US3540444A - Plastic ampoule for use with hypodermic injector - Google Patents

Description

References Cited UNITED STATES PATENTS 7/1953 Scherer........................

United States Patent Grosse Pointe Woods, Michigan [21 Appl. No. 697,891 [22] Filed [72] inventor Stephen T. Moreland 2,645,338 128/272X 2,754,818 7/1956 Scherer 128/173 3,091,240 5/l963 McConnaughey et a1. 128/218 3,424,155 1/1969 Sarnoff......................... 128/218 Jan. 15, 1968.

[45 Patented Nov. 17, 1970 [73] Assignee R. P. Scherer Corporation a corporation of Michigan FOREIGN PATENTS Primary Examiner-Richard A. Ga'udet Assistant Examiner-John B. Mitchell Att0rney- Mollnare, Allegretti. Newitt and Witcoff [54] PLASTIC AMPOULE FOR USE WITH HYPODERMIC INJECTOR 6 Claims, 11 Drawing Figs.

ABSTRACT: An ampoule for a hypodermic jet injector. The

end of the ampoule, through which medicament passes, is con- 128/173 structed of a resilient material. Crosscuts are scribed in the A61m 5/28 resilient end so that a plunger driving a plug into the opposite 128/ i73(H) end of the ampoule forces medicament through the crosscut end by bursting it along lines coincident with the cuts.

[51] Int. [50] FieldofSearch........................................... I

218.272; 206/43,63.2; ZZZ/327,490,541

Patented Nov. 11, 1910 3,540,444

sheet 1 of 2 41 .Zfidntor: Sie fien Z'Moreland L 2 male M W was Patented Nov. 17, 1970 A v I 3,546,444

4 In Me 72 Z07? Sig when T Moreland fgs,

PLASTIC. AMI'OULE FOR USE WITH HYPODERMIC i I INJECTOR BACKGROUND OF THE INvENTIoN tion, which is usually-formed froma stainless steel material,

and a plug which fits in an open end ofthe ampoule.

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

A typeof-ampoule heretofore utilized with a hypodermic jet injector isdisclosed in U.S. Pat. No. 2,688,968 granted to Scherer, on Sept. 14, 1954. Such an ampoule includes an 4 opening in one end of the capsule for the passage of medicament and a displaceable driving plug at the opposite end ofthe ampoule. While these ampoules are very satisfactory, they are not transparent which is a desirable characteristic for ampoules. Moreover ampoules of this construction make direct contact with the patients skin, the medicament being discharged through the orifice in the ampoule. Thus, protection against slippage of the ampoule by a discharge nozzle attached to the jetinjector and especially constructed to prevent slippage is not possible.

SUMMARY or THE INVENTION In a principal aspect the present invention comprises an improved ampoule for use with a hypodermicjet injector, the ampoule being comprised of a cylindrically shaped capsule with one openend and a plug which fits into the open end. The

2 FIG. 5 is acrossrsectional view of the ampoule and :et injec tor illustrated in FIG. 4 positioned in contact with the skin of .1 patient; I

FIG. 6 is a cross-sectional view of the improved ampoule of FIG. I following depression of the plunger and plug toforce medicament from the ampoule through the jet injector nozzle;

FIG. 7' is an end view of the first embodiment of the ampoule;

FIG. 8 is a cross-sectional view of a second preferred embodimentof the ampoule;

FIG. 9 is an end view of the embodiment shown in FIG. 8; FIG. 10 is a cross-sectional view of the embodiment shown in FIG. 8 as positioned within a hypodermic jet injector unit; and FIG. 11 is an enlarged cross-sectional view of the rounded end portion and nozzle orifice of the embodiment illustrated in FIG. 8 during expulsion of medicament from the ampoule.

DESCRIPTION OF THE PREFERRED EMBODIMENTS FIGS. '1 through 7 illustrate a first preferred embodiment of I the present invention and FIGS. 8 through 11 illustrate a second preferred embodiment.

Referring now to FIGS. 1 through 7, those of the first preferred embodiment, there is shown in FIG. 4 the front end portion of atypical hypodermic jet injector unit, for example, of the type shown by Scherer in U.S. Pat. No. 2,754,818. The ampoule of the invention, generally shown at 12, is positioned inchamber 14 defined innozzle 16. Thenozzle 16 is threadably attached tobody 18 of the hypodermic jet injector unit. Within the body I8 is aplunger 20 which is driven by driving means (not shown). Theplunger 20 can thus be moved to the left of its position illustrated in FIG. 4 to cause medicament to be discharged from theampoule 12 through the end of thenozzle 16. Abumper 22 is provided to engage theplunger 20 at the end of the driving stroke.

Thenozzle 16 includes a central orifice 24leading from thechamber 14 through a flaredsection 26. The flaredsection 26 is normally not occupied by medicament or theampoule 12 but is necessary for proper discharge of the medicament from the ampoulel2 as will be described below.

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 ampoule by forcing a plunger against the plug causes the closed end to burst along seams coincident withthe cuts in the closed end. There is also disclosed a method of filling the ampoules with medicament in addition to various embodiments of the invention and packaging means for the improved ampoule.

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

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

One further object of the present invention is'to provide an improved ampoule 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. I is a side crosssectional view ofa first embodiment of the improved ampoule in a container case;

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

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 ampoule of FIG. I as positioned in a hypodermic jet injector before medicament has been forced therefrom;

Theampoule 12 includes a cylindrically shaped body orcapsule 28 having an open end to receive a plug or stopper 29. Acircumferential flange 30 surrounds the open end of thecapsule 28. When the ampoule I2 is inserted into the chamber l4,theflange 30 coacts with the nozzle I6,to precisely position theampoule 12 at a fixed depth within the chamber I4, to provide a seal between thenozzle 16 and thebody 18, and to secure theampoule 12 in a precise position in relation to thenozzle 16andthe body 18. Thecapsule 28 includes acircumferential ridge 32 around the inside of the end opposite theflange 30.

The ampoule I2 alsoincludes aclosed end section 34 which is preferably rounded and adapted to fit into the end of thecapsule 28opposite plug 29. The closed orrounded end section 34 includes a circumferential groove 36 adapted to mate with theridge 32 and hold therounded end section 34 in a snug intimate relation with thecapsule 28. Therounded end section 34 is preferably fabricated from a soft, resilient material such as rubber or the like.

As more fully illustrated in FIG. 7 the rounded end portion includes a plurality ofcuts 38, 39, 40 and 41 which meet at a common point at the center of therounded end 34. The cuts pass completely through therounded end section 34. Thus, when pressure is exerted on a volume ofmedicament 47 within theampoule 12, the sections of therounded end 34, between adjacent cuts, 38 and 39, 39 and 40, 40 and 41, 4I and 38 are forced apart to allowmedicament 47 to pass out therounded end 34.

The stopper or plug 29, as shown in FIG. 4, inserted in'the and pushes thestopper 29 into the capsule28 to drivemedicament 47 from theampoule 12.

Referring now to FIGS. 5 and 6, there is illustrated the sequence of operations during discharge ofmedicament 47 from the jet injector. In FIG. 5 thenozzle 16 has been positioned against theskin 52 ofa patient. Slight pressure is maintained on thenozzle 16 so that part of the nozzle'l6 in the region of theorifice 24 causes a slight depression in the layers ofskin 52 and 53 andflesh 49.

FIG. 6 illustrates the next step in the sequence of operations. In FIG. 6 the plunger has been depressed to drive thestopper 29 into thecapsule 28 thereby causingmedicament 47 to he forced through therounded end section 34 of the am poule 12 into the flaredsection 26 of the chamber I4. Medicament then passes out through theorifice 24 of thenozzle 16. A stream ofmedicament 47 passing through theorifice 24 pierces the layers ofskin 52 and 53 and passes into theflesh 49 of the patient.

Therounded end section 34 of the ampoule l2 splits alonglines 38 through 41 as set forth above to define four flaps, for example, flap 55 in FIG. 6 betweencuts 38 and 41. The flaps, as at 55, fit into the flaredsection 26 ofthechamber 14 without inhibiting the movement ofmedicament 47 through theorifice 24.

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

A cap orclosure 62 holds theliner 60 in position within thecartridge 57 andprovides an airtight seal within thecartridge 57. Thus ampoule I2 is held in a substantially immovable position and is protected against bumping and possible rupture or contamination. The spaces between the ampoule l2 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. 10 the second embodiment of anampoule 64 is adapted to fit into the hypodermic jet injector having the same components as previously described for the first preferred embodiment of an ampoule l2. FIG. 8 illustrates the second embodiment of theampoule 64 in a packaged form. Theampoule 64 includes acapsule 66 with a plug orstopper 68 inserted in an open end ofcapsule 66. Theplug 68 is preferably fabricated from a self-healing rubber. Thecapsule 66 is preferably fabricated from a polycarbonate-type, clear, transparent plastic material, compatible with injectahle medicaments. The lower or rounded end portion of thecapsule 66 has thinner walls than the main side cylindrical walls ofthecapsule 66; however, the capsule is a single integral molded piece in contrast to ampoule 12 which includes a separablerounded end 34 and acapsule 28. The thin walls of .the rounded end ofcapsule 66 assures that the rounded end portion of thecapsule 66 will he more flexible than the main side walls ofcapsule 66.

Thecapsule 66 also includes acircumferential flange 70 around its-molded open end which is utilized in the same manner previously described for the ampoule l2; namely, as a holding and sealing means between thenozzle 12 and thebody 18 of the jet injector. Theflange 70 for theampoule 64 also cooperates with a tear-offaluminum closure seal 72 utilized in packaging theampoule 64 to hold theseal 72 on thecapsule 66. Agasket 74 is positioned between theseal 72 and theflange 70 to insure a complete, airtight seal of the packagedampoule 64.

Referring now to FIGS, 9 and 11 there is shown the end construction of theampoule 64. Whereas in the first embodiment ampoule I2 cuts were made entirely through the rounded end .34 of the ampoule l2, nowdiagonal reductions 76 and 77 in the thickness of the wall are formed in the outer surface of the nose of thecapsule 66. Thediagonal 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 thereductions 76 and 77 in the thickness of the wall in the nose of thecapsule 66.

When theplunger 20 is depressed forcing thestopper 68 to drivemedicament 47 from theampoule 64, the rounded end of thecapsule 66 ruptures along the lines defined by thereductions 76 and 77 in thickness of the nose of thecapsule 66. This is illustrated in FIG. 11.Medicament 47 thus may pass through the ruptured opening and through theorifice 24 into a patient in the same manner as previously described for theampoule 12.

As has been illustrated in the first preferred embodiment of the ampoule I2 and the second preferred embodiment of the ampoule 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 cats 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 (ampoule 64) and a detachable rounded end with cuts entirely therethrough (ampoule 12). Other combinations are quite possible and the'invention is not limited to those preferred embodiments disclosed herein.

While there has been disclosed preferred embodiments of the ampoule of the present invention, 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.

lclaim: I

I. In a hypodermic unit of the type adapted to receive an ampoule in anozzle compartment and including means to force medicament from one end of said ampoule through a nozzle orifice of said unit and into a patient, an improved, separable ampoule comprising, in combination:

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 extending partially through said closed end from the outside thereof such that a pressure differential between the inside and outside of said ampoule causes medicament to pass in the direction of decreasing pressure through an opening in said closed end defined by ruptured of said closed end along said cuts; and

a plug fitted into said open end of said ampoule to thereby define an enclosed chamber within said ampoule for holding medicament, said plug being slidable along the inside of said ampoule to cause pressure differential between the inside and outside of said ampoule.

2. The ampouleof claim 1 wherein there are four of said cuts meeting at a common point on said closed end, any adjacent pair of cuts defining substantially a right angle, said point being positioned on the end of said ampoule such that said point upon insertion into a hypodermic will substantially coincide with said nozzle orifice.

3. The ampoule of claim I wherein said cuts meet at a common pointand extend entirely through said closed end;

4. The ampoule of claim I wherein said cuts meet at a common point to define a pattern of lines along which said closed end will rupture with sufficient pressure differential.

5. The ampoule of claim 1 wherein said closed end is detachable from said ampoule, said ampoule being formed from a semi'rigid material and said closed end being formed from a pliant, rupturable material.

nozzle orifice and providing an area into which portions of said closed end are displaced upon rupture of said closed end due to said pressure differential.

Images