WO2003088893A2

WO2003088893A2 - Multi-component ampule

Info

Publication number: WO2003088893A2
Application number: PCT/US2002/025321
Authority: WO
Inventors: J. Stuart Parsons
Original assignee: Equidyne Systems, Inc.
Priority date: 2002-04-19
Filing date: 2002-08-08
Publication date: 2003-10-30
Also published as: WO2003088893A3; US20030196928A1; AU2002332492A1; AU2002332492A8

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 (16), an elastomeric diaphragm (20), and an elastomeric plunger (23). The secondary packaging components include a plastic outer shell (18) and a plastic adapter (22). 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.

Description

MULTI-COMPONENT AMPULE

[0001] Ampules discussed herein generally relate to ampules that are used for long term storage of medications and the like, and more specifically to multi-component ampules that are made from different materials and their applications.

CROSS-REFERENCE TO RELATED APPLICATION

[0002] The present application claims the benefit of provisional application No.

60/374,461 entitled "Multi-Component Ampule" filed April 19, 2002, the content of which is expressly incorporated herein by reference.

BACKGROUND

[0003] 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 US Pat. Nos. 5,499,972; 5,569,189; and 5,704,911, their contents are hereby expressly incorporated herein by reference.

[0004] 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.

[0005] 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 ofthe 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 ofthe piston. Thus, a suitable ampule for use with the jet injector is one that is capable of handling the aforementioned pressure range. [0006] Subsequent to discharging the medication, the ampule, plunger, and shaft may be separated from the jet injector and be disposed of. The injector, however, can be re-used by resetting the spring, as disclosed in the '911 patent. A new ampule, plunger, and shaft may then be connected to the jet injector by threading the ampule into the receiving end ofthe cylinder of the jet injector. [0007] Another hypodermic jet injector example is disclosed in serial number

09/751 ,525 filed December 29, 2000 and entitled "Low Cost Disposable Needleless Injector System for Variable and Fixed Dose Applications", the content of which is incorporated herein by reference. The '525 serial number discloses a jet injector assembly designed for low cost production and for disposability after a single use. The disposable jet injector assembly generally comprises an ampule threadedly or permanently attached to a jet injector. Within the jet injector, the device includes a spring that is in dynamic communication with a shaft and a piston. The shaft is coaxially disposed within the piston and is moveable or slidable within the piston even when the piston is in a cocked position. However, the disposable jet injector generally comes pre-cocked or pre-set in a package from the factory and only requires filling the ampule with medication at the point of injection. The shaft has a length such that a portion of the shaft extends out from the jet injector housing to facilitate filling the ampule, by grasping and moving the extended shaft portion.

[0008] The ampule is threadedly or permanently fixed to the jet injector by adhesive, heat, or ultrasonic welding. The shaft, via the extension, allows medication to be drawn into the ampule when it is retracted from a first position to a second position, which creates a vacuum in the ampule to thereby draw in medication. The injector assembly is used by placing the discharge nozzle next to a skin and then firing the trigger, as discussed above with reference to the re-useable jet injector model.

[0009] Although both the disposable and the re-useable jet injector assemblies are effective, reliable, and economical, they suffer from at least one shortcoming. Among other things, they utilize thermoplastic ("plastic") ampules for manufactur ability and for high-pressure compatibility. Plastic is relatively ductile, has a low modulus of elasticity, is highly impact resistant, and components that are made from plastic are relatively easy to fabricate. However, plastic ampules produced from plastic are generally not suitable for long term storage of medications, injectable suspensions, or the like. This is because certain ingredients that are added during the fabrication process ofthe plastic ampules can leach into the medication. Certain drugs or components ofthe drugs are also known to bind with the plastic or be absorbed by the plastic. Oxidation, degradation, and or precipitation of the medication are also known to occur with prolonged storage of the medication in plastic ampules. It is also possible for a component ofthe drug to migrate through the walls ofthe plastic ampule, and oxygen, carbon dioxide, or other gasses may pass through the plastic into the drug. Hence, plastic ampules are generally not FDA approved for long term storage of medications and injectable suspensions.

[0010] ASTM Type I Class A and United States Pharmacopeia (USP) Type I glass are FDA approved glass for prolonged storage of medications and injectable suspensions. However, glass has a high modulus of elasticity and is highly brittle. Thus, if an ampule is made from glass, the ampule has to be sufficiently thick in order to have the hoop strength necessary to accommodate an operating pressure of about 3,000 to 3,500 psi, and about 5,000 to 6,000 psi at the start ofthe injection cycle. A glass ampule that is capable of withstanding this pressure range, however, can be expensive, unsightly, and undesirable when used in connection with the jet injectors described.

[0011] There is therefore a need for a multi-component ampule that is useable with conventional jet injectors, that is capable of long term storage of medications and injectable suspensions, and that uses FDA approved materials. Additionally, there is also a need for a method of using the multi-component ampule with the conventional jet injectors.

SUMMARY OF THE INVENTION

[0012] The present invention specifically addresses and alleviates the above-mentioned deficiencies associated with the prior art assemblies. More particularly, the present invention comprises a multi-component ampule which has an inner FDA approved glass cylinder, an outer plastic housing, and an FDA approved elastomeric nozzle. Together, these components define a medicine space that is suitable for storing medications and the like for prolonged periods. The glass and the elastomer provide FDA approved primary packaging components while the plastic outer shell provide acceptable secondary packaging containment and reinforcement.

[0013] Exemplary multi-component ampules provided in accordance with practice of the present invention include ampules that have a primary packaging component and a secondary packaging component. Broadly speaking, the multi-component ampule is characterized by an inner cylinder of a first material, an outer shell of a second material, and a diaphragm of a third material. [0014] While the primary packaging component is configured for contacting with the medication for prolonged periods, the secondary packaging component is configured for reinforcing and for covering the primary packaging component so that the primary component may be kept to a inimum thickness. [0015] The ampules discussed herein are configured for used with either reusable spring injectors or disposable spring injectors. Depending on the connection point between the multi- component ampule and the jet injector, the ampule's outer plastic housing may be modified to permanently attach or threadedly attach to the jet injector.

[0016] Broadly speaking, the preferred 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 connected to a jet injector, which comprises a piston compressing a spring and being held by an engagement member located within a housing, wherein when the engagement member is released from the piston, the piston advances a shaft proximally to discharge the medication contained within the multi-component ampule out from the nozzle. [0017] Thus, accordingto the embodiments disclosedherein, multi-component ampules with FDA approved materials for primary packaging components are useable with various conventional injector mechanisms to facilitate the administration of injections such as vaccines, hormones, local anesthetics and insulin.

[0018] It is understood that changes in the specific structure shown and described may be made within the scope ofthe claims without departing from the spirit ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] These and other features, aspects and advantages ofthe present invention will be more fully understood when considered with respect to the following detailed description, appended claims and accompanying drawings, wherein:

[0020] FIG. 1 is a semi-schematic cross-sectional view of an exemplary multi- component ampule provided in accordance with practice ofthe present invention;

[0021] FIG. 2 is a semi-schematic cross-sectional view of an outer shell shown separated from the multi-component ampule of FIG. 1; [0022] FIG.3 is ase i-schematiccross-sectionalviewofadiaphragmshownseparated from the multi-component ampule of FIG. 1;

[0023] FIG. 4 is a semi-schematic cross-sectional view of an inner cylinder shown separated from the multi-component ampule of FIG. 1 [0024] FIG. 5 is a semi-schematic end view of a cap cover shown separated from the multi-component ampule of FIG. 1;

[0025] FIG.6 is a semi-schematic cross-sectional view ofthe cap cover of FIG. 5 taken at line 6-6; [0026] FIG. 7 is a semi-schematic end view of a cap seal shown separated from the multi-component ampule of FIG. 1;

[0027] FIG. 8 is a semi-schematic cross-sectional view ofthe cap seal of FIG. 7 taken at line 8-8;

[0028] FIG. 9 is a semi-schematic cross-sectional view of a threaded nipple shown separated from the multi-component ampule of FIG. 1;

[0029] FIG. 10 is a semi-schematic side view of an exemplary plunger provided in accordance with practice ofthe present invention;

[0030] FIG. 11 is a semi-schematic side view of an alternative plunger provided in accordance with practice ofthe present invention; [0031] FIG. 12 is a semi-schematic side view of an exemplary shaft coupled to yet another alternative plunger provided in accordance with practice ofthe present invention;

[0032] FIG. 13 is a semi-schematic cross-sectional view ofthe ampule shown in FIG.

1 in a filled state;

[0033] FIG. 14 is a semi-schematic cross-sectional view ofthe ampule shown in FIG. 13 with a protective housing provided in accordance with practice ofthe present invention covering a portion ofthe shaft;

[0034] FIG. 15 is a semi-schematic cross-sectional view of an exemplary re-useable jet injector assembly with the ampule of FIG. 1 provided in accordance with practice of the present invention; [0035] FIG. 16 is a semi-schematic cross-sectional view ofthe re-useable jet injector assembly of FIG. 15 in a spent or discharged state;

[0036] FIG. 17 is a semi-schematic cross-sectional view of an exemplary disposable jet injector assembly with the ampule of FIG. 1 provided in accordance with practice ofthe present invention; [0037] FIG. 18 is a partial semi-schematic cross-sectional view of the disposable jet injector assembly of FIG. 17 with modified attachments between the jet injector and the ampule; [0038] FIG. 19 is a semi-schematic cross-sectional side view a multi-component ampule that has a recessed section on the distal end of the outer shell with a protective housing provided in accordance with practice ofthe present invention;

[0039] FIG. 20 is a semi-schematic cross-sectional side view ofthe outer shell of FIG. 19; and

[0040] FIG.21 is a semi-schematic cross-sectional side view of a disposable jet injector assembly having a multi-component ampule threaded to a jet injector.

DETAILED DESCRIPTION [0041] The detailed description set forth below in connection with the appended drawings is intended as a description ofthe presently preferred embodiments ofthe 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 ofthe invention. Also, as denoted elsewhere herein, like element numbers are intended to indicate like or similar elements or features.

[0042] 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.

[0043] 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.

[0044] Materials for the outer shell 18 and the cap cover 22 are made from plastic such as polycarbonate, acrylonitrile-butadiene, or the like. Materials for the diaphragm20 and the plunger 23 are preferably made from an elastomer such as silicone rubber, fluroelastomer and the like. As will be appreciated, the outer shell 18 is preferably transparent so that the contents may be observed during shipment and during use, such as before an injection. Together the diaphragm 20, the plunger 23, and the inner cylinder 16 make up part ofthe primary packaging containment while the outer shell 18 and the cap cover 22 make up part ofthe secondary packaging containment. [0045] Also shown in FIG. 1 is a plunger 23 and a shaft 24 disposed within the inner cylindrical bore 26 ofthe inner cylinder 16. The plunger 23 is shown pushed against the diaphragm 20 as if in a fired position or a position wherein the jet injector 12 is spent, as further discussed below. The position shown also depicts a ready position for filling the ampule 10 with medication, for example, by removing the cap cover 22, placing the tip into a medicine vial and moving the shaft proximally to draw in the medication. As shown, the plunger 23 is in a sealing engagement with the internal surface ofthe inner cylinder 16, as further discussed below.

[0046] A resilient cap seal 27 is shown compressed between the cap 22 and the diaphragm 20 at the distal end of he ampule (FIG. 1). The cap seal 27 is disposed between the cap cover 22 and the distal end ofthe ampule 10 and is configured to be compressed by the cap and the diaphragm to provide compliance for the nozzle 28. When the ampule 10 is filled with medication (for example at the factory), the compressed cap seal 27 prevents the medication from leaking from the inner cylinder 16 via the nozzle 28 and as well as preserves the medication's sterility by preventing contaminants from passing through the nozzle and into the medication. Alternatively, instead of utilizing the cap seal 27 to seal the nozzle 28, the present embodiment may be practiced by configuring the cap 22 with a thicker cap ridge portion 30. This cap ridge portion 30 can then contact the diaphragm 20 at about the nozzle 28 to directly compress the nozzle. The diaphragm 20, as previously discussed, is made from an elastomer and is therefore resilient in nature. The diaphragm's resiliency allows it to be compressed against the cap ridge portion 30 to thereby provide a seal for the nozzle 28, without the need for a cap seal 27. [0047] Referring now to FIG. 2, there is shown the outer shell 18 provided in accordance with practice ofthe present invention. In an exemplary embodiment, the outer shell 18 is an integrally molded unit that has a cylindrical body 32, a distal end 34, and a proximal end 36. At the distal end 34, the outer shell 18 includes an end wall 38 with an end opening 40 centrally located therein. The distal end 34 also includes external threads 42 for engaging with the cap cover

22. However, instead of having external threads 42 to engage the cap, an aluminum shield can be removeably bonded to the outside surface ofthe end wall 38 to provide the necessary seal for the nozzle 28, which is similar to a seal in an over-the-counter medicine container. [0048] At the proximal end 36, there is shown a set of internal threads 44 and an enlarged portion 45. The internal threads 44 are configured to engage with the threaded nipple 14 (FIG. 1) for coupling the ampule 10 to the jet injector 12. However, as f rther discussed below in connection with FIG. 18 , instead of having the internal threads 44 at the proximal end, the outer shell 18 can include a smooth tapered sleeve. The tapered sleeve would allow the outer shell to telescopically fit over or into the distal end ofthe jet injector and be permanently affixed to the jet injector by either adhesive or welding. The enlarged portion 45 distal ofthe threads 44 is a relief point for a machine tool, which may otherwise be eliminated if the threads 44 were molded instead of machined.

[0049] Referring now to FIG.3 , there is shown a diaphragm 20 provided in accordance with practice ofthe present invention. The diaphragm includes a base portion 46, a top portion 48, and a protrusion 50, which comprises the nozzle 28. The base portion 46 includes a base 52 and a cross-sectional area that is proximate the cross-sectional area 47 ofthe cylindrical bore 41 (FIG. 2). The top portion 48 has a cross-sectional area that is proximate the cross-sectional area ofthe end opening 40. The diaphragm 20 is configured to slidingly engage with the cylindrical bore 41 ofthe outer shell 18 and rests within the bore at the distal end ofthe outer shell. In this rested position, the top portion 48 is received within the end opening 40 and is seated flushed with the external end surface ofthe end wall 38 (FIG. 1). The protrusion 50, however, projects outward from the flushed top portion 48 to provide a distinct contact point for the nozzle 28 when placed against the skin for injection. In an exemplary embodiment, the fit between the base portion 46 and the cross-sectional area 47 ofthe bore 41, and between the top portion 48 and the end opening 40 ofthe outer shell is preferably about zero to two thousandths total clearance.

[0050] As shown in FIG. 3 , the diaphragm 20 further includes a beveled cutout 54 that terminates into an orifice 56. The combination ofthe cutout 54 and the orifice 56 resembles a funnel and defines the nozzle 28 for discharging the medication. In an exemplary embodiment, the orifice 56 has an opening of about 0.005 to 0.010 inch, witharange of about 0.006 to 0.008 inch being more preferred.

[0051] Referring now to FIG. 4, there is shown an inner cylinder 16 provided in accordance with practice ofthe present invention. In an exemplary embodiment, the inner cylinder 16 is a cylindrical glass tube that has a first end 56a and a second end 56b. The inner cylinder 16 has an outer circumferential surface 58 configured to matingly abut against the cylindrical bore 41 ofthe outer shell 18. The inner cylinder includes the inner bore 26 for containing medication, as previously discussed. When the multi-component ampule 10 is assembled (FIG. 1), the inner cylinder 16 is configured to abut against the base 52 of the diaphragm 20 by its first end 56a and against the threaded nipple 14 by its second end 56b. The contact at the first end 56a is referred to as the first interface 62 and the contact at the second end 56b is referred to as the second interface 64. When the threaded nipple 14 is engaged and tightened against the internal threads 44, the first 62 and the second 64 interfaces are loaded and the seams defined by the interfaces are sealed from leakage (FIG. 1).

[0052] Glass is highly brittle and has a high modulus of elasticity. Glass also has a narrow proportional limit and readily fails with mmimum induced strain. Thus, if a glass ampule is used with a jet injector, the glass ampule will break and will explode unless it is adequately thick. This is because a pressure of about 3,000 to 3,500 psi, and about 5,000 to 6,000 psi at the start ofthe injection, is generally required to administer drugs subcutaneously without a needle. In the multi- component ampule 10 provided in accordance with practice of the present invention, the inner cylinder 16, which is made from glass, is braced by the plastic outer shell 18 for reinforcement. Together, the plastic outer shell 18 and the glass inner cylinder 16 have a combined hoop strength that is sufficient to contain the pressure generated by the jet injector 12 without making the glass unnecessarily thick.

[0053] For the outer shell 18 to adequately brace or reinforce the inner cylinder 16, the slack or clearance between the cylindrical bore 26 of the outer shell and the outer circumferential surface 58 of the inner cylinder should be sufficiently tight. In an exemplary embodiment, the clearance between the outer shell 18 and the inner cylinder 16 is preferably "hand-tight". That is, when the inner cylinder 16 is inserted into the outer shell 18, the insertion should not require tools or machines but only a force produceable by the hand. In other words, the fit between the components can be a non-interference fit. Examples of hand-tight clearance is clearance ranging from about zero to four thousandths total clearance, with about zero to two thousandths total clearance being preferred, and with about zero to one thousandths total clearance being more preferred. Examples ofthe inner cylinder 16 wall thickness can range from about 0.07 to 0.095 inch with 0.083 inch being more preferred. Examples ofthe outer shell 18 wall thickness can range from about 0.085 to 0.15 inch with 0.09 to 0.10 inch being more preferred. A person of ordinary skill in the art can appreciate that other thickness and total clearances other than the aforementioned ranges can be implemented and that these figures are exemplary only. Indeed, by changing the operating pressure, by using a glass compound, by using different plastic, by using a thinner glass and a heavier shell, etc., the fit between the inner cylinder and the outer shell and the wall thickness of the individual components can vary. Thus, such variations are contemplated to fall within the scope of the present invention.

[0054] Referring now to FIG. 5 and 6, there is shown a cap cover 22 provided in accordance with practice ofthe present invention. The cap cover 22 comprises internal threads 66 for threadedly engaging the external threads 42 located on the outer shell 18. The cap cover 22 includes a relief point 68 for machining the internal threads 66 but may be eliminated if the threads were molded rather than machined.

[0055] The cap cover 22 also includes an end wall 70 and a recessed portion 72 centrally disposed thereon. The recessed portion 72 is configured to receive a cap seal 27 (FIGs. 1 , 7, and 8). As previously discussed, the cap seal 27 provides the necessary seal to the nozzle 28 when compressed by the cap cover 22 and the protrusion 50 located on the diaphragm 20. The cap seal 27 may be made from a number of FDA approved soft rubber or elastomer, such as silicone rubber. Still referring to FIG. 5, there is shown a series of serration members 74 circumferentially disposed along the exterior surface ofthe cap cover 22 for better gripping the cap cover when the same is removed. However, a smooth exterior cap surface, a dispersed array of bumps or similar gripping means may also be practiced without deviating from the scope ofthe invention. [0056] Referring now to FIGs. 7 and 8, there is shown a cap seal 27 provided in accordance with practice of the present invention. The cap seal 27 shown can be made from a variety of FDA approved elastomers or thermoplastics, such as silicone rubber and PTFE. The cap seal 27 resembles a coin in that it is circular, has a thickness X, and a cross-sectional area. The cross-sectional area is configured to fit within the recessed portion 72 located on the end wall 70 of the cap cover 22. The fit between the cap seal 27 and the recessed portion 72 is slightly interference to slightly positive clearance. The cap seal 27 is configured to be compressed by the cap cover 22 and the nozzle 28 to provide a seal for the orifice 56. Preferably, the cap seal 27 provides about 0.005 to 0.030 inch compression when compressed by the cap cover and the nozzle, with a range of about 0.008 to 0.015 inch being more preferred. [0057] Referring now to FIG. 9, there is shown a threaded nipple 14 provided in accordance with practice ofthe present invention. In an exemplary embodiment, the threaded nipple 14 is symmetrical about a center flange 76 and has male threads 78 disposed on either side of the flange. The threaded nipple 14 also includes a bore 80, which acts as a channel to allow communication between the jet injector 12 and the ampule 10.

[0058] It can be appreciated that the threaded nipple 14 can be non-symmetrical and may depend on the relative dimensions ofthe receiving end ofthe jet injector 12 and the size ofthe proximal end 36 ofthe outer shell 18. For instance, the receiving end ofthe jet injector 12 may have a 0.5 inch threaded opening and the proximal end 36 of the outer shell 18 may have a 0.7 inch threaded opening. The threaded nipple 14 therefore will be non-symmetrical in order to accommodate the two different dimensions.

[0059] As discussed above, a plunger is configured to move from a proximal position to a distal position in the ampule 10 when the jet injector is fired to expel the medication out ofthe nozzle 28 (FIG. 1). The plunger moves by the action ofthe spring located within the jet injector, which is configured to push the piston, which then pushes the shaft, which then pushes the plunger to discharge the medication. The distal movement ofthe plunger compresses the medication and builds up pressure as it compresses the medication within the ampule space to deliver the necessary medication subcutaneously. The ampule space will herein be referred to as a variable medicine space, which is defined by the space between inner bore 26, the diaphragm 20, and the plunger. For reference purposes, this variable medicine space is labeled as medicine space 61 (FIG. 13 & 14, and further discussed below). The volume defined by the variable medicine space 61 will vary depending on the location ofthe plunger within the ampule 10. [0060] For pressure to adequately build within the medicine space 61 to a working pressure of about 3,000 to 3,500 psi, and about 5,000 to 6,000 psi at the start ofthe injection, the plunger must maintain a seal against the glass inner cylinder 16 as it travels distally in the inner bore 60 to discharge the medication out the nozzle 28. Leakage or blow-by of medication around the moving plunger should therefore be reduced to a minimum or even be eliminated as leakage will decrease the pressure build-up generated by the advancing plunger

[0061] Referring now to FIGs. 10 and 11, there is shown exemplary plungers 82, 84 provided in accordance with practice of the present invention. The exemplary plungers 82, 84 provide satisfactory sealing against the inner bore 26 ofthe glass cylinder 16 for building necessary operating pressure. Referring specifically to FIG. 10, the plunger 82 shown is symmetrical and includes two pusher ends 86, three marker rings 88, and two wells 90. The plunger 82 is symmetrical about the center marker ring 88 and is preferably practiced with a disposable jet injector, for reasons further discussed below. Due to its symmetrical configuration, the plunger 82 may be placed into the inner bore 26 of the glass cylinder 16 with either pusher end 86 in first. This flexibility facilitates automation by allowing a robotic machine to insert the plunger 82 into the ampule irrespective ofthe plunger orientation.

[0062] The plunger 84 shown in FIG. 11 is an alternative plunger. The plunger 84 is symmetrical about the center and includes two pusher ends 86, two marker rings 88, and one well 90. Both plungers 82, 84 may be made from an acceptable FDA approved elastomer such as silicone, ethylene-propylene-diene (EPDM), and the like. Alternatively, the plungers 82, 84 may have more than three marker rings, may have one or more marker rings with one or more a seal rings 88 (FIG. 12) or any combination thereof.

[0063] Referring now to FIG. 12, there is shown a shaft 24 with an over-molded plunger 23 on one end and an integrally molded ribbed section 92 on the other end. The integrally molded ribbed section 92 is configured to be pushed against by a piston as the piston is propelled by a spring to launch the plunger 23 into the inner bore 26 of the glass cylinder 16 towards the diaphragm 20 located at the distal end ofthe ampule 20 (FIGs. 1 and 15). The plunger 23 shown is another alternative plunger which includes a pusher end 86, a receiving end 92, a marker ring 88, a seal ring 94, and a well 90. The seal ring 94 is similar to the marker ring 88 except it is slightly wider and provides more surface contact with the inner bore 26 ofthe inner cylinder 16. The plunger 23 is removeably connected and co-molded to the shaft as described in the '525 serial number. The shaft 24 may be made from a number of plastic materials such as ABS, AB, polycarbonate, PNC plastic with fiberglass injection, and the like. The shaft 24 with the over-molded plunger 23 is preferably used with the reusable injector.

[0064] FIG. 13 shows the multi-component ampule 10 in a filled position or ready position. The ampule 10 may be filled with medication in a sterile environment and packaged in the configuration shown. In the filled position, the shaft 24 is drawn proximally and extends beyond the proximal end ofthe nipple 14. Medicine or injectable suspension of pre-determined quantity is filled within the medicine space 61, which is the space defined by the glass inner bore 60, the diaphragm 20, and the plunger 23. In this filled position, the plunger 23 is withdrawn proximally but still remains in contact with the glass inner cylinder 16. That is, the plunger 23 does not move proximally beyond the proximal end ofthe inner cylinder 16, such as into the bore 80 of he nipple 14. By limiting the maximum proximal movement of the plunger 23, the medicine that is filled within the medicine space 61 is only in contact with FDA approved package materials for long term storage. This ensures prolonged storage capability when the medication is only in contact with the primary packaging containment, which includes the inner cylinder 16, the plunger 23, and the diaphragm 20. Optionally, the exterior surface ofthe ampule 10 (i.e., the outer shell 18) may have markings to identify the level or volume of medication that is filled within the ampule.

[0065] The filled multi-component ampule 10 shown in FIG. 13 is configured to be received by a jet injector, such as those shown in FIGs. 15-17, shown in US Pat. Nos. 5,499,972; 5,569, 189; and 5,704911 ; and shown in serial number 09/751 ,525. The jet injector may receive the ampule 10 by threading the nipple 14 into a threaded end of the jet injector (FIG. 15) or by permanently attaching the ampule via adhesive or welding with the jet injector (FIG. 18).

[0066] Turning to FIG. 14, there is shown a filled multi-component ampule 10, as discussed in connection with FIG. 13, with a protective housing 95 mounted to the proximal end of the threaded nipple 14. The protective housing 95 can be made from a transparent thin-walled plastic such as polyethylene or polycarbonate. The protective housing 95 includes an open base 96, an enclosed tip 98, and a threaded internal bore 100 for threadingly engaging with the nipple 14. As readily understood, the protective housing prevents the shaft 24 from being accidentally moved or bumped during packaging or shipping. In addition, the protective housing 95 also preserves the sterility of the medication by acting as an enclosure and eliminating leak source or path that can contaminate the medication. Although the protective housing 95 is shown with a tapered neck 102, the protective housing can have the shape of a uniform cylinder or any variation thereof provided it serves the aforementioned functions. The filled ampule 10 with the protective housing 95 may be packaged in the manner described in the '525 serial number for shipping and storing. It is understood that the shape of the packages described in the '525 serial number will have to be modified to accommodate the ampule 10 described herein.

[0067] Turning to FIGs. 15 and 16, there is shown an exemplary use of the multi- component ampule 10 in accordance with practice of the present invention. In an exemplary embodiment, the filled ampule 10 (FIGs. 13 and 14) can be removed from its packaging material and assembled onto the re-useable jet injector 12 by threading the nipple 14 into the receiving end 96 of the jet injector. Once the filled ampule 10 is installed, the jet injector assembly 98 is ready for injection (FIG. 15).

[0068] The re-useable jet injector 12 showninFlGs. 15 and 16 is substantially the same as those disclosed in the 5,499,972; 5,569,189; and 5,704,911 patents. Generally speaking, the jet injector 12 shown in FIGs. 15 and 16 includes an injector housing 100, amain spring 102 for driving a piston 104 against the shaft 24, which in turn drives the plunger 23 into the medicine space 61 to discharge the medicine out ofthe nozzle 28. The jet injector 12 also includes a trigger 106 that is pivoted on a pivoting pin 108 and held in an inward direction by a secondary spring 110. The trigger 106 is mechanically connected to a trigger extension arm 112, which provides the means for depressing or activating the trigger.

[0069] A safety ring 114 is provided at the distal end ofthe jet injector 12 that is in sliding engagement with a plastic sleeve 116. When the safety ring 114 is engaged, by sliding the safety ring proximally with respect to the plastic sleeve 116 until it comes to rest under the trigger extension arm 112, a downward movement by the trigger extension arm 112 about the pivoting pin 108 is delimited by the safety ring. The plastic sleeve 116 is in concentric relationship with the jet injector 12 and may be secured to the distal end ofthe jet injector by detents, tongue and groove means, fasteners, adhesive, or the like. [0070] The main spring 102 is held in a compressed or cocked position by the trigger ' s engagement tip 118, which engages the flange 119 on the piston 104. As readily apparent, disengagement ofthe engagement tip 118 from the piston 104 by depressing on the trigger extension arm 112 will cause the main spring 102 to uncoil and propel the piston 104 distally. When so propelled, the piston 104 moves distally and pushes against the shaft's receiving end 92, which pushes the shaft 24 distally. As previously discussed, this causes the plunger 23 to propel forward and compresses the medication, which then discharges out ofthe nozzle 28. It is understood that the cap 22 must be removed and the nozzle 28 placed against the skin of a patient before the trigger is fired for an effective delivery.

[0071] FIG. 16 shows the jet injector assembly 98 of FIG. 15 in a fired or discharged state. As shown, the trigger extension arm 112 is depressed, the main spring 102 is fully uncoiled, the piston 104 is advanced distally against a stop member 120, and the shaft 24 and plunger 23 are advanced distally toward the diaphragm 20. It can be appreciated that the plunger 23 is preferably advanced until it contacts the diaphragm 20 so that all or substantially all of the medication is discharged out ofthe nozzle and into the patient (FIG. 16). This maximum distal travel minimizes wastes, as certain medications can be quite costly. Although the trigger extension arm 112 is shown depressed (FIG. 16), the trigger extension arm should pivot radially outward due to the secondary spring 110 (FIG. 15) immediately upon release ofthe trigger extension arm by the user.

[0072] Referring now to FIG. 17, there is shown an and alternative use for the multi- component ampule 10 with a disposable jet injector provided in accordance with practice of the present invention, generally designated as 122. The jet injector assembly 122 depicted in FIG. 17 is a disposable type and resembles the type disclosed in the '525 serial number. The jet injector assembly 122 shown is termed disposable because once the medicine is dispensed following an injection, the entire jet injector assembly 122 is preferably discarded. The multi-component ampule 10 is used with the jet injector 124 by threading the nipple 14 to the receiving end of the jet injector in a similar manner as discussed with the re-useable model (FIGs. 15 and 16). The disposable jet injector 122 is shown in a fired or dispensed position.

[0073] Broadly speaking, the disposable jet injector 124 includes a housing 125, a main spring 126, a piston 128, a shaft 130, a trigger 132, and a safety device 134. The shaft further includes a gripping ball 140, a shoulder 136, and first and second cushion members 138a, 138b for limiting the distal movement of the shaft 14. This is implemented by configuring the cushion member 139b to abut the end ofthe nipple 14 when the shaft is propelled distally during an injection. The gripping ball 140 at the proximal end ofthe shaft 130 provides a gripping surface for a gripping tool (not shown) to grip and load or cock the main spring 126, as discussed in the '525 serial number.

[0074] When the shaft 130 is grasped and drawn proximally (towards the left of FIG.

17), the cushion member 138b pushes against the piston 128, at the drum portion 135 ofthe piston.

As the shaft 130, cushion member 138b, and drum portion 135 moves proximally past the engagement tip 123 located on the trigger 132, the engagement tip 123 pivots downward, about a pivotpoint 129, to lock the piston and the spring 126. The contact between the engagement tip 123 and the drum portion 135 ofthe piston 128 maintains the spring 126 in the compressed position until the jet injector is fired (not shown). As disclosed in the '525 serial number, subsequent to cocking the jet injector assembly 122 by grasping and pulling on the shaft to lock the drum portion 135 against the engagement tip 123, the shaft remains freely moveable. That is, the shaft 126 still freely moves within the piston 128, as the shaft is coaxially disposed within the piston.

[0075] In an exemplary embodiment, the shaft 130 has a substantially flat distal end

131 (FIG. 17) and is not coupled to the plunger 82, which is preferably of a symmetrical type plunger. The advantage of using a symmetrical plunger is that the disposable jet injector assembly 124 is contemplated to be assembled automatically by robotic machines. Therefore, having components that are symmetrical or that are easily recognizable by the robotic machines will facilitate the automation process. Thus, the shaft distal end 131, since it does not attach to the plunger 82, can take on a number of configurations including a beveled end, a cone end, a flat end, etc.

[0076] As readily apparent, the disposable jet injector assembly 122 shown is intended to be pre-filled and packaged with medication at the factory (as the shaft 130 and the plunger 82 are not attached to provide means for filling the ampule 10). The pre-filled multi-component ampule 10 may be packaged and shipped either as two separate components (with the multi-component 10 pre-filled and separately packaged from the disposable jet injector) or pre-filled and packaged together as shown in FIG. 17. In an injection application for a separately packaged embodiment, the user simply removes the packaging material from both the disposable jet injector and the multi- component ampule and then thread the nipple 14 onto the disposable jet injector housmg. Then depending on the dosage needed, the user may move the shaft 130 distally, after removing the cap 22, to release excess medication contained within the ampule.

[0077] Although shown with the symmetrical plunger, the disposable jet injector assembly 122 may also be practiced with the plunger co-molded or attached to the shaft 130 and packaged with the spring pre-cocked at the factory. In this alternative application, when the end user uses the jet injector assembly 122, he or she will have to fill the multi-component ampule 10 with medication by grasping and pulling the shaft proximally to draw in the medication.

[0078] FIG. 17 shows the disposable jet injector assembly 124 in a fired or discharged state (as the spring is released). Thus, it is understood that the end cap 22 should be removed from the ampule 10 before the trigger 132 is depressed to deliver the medication subcutaneously. Although FIG. 17 shows the plunger 82 spaced apart from the diaphragm, it is understood that the present embodiment is preferably practiced with the plunger 82 moved completely distally until it touches the diaphragm to thereby ensure that all the mediation is discharged and not wasted by remaining in the medicine apace 61.

[0079] Referring now to FIG. 18, there is shown an alternative interface for connecting a modified multi-component ampule 141 to the disposable jet injector 124. In the alternative embodiment, the proximal end ofthe outer shell 18 ofthe modified multi-component ampule 141 is configured to include an integrally molded coupler 142 rather than internal threads 44 as discussed with reference to FIGs. 1 and 2. The modified outer shell 18 can be filled with medication in a sterile environment with the cap 22 and the plunger 82 acting as seals to preserve the sterility ofthe medication. [0080] In a corresponding fashion, the disposable jet injector 124 is configured to include an integrally molded sleeve 144. The coupler 142 on the ampule 141 is configured to fit over the sleeve 144 on the disposable jet injector 124. Once the coupler and the sleeve are mated, the interface between the two can be welded by heat or ultrasound or permanently affixed via adhesive. Still alternatively, the coupler 142 may be molded with spaced apart ridges 146 so that after the coupler is fitted with the sleeve 144, heat or ultrasonic energy may be applied to'the interface region to cause the ridges to melt and to fuse the jet injector and the ampule together. When implemented, the fusion provides for a more permanent attachment. [0081] FIG. 19 shows an alternative multi-component ampule 150 having a generally flushed nozzle in a filled state with a protective housing 95 provided in accordance with practice of the present invention. The alternative multi-component ampule 150 includes essentially the same components as the multi-component ampule 10 disclosed with reference to FIGs. 1 and 14. For example, multi-component ampule 150 includes essentially the same protective housing 95, nipple

14, shaft 24, plunger 23, diaphragm20, and inner glass cylinder 16. However, the cap cover 152 and the shell 154 have been modified to provide the multi-component ampule 150 with a flushed diaphragm 20 to outer shell configuration.

[0082] Referring specifically to FIG. 20, the modified outer shell 154 includes an end wall 156 that has a recessed portion 158 and a tapered cone section 160, which is also recessed within the end wall. The end wall 156 is configured to receive the diaphragm 20 in a flushed configuration by having a structure that corresponds to the contour ofthe diaphragm. For example, the tapered cone section 160 is configured to receive the diaphragm's protrusion 50, the recessed portion 158 is configured to receive the diaphragm's top portion 48, and the cylindrical bore 41 is configured to receive the diaphragm's base portion 46. As a result, the nozzle 28 located on the diaphragm 20 is positioned flushed or substantially flushed with the end exterior surface of the modified outer shell 154 (FIG. 19).

[0083] With a flushed or substantially flushed diaphragm 20 to outer shell 154 arrangement, the cap cover 152 is modified to include a relatively shallower recessed portion 72 than the cap cover 22 shown in FIGs. 1 and 6. Among other things, this modification is implemented to take up the space that is vacated by the diaphragm's protruding nozzle section 28, 50. As readily apparent, by molding the cap ridge portion 30 with a relatively thicker dimension than the same dimension shown in FIGs. 1 and 6, the same cap seal 27 may be used to provide the necessary compliance or crushed to properly seal the nozzle 28 from leak/contamination. Alternatively, the cap cover 152 can be the same as the previously described cap cover 22 (FIG. 6) but the cap seal 27 is modified to have a wider thickness X to provide the necessary compliance or crushed to seal the nozzle 28. Under either scenario, a cap seal 27 compression of about 0.005 to 0.030 inch is preferred, with a range of about 0.008 to 0.015 inch being more preferred.

[0084] Use ofthe multi-component ampule 150 shown in FIG. 19 is the same as for the multi-component ampule 10 shown with reference to FIGs. 15-17.

[0085] Referring now to FIG. 21, there is shown an alternative disposable jet injector assembly 162, which incorporates a threaded male nipple 164 into the distal end of a disposable jet injector 166 to directly couple with the multi-component ampule 150. In directly coupling the jet injector 166 with the multi-component ampule 150, the threaded nipple 14, which is used with the disposable jet injector assembly shown in FIG. 17, is eliminated. Although the jet injector 166 is shown without a spring, the spring is assumed to be disposed in between the piston 128 and the housing 125, and coaxially over the shaft 130, similar to FIG. 17. [0086] The jet injector assembly 162 is shown in a filled state, with The multi- component ampule 150 having a symmetrical plunger 82 disposed near the proximal end ofthe inner glass cylinder 16 and medicine contained within the medicine variable space 61. Preferably, medicine is separately pre-filled in the multi-component ampule 150, under a sterile environment, before it is assembled onto the jet injector 166. Preferably, the pre-filled multi-component ampule 150 is then assembled onto the jet injector 166 and the assembled disposable jet injector assembly

162 packaged for storage and/or shipping.

[0087] Although the preferred embodiments ofthe invention have been described with some specificity, the description and drawings set forth herein are not intended to be delimiting, and persons of ordinary skill in the art will understand that various modifications may be made to the embodiments discussed herein without departing from the scope of the invention, and all such changes and modifications are intended to be encompassed within the appended claims. Various changes to the ampule may be made including manufacturing the dimensions differently, using different FDA approved materials, changing the tolerances, etc. Other example of changes may include modifying the way the ampule is connected to the jet injector, the way the shaft and the piston are shaped/configured, and the way the plunger is shaped/configured. Accordingly, many alterations and modifications may be made by those having ordinary skill in the art without deviating from the spirit and scope ofthe invention.

Claims

CLAIMSWhat 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 ofthe 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 ofthe 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 ofthe 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 ofthe 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 portior ofthe 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 ofthe 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 ofthe 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 ofthe 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 ofthe diaphragm and the tapered portion is configured to receive a nozzle section ofthe 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 ofthe 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 ofthe 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 ofthe diaphragm and the tapered portion is configured to receive the nozzle section ofthe 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 claim45, 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 claim48, 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 ofthe 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.