Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-10-13
2001-11-20
Nguyen, Anhtuan T. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S263000, C604S110000, C128S919000
Reexamination Certificate
active
06319232
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to a protective device to prevent accidental contact with the sharp surface of an object and more particularly to a protective device having a locking mechanism to prevent reuse of a needle.
While the accidental needle sticks have always plagued healthcare practitioners, the advent of AIDS and various other potentially lethal blood borne pathogens has increased the consequences of such needle sticks. Various attempts have been made to minimize such risks. For instance, devices have been introduced to shield the healthcare practitioner from making contact with a potentially contaminated needle, but have met with limited effectiveness.
A needle protection device (or shield) must meet certain criteria to be effective. First, it must provide protection to the healthcare practitioner—in other words provide an effective barrier to prevent accidental contact with the needle. Second, it must be simple to use so that the healthcare practitioner can effectively perform his or her job while at the same time availing themselves of the protection afforded by the protection device. Third, it must be cost effective so that hospitals will not incur undue costs. Fourth, it must provide protection on a timely basis to shield all healthcare workers from the device.
In addition to the criteria listed, a protective device should also prevent exposure of the needle once disposed, be intuitive to use and accommodate a variety of needle sizes.
Past designs for needle protection devices included various forms of pivoting shrouds or shields that surround the needle. These designs can be divided into two broad categories based upon the locking mechanism. The first category utilizes a reversible locking mechanism. This design allows the healthcare practitioner to repeatedly use the shrouding mechanism. Thus, a healthcare practitioner can engage the lock after filling the hypodermic syringe and remove the shroud just prior to injection. But this type of locking mechanism does not allow for permanent locking of the shroud about the needle, preventing reuse. The second category of needle protection devices utilizes a single use locking mechanism. This design prevents the healthcare practitioner from repeatedly using the shrouding mechanism. So a healthcare practitioner can engage the lock only after final use of the needle, just prior to disposal.
Neither of the two broad categories provide for both a temporary locking mechanism and a permanent locking mechanism. Thus, neither of the two designs allow for temporary locking of the shroud about the needle for intermediate protection and permanent locking of the shroud about the needle for final protection and disposal.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to provide a needle shield that prevents accidental needle contact by the healthcare provider.
It is a further object of the invention to provide a needle shield that does not interfere with the normal operation of the syringe.
It is an additional object of the invention to provide a needle shield that pivots away from the needle to allow use application of the needle.
It is another object of the invention to provide a needle shield that may be used with pre-existing needles and not require redesign of the pre-existing needle.
It is another object of the invention to provide a needle shield with a temporary locking mechanism to prevent exposure of the needle.
It is another object of the invention to provide a needle shield with a permanent locking mechanism to prevent reuse.
It is an additional object of the invention to provide a needle shield having a locking mechanism that engages under the control of the healthcare practitioner.
It is a further object of the invention to provide a needle shield that is cost effective to produce.
Other objects will be obvious and will appear hereinafter. The invention comprises an article of manufacture as exemplified in the following summary and detailed description.
The protection device of the present invention is an assembly which is integrally molded with a needle assembly or separately fabricated and later mated to a needle via the needle hub. The protection device includes a collar which is either compression fitted to or integrally molded with the needle hub. Attached to the hub is a hinge that ultimately allows the shield portion of the assembly to pivot away from the needle. The hinge is mated to a channel portion, which is itself mated to a transition portion connected to the shield. The channel portion is sized so as to frictionally engage the needle shaft, thereby creating a temporary locking mechanism to hold the shield next to the needle. Disposed upon the channel portion is a permanent locking mechanism. The permanent locking mechanism locks the shield in the protective position, permanently shielding the needle.
The present invention further includes variations on this design. The temporary locking mechanism may be placed in the shield assembly or disposed in the transition piece. In addition, the permanent locking mechanism may be placed in any location, including the shield, and may further comprise a one-way lock. The hinge may be formed as a single or multiple piece design.
The above mentioned objectives of the present invention will become more apparent and the invention itself better understood with reference to the following description of the embodiments of the present invention in conjunction with the accompanying drawings.
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Clioate, Hall & Stewart
Nguyen Anhtuan T.
Safeguard Medical Limited
Thissell Jeremy
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