U.S. patent number 3,853,157 [Application Number 05/334,959] was granted by the patent office on 1974-12-10 for process and apparatus for dispensing liquid compositions intended for parenteral administration.
Invention is credited to Anthony J. Madaio.
United States Patent |
3,853,157 |
Madaio |
December 10, 1974 |
PROCESS AND APPARATUS FOR DISPENSING LIQUID COMPOSITIONS INTENDED
FOR PARENTERAL ADMINISTRATION
Abstract
An injection syringe is charged with liquid to be dispensed
prior to attachment of the needle by mating the filling end of the
syringe to the outlet valve of a propellent-pressurized container
of the liquid. The liquid is dispensed as a solid stream (i.e., in
"plug flow") unaccompanied by any propellent. One way of achieving
this is by using a propellent which is insoluble in the dispensable
liquid. Another method would employ a double contianer. Thus, the
liquid within the pressurized container can be kept separate from
the propellent, e.g., by means of an impervious barrier in the form
of a flexible bag containing the liquid to be dispensed.
Alternatively, the container itself can be a cylinder of glass or
other suitable material fitted at the bottom with a rubberlike
septum. This septum separates the dispensable liquid from the
propellent and is forced upward like a plunger or piston when the
valve is opened. The upper portion of the container would hold the
dispensable liquid. The chamber on the other side of the plunger or
piston houses the propellent. The discharge end is hermetically
fitted to the outlet valve of the pressurized container. Upon
releasing the valve, the pure liquid is forced out of the
pressurized container and into the barrel of the syringe at a rate
determined by the pressure of the propellent.
Inventors: |
Madaio; Anthony J. (Bronxville,
NY) |
Family
ID: |
23309627 |
Appl.
No.: |
05/334,959 |
Filed: |
February 22, 1973 |
Current U.S.
Class: |
141/2; 141/27;
141/370 |
Current CPC
Class: |
B65D
83/425 (20130101); A61M 5/1782 (20130101); B65D
83/62 (20130101); A61M 2207/00 (20130101); A61J
1/2086 (20150501); A61J 1/2096 (20130101); A61J
1/2031 (20150501) |
Current International
Class: |
A61M
5/178 (20060101); B65D 83/14 (20060101); A61J
1/00 (20060101); B65b 003/10 () |
Field of
Search: |
;141/2,3,26,27,20,370
;128/215 ;23/253,259 |
References Cited
[Referenced By]
U.S. Patent Documents
|
|
|
3169670 |
February 1965 |
Hrebenak et al. |
3610297 |
October 1971 |
Raaf et al. |
|
Primary Examiner: Bell, Jr.; Houston S.
Attorney, Agent or Firm: Pennie & Edmonds
Claims
I claim:
1. An apparatus for dispensing a liquid composition intended for
parenteral administration comprising in combination a rigid
container having an opening at one end and adapted to contain under
pressure the liquid composition and a gas or liquified gas
essentially insoluble in the liquid composition, a closure for the
opening having a portion adapted to project into the dispensible
liquid composition in the container, a valve within the closure for
discharging the liquid composition from the container through the
inwardly projecting portion of the closure to an outlet of the
container, and a hypodermic syringe comprising a barrel of constant
diameter having an opening at one end and terminating at the other
end in a hollow filling tip hermetically engaged directly with the
outlet of the container to form a fluid-tight conduit for the
liquid composition from the outlet to within the barrel of the
syringe and a plunger slideably disposed within the barrel and
responsive to the pressure exerted by the liquid composition
entering the barrel of the syringe.
2. An apparatus for dispensing a liquid composition intended for
parenteral administration comprising in combination a rigid
cylindrical container having an opening at the top end and sealed
at the bottom end and adapted to contain the liquid composition and
a gas or liquified gas propellent under positive pressure, a
closure for the opening, a partition dividing the container into a
top portion and a bottom portion, said partition being slideably
disposed within the container and adapted to provide an impervious
barrier between the propellent in the bottom portion of the
container and the liquid composition in the top portion of the
container, a valve within the closure for discharging the liquid
composition from the top portion of the container through the
closure to an outlet of the container, and a hypodermic syringe
comprising a barrel of constant diameter having an opening at one
end and terminating at the other end in a hollow filling tip
hermetically engaged directly with the outlet of the container to
form a fluid-tight conduit for the liquid composition from the
outlet to within the barrel of the syringe and a plunger slideably
disposed within the barrel and responsive to the pressure exerted
by the liquid composition entering the barrel of the syringe.
3. An apparatus for dispensing a liquid composition intended for
parenteral administration comprising in combination a rigid
container having an opening at one end and adapted to contain the
liquid composition and a gas or liquified gas under positive
pressure, a closure for the opening having a portion projecting
into the container, a bag of flexible material of a size when
filled with the liquid composition to substantially fill the
container and adapted to provide an impervious barrier between the
gas or liquified gas and the liquid composition and said bag having
a neck portion hermetically surrounding the inwardly projecting
portion of the closure, a valve within the closure for discharging
the liquid composition from the bag through the inwardly projecting
portion of the closure to an outlet of the container, and a
hypodermic syringe comprising a barrel of constant diameter having
an opening at one end and terminating at the other end in a hollow
filling tip hermetically engaged directly with the outlet of the
container to form a fluid-tight conduit for the liquid composition
from the outlet to within the barrel of the syringe and a plunger
slideably disposed within the barrel and responsive to the pressure
exerted by the liquid composition entering the barrel of the
syringe.
4. An apparatus according to claim 3 wherein the valve is adapted
to discharge a predetermined fixed amount of liquid composition
from the bag through the inwardly projecting portion of the closure
to the outlet of the container and into the barrel of the
syringe.
5. An apparatus according to claim 3 wherein the outlet of the
container is a chamber adapted to be removeably force fitted over
the hollow filling tip of the syringe to form a fluid-tight conduit
for the liquid composition from the outlet to within the barrel of
the syringe.
6. An apparatus according to claim 3 wherein the closure for the
opening in the container has a bore leading from the interior of
the flexible bag to the exterior of the closure, said bore having
the operating member of the valve slideably and hermetically
disposed therein and extending from the portion of the closure
projecting into the container to a point exterior to the closure,
said operating member of the valve having a conduit therein to
provide communication between the interior of the bag and the
outlet of the container when the valve is opened, said valve being
opened and closed by the sliding movement of the operating member
of the valve.
7. A method of dispensing a liquid composition intended for
parenteral administration comprising the steps of:
a. hermetically engaging the hollow filling tip of a hypodermic
syringe directly with the outlet of a container having an opening
at one end and containing under positive pressure the liquid
composition and a gas or liquified gas essentially insoluble in the
liquid composition, a closure for the opening having a portion
projecting into the dispensable liquid composition in the
container, a valve within the closure for discharging the liquid
composition from the container through the inwardly projecting
portion of the closure to the outlet of the container, said syringe
comprising a barrel of constant diameter having an opening at one
end and terminating at the other end in the hollow filling tip and
a plunger slideably disposed within the barrel;
b. opening the valve to discharge the liquid composition from the
container through the inwardly projecting portion of the closure to
the outlet of the container and into the barrel of the syringe
which is further characterized in that the plunger slideably
disposed within the barrel is responsive to the pressure exerted by
the liquid composition entering the barrel of the syringe;
c. continuing step (b) until the barrel of the syringe has been
filled with a desired volume of liquid composition;
d. closing the valve; and
e. disengaging the filling tip of the syringe from the outlet of
the container.
8. A method of dispensing a liquid composition intended for
parenteral administration comprising the steps of;
a. hermetically engaging the hollow tip of a hypodermic syringe
directly with the outlet of a rigid cylindrical container having an
opening at the top end and sealed at the bottom end and adapted to
contain the liquid composition and a gas or liquified gas
propellent under positive pressure, a closure for the opening, a
partition dividing the container into a top portion and a bottom
portion, said partition being slideably disposed within the
container and adapted to provide an impervious barrier between the
propellent in the bottom portion of the container and the liquid
composition in the top portion of the container, a valve within the
closure for discharging the liquid composition from the top portion
of the container through the closure to the outlet of the
container, said syringe comprising a barrel of constant diameter
having an opening at one end and terminating at the other end in
the hollow filling tip and a plunger slideably disposed within the
barrel;
b. opening the valve to discharge the liquid composition from the
container through the closure to the outlet of the container and
into the barrel of the syringe which is further characterized in
that the plunger slideably disposed within the barrel is responsive
to the pressure exerted by the liquid composition entering the
barrel of the syringe;
c. continuing step (b) until the barrel of the syringe has been
filled within a desired volume of liquid composition;
d. closing the valve; and
e. disengaging the filling tip of the syringe from the outlet of
the container.
9. A method of dispensing a liquid composition intended for
parenteral administration comprising the steps of:
a. hermetically engaging the hollow tip of a hypodermic syringe
directly with the outlet of a container having an opening at one
end and adapted to contain a gas or liquified gas under positive
pressure, a closure for the opening having a portion projecting
into the container, a bag of flexible material of a size when
filled with liquid composition to substantially fill the container
and adapted to provide an impervious barrier between the gas or
liquified gas and the liquid composition and said bag having a neck
portion hermetically surrounding the inwardly projecting portion of
the closure, a valve within the closure for discharging the liquid
composition from the bag through the inwardly projecting portion of
the closure to an outlet of the container, said syringe comprising
a barrel of constant diameter having an opening at one end and
terminating at the other end in the hollow filling tip and a
plunger slideably disposed within the barrel;
b. opening the valve to discharge the liquid composition from the
bag through the inwardly projecting portion of the closure to the
outlet of the container and into the barrel of the syringe which is
further characterized in that the plunger slideably disposed within
the barrel is responsive to the pressure exerted by the liquid
composition entering the barrel of the syringe;
c. continuing step (b) until the barrel of the syringe has been
filled with a desired volume of liquid composition;
d. closing the valve; and
e. disengaging the filling tip of the syringe from the outlet of
the container.
10. A method according to claim 9 wherein the valve is adapted to
discharge a predetermined fixed amount of liquid composition from
the bag through the inwardly projecting portion of the closure to
the outlet of the container and into the barrel of the syringe.
11. A method according to claim 9 wherein the outlet of the
container is a chamber adapted to be removeably force fitted over
the hollow filling tip of the syringe to form a fluid-tight conduit
for the liquid composition from the outlet to within the barrel of
the syringe.
12. A method according to claim 9 wherein the closure for the
opening in the container has a bore leading from the interior of
the flexible bag to the exterior of the closure, said bore having
the operating member of the valve slideably and hermetically
disposed therein and extending from the portion of the closure
projecting into the container to a point exterior to the closure,
said operating member of the valve having a conduit therein to
provide communication between the interior of the bag and the
outlet of the container when the valve is opened, said valve being
opened and closed by the sliding movement of the operating member
of the valve.
Description
BACKGROUND OF THE INVENTION
This invention relates to the filling of injection syringes. More
particularly, it relates to a novel process and apparatus for
charging hypodermic syringes with liquids intended for parenteral
administration with a minimum of inconvenience and danger from
external contaminants.
In loading hypodermic syringes with liquids intended for parenteral
administration, i.e., intended for injection into the body through
a hollow, skin-piercing needle, it had heretofore been the common
practice to first assemble the components of the empty sterile
syringe (i.e., needle, barrel and plunger) with the plunger fully
depressed. For glass ampules or other single dose containers, the
tip of the needle is submerged in the liquid and the plunger is
then withdrawn, thereby drawing liquid up into the barrel of the
syringe. Although this procedure has been in widespread use for
many years, the method suffers from a number of drawbacks. For one
thing, the force by which the liquid is drawn up through the needle
and into the syringe barrel, namely, the vacuum incrementally
formed with the barrel as the plunger is withdrawn, will draw in
enviromental atmospheric air. This presents a possible source of
contamination, for example, in the form of air-borne
micro-organisms and particulate matter. Also, the breaking of the
glass ampule can cause glass particles to fall into the ampule, in
which case they can be drawn into the syringe with the liquid
medication and subsequently injected into the patient.
One of the methods developed for attempting to cope with this
problem has been the use of liquid reservoirs or containers capped
with a rubberlike septum or diaphragm which is self-sealing after
penetration by and withdrawal of the needle portion of the syringe.
Although the use of a septum undoubtedly protects the reservoir
from airborne contaminants to some extent, the degree of protection
is far from complete since contamination can still occur by virtue
of the repeated physical penetration through the septum and into
the reservoir by the needle itself and possible corring of the
rubberlike septum. Also, the edge of the needle can be burred by
the septum as the former is pushed into the container. Prior to
removal of the liquid medication from the dispensing container, the
syringe must be filled with a volume of atmospheric air equal to
the volume of the liquid medication being withdrawn. Air is thereby
injected into the container each time medication is removed.
Furthermore, the self-sealing ability of the septum deteriorates
with repeated penetration due to a degeneration in the integrity of
the septum material.
Another method of parenteral administration of liquids which has
been developed in order to minimize the problem of contamination
has been to pre-package the liquids in small vials which provide
one or a few dosages. This expedient, albeit more sanitary, still
suffers from yet another disadvantage inherent to most previously
known methods for loading syringes. In particular, during the
filling step, it has been necessary to withdraw the plunger of the
syringe carefully and at a slow rate with the orifice of the needle
constantly submerged below the surface of the liquid in order to
prevent entrainment of air bubbles within the syringe. To avoid
this particular problem, a variant of the "small vial" approach has
been used which entails the use of disposable syringes pre-packaged
with liquid already in them for "one-shot" injection after which
the spent syringes are thrown away. However, this expedient, like
the one previously mentioned is wasteful of materials and tends to
discourage the shipment and storage of liquids in bulk form. As a
result, the use of small vials or disposable syringes represents an
undesirable added cost factor, particularly in places such as
hospitals and clinics where parenteral administration of liquid
medication is carried out routinely on a large scale. Therefore a
need has existed for loading hypodermic syringes which avoids the
aforementioned difficulties.
Accordingly, it is an object of the present invention to provide an
improved method and apparatus for filling injection syringes with
liquids intended for parenteral administration.
Another object is to provide an improved method and apparatus for
filling injection syringes with liquids without risk of
contamination by exposure of the liquid to foreign substances or
organisms that are air-borne.
Yet another object is to provide an improved method and apparatus
for filling injection syringes with liquids at a convenient rate
without entrainment of atmospheric air within the filled
chamber.
These and other objects of the present invention as well as the
advantages thereof can be had by reference to the following
detailed description, drawings and claims.
SUMMARY OF THE INVENTION
The foregoing objects are achieved according to the present
invention by an apparatus and process whereby a syringe, e.g., a
"hypodermic needle" is loaded quickly, sanitarily and with minimum
risk of entraining atmospheric air within the chamber or barrel of
the syringe.
According to the process of the invention, a "hypodermic" syringe
to be used for injecting liquids into the body and comprising a
barrel, plunger and hollow injection needle is filled with the
liquid to be administered by engaging the filling tip of the barrel
with the outlet of a pressurized can or container of liquid to be
dispensed. The filling tip of the syringe and the outlet of the
container are engaged hermetically so that a fluid-tight seal
between the two components results, thereby ensuring against
leakage of liquid at this point during the dispensing step. The
pressurized container of liquid is fitted with a plug or closure
and a valve to contain the pressurized contents and regulate the
amount of liquid dispensed to the syringe. The container is further
characterized in its design so that only the liquid to be dispensed
is propelled from the container when the valve is opened.
Upon opening the valve, only the dispensable liquid is forced
through the outlet of the container into the filling tip of the
syringe. The pressure within the container causes the liquid
entering the syringe through the filling tip to push back the
plunger, thereby filling the barrel with liquid. The valve on the
container is kept open, either manually or automatically, until the
desired quantity of liquid has filled the syringe. At this point,
the valve is closed, shutting off the flow of liquid from the
container. Then, the filling tip of the syringe is disengaged from
the outlet of the container and the injection needle is attached to
the filling tip of the syringe, whose liquid contents are now ready
for parenteral administration. The valve outlet is equipped with a
shield which can be closed so that the container can be stored for
future syringe-filling operations.
Further features of the method of this invention are presented
below in connection with the apparatus associated therewith, which
comprises, in combination, a container for the dispensable liquid,
a closure and valve for the container which are fitted with an
outlet and a hypodermic syringe comprising a barrel and a plunger.
One end of the barrel is adapted to serve as the filling tip of the
syringe when the injection needle is not in place. In the apparatus
of the invention, the filling tip of the syringe is mated with the
outlet of the container to give a fluid-tight seal to prevent
leakage of liquid during the dispensing or filling process of the
invention.
The container for the liquid to be dispensed is adapted for storage
of the liquid therein under pressure. Pressurization of the
container is achieved during its manufacture by introducing a
suitable pressurizing agent or propellent, e.g., a gas or liquified
gas, into the container along with the liquid to be dispensed.
Accordingly, the container is desirably constructed of a rigid
material such as metal or glass, subject to the proviso that the
portions of the container which come into contact with the contents
are of materials which are inert to those contents or specially
treated so that corrosion or formation of harmful products within
the container are avoided. Alternatively, when the dispensible
liquid is kept in an impervious inner container as described
hereinbelow, there can be added to the propellent in the outer
container one or more suitable corrosion inhibitors which do not
come into contact with the dispensable liquid.
The use of glass in constructing the container for the dispensible
liquid is advantageous when it is desired to monitor the amount of
dispensable liquid remaining in the container by visual inspection.
Glass containers also facilitate inspection of the medication for
particulate matter.
It is a feature of the present invention that the container,
closure and valve are designed to permit only the dispensable
liquid and not the propellent to be discharged from the container
into the syringe. One way of achieving this is to select a
propellent composition which is essentially insoluble in the
dispensable liquid so that a two-phase (liquid-gas) or three phase
(liquid-liquid-gas) system is established within the container, one
phase being the dispensable liquid and the other phase or phases
being the propellent. The dispensable liquid phase will be above,
below or between the propellent phase or phases depending on the
density of the dispensable liquid relative to that of the
propellent. Thus, when the propellent is a gas, the dispensable
liquid will normally form the lower of the two phases (liquid-gas).
When the propellent is a liquified gas of the type described in
further detail hereinafter, the dispensable liquid will form the
lowest of the two liquid phases in the three-phase
(liquid-liquid-gas) system if the liquid propellent is less dense
than the dispensable liquid. If the dispensable liquid is less
dense than the liquid propellent, then the dispensable liquid will
form the upper of the two liquid phases.
The closure and valve of the container are designed so that when
the valve is opened, egress is provided only for the dispensable
liquid by means of a hollow open-ended portion ("dip-tube") of the
closure which extends or projects into the container to a point
within the phase corresponding to the dispensable liquid.
In a preferred aspect of the present invention, the requisite
separation between the propellent and the dispensable liquid is
achieved by utilizing one of three methods: (1) using a propellent
which is insoluble in the liquid medication; (2) using a container
within a container, the inner container being a collapsible bag or
bladder holding the dispensable liquid out of contact with the
propellent which is in the outer container, as described, for
example, in U.S. Pat. No. 2,937,791; and (3) the use of a
cylindrical container, the top portion being hermetically sealed to
the closure and valve, and the bottom end having an impermeable
rubberlike septum or portion adapted to slide upward within the
cylinder like a piston when the valve is opened. This occurs
because of the pressure exerted on the septum by the propellent as
described, for example in U.S. Pat. No. 3,407,974. The cylindrical
container is desirably, but not necessarily, made of glass. The
propellent occupies the space between the rigid wall of the
container and the outer surface of the bag or below the piston at
the bottom of the glass cylinder. The closure and valve of the
container are designed so that a hollow, open-ended portion of the
closure extends or projects into the bag or glass cylinder, the
neck of the bag or glass cylinder being permanently and
hermetically sealed to the inwardly projecting portion of the
closure. When the valve is opened, only the contents of the bag or
the top portion of the glass cylinder, i.e., the dispensable
liquid, are expelled from the container through the inwardly
projecting portion of the closure to the outlet of the container.
Both the collapsible bag which is made of a flexible material and
the glass cylinder must be chemically inert and physically
impervious to both propellent and dispensable liquid, thereby
forming an inpenetrable barrier between the two substances. The
hermetic seal between the inwardly projecting portion of the
closure and the neck of the bag or glass cylinder surrounding this
portion contributes to the fluid-tight integrity of the separation
between propellent, dispensable liquid and atmospheric air. When
the valve is opened, the pressure of the propellent acts on the bag
or piston at the bottom of the glass cylinder to expel the
dispensable liquid alone from the container. The bag, being
flexible, collapses to the extent that liquid is removed therefrom.
Likewise, the volume of upper portion of the glass cylinder
decreases due to the upward movement of the piston. Since the
container is manufactured so that either the bag or upper portion
of the glass cylinder is initially completely filled with
dispensable liquid, the gradual collapse or shrinkage of the bag or
decrease in volume of the glass cylinder during the practice of the
method of this invention ensures that all of the space within the
bag or glass cylinder at any time is occupied by the dispensable
liquid and that only this liquid is dispensed from the outlet of
the container from the instant the valve is opened. This feature is
critical to the success of the present invention, since the present
method would be defeated if gaseous materials were to be expelled
along with the dispensable liquid which is the case, for example,
in U.S. Pat. No. 3,220,413; U.S. Pat. No. 3,540,448 and U.S. Pat.
No. 3,656,482.
Since the propellent is not consumed during the lifetime of the
container, it is possible to use a bag for the dispensable liquid
which, when filled, occupies most of or substantially fills the
space within the rigid container. The remaining space need only be
sufficient to contain enough propellent to establish and maintain
the desired propellent pressure. Furthermore, the use of a bag to
contain the dispensable liquid in the manner described hereinabove
permits holding the container in any convenient position when
discharging the liquid.
The materials of which the bag can be constructed consistent with
the aforementioned requirements include films of rubber or
polyolefins, e.g., polyethylene.
The rate of flow of dispensable liquid from the container into the
syringe depends to a large extent on the pressure exerted by the
propellent system within the container. Propellent pressures
suitable for use in the present invention are in turn determined by
the proper selection of propellent gases and/or liquified gas. When
a compressed gas, e.g., nitrogen and liquified lower alkanes such
as propane, is used as the propelling agent, the pressure
established within the container depends primarily on the
concentration of the gas. On the other hand, when liquified gases
are used, the pressure established will depend on the vapor
pressure of the liquified gas. In this connection, the use of
liquified gases possesses the advantage that the pressure within
the container remains constant during the gradual exhaustion of the
dispensable liquid as long as at least one drop of liquified gas
remains in the container. In this way, the rate of discharge of
dispensable liquid from the container remains constant during the
lifetime of the container. On the other hand, propellents made up
entirely of pressurized gas will experience a gradual decrease in
pressure and consequent decrease in rate of flow of dispensable
liquid due to the increasing volume occupied by the propellent gas
as the contents of the bag become exhausted and the bag
collapses.
Liquifiable gases suitable for use in the present invention include
normally gaseous chlorofluoroalkane propellents such as
dichlorodifluoromethane, CCl.sub.2 F.sub.2, mixtures of
dichlorodifluoromethane with dichlorotetrafluoro-ethane,
(CClF.sub.2).sub.2, and mixtures of dichlorodifluoromethane with
monochlorodifluoroethane, CClF.sub.2 CH.sub.3. The requisite
pressure within the container can be achieved by selecting the
proper relative amounts of the aforementioned liquifiable gaseous
propellents as disclosed, for example, in Soap and Sanitary
Chemicals, 29(9), 142, 147 (1953).
The closure and valve, like the other portions of the container,
are constructed of materials which, to the extent that they come
into contact with the dispensable liquid, are chemically inert
thereto. Valves suitable for use according to the present invention
can be of the manually operated type. Alternatively, the valve can
be of the automatic shut-off variety whereby a predetermined fixed
quantity of liquid can be dispensed to the syringe. The use of a
metered valve is an advantage, for example, when rapid filling of a
large number of syringes is desired within a minimum period of
time.
If desired, a filter can be interposed in the path of the
dispensable liquid at some convenient point in the closure, valve
or outlet to guard against the escape of any particulate matter
which might be present in the container and which might otherwise
find its way into the syringe. The closure, valve and outlet
assemblies of the container can be adapted to receive a cover or
shield to protect these components, especially the valve mechanism,
from dust when the container is not in use. The shield or cover can
be permanently affixed to the outlet (discharge chamber) so as to
allow any size syringe to enter. This type of shield is desirably
adapted to receive a removable cap which is replaced when the
apparatus is not in use. The shield is also desirably constructed
to permit routine cleaning thereof with an antiseptic such as
alcohol.
It is a prime desideratum of this invention that the outlet of the
container be adapted to hermetically and removeably engage the
filling tip of the syringe component of the present apparatus. In
conventional hypodermic syringes which are suitable for use in the
present invention, the filling tip on the barrel is often of the
type depicted in the accompanying drawings. With this type of
filling tip, the outlet of the container for the dispensable liquid
would form a discharge chamber which would be force-fitted over the
filling tip of the syringe barrel in the same way that the
injection needle would be fitted over the filling tip after the
barrel has been filled according to the method of this invention.
In addition to discharge chamber-filling tip combinations of the
force-fitted type, other designs can be employed, such as where the
filling tip of the syringe and the discharge chamber are provided
with screw threads Luer-Lok) or adapted to be snapped together to
form the requisite fluid-tight seal.
The apparatus and method of the present invention has numerous
advantages not possessed or obtainable with conventional
arrangements. Thus, since the container for the dispensable liquid
is never penetrated by foreign bodies during its lifetime, there is
no danger of contamination of the liquid to be dispensed from
airborne bacteria, particulate matter, and the like. Accordingly,
the contents of the container can be kept sterile and the
quantities of dispensable liquid which can be stored are much
larger than heretofore permitted in conventional containers, whose
contents are repeatedly exposed to the atmosphere during
syringe-filling operations. Furthermore, since the propellent is
not consumed during the lifetime of the container, only the
dispensable liquid need be replaced and this can be done repeatedly
provided conditions of sterility are maintained during each
refilling operation.
DESCRIPTION OF THE DRAWINGS
Referring now to the drawings,
FIG. 1 is a vertical sectional view of an embodiment of the
apparatus of the invention showing the relative placement of the
components thereof.
FIG. 2 is a vertical sectional view of a conventional syringe
(minus the needle component) whose relative position in the
apparatus is shown in phantom in FIG. 1.
FIGS. 3 through 8 are a series of vertical sectional views
representing the principal steps involved in using the present
apparatus according to the process of the invention.
With particular reference to FIG. 1, an outer can 1 is constructed
of a rigid material, for example, metal or glass, which is capable
of withstanding the positive pressure exerted by the propellent 2
contained between the outer can and flexible bag 5. The flexible
bag 5 is made of a suitable material such as polyethylene or the
like and contains liquid composition 6 which is intended for
parenteral administration.
The neck of the flexible bag 5 is permanently attached to the
depending end of a plug 7 which is contained within cap 3. The neck
of flexible bag 5 forms thereby an hermetic or fluid-tight seal
with plug 7. The plug 7 is made of a plastic rubberlike or
silicone-coated material such that the plug is permanently
positioned within the cap 3 by force-fitting the plug into the
widened upper portion 27 of the cap.
The plug 7 has a central bore 9 in which is slidably mounted the
discharge valve stem 11. The lower end of the valve stem 11 is
flared outwardly to form a tapered segment 13 which cooperates with
the corresponding tapered countersunk cavity 15 in the bottom of
plug 7. Tapered segment 13 is fitted to valve stem 11 by means of a
threaded protuberance 38 on the tapered segment which engages a
corresponding threaded hole in the bottom of valve stem 11. The
tapered segment 13 forms a fluid tight cut-off when the valve stem
11 is held in the "up" position by the compression spring 17 which
surrounds the valve stem within a recess 19 formed by enlarging the
central bore 9. The upper end of the spring 17 abuts against
enlarged portion 21 of valve stem 11 which in turn abuts against
the bottom surface of valve head 29. The valve head 29 is
advantageously made of metal and is secured to the top of plug 7 by
engagement with the threaded upper portion 31 of cap portion 3.
The upper end of the valve stem 11 is connected to a button 33 by
means of a threaded protuberance 35 which engages a correspondingly
threaded hole in the top of the valve stem. Upon depressing the
button 33, the valve stem 11 moves to the "down" position shown in
phantom and exposes inlet port 36 in valve stem 11 to liquid
composition 6. Then as a result of the pressure exerted by
propellent 2, the liquid composition 6 enters inlet port 36, flows
up through channel 37 within valve stem 11 and out of exit port 39
which is now exposed to the outside through orifice 41. The sliding
interface between valve head 29 and valve stem 11 is sealed to
prevent leakage of liquid 6 between the two sliding surfaces by
means of a flexible "O" ring 23 which surrounds valve stem 11
within the recess 24 formed by enlarging the central bore 9.
When the liquid composition 6 leaves the container through exit
orifice 41, it does so under pressure and enters the filling end of
syringe 46 which is shown in phantom position as it would appear
during the practice of the present invention.
In FIG. 2, there is depicted a syringe 46 of a type suitable for
use in the present invention from which the injection needle has
been removed. The cylindrical barrel 47 of syringe 46 can be made
of a suitable molded plastic material, e.g., polyethylene. The
barrel 47 of syringe 46 reduces at the front end to a hollow
tapered filling tip 45 which mates with the corresponding tapered
female butt end of the needle (not shown) to give a fluid-tight
squeeze fit.
During the practice of the invention, filling tip 45 of syringe 46
mates with the correspondingly tapered discharge chamber 43 of
valve head 29 to give a fluid-tight squeeze fit as shown in phantom
in FIG. 1. Upon depressing button 33, liquid is discharged from
exit orifice 41 directly into inlet orifice 49 of filling tip 45.
Because of the close fit between filling tip 45 and discharge
chamber 43, there is no escape of liquid to the outside during the
filling operation.
Referring to FIG. 2, the liquid entering inlet orifice 49 under
pressure exerts a force on the front end of plunger 51 which is
slideably mounted within barrel 47. The force exerted by the liquid
pushes plunger 51 out of the filling chamber 53 causing the chamber
to become filled with liquid. Flared portions 55 and 57 of the
barrel 47 and plunger 51 respectively provide gripping surfaces for
the operator's fingers during parenteral administration of the
liquid composition from the syringe.
Referring to FIGS. 3 through 8, FIG. 3 shows filling can 1 and
syringe 46 at the commencement of the filling process according to
the present invention prior to the engagement of discharge chamber
43 with filling tip 45. At this point, the button 33 is in the "up"
or closed position. FIG. 4 shows discharge chamber 43 and filling
tip 45 in engagement ready for dispensing of liquid 6 upon
depressing button 33.
FIG. 5 shows the dispensing of liquid 6 into the syringe 46 with
the button 33 in the "down" or open position. During this stage of
the process, the volume of liquid 6 in the flexible bag 5 decreases
to the same extent that the liquid fills the syringe 46. FIG. 6
shows the apparatus of the invention at that stage in the process
when the syringe 46 has been filled with the desired amount of
liquid composition 6. At this point, the button 33 is released,
whereupon it returns to the "up" or closed position. FIG. 7 shows
the syringe 46 filled with the desired amount of liquid 6 and the
filling tip 45 withdrawn from engagement with discharge chamber 43.
FIG. 8 shows the liquid-filled syringe fitted with an injection
needle ready for administering the liquid 64.
The accompanying drawings and foregoing specification have
described the present invention in a preferred form. However, it
will be understood that modifications and changes can be made
without departing from the scope of the invention which is defined
in the appended claims.
* * * * *