|Publication number||US3540444 A|
|Publication date||Nov 17, 1970|
|Filing date||Jan 15, 1968|
|Priority date||Jan 15, 1968|
|Publication number||US 3540444 A, US 3540444A, US-A-3540444, US3540444 A, US3540444A|
|Inventors||Moreland Stephen T|
|Original Assignee||Scherer Corp R P|
|Export Citation||BiBTeX, EndNote, RefMan|
|Referenced by (31), Classifications (10)|
|External Links: USPTO, USPTO Assignment, Espacenet|
References Cited UNITED STATES PATENTS 7/1953 Scherer........................
United States Patent Grosse Pointe Woods, Michigan [21 Appl. No. 697,891  Filed  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  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  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.
 Int.  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 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 I8 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 ampoule 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 24leading from the chamber 14 through a flared section 26. The flared section 26 is normally not occupied by medicament or the ampoule 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;
The ampoule 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 capsule 28. When the ampoule I2 is inserted into the chamber l4,the flange 30 coacts with the nozzle I6,to precisely position the ampoule 12 at a fixed depth within the chamber I4, to provide a seal between the nozzle 16 and the body 18, and to secure the ampoule 12 in a precise position in relation to the nozzle 16 andthe body 18. The capsule 28 includes a circumferential ridge 32 around the inside of the end opposite the flange 30.
The ampoule I2 alsoincludes 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.
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 ampoule 12, the sections of the rounded end 34, between adjacent cuts, 38 and 39, 39 and 40, 40 and 41, 4I 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 and pushes the stopper 29 into the capsule28 to drive medicament 47 from the ampoule 12.
Referring now to FIGS. 5 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 ofa patient. Slight pressure is maintained on the nozzle 16 so that part of the nozzle'l6 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 has been depressed to drive the stopper 29 into the capsule 28 thereby causing medicament 47 to he forced through the rounded end section 34 of the am poule 12 into the flared section 26 of the chamber I4. 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 ampoule l2 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 thechamber 14 without inhibiting the movement of medicament 47 through the orifice 24.
FIGS. 1, 2 and 3 show the ampoule 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 ampoule through an open end. A triangular-shaped rubber liner or spacer 59 is positioned on the bottom of the cartridge 57. The medicament filled ampoule l2 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 ampoule 12. 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 andprovides an airtight seal within the cartridge 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 an ampoule 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 the ampoule 64 in a packaged form. The ampoule 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 polycarbonate-type, clear, transparent plastic material, compatible with injectahle medicaments. The lower or rounded end portion of the capsule 66 has thinner walls than the main side cylindrical walls ofthe capsule 66; however, the capsule is a single integral molded piece in contrast to ampoule 12 which includes a separable rounded end 34 and a capsule 28. The thin walls of .the rounded end of capsule 66 assures that the rounded end portion of the capsule 66 will he more flexible than the main side walls ofcapsule 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 ampoule 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 ampoule 64 also cooperates with a tear-off aluminum closure seal 72 utilized in packaging the ampoule 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 ampoule 64.
Referring now to FIGS, 9 and 11 there is shown the end construction of the ampoule 64. Whereas in the first embodiment ampoule I2 cuts were made entirely through the rounded end .34 of the ampoule l2, 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 ampoule 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 ampoule 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.
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.
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US5171304 *||Jun 10, 1991||Dec 15, 1992||Duphar International Research B.V.||Flexible sealing member for injection device|
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|US6123684 *||Jul 26, 1999||Sep 26, 2000||Medi-Ject Corporation||Loading mechanism for medical injector assembly|
|US6217911||Jul 5, 1996||Apr 17, 2001||The United States Of America As Represented By The Secretary Of The Army||sustained release non-steroidal, anti-inflammatory and lidocaine PLGA microspheres|
|US6410056||May 22, 1995||Jun 25, 2002||The United States Of America As Represented By The Secretary Of The Army||Chemotherapeutic treatment of bacterial infections with an antibiotic encapsulated within a biodegradable polymeric matrix|
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|US6528097||Nov 20, 2000||Mar 4, 2003||The United States Of America As Represented By The Secretary Of The Army||Sustained release non-steroidal, anti-inflammatory and lidocaine PLGA microspheres|
|US6610042||Feb 14, 2001||Aug 26, 2003||Felton Medical, Inc.||Disposable unit-dose jet-injection syringe for pre-filled and/or transfilled liquid injectable medical drug or vaccine products and method thereof|
|US6626871||Oct 10, 2000||Sep 30, 2003||Felton International, Inc.||Method and apparatus for removing cap from medical device|
|US6802826||Oct 10, 2000||Oct 12, 2004||Felton International, Inc.||Universal anti-infectious protector for needleless injectors|
|US6844010||Jul 18, 2000||Jan 18, 2005||The United States Of America As Represented By The Secretary Of The Army||Therapeutic treatment and prevention of infections with a bioactive materials encapsulated within a biodegradable-biocompatible polymeric matrix|
|US6855331||Jun 10, 2002||Feb 15, 2005||The United States Of America As Represented By The Secretary Of The Army||Sustained release hydrophobic bioactive PLGA microspheres|
|US6902743||Apr 6, 1998||Jun 7, 2005||The United States Of America As Represented By The Secretary Of The Army||Therapeutic treatment and prevention of infections with a bioactive material(s) encapuslated within a biodegradable-bio-compatable polymeric matrix|
|US6939546||Jan 26, 1998||Sep 6, 2005||The United States Of America As Represented By The Secretary Of The Army||Model for testing immunogenicity of peptides|
|US6942638 *||May 30, 2002||Sep 13, 2005||Kerry Quinn||Needleless injector and ampule system|
|US7033608||Jun 22, 1999||Apr 25, 2006||The United States Of America As Represented By The Secretary Of The Army||“Burst-free” sustained release poly-(lactide/glycolide) microspheres|
|US7604811||Dec 10, 1996||Oct 20, 2009||The United States Of America As Represented By The Secretary Of The Army||Oral-intestinal vaccines against diseases caused by enteropathic organisms using antigens encapsulated within biodegradable-biocompatible microspheres|
|US7618393||Nov 13, 2006||Nov 17, 2009||Pharmajet, Inc.||Needle-less injector and method of fluid delivery|
|US7699802||May 3, 2005||Apr 20, 2010||Pharmajet, Inc.||Needle-less injector|
|US7887506||Nov 21, 2000||Feb 15, 2011||Pulse Needlefree Systems, Inc.||Safety mechanism to prevent accidental patient injection and methods of same|
|US8118777||May 26, 2010||Feb 21, 2012||Cook Medical Technologies Llc||Systems and methods for delivering therapeutic agents|
|US8361054||Dec 8, 2009||Jan 29, 2013||Cook Medical Technologies Llc||Apparatus and methods for containing and delivering therapeutic agents|
|US8529500||Jun 16, 2011||Sep 10, 2013||Pharmajet, Inc.||Needle-less injector and method of fluid delivery|
|US8728032||Jan 17, 2012||May 20, 2014||Cook Medical Technologies Llc||Systems and methods for delivering therapeutic agents|
|US9101744||Dec 21, 2012||Aug 11, 2015||Cook Medical Technologies Llc||Systems and methods for delivering therapeutic agents|
|US20100174268 *||Jul 8, 2010||Meridian Medical Technologies, Inc.||Methods of venting, sealing, and dispensing from a medicament container|
|USRE40786||Jun 2, 2000||Jun 23, 2009||The United States Of America As Represented By The Secretary Of The Army||Vaccines against intracellular pathogens using antigens encapsulated within biodegradable-biocompatible microspheres|
|USRE41157||Nov 30, 1999||Mar 2, 2010||The United States Of America As Represented By The Secretary Of The Army||Microparticle carriers of maximal uptake capacity by both M cells and non-M cells|
|EP0001452A1 *||Oct 9, 1978||Apr 18, 1979||BioNexus, Inc.||Ampule for long-term storage of polymerizable substances|
|EP0461693A1 *||May 28, 1991||Dec 18, 1991||Duphar International Research B.V||Flexible sealing member for injection device|
|WO1981000701A1 *||Sep 11, 1980||Mar 19, 1981||Population Res Inc||Female sterilization|
|International Classification||A61M5/28, A61M5/30, A61M5/24, A61J1/06|
|Cooperative Classification||A61M5/2459, A61M5/30, A61J1/062|
|European Classification||A61J1/06B, A61M5/30|