Cross-Rcfcrence to Related Application

This application claims the benefit of U.S. Provisional Application No. 62/041 ,344, filed on August 25, 2014, which is incorporated herein by reference in its entirety.

Field of Invention

This invention relates to medical devices for injection of liquids. More particularly, this invention relates to plastic ampoules suitable for dispensing liquid for injection into a patient.

Background of the Invention

Ampoules made of a thermoplastic material such as polyethylene, polypropylene, and the like are known in the art. Attempts have also been made to produce collapsible ampoules, but such attempts have met with limited success inasmuch as complete evacuation of ampoule contents, and thus accurate dosing of the ampoule contents to be dispensed, has been difficult to achieve, especially when the amounts to be dispensed are relatively small.

The ampoules described hereinbelow avoid or substantially overcome the shortcomings of prior art ampoules and provide an ampoule particularly well suited for dispensing accurate doses of injectable liquids.

Summary of Invention

A hermetically sealed, prefilled ampoule has a body portion, a neck portion unitary with the body portion, a dispensing device extending from the neck portion and defining a delivery aperture, a removable, protective cap over the dispensing device and occluding the delivery aperture, and a frangible web unitary with the cap. The body portion provides an internal cavity containing a liquid and is defined by hollow, collapsible bellows constituted by a front bellows portion, a back bellows portion and a concave, i.e., bulging inwardly, end wall. The front bellows portion is contiguous with the neck portion. The back bellows portion is contiguous with the end wall and is collapsible against the front bellows portion to evacuate fully the internal cavity of the body portion by a force applied inwardly against the end wall. In a preferred embodiment, the back bellows portion has an inherent over-the-center bias toward contact with inner surface of the front bellows portion when moved into collapsed configuration.

The dispensing device can be a nozzle, a hypodermic needle, a combination of both, and the like. When the dispensing device is a nozzle, the nozzle can have a male luer lock taper for receiving a female luer lock fitting of a hypodermic needle. The nozzle can be unitary with the neck portion, or can be a separate, preformed insert mounted in the neck portion.

Brief Description of the Drawings

In the drawings,

FIGURE 1 shows a side elevation, partly in section, of an ampoule embodying the invention and provided with a preformed insert with a hypodermic needle in the neck portion of the ampoule;

FIGURE 2 shows the ampoule of FIGURE 1 with hypodermic needle exposed and the protective cap removed;

FIGURE 3 shows the ampoule of FIGURE 2 with the bellows portion thereof collapsed;

FIGURE 4 shows a side elevation, partly in section, of an alternate ampoule embodying the invention, wherein the hypodermic needle is mounted to the dispensing needle by luer lock connection fittings on the dispensing nozzle and the hypodermic needle;

FIGURE 5 shows the ampoule depicted in FIGURE 4 with protective cap removed and the hypodermic needle exposed;

FIGURE 6 shows side elevation, partly in section, of yet another ampoule embodying the invention;

FIGURE 7 shows the ampoule in FIGURE 6 with protective cap removed and the hypodermic needle exposed;

FIGURE 8 shows side elevation, partly in section, of a further ampoule embodying the invention, wherein the end wall of the bellows portion is provided with a depending stem portion;

FIGURE 9 shows the ampoule of FIGURE 8 with protective cap removed and hypodermic needle exposed; FIGURE 10 shows the ampoule of FIGURE 8 with the bellows portion thereof collapsed;

FIGURE 1 1 shows side elevation, partly in section, of another ampoule embodying the invention wherein the dispensing nozzle terminates in a male luer lock fitting and the delivery aperture of the nozzle is occluded by a protective twist-off cap;

FIGURE 12 shows the ampoule of FIGURE 1 1 with the protective cap removed and a hypodermic needle with a female luer lock fitting mounted to the nozzle;

FIGURE 13 shows an ampoule similar to that shown in FIGURE 1 1 further provided with a dependent stem portion that extends away from the end wall;

FIGURE 14 shows the ampoule of FIGURE 13 with the protective cap removed and a hypodermic needle with a female luer lock fitting mounted to the dispensing nozzle; and

FIGURE 15 is an enlarged view, partly in section, of the bellows portion of an ampoule embodying the invention.

Detailed Description of Preferred Embodiments

The ampoules described herein are well suited as disposable items for delivery of a medicament to a patient in unit dosage form by injection. These ampoules can be prefilled with a predetermined amount of a desired liquid medicament during manufacture utilizing a blow-fill-seal system of the type described in U.S. Patent No. 4,707,966 to Weiler et al., which is incorporated herein by reference in its entirety.

Referring to the drawings, FIGURE 1 shows an ampoule 10 provided with a twist-off enclosure or protective cap 12. Ampoule 10 has body portion 14 which is unitary with neck portion 16. Dispensing device 18 is received within neck portion 16 and comprises cylindrical plug 20 with collar 22 mounted in neck portion 16 and nozzle 24 that extends beyond neck portion 16 and terminates in hypodermic needle 26 enveloped by overcap 28 which, in turn, is surrounded by protective cap 12 with tabs 30 and 32. Overcap 28 terminates in flange 34. If desired, a portion of plug 20 can be provided with a scabrous surface 21. The cylindrical plug defines an internal flow passageway to nozzle 24 and may include a one-way valve that prevents return flow of liquid back into body portion 14.

Protective cap 12 is unitary with neck portion 16 and is delineated therefrom by frangible membrane or web 37.

Body portion 14 is unitary with neck portion 16 and comprises hollow, collapsible bellows having a front bellows portion 36 associated with back bellows portion 38 and end wall 40. The front bellows portion 36 is contiguous with neck portion 16. The back bellows portion 38 is contiguous with concave end wall 40 and is collapsible against front bellows portion 36 by a force applied inwardly against the end wall so as to expel substantially the entire volume of liquid contained within the body portion of the ampoule.

Preferably back bellows portion 38 is fabricated with an inherent over-the-center bias toward contact with the inner surface of the front bellows portion 36 when moved or urged into collapsed configuration while the ampoule contents is dispensed through hypodermic needle 26.

Nozzle 24 and plug 20 have a central flow passageway (not shown) which provides flow communication between hollow body portion 14 and hypodermic needle 26 when bellows portion 24 is collapsed.

To dispense a liquid contents from body portion 14, protective cap 12 and overcap 28 are removed by twisting protective cap 12 so as to expose hypodermic needle 26.

Ampoule 10 with protective cap 12 and overcap 28 removed is shown in FIGURE 2.

To dispense a liquid contents from body portion 14, concave end wall 40 is pushed inwardly toward the position shown in FIGURE 3 so that back bellows portion 38 is urged toward and collapses against front bellows portion 36.

Referring to FIGURE 4, ampoule 50 likewise comprises a twist-off protective cap 52 hollow body portion 54 unitary with neck portion 56. Dispensing device 58 is mounted in neck portion 56 and comprises cylindrical plug 60 with collar 62 and nozzle 64 extending beyond neck portion 56. Scabrous surface 61 is provided on a portion of the external surface of plug 60 to facilitate retention of plug 60 in neck portion 56 after molding. In this particular embodiment, nozzle 64 is configured to receive female luer lock fitting 67, i.e., the nozzle 64 has the configuration of a male luer lock fitting. Flange 69 of luer lock fitting 67 is retained in neck portion 56. Protective cap 52, provided with tabs 70 and 72, envelops overcap 68 and flange 74 and is removed together with protective cap 52 when hypodermic needle 66, permanently held by neck portion 56 on nozzle 64 is exposed in preparation for use.

Frangible web 77 delineates protective cap 52 from neck portion 56 and is broken when tabs 70 and 72 are twisted.

The bellows of body portion 54 is the same as that for the embodiment shown in FIGURES 1-3 and functions in the same manner. That is, front bellows portion 76 is contiguous with neck portion 56 and back bellows portion 78 is contiguous with concave end wall 80.

FIGURE 5 shows the ampoule of FIGURE 4 after removal of protective cap 52 and hypodermic needle overcap 68 in preparation for use.

Ampoule 90 shown in FIGURE 6 comprises protective cap 92 over dispensing device 98 situated in neck portion 96 thereof. Body portion 94 is hollow and is unitary with neck portion 96. Cylindrical plug 100 with collar 102 is part of dispensing device 98 and is provided with nozzle 104 contoured as a male luer lock fitting. Hypodermic needle 106 having a female luer lock fitting 107 with flange 1 19 is fitted over nozzle 104. Hypodermic needle 106 is also provided with overcap 108 that terminates at its open end in flange 1 14.

Tabs 1 10 and 1 12 on protective cap 92 facilitate removal of cap 92 by twisting when frangible web 1 17 joining protective cap 92 with neck portion 96 is severed.

Body portion 94 comprises front bellows portion 1 16, back bellows portion 1 18 and end wall 120. Front bellows portion 1 16 is unitary with neck portion 96 and contiguous therewith. Back bellows portion 1 18 is contiguous with front bellows portion 1 16 and with end wall 120.

Body portion 94 contains the liquid to be dispensed through hypodermic needle 106.

Prior to use body portion 94, the liquid-containing compartment, is sealed from hypodermic needle 106 by a breakable membrane, a one-way flow control valve such as spring-biased ball 101, and the like, in the dispensing device 98 and which opens a flow passageway when external pressure is applied to collapse the bellows portion 1 16 and 1 18. Other suitable one-way flow control valves that can be utilized are duckbill valves, umbrella valves, belleville valves, dome valves, and the like.

FIGURE 7 shows ampoule 90 ready for use, with protective cap 92 removed and hypodermic needle 106 exposed.

Referring to FIGURE 8, ampoule 130, while similar to ampoule 90 shown in FIGURES 6 and 7, is further provided with stem 162 which extends from end wall 160 and facilitates the dispensing of ampoule contents.

Ampoule 130 has a twistable protective cap 132 with tabs 150 and 152 that envelops hypodermic needle 146 as well as its overcap 148 with flange 154. Frangible web 157 unitary with cap 132 and neck portion 136 delineates cap 132 from neck portion 136. Nozzle 144 carried by plug 140 with collar 142 is part of dispensing device 138 and is contoured as a male luer lock fitting and receives the female luer lock fitting 147 of hypodermic needle 146. Flange 159 of female luer lock fitting 147 is retained in neck portion 136.

Plug 140 is similar to plug 100 shown in FIGURE 6 and is held in the neck portion 136 of ampoule 130. Plug 140 is provided with a through passageway which is in flow communication with hollow body portion 134 as well as nozzle 144 and hypodermic needle 146. A one-way valve, usually a biased one-way ball valve, is situated in the through passageway.

Front bellows portion 156, back bellows portion 158 and end wall 160 together with stem plunger 162, unitary with concave end wall 160, define body portion 134 of ampoule 130. The back bellows portion 158 is wider than the front bellows portion 156 by about 15 percent.

Plunger 162 facilitates collapsing of the bellows and comprises stem 164 that terminates in foot portion 164 and can be hollow or solid as desired.

FIGURE 9 shows ampoule 130 with protective cap 132 removed and hypodermic needle 146 exposed and ready for use.

FIGURE 10 shows ampoule 130 with body portion 134 collapsed after the liquid contents thereof has been dispensed. Stem 162 optionally can be provided with a peripheral barb or a plurality of barbs that interlock with the neck portion 136 and prevent re-use of the ampoule.

FIGURE 1 1 shows an ampoule that has been fabricated in its entirety by blow molding. In particular, ampoule 170 comprises a body portion 174 unitary with neck portion 176 which includes dispensing device 178 in the form of unitary nozzle 184, and protective cap 172 which is unitary with nozzle 184 and occludes aperture 185 at the distal end of nozzle 184. Cap 172 includes twist-off tab 180 which is separated from nozzle 184 by frangible web 187.

Body portion 174 comprises front bellows portion 186, back bellows portion 188 and end wall 190.

Nozzle 184 is contoured to provide a male luer lock fitting. When ampoule 170 is prepared for use, protective cap 172 is removed and a hypodermic needle is fitted onto nozzle 184.

As shown in FIGURE 12, hypodermic needle 196 with female luer lock fitting 197 is positioned on nozzle 184. If desired, nozzle 184 having the male luer lock contour can be a prefabricated, usually injection molded, piece which is inserted into the neck portion 176 of the ampoule during the blow molding process.

A variant of the ampoule embodiment depicted in FIGURES 1 1 and 12 is shown in FIGURES 13 and 14 as ampoule 200 having body portion 204, neck portion 206, and protective cap 202 occluding nozzle 214 which serves as the dispensing device 208. Cap 202 is provided with tab 210 and is attached to the distal end of nozzle 214 by unitary frangible web 217. Body portion 204 comprises front bellows portion 216, back bellows portion 218 and concave end wall 220. The back bellows portion 218 is wider than the front bellows portion 216 by about 15 percent. Plunger 222 extends from end wall 220 and is unitary therewith.

Plunger 222 has stem 224 which terminates in foot 226. Plunger 222 can be solid or hollow, as desired. Preferably, stem 224 is hollow so as to trap any air present in body portion 204. Stem 224 can be provided with longitudinal ribs for enhanced rigidity, if desired.

Upon removal of protective cap 202, hypodermic syringe 216 with female luer lock fitting 227 can be fitted over nozzle 214 as shown in FIGURE 14. The function and operation of plunger 222 is the same as that described for plunger 162 in FIGURES 13 and 14.

The length of plungers 162 and 222 is equal at least to the depth of the body portion of the ampoule. Preferably, the plungers are about twice as long as the depth of the body portion of the ampoule.

FIGURE 15 shows collapsible bellows-type body portion 304 of an ampoule containing injectable liquid 305. Body portion 304 is defined by front bellows portion 316, back bellows portion 318 and end wall 320.

In the body portion of the ampoules described herein, the included angle between the front bellows portion and the back bellows portion is about 90 degrees. Relative to an imaginary plane P that bisects the body portion of the ampoule at the juncture of the front bellows portion and the back bellows portion, the angle between the front bellows portion and the imaginary plane (angle a) is greater than the angle between back bellows portion and the imaginary plane (angle β) as shown in FIGURE 15. Preferably angle a is greater than 45 degrees and angle β is less than 45 degrees.

Ampoules described herein can be made using blow-fill-seal packaging technology that utilizes in-line forming and sealing of a polymeric material to a container of desired shape. A blow-fill-seal machine includes a polymer granule storage and feeding system, a screw extruder with parison head, a sterile air-filling chamber, mold halves to form and close the container, and downstream equipment including, for example, leak-detecting systems. Aseptic processing equipment, such as stainless-steel tanks and sterile filters, ensure that the blow-fill-seal machine is fed with sterile liquid. Polymer granules are fed via a vacuum tubing system into the hopper of the blow-fill-seal extruder, where they are heated to form a melt (about 160-210 degrees C). The homogeneous polymer melt is formed via a circular orifice into a plastic parison (hollow tube), which is prevented from collapse by a stream of sterile filtered air. The lower part of the divided mold halves can now close to seal the bottom of the open parison. The parison wall is blown and/or sucked into the cooled mold walls to form the lower part of the container. A filling mandrel introduces a predetermined volume of product into the container and, after withdrawal of the filling mandrel, the upper part of the mold closes to form and seal the upper part of the blow-fill-seal container. Thus, the forming, filling and sealing steps are made in one unit operation.

The typical materials used in blow-fill-seal molding comprise polyethylene, polypropylene, and the like. Both are considered inert and give a good balance of properties, enabling easy forming, opening and handling of the finished container.

The foregoing description and the drawings are illustrative of the present invention. Still other variants and rearrangements of parts are possible and will readily present themselves to those skilled in the art.