Controlled medicament security enclosure system

Details Controlled medicament security enclosure system Controlled medicament security enclosure system

2000-11-21

2003-04-22

Lazarus, Ira S. (Department: 3749)

Surgery

Container for blood or body treating material, or means used...

C206S363000, C604S091000, C604S259000, C604S162000

Reexamination Certificate

active

06551298

ABSTRACT:

TECHNICAL FIELD
The invention pertains to drug delivery systems in general and more particularly to a controlled medicament enclosure system that is secured by permanently sealing a two piece enclosure, which contains medicament vials, by snapping two halves of the enclosure together.
BACKGROUND ART
Previously, many types of reservoir modules have been used in endeavoring to provide an effective means for enclosing and protecting medicament containing vials. Some systems employ plastic global containers or even plastic bags for containment and distribution of medicinal agents.
A search of the prior art did not disclose any patents that possess the novelty of the instant invention, however the following U.S. patents are considered related:
U.S. Pat. No.
Inventor
Issue Date
5,324,258
Rohrbough
Jun. 28, 1994
5,060,812
Ogle, II
Oct. 29, 1991
4,657,486
Stempfile et al.
Apr. 14, 1987
4,259,956
Ogle
Apr. 7, 1981
Rohrbough in U.S. Pat. No. 5,324,258 teaches a medicament reservoir module for attachment to a pumping and control module which incorporates a conventional vial that is sealed at an open end with a penetrable stopper. A hollow needle is attached to an adapter that releasibly connects the stopper and pierces the stopper, thus providing a medicament flow path through a slack length of flexible tubing. The tubing attaches to a peristaltic pump in a pumping and control module. A housing supports the vial, encloses the adapter, hollow needle, and slack tubing, and releasibly connects to the pumping and control module, thereby providing a detachable reservoir module.
U.S. Pat. No. 5,060,812 issued to Ogle, H is for a medication container stopper which has a elastomeric plug forming a friction fit in an opening of a container. A first cavity in an exterior surface of the plug opens and diverges away from an interior surface of the plug. A second cavity similarly opens and diverges away from the exterior surface of the plug. The bottom of the cavities have an elongated groove with a bottom which defines one face of a diaphragm which is of a thickness that permits the diaphragm to be ruptured by inserting a conventional hypodermic syringe nozzle into the cavity in the exterior surface of the plug.
Stempfile, et al. in U.S. Pat. No. 4,657,486 discloses a portable infusion device for injecting medicinal fluids into human or animal bodies by means of a positive pressure pump that is automatically operated at selected time intervals to inject accurate amounts of fluid medicine into the body.
Ogle in U.S. Pat. No. 4,259,956 teaches a medicament package having a shell vial with an open end. An imperforate resilient stopper seals a closed end of the vial, and a peripheral portion of the stopper facing the open end prevents the outward movement of the stopper within the vial. The stopper is adapted to reciprocate in a piston-like fashion though the closed end of the vial to expel the contents through a hollow needle when punctured thorough the stopper.
DISCLOSURE OF THE INVENTION
In the past, controlled injectables have been housed in a variety of containers which include a sterile reservoir for connection directly to an ambulatory infusion pump, also referred to as a peristaltic pump, using hooked brackets for attachment. Other devices are enclosed in housings that are removably attached to the pumping apparatus and use vials that are replaceable and mount into the housing. Still other approaches to the storage of medicament in a packaged arrangement is to use a flexible bag which decreases in size as the liquid within is dissipated by the negative pressure created by the peristaltic pump.
The primary object of the invention is to provide a security box or enclosure that is safe to handle and easy to use as the construction of the enclosure is such that two halves are formed, and when one or more medicament vials are positioned therein, with tubing projecting from one end, the halves are snapped together and form a permanent juncture, thus protecting the sterile material for a single use.
An important object of the invention is that it is easy to use. When the vials are filled with the liquid medicament and the tubing is attached, they are simply placed inside the bottom half of the security enclosure. The top half of the enclosure is then positioned above, thereby permitting them to mate easily, and when compressed together they permanently snap in place to form a positive closure with no further handling necessary.
Another object of the invention is its convenience, as the device is smaller in size then conventional enclosures and for portable drug delivery systems it is considerably easier to carry since it is flat and has no outside projections.
Still another object of the invention is that a short hollow needle is utilized in the vial that is less than 2 inches (5.08 cm) long which has an advantage over the prior art that requires a much longer needle with its accompanying difficulties.
Yet another object of the invention is its adaptability, as more than one vial may be packaged in the enclosure by simply adding a partition and using multiple vials that are attached together on the outside with flexible tubing.
A further object of the invention is directed to a much longer shelf life of the medicament when it is stored in a glass vial. For example, if the medication is morphine the shelf life is from 7 to 10 days in plastic bags even if refrigerated. In glass vials the medication shelf life is extended to 18 months or longer.
A significant object of the invention is that the enclosure can be made in a rectangular shape, an enclosure having a top half with rounded edges or an enclosure with all edges rounded. In particular, the rectangular shaped enclosure allows multiple enclosures to be easily stacked together when packaged in a shipping container.
A final object of the invention is directed to its ability to be easily produced in a formal government approved Current Good Manufacturing Practice facility, as it meets or exceeds the requirements of Federal Code 21 CFR chapter 1, supervised by the Federal Food and Drug Administration.
These and other objects and advantages of the present invention will become apparent from the subsequent detailed description of the preferred embodiment and the appended claims taken in conjunction with the accompanying drawings.


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