirably, the needle shield includes an elongated housing having a slot extending along its length for accommodating and protectively engaging the needle cannula, with the needle shield being pivotally engageable with the needle cannula. Preferably, the needle shield is integrally formed with the housing of the needle holder through a living hinge.
Preferably, the rearward end of the housing is flared outwardly. In particularly preferred embodiments, the cutaway portion of the tubular wall and the needle shield are axially aligned along the housing.
The present invention is further directed to a method for packaging a plurality of needle holders designed for use in combination with needle assemblies. Such a method involves providing a plurality of needle holders as set forth above, and stacking the plurality of needle holders such that the forward end of each needle holder is nested within the rearward end of another needle holder, with the needle shield of each needle holder accommodated within the cutaway portion of another needle holder.
In a further embodiment, the needle holder includes a generally tubular hollow housing having a forward end and a flared rearward end, with the housing including a notch extending from the rearward end along a portion of the housing, and with a pivoting elongated needle shield attached to the housing. A plurality of such needle holders can be nestably stacked together, with the needle shield of one needle holder extending through the notch of an adjacent needle holder.
In yet a further embodiment, the present invention is directed to a kit or storage system for a plurality of needle holders, with each of the plurality of needle holders including a hollow housing having a generally tubular wall extending between a forward end and a rearward end, with the tubular wall including a cutaway portion extending from the rearward end along a portion of the tubular wall and with an elongated shield pivotably attached to the forward end of the housing. The plurality of needle holders are nested within each other such that the shield of each needle holder extends within the cutaway portion of an adjacent needle holder.


REFERENCES:
patent: 4416663 (1983-11-01), Hall
patent: 47

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