Fluid collection holder

Surgery – Diagnostic testing – Liquid collection

Reexamination Certificate

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Details

C604S192000

Reexamination Certificate

active

06595931

ABSTRACT:

BACKGROUND
1. Technical Field
The present disclosure generally relates to the field of fluid collection holders employed with fluid collection tubes, and more particularly, to a blood collection holder configured to shield both ends of a double needle cannula.
2. Description of the Related Art
Medical and dental syringes exposed to the AIDS virus or any number of infectious diseases, contaminants, etc., can present serious safety hazards to practitioners, due to accidental contact with needles. A particular danger exists during attachment and removal of a needle from a fluid collection holder, syringe, etc. A number of different devices have been proposed to minimize the possibility of spreading infectious disease due to accidents of this type. One type of medical device uses a needle which is retained in a retracted position after the needle is used to guard against accidental sticks. See, for example, U.S. Pat. Nos. 4,650,468; 4,675,005; 4,692,156; and 4,507,117. These devices are generally of the hypodermic syringe type having a single needle point.
Conventional blood collection procedures involve, such as, for example, venipuncture to draw blood into a blood collection tube, such as, test tubes, etc. The devices used typically include a double ended cannula or needle mounted to one end of a housing that supports the double ended needle. The double ended needle is covered by a protective guard prior to use.
The conventional double ended needle includes a hub having a distal needle portion extending in one direction and a proximal needle portion extending in the other direction. The hub of the double ended needle is threadably engaged with a threaded aperture of the housing supporting the double ended needle. The other end of the housing is open to receive the evacuated blood collection tube which has a stopper to penetrably receive the proximal needle portion. During the procedure, blood flows through the double ended needle into the test tube and can be repeated for several blood collection tubes.
Prior to blood withdrawal, the protective guard is removed and the distal needle portion of the double ended needle is uncovered for insertion into the patient's vein. Typically, after use, the double ended needle is capped with the protective guard or the double ended needle can be retracted within the housing. However, these devices require the user to use both hands to cap the double ended needle or retract the double ended needle within the housing after use. These designs are relatively complicated and time consuming in use. Furthermore, these types of devices present packaging problems for shipping due to their configuration, adding to the costs of manufacture.
Accidental needle stick may be encountered with manipulation of the blood collection device during detachment, replacement or installation of the double ended needle. Inadvertent sticking may also occur during loading and unloading of the blood collection tube with the housing.
Various devices have been developed to minimize the likelihood of inadvertent needle stick from either the distal needle portion or the proximal needle portion. U.S. Reissue Pat. No. 35,539 shows a retractable double ended needle that prevents inadvertent sticking on the proximal needle portion by closing a cap door attached to the rear end of the housing. Another attempt at preventing inadvertent sticking of a double ended needle is disclosed in Denmark Application WO 90/02515, showing a movable protective member that engages a cam projecting from an inner surface of a holder for blocking the proximal needle portion of the double ended needle. These types of devices, however, may not provide uniform and reliable motion as the protective member and the cam tend to jam or move offline, resulting in faulty operation and a dangerous condition to the user.
Therefore, it would be desirable to have a fluid collection apparatus having a shielding capability that protects the user from the ends of a double ended needle by forming a protective configuration about the ends of the double ended needle during operation of the fluid collection apparatus. Desirably, the fluid collection apparatus guides movement of its working components to provide dependable performance and increased safety to the user.
SUMMARY
Accordingly, a fluid collection apparatus is disclosed to be employed with evacuated blood collection tubes and double ended blood collection cannulas for drawing blood and/or fluids from patients. The fluid collection apparatus protects a practitioner from both ends of a double ended needle. This and other advantages are accomplished by retraction of a distal end of the double ended needle and a plurality of segments that form a protective configuration about a proximal end of the double ended needle. The fluid collection apparatus guides movement of its working components to provide dependable performance and increased safety to the practitioner during a blood and/or fluid collection procedure.
In one particular embodiment, a fluid collection apparatus is provided, in accordance with the principles of the present disclosure. The fluid collection apparatus includes a housing and a slide that is moveably supported by the housing. The slide has a cannula tab adapted to support a cannula which may include such as, for example, a double ended needle, and a plurality of connected segments that are moveably extending from the slide. Proximal movement of the slide causes the plurality of segments to contract in a configuration forming a shield about a proximal end of the double ended needle. This structure advantageously protects a user from inadvertent needle stick with one-handed operation. The housing may define a slot in an outer surface thereof that is configured to receive a portion of the slide for guiding movement of the slide. The slot can be elongated along a longitudinal axis of the housing facilitating axial movement of the slide in a predetermined manner. This configuration advantageously provides guided movement of the slide.
The cannula tab can include a boss disposed adjacent a distal portion of the slide. The double ended needle is mounted with the boss. The double ended needle may be threadably received by the boss. The cannula tab may include a segment member having a button mounted thereto. The button is disposed within at least a portion of the slot and slideably engages the slot to facilitate movement of the slide. Alternatively, the segment member includes a transverse portion having the double ended needle mounted therewith. The transverse portion is configured to spatially orient projection of the double ended needle from the housing.
The plurality of segments can include an end portion extending from a proximal end thereof. The end portion is disposed within a portion of the slot and cooperatively engages the slot to facilitate contraction of the plurality of segments. The plurality of segments may include at least one planar surface. Desirably, the plurality of segments are connected by hinges for relative movement. Most desirably, the slide has a range of movement including a distal position whereby a distal end of the double ended needle extends outside of the housing and a proximal position whereby the distal end of the double ended needle is retracted within the housing. The button may releasably lock the slide in the distal position.
In an alternate embodiment, the fluid collection apparatus includes a shield that extends from the cannula tab and an end portion that extends from the shield. The end portion is moveably disposed within at least a portion of the slot of the housing such that proximal movement of the slide causes the end portion to engage the slot so that the shield forms a protective configuration about a proximal end of the cannula. The shield may include a plurality of connected segments moveably extending from the cannula tab. The cannula tab may include a longitudinal portion having a button mounted thereto. The button is disposed within at least a portion of the slot and slideably engages the slot to

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