Multi-component ampule

Abstract

Multi-component ampules for use with re-useable and disposable jet injectors are described which have primary and secondary packaging components. The primary packaging component includes an inner glass cylinder, an elastomeric diaphragm, and an elastomeric plunger. The secondary packaging components include a plastic outer shell and a plastic adapter. The primary packaging components allow medications and injectable suspensions to be stored for prolonged periods while the secondary packaging components provide structural integrity and adaptability for the ampule. Exemplary methods of use are also disclosed.

What is claimed is:  
     
         1 . A multi-component ampule comprising an inner cylinder of a first material, an outer shell of a second material, and a diaphragm of a third material.  
     
     
         2 . The multi-component ampule according to  claim 1 , wherein the outer shell further comprises an opening at a distal end and a bore, wherein at least a portion of the diaphragm is disposed within the opening and wherein the inner cylinder is disposed within the bore.  
     
     
         3 . The multi-component ampule according to  claim 1 , further comprising a re-usable jet injector, the jet injector is threadedly coupled to the ampule by a threaded nipple.  
     
     
         4 . The multi-component ampule according to  claim 1 , further comprising a disposable jet injector, the disposable jet injector is permanently attached to the ampule by adhesive or by welding.  
     
     
         5 . The multi-component ampule according to  claim 1 , wherein the first material is Type 1 glass, the second material is polycarbonate, and the third material is an approved FDA elastomer.  
     
     
         6 . A multi-component ampule comprising an outer shell of a first material having a bore, a distal end, and a proximal end, the distal end having external threads and the proximal end having internal threads; an inner cylinder disposed within the outer shell of a second material having an external surface that is hand-tight with the bore of the outer shell, and a diaphragm that is in contact with both the outer shell and the inner cylinder.  
     
     
         7 . The multi-component ampule of  claim 6 , wherein the inner cylinder is made from a glass material.  
     
     
         8 . The multi-component ampule of  claim 6 , wherein the outer shell is made from a polycarbonate material.  
     
     
         9 . The multi-component ampule of  claim 6 , wherein the diaphragm is made from a silicone material.  
     
     
         10 . The multi-component ampule of  claim 6 , further comprising a cap cover threadedly engaged to the external threads.  
     
     
         11 . The multi-component ampule of  claim 6 , further comprising a plunger, the plunger is at least partially disposed within the inner cylinder.  
     
     
         12 . The multi-component ampule of  claim 7 , further comprising a threaded nipple, the threaded nipple is threadedly engaged with the internal threads of the outer shell and imparts a force against the inner shell, which imparts a corresponding force against the diaphragm.  
     
     
         13 . The multi-component ampule of  claim 8 , further comprising a threaded nipple, the threaded nipple is threadedly engaged with the internal threads of the outer shell and imparts a force against the inner shell, which imparts a corresponding force against the diaphragm.  
     
     
         14 . The multi-component ampule of  claim 11 , further comprising a threaded nipple, the threaded nipple is engaged with the internal threads of the outer shell and imparts a force against the inner shell, which imparts a corresponding force against the diaphragm.  
     
     
         15 . The multi-component ampule of  claim 14 , further comprising a shaft and a shaft end, the shaft is partially disposed within the threaded nipple and the shaft end is either located adjacent to the plunger or is attached to the plunger.  
     
     
         16 . The multi-component ampule of  claim 15 , further comprising a protective housing, the protective housing is attached to the threaded nipple and is coaxially disposed over at least a portion of the shaft.  
     
     
         17 . The multi-component ampule of  claim 6 , further comprising medication, the medication is stored within the multi-component ampule.  
     
     
         18 . The multi-component ampule of  claim 11 , further comprising medication, the medication is stored within the multi-component ampule.  
     
     
         19 . A multi-component ampule comprising an outer shell of a first material having a bore, a distal end, and a proximal end, the proximal end having a coupler for sliding engagement with a sleeve; an inner cylinder disposed within the outer shell of a second material having an external surface that is hand-tight with the bore of the outer shell, and a diaphragm that is in contact with both the outer shell and the inner cylinder.  
     
     
         20 . The multi-component ampule of  claim 17 , wherein the inner cylinder is made from a glass material.  
     
     
         21 . The multi-component ampule of  claim 17 , wherein the outer shell is made from a polycarbonate material.  
     
     
         22 . The multi-component ampule of  claim 17 , wherein the diaphragm is made from a silicone material.  
     
     
         23 . The multi-component ampule of  claim 17 , further comprising a safety seal cover attached to a distal end of the outer shell.  
     
     
         24 . The multi-component ampule of  claim 17 , further comprising spaced apart ridges located on the coupler, the spaced apart ridges are configured to melt when exposed to heat.  
     
     
         25 . The multi-component ampule of  claim 17 , further comprising a jet injector, said jet injector comprising a housing and a sleeve located on a distal end of the housing, the sleeve is configured to engage with the coupler.  
     
     
         26 . The multi-component ampule of  claim 24 , further comprising a jet injector, the jet injector comprising a housing and a sleeve located on a distal end of the housing, the sleeve is configured to engage with the coupler.  
     
     
         27 . The multi-component ampule of  claim 25 , wherein the jet injector further comprising a spring, a piston, and a shaft, wherein shaft is coaxially disposed with the piston, and wherein the piston is configured to compress the spring when the shaft is moved proximally.  
     
     
         28 . The multi-component ampule of  claim 27 , wherein the shaft partially extends outside of the housing.  
     
     
         29 . The multi-component ampule of  claim 27 , wherein the piston maintains the spring in the compressed position by engaging with an engagement tip.  
     
     
         30 . The multi-component ampule of  claim 26 , further comprising medication, the medication is stored within the multi-component ampule.  
     
     
         31 . The multi-component ampule of  claim 17 , wherein the outer shell further comprises an end wall having a recessed portion and a tapered portion for receiving the diaphragm.  
     
     
         32 . The multi-component ampule of  claim 17 , wherein the diaphragm is positioned in a recessed portion of the outer shell and is substantially flushed with the outer shell's exterior end surface.  
     
     
         33 . The multi-component ampule of  claim 31 , wherein the recessed portion is configured to receive a base portion of the diaphragm and the tapered portion is configured to receive a nozzle section of the diaphragm.  
     
     
         34 . The multi-component ampule of  claim 17 , wherein the outer shell comprises a proximal end and a distal end, and wherein the distal end comprises an end wall and the proximal end comprises a threaded member.  
     
     
         35 . The multi-component ampule of  claim 34 , wherein a symmetrical plunger is positioned within the inner cylinder.  
     
     
         36 . A needleless jet injector assembly comprising a multi-component ampule connected to a jet injector, the multi-component ampule comprises an outer shell of a first material, an inner cylinder of a second material, and a nozzle section of a third material; the jet injector comprises a housing and a piston compressing a spring and being held by an engagement member, wherein when the engagement member is released from the piston, the piston advances a shaft proximally to discharge medication from the nozzle section.  
     
     
         37 . The needleless jet injector assembly of  claim 36 , further comprising a plunger being in contact with the medication, and wherein the plunger is configured to pressurize the medication when the shaft advances proximally.  
     
     
         38 . The needleless jet injector assembly of  claim 36 , wherein the multi-component ampule is connected to the jet injector by a thread engagement or by a coupler to sleeve engagement.  
     
     
         39 . The needleless jet injector assembly of  claim 36 , wherein the shaft is coaxially disposed within the piston and partially extends outside of the housing.  
     
     
         40 . The needleless jet injector assembly of  claim 36 , wherein the multi-component ampule further comprises a cap threadedly engaged to a distal end of outer shell.  
     
     
         41 . The needleless jet injector of  claim 36 , wherein the shaft is positioned end-to-end with the piston.  
     
     
         42 . The needleless jet injector of  claim 36 , wherein the outer shell further comprises an end wall having a recessed portion and a tapered portion for receiving the nozzle section.  
     
     
         43 . The multi-component ampule of  claim 36 , wherein the nozzle section is positioned in a recessed portion of the outer shell and is substantially flushed with the outer shell's exterior end surface.  
     
     
         44 . The multi-component ampule of  claim 42 , further comprising a diaphragm and wherein the recessed portion is configured to receive a base portion of the diaphragm and the tapered portion is configured to receive the nozzle section of the diaphragm.  
     
     
         45 . The multi-component ampule of  claim 36 , wherein the outer shell comprises a proximal end and a distal end, and wherein the distal end comprises an end wall and the proximal end comprises a threaded member.  
     
     
         46 . The multi-component ampule of  claim 45 , wherein a symmetrical plunger is positioned within the inner cylinder.  
     
     
         47 . A multi-component ampule comprising an outer shell having external threads at its distal end and internal threads at its proximal end and made from a plastic material, an inner cylinder made from a glass material having a plunger disposed therein, and a nozzle section made from a silicone material; the outer shell has a cap threadedly engaged to its external threads and a nipple threadedly engaged to its internal threads; and wherein the nipple is partially covered by a protective cover, which is connected to the nipple.  
     
     
         48 . A method for injecting medication subcutaneously without a needle, the method comprising: 
 taking a needleless injector assembly and firing a trigger to discharge medication into a skin, wherein the needleless injector assembly comprises: 
 a multi-component ampule, the multi-component ampule comprises an outer shell made from a first material, an inner cylinder made from a second material, and a nozzle section made from a third material, and  
 a jet injector, the jet injector comprises a spring, a piston, a shaft, and a trigger for firing the needleless injector assembly.  
   
     
     
         49 . The method of  claim 48 , wherein substantially all of the jet injector assembly is disposed of after a single injection.  
     
     
         50 . The method of  claim 48 , wherein the multi-component ampule is removable from the jet injector, and wherein only the multi-component ampule is disposed of after a single injection.  
     
     
         51 . The method of  claim 50 , wherein the shaft is disposed of after single injection.  
     
     
         52 . The method of  claim 48 , wherein the multi-component ampule is permanently attached to the jet injector and wherein the multi-component ampule is pre-filled with medication.  
     
     
         53 . The method of  claim 48 , wherein the multi-component ampule is threadedly engaged to the jet injector after the multi-component ampule is filled with medication.  
     
     
         54 . A multi-component ampule comprising an outer shell made from a first material, an inner shell made from a second material, and a nozzle section made from a third material; wherein the outer shell comprises a end wall and a recessed portion defined therein, and wherein the nozzle section is disposed within the recessed portion and the nozzle section is substantially flushed with the end wall's exterior surface.  
     
     
         55 . The multi-component ampule of  claim 54 , wherein the outer shell comprises a threaded member on a proximal end section for engaging with a jet injector.  
     
     
         56 . The multi-component ampule of  claim 54 , further comprising a diaphragm, wherein the diaphragm comprises a base section and a protruding section and wherein both the base section and the protruding section are both recessed within the end wall such that substantially none of the diaphragm protrudes from the end wall's exterior surface.  
     
     
         57 . The multi-component ampule of  claim 54 , further comprising a symmetrical plunger disposed within the inner cylinder.  
     
     
         58 . The multi-component ampule of  claim 57 , wherein the first material is plastic, the second material is glass, and the third material is silicone.