Special receptacle or package – For a tool – Body treatment
Reexamination Certificate
1999-12-10
2001-12-25
Bui, Luan K. (Department: 3728)
Special receptacle or package
For a tool
Body treatment
C206S524400, C604S110000
Reexamination Certificate
active
06332534
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to systems for the safe disposal of medical instruments having sharp edges or points that may have been contaminated by infectious diseases or other harmful organisms. More particularly, the invention relates to a device for the rapid and safe disposal at the point of use of at least the sharp portion of used medical instruments such as, e.g., hypodermic needles, scalpel blades, suturing needles and lancets.
The present invention is an improvement over the system disclosed in U.S. Pat. No. 5,322,165, licensed to applicant herein.
2. Prior Art
The safe disposal of medical instruments contaminated during a medical procedure with tissue and body fluids is a major health concern. Infectious diseases such as the AIDS virus and hepatitis, for example, can be transmitted through contact with contaminated instruments. Hypodermic needles, trocars and other instruments having sharp edges or points are particularly dangerous to personnel handling them. Disposing of the used medical instruments within the operating rooms, patient rooms, laboratories and other facilities is a task that exposes the doctors, nurses and other personnel to the risk of being inadvertently stuck or pricked by the contaminated sharp instruments. Injuries frequently have occurred, for instance, while attempting to cap used hypodermic needles in preparation for their transport and disposal through incineration or other means.
Current procedures require the collection and removal of the dangerous “sharps” to another site for decontamination, encapsulation or other protective measures. This means that the unprotected medical instruments could be retrieved and reused by unauthorized persons between the time the instruments are used in a medical procedure and the time they are destroyed or rendered incapable of further use.
Numerous devices and systems have been developed in the prior art in an effort to solve the problem of safe disposal of contaminated medical instruments.
Prior U.S. Pat. Nos. 4,816,307 and 4,900,500 to Honeycutt, and U.S. Pat. No. 4,845,923 to Donovan, disclose methods for encasing “sharps” in containers having resins which harden and encapsulate the instruments. The processes disclosed in these patents are slow reacting, do not provide a capsule that is resistent to crushing, and in some cases require handling of chemicals by the staff at the point of use.
U.S. Pat. No. 5,322,165 to Melker, et al., discloses an instrument encasement system in which a container is divided into two compartments by a frangible membrane, one compartment containing a hardenable resin and the other compartment containing a particulate filler and an activator. Upon insertion of a medical instrument through a penetrable top and through the frangible membrane, the contents of the compartments mix, creating a reaction that quickly hardens the resin and particulate material mixture and encases the sharp portions of the medical instrument. The system described in this patent does provide a quick reaction time for hardening of the resin and also provides a capsule or container for holding the sharps. However, a relatively large volume of resin is required, in spite of the use of the filler, and manufacturing difficulties may be encountered, particularly with reference to the placement of the frangible disc and the penetrable end wall.
Accordingly, there is need for a system for the rapid and safe disposal at the point of use of used medical instruments, wherein the system is simple and economical in construction.
SUMMARY OF THE INVENTION
The present invention provides a device and system for the rapid and safe disposal at the point of use of used medical instruments, wherein the system is simple and economical in construction and is easy to use.
In accordance with the invention, a container is provided for receiving at least the sharp portion of at least one medical instrument. The container has a wall on one end penetrable by the sharp instrument, and is separated into two fluid-tight compartments by a frangible membrane. One of the compartments contains a hardenable substance, such as epoxy, resin or other material, and the second compartment is configured to have a small internal free volume and contains an activator to react with the resin, epoxy or other hardenable material to cause it to quickly harden when the two are admixed. The hardened material bonds to and encapsulates the sharp portion of the instrument, rendering it incapable of further use.
The small internal volume of the second compartment enables less hardenable material to be used, and results in quicker mixing of the material and the activator and consequent quicker hardening of the material when the frangible membrane is broken. Moreover, the structure forms a large surface area for bonding with the hardenable substance, thereby securely bonding the instrument to the container.
For ease of manufacture, the container comprises two parts which may be joined together with the frangible membrane between them to form the two compartments. Prior to assembly, the hardenable substance and the activator may be suitably placed in the respective compartments.
In a preferred embodiment, the hardenable substance may comprise a cyanoacrylate resin (CA), and the activator may comprise sodium bicarbonate or sodium hydroxide. Other suitable multi-part adhesive compositions may be used.
The hardenable substance preferably comprises a liquid of low viscosity, i.e., similar to the viscosity of water, and the activator may be liquid or particulate and placed loose in its compartment, or coated onto the internal surface of the compartment.
In one embodiment of the invention, the compartment comprises a glass ampoule divided into two compartments by a frangible membrane, and held within a housing having a top with a wall penetrable by the sharp instrument.
In a preferred construction, the container has a width of about one-half inch and a length or depth of about one inch. It should be understood, however, that the container could have other sizes, as desired. Moreover, the container can be made of any suitable material, although plastic is preferred. The frangible membrane preferably comprises a thin glass disc, such as that available from Erie Scientific of Portsmouth, N.H., for use as a microscope cover glass. These discs come in a range of thicknesses, but a thickness of about0.004 inch is preferred. If desired, the disc can be scored or etched to make it more frangible.
For ease of handling and disposal, a plurality of the containers may be held in a suitable structure. One suitable arrangement comprises a tray-like housing having a plurality of recesses or openings therein for receiving the containers. The containers may be lifted from the tray and disposed of one-by-one, or left in the tray until all of the containers have been used, and then disposed of as a group along with the tray.
REFERENCES:
patent: 2766755 (1956-10-01), Greene
patent: 4845923 (1989-07-01), Donovan
patent: 4919264 (1990-04-01), Shinall
patent: 4973315 (1990-11-01), Sincock
patent: 5038929 (1991-08-01), Kubofcik
patent: 5084027 (1992-01-01), Bernard
patent: 5211285 (1993-05-01), Haber et al.
patent: 5322165 (1994-06-01), Melker et al.
patent: 5334400 (1994-08-01), Purdham
patent: 5687444 (1997-11-01), Hakker
patent: 6123193 (2000-09-01), Vojtasek et al.
Bui Luan K.
Innovative Consumer Products, Inc.
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