US3650084A

US3650084A - Method for filling and sealing plastic ampoules

Info

Publication number: US3650084A
Application number: US4884A
Authority: US
Inventors: Stephen T Moreland
Original assignee: Catalent Pharma Solutions Inc
Current assignee: Catalent Pharma Solutions Inc
Priority date: 1968-01-15
Filing date: 1970-01-22
Publication date: 1972-03-21
Anticipated expiration: 1989-03-21

Abstract

An ampoule for a hypodermic jet injector. The end of the ampoule, through which medicament passes, is constructed of a resilient material. Cross-cuts are scribed in the resilient end so that a plunger driving a plug into the opposite end of the ampoule forces medicament through the cross-cut end by bursting it along lines coincident with the cuts. Alternate end cuts, a storage case, and methods for filling the ampoules are also disclosed.

Description

United States Patent M r land 1 51 Mar. 21, 1972 [54] METHOD FOR FILLING AND SEALING References Cited PLASTIC AMPOULES UNITED STATES PATENTS [721 Mm'andv Gmsse Pime 107,582 9/1870 Wolfe et a1. ..53/32o 2,501,652 3/1950 Barrickman ..53/37 [73] Assignee: R. P. Scherer Corporation 2,645,338- 7/1953 Scherer 128/173 H UX I 3,267,636 8/1966 Stemberg ..53/35 3,552,095 1/1971 Inman ..141/247 x 211 Appl. No; 4,884

Primary Examiner-Edward .l. Earls Related Application Data Attorney-Molinare, Allegretti, Newitt & Witcoff [62] Division of Ser. No. 697,891, Jan. 15, 1968, Pat. No.

3 540 444 [57] ABSTRACT An ampoule for a hypodermic jet injector. The end of the am- [52] U.S. Cl ..53/37,li3l/23,15:fifi8i poule through which medicament passes, is constructed of a 51 I t 1565b 7/28 resilient material. Cross-cuts are scribed in the resilient end so E g 267 268 that a plunger driving a plug into the opposite end of the ampoule forces medicament through the cross-cut end by bursting it along lines coincident with the cuts. Alternate end cuts, a storage case, and methods for f lling the ampoules are also disclosed.

1 Claims, 16 Drawing Figures EATENTED MAR 21 I972 SHEET 1 BF 3 Sig 06272 I'M/oreland PATENTEDMARZI I972 9, 650,084

sum 2 UF 3 II'I'IJIIIIIIIIIIII I l 22 H i I 2/6 72507: 525 070427; 77. Morelana? METHOD FOR FILLING AND SEALING PLASTIC AMPOULES CROSS REFERENCE TO A RELATED APPLICATION This is a division of application Ser. No. 697,891, filed Jan. 15, 1968, now U.S. Pat. No. 3,540,444.

BACKGROUND OF THE INVENTION This invention relates to an improved ampul for use with a hypodermic jet injector and a method of filling the ampul.

There are presently available various types of hypodermic jet injector devices. Typical of those available is the one shown in U.S. Pat. No. 2,754,818 granted to Scherer on July 17 1956. In a jet injector of the type disclosed by Scherer, an ampul filled with medicament is positioned in the discharge end of the injector. The ampul includes a main body section, which is usually formed from a stainless steel material, and a plug which fits in an open end of the ampul.

The plug is driven by a plunger of the jet injector into the body of the ampul forcing medicament out through an opening in the opposite end of the ampul and through the nozzle orifice of the jet injector. Medicament which passes through the nozzle orifice then pierces the skin of the patient and enters the patient. Such a device has been quite favorably received and is especially useful for mass innoculation programs.

A type of ampul heretofore utilized with a hypodermic jet injector is disclosed in U.S. Pat. No. 2,688,968 granted to Scherer, on Sept. 14, 1954. Such an ampul includes an opening in one end of the capsule for the passage of medicament and a displaceable driving plug at the opposite end of the ampul. While these ampuls are very satisfactory, they are not transparent which is a desirable characteristic for ampuls. Moreover ampuls of this construction make direct contact with the patients skin, the medicament being discharged through the orifice in the ampul. Thus, protection against slippage of the ampul by a discharge nozzle attached to the jet injector and especially constructed to prevent slippage is not possible.

SUMMARY OF THE INVENTION In a principal aspect the present invention comprises an improved ampul for use with a hypodermic jet injector, the ampul being comprised of a cylindrically shaped capsule with one open end and a plug which fits into the open end. The opposite end of the capsule is rounded and is made from a flexible material. The rounded end has a pattern of cuts. Thus the pressure created inside the ampul by forcing a plunger against the plug causes the closed end to burst along seams coincident with the cuts in the closed end. There is also disclosed a method of filling the ampuls with medicament in addition to various embodiments of the invention and packaging means for the improved ampul.

It is thus an object of the present invention to provide an improved ampul for use with a hypodermic jet injector unit.

It is a further object of the present invention to provide a rugged yet economical ampul for use with a hypodermic jet injector unit.

Still another object of the present invention is to provide a method for filling the improved ampul with medicament.

One further object of the present invention is to provide an improved ampul with a corresponding improved nozzle construction.

These and other objects, advantages and features of the present invention will be more fully understood by reference to the detailed description which follows.

BRIEF DESCRIPTION OF THE DRAWINGS In the detailed description which follows, reference will be made to the drawings which include the following figures:

FIG. 1 is a side cross-sectional view of a first embodiment of the improved ampul in a container case;

FIG. 2 is a left-hand end view of the embodiment shown' in FIG. 1;

FIG. 3 is a cross-sectional view of the embodiment shown in FIG. 1 taken substantially along the line 3-3 in FIG. 1;

FIG. 4 is a cross-sectional view of the ampul of FIG. 1 as positioned in a hypodermic jet injector before medicament has been forced therefrom;

FIG. 5 is a cross-sectional view of the ampul and jet injector illustrated in FIG. 4 positioned in contact with the skin of a patient;

FIG. 6 is a cross-sectional view of the improved ampul of FIG. 1 following depression of the plunger and plug to force medicament from the ampul through the jet injector nozzle;

1 FIG. 7 is an end view of the first embodiment of the ampul; I

ampulj FIG. 8 is a cross-sectional view of a second preferred embodiment of the ampul;

FIG. 9 is an end view of the embodiment shown in FIG. 8;

FIG. 10 is a cross-sectional view of the embodiment shown DESCRIPTION OF THE PREFERRED EMBODIMENTS FIGS. 1 through 7 illustrate a first preferred embodiment of the present invention, FIGS. 8 through 11 illustrate a second preferred embodiment, FIGS. 12 through 14 illustrate a method for filling the embodiment illustrated in FIGS. 1 through 7 with medicament, and FIGS. 15 and 16 illustrate a method for filling the embodiment illustrated in FIGS. 8 through 11 with medicament.

Referring now to FIGS. 1 through 7, those of the first preferred embodiment, there is shown in FIG. 4 the front end portion of a typical hypodermic jet injector unit, for example, of the type shown by Scherer in U.S. Pat. No. 2,754,818. The ampul of the invention, generally shown at 12, is positioned in chamber 14 defined in nozzle 16. The nozzle 16 is threadably attached to body 18 of the hypodermic jet injector unit. Within the body 18 is a plunger 20 which is driven by driving means (not shown). The plunger 20 can thus be moved to the left of its position illustrated in FIG. 4 to cause medicament to be discharged from the ampul 12 through the end of the nozzle 16. A bumper 22 is provided to engage the plunger 20 at the end of the driving stroke.

The nozzle 16 includes a central orifice 24 leading from the chamber 14 through a flared section 26. The flared section 26 is normally not occupied by medicament or the ampul 12 but is necessary for proper discharge of the medicament from the ampul 12 as will be described below.

The ampul 12 includes a cylindrically shaped body or capsule 28 having an open end to receive a plug or stopper 29. A circumferential flange 30 surrounds the open end of the cap sule 28. When the ampul 12 is inserted into the chamber 14, the flange 30 coacts with the nozzle 16 to precisely position the ampul 12 at a fixed depth within the chamber 14, to provide a seal between the nozzle 16 and the body 18, and to secure the ampul 12 in a precise position in relation to the nozzle 16 and the body 18. The capsule 28 includes a circumferential ridge 32 around the inside of the end opposite the flange 30.

The ampul 12 also includes a closed end section 34 which is preferably rounded and adapted to fit into the end of the capsule 28 opposite plug 29. The closed or rounded end section 34 includes a circumferential groove 36 adapted to mate with the ridge 32 and hold the rounded end section 34 in a snug intimate relation with the capsule 28. The rounded end section 34 is preferably fabricated from a soft, resilient material such as rubber or the like. 1

As more fully illustrated in FIG. 7 the rounded end portion includes a plurality of

cuts

38, 39, 40 and 41 which meet at a common point at the center of the rounded end 34. The cuts pass completely through the rounded end section 34. Thus, when pressure is exerted on a volume of medicament 47 within the ampul 12, the sections of the rounded end 34, between adjacent cuts, 38 and 39, 39 and 40, 40 and 41, 41 and 38 are forced apart to allow medicament 47 to pass out the rounded end 34.

The stopper or plug 29, as shown in FIG. 4, inserted in the open end of the capsule 28 assures that medicament 47 is maintained within the ampul 12. During operation of the hypodermic jet injector, the plunger 20 fits against stopper 29 and pushes the stopper 29 into the capsule 28 to drive medicament 47 from the ampul 12.

Referring now to FIGS. and 6, there is illustrated the sequence of operations during discharge of medicament 47 from the jet injector. In FIG. 5 the nozzle 16 has been positioned against the skin 52 of a patient. Slight pressure is maintained on the nozzle 16 so that part of the nozzle 16 in the region of the orifice 24 causes a slight depression in the layers of

skin

52 and 53 and flesh 49.

FIG. 6 illustrates the next step in the sequence of operations. In FIG. 6 the plunger 20 has been depressed to drive the stopper 29 into the capsule 28 thereby causing medicament 47 to be forced through the rounded end section 34 of the ampul 12 into the flared section 26 of the chamber 14. Medicament then passes out through the orifice 24 of the nozzle 16. A stream of medicament 47 passing through the orifice 24 pierces the layers of

skin

52 and 53 and passes into the flesh 49 of the patient.

The rounded end section 34 of the ampul 12 splits along lines 38 through 41 as set forth above to define four flaps, for example, flap 55 in FIG. 6 between

cuts

38 and 41. The flaps, as at 55, fit into the flared section 26 of the chamber 14 without inhibiting the movement of medicament 47 through the orifice 24.

FIGS. 1, 2 and 3 show the ampul of the invention enclosed in a storage case. The case includes a cylindrically shaped cartridge 57 fabricated from a plastic material and adapted to receive the ampul through an open end. A triangular-shaped rubber liner or spacer 59 is positioned on the bottom of the cartridge 57. The medicament filled ampul 12 is inserted into the cylindrical cartridge 57 to rest on the spacer 59. A second rubber liner or spacer 60 fits over the rounded end 34 of the ampul l2. Liner 60 provides a seal around the open top end of the cartridge 57.

A cap or closure 62 holds the liner 60 in position within the cartridge 57 and provides an airtight seal within the cartridge 57. Thus ampul 12 is held in a substantially immovable position and is protected against bumping and possible rupture or contamination. The spaces between the ampul 12 and the interior walls of the cartridge have preferably been purged of air and filled with an inert gas to prevent aging and deterioration of the medicament.

FIGS. 8 through 11 show a second preferred embodiment of the invention. As illustrated in FIG. the second embodiment of an ampul 64 is adapted to fit into the hypodermic jet injector having the same components as previously described for the first preferred embodiment of an ampul 12.

FIG. 8 illustrates the second embodiment of the ampul 64 in a packaged form. The ampul 64 includes a capsule 66 with a plug or stopper 68 inserted in an open end of capsule 66. The plug 68 is preferably fabricated from a self-healing rubber. The capsule 66 is preferably fabricated from a polycarbonatetype, clear, transparent plastic material, compatible with injectable medicaments. The lower or rounded end portion of the capsule 66 has thinner walls than the main side cylindrical walls of the capsule 66; however, the capsule is a single integral molded piece in contrast to ampul 12 which includes a separable rounded end 34 and a capsule 28. The thin walls of the rounded end of capsule 66 assure that the rounded end portion of the capsule 66 will be more flexible than the main side walls of capsule 66.

The capsule 66 also includes a circumferential flange 70 around its molded open end which is utilized in the same manner previously described for the ampul l2; namely, as a holding and sealing means between the nozzle 12 and the body 18 of the jet injector. The flange 70 for the ampul 64 also cooperates with a tear-off aluminum closure seal 72 utilized in packaging the ampul 64 to hold the seal 72 on the capsule 66. A gasket 74 is positioned between the seal 72 and the flange 70 to insure a complete, airtight seal of the packaged ampul 64.

Referring now to FIGS. 9 and 11 there is shown the end construction of the ampul 64. Whereas in the first embodiment ampul 12 cuts were made entirely through the rounded end 34 of the ampul 12, now

diagonal reductions

76 and 77 in the thickness of the wall are formed in the outer surface of the nose of the capsule 66. The

diagonal reduction

76 and 77 in the thickness of the capsule wall intersect at substantially right angles. FIG. 8 illustrates a cross-sectional view of the configuration of the

reductions

76 and 77 in the thickness of the wall in the nose of the capsule 66.

When the plunger 20 is depressed forcing the stopper 68 to drive medicament 47 from the ampul 64, the rounded end of the capsule 66 ruptures along the lines defined by the

reductions

76 and 77 in thickness of the nose of the capsule 66. This is illustrated in FIG. 11. Medicament 47 thus may pass through the ruptured opening and through the orifice 24 into a patient in the same manner as previously described for the ampul 12.

As has been illustrated in the first preferred embodiment of the ampul 12 and the second preferred embodiment of the ampul 64 there may be a detachable rounded end section or an integral rounded end section, and there may be cuts passing completely through the rounded end section or cuts passing partially through the rounded end section. There has been illustrated only two combinations of these features; namely, an integral rounded end with cuts partially therethrough (ampul 64) and a detachable rounded end with cuts entirely therethrough (ampul 12). Other combinations are quite possible and the invention is not limited to those preferred embodiments disclosed herein.

Referring now to FIGS. 12 through 14, there is shown a method for filling an ampul of the type having cuts entirely through the rounded end section. FIG. 12 shows schematically the first step in the operation. A stopper or plug 76 is positioned on top of a rod 78 beneath the chamber 80 in chamber assembly 82. The chamber assembly 82 is freely slidable on the rod 78 and may slide to engage any of a number of stepwise stops on a rotatable tube 83 to thereby position the chamber assembly 82 in relation to the rod 78. As illustrated in FIG. 12 stop 84 has engaged the chamber assembly 82 so that the stopper 76 may be positioned within the slot at the side of the chamber assembly 82 and on top of the rod 78.

The next step is illustrated in FIG. 13. The chamber assembly 82 is engaged by the stop 86. The chamber assembly 82 thus drops down over the rod 78 and stopper 76 to close the chamber 80 at the bottom end. Medicament 88 is then poured into the chamber 80 of the chamber assembly 82.

In the next step illustrated in FIG. 14 an ampul body carrier 90 with an ampul capsule 91 situated on the interior thereof, is fixedly positioned over the end of the chamber assembly 82. The body carrier 90 is held in position by the locking cylinder 92 which threadably engages the chamber assembly 82.

The chamber assembly 82 finally engages the bottom stop 94. This causes the rod 78 to force the plug up into the ampul capsule 91. Simultaneously any extra medicament 88 is forced through a passage 96 defined in the top of the body carrier 90. The locking assembly 92 is then removed to permit the removal of the body carrier 90 and the filled ampul. As can be appreciated by examination of FIG. 14, this method of filling an ampul will work only for an ampul of the type having cuts completely through the rounded end of the ampul.

The apparatus disclosed for carrying out the method of filling ampuls is for laboratory use. In a mechanized filling apparatus for production line use, there would probably be a multiplicity of rods, such as 78, mounted on a rotary indexing table, the chamber would then be driven to successive filling stations by a cam mechanism.

FIGS. and 16 illustrate a method of filling an ampul of the type having reductions molded partially through the rounded end such as ampul 64 previously described. Referring first to H6. 15, the ampul capsule 97 is inserted into a chamber 98 in the block 100 with the rounded end down and the open end up. The ampul capsule 97 is then filled with medicament 101.

F l0. 16 illustrates the following steps. A stopper 103 is fixed to a plunger 104 having a hollow needle 105 passing therethrough. The plunger is then lowered to direct the stopper 103 into the open end of the capsule 97. Excess medicament 101 passes through the hollow needle 105. The plunger 104 is then lifted simultaneously withdrawing the hollow needle 105 from the stopper 103. The stopper 103, which is fabricated from a self-sealing rubber, then seals the medicament within the capsule 97. The filled ampul may then be removed from the block 100.

While there has been disclosed preferred embodiments of the ampul of the present invention and methods for filling these embodiments with medicament, it is to be understood that all those embodiments obvious to persons skilled in the art and all those embodiments which are equivalent to the presently claimed subject matter are to be included within the scope of the appended claims.

I claim:

1. A method for loading medicament into an ampul of the type for use with a hypodermic jet injector unit, wherein said ampul comprises a cylindrically shaped capsule having one open end, one closed end, an inside and an outside, said closed end formed from a flexible, rupturable material and having defined therein a plurality of cuts such that a pressure differential between the inside and outside of said ampul causes medicament to pass in the direction of decreasing pressure through an opening in said closed end defined by rupture of said closed end along said cuts; and a plug fitted into said open end of said ampul to thereby define an enclosed chamber within said ampul for holding medicament, said plug being slidable along the inside of said ampul to cause pressure differential between the inside and outside of said ampul, said method comprising the steps of:

positioning said plug on top of a vertical loading rod,

forcing said plug into a cylindrical chamber,

filling said chamber with medicament,

attaching said capsule to the top of said chamber with said open end down, and

forcing said plug and medicament from said chamber and up into said capsule.

Claims

1. A method for loading medicament into an ampul of the type for use with a hypodermic jet injector unit, wherein said ampul comprises a cylindrically shaped capsule having one open end, one closed end, an inside and an outside, said closed end formed from a flexible, rupturable material and having defined therein a plurality of cuts such that a pressure differential between the inside and outside of said ampul causes medicament to pass in the direction of decreasing pressure through an opening in said closed end defined by rupture of said closed end along said cuts; and a plug fitted into said open end of said ampul to thereby define an enclosed chamber within said ampul for holding medicament, said plug being slidable along the inside of said ampul to cause pressure differential between the inside and outside of said ampul, said method comprising the steps of: positioning said plug on top of a vertical loading rod, forcing said plug into a cylindrical chamber, filling said chamber with medicament, attaching said capsule to the top of said chamber with said open end down, and forcing said plug and Medicament from said chamber and up into said capsule.