U.S. patent number 3,810,469 [Application Number 05/256,407] was granted by the patent office on 1974-05-14 for multiple compartment hypodermic devices.
This patent grant is currently assigned to Ampoules, Inc.. Invention is credited to Alfred A. Hurschman.
United States Patent |
3,810,469 |
Hurschman |
* May 14, 1974 |
MULTIPLE COMPARTMENT HYPODERMIC DEVICES
Abstract
A multichamber hypodermic ampoule of the contained needle type
and a method of assembling and filling such an ampoule are
disclosed. The ampoule includes multiple chambers for premixing a
powdered medicament with a diluent and injecting the mixture. One
end of one chamber is closed by a plunger and the other end of that
chamber is closed by a first pierceable diaphragm. A hollow needle
is operatively associated with the plunger and is initially
contained within that chamber. The first pierceable diaphragm is
slidably mounted in one end of a second chamber which contains the
diluent, and the other end of that chamber is closed by a second
pierceable diaphragm. The plunger is provided with a first
cylindrical portion having a plurality of axially extending and
radially projecting ribs, and is provided with a second cylindrical
portion which is adapted to form a seal with the chamber. The
ampoule is assembled and filled by affixing the first diaphragm to
one end of the first chamber, slidably mounting the first diaphragm
in one end of the second chamber, filling the second chamber with a
diluent, affixing the second diaphragm to the other end of the
second chamber, staking the pointed end of a needle in said first
diaphragm, partially filling the first chamber with a medicament to
be lyophilized, and partially inserting the plunger in the first
chamber so that passageways defined by the ribs permit vapor to be
sublimed from the chamber during a lyophilization process. When
lyophilization is complete and the medicament in the first chamber
is in a powdered or freeze-dried condition, the plunger is fully
inserted to seal the ampoule and to contact the head of the
needle.
Inventors: |
Hurschman; Alfred A. (Hudson,
OH) |
Assignee: |
Ampoules, Inc. (Macedonia,
OH)
|
[*] Notice: |
The portion of the term of this patent
subsequent to May 29, 1990 has been disclaimed. |
Family
ID: |
22972120 |
Appl.
No.: |
05/256,407 |
Filed: |
May 24, 1972 |
Current U.S.
Class: |
604/88; 206/365;
604/196; 206/222; 215/248; 604/416 |
Current CPC
Class: |
A61M
5/284 (20130101); A61M 2005/3123 (20130101); A61M
5/288 (20130101) |
Current International
Class: |
A61M
5/28 (20060101); A61M 5/31 (20060101); A61m
005/28 (); A61j 005/00 () |
Field of
Search: |
;128/215,216,218R,218P,218NV,218F,218M,218D,218DF,272,220
;215/47,52,56 ;206/63.2R,56R,47A |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
1,255,197 |
|
Apr 1960 |
|
FR |
|
55,913 |
|
Jul 1966 |
|
DL |
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: McGowan; J. C.
Attorney, Agent or Firm: McNenny, Farrington, Pearne &
Gordon
Claims
I claim:
1. A multichamber hypodermic ampoule comprising a first cylinder; a
first diaphragm sealed to and closing one end of said first
cylinder; a plunger slidably disposed in the other end of the first
cylinder to provide a first chamber between said plunger and said
first diaphragm; said plunger comprising a cylindrical plug having
a first cylindrical portion which comprises means to effect a
substantially liquid-tight seal with said first cylinder, and
having a second cylindrical portion which comprises means engaging
said first cylinder, and means providing at least one passageway
along an axial extent of said second cylindrical portion; a
hypodermic needle disposed in said first chamber for movement with
said plunger toward said first diaphragm and having an open end
adjacent said plunger and an opposite pointed discharge end
adjacent said first diaphragm; a powdered medicament in said first
chamber; a second cylinder axially aligned with said first cylinder
and having one end closed by insertion of said first diaphragm
therein with a peripheral portion of the first diaphragm in axial
alignment with the inner surface thereof; a second diaphragm
closing the other end of said second cylinder; said first and
second diaphragms and second cylinder, together, defining a second
chamber; and a fluid medicament in said second chamber; whereby
said fluid and solid medicaments may be mixed preparatory to making
an injection by first moving said plunger and needle sufficiently
toward said first diaphragm to project the pointed end of the
needle through said first diaphragm to establish communication
between the two chambers and by then moving said first cylinder,
first diaphragm, plunger, and needle as a unit toward said second
diaphragm to progressively reduce the volume of said second chamber
substantially to zero and thereby express said liquid medicament
through the needle into the first chamber while bringing said first
and second diaphragms substantially into engagement and disposing
the pointed end of said needle in position to project said needle
through said second diaphragm upon further movement of said plunger
toward said first and second diaphragms.
2. A multichamber hypodermic ampoule according to claim 1, wherein
said second cylindrical portion is adjacent said hypodermic
needle.
3. A multichamber hypodermic ampoule according to claim 1, wherein
said second cylindrical portion includes a plurality of radially
projecting ribs which engage said first cylinder and wherein
passageways along said axial extent are defined by adjacent
ribs.
4. A multichamber hypodermic ampoule according to claim 1, wherein
said cylindrical plug has an axially projecting portion extending
from said first cylindrical portion, the axial extent of said
projecting portion being greater than the axial extent of said
first diaphragm but being less than the combined axial extents of
said first and second diaphragms.
5. A multichamber hypodermic ampoule according to claim 1, wherein
said plug is provided with radially extending lip means at one end
of said first cylindrical portion and spaced from said second
cylindrical portion.
6. A multichamber hypodermic ampoule according to claim 1, wherein
said second cylindrical portion is adjacent said hypodermic needle
and includes a plurality of radially projecting ribs which engage
said first cylinder, wherein passageways along said axial extent
are defined by adjacent ribs, wherein said cylindrical plug has an
axially projecting portion extending from said first cylindrical
portion, the axial extent of said projecting portion being greater
than the axial extent of said first diaphragm but being less than
the combined axial extents of said first and second diaphragms, and
wherein said plug is provided with radially extending lip means at
one end of said first cylindrical portion and spaced from said
second cylindrical portion.
Description
BACKGROUND OF THE INVENTION
This invention relates to disposable hypodermic ampoules which
include multiple chambers for premixing a powdered, lyophilized
medicament with a diluent. A number of drug compounds, including
some antibiotics, some vaccines, and several other injectable
products, require that an active ingredient (usually in a powder
form) be mixed with an injection vehicle or diluent (usually water)
shortly before administration. One widely accepted procedure for
mixing powder and liquid medicament components is to provide them
in separate vials, each having its own rubber stopper closing its
outlet opening. The liquid is withdrawn from its vial by a needle
and syringe, and is then injected into the vial containing the
powder. The thus-mixed liquid and powder in the latter vial, after
shaking it where required, is withdrawn as a solution by the same
needle and syringe, and the injection is effected therewith in a
conventional manner.
Attempts have been made to provide a multicompartment vial wherein
liquid and solid components to be mixed prior to injection are
separately contained in a manner that permits mixing them within
the common vial. For example, U.S. Pat. No. 2,495,942 to W. A.
Nosek, provides an outer container having an inner container
mounted therein. The outer container contains a liquid medicament
and the inner container contains a solid medicament. The inner
container is releasably sealed to a stopper which closes both
containers. By depressing the stopper, the inner container is
released so that its solid contents may mix with the liquid. The
mixture is then withdrawn by piercing the stopper with the needle
of a hypodermic syringe. Such an arrangement, however, is not
readily applicable to the contained needle type of hypodermic
ampoules to which the present invention relates, apart from other
objections thereto.
Another proposal for providing a multichamber container is set
forth in U.S. Pat. No. 3,342,180 to Sandhage et al., dated Sept.
18, 1967. In that patent, the patentees provide a vial which is
separated into two chambers by a plunger. Powder is provided in a
lower chamber and liquid is provided in the upper chamber. The
plunger is provided with a one-way check valve so that, upon
retraction of the plunger, the liquid is forced through the valve
and into the compartment containing the powder. The vial is
provided with an external needle at its lower end so that the mixed
medicament may be injected into the patient. Again, apart from
other objections thereto, such an arrangement is not readily
applicable to the contained needle type of hypodermic ampoules to
which the present invention relates.
As a result of the foregoing problems, and numerous others, prior
hypodermic ampoules of the contained needle type to which the
present invention relates, all have been subject to severe
limitations on their practical utility, and their uses have been
restricted accordingly. These problems have been largely overcome
by the multichamber hypodermic ampoule disclosed in the copending
application of Hurschman et al, Ser. No. 114,493, filed Feb. 11,
1971, now U.S. Pat. No. 3,735,761. According to that application, a
multichamber hypodermic device is provided which includes first and
second coaxially disposed cylinders. The cylinders respectively
provide first and second medicament-containing chambers, the
adjacent ends of which are separated by a first, puncturable,
piston-like diaphragm. This first diaphragm extends across and
around the end of the first cylinder to close and seal the same and
is slidably mounted in the adjacent end of the second cylinder to
close and separately seal the same. These two seals are exposed to
and separated by the ambient atmosphere so as to avoid liquid
seepage from one chamber into the other. The other end of the first
cylinder slidably carries a plunger. A hypodermic needle is
operatively associated with the plunger with its pointed end
extending axially toward a pierceable central portion of the first
diaphragm. The other end of the second cylinder is closed and
sealed by a puncturable clip and diaphragm assembly having its
pierceable portion also axially aligned with the pointed end of the
needle.
The first chamber is partially filled with a first medicament,
usually in powder form, and the excess space therein is preferably
partially evacuated. The second chamber is filled with a second
liquid medicament or vehicle for the first medicament. These
medicament components are mixed by partially depressing the plunger
so that the pointed end of the needle cannula pierces the first
diaphragm. The partial vacuum in the excess space in the first
chamber facilitates the flow of liquid from the second chamber
through the needle and into the first chamber as the first
diaphragm moves toward and into engagement with the second
diaphragm, thus mixing the two medicaments. When the second chamber
is exhausted and its volume reduced essentially to zero in this
manner, an injection may be effected by pressing the puncturable
clip and diaphragm assembly against the skin of a patient and
further depressing the plunger to the end of its stroke.
According to assembly and filling techniques described in the
copending application of Hurschman et al., the first chamber is
partially filled with a carefully measured amount of a powdered
medicament and is partially evacuated. Since a typical charge of
powdered medicament weighs 18 milligrams, considerable care must be
exercised during this particular charging operation. The necessary
weighing operation, therefore, militates against the filling and
assembly of such multichamber hypodermic devices on a high
production basis.
SUMMARY OF THE INVENTION
This invention provides a method for assembling and filling a
multichamber hypodermic device and provides a multi-chamber
hypodermic device having one chamber which is capable of being
partially filled with a liquid medicament to be lyophilized or
freeze-dried to a powdered state so that the powdered medicament
need not be separately lyophilized, carefully weighed, and then
deposited in the first chamber. According to this invention, the
multichamber hypodermic device includes first and second coaxially
disposed cylinders which respectively provide first and second
medicament-containing chambers, the adjacent ends of which are
separated by a first, puncturable, piston-like diaphragm. This
first diaphragm extends across and around the end of the first
cylinder to close and seal the same, and is slidably mounted in the
adjacent end of the second cylinder to close and separately seal
the same. These two seals are exposed to and separated by the
ambient atmosphere so as to avoid liquid seepage from one chamber
into the other. The other end of the first cylinder slidably
carries a plunger. A hypodermic needle is operatively associated
with the plunger with its pointed end extending axially toward a
pierceable, central portion of the first diaphragm. The other end
of the second cylinder is closed and sealed by a puncturable clip
and diaphragm assembly having its pierceable portion also axially
aligned with the pointed end of the needle.
The hypodermic device is assembled and filled by first assembling
the first diaphragm across an end of the first cylinder and
inserting the first diaphragm in one end of the second cylinder. A
pointed hollow needle is then inserted in the first cylinder and
staked in the first diaphragm to complete a sub-assembly which
consists of the first and second cylinders, the first diaphragm,
and the needle. The second cylinder is filled with the diluent and
the clip and second diaphragm are applied to the open mouth of the
second cylinder. A measured amount of the liquid to be lyophilized
is then metered into the open mouth of the first cylinder to
partially fill the same.
The plunger according to this invention comprises a plug having
first and second adjacent cylindrical portions. The first
cylindrical portion has a surface which is adapted to form a
liquid-tight seal with the inner wall of the first cylinder. The
second cylindrical portion includes a plurality of axially
extending and radially projecting ribs which are adapted to provide
axial passageways to the interior of the first cylinder when the
second cylindrical portion is inserted in the first cylinder with
the first cylindrical portion extending axially out of the first
cylinder. With the first portion extending axially out of the
cylinder, and with the ribs providing access to the interior of the
cylinder, the entire assembly is placed in a conventional
lyophilization chamber. If desired, the ampoules may be pre-frozen
prior to placement in the lyophilization chamber to reduce the
in-chamber cycle time.
A conventional lyophilization chamber includes a sealable enclosure
having a plurality of shelves which are initially spaced apart but
which may be moved together by a hydraulic ram. Trays of hypodermic
devices are placed on the shelves so that the devices are in an
upright position with their partially inserted plungers directed
toward the lower surface of an upper adjacent shelf. The chamber is
sealed and the ampoules are subjected to extremely low temperatures
to freeze the liquid medicament in the first chamber and, of
course, the diluent in the second chamber (or, if the ampoules are
pre-frozen, to maintain the frozen condition of the liquids). The
lyophilization chamber is then evacuated so that the frozen liquid
phase of the medicament in the first chamber is sublimed and drawn
as a vapor through the passageways formed by the ribs of the
plungers. During this operation, some heat may be supplied to the
chamber to balance the latent heat of vaporization or sublimation
of the frozen liquid. Care must be taken, however, so as not to
permit the frozen liquid to achieve a liquid state. After the
medicament is dried in this manner and reduced to a highly porous
mass of powder, the hydraulic ram is actuated to move the bottom
shelf upwardly so that the plungers on each shelf engage the lower
surface of an upper, adjacent shelf. In this manner, the plungers
are fully seated in their cylinders and each first cylinder is
sealed to produce a completed product.
Just prior to an injection, the powdered medicament is mixed with
the diluent by partially depressing the plunger so that the pointed
end of the needle cannula pierces the first diaphragm, The partial
vacuum in the excess space in the first chamber facilitates the
flow of liquid from the second chamber through the needle and into
the first chamber as the first diaphragm moves toward and into
engagement with the second diaphragm, thus mixing the two
medicaments. When the second chamber is exhausted and its volume
reduced essentially to zero in this manner, an injection may be
effected by pressing the clip and puncturable diaphragm assembly
against the skin of a patient and further depressing the plunger to
the end of its stroke.
BRIEF DESCRIPTION OF THE DRAWING
FIG. 1 is a cross sectional view of a multichamber hypodermic
ampoule according to this invention, showing the plunger partially
inserted for lyophilizing a medicament in a first chamber of the
ampoule.
FIG. 2 is a cross sectional view of the ampoule shown in FIG. 1,
the plane of the section being indicated by the line 2--2 in FIG.
1.
FIG. 3 is a cross sectional view of a multichamber hypodermic
ampoule according to this invention, showing the plunger in a
position which seals the first chamber after completion of the
lyophilization process.
FIG. 4 is a cross sectional view of a multichamber hypodermic
ampoule according to this invention, showing the component parts of
the ampoule in the position attained after completion of a mixing
operation.
FIG. 5 is a fragmentary, elevational view of a lyophilizing chamber
having a multiplicity of multichamber hypodermic ampoules loaded
therein.
FIG. 6 is a fragmentary, elevational view of a lyophilizing chamber
similar to FIG. 5, but showing chamber shelves in positions
attained during the latter stages of a lyophilizing process.
FIG. 7 is a perspective view of a hollow, pointed needle employed
in this invention.
DETAILED DESCRIPTION OF THE INVENTION
An ampoule 10 is adapted to perform a subcutaneous injection and
includes a first cylinder 11 and a second cylinder 12 of larger
diameter, both being preferably made from glass tubing. One end of
the first cylinder 11 has a radially extending annular bead 13
which is received within an annular groove 14 provided in a first
diaphragm 15. The first diaphragm 15 is preferably made from
rubber, and is received with an interference fit within one end of
the second cylinder 12. This radially compresses the diaphragm 15
and causes it to more tightly embrace the annular bead 13.
The other end of the first cylinder 11 is closed by a rubber
plunger 16 which comprises a cylindrical plug having a first
cylindrical portion 17 and a second cylindrical portion 18. The
first cylindrical portion 17 includes a pair of beads 19 and 20
which are separated by a land 21 and which have a diameter which is
slightly greater than the inside diameter of the first cylinder 11,
to thereby effect a substantially liquid-tight seal with the first
cylinder when the beads are positioned as indicated in FIGS. 3 and
4. The second cylindrical portion 18 includes a plurality of
axially extending and radially projecting ribs 22 which are defined
by axially extending slots 23. The slots 23 and the ribs 22 define
axial passageways to the interior of the first cylinder 11 when the
plunger is partially inserted in the cylinder 11, as is illustrated
in FIG. 1.
The rubber plunger 16, the first cylinder 11, and the first
diaphragm 15, together, define a first chamber 24. Entirely
enclosed within the first chamber 24 and staked in the diaphragm 15
is a hypodermic needle 25. The needle 25 is hollow and has a
pointed end 26. For reasons which will become apparent, the needle
25 has a cross-shaped base 25a.
In a manner which will be hereinafter explained in greater detail,
the chamber 24 is partially filled with a powdered medicament 27
and is partially evacuated. In the condition illustrated in FIG. 3,
friction between the plunger 16 and the wall of the cylinder 11 and
resistance of the diaphragm 15 to penetration by the needle 25, of
course, aid in preventing the plunger 16 from prematurely moving
toward the diaphragm 15. To further aid in preventing premature
movement of the plunger 16, a radially extending lip 28 is provided
at one end of the cylindrical portion 17 so that it engages the
upper end of the cylinder 11 during this condition of the
assembly.
The other end of the second cylinder 12 is closed by a second
diaphragm 29 and a clip 30. The clip 30 is cup-shaped and has an
inner annular groove 31 in its cylindrical side wall which snaps
over a bead 32 which is provided on this end of the cylinder 12.
The clip 30 also includes a bottom wall 33 having a central
aperture 34 therethrough. The bottom wall 33 has a concave outside
surface which includes an outer rim 35 which tapers upwardly toward
the aperture 34.
The diaphragm 29 is preferably molded from rubber or synthetic
rubber and is shaped to function in accordance with the teachings
of U.S. Pat. No. 3,094,988 to Dunmire. It includes an outer annular
portion 36, a thick, elongated, centrally located needle guiding
and liquid sealing gland 37, and a relatively thin, flexible,
corrugated, intermediate portion 38 connecting the gland and the
outer portion to permit relative axial movement therebetween. The
gland extends through the aperture 34 in the clip 30. An axial
needle passage 39 may extend into the upper end of the gland from
the inside and terminate short of the opposite, lower end of the
gland to form a thin, easily puncturable wall 40 closing the bottom
of the passage.
The first diaphragm 15, the second diaphragm 29, and the cylinder
12, together, define a second chamber 41. The second chamber 41 is
filled with a diluent in a manner which will hereinafter be
explained.
The diluent in the second chamber is mixed with the solid powder
medicament in the first chamber prior to injection in a manner
which will now be explained. With the plunger 16 in the position
illustrated in FIG. 3, and with the pointed end 26 of the needle 25
received and staked within a passageway 42 in the diaphragm 15, the
plunger 16 is pushed axially toward the first diaphragm 15 until
the needle 25 pierces this diaphragm and provides communication
through the needle and through an opening 43 in the needle cannula
between the second chamber 41 and the first chamber 24. Once
communication is established between these chambers, the liquid is
drawn upwardly into the first chamber by downward movement of the
cylinder 11 and the first diaphragm 15, together, into engagement
with the second diaphragm 29, as shown in FIG. 4. At this stage,
the pointed end of the needle 25, which previously pierced the
first diaphragm 15, has entered the gland 37 of the diaphragm
29.
To ensure that the pointed end of the needle will not be initially
extended too far beyond the first diaphragm 15 after it pierces
that diaphragm, the plunger 16 is provided with a centrally raised
portion 44 which extends beyond the end of the cylinder 11 when the
ampoule is initially assembled and is in the condition illustrated
in FIG. 3. The raised portion 44, therefore, extends beyond the end
of the cylinder 11 for a distance which substantially corresponds
to the thickness of the portion of the diaphragm 15 to be pierced
plus the desired extension of the needle beyond the diaphragm 15
during the mixing operation. To perform the penetration operation,
therefore, the raised portion 44 is depressed until the top of the
raised portion 44 is flush with the top mouth of the cylinder 11,
as illustrated in FIG. 4.
When the ampoule 10 is in the condition illustrated in FIG. 4, and
the ampoule has been inverted several times or vigorously shaken as
reliable mixing of the medicament components may require (generally
not necessary), the ampoule is in a condition suitable for making a
subcutaneous injection. To perform the injection, the clip 30 and
the diaphragm 29 are placed adjacent the patient's skin and the
plunger is fully depressed until the plunger 16 engages the
diaphragm 15. During the plunger depressing step, the needle
penetrates the wall 40, and fluid is exhausted from the first
chamber through the needle opening 43 and through the opening in
the end of the needle as the needle penetrates the skin and
subcutaneous fat of the patient. This operation is normally
performed by mounting the ampoule in an applicator.
The ampoule 10 is assembled and filled by applying the diaphragm 15
to one end of the cylinder 12 and then inserting the diaphragm 15
in an open end of the cylinder 12. The cylinder 12 is then filled
with a suitable diluent such as water. The diaphragm 29 is then
placed over the beaded end of the cylinder 11 and is secured in
place by snapping the clip 30 over the bead 32. The needle 25 is
then inserted in the open end of the cylinder 11 and staked within
the passageway 42 of the diaphragm 15. A powdered
medicament-containing solution is then metered into the cylinder
11. The amount of medicament-containing liquid metered into the
cylinder 11 depends upon the amount of powdered medicament which is
to be retained in the chamber 24. After the liquid is metered into
the chamber 24, the plunger 16 is partially inserted in the
cylinder 11 so that a part of the second cylindrical portion 18
extends beyond the end of the cylinder 11, as is illustrated in
FIG. 1.
The ampoule is then placed in a lyophilization chamber and is
subjected to a conventional freeze-drying cycle to remove
substantially all of the moisture from the chamber 24. To
accomplish this objective, a multiplicity of ampoules 10 are placed
in a lyophilization chamber 50, shown schematically in FIGS. 5 and
6. A number of ampoules 10 are loaded on trays 51, 52, 53, and 54.
The trays 51-54 are respectively placed on movable platens or
shelves 55, 56, 57, and 58, which are located within an enclosure
59. The shelves 55-58 are slidably mounted for upward movement on
guide rods 60 and 61, but are prevented from downward movement
beyond the positions illustrated in FIG. 5 by stop means (not
shown).
With the ampoules 10 loaded on the trays so that the plungers are
directed upwardly toward an adjacent shelf, the enclosure 59 is
closed and sealed by a door 62. After the enclosure is sealed, the
ampoules 10 are subjected to extremely low temperatures to freeze
the medicament in each chamber 24. The freezing process is
controlled in a known manner so that the ice formation has a
multiplicity of cracks or spaces between ice crystals. After the
medicament is frozen, the frozen liquid matrix is removed by
evacuating the enclosure 59 to thereby subject the frozen
medicament to extremely low pressures. The frozen liquid matrix is
thereby drawn off as a vapor through the passageways provided by
the ribs 22 and the slots 23 in each plunger 16. It should be noted
that the cross-shaped base 25a of the needle 25 permits passage of
the vapors from the chamber 24 and also serves to retain the needle
in a preselected position by contacting the inner wall of the
cylinder 11. During the sublimation operation, it may be necessary
to add some heat to balance the heat of vaporization or
sublimation. When the moisture has been removed from each chamber
24, and while the vacuum is applied, the plungers 16 are driven to
the position illustrated in FIG. 3 to seal the chambers 24 in the
following manner.
Referring now to FIG. 6, a ram 63 is actuated to drive the lowest
shelf 55 upwardly. When the plungers of the ampoules positioned on
that shelf engage the shelf 56, the shelf 56 is also driven
upwardly. This procedure continues until the plungers of the
ampoules on the shelf 58 engage a top stationary plate 64. The ram
63 then subjects the plungers 16 to a predetermined movement
sufficient to advance the plungers to the position illustrated in
FIG. 3 and into contact with the needle base 25a. To prevent
advancement of the plungers 16 beyond that position, spacer bars S
are provided on each shelf. The spacer bars S have a longitudinal
dimension corresponding to the longitudinal extent of the ampoule
illustrated in FIG. 3. The ram 63 is then lowered, atmospheric
pressure is applied to the chamber 59, the door 61 is opened, and
the trays are removed from the lyophilization chamber.
It should be appreciated that this invention is applicable not only
to the subcutaneous multichamber hypodermic ampoule illustrated
herein, but is also applicable to the various multichamber
hypodermic ampoule variations disclosed in the copending
application of Hurschman et al. Therefore, the invention is not
restricted to the slavish imitation of each and every detail set
forth above. Obviously, multichamber hypodermic ampoules and
assembly and filling techniques may be provided which change,
eliminate, or add certain specific details without departing from
the scope of the invention.
* * * * *