Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-01-24
2004-09-14
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S162000
Reexamination Certificate
active
06790199
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to the field of protective devices used in health care, and, more particularly, to a needle protective assembly for needles used for collecting blood from, or dispensing medication to, a patient. The assembly includes a protective cover for covering the tip of a needle used with the assembly, after usage, to avoid accidental needlesticks.
2. Description of the Related Art
Over the last few years, there has been a widely reported surge in the occurrence of diseases which are communicable by the transmission of bodily fluids. This has caused a growing concern among healthcare professionals about the inadvertent transmission of disease by the accidental sticking of one's self with a contaminated needle, thereby causing the healthcare professional to be at risk when handling contaminated needles.
My prior patent, U.S. Pat. No. 5,195,993, disclosed a needle protecting assembly for use with hypodermic syringes. The disclosure of my prior patent is hereby incorporated herein by reference. In that patent, I disclose a needle protective assembly useful with traditional hypodermic needles. The assembly includes a slidable sheath which moves along a hypodermic needle to lockingly cover the tip, and thereby prevent accidental needlesticks. The patented device is useful, but not in every application which involves the use of needles for piercing the human body.
In my co-pending application, I disclose a needle protective assembly for a butterfly wing IV blood collection and scalp vein set, which is useful primarily in specific applications involving long-term attachment of a needle to a patient' s vein. This device, too, has utility, but does not cover all possible uses of medical needles.
For example, one area which has been underserved by the prior art is the field of multi-draw needles used for drawing several vials of blood from a patient with only one needlestick. In these applications, a blood collection tube holder is fitted with a needle for drawing blood. A vial for holding blood drawn from the patient is placed in the blood collection tube holder. The top of the vial includes a self-sealing rubber top which is pierced by the end of the needle opposite the end which is inserted into the patient. The needle conducts blood from the patient into the vial. If more than one vial of blood is required, the first vial may be removed, and replaced by a second vial, without removing the needle from the patient's vein, thereby reducing the amount of trauma suffered by repeated needlesticks, and avoiding scarring.
The medical professional drawing blood in this fashion has the same imperative to avoid an accidental needlestick and prevent infection as the user of the mentioned devices, but the prior devices may not be suitable for all applications.
One aspect of my first invention disclosed in U.S. Pat. No. 5,195,993 was that it had a relatively large profile, or outer diameter. This limited its applicability in some applications. The butterfly device disclosed in my above-referred co-pending application addresses this issue, and reduces the overall profile of the needle protective assembly, but it, too, does not have utility in all applications due to its overall configuration, and specific applicability to an IV blood collection and scalp vein set.
Neither invention is targeted to the particular problems encountered in the field of multi-draw blood collection assemblies, in which the smaller overall profile is desired, with the ability to connect to a larger blood collection tube.
One product has been sold to that market, a part of the SAFE-POINT line of blood collection needles (Models M-D and VAC) sold by North American Medical Products, Inc. In this product, a needle protecting assembly of a slightly reduced size (compared to that disclosed in my original patent) is used in a multi-draw blood collection system. In this assembly, a standard blood collection needle is press-fit into a two-piece protective assembly. The standard needle is purchased with the needle held inside a protective plastic cover, to avoid accidental needlesticks prior to use. The protective plastic cover is then broken off, and discarded. After use, the medical professional moves a slidable outer sheath over a fixed barrel from a retracted position in which the needle is exposed, into an extended position in which the needle is covered. This configuration has a slightly reduced profile but it is not sufficiently reduced for some applications.
Additionally, the prior devices suffer from the drawback that they require assembly before use, and it would be useful to provide a simple unitary device capable of being used without the need to attach a needle to another device, so that it may be manufactured more easily and less expensively.
SUMMARY OF THE INVENTION
It is therefore an object of the invention to provide a needle protective assembly having a reduced profile compared to prior devices.
It is a further object of the invention to provide a needle protective assembly which may be manufactured easily and conveniently.
Briefly stated, the invention is directed to a needle protective assembly in which a slidable sheath is mounted over a barrel which, in turn, encircles a needle. The sheath is adapted to slide along the barrel, and cover the needle after use, protecting against accidental needlesticks. The inner barrel is integrally formed with a hub in which the needle is mounted, and which may be used to attach the inventive protective assembly to a blood collection vial holder, or a hypodermic syringe, depending upon the application. In some embodiments, the protective assembly may also be formed integrally with either the blood collection vial holder, or the hypodermic syringe.
The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of the disclosure. For a better understanding of the invention, its operating advantages, and specific objects attained by its use, reference should be had to the drawing and descriptive matter in which there are illustrated and described preferred embodiments of the invention.
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Casler Brian L.
Cohen & Pontani, Lieberman & Pavane
North American Medical Products, Inc.
Thissell Jeremy
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