U.S. patent number 3,797,491 [Application Number 05/283,504] was granted by the patent office on 1974-03-19 for method of performing an intramuscular injection.
This patent grant is currently assigned to Ampoules, Inc.. Invention is credited to Alfred A. Hurschman.
United States Patent |
3,797,491 |
Hurschman |
March 19, 1974 |
METHOD OF PERFORMING AN INTRAMUSCULAR INJECTION
Abstract
Hypodermic ampoules of the contained-needle type, a method of
assembling and filling such ampoules, and combinations of such
ampoules with so-called "applicators" for actuating the ampoules to
make injections are disclosed. Each of several ampoule forms has at
least one cylindrical, medicament-containing chamber and a plunger
closing one end thereof. A hollow needle is fixed to the plunger
and is initially contained within such a chamber. The other end of
the ampoule is sealed by a diaphragm which is pressed against a
beaded end portion of a cylinder and is sealed thereto by a
cup-shaped clip which snaps over the beaded end portion to thereby
compress the diaphragm against the end portion. The clip has a
peripheral rim about a recessed bottom end which stretches the
patient's skin to facilitate the injection. According to one aspect
of the invention, such an ampoule is designed to perform a
subcutaneous injection. According to a further aspect of the
invention, such an ampoule is designed to perform an intramuscular
injection. According to a still further aspect of the invention,
the ampoule includes multiple chambers for premixing a medicament
with at least one other medicament and injecting the mixture,
either subcutaneously or intramuscularly. Applicators designed to
receive and hold the several forms of ampoules and to actuate them
as required by their particular forms and functions provide several
applicator-ampoule combinations of novel structure and
functions.
Inventors: |
Hurschman; Alfred A.
(Streetsboro, OH) |
Assignee: |
Ampoules, Inc. (Macedonia,
OH)
|
Family
ID: |
26812252 |
Appl.
No.: |
05/283,504 |
Filed: |
August 24, 1972 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
114493 |
Feb 11, 1971 |
3735761 |
May 29, 1973 |
|
|
Current U.S.
Class: |
604/511; 604/201;
604/196 |
Current CPC
Class: |
A61M
5/32 (20130101); A61M 5/28 (20130101); A61M
5/284 (20130101); A61M 5/288 (20130101); A61M
5/329 (20130101) |
Current International
Class: |
A61M
5/28 (20060101); A61M 5/32 (20060101); A61m
005/28 () |
Field of
Search: |
;128/218M,218D,218R,215,216,272,218DA |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: McGowan; J. C.
Attorney, Agent or Firm: McNenny, Farrington, Pearne &
Gordon
Parent Case Text
This application is a division of application Ser. No. 114,493,
filed Feb. 11, 1971, now U.S. Pat. No. 3,735,761, issued May 29,
1973.
Claims
What is claimed is:
1. A method of performing an intramuscular injection comprising the
steps of:
A. providing a hypodermic ampoule comprising:
a. a cylinder,
b. a diaphragm closing and sealing one end of said cylinder and
having a central, puncturable portion,
c. a slidable plunger in the opposite end of said cylinder and
spaced from said diaphragm to provide a chamber therebetween,
d. a liquid medicament in said chamber,
e. a hollow needle disposed in said chamber and extending axially
thereof from said plunger to said diaphragm for piercing the
diaphragm upon inward movement of the plunger, said needle having
an opening from said chamber into the needle at one end adjacent
said plunger and an opposite, pointed, discharge end adjacent said
diaphragm,
the volume of medicament in said chamber being substantially less
than the initial volume of said chamber so that, when the axis of
said cylinder is vertically disposed with its plunger end
uppermost, said plunger is initially sufficiently spaced from the
medicament to permit it to be moved inwardly for moving the pointed
end of the needle through and beyond said diaphragm before the
plunger contacts the medicament to express it through the
needle;
B. preprojecting said needle by moving said plunger inwardly until
it substantially contacts the medicament, so that the pointed end
of the needle pierces the diaphragm and so that a portion of the
needle extends beyond said diaphragm; after preprojecting said
needle, projecting said extended needle portion through the skin of
a patient so that the pointed end of the needle enters a muscle of
the patient and;
C. further moving the plunger inwardly to inject medicament into
said muscle.
Description
BACKGROUND OF THE INVENTION
This invention relates to disposable hypodermic ampoules that
provide a chamber containing both a medicament to be injected and
the hypodermic needle through which the injection is made, the
injection being performed by collapsing or otherwise actuating the
device to project the pointed end of the needle through a
puncturable wall of the ampoule and then into the patient while
reducing the volume of the medicament-containing chamber to express
the medicament through the needle and into the patient. Such
ampoules are referred to herein by the generic designation,
"contained-needle type."
Ampoules of this general character are represented, for example, by
two series of United States patents granted, respectively, to
Russell P. Dunmire and to Stanley J. Sarnoff or Stanley J. Sarnoff
et al. The principal ones of those patents to Dunmire are U.S. Pat.
Nos. 2,769,443, 3,094,987, 3,094,988, and 3,236,237, and the
principal ones of those patents to Sarnoff (or Sarnoff et al.) are
U.S. Pat. Nos. 2,704,072, 2,832,339, 3,302,955, and 3,396,726. The
devices of those patents of Dunmire and Sarnoff (or Sarnoff et al.)
involve a particularly advantageous mode of operation in that the
medicament is injected into the patient from the pointed end of the
needle as it travels longitudinally to its maximum depth of
penetration, thus distributing the medicament for faster absorption
and minimizing discomfort and trauma sometimes occasioned by
injecting all of the medicament in one location after the needle
has been inserted to the maximum depth. They also greatly reduce
the chances for contamination of the medicament or the needle; they
require little or no skill on the part of the user, and even make
self-injection safe and practical; and they have numerous other
inherent advantages which the art has long recognized. However,
none of the devices of that general type has yet been perfected
sufficiently for widespread use.
For inspection purposes after filling, it is important that
ampoules of the contained-needle types disclosed in the Dunmire and
Sarnoff (or Sarnoff et al.) patents have transparent walls. In
order to make the collapsible walls of the ampoules of the Dunmire
patents transparent, it has been necessary to mold them from
synthetic resin materials which, because of their possible
reactivity with certain medicaments during prolonged periods of
storage after filling and before use, have limited the use of such
ampoules. Although the components of such devices could be molded
of suitably inert natural rubber, that material does not have the
transparency required for inspection after filling and, therefore,
cannot be used for many applications.
Although the ampoule shell walls that are in contact with a
contained medicament during storage of the devices of the Sarnoff
(or Sarnoff et al.) patents could be made of transparent, inert,
glass tubing and sufficiently inert, molded rubber, end closures
for the tubing, so as to avoid the aforementioned inspection
problem, the forms of devices shown in those patents have involved
various structural, assembly, operational, and/or cost problems
that have limited their usefulness and, hence, their commercial
acceptance. For example, the puncturable end wall of the devices of
those patents of Sarnoff (or Sarnoff et al.) are incapable of
sealing against the skin of a patient as required to avoid loss of
medicament by seepage between the ampoule end wall and surface of
the skin, particularly in the case of such devices designed and
used for making relatively shallow subcutaneous injections. When
designed as shown in those patents and used as intended for making
intramuscular injections, the flow of medicament out of the pointed
end of the needle begins as soon as the needle point emerges from
the ampoule for penetrating the skin, and such flow continues until
the needle has penetrated to its maximm depth in the muscle layer.
The result is neither a normal subcutaneous injection nor a normal
intramuscular injection but, rather, is a combination of the two
that has been acceptable only for very limited injection purposes.
The devices of those Dunmire patents, on the other hand, were ideal
for making subcutaneous injections, but for the same reason as the
devices of the patents of Sarnoff (or Sarnoff et al.), were
incapable of giving a normal intramuscular injection.
Devices have been proposed which are designed for making
subcutaneous injections. One such device is shown in U.S. Pat. No.
3,396,726 to Sarnoff and includes a cylinder which defines a
medicament-containing ampoule. A piston driven needle is contained
in the ampoule and one end of the ampoule is closed by a pierceable
diagphragm. The cylinder is only partially filled by the medicament
so that the needle may be driven through the diaphragm and into the
muscle prior to ejection of the medicament from the needle. However
the disclosed method of performing the intramuscular injection
according to the Sarnoff patent necessitates the injection of air
into the patient. When an injection is performed by skilled
personnel, there is little danger if air is injected into the
patient. Desirably, however, an injection device should be designed
so that an injection may be performed by unskilled personnel such
as the patient himself. Unskilled personnel may inject air into a
blood vessel and it is therefore important to provide an ampoule
and an injection procedure which eliminates this possibility.
As further examples of problems not heretofore solved, some of the
devices of those patents of Sarnoff (or Sarnoff et al.) and of
other prior art, in order to ensure a proper seal between a
tubular, glass sidewall of an ampoule and a puncturable diaphragm
closing one end thereof, have included diaphragm retaining members
that are integral parts of an applicator for actuating the ampoule
(e.g., U.S. Pat. No. 2,832,339 to Sarnoff et al.), or have included
diaphragm retaining members that hold the medicament-containing
ampoule in operative position within an applicator (e.g., U.S. Pat.
No. 2,866,458 to Hein, Jr.) Such structures necessitate assembly
and filling of an ampoule during the assembly of the ampoule within
an applicator. However, it is frequently desirable to assemble and
fill an ampoule of the contained-needle type and then ship that
ampoule to the user so that the user may install it in an
applicator.
A more acceptable solution to the problem of sealing a diaphragm to
a medicament-containing cylinder may be found in U.S. Pat. No.
2,704,073 to Jensen. In the Jensen patent, the diaphragm is sealed
against one end of a cylinder by a cup-shaped clip which snaps over
a beaded end portion of the cylinder to press the diaphragm against
the end of the cylinder. This permits an ampoule to be assembled
prior to shipment and later installed in an ampoule applicator.
However, it provides a relatively large, substantially flat,
skin-contacting surface that is incapable of sealing against loss
of medicament by seepage between that end wall and the skin.
Moreover, neither the aforementioned Jensen patent nor any of the
previously mentioned patents of Sarnoff et al. and Hein, Jr.
provides a puncturable diaphragm that will permit an ampoule that
is substantially full of liquid to be actuated to reduce the liquid
chamber volume and force the needle through the diaphragm without
occassionally (at least) creating a hydraulic lock that either
bursts the ampoule or prevents initial movement of a plunger for
causing the needle to puncture the diaphragm and thereby release
the liquid for injection. Dunmire U.S. Pat. Nos. 3,094,988 and
3,236,237, which disclose solutions of the latter problem in the
case of molded plastic ampoules, fail to provide solutions for the
other problems described above.
The applicator disclosed in U.S. Pat. No. 3,236,237 to Dunmire
involves a special endwall construction that cooperates with the
special diaphragm of Dunmire U.S. Pat. No. 3,094,988 to perform the
desirable functions set forth therein. However, in many instances
it is desirable or necessary to perform an injection without
employing an applicator. Furthermore, it may be desirable to
perform an injection with an applicator different than the
particular kind set forth in that patent, so that the advantages
afforded by the teachings of the patent must be lost or achieved in
some other manner.
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 (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, are withdrawn as a dispersion 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 or 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.
19, 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, have all been subject to severe
limitations on their practical utility, and their uses have been
restricted accordingly. The present invention is directed to the
provision of a basic ampoule design of the contained-needle type
that is adaptable for making both subcutaneous and intramuscular
injections, either of a contained premixed medicament or of two or
more separated medicament components that are mixed in the ampoule
itself. A major objective is to achieve all of this
1. with a maximum utilization of basic parts of both the ampoules
and applicators therefor,
2. with a minimum variation in the techniques of assembling,
filling, and using the ampoules, and
3. while overcoming or avoiding the many problems that have
heretofore prevented general use of the desirable, contained-needle
type of injection device.
SUMMARY OF THE INVENTION
In its simplest form, this invention provides a disposable ampoule
of the contained-needle type having a rigid, cylindrical sidewall,
an actuating, needle-carrying plunger in one end thereof, and an
improved, skin-engaging, puncturable, endwall assembly at its
opposite end that is suitable for use, also, in the other forms of
the invention disclosed herein and for use with a variety of
applicators or without employing any applicator. The improved,
puncturable, endwall assembly includes the main features of the
puncturable diaphragm of Dunmire U.S. Pat. No. 3,094,988 and a
novel clip for fastening the diaphragm to the cylindrical
sidewall.
The clip according to this invention is cup-shaped and has a
cylindrical sidewall provided with an annular groove which snaps
over a radially extending, circumferential bead adjacent the end of
the cylinder. The bottom of the clip has a central opening therein
or receiving a central, needle-guiding, gland portion of the
puncturable diaphragm. The external bottom surface of the clip is
concave and tapers inwardly from an outer rim portion to the
central opening so that, upon engagement of the clip with the skin
to effect an injection, the skin is stretched to resist indentation
by the gland and produce a more reliable seal between the gland and
the skin, while urging the gland axially inwardly toward the point
of the needle to facilitate actuation of the ampoule. This latter
feature permits the ampoule to be employed with or without an
applicator. If an applicator is to be employed, however, it need
not be specially designed to itself perform the skin-stretching
function as disclosed in Dunmire U.S. Pat. No. 3,236,237.
This invention also provides an intramuscular, disposable,
hypodermic ampoule which includes a longer cylindrical sidewall
closed at one end by the puncturable diaphragm assembly and closed
at its other end by a slidable plunger carrying a needle with a
longer cannula. In this case, the cylinder is only partially filled
with medicament. Prior to an injection, the plunger is partially
depressed by pushing it toward the diaphragm so that the needle
projects through and beyond the diaphragm and so that air within
the ampoule is expelled prior to initiating the injection. The
projecting end of the needle is then pushed through the skin and
fascia layers and into the muscle of the patient, and the plunger
is completely depressed to inject the medicament as the needle
travels further into the muscle. A removable protective shield for
the partially advanced needle is preferably provided as an
attachment to the puncturable clip and diaphragm assembly and is
removed just prior to making the actual injection. Otherwise, this
form of the invention differs from the first described form
primarily in the lengths of the cylindrical sidewall and needle
cannula.
This invention also provides a multichamber, hypodermic device
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 mounted on 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 the above described, 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.
This invention also provides similar multichamber devices like the
one last described but with the similar provision in the second
cylinder of one or more additional, coaxially disposed chambers
containing additional, liquid medicament components to be
sequentially mixed in a like manner with the first two components
prior to making the actual injection.
A basic applicator design is provided for receiving and actuating
each of the several ampoule forms to perform the particular
injections for which each is designed.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a single chamber ampoule according
to this invention.
FIG. 2 is an enlarged, cross-sectional view, the plane of the
section being indicated by the line 2--2 in FIG. 1.
FIGS. 3 and 4 are cross-sectional views similar according to FIG.
2, but showing the ampoule in an applicator and showing component
parts of the ampoule and applicator in positions attained during an
injection.
FIG. 5 is a cross-sectional view of an ampoule which is adapted to
perform an intramuscular injection according to a further aspect of
this invention.
FIG. 6 is a cross-sectional view similar to FIG. 5, but showing
component parts of the ampoule in position attained prior to an
injection.
FIG. 7 is a cross-sectional view similar to FIG. 6, but showing the
ampoule mounted in an applicator and ready for an injection.
FIG. 8 is a cross-sectional view similar to FIG. 7, but showing the
ampoule in a position performing an injection.
FIG. 9 is a perspective view of a multichamber hypodermic ampoule
according to a further aspect of this invention.
FIG. 10 is a cross-sectional view of the ampoule of FIG. 9, the
plane of the section being indicated by the line 10--10 in FIG.
9.
FIGS. 11, 12, and 13 are cross-sectional views similar to FIG. 10,
but showing component parts of the ampoule in positions attained
after initiating a mixing operation, completion of the mixing
operation, and completion of an injection operation,
respectively.
FIG. 14 is a cross-sectional view of a multichamber hypodermic
ampoule according to a further aspect of this invention.
FIG. 15 is a cross-sectional view of a multichamber hypodermic
ampoule according to a still further aspect of this invention. the
cm
FIGS. 16 and 17 are cross-sectional views illustrating the
component parts of the ampoule of FIG. 15 in positions attained at
the completion of a mixing operation and after further actuation to
ready it for making an injection, respectively.
FIG. 18 is a perspective view of a needle which may be employed in
combination with devices according to this invention.
FIGS. 19 and 20 illustrate progressive filling and assembly
operations to produce the ampoule illustrated in FIGS. 9 through
13.
FIG. 21 is a fragmentary perspective view of an ampoule retaining
clip provided in the applicators illustrated in FIGS. 7, 8, and
17.
FIG. 22 is a bottom end view of an ampoule mounted in the
applicator illustrated in FIGS. 7, 8, and 17.
DETAILED DESCRIPTION OF THE INVENTION
Referring now to the drawings, and particularly to FIGS. 1 through
4, a single chamber ampoule 10 is illustrated. The ampoule 10 is
adapted to perform a subcutaneous injection and includes a cylinder
11. The cylinder 11 is preferably made from glass tubing and has a
radially extending annular bead 12 at one end. That end of the
cylinder 11 is closed by a diaphragm 13 which is pressed against it
by a plastic clip 14. The clip 14 is a cup-shaped and has an inner
annular groove 15 in its cylindrical sidewall which snaps over the
bead 12. The clip 14 also includes a bottom wall 14a having a
central aperture 14b therethrough. The bottom wall 14a has a
concave outside surface which includes an outer rim 14c and which
tapers upwardly toward the aperture 14b.
The diaphragm 13 is preferably molded from 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 16, a
thick, elongated, centrally located, needle guiding and liquid
sealing gland 17, and a relatively thin, flexible, corrugated,
intermediate portion 18 connecting the gland and the outer portion
to permit relative axial movement therebetween. The gland extends
through the aperture 14b in the clip 14. An axial needle passage 19
may extend into the upper end of the gland from the inside and
terminates short of the opposite, lower end of the gland to form a
thin, easily puncturable wall 20 closing the bottom of the passage.
Alternatively, this needle passage may be omitted when molding the
diaphragm and, in effect, be formed by partial piercing of the
gland by the needle during assembly of the ampoule.
The other end of the cylinder 11 is closed by a plunger 21 which is
also preferably molded from rubber and formed to have a sliding
interference fit with the inner sidewall of the cylinder 11. The
plunger 21, diaphragm 13, and cylinder 11, together, define a
chamber 22 which is substantially filled with a liquid
medicament.
Entirely enclosed within the chamber 22 is a hypodermic needle 23
(FIG. 18) which is preferably of the type disclosed in U.S. Pat.
No. 3,173,200 to Dunmire et al. The illustrated circular base 24 at
the butt end of the needle 23 is mounted on the plunger 21 so that
the needle is in substantial axial alignment with the cylinder 11
and has a pointed end 25 projecting downwardly and received within
the axial needle passage 19 of the diaphragm gland 17 in position
to be forced through the thin wall 20 of the gland. Mounting of the
needle base 24 on the plunger 21 is effected by snapping the
peripheral edge of the needle base under an annular lip 26 that is
an integral part of the plunger. Flow into the butt end of the
needle from the chamber 22 occurs through an opening 27 in the
cannula wall adjacent the base 24 of the needle.
An injection is effected by first pressing the diaphragm gland 17
firmly against the patient's skin S, thus indenting the skin until
the rim 14c of the bottom of the clip 14 also firmly engages the
patient's skin. As may be seen in FIGS. 3 and 4, when the clip 14
and the gland 17, together, firmly engage the skin S, the skin is
stretched and domes upwardly to thereby seal it more tightly
against the gland while forcing the gland axially inwardly toward
the pointed end 25 of the needle 23. Force is then applied to the
upper end of the plunger 21 (either manually or by means of an
ampoule applicator) to move it downwardly toward the diaphragm 13
so that the needle 23 penetrates the gland wall 20 (see FIG. 3) and
enters the patient's skin. As the plunger is depressed in this
manner, the liquid medicament in the chamber 22 is forced through
the opening 27 in the upper end of the needle, through the needle
cannula, and into the subcutaneous tissue of the patient. By reason
of the simultaneous upward pressure of the skin S on the gland 17
and the outward flexibility of the corrugated diaphragm portion 18,
the needle is easily driven through the gland wall 20 before
hydraulic pressure within the ampoule can block movement of the
plunger. Also, the seal between the gland 17 and the skin S
virtually prevents any seepage of medicament therebetween as the
point of the needle moves into the skin layer and thereafter.
Because both of these advantages are obtainable with the present
invention with or without the use of an applicator, since both
result from the new construction of the ampoule, itself.
If force is applied to the upper end of the plunger 21 by means of
an applicator, the applicator may be of the type shown and
described in the copending application of Hurschman, Ser. No.
114,423, filed Feb. 11, 1971. A lower end portion 28 of that
applicator is illustrated in FIGS. 3 and 4. The ampoule 10 is
mounted within the portion 28 by a bayonet-type connection between
the ampoule 10 and the portion 28. As is more fully set forth in
the application of Hurschman, this connection is effected by
providing axially extending, diametrically opposed slots (not shown
herein) through an inwardly extending flange portion 29 of the
applicator and by providing cooperating, radially extending lugs
14d on the clip 14. The lugs 14d are received within the slots and
enter channels 29a and 29b which extend in a clockwise direction
and taper radially inwardly toward the inner cylindrical sidewall
of the portion 28. The ampoule may be removably retained in the
applicator by inserting the lugs 14d into the slots and turning the
clip 14 in a clockwise direction until the lugs 14d firctionally
engage the inwardly tapering sidewalls of the channels 29a and 29b.
The means to apply force to the plunger 21 includes a spring biased
force applying head 28a which is held in a retracted position
illustrated in FIG. 3 by detent means (not shown). When the detent
means is released, the force applying head drives the plunger 21 to
the position illustrated in FIG. 4.
Referring now to FIGS. 5 through 8, a single chamber ampoule 30 is
illustrated. The ampoule 30 is adapted to perform an intramuscular
injection and includes a cylinder 31 which is preferably made from
glass tubing. One end of the cylinder 31 is provided with a
radially extending annular bead 32, and that end of the cylinder is
closed by a rubber diaphragm 33 that may be identical with the
diaphragm 13 of FIGS. 2-4. The diaphragm 33 is pressed and held
against the bead 32 by a clip 34 similar to the clip 14 of FIGS.
2-4. The other end of the cylinder 31 is closed by a rubber plunger
41 having an enlarged portion 42 which forms a sliding interference
fit with the inner sidewall of the cylinder 31. The plunger 41 is
provided with an axially extending reduced upper portion 43 which
initially extends beyond the cylinder 31.
The plunger 41, diaphragm 33, and cylinder 31, together, define a
chamber 44 which is partially filled with a liquid medicament. A
space Sp (FIG. 5) is provided between the level of the medicament
and the initial position of the plunger, and the axial extend of
the portion 43 of the plunger 41 corresponds to the axial extent of
the space Sp.
Contained within the chamber 44 is a needle 45 which may be
identical with the needle 23 illustrated in FIGS. 2-4 and 18 except
for having a longer cannula and is disposed and mounted in the
chamber similarly to the arrangement of FIGS. 2-4. A needle guard
46 is removably fixed to the clip 34 and extends axially therefrom.
The needle guard 46 is preferably of transparent plastic, is
cup-shaped, and has an open mouth which forms an interference fit
with an annular, axially projecting shoulder portion 47 of the clip
34. For purposes which will hereinafter become apparent, the guard
46 so provided with a knurled bottom rib 48 and has an axial extent
which is greater than the space Sp.
To ensure an intramuscular type injection, the needle 45 must pass
through the skin, underlying surface layers of fat, and the fascia
layer and enter the muscle prior to medicament flow through the
needle. Therefore, the chamber 44 is designed so that its volume is
greater than the volume of medicament contained therein. Prior to
effecting an injection, the plunger 41 is depressed until the upper
end of the portion 43 is level with the top of the cylinder 31, at
which point the lower end of the plunger contacts the surface of
the liquid in the chamber 44. During this depression operation, the
needle 45 pierces the diaphragm 33 and the air or gas in the space
Sp is substantially expelled through the needle. This operation is
most conveniently performed by placing the needle guard 46 on a
flat surface and pressing the plunger portion 43 downwardly until
the ampoule 30 achieves the condition illustrated in FIG. 6. If
desired, the plunger may be depressed in this manner until the
appearance of a drop of medicament at the point of the needle
(visible through the transparent sidewall of the needle guard 46)
indicates the elimination of substantially all air or gas from the
chamber 44. This operation projects the needle 45 a predetermined
distance beyond the diaphragm 33, which distance substantially
corresponds to the normal maximum depth of the muscle beneath the
skin of the patient, and air or gas in the chamber 44 is
substantially fully expelled in the process.
After achieving the condition illustrated in FIG. 6, an
intramuscular injection may be effected by manually removing the
needle guard 46, inserting the needle through the skin, fatty
layer, and fascia layer and into the muscle, and then completely
depressing the plunger 41. A preferred method of effecting an
injection, however, is to employ an applicator. As fragmentarily
shown herein, such an applicator includes a spring-biased plunger
50 (FIGS. 7 and 8) mounted within a casing 51. An applicator
adapted to perform an intramuscular injection includes an
elongated, metal, bell-shaped mouth portion 52 which is provided
with diametrically opposed inner spring clips 53 or the like (see
FIG. 21) which are spot welded to the inner sidewall of the portion
52. The clips 53 retain the ampoule diaphragm clip 34 in the
position illustrated in FIG. 7, so that the partially advanced
needle 45 is initially recessed in the applicator. With the needle
guard attached, the ampoule 30 is mounted within hte applicator by
inserting a pair of diametrically opposed lugs 34a provided on the
clip 34 into a cooperating pair of slots 52a (FIG. 22 which extend
axially through a radially inwardly extending flange 52b. This
operation is performed by grasping the knurled bottom rib 48 on the
needle guard 46. The ampoule is pushed upwardly into the casing 51
until the lugs 34a are above the level of the spring clips and is
then rotated 90.degree. until the lugs 34a rest on the clips 53
(see FIG. 7). It is desirable to remove the guard 46 after the
ampoule 30 is mounted in the applicator to prevent contamination of
the needle. The needle guard is removed by pulling one portion of
the rib 48 downwardly while pushing a diametrically opposed portion
of the rib upwardly since an axial force applied to the rib may
disengage the lugs from their retaining spring clips. After the
needle guard is removed, the mouth 52 of the applicator is placed
against the skin of the patient and the plunger is fired. The
applicator spring clips 53 are designed so that they release the
ampoule diaphragm clip 34 prior to movement of the plunger 41
relative to the ampoule clyinder 31. To this end, the springs are
designed so that the force required to drive the lugs 34a from
their retained position is less than the force required to move the
plunger 42 relative to the cylinder 31. In this manner, the needle
45 is driven into the muscle M (FIG. 8) prior to injection of the
medicament. After the needle 45 enters the muscle, the plunger 41
again moves toward the diaphragm 33 to perform the injection by
expressing the medicament through the needle 45 as it is driven
further into the muscle M. The injection is complete when the
plunger engages the diaphragm.
Referring now to FIGS. 9 through 13 of the drawings, a multichamber
ampoule 110 is illustrated. The ampoule 110 is adapted to perform a
subcutaneous injection and includes a first cylinder 111 and a
second cylinder 112 of larger diameter, both being preferably made
from glass tubing. One end of the first cylinder 111 has a radially
extending annular bead 113 which is received within an annular
groove 114 provided in a first diaphragm 115. The first diaphragm
115 is preferably made from rubber and is received with an
interference fit within one end of the second cylinder 112. This
radially compresses this diaphragm and causes it to more tightly
embrace the cylinder bead 113.
The other end of the first cylinder 111 is closed by a rubber
plunger 116 which, together with the first cylinder 111 and the
first diaphragm 115, defines a first chamber 117. The plunger 116
is preferably made of rubber and has an interference fit in the
first cylinder.
Entirely enclosed within the first chamber 117 is a hypodermic
needle 118 which may be identical with the needle 23 illustrated in
FIGS. 2-4 and 18 except for having a longer cannula. The
illustrated circular base 119 at the butt end of the needle 118 is
mounted on the plunger 116 similarly to the arrangement of FIGS.
2-4 so that the needle is in substantial axial alignment with the
cylinder 111 and has a pointed end 120 projecting downwardly and
into the diaphragm 115 in position to be forced through the
unpierced remainder thereof.
As will be hereinafter explained in greater detail, the chamber 117
is at least partially filled with a powdered medicament 123 and is
partially evacuated. A sliding interference fit between the
diaphragm 115 and the inner sidewall of the cylinder 112 aids in
sealing the bead 113 within the annular groove 114. Friction
between the plunger 116 and wall of the cylinder 111 and resistance
of the diaphragm 115 to penetration by the needle 118, of course,
prevent the plunger 116 from prematurely moving toward the
diaphragm 115.
The other end of the second cylinder 112 is closed by a second
diaphragm 124 and a clip 125 constructed and operating like the
previously described similar diaphragm and clip of FIGS. 2-4, the
diaphragm comprising portions 127, 128, and 129 corresponding to
portions 16, 17, and 18 of the diaphragm of FIGS. 2-4 and having a
similar needle receiving passage 130 ending in a puncturable wall
131 closing the bottom of the passage.
The first diaphragm 115, second diaphragm 124, and cylinder 112,
together, define a second chamber 132. The second chamber 132 is
filled with a liquid medicament in a manner which will hereinafter
be explained.
The liquid medicament 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. The plunger 116 is pushed
axially toward the first diaphragm 115 until the needle 118 pierces
this diaphragm and provides communication through the needle
between the second chamber 132 and the first chamber 117, as shown
in FIG. 11. Once communication is established between these
chambers, the liquid is drawn upwardly into the first chamber by
downward movement of the cylinder 111 and first diaphragm 115,
together, into engagemnt with the second diaphragm 124, as shown in
FIG. 12. At this stage, the pointed end of the needle 118, which
previously pierced the first diaphragm 115, has entered the gland
128 of the diaphragm 124.
To ensure that the pointed end of the needle will not be initially
extended too far beyond the first diaphragm 115 after it pierces
that diaphragm, the plunger 116 is provided with a centrally raised
portion 140 which extends beyond the end of the cylinder 111 when
the ampoule is initially assembled. The raised portion 140,
therefore, extends beyond the end of the cylinder 111 for a
distance which substantially corresponds to the thickness of the
portion of the diaphragm 115 to be pierced plus the desired
extension of the needle beyond the diaphragm 115 during the mixing
operation. To perform the penetration operation, therefore, the
raised portion 140 is depressed until its upper or outer end is
flush with the top mouth of the cylinder 111, as illustrated in
FIGS. 11 and 12.
When the ampoule 110 is in the condition illustrated in FIG. 12 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 diaphragm 124
is placed adjacent the patient's skin and the plunger is fully
depressed until it assumes the position illustrated in FIG. 13.
During the plunger depressing step, the needle penetrates the wall
131, and fluid is exhausted from the first chamber through the
needle opening adjacent the plunger 116 and through the opening in
the end of the needle as the needle penetrates the skin and
subcutaneous fat of the patient.
Referring now to FIG. 14, an ampoule 150 is illustrated. The
ampoule 150 is suited for performing an injection requiring the
premixing of two or more liquid medicaments with each other or with
each other and with a solid medicament. The ampoule 150 includes a
first cylinder 151 which is preferably made from glass and which
has a beaded rim portion 152 at its lower end. The rim portion 152
is received within an annular groove 153 which is provided in a
first diaphragm 154. The diaphragm 154 closes one end of the
cylnder 151, and the other end of the cylinder 151 is closed by a
plunger 155. A needle 156 similar to the needles 23 and 118 (except
for cannula length) is mounted on the plunger 155 similarly to the
arrangement of FIGS. 2-4. A pointed end 159 of the needle 156 is
received within a passage 160 in the first diaphragm 154. The
plunger 155, cylinder 151, and the diaphragm 154, together, define
a first chamber 161. As will be hereinafter explained in greater
detail, the chamber 161 is partially evacuated during the assembly
operation and is at least partially filled with a liquid or
powdered medicament 162.
The first diaphragm 154 is slidably received within a second
cylinder 163. The second cylinder 163 has its upper end closed by
the first diaphragm 154 and has its lower end closed by a second
diaphragm 164 and a clip 165 constructed and operating like the
previously described similar diaphragm and clip of FIGS. 2-4.
Intermediate diaphragms 167 and 168 are provided in the cylinder
163. The intermediate diaphragms 167 and 168, the diaphragms 154
and 164, and the cylinder 163, together, define second, third, and
fourth chambers 169, 170, and 171, respectively. The chambers 169,
170, and 171 are filled with different liquid medicaments.
The medicaments contained in the chambers 169-171 are mixed
together, and that mixture is in turn mixed with the powder 162 in
the following manner. The plunger 155 is pushed downwardly until
the needle 156 pierces the first diaphragm 154 to provide fluid
communication between the chamber 169 and the chamber 161. The
fluid in the chamber 169 is drawn through the hollow needle 156 and
into the chamber 161. After the liquid in the chamber 169 is
exhausted in this manner, the diaphragm 154 contacts the diaphragm
167 and the pointed end 159 of the needle enters a passage 172 in
the diaphragm 167. Further pressure on the plunger 155 causes the
needle 156 to pierce the diaphragm 167 to thereby draw liquid from
the the chamber 170 into the chamber 161 and move the diaphragm 167
against the diaphragm 168. The pointed end 159 of the needle 156
then enters a passage 173 in the diaphragm 168 and further pressure
on the plunger 155 drives the needle 156 through the diaphragm 168
to thereby draw liquid from the chamber 171. After the liquid in
the chamber 171 is exhausted, the diaphragm 168 contacts the
diaphragm 164 and the pointed end of the needle is received within
a passage 174 provided in the diaphragm 164.
After the several liquids are mixed with each other and with the
material 162 in the chamber 161, the ampoule 150 is in a condition
to perform an injection. This injection is performed by placing the
diaphragm 164 against the skin of the patient and by depressing the
plunger 155 until the plunger 155 contacts the diaphragm 154. It
should be appreciated that any number of liquids may be mixed in
this manner with or without a powdered medicament, after which the
ampoule, with or without an applicator of the kind partially shown
in FIGS. 3 and 4, may be used to make a subcutaneous injection in
the general manner previously described.
Referring now to FIGS. 15, 16, and 17, an ampoule 180 is
illustrated, The ampoule 180 may be employed to mix liquid and
powdered medicaments prior to an injection, and may be employed to
effect an intramuscular rather than subcutaneous injection. The
ampoule 180 is generally similar to the ampoule 110 in that it
includes a first cylinder 181 which is closed at one end by a
rubber plunger 182 and is closed at the other end by a first
diaphragm 183. A needle 184 is fixed to the plunger 182 in the same
manner previously described, and the diaphragm 183 is slidably
received in a second cylinder 185. The second cylinder 185 is
closed at its lower end by a second diaphragm 186 and a clip 187
constructed and operating like the previously described similar
diaphragm and clip of FIGS. 2-4. A needle guard 188 similar to the
needle guard 46 of FIGS. 5 and 6 is removably fixed to the clip 187
and extends axially therefrom as previously described with
reference to the latter figures of the drawings.
The first cylinder 181, diaphragm 183, and plunger 182, together,
form a first chamber 190 which is evacuated and partially filled
with a powdered medicament 191. The second cylinder 185 and
diaphragms 183 and 186, together, form a second chamber 192 which
is filled with a liquid medicament 193.
The medicaments 191 and 193 are mixed in a manner similar to the
mixing procedure set forth with regard to the ampoule 10 of FIGS.
9-13. The plunger 182 is pushed axially until the needle 184
pierces the diaphragm 183 and provides liquid communication between
the chambers 190 and 192. When such communication is established,
the diaphragm 183 moves into engagement with the diaphragm 186, and
the parts of the ampoule 180 assume the positions illustrated in
FIG. 16.
To ensure an intramuscular type injection, the needle 184 must pass
through the skin and the surface layers of fat and enter the muscle
prior to medicament flow through the needle. Therefore, the chamber
190 is designed so that its volume is greater than the total volume
of medicament to be contained therein. Thus, as is illustrated in
FIG. 16, there is a space Sp between the liquid level and the
plunger 182 when the diaphragms 183 and 186 are drawn together.
Prior to effecting an injection, the plunger 182 is further
depressed until the plunger 182 contacts the surface of the liquid
in the chamber 190. This operation projects the needle 184 a
predetermined distance beyond the diaphragm 186, which distance
substantially corresponds to the normal maximum depth of the muscle
beneath the skin of the patient, and air or gas in the chamber 190
is substantially fully expelled in the process as previously
described with reference to FIGS. 5-8.
An injection may then be performed by removing the needle guard 188
and manually applying the ampoule 180 against the skin of the
patient so that the needle 184 penetrates the skin and enters the
muscle. After this operation, the plunger 182 is completely
depressed to inject the medicament into the muscle. Desirably,
however, the injection is performed by an applicator which may
generally correspond to the applicator.
Referring now to FIGS. 19 and 20, the ampoule 110 is assembled and
filled by first attaching the needle 118 to the plunger 116 as
previously described with reference to FIGS. 2-4 and then inserting
the plunger in one end of the cylinder 111, as shown in FIG. 19.
With the open mouth of the cylinder 111 in an upright position, the
cylinder 111 is at least partially filled with the powdered
medicament 123 and is subjected to a vacuum during or at the
conclusion of the introduction of powdered medicament. While
subjected to the vacuum, the first diaphragm 115 is applied to the
mouth of the cylinder. Thereafter, the second cylinder 112 is
applied to the diaphragm 115, as illustrated in FIG. 20. The second
cylinder 112 is then filled with a liquid medicament, and the
remaining components are assembled to provide the ampoule shown in
FIGS. 9 to 13.
The invention is not restricted to the slavish imitation of each
and every detail set forth above. Obviously, hypodermic devices may
be provided which change, eliminate or add certain specific details
without departing from the scope of the invention.
* * * * *