Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
WO 92/08508 _ 1 _ r t~',P"~ PCr/AU!)1/0()514
EDLElESS HYPODERMIC J~ ~F~R DEVICE
Backqround QF the Inventio~
This inventlon relates to a needleless hypodermic jet injector
device and, more partlcularly, to such a device which lncludes a
disposable gas powered plunger and a disposable medicament vlal.
S For many years it has been the practice to deposit medicaments into
the hypoderma by the use of a dev~ce includ~ng a tubular needle connected
to a reservoir of medicament incorporating a piston. The needle was
lnserted throu~h the ep7der~1s lnto th~ hypoderma and the medicament ~as
dlscharged by movlng the p7ston along the reservoir. Such dev~ces have
several problems. F~rstly, the penetrat~on o~ the needle ls a possible
tause for 7nfect7On and there ls patient res7stance to the discomfort
associated wlth the insertion o~ the needle.
It has been known to provide d~sposable injector devices, which are
used once and then thrown away. Such devices have use ln administratlon
of, for example, local anaesthetic, lnsulln and the like.
In particular, the diabetes sufferer has to endure the pain and
inconvenience of frequent hypoderm~c needle ~njections to administer the
insulin used ~n the con~rol of dlabetes.
In the case of the diabetes sufferer, it is deslrable to have a
presterillsed, d7sposable dev~ce for s7ngle and mult~ple (lnsulin~
7n~ection use, that has lts own power source while being small and llght
enough for the user to carry dur7ng the day. The dev7ce should be such
that the user can vary the selected dose conveniently and accuratPly and
lt should be conven7ently and safely operated.
Z5 The dlabetes sufferer n~eds to in~ect on at 1 ast one and up to
three occaslons dal1y, 7nsul~n at a dosage varylng ~rom less than 0.1
mill~l7tres up to a maxlmum o~ 0O3 m711711tres.
Gas and spr7ng operated jet ln~ection devices have b~en lnvented as
alternatives to the needle dev~ces. In ~he gas operated devlce, llquid
med1eament ls dlscharged from a reservolr through a port as a spray by a
p~ston moved along the reservolr by sub~ect~ng it to a force created by
the sudden release of gas. These dev7ces have the obvlous advan~ages
u that there 7s no sk1n penetration hence no d~scom~ort and no posslbility
of ~nfect1On. In addltlon, they are more easlly used by persons of
ltmited s~ll. -
The rommon fornls o~ gas devlee co~pr~se a holder to whlch lscoupled a contalner of med~cament ~n a manner al~gn~ng ~t w~th ~he piston
to be gas operated and which provides means to hold a gas ~lled eapsule
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in the holder. By puncturing the capsule the gas is released into a
cylinder and the piston therein is driven into the container to discharge
the medicament through a port in the container.
Such an arrangement has several disadvantages. For example, the
holder, as provided, is a relatively la7ge member and is complex having
to prov~de securement means for the med~cament container and the gas
capsule. It has to provlde a plston mounting arrangement and means to
releasably ho1d the gas capsule in a gas tlght manner and puncture the
gas capsule. In short, the device is large and complex and
correspondingly expens7ve.
One existlng needleless injection dev~ce is descr~bed ln US Patent
No. 4,680,027 to Parsons et al. It employs a disposable syringe that is
filled by the user with a selected amount of medlcat~on. Then a separate
power supply mechanism is attached to the lnstr~ment and trlggered to
drive a plunger against the med~cation. This produces a h~gh pressure
jet for in~ectlon purposes.
Although effective ln many respects, the separate power supply
mechanism reduces the portabillty and convenience of the Parsons device.
Consequently lt 7s des~rahle to have a needleless ln~ectlon system that
overcomes thls conc~rn.
US Patent No. 41596,556 describes a hypodermic injection apparatus
hav~ng a spr~ng-loaded f1ring mechanlsm that operates to release carbon
dlox~de from a capsule. Thls propels the capsule and a plunger toward a
discharge aperture to discharge medicatlon through the aperture.
However, in heing self cocking, reloadable, and reusable the device ls
somewhat compl~cated.
US Patent No. 3,688,765 descr1bes another devtce that is intended
for portable use. However, lt uses a syringe in the form of a prefilled,
sealed, ampoule that precludes dosage select~on a~ ~he t~me of use In
30 addition, the detachable syringe, disposable carbon diox~de unit and
re-usable pressur~s~ng unit rspresent three separate components w1th
whlch the user must contend.
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~ The present 1nvention, therefore, seeks t~ provide a simple and
easy to use dlsposable, needleless, syr~n~e, whlch reduces at least some
of the above dlsadvantages and wh~ch can be eas~ly use~ to ca~er ~or the
needs of the d~abetes suff~rer.
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Accordingly, in one aspect the invention provides a disposable,
needleless hypodermic jet injector device for introducing a llquid into a
pat1entt the liquid being contained in a vial which includes a hollow
body having an orlfice end through which the l~quid exlts from withln the
vial, and a vlal plug movably mounted within the hollow body and operable
to push the liquid out through said orifice end, said device comprising a
body portion having a first end including means for ad~ustably receiving
said vial and a second end including means for recelving a gas capsule,
the gas capsule having a plural~ty of independent, pressurlsed
gas-contain~ng chambers, each chamber havlng an openable exit port in an
end of the capsule receivable within the device, the body port~on further
comprising a first part, adjacent said flrst end, includlng a cylinder
containing a piston movable wlthin said cylinder, said piston being
provlded w~th a plston rod extending towards said first end for engaging
w~th the vlal plug to cause movement thereof when the piston ~s moved in
the cylinder, and a second part, adjacent said second end, lnclud~ng a
passage extend~ng from the first part to a part of said second end, the
remainder of the second end be~ng closed, for cooperating w~th each of . .
the openable exit ports, ~n turn, and tr~gger means arranged for opening
the one of the openable exlt ports which cooperates with the passage for
causlng gas to exit from the respective chamber, flow through the passage
and cause the p~ston to move thereby cauxlng the p~ston rod and vial plug
to be moved.
Preferably, the means ~or receiving the vial compr~ses a mountlng
means for rece~vlng and mount~ng the vial in an ad~ustable fashion so
that the dose dellvered therefrom can be ad~usted according ~o volume of
liquid to be del1vered. In a pre~erred embodiment, the mounting means
comprlses a threaded recess w1th wh~ch an ~xternal thread vn the v~al can
cooperate so that the via1 can be threaded long~tudlnally along the
recess to adjust the volume of llquid prov~ding the dose. Preferably,
the mountlng means includes one or more detent means for engaging the
vlal at one or more positions correspond~ng to particular predetermined
doses.
In one prefelred e~bodlment, the means for recelving the gas
capsule compr~se~ a thread for cooperat~ng w~th a matching thread on the
gas capsule. Preferably, the passage is open at a restricted part of the
second end for cooperat~ng with only one o~ ~he openable ex~t ports o~
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the capsule. In a preferred embodiment, the means for receiving the gas
capsule allows the gas capsule and the passage opening at the second end
to be relatively moved, for example rotated, so as to bring each of the
openable ex~t ports, in turn, into cooperation with the passage opening.
Preferably, the passage opening takes up a thlrd of thQ area of the
second end, the gas capsule having three gas chambers, each having an
openable exit port ln one respective thlrd of the end of the capsu1e, the
capsule be~ng rotatable to bring each exlt port lnto cooperation wlth the
passage openlng, ln turn. Preferably, the means for recelving the gas
10 capsule includes detent means at each of the posltions at wh~ch an exlt
port is in cooperation with the passage opening.
The trigger means preferably comprlses a finger portion on the
outside of the body port~on, a longitudinal trlgger port~on within the
passage and a connecting portion connectlng the f~nger portion and the
15 trigger port~on and extending through a longl~udinal aper~ure in the wall
of the body portion. The trlgger ~eans is preferably longltudlnally
movable wlthln the aperture such that the trigger portlon moves withln
the passage, an end of tr~gger port~on reachlng the second end of the
body port~on so as to engage and open the openable exit port of the gas
20 capsule when the trigger means has been moved towards the second end. A
bias~ng means preferably blases the trlgger means towards the flrst end
of the device.
In a second aspect of the present ~nvent1On, there ls prov~ded a
gas capsule havlng a plurality of ~ndependent, pressurised gas-containing
25 chambers, each chamber having an openable exit port in an end of the
capsule for cooper~tion, ~n turn, w~th an open~ng ~n an inJector dev~ce.
r - Preferably, the end of the capsule ls cireul ar and the exit ports
are equally clrcumferentially spaced therein. Preferably, the chambers
are long1tudinally extending in the capsule. In one preferred
30 embod1ment, three chambers are provlded; although any number could be
used.
The end of the capsule is preferably provided wlth a thread for
cooperating w1th a matching thread on the ~njector device. The openable
ex~t ports are preferably prov~ded with valve means whlch can be opened
35 by a trlgger ~eans on the lnjector dev~ce. r
It wlll be apparent, therefore, that the tr~gger means dlrectly
releases eompressed gas, stored ~n the capsule, from each capsule
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WO ~2/08508 _ 5 _ ~ PCI-/AU"I/OU514
chamber, one at a time. By rotating the capsule, each of the three gas
charges can be released.
The gas pressure acts upon the piston to drivé the piston rod which
in turn acts upon the plug in the vial to eject the selected dosage of
medication through an orlfice in the discharge end of the vial section.
Brief Description ~ The Dr~wings
One embodiment of the invention will now be more fully described,
by way of example, with reference to the drawings, of which:
Figure 1 ~s a cross-sectional view of an lnjector devlce accord~ng
~o the invention wlth a vlal and gas capsule attached thereto;
Figure 2 ls a cross-sectional view of a trigger used in the
injector device along line A-A of Figure l;
Figure 3 ~s a cross-sectional view of the body port~on o~ the
device along line B-B of Figure l; and
Figure 4 is a cross-sectional view of the gas capsule along l~ne
C-C of Figure 1.
~etailed D~scription of A Pref~rr~d Emb~d~m~n~
As illustrated ~n the drawings, the an ~n~eetor device 1 according
to one embodiment of the lnvention comprises a cyllndrieal body portton 2
having an external thread section 3 at one end, an internal thread
section 4 at the other end, and a passage 5 extending longitudinally
thro~gh the body port~on 2 between the two ends. The passageway 5 at the
other end ~s o~ substantially the same ~dth as the ~nternal diameter of
the internal threaded sect~on 4, but, at the first end, is of reduced .
25 cross-sectlonal area, as shown ln Figure 3, so as to cover only a third sector of the lnternal diameter of the body portion 2.
Body portlon 4 ~s also provided w~th a slot 6 ln wh~ch trigger 7 is
assembled into and moves slidably within body portion 2. Tr~gger 7, as
shown in F19ure 2, lncludes finger portlcn 8 arranged outside body
portion 4, tr~gger plunger 9 arranged within passageway 5 and trigger
stem lO conneet~ng the finger.portion 8 and ~he ~rigger plunger 9 through
slot 6. The slot 6 is longltudinal so as to allow long1tud~nal movement
oF'the flnger'portion 8.to cause..longitudinal..movement of the trlgger
plunger 9 within passageway S. ' ' ~ ..
35 :: '; Threaded onto the lnternal''thread section 4 o~ body portion 2 1s ' 'cyl~nder port1On 11 havtng a longltudinal bore 12.thereln ex~ending from
passageway 5 to an ~nternally threaded end sec~ion 13. A shoulder 14 ~s
provided ~n the bore 12 adjaeent th~ internally ~hreaded end section 13.
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Cylinder portlon 11 is attached to body portion 2 by screwing the
cylinder portion into the body internal thread section 4 until a shoulder
25 on outside of cylinder portion 11 engag~s body end ~ace 26.
The shoulder 14 serves as a piston stop, as will be descrlbed
later, and a guide for a plunger 15 having a piston head 16 sealingly
sl~d~bly mounted in the cylinder bore 12. There is a gas exhaust port 46
in the wall of the cyllnder port~on 11 ln communication w~th the bore 12.
A 17qu7d medlcament vial 17 is provided as a fitment for the
device. The v~al 17 has a vial thread section 18 enabling 7t to be
screwed into the cylinder thread section 13. The vial has an or7fice 19
at its fore end and the orifice 19 7s sealed by a seal that will yield
when pressure is applied to liquid medicament housed 1n a bore 20 of vial
12. Pressure is applied to the medicament by a plug 21 slidably housed
ln the vial bore 20.
1~ The exterior of the vial 17 is marked in any su7table manner to
indicate fractions of the capac7ty of the vial bore 20. For example
there may be external markings on the vial to divide the bore length ~nto
five sect~ons each of Y mls.
By threading the v1al 17 into the cyl7nder portion 11, the markings
on the v~al 17 will pass by a datum mark on the cyl~nder portion 11, for
example an end face 22 of the cyllnder portion 11 could be such a mark.
~etent means ~s pre~erably prov~ded whereby the detent is releasably
engaged each time a graduat~on on the vlal 17 is allgned w1~h the datum
mark. In this way the vial 17 can be releasably locked 7n a des1red
25 posttlon.
By ax1ally movlng the vial 17 (as a result of rotat~ng ~t) the
position of the v~al 17 relativ~ to the end 24 of the plunger 15
: changes. ~hen the vial 17 7s ~ully "ln" the maxlmum amount o~ the :.
med1eament wlll be e~ect~d. By thread7ng the v~al 17 "out", the amount
~0 of medlcament e~ected w~ll be reduced.
- `. It ~ill be noted that, as illustrated, the plunger i5 ~s ln its
zero position when al7gned with the end face 22 of the cyllnder portion
`11. The stroke o~ the;pis~on head l6 ls llm~ted to ~he distance "X" and
therefore when the vial 17 ls threaded fully:into the cylinder portion 11
-35: so that the:end fat:e 23 of v1al l7 engages the end o~ the threaded
sett10n of the cyl7nder psrtlon 11, the plug Zl will be ad~acen~ the end
24 of th~ plunger 15.
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W O 92/08508 _ 7 _ -~ Pcr/Au9l/oos-l4
The maximum stroke of the plug 21 is slightly greater than "X". It
follows that when the piston head 16 moves the distance "X", the plug 21
will move the same distance and subs~antially the whole of the medicament
in the vial 17 wlll be ejected, If the! vial 17 is moved "out" of the
cyl~nder portion 11, the plunger end 24 will be spaced from the plug 21
and although the plunger 15 will move "X", the plug 21 ~ill move less
than "X".
A gas capsule 27 comprising three longitudlnal chambers 28, 29, 30
and three valves 31, 32, 33 arranged at exit ports ~3, 4~, ~5 of ~he
respective long~tudlnal chambers 28, 29, 30, ls attached to body port~on
24 by screwing an internal thread section 34 onto the body external
thread section 3 until an end face 35 of the capsule 27 approaches an end
face 36 of the body external thread section 34 and capsule pins 37, 38,
39 provided on the capsule end face 35 engage detents 40, 41, 42 provlded
on the body end ~ace 36. As shown in F~gure 4, ~he three longitudlnal
chambers each take up a third sector of the capsule 27 and the detents
are arranged so that only one of the valves 31, 31, 33 is aligned wlth
the end of the passageway 5 in body port~on 2.
As tr19ger 7 ls moved slidably along slot 6 in body port~on 2
towards eapsule 27, the trigger plunger 9 moves through passageway 5 to
operate on the one of the valves 31, 32, 33 wh~ch ~s allgned w~th the
passageway 5 to rel~ase the gas pressure ~rom the correspondlng one of
the chambers 28, 29, 30 and allow gas ~o travel through passageway 5 ln
body port~on 2 and lnto cyi~nder portion 11, drlving p1ston head 16 and
25 plunger 15 into v1al 17 and dtsplae~ng p7ug 21 and the contents of v~al
17 in the form of a h~gh pressure ~et through the orifice 19.
The gas ln the chambers 28, ~9, 30 ~s released by ~he trigger
plunger 9 enter1ng through exlt ports 43, 44, 45 and openlng valves 31,
32, 33.
The three detents 40, 41, ~2 on b~dy ~nd ~ace 36 and the three
correspondlng capsule pins 37, 38, 39 on capsule end face 35 ensure th~t
alignment of tr1gger plunger 9 and exi~ por~s q3, 44, 45 ~s malntalned ~n
only three posslble positlons.
It 1s presently intended that the devic.e will be made
substant~ally completely ~rom thermosett~ng plas~le matPri al s ~ u s i ng the
~iection mouldlng process.
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OperatlQnal~ equence
In an operational sequence, a v~al 17 would be fitted to the device
1 and the amount of med~cament to be ejected would be chosen by the
degree to which the vial 17 is threaded into the cylinder portion 11.
The device would be positioned wil:h the or~fice 19 over the part o~
the user where the "inject~on" is to take place.
As ~he trigger 7 is slldably moved along the body portion 2, the
trigger plunger 9 would enter one of the exit ports 43, 44, 45, opening
the correspond~ng one of valves 31, 32, 33, and thereby releaslng gas
from the correspond~ng one of chambers 28, 2~, 30.
The gas travels through body port~on Z, dr~ving p~ston head 16 and
plunger 15 the distance "X" until plston head 16 engages the cylinder
shoulder 14. At this time the exhaust psrt 46 w~ll be uncovered and the
gas behind the piston head 16 escapes to atmosphere.
Whilst the p~ston head 16 is advancing ~he plunger end face 2
would be dr~ving the plug 21 along the vial bore 20 causing the
medicament therein to e~ect through orifice 19.
Depending on the amount the vial 17 1s threaded into the cylinder
portion 11, the plug Zl w~ll move the d~stance "X" or a fraction of that
distance and tne amount of med kament e~ected will vary accordingly.
~hilst a presently preferred embodiment of the ~nvention has been
described hereinbefore ~t ~s to be understo~d that var~ations can De made
to the spec1f~c embodlment descrlbed w~thout departing from the invent1Ye
concept. By way of example only:
The manner ln wh1ch the piston 9 i5 regulated ~n its travel can be
other than ~s dlsclosed.
The manner ~n whlch thP cartridge chamber valves are open~d can be
other than as descr~bed.
The manner ~n whlch the gas under pressure ln the cartridge
chambers ls sealed can be other than as described.
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