Multi-component ampule

#Jet injection devices are well known in the art for administering intramuscular and subcutaneous medications without needles. Examples of hypodermic jet injectors are described in U.S. Pat. Nos. 5,499,972; 5,569,189; and 5,704,911, their contents are hereby expressly incorporated herein by reference.

#In general, these patents disclose a hypodermic jet injector device that has an ampule for holding liquid medication and a jet injector for receiving the ampule and for injecting medication contained within the ampule subcutaneously without a needle. The ampule is generally a single integral component made from a thermoplastic material that has a nozzle on one end for discharging medication, the discharge end, and an opening on the other end for securing the ampule to a jet injector, the inlet end. The inlet end further includes a connectable end, such as an end with external or internal threads or a sleeve for mechanically coupling to the jet injector. The ampule's physical characteristics such as wall thickness and diameter are determined in part by the desire delivery dosage, the plunger type, the nozzle size, and the operating pressure for delivering the medication subcutaneously without a needle.

#The jet injector includes a metallic cylinder enclosed on one end, such as with a plug or cap, and open on the other end for receiving the ampule. Within the cylinder, the components of the jet injector generally include a spring, a piston, a shaft, a plunger, and a trigger. The jet injector device operates by cocking or compressing the spring, which is in mechanical communication with the piston. The trigger is used to set off the spring, which drives the piston, which then drives the shaft, and which then drives the plunger into the medication to discharge the medication out the nozzle at the distal end of the ampule. A typical operating pressure for a jet injector device to deliver medication subcutaneously without a needle is in the range of about 3,000 to 3,500 psi at the nozzle, with a much higher pressure range of about 5,000 to 6,000 psi developed during the initial thrust of the piston. Thus, a suitable ampule for use with the jet injector is one that is capable of handling the aforementioned pressure range.

#These and other features, aspects and advantages of the present invention will be more fully understood when considered with respect to the following detailed description, appended claims and accompanying drawings, wherein:

#FIG. 1 is a semi-schematic cross-sectional view of an exemplary multi-component ampule provided in accordance with practice of the present invention;

#FIG. 2 is a semi-schematic cross-sectional view of an outer shell shown separated from the multi-component ampule of FIG. 1;

#The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of the multi-component ampule in accordance with the present invention and is not intended to represent the only forms in which the present invention may be constructed or utilized. The description sets forth the features and the steps for constructing and using the multi-component ampule of the present invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and structures may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention. Also, as denoted elsewhere herein, like element numbers are intended to indicate like or similar elements or features.

#Referring now to FIG. 1, there is shown a multi-component ampule (herein “ampule”) provided in accordance with practice of the present invention, which is generally designated 10. The ampule 10 shown is connected to a jet injector 12 (partially shown), which may be a disposable or a reusable type jet injector, via a threaded nipple 14. Broadly speaking, the ampule 10 shown includes an inner cylinder 16, an outer shell 18, a diaphragm 20, and a cap cover 22, herein collectively referred to as components. Together, the components provide long-term storage capability and allow the ampule 10 to be used in high-pressure applications, such as those discussed further below.

#In an exemplary embodiment, the inner cylinder 16 is made from an FDA approved glass for packaging human drugs and biological products, which currently includes ASTM Type I, Class A, and United States Pharmacopeia (USP) Type I glass. However, materials other than glass are contemplated to be used for the inner cylinder 16 provided they meet FDA requirements for long term storage of injectable human drugs. These alternative materials may include Type II glass, certain plastic, and certain elastomeric components which comply with USP Elastomeric Closures for Injections requirements. Such alternative materials may include polypropylene and silicone polymer.