Apparatus and method for filling an ampule of a needle-less...

Fluent material handling – with receiver or receiver coacting mea – Processes – Plural materials

Reexamination Certificate

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C141S018000, C141S027000, C141S100000, C141S351000, C141S357000, C141S363000, C141S383000, C141S384000, C604S082000, C604S416000

Reexamination Certificate

active

06302160

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to devices and methods for filing an ampule of a needle-less injector prior to an injection, and in particular, embodiments for filing an ampule of a needle-less injector or syringe, with a medication 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 added to the syringe prior to an injection to maintain potency. This requires the medication to be drawn into the syringe 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 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 loaded prior to injection.
SUMMARY OF THE DISCLOSURE
It is an object of an embodiment of the present invention to provide an improved device and method for filing 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 filling an ampule of a needle-less injector suitable for injecting fluid includes an ampule and a fluid holder. The ampule is for containing the fluid, and the fluid holder is for loading the fluid. The fluid holder also includes a fluid plunger rod. In preferred embodiments, the ampule is coupled to the fluid holder to provide fluid communication between the ampule and the fluid holder. Also, the fluid plunger rod is depressed to load the fluid from the fluid holder into the ampule to fill the ampule of the needle-less injector. In further embodiments, the ampule further includes an ampule plunger rod. After the ampule is loaded with the fluid, the ampule plunger rod is depressed to expel bubbles back into the fluid holder from the ampule of the needle-less injector. Preferably, the ampule is loaded with fluid just prior to injection of the fluid due to a short shelf life of the fluid. Also, the ampule of the needle-less injector is attached to the needle-less injector after filing with the fluid.
According to further embodiments of the present invention, a method of filling an ampule of a needle-less injector suitable for injecting fluid includes the steps of: providing an ampule for containing the fluid; providing a fluid holder containing a fluid; providing the fluid holder with a fluid plunger rod; coupling the ampule to the fluid holder to provide fluid communication between the ampule and the fluid holder; and depressing the fluid plunger rod to load the fluid into the ampule to fill the ampule of the needle-less injector. Further embodiments include the steps of: providing the ampule with an ampule plunger rod; and depressing the ampule plunger rod, after the ampule is loaded with fluid, to expel bubbles back into the fluid holder from the ampule of the needle-lee injector. Preferably, the step of filling the ampule occurs just prior to injection of the fluid due to a short shelf life of the fluid. 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.
Other features and advantages of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, various features of embodiments of the invention.


REFERENCES:
patent: 4338980 (1982-07-01), Schwebel et al.
patent: 1258019 (1989-08-01), None
patent: 2749169 (1997-12-01), None
patent: 9619252 (1996-06-01), None
patent: 8908469 (1989-09-01), None
patent: 9619252 (1996-06-01), None
patent: 9725015 (1997-07-01), None

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