1 2
MULTIPLE COMPARTMENT HYPODERMIC and second coaxially disposed cylinders. The cylinders
DEVICES respectively provide first and second medicamentcontaining chambers, the adjacent ends of which are separated by a first, puncturable, piston-like dia5 phragm. This first diaphragm extends across and
This invention relates to disposable hypodermic am- around the end of the first cylinder to close and seal the
poules which include multiple chambers for premixing same and is slidably mounted in the adjacent end of the
a powdered, lyophilized medicament with a diluent. A second cylinder to close and separately seal the same,
number of drug compounds, including some antibiot- These two seals are exposed to and separated by the
ics, some vaccines, and several other injectable prod- io ambient atmosphere so as to avoid liquid seepage from
ucts, require that an active ingredient (usually in a one chamber into the other. The other end of the first
powder form) be mixed with an injection vehicle or dil- cylinder slidably carries a plunger. A hypodermic nee
uent (usually water) shortly before administration. One die is operatively associated with the plunger with its
widely accepted procedure for mixing powder and liq- pointed end extending axially toward a pierceable cen
uid medicament components is to provide them in sep- 15 tral portion of the first diaphragm. The other end of the
arate vials, each having its own rubber stopper closing second cylinder is closed and sealed by a puncturable
its outlet opening. The liquid is withdrawn from its vial clip and diaphragm assembly having its pierceable por
by a needle and syringe, and is then injected into the tion also axially aligned with the pointed end of the
vial containing the powder. The thus-mixed liquid and needle.
powder in the latter vial, after shaking it where re- 20 The first chamber is partially filled with a first medi
quired, is withdrawn as a solution by the same needle cament, usually in powder form, and the excess space
and syringe, and the injection is effected therewith in therein is preferably partially evacuated. The second
a conventional manner. chamber is filled with a second liquid medicament or
Attempts have been made to provide a multicom- vehicle for the first medicament. These medicament partment vial wherein liquid and solid components to 25 components are mixed by partially depressing the be mixed prior to injection are separately contained in plunger so that the pointed end of the needle cannula a manner that permits mixing them within the common pierces the first diaphragm. The partial vacuum in the vial. For example, U.S. Pat. No. 2,495,942 to W. A. excess space in the first chamber facilitates the flow of Nosek, provides an outer container having an inner liquid from the second chamber through the needle and container mounted therein. The outer container con- 30 into the first chamber as the first diaphragm moves tains a liquid medicament and the inner container con- toward and into engagement with the second diatains a solid medicament. The inner container is releas- phragm, thus mixing the two medicaments. When the ably sealed to a stopper which closes both containers. second chamber is exhausted and its volume reduced By depressing the stopper, the inner container is re- essentially to zero in this manner, an injection may be leased so that its solid contents may mix with the liquid. 35 effected by pressing the puncturable clip and diaThe mixture is then withdrawn by piercing the stopper phragm assembly against the skin of a patient and furwith the needle of a hypodermic syringe. Such an ar- ther depressing the plunger to the end of its stroke, rangement, however, is not readily applicable to the According to assembly and filling techniques decontained needle type of hypodermic ampoules to scribed in the copending application of Hurschman et which the present invention relates, apart from other 40 al., the first chamber is partially filled with a carefully objections thereto. measured amount of a powdered medicament and is
Another proposal for providing a multichamber con- partially evacuated. Since a typical charge of powdered
tainer is set forth in U.S. Pat. No. 3,342,180 to Sand- medicament weighs 18 milligrams, considerable care
hage et al., dated Sept. 18, 1967. In that patent, the pat- must be exercised during this particular charging oper
entees provide a vial which is separated into two cham- 45 ation. The necessary weighing operation, therefore,
bers by a plunger. Powder is provided in a lower cham- militates against the filling and assembly of such multi
ber and liquid is provided in the upper chamber. The chamber hypodermic devices on a high production ba
plunger is provided with a one-way check valve so that, sis.
upon retraction of the plunger, the liquid is forced Ctiuhadv^tuc Hvtwem-ti,tm
through the valve and into the compartment containing 50 SUMMARY OF THE INVENTION
the powder. The vial is provided with an external nee- This invention provides a method for assembling and
die at its lower end so that the mixed medicament may filling a multichamber hypodermic device and provides
be injected into the patient. Again, apart from other a multi-chamber hypodermic device having one cham
objections thereto, such an arrangement is not readily 5J ber which is capable of being partially filled with a liq
applicable to the contained needle type of hypodermic uid medicament to be lyophilized or freeze-dried to a
ampoules to which the present invention relates. powdered state so that the powdered medicament need
As a result of the foregoing problems, and numerous not be separately lyophilized, carefully weighed, and
others, prior hypodermic ampoules of the contained then deposited in the first chamber. According to this
needle type to which the present invention relates, all 60 invention, the multichamber hypodermic device in
have been subject to severe limitations on their practi- eludes first and second coaxially disposed cylinders
cal utility, and their uses have been restricted accord- which respectively provide first and second medica
ingly. These problems have been largely overcome by ment-containing chambers, the adjacent ends of which
the multichamber hypodermic ampoule disclosed in are separated by a first, puncturable, piston-like dia
the copending application of Hurschman et al, Ser. No. 65 phragm. This first diaphragm extends across and
114,493, filed Feb. 11, 1971, now U.S. Pat. No. around the end of the first cylinder to close and seal the
3,735,761. According to that application, a multichain- same, and is slidably mounted in the adjacent end of
ber hypodermic device is provided which includes first the second cylinder to close and separately seal the
