Fluent material handling – with receiver or receiver coacting mea – Processes – Filling dispensers
Reexamination Certificate
1998-11-14
2001-05-01
Maust, Timothy L. (Department: 3751)
Fluent material handling, with receiver or receiver coacting mea
Processes
Filling dispensers
C141S009000, C141S018000, C141S027000, C141S100000, C141S312000, C141S319000, C141S357000, C141S383000, C141S384000, C604S068000, C604S082000, C604S416000
Reexamination Certificate
active
06223786
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to devices and methods for mixing medication and filling an ampule of a needle-less injector prior to an injection, and in particular, embodiments for filling an ampule of a needle-less injector or syringe, with a medication that must be mixed just prior to administration in an injection.
BACKGROUND OF THE INVENTION
Typically, injections are performed with syringes that pierce the skin with a needle to deliver medication to a desired location on a body. In a large number of cases the syringes are pre-filled with a medication. However, if the medication does not have a long shelf life, it must be mixed just prior to an injection to maintain potency. This requires the medication to be mixed externally to the syringe and then drawn in using needles or the like. After drawing in the medication, the injection is administered in a normal manner. But, after the injection there are one or more needles that need to be disposed of, increasing costs and increasing the potential health hazards from exposure to used needles.
As an alternative to needle delivery injections, needle-less medication injections have been performed with “permanent gun” instruments, generally referred to as “jet injectors”. These devices use either a compression spring or a compressed inert gas to propel the fluid medication (via a push rod plunger) through a small orifice (an injector nozzle) which rests perpendicular to and against the injection site. The fluid medication is generally accelerated at a high rate to a speed of between about 800 feet per second (fps) and 1,200 fps (approximately 244 and 366 meters per second, respectively). This causes the fluid to pierce through the skin surface without the use of a needle, resulting in the medication being deposited in a flower pattern under the skin surface. These reusable jet injectors can accept pre-loaded medication cartridges, but again the cartridges must be pre-loaded just prior to an injection for certain medications with short shelf lives. The procedure is to again use a needle and a syringe to mix and then load the medication in the cartridge prior to an injection. After drawing in the medication, the needle-less injection is administered in a normal manner. But, after the injection there are again one or more needles that need to be disposed of, increasing costs and increasing the potential health hazards from exposure to used needles.
Single use needle-less jet injectors offer an alternative to multi-use, needle-less injectors, since they are low cost and can be pre-loaded at the point of manufacture. However, if the medication does not have a long shelf life, the pre-loading is impractical. Thus, single-use, needle-less injectors have not been usable with medications that must be mixed prior to injection. An alternative to overcome this drawback was to include a two compartment ampule in the injector, which is opened up with a piercing mechanism and combined together to mix the medication as the injection takes place. Although, this obviates the need for needles, the results are unsatisfactory, since the medication is not always thoroughly mixed and properly deposited under the skin. In addition, improper mixing can allow the medication (particularly large molecule medications) to be destroyed or altered during the injection process. Further, it is possible for the piercing mechanism included in the ampule to break the barrier between diluent and reagent may block or obscure the orifice, or jam the needle-less injector leading to an improper injection.
SUMMARY OF THE DISCLOSURE
It is an object of an embodiment of the present invention to provide an improved device and method for filling an ampule of a needle-less injector, syringe or the like, that obviates for practical purposes, the above-mentioned limitations.
According to an embodiment of the present invention, an apparatus for mixing medication and filling an ampule of a needle-less injector suitable for injecting liquid medication includes a reagent holder and a diluent holder. The regent holder is for containing a reagent, and the diluent holder is for containing a diluent. The diluent holder also includes a diluent plunger rod. In preferred embodiments, the reagent holder is coupled to the diluent holder to provide fluid communication between the reagent holder and the diluent holder. Also, the diluent plunger rod is depressed to load the diluent from the diluent holder into the reagent holder to mix with the reagent to produce the liquid medication for filling the ampule of the needle-less injector. In further embodiments, the reagent holder further includes a reagent plunger rod. After the reagent and the diluent are mixed in the reagent holder to produce the liquid medication, the reagent plunger rod is depressed to load the liquid medication back into the diluent holder for filling the ampule of the needle-less injector. Preferably, the reagent and the diluent are mixed just prior to injection of the liquid medication due to a short shelf life of the liquid medication. Also, the ampule of the needle-less injector is attached to the needle-less injector after filling with the liquid medication.
In particular embodiments, the reagent holder is the ampule of the needle-less injector. In other embodiments, the diluent holder is the ampule of the needle-less injector.
In preferred embodiments of the present invention, a reagent holder for mixing medication and filling an ampule of a needle-less injector suitable for injecting liquid medication includes a housing, and a reagent plunger rod. The housing is for containing a reagent, and includes attachment means (such as snaps or threads) for coupling the housing to the ampule of the needle-less injector containing a diluent. The reagent plunger rod is coupled to the housing to contain the reagent in the housing. When the reagent holder is coupled to the ampule of the needle-less injector by the attachment means, fluid communication is provided between the reagent holder and the ampule of the needle-less injector. In addition, when the diluent plunger rod is depressed to load the diluent into the reagent holder, which moves the reagent plunger rod to accommodate the diluent, the diluent is mixed with the reagent to produce the liquid medication for filing the ampule of the needle-less injector. In further embodiments, after the reagent and the diluent are mixed in the reagent holder to produce the liquid medication, the reagent plunger rod is depressed to load the liquid medication into the ampule of the needle-less injector to fill the ampule of the needle-less injector.
According to further embodiments of the present invention, a method of mixing medication and filling an ampule of a needle-less injector suitable for injecting liquid medication includes the steps of: providing a reagent holder containing a reagent; providing a diluent holder containing a diluent; providing the diluent holder with a diluent plunger rod; coupling the reagent holder to the diluent holder to provide fluid communication between the reagent holder and the diluent holder; and depressing the diluent plunger rod to load the diluent into the reagent holder to mix with the reagent to produce the liquid medication for filling the ampule of the needle-less injector. Further embodiments include the steps of: providing the reagent holder with a reagent plunger rod; and depressing the reagent plunger rod, after the reagent and the diluent are mixed in the reagent holder to produce the liquid medication, to load the liquid medication into the diluent holder for filling the ampule of the needle-less injector. Preferably, the step of mixing the reagent and the diluent occurs just prior to injection of the liquid medication due to a short shelf life of the liquid medication. Also, the method includes the step of attaching the ampule of the needle-less injector to the needle-less injector after filing with the liquid medication.
In particular embodiments, the reagent holder is formed as the ampule of the needle-less injector. In other
Maust Timothy L.
Pen Jet Corporation
Pillsbury & Winthrop LLP
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