Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-11-13
2004-01-06
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S110000, C604S164080
Reexamination Certificate
active
06673047
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The subject invention relates to a blood collection set having a needle cannula and a shield that can be driven forwardly to safely shield the needle cannula.
2. Description of the Related Art
A prior art blood collection set includes a small diameter needle cannula having a pointed distal end and a proximal end mounted to a thermoplastic hub. Portions of the blood collection set near the hub may be provided with a pair of flexible wings. The wings can be folded into face-to-face engagement with one another to facilitate digital manipulation of the small needle cannula. The wings then can be folded away from one another and taped into face-to-face engagement with the skin of the patient near a puncture site. The prior art blood collection set further includes a flexible plastic tube that has one end connected to the hub and an opposed end connected to a fitting. The fitting can be placed in communication with a reservoir to which collected blood may be directed.
The needle cannula of the prior art blood collection set typically is shielded prior to and after use to prevent accidental sticks. Needle shields used with prior art blood collection sets have taken many forms. Typically, a prior art blood collection set is packaged with a rigid tubular cap telescoped over the needle cannula to prevent accidental sticks prior to use. This tubular cap is removed from the needle cannula immediately prior to use of the blood collection set. Most prior art blood collection sets further include a second shield that is telescoped over the needle cannula and hub. The second shield may include at least one slot through which wings of the prior art hub may extend. Thus, the medical technician who uses the prior art blood collection set will hold the wings of the needle hub in one hand and the shield in the other hand after removing the needle cannula from the patient or blood donor. The wings then are slid proximally relative to the shield, thereby drawing the needle cannula into the shield. Some prior art shields are configured to engage the wings when the needle cannula has been shielded to make a re-exposure of the needle cannula difficult.
The digital manipulation that is required to shield the used needle cannula of a prior art blood collection set creates the potential for generating the accidental needle stick that the shield is intended to avoid. In particular, it is undesirable to rely upon a shielding that requires two hands to be moved in opposite directions in proximity to the point of a used needle cannula. Accordingly, the inventors herein have recognized the desirability of providing an automatically shieldable needle cannula for a blood collection set.
SUMMARY OF THE INVENTION
The subject invention relates to a blood collection set which comprises a needle cannula having a proximal end, a pointed distal end and a lumen extending therebetween.
The blood collection set further includes a hub that may be molded from a thermoplastic material. The hub includes proximal and distal ends. Additionally, the hub includes inner and outer tubes extending between the proximal and distal ends. The inner and outer tubes are connected to one another at the proximal end of the hub. However, the inner and outer tubes are spaced from one another at all other locations to define a cylindrical space that is open at the distal end of the hub. The outer tube of the hub includes a longitudinal slit extending continuously between the proximal and distal ends. Additionally, the outer tube includes a pair of transverse wings extending outwardly near the distal end of the hub. Biasing means is provided for urging the slit open. However, the wings can be deflected toward one another and against the force of the slit biasing means. Movement of the wings toward one another closes the slit, while movement of the wings away from one another in response to forces of the slit biasing means opens the slit. The slit biasing means may be a separate spring extending between the wings. Alternatively, the slit biasing means may rely, at least in part, on the inherent resiliency of the outer tube of the hub. The passage extends continuously through the inner tube from the proximal end of the hub to the distal end. The distal end of the inner tube of the hub is securely mounted to the proximal end of the needle cannula. Thus the lumen through the needle cannula communicates with the passage through the inner tube of the hub.
The blood collection set may further include a length of flexible tubing having opposed proximal and distal ends. The distal end of the flexible tubing may be connected to the proximal end of the hub such that the lumen through the needle cannula and the passage through the hub both communicate with the passage through the flexible tubing. The flexible tubing further includes a proximal end that may be connected to a fitting. The fitting may comprise a needle cannula that enables the blood collection set to be placed in communication with a reservoir for receiving a sample of blood. The tubing and the fitting may be of conventional design.
The blood collection set may further include a substantially rigid generally tubular safety cap mounted over the needle cannula for protection against accidental needle sticks prior to use of the blood collection set. The safety cap may include a proximal end that is frictionally engaged with the hub. The rigid tubular safety cap may be removed immediately prior to use of the blood collection set.
The blood collection set further includes a safety shield that is telescoped in the cylindrical space between the inner and outer tubes of the hub. The safety shield is moveable from a proximal position, where the needle cannula is exposed, to a distal position, where the needle cannula is safely shielded. Shield biasing means are provided between the shield and the hub for urging the shield to the distal position. The shield biasing means may be a coil spring that surrounds a portion of the hub. The safety shield is dimensioned to move in the cylindrical space between the inner and outer tubes of the hub only when the outer tube of the hub is biased into a position where the longitudinal slit is open. However, movement of the wings toward one another closes the slit and prevents axial movement of the shield relative to the hub and the needle cannula.
The needle assembly is used by positioning the shield in the proximal position and against the force of the shield biasing means. The wings then are squeezed together to close the slot and hold the shield in the proximal position. The needle assembly then can be used in a conventional manner. After use, the wings are released and resiliently return to their initial position. This resilient movement of the wings opens the slot and enables the shield to be propelled distally under the force of the shield biasing means.
REFERENCES:
patent: 4813940 (1989-03-01), Parry
patent: 5330438 (1994-07-01), Gollobin et al.
patent: 5498241 (1996-03-01), Fabozzi
patent: 5899886 (1999-05-01), Cosme
patent: 0409180 (1991-01-01), None
patent: WO 98/42393 (1998-10-01), None
Crawford Jamieson William Maclean
Livanos Stefanie
Becton Dickinson and Company
Casler Brian L.
Rittman, Esq. Scott J.
Thomas, Esq. Nanette S.
Thompson Michael M
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