Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-12-22
2003-02-25
Yuen, Henry C. (Department: 3747)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S412000
Reexamination Certificate
active
06524279
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
A venous blood collection assembly via vacuum tubes for conveniently minimizing accidental needlesticks in users and maximizing safety for patients.
2. Prior Art
Since the recognized advent of the acquired immunodeficiency syndrome (AIDS) in 1981 and recognition that other bloodborne viruses, such as hepatitis B virus (HBV) and hepatitis C virus (HCV), are being transmitted to healthcare workers (HCWs) at alarming rates via accidental needlestick exposures to blood or other body fluids, maximal efforts toward preventing such exposures have been stressed by the medical device industry, as well as the U.S. Government. Over a thousand patents have issued or pend for safer devices capable of shielding HCWs from an estimated 800,000 accidental needlesticks during the use of approximately six billion hollow steel needles used annually in US patient care. It is expected that within nine months after our President's signature of the Needle Stick Safety Prevention Act on Oct. 6, 2000, the common use of safety engineered needlestick prevention devices will be mandatory throughout the USA.
In the field of assemblies patented and pending for blood collection via vacuum tubes, the following prior art seems cogent:
Needles originally designed for blood collection into vacuum tubes comprised a leading ±1.0″20 to 23 G first needle sharp on the leading end and a second ±0.5″20 G needle sharp on the trailing end permanently affixed into a single unit by a hub having a slip connector on the leading end for attachment of a protective scabbard for the first needle and a threaded connector on the trailing end for reversibly affixing the second needle into the cavity of a vacuum tube holder before insertion of the vacuum tube. Also, the trailing end of the hub was made with a slip connector for a protective scabbard for the second needle, such that the open ends of each scabbard abutted one to another and could be sealed further with a breakable label for the assembled sterilized contents in a very compact package. Later, was added an elastomeric tubular sleeve with a closed trailing end and an open leading end affixed by elastic recoil to the trailing end of the hub holding both needles. The purpose of this air-tight sleeve was to prevent blood leakage into the cavity of the holder before the vacuum tube is inserted, to minimize leakage between insertions of more than one vacuum tube, and to minimize leakage after the last vacuum tube has been extracted from the cavity of the vacuum tube holder. When it became obvious that neither the first, nor the second needle should be manually recapped with its originally supplied protective scabbard, the lids of containers for used sharps in blood collection stations and on portable blood collection trays were modified with special receptacles which allowed HCWs to safely detach the hub holding two exposed sharp needles by unscrewing the trailing end of the hub from the vacuum tube holder into the cavity of the sharps container, using one hand while doing so.
Following blood collection apart from handy sharps containers with appropriate needle removal receptacles, it became obvious that the exposed first needles are hazardous for patients, phlebotomists and other HCWs. The early remedies were vacuum tube holders with outer sleeves which slide forward and lock after use to protect finger access to the bevel of the first needle used to withdraw venous blood. Such devices proved cumbersome, required two hands to activate the protective sleeve after the leading needle is withdrawn from a patient's vein and require disposal of the vacuum tube holder containing the first needle and the second needle which punctures the leading cap on vacuum tubes.
Commercial development then turned toward intrinsic means for shielding the bevel and shank of the first needle, especially by methods applicable to syringe
eedle combinations used for giving injections. A variety of devices of two fundamental types evolved rapidly.
The first type basically comprises a variety of sleeves permanently attached to the leading part of the needle which can be finger-manipulated to safely cover the bevel and shank after the needle is withdrawn from the vein of a patient. One of the first was the ICU Medical Blood Collection Needle twice usual length, over which a sliding tube is manipulated to lock over and shield the leading bevel and shank after withdrawal from a vein, along with a trailing needle whose hub screws into the leading end of a standard vacuum tube holder. Although the vacuum tube holder could be used again with another similar needle, the length of the needle beyond the vacuum tube holder made venous access awkward for many phlebotomists, and provided no intrinsic means for safe disposal of the trailing second needle. To obviate such problems Sims-Portex developed the Needle-Pro™. a singly hinged plastic shield permanently attached to the first needle hub which swings from one side to cover and lock in the exposed needle shank and bevel. Becton-Dickinson developed a doubly hinged device, called Safety-Glide™, attached similarly which slides forward and locks to enclose and protect the first needle with straight forward finger action. Others developed compressed spring operated systems whose latches permitted the spring extension of protective caps over the first needle bevel after use. Still others, such as Retractible Technologies developed the Vanish Point™ (U.S. Pat. No. 5,423,758) spring-operated device attached to the trailing end of the first needle hub which, with forward pressure exerted on an inserted sleeve by means of a trailing hinging cap on the vacuum tube holder, releases the spring such that the first and second needles vanish, along with their common hub, into the confines of the cavity in the holder whose trailing end is closed by the hinging cap.
The second type of intrinsic means for shielding the first needle is exemplified in the Bioplexus Puncture Guard® system which embodies an obturator with a blunt tip which is passed through the bore of the first needle to extend beyond the sharp tip of the needle bevel and locked in place by a latch mechanism inside the needle hub, when the user exerts increased forward pressure on a vacuum tube inserted into the vacuum tube holder, after final use for blood collection.
Currently in California, where the use of safety-engineered needles for preventing needlesticks is universally directed under CPL 2-2.44D (Nov. 5, 1999), the use of the Becton-Dickinson Safety Glide™ or Bioplexus Puncture Guard® protectors for the first needles, in conjunction with modified reusable vacuum tube holders appears most common for blood collection. The embodied modifications in the vacuum tube holders consist of differing manually activated latch mechanisms for expanding the diameter of the leading aperture in the vacuum tube holder, such that the threaded trailing end of the first and second needle hub can be dropped through a large diameter aperture through the top of a sharps container when convenient, and the vacutainer holder can be reused subsequently.
The Becton-Dickinson Safety Glide™ system retains at least three potential hazards: (a) the leading needle must be withdrawn from a patient's vein before the needle can be protected; (b) the latch for releasing the trailing needle from the reusable vacutainer holder is not always easy to operate; and (c) the bulk and external leading diameter of the modified Vacutainer™ holder provides a suboptimal angle of venous access by and venous withdrawal of the leading needle. The Bioplexus Puncture Guard® system retains at least three potential hazards: (a) advancement of the obturator through the leading needle bore before the needle is withdrawn could cause venous injury; (b) the latch in the reusable Drop It® vacuum tube holder for releasing the trailing needle sometimes fails, such the obturator and the leading needle bevel are further advanced into the vein of the patient with actual vein injury
Gimie Mahmoud
Yuen Henry C.
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