U.S. patent number 3,552,387 [Application Number 04/745,156] was granted by the patent office on 1971-01-05 for combination syringe and vial.
Invention is credited to Peter A. Stevens.
United States Patent |
3,552,387 |
Stevens |
January 5, 1971 |
COMBINATION SYRINGE AND VIAL
Abstract
The invention relates to a combination syringe and vial, each
containing a separate chamber having an individual ingredient
therein. The syringe and vial are assembled in interconnected
relation to each other with the hub and cannula of the syringe
extending within the vial in a manner to simultaneously support and
seal the hub of the syringe with respect to a first closure in the
vial and the distal portion of the cannula with respect to a second
closure supported by the vial and in spaced-apart relation to the
first closure, to maintain the respective chambers sealed off from
each other. The first closure has a preformed axial bore extending
entirely therethrough, and the second closure has a preformed
axially extending channel therein. The dispensing of the
ingredients occurs by displacing in a longitudinal direction the
syringe and vial until the seal between the distal portion of the
cannula and second closure is released, permitting movement of the
plunger in the syringe to force the ingredient therein into the
vial with resultant mixing of the two ingredients.
Inventors: |
Stevens; Peter A. (Middlebury,
CT) |
Family
ID: |
24995489 |
Appl.
No.: |
04/745,156 |
Filed: |
July 16, 1968 |
Current U.S.
Class: |
604/88; 604/201;
604/89; 604/415 |
Current CPC
Class: |
A61J
1/2093 (20130101); A61J 1/2096 (20130101); A61M
5/31596 (20130101); A61J 1/2031 (20150501); A61J
1/2041 (20150501); A61J 1/201 (20150501) |
Current International
Class: |
A61J
1/00 (20060101); A61M 5/315 (20060101); A61m
005/18 (); A61m 005/24 () |
Field of
Search: |
;128/218,218M,218R,272 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
1,167,766 |
|
Aug 1958 |
|
FR |
|
1,064,691 |
|
Sep 1959 |
|
DT |
|
848,081 |
|
Sep 1952 |
|
DT |
|
Primary Examiner: Koren; Samuel
Assistant Examiner: Czerwonky; James H.
Claims
I claim:
1. A device for both maintaining separately and thereafter mixing
ingredients, comprising in combination:
A. syringe means having a cannula extending therefrom and
communicating with a storage chamber for containing an ingredient,
said syringe means having plunger means in said storage
chamber;
B. vial means having a mixing chamber for containing an ingredient,
and a first opening and a second opening in spaced-apart relation,
each communicating with said mixing chamber;
C. supporting means comprising first and second closure means
inserted respectively in said first and second openings and having
a preformed axial bore extending entirely through said first
closure means and a preformed axially extending channel in said
second closure means communicating with said chamber and in coaxial
alignment with said axial bore for receiving said syringe means and
the proximate portion of the cannula in said axial bore and the
distal portion of the cannula in the axially extending channel for
mounting said syringe means on said vial means to provide support
at spaced-apart positions for said syringe means and said cannula,
with said cannula extending into and being supported in said mixing
chamber, so as to releasably connect and firmly retain said syringe
means and said cannula relative to said vial means; and
D. said first and second closure means each having at least one
portion thereof comprising sealing means for frictionally engaging
said syringe means and said cannula distal portion in said mixing
chamber, said sealing portion in said axial bore being of a
diameter relative to the outer diameter of the syringe to provide
sealing engagement therebetween, and said sealing portion in said
axially extending channel being of a diameter relative to the outer
diameter of said cannula to provide sealing engagement
therebetween, such that said cannula distal portion is dislodged
from said sealing means in said mixing chamber by longitudinally
displacing said vial means and syringe means a preselected distance
until said distal portion is removed from said sealing means, so as
to permit said syringe ingredient to be discharged into said vial
means and mixed with said vial ingredient, and the resultant fluent
mixture can be withdrawn from said vial means into said syringe
means.
2. A device according to claim 1, wherein the longitudinal length
of said sealing means between said syringe means and said vial
means is greater than the longitudinal length of said sealing means
between the distal portion of said cannula and said vial means, so
as to permit the withdrawal of said cannula from sealing engagement
in said mixing chamber while said vial means remains in sealing
engagement with said syringe means to maintain sterility in said
mixing chamber.
3. A device according to claim 1, wherein the longitudinal length
of said supporting means between said syringe means and said vial
means is greater than the longitudinal length of said supporting
means between the distal portion of said cannula and said vial
means, so as to permit the withdrawal of said cannula from
supporting engagement within said mixing chamber while said vial
remains in supported relation with said syringe means to permit the
mixture to be obtained.
4. A device according to claim 1, wherein said supporting means
retains the distal portion of said cannula in a fixed position to
prevent lateral movement thereof.
5. A device according to claim 4, wherein said distal portion is
supported a length at least equal to .01 inches.
6. A device according to claim 1, wherein the total longitudinal
length of said device is not increased more than 20 percent of said
individual syringe means, so as to obtain a compact assembly
thereof.
7. A device according to claim 1, wherein said second closure means
is dimensioned with respect to said second opening in said vial
means such that when positioned therein a radially inwardly
directed force is applied to compress said sealing portion of said
axially extending channel against said cannula to further maintain
fluidtight sealing engagement therebetween.
8. A device according to claim 7, wherein the longitudinal length
of said channel is at least equal to the diameter of said
cannula.
9. A device according to claim 7, wherein said second closure means
includes a body portion extending within said second opening and a
radial flange integrally formed therewith and extending exteriorly
of said vial and an overseal secured to said vial means and said
radial flange said channel extending substantially the length of
said body portion.
10. A device according to claim 1, wherein said second opening
extends through said vial and said second closure means is
sealingly inserted therein.
11. A device according to claim 1, further including overseals
retaining said first and second closure means relative to said vial
means.
12. A device according to claim 1, wherein said second opening
terminates in said mixing chamber and forms a seat for retaining
said second closure therein.
13. A device according to claim 1, wherein said first and second
openings are of a circular configuration and said first opening is
of a diameter equal to or greater than the diameter of said second
opening to permit the displacement of said second closure through
said first opening.
14. A device according to claim 1, wherein said channel terminates
in an enlarged pocket contained in said second closure into which
the tip of said cannula extends.
15. A device for both maintaining separately and thereafter mixing
ingredients, comprising in combination:
A. syringe means having a cannula extending therefrom and
communicating with a storage chamber for containing a sterile
ingredient, said syringe means having plunger means in said storage
chamber;
B. vial means having a mixing chamber for containing a sterile
ingredient with a first opening and a second opening in
spaced-apart relation, each communicating with the mixing
chamber;
C. first closure means sealingly inserted in the first opening of
said vial means;
D. second closure means inserted in the second opening of said vial
means and fixedly secured thereto;
E. first supporting means integral with said first closure means in
the form of a preformed axial bore extending entirely therethrough
mounting said syringe means on said vial means so as to releasably
connect and firmly hold said syringe means and the proximate end of
the cannula with respect to said vial means, in said axial bore,
with said cannula extending through said first closure means and
into said mixing chamber;
F. second supporting means integral with said second closure means
in the form of a preformed axially extending channel extending
therein and communicating with said mixing chamber, so as to
releasably connect and firmly hold the distal portion of said
cannula within said mixing chamber relative to said vial means,
such that the resistance of said respective supporting means must
be overcome before longitudinally displacing said vial means and
syringe means;
G. first sealing means integral with said first closure means for
functioning as a seal by having at least a portion of said axial
bore relative to the syringe means extending therethrough of a
diameter to provide for frictionally engaging said syringe and
sealing said mixing chamber from the atmosphere; and
H. second sealing means integral with said second closure means and
communicating with said mixing chamber for functioning as a seal by
having at least a portion of said axially extending channel in said
second closure means of a diameter relative to the outer diameter
of said cannula for frictionally engaging said cannula distal
portion in said mixing chamber, such that it is dislodged from said
sealing means by longitudinally displacing said vial means and
syringe means a preselected distance until said distal portion is
removed from said sealing means, so as to permit said syringe
ingredient to be discharged into said vial means and mixed with
said vial ingredient, and the resultant fluent mixture can be
withdrawn from said vial means into said syringe means after which
said supporting means is released so that said syringe means can be
used to inject said mixture.
16. A device according to claim 15, wherein the longitudinal length
of said first sealing means between said syringe means and said
vial means in said first closure means is greater than the
longitudinal length of said second sealing means between the distal
portion of said cannula and said vial means in said second closure
means, so as to permit the withdrawal of said cannula from sealing
engagement with said second closure means while said vial means is
simultaneously in sealing engagement with said syringe means to
maintain sterility in said mixing chamber.
17. A device according to claim 16, wherein said second sealing
means further includes said second closure means dimensioned with
respect to said second opening in said vial such that when
positioned therein a radially inwardly directed force is applied to
compress said channel against said cannula to further maintain
fluidtight sealing engagement therebetween.
18. A device for both maintaining separately and thereafter mixing
sterile ingredients and for injecting the mixture, comprising in
combination:
A. syringe means having a cannula extending therefrom and
communicating with a storage chamber for containing a sterile
ingredient, said syringe means having plunger means in said storage
chamber;
B. vial means having a mixing chamber for containing a sterile
ingredient with first and second openings in spaced-apart relation,
each communicating with the mixing chamber;
C. first closure means sealingly inserted in the first opening of
said vial;
D. second closure means inserted in the second opening of said
vial;
E. first supporting means integral with said first closure means in
the form of a preformed axial bore extending entirely therethrough
for mounting said syringe means and the proximate portion of said
cannula on said vial means so as to releasably connect and firmly
hold said syringe means and cannula with respect to said vial means
in said axial bore with said cannula extending into said mixing
chamber;
F. second supporting means integral with said second closure means
in the form of a preformed axially extending channel extending
therein and communicating with said mixing chamber, so as to
releasably connect and firmly hold the distal portion of said
cannula within said mixing chamber relative to said vial means,
such that the resistance of said respective supporting means must
be overcome before longitudinally displacing said vial means and
syringe means;
G. first sealing means integral with said first closure means for
functioning as a seal by having at least a portion of said axial
bore relative to the syringe means extending therethrough of a
diameter to provide for frictionally engaging said syringe and
sealing said mixing chamber from the atmosphere;
H. second sealing means integral with said second closure means and
communicating with said mixing chamber for functioning as a seal by
having at least a portion of said axially extending channel in said
second closure means of a diameter relative to the outer diameter
of said cannula for frictionally engaging said cannula distal
portion in said mixing chamber and sealing said mixing chamber from
said storage chamber, such that said cannula is dislodged from said
closure means by longitudinally displacing said vial means and
syringe means a preselected distance until said distal portion is
removed from said second sealing means, so as to permit said
syringe ingredient to be discharged into said vial means and mixed
with said vial ingredient, and the resultant fluent mixture can be
withdrawn from said vial means into said syringe means after which
said first supporting means is released so that said syringe means
can be used to inject said mixture;
I. said first sealing means being greater in length than said
second sealing means, so as to permit the withdrawal of said
cannula distal portion from sealing engagement with said second
closure means while said syringe simultaneously remains in sealing
engagement with said vial means to maintain sterility in said
mixing chamber; and
J. said first supporting means being greater in length than said
second supporting means, so as to retain said syringe means in
supported position relative to said vial means by said second
supporting means after said cannula is withdrawn from said first
supporting means.
Description
BACKGROUND OF THE INVENTION
This invention relates to packaging, mixing and dispensing
apparatus, and more particularly to such an apparatus, wherein two
materials are packaged in individual containers for separate
maintenance of the materials prior to their use in combination.
Much prior effort has been directed to apparatus or injectors
wherein a powder and a diluent, or two diluents, are separately
packaged in the required amounts, with the mixture being
accomplished by injecting the diluent into the powder, and the
mixture ejected as needed. Such prior effort is exemplified by U.S.
Pat. No. 3,330,281, which discloses the use of a separate cap on
the cannula, for example, to maintain the respective chambers
containing the powder and diluent sealed from each other. The use
of a cap on the cannula has the drawback of not being able to
control the closure caps position after it is removed from the
cannula, since a certain quantity of the mixture might be entrapped
therein. An additional drawback of this device is that a positive
pressure has to be applied to the plunger to force the fluid
through the cannula and overcome the frictional resistance between
the cap and cannula to remove the cap from the cannula. This limits
the frictional fit between the closure cap and cannula since, if
the frictional fit is too great the pressure applied by the plunger
may not be sufficient to dislodge the cap. Another way of possibly
dislodging the cap is to retract the cannula from the sterilized
chamber until the cap engages the closure of the vial and is forced
off it. The disadvantage of this is that the cannula is
substantially removed from the sterile chamber before the mixing of
the ingredients is complete which might lead to contamination
thereof.
OBJECTIVES OF THE INVENTION
It is the general object of the present invention to avoid and
overcome the foregoing and other difficulties of and objections to
prior art practices by the provision of an improved disposable
preloaded hypodermic syringe and vial.
Another object of the present invention is to provide an improved
disposable preloaded hypodermic syringe and vial that is of compact
configuration and minimum length.
Another object of the present invention is to provide a syringe and
vial package having a positive seal between the respective chambers
thereof.
Another object of the present invention is to maintain the cannula
of the syringe assembly at each end thereof in a supported position
during shipment and storage thereof.
Other objects and advantages of the present invention will become
apparent as the disclosure proceeds.
BRIEF SUMMARY OF THE INVENTION
The inventor has discovered that a simple but unique combination of
elements provides for an ideal unit that is capable of being stored
for prolonged periods of time and is safe for shipment with a
minimal of packaging materials required. By the present device the
essential components of a package which contains a syringe and a
vial, are combined without the associated other parts presently
found in the art today. Therefore extraneous covers or other guards
are not required and the proper dimensional relationship of the
syringe and vial coact with each other to provide a unitary
assembly that may be easily and conveniently placed into operation
in a manner presently known by those who are using devices of a
similar nature. The simplicity and uniqueness of the coaction
between the basic elements is a departure from compartmented
devices of the art, which demonstrates the remarkable ingenuity of
the present invention which has been able to eliminate all those
extraneous parts presently found in prior-art devices.
By being able to do this the inventor is also capable of providing
a total assembly essentially not greater in length than the
individual syringe, such that minimum packaging space is required,
and considering that millions of the same are sold on a yearly
basis the volume of space saved in both storage and shipment is
also of an economical magnitude worthy of consideration.
The device of this invention comprises essentially means defining a
pair of chambers for containing a first sterile ingredient for
injection to which is affixed means defining a mixing chamber for
containing a second sterile fluid ingredient for injection. A
penetrable first closure seals the open upper end of the mixing
chamber. Communication between the mixing and storage chambers is
provided by a cannula mounted on the means defining the mixing
chamber and extending through the penetrable first closure into a
second closure fixedly mounted within the mixing chamber for
sealing off the passageway in the cannula connecting the chambers
and retaining the distal portion in a supported position.
In its preferred embodiment the device of this invention comprises
a mixing vial containing a second sterile ingredient for injection
atop of which is positioned a syringe containing a first sterile
fluid ingredient, such as a diluent, for injection. The cannula of
the syringe extends into the vial through a penetrable first
closure which both seals the neck of the vial and affords rigidity
in the connection between the syringe and the vial of the mounted
assembly. The second closure member is fixedly mounted and
contained within the vial means and is adapted to seal off the
distal portion or end of the cannula inside the vial, such that a
seal between the respective chambers is obtained and the distal
portion of the cannula is radially supported to absorb any shock or
other vibrations transmitted to the assembly. The obtainment of a
mixture of the ingredients in their respective chambers is obtained
by first longitudinally moving them relative to each other such
that the distal end is moved and freed from its sealing engagement
with the second closure member. At that time the piston of the
syringe is moved axially forward such that the ingredient therein,
generally a fluid, moves through the hollow cannula into the mixing
chamber, causing the fluid ingredient in the syringe to mix with
the sterile ingredient in the vial. The entire unit is then
inverted, the syringe withdrawn to a low point in the inverted vial
and the mixed ingredients drawn into the syringe in the usual
manner. The syringe is then withdrawn from the vial and is ready
for use.
The inventor has found that by providing a second closure member
coupled to the opposite end of the vial, that the entire syringe
assembly need only be retracted a preselected distance so as to
have the open distal portion of the cannula released from the
second closure member thereby permitting a greater degree of
frictional resistance between the cannula and being assured of a
more positive seal.
BRIEF DESCRIPTION OF THE DRAWINGS
Although the characteristic features of this invention will be
particularly pointed out in the claims, the invention itself, and
the manner in which it may be made and used, may be better
understood by referring to the following description taken in
connection with the accompanying drawings forming a part hereof, in
which:
FIG. 1, is a partial cross-sectional view of a syringe and vial
interconnected in accordance with the invention;
FIGS. 2--4, illustrate in schematic form the method of packaging
and assembling the syringe and vial illustrated in FIG. 1;
FIGS. 5 and 6, show fragmentary cross sections of various forms of
closure members to support and seal the cannula to the vial;
FIG. 7, is a partial view of an assembly with the vial partially in
cross section illustrating another form of the vial of the present
invention; and
FIG. 8--10, illustrate in schematic form the method of packaging
and assembling the syringe and vial illustrated in FIG. 7.
DETAILED DISCUSSION OF THE INVENTION
Specific reference to the form of the present invention illustrated
in the drawings, and referring particularly to FIG. 1, an assembly
generally indicated by the reference numeral 10, includes in
combination syringe means 12 and vial means 14 assembled and
operative together to obtain the desired end usage of dispensing
one or more sterilized ingredients.
The syringe means 12 has a cylindrical barrel 16 which is removably
mounted on top of the vial 14. The barrel 16 terminates at its
upper end in a finger engageable collar 18 and at its lower end in
a hub or boss 20, which is of reduced diameter. The lower end of
the barrel 16 has a cannula 22 extending therefrom and rigidly
secured thereto in sealing engagement therewith and having a hollow
passageway 24 communicating with the first or storage chamber 26 in
the barrel 16 and at its opposite end with the distal end or
portion 28 of the cannula 22 which has a pointed tip of any desired
configuration. The cannula 22 may be coupled directly to the barrel
without the use of a hub. Plunger 30 with thumb engageable flange
32 is slidably mounted in barrel 16. One end of the plunger extends
beyond the barrel 16 and the other end is connected to the piston
34, which is exposed in the barrel 16. Annular grooves 36 may be
provided in piston 34 in the form of annular ridges for slidable
and sealing engagement with the interior surface 38 of the barrel
16. Accordingly, the syringe means 12 is essentially a separate
assembly and as hereinafter described will be used for initially
storing a first sterilized ingredient 40 contained in the storage
chamber 26, and which may be in a liquid or powder form.
The vial means 14 in accordance with the embodiment illustrated in
FIG. 1, includes a receptacle 42 having an interior mixing or
second chamber 44 and at one end thereof having a first neck 46
terminating in a first opening 48 and at its opposite end having a
second neck 50 terminating in a second opening 52, which openings
may be in axial alignment with each other. First penetrable closure
means 54 in the form of a closure member is secured in first neck
46, having a body portion 56 extending within the first opening 48
with an integrally formed flange 58 engaged with the upper flange
edge 60 of the first neck 46. The first closure means 54 also has
first supporting means associated therewith in the form of an
inwardly extending opening bore 62 into which the hub 20 of the
barrel 16 is received, in frictional engagement therewith, thereby
lending rigidity to the assembly and sealing the interior of the
vial 14 against the atmosphere. The longitudinal length of said hub
20 is indicated by the dimension E, and is intended to be greater
than the axial length of the supported section of the distal
portion 28 of the cannula 22, as hereinafter explained. Overseal 64
provides a tamper-proof protection for the first closure member 54
and clamps the flange 58 against the neck 46. There exists a slight
frictional interference between the opening diameter of the bore 62
and that of the hub 20 such that a force is required for separation
of the two.
The first closure member 54 is provided with an aperture 74 which
is in coaxial alignment with bore 62 such that the cannula 22
extends therethrough. In addition a conical depression 76 is
provided at the lower end of the first closure member 54 such that
a well is formed when the first ingredient 40 and second ingredient
78, which also may be a liquid, powder, or combination thereof, are
mixed together and removed from the mixing chamber 44.
The opposite end of the vial 14 is provided with a second closure
means in the form of a closure member 66 having a body portion 68
extending into the second opening 52, and having a radial flange 70
for engagement with the lower flange end 72 of the neck 50. In like
manner an overseal 64 provides tamper-proof protection for the
second closure member 66. The second closure member may be inserted
from the side of the receptacle or the end as shown.
The second closure member 66 is provided with sealing means and
second supporting means to both seal off the passageway 24 of the
cannula 22 from the mixing chamber 44 and simultaneously support
the distal end 28 thereof. The sealing means is in the form of an
axially extending channel 80, the axial length of the channel is
indicated by the dimension L with the cannula 22 extending therein
a distance C which is less than or equal to the dimension E, as
hereinafter explained. The channel 80 includes a tapered opening 82
such that in assembly of the syringe means 12 and vial means 14
they may be axially directed into each other. The second closure
member 66 also acts as the support means by retaining the distal
portion 28 of the cannula 22 in a fixed position such that the
distal portion 28 is axially supported when assembled and a seal is
formed such that the first ingredient 40 which is illustrated as a
liquid will remain in the storage chamber 26 and not find its way
to the mixing chamber 44. The sealing engagement is provided by the
depth of the distal portion 28 extending within the channel 80 as
illustrated by the dimension C. The dimension C may range from .01
to .50 inches. The degree of frictional interference between the
axial channel 80 having a diameter indicated by the dimension G and
the outer diameter D, at the distal portion 28 may be
predetermined. To assure greater sealing engagement between the
second closure member 66 and cannula 22 the proper degree of
frictional interference is selected.
An advantage of the present invention is that the degree of
frictional interference may be controlled since a radially applied
force in the direction of arrow F may be applied along the axial
length characterized by the dimension C since in its preferred
embodiment the dimension A of the second opening 52 is less than
the dimension B of the body portion of the second closure member 66
such that the degree of frictional interference therebetween does
exist and may be controlled. In this manner a minimal degree of
frictional interference may be provided between the distal portion
28 and the channel 80 such that the distal portion 28 may be
inserted within the channel 80 without incurring any coring, as by
scraping particles of the second closure member 66 as the cannula
22 is inserted therein. Since the closure members may be made out
of a rubber or plastic material coring can take place and possibly
clog up the passageway 24. By being able to selectively
characterize the dimensions A, B, D and G it is possible to obtain
a seal with respect to all engaging surfaces of the vial, cannula
and second closure member to assure maximum protection of both
sealing means and support means. For certain applications the
channel may be formed by embedding the distal portion within the
second closure member.
Thus, second supporting means which is illustrated as integrally
formed in the second closure member 66 also provides the support
for the distal portion 28 such that each respective ends of the
cannula 22 are supported during the entire shipment and storage up
to the time of usage. This isolates the cannula and assures the
proper support such that any vibrations incurred or transmitted in
shipment to the assembled unit 10 will not affect the seal between
the cannula 22 and the second closure member 66, and syringe means
12 and first closure member 54. By providing this structural
arrangement it is possible to utilize a cannula having a smaller
external diameter from the same structural material, which is
generally metallic, than when same is free at one end thereof and
can be freely vibrated.
In operation the user receives the assembly 10 as illustrated in
FIG. 1, with the first ingredient 40 in the storage chamber 26 and
the second ingredient 78 in the mixing chamber 44, and to permit
the free flow of the material between the respective chambers of
the syringe means 12 and vial means 14 they are moved
longitudinally away from each other until the tip of the cannula 22
is dislodged from the first supporting means of the second closure
member 66 by displacing them a preselected distance. When retracted
the first ingredient 40, illustrated as a fluid, can be discharged
into the vial means 14 and mixed with the second ingredient 78,
illustrated as a powder, and the resultant fluent mixture can be
withdrawn from said vial means 14 into the syringe means 12 after
which the first supporting means is released so that the syringe
means is removed from its assembly with the vial means and can be
used to inject said mixture.
Since the axial length of support of the hub 20, as indicated by
dimension E, is greater than the axial length of support of the
distal portion 28 of the cannula 22, as indicated by dimension C,
the hub 20 remains in sealing and supporting engagement with first
closure member 54 during the mixing operation to preserve
sterility. In addition the supporting means between the hub 20 and
first closure member 54 assures support of the vial 14 on the
syringe 12 after the distal portion 28 has been retracted from the
sealing means. Thus, in accordance with the invention the syringe
means 12 is only retracted a minimal distance in the direction of
arrow 85 such that the sterility of the cannula is preserved since
there is no substantial exposure, if any, of any portion of the
cannula that is contained within one of the respective chambers and
the atmosphere. This is important since it is not necessary to
reinsert the cannula in order to obtain the combined mixture.
An additional important advantage of the present invention, as can
now be see after a description thereof, is that the axial length T
of the assembly 10 is at a minimum. The total length is kept at a
minimum since the distal portion 28 is essentially at the extreme
end of vial means 14. In actual practice it has been found that the
assembly 10 is not increased in length by more than 20 to 30
percent of the original length of the syringe means 12. For
example, if the syringe means 12 has an axial length of 5 inches
then the total assembly 10 as indicated by the dimension T will not
generally exceed 6 inches. This is an important factor in that it
maintains the total package at a minimal length, which due to the
cost of storage space and the number of units used per year is a
sizable savings.
FIGS. 2 through 4 illustrate one method of assembly of the
embodiment of the invention illustrated in FIG. 1, and same is
accomplished such that the end package 10 has within the vial means
14 the second ingredient 78 within the mixing chamber 44 while the
distal portion 28 of the cannula 22, which has a passageway 24
extending therethrough is packaged free of the second ingredient
78. To accomplish the assembly, the vial means 14 is supplied
having the first closure member 54 and the associated overseal 64
in assembled relation to each other and the syringe means 12 is
inserted through the aperture 74, and bore 62 in the first closure
member 54 such that the distal portion 28 of the cannula 22 is
contained within the mixing chamber 44, as illustrated in FIG. 2.
Accordingly, the syringe means 12 is inserted through the first
closure member 54 such that the distal portion 28 thereof extends
within the mixing chamber 44 and in coaxial alignment with the
second opening 52 of the second neck portion 50 at the opposite end
of the vial 14.
The distal portion 28 of the cannula 22 is then covered as by
providing a cover member 94 having radial flanges 96 which are
secured to a chute 98 in the shape of a funnel having a conical
portion 100 and a cylindrical portion 102, which latter portion is
inserted in the second opening 52 such that the supply of the
second ingredient 78 from a supply source 104 may be permitted to
flow into the vial means 14 by gravity, or if desired under
pressure. The supply source 104 is synchronized such that a
predetermined amount of ingredient 78 is automatically placed
therein. The ingredient may be either in a powder, liquid, or other
forms such as a combination of the two. Once the chute 98 and the
associated closure 94 is positioned in place then the vial 14 is
filled with the preselected quantity of the ingredient through the
opening 52. Subsequent thereto the cover member 94 is removed from
over the distal portion 28 of the cannula 22 such that the second
closure member 66 may be positioned in place as seen in FIG. 3.
The second closure member 66 is initially supported by support
means 106 which either by friction or other means retains it in
fixed position and the support means 106 by mechanical conventional
means is moved axially in the direction of arrow 108, relative to
the vial means 14, which may also be supported by securement means
110 in engagement with the vial means 14. Accordingly, once the
second closure member 66 is inserted over the tip of the cannula 22
it is then moved axially relative to the vial 14 until it reaches
the position shown in FIG. 3. The body portion 68 of the second
closure member 66 is selected to have a cross-sectional area which
is generally cylindrical and complementary to the opening 52 such
that there is a degree of frictional resistance, as by a slight
interference between the two. Accordingly, the static force
supplied in the direction of arrow 108 is sufficient to overcome
this frictional resistance such that the second closure member 66
is seated therein. In like manner the channel 80 in the second
closure member may be of a circular cross section and dimensioned
to provide an interference fit with the outer surface of the
cannula 22 such that frictional interference exists. In the same
manner the static force as applied in the direction of arrow 108
should also be sufficient to overcome this static force so as to
obtain a double seal formed by the relative compressed surface
areas of engagement of the second closure member 66 with both the
vial means 14 and cannula 22.
Thus, the assembly formed in FIG. 2, is obtained by moving the vial
means 14 and supported second closure member 66 axially relative to
each other until the distal end 28 of the cannula 22 is positioned
within the channel 80 in the form of an axial bore, and the second
closure member 66 is contained within the second opening 52 whereby
the seal between the two is obtained. The overseal 64 is then
applied by capping means 112 which is adapted to actually force it
over the second closure member 66 and the neck of the vial 14 to
provide a tamper-proof assembly by applying a static force in the
direction of 108.
While the axial movement of the second closure member 66 and vial
means 14 towards each other occurs a frictional resistance or
interference between the syringe assembly 12 and first closure
member 54 is not always sufficient to prevent axial movement
therebetween and accordingly retention means (not shown) for the
syringe 12 and vial 14 may be utilized to maintain them in fixed
relation to each other as the second closure member 66 is
positioned within the second opening 52.
FIG. 5, illustrates another form of the invention in which the
second closure member 66a is similar to that illustrated in FIG. 1,
and has an overseal 64a that secures it to the neck 50a of the vial
means 14a. Extending from the body portion 68a is a shoulder
portion 84a having the axial channel 80a extending therein a
distance L. In this form of the invention the axially applied
pressure present in FIGS. 1 and 4, by the interference fit between
the vial opening and body member is not available, and the degree
of frictional interference between the axial channel 80a and the
diameter at the distal portion 28a of the cannula 22a is relied
upon to obtain the sealing engagement between the respective
surfaces and the holding of the cannula in a fixed position against
longitudinal or lateral movement.
FIG. 6, illustrates another form of the invention in which the
second closure member 66b is again similar to that illustrated in
FIG. 1, and includes an overseal 64b which secures the second
closure member 66b to the neck portion 50b of the vial means 14b.
The second closure member 66b includes an axially extending channel
80b which terminates in opening or pocket 86b into which the distal
portion 28b may be positioned. A radial undercut 88b may be
provided such that the axially applied force which arises due to
the relative frictional interference between the outer diameter of
the body portion 68b and the second opening 52b is confined to the
distance C. The undercut or radial flange provides for this
isolated area of radially directed pressure which simultaneously
produces the sealing means that is required and axially supports
the end of the cannula 22b against lateral or longitudinal
movement, prior to usage.
FIG. 7, illustrates another form of the invention which is similar
to FIG. 1, except that the second opening 52c in the second neck
50c of vial 14c has a closed bottom 92c to form a closure seat 90c
therein. The second closure member 66c includes a body portion 68c
having a diameter less than the internal diameter of the opening
52c and a flange portion 70c having a diameter designed to provide
a frictional interference with the opening 52c in the mixing
chamber 44c with which it communicates. The supporting and sealing
means is provided by the second closure member 66c and includes an
axially extending channel 80c which is in sealing engagement with
the distal portion 28c of the cannula 22c may be of a selected
length, as discussed with respect to FIG. 1.
The form of the invention illustrated in FIG. 7, has the advantage
of not requiring the assembly of an additional overseal and in this
manner the second closure member 66c is inserted through the first
opening 48c and the syringe means 12c is retained in fixed position
to the vial means 14c in the same manner as described with respect
to FIG. 1.
FIGS. 8 through 10, illustrate the method of filling and packaging
the assembly 10c, consisting of a syringe means 12c and vial means
14c in accordance with the embodiment of the invention illustrated
in FIG. 7. In this embodiment the second closure member 66c is
adapted to be inserted through the first opening 48c of the vial
14c and is initially supported by a support member 114c in axial
alignment with the closure seat 90c which is formed by the second
opening 52c and bottom 92c of the vial 14c. The second closure
member 66 c is inserted through the first opening 48c and moved
axially relative to the vial 14c until the second closure member
66c is contained within the closure seat 90c as illustrated in FIG.
8, and is in seated position therein. To prevent the removal during
shipment of the second closure member 66c there exists a degree of
frictional interference between the diameter of the closure seat
90c and the second closure member 66c which interference is
overcome by the axial force in the direction of arrow 108c as the
second closure member 66 c and vial 14c is moved towards each other
until the position shown in FIG. 8 is reached. The vial 14c is then
filled with a preselected quantity of the ingredient 78c through
said first opening 48c which ingredient may be of a liquid, powder
or combination thereof.
The vial is filled by inserting in the first opening 48c the chute
98c which has in communication therewith the supply source 104c
which is adapted to automatically dispense predetermined quantities
of the ingredient therein. The axial channel 80c is preferably
covered during the filling of the vial 14c to prevent the
ingredient 78 c from entering therein. This may be accomplished by
retaining the support member 114c therein. Once the vial 14c is
filled the first closure member 54c is inserted and said first
opening 48c is dimensioned in a manner to seal off said opening
from the atmosphere. Thereafter or simultaneously therewith the
overseal 64c may be applied by capping means 112c to retain the
first closure member and vial in position. The capping means 112c
is hollow to permit the removal of the support means 114c after the
vial 14c is tilted to a position in which the ingredient cannot
clog up the channel 80c or aperture 74c. This may be accomplished
by angularly displacing or positioning the vial as seen in respect
to FIG. 10, such that the ingredient 78c, shown as a powder, is in
a corner of the vial permitting the removal of the support member
114c and the assembly of the syringe 12c.
The assembled unit 10c which has the cannula 22c extending
therefrom is then inserted through the opening 74c in the first
closure member 54c until the distal end 28c thereof extends within
the axial channel 80c of the second closure member 66c and is both
axially supported and a seal is formed therebetween.
Substantially the same method of assembly as illustrated in FIGS.
8--10, may be used to assemble the embodiments illustrated in FIGS.
1, 5 and 6, in that the second closure member is first inserted in
the vial, then the channel is covered and the vial filled, with the
vial then being rotated leaving the channel free of the ingredients
to permit the first closure member to be inserted in the first
opening and the syringe thereafter positioned as seen in FIG.
1.
CONCLUSION
A particularly desirable feature of the present invention is the
ease in which it can be utilized such that the sterilized
ingredient portions thereof remain free of exposure from possible
contamination prior to the obtainment of the mixture of the
ingredients therein. In operation the vial is retracted a minimal
amount generally in the range of .01 to .5 inches such that the
distal end is retracted from the second closure and is free such
that the plunger may be manually manipulated to dispense the
ingredients from the storage chamber into the mixing chamber to
have a mixture of the two materials occur. It is most important
that the cannula does not have to be substantially removed from the
vial to perform this mixing operation, thereby minimizing any
contamination that could possibly occur.
Additionally, it is now possible to axially or longitudinally and
laterally support the cannula at each end thereof so as to be
assured, irrespective of the transportation, storage and handling
associated with the final assembly, that there is a minimum chance
of any fracture occurring either in the cannula or at its seal with
the syringe. It can be appreciated that the cannula acts as a
flexible member and due to vibrations transmitted to the assembly
it is possible to affect a flexure thereof and a possible fracture
at one or more points or particularly the seal with the syringe. If
this occurs the danger of an injury resulting when the syringe is
used is easily foreseeable. By being able to support the cannula at
both ends thereof the degree of assurance that the package will be
in usable condition is materially increased.
Considering the total number of units used per year the volume of
each package becomes an important matter in the transportation,
storage and the cost of manufacturing materials for packaging same.
Accordingly, the present invention permits a condensed assembly
since essentially the distal portion of the cannula is almost
adjacent the bottom of the vial such that the longitudinal length
of the assembly is substantially equal to the longitudinal length
of the syringe. In prior-art practices, this is generally not the
case since there is a substantial distance between the distal
portion of the cannula, and the end of the components associated
therewith.
While particular embodiments of the present invention have been
shown and described, it will be understood that many changes and
modifications may be made, and it is, therefore, intended by the
appended claims to cover all such changes and modifications as fall
within the true spirit and scope of the present invention.
* * * * *