Disposable needle stick prevention aid to prevent needle...

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Details

C604S263000

Reexamination Certificate

active

06648857

ABSTRACT:

BACKGROUND OF THE INVENTION
(a) Field of the Invention
This invention relates to a device for preventing needle stick injury and more particularly, but not by way of limitation, to a disposable needle stick prevention aid for engaging a needle cap in a press fit. The needle cap can be used with a dental or medical needle attached to a syringe.
(b) Discussion of Prior Art
A NIOSH/CDC (OSHA) (Center for Disease Control) report an estimated 800,000 needle stick injuries per year. Obviously, needle stick is a serious health concern in the United States and the report suggests the use of some type of recapping device to prevent these types of injuries.
Heretofore, there have been a variety of different types of protective devices used to prevent needle stick from a contaminated needle. The needle attached to a syringe is used for an injection of a fluid into a human or animal body. When performing an injection, a health care provider must focus intensely using near vision on the injection site opening. While each needle is covered with a protective needle cap, the cap has to be removed prior to an injection.
After the injection, the health care provider must then recap the needle into a very small needle cap of less than ⅜ inch. Therefore, inserting the used needle back into the protection cap is not easy and needle stick accidents occur as mentioned above. Also after the injection, the needle may or may not be contaminate d with a life threatening virus or blood disease. HIV, Hepatitis A, B and C can be inhabitants of a freshly used needle. A large percentage of the needle stick injuries reported to the CDC result in HIV or Hepatitis. Therefore, safe recapping of the used needle is extremely important prior to the disposal of the syringe, needle and cap.
In U.S. Pat. No. 5,304,148 to Lannoye et al., a needle cap with expandable shield is disclosed. The shield is incorporated into the structure of the cap and folded when packaged. When the cap is unpackaged, the shield expands outwardly to help prevent needle stick. The shield also includes a flat edge to prevent the cap and shield from rolling on a flat surface. The patents mentioned in Lannoye et al. are incorporated herein by reference.
Also, an angular shaped needle stick protective shield is currently on the market and made of sheet cardboard. The shield includes cross-hair slits or cross-hatch slits in the center of the shield. When a needle cap is pushed through the cross-hair slits, the sides of the slits expand outwardly and next to the side of the cap. This type of protective shield is flawed since gaps or spaces open up next to the slits and the side of the needle cap when the needle cap is inserted through the slits. The gaps or spaces leave sufficient openings for a contaminated needle to be receive therethrough with the possibility of an accidental needle stick on a hand holding the needle cap when recapping the needle.
None of the above mentioned prior art patents specifically disclose the unique features, structure and function of the subject disposable needle stick prevention aid as described herein.
SUMMARY OF THE INVENTION
A primary object of the subject invention is to protect a health care provider from needle stick from the start of a needle injection in a patient until the contaminated needle is safely disposed of in a biohazard waste container. The disposable needle stick prevention aid helps prevent or greatly reduce possible needle stick when recapping a contaminated needle attached to a syringe and when removing the needle from a dental syringe prior to disposal. Currently, the subject stick prevention aid is the only needle stick prevention device approved by the FDA.
Another object of the invention is the stick prevention aid is independent of the needle cap and is adapted for quickly mounting in a press fit on a medical syringe needle cap, a dental syringe needle cap and other sizes and shapes of needle caps.
Yet another object of the stick prevention aid is that the aid is made of a needle puncture resistant protective shield having a center hole focal point indicator. The protective shield includes a center hole in the center of the shield for receiving a portion of the needle cap therethrough. The center hole focal point indicator can be pair of different colored target rings disposed around the center hole, arrows pointing toward the center hole or a similar visual aid to help a health care provider with a precise recapping focal point when reinserting the needle back into an open end of the needle cap held by the shield.
A further object of the target shield is the side of the center hole is dimensioned to be received around the outer circumference of the needle cap in a press fit. This feature eliminates any gap or space between the side of the center hole and the side of the needle cap, thus preventing a contaminated needle from being inserted between the side of the center hole and needle cap.
Still another object of the invention is the stick prevention aid is inexpensive, lightweight, easy to use and is designed to be discarded with the used needle, needle cap and a medical syringe. Also in dentistry where a large dental syringe is used for delivering dental anesthetics, the used needle is unscrewed from the syringe. At this time, the contaminated needle, needle cap and protective shield are thrown away. The dental syringe is then reused with a new needle and needle cap attached thereto.
Another object of the target shield is the periphery of the shield is angular is shape to prevent the protective shield and needle cap held thereon from rolling on a flat surface, such as a bottom of an instrument tray. This feature facilitates the use of a one-handed “scoop” technique when recapping the contaminated needle thereby providing added safety in the recapping of the needle. Also, a contaminated needle is prevented from being dragged across the surface or touching the surface of the instrument tray when using the “scoop” technique, thus preventing cross-contamination.
The disposable needle stick prevention aid includes a lightweight needle protective shield with a center hole centered thereon. The center hole is used for receiving a portion of a needle cap therethrough in a press fit. On a front face or a back face of the protective shield is a center hold focal point indicator. The focal point indicator can be a target with target rings of different colors, arrows pointing toward the center hole and like visual indicators for helping the health care provider guide a used needle toward an open end of needle cap attached to protective shield. The needle protective shield also includes angular sides disposed around it's periphery. The angular sides prevent the protective shield and attached needle cap from rolling freely on a flat surface.
These and other objects of the present invention will become apparent to those familiar with various types of needle stick prevention devices when reviewing the following detailed description, showing novel construction, combination, and elements as herein described, and more particularly defined by the claims, it being understood that changes in the embodiments to the herein disclosed invention are meant to be included as coming within the scope of the claims, except insofar as they may be precluded by the prior art.


REFERENCES:
patent: 4559042 (1985-12-01), Votel
patent: 4573975 (1986-03-01), Frist et al.
patent: 4717386 (1988-01-01), Simmons
patent: 4781697 (1988-11-01), Slaughter
patent: 4840618 (1989-06-01), Marvel
patent: 4892525 (1990-01-01), Hermann et al.
patent: 4900309 (1990-02-01), Netherton et al.
patent: 4919656 (1990-04-01), Bracker et al.
patent: 4981476 (1991-01-01), Aichlmayr et al.
patent: 4986816 (1991-01-01), Steiner et al.
patent: 5607403 (1997-03-01), Kretzschmar et al.
patent: 6488666 (2002-12-01), Geist
patent: 2 620 339 (1989-03-01), None

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