U.S. patent number 3,826,260 [Application Number 05/212,592] was granted by the patent office on 1974-07-30 for vial and syringe combination.
This patent grant is currently assigned to The Upjohn Company. Invention is credited to Fred M. Killinger.
United States Patent |
3,826,260 |
Killinger |
July 30, 1974 |
VIAL AND SYRINGE COMBINATION
Abstract
A syringe barrel having a perforable seal closing an end thereof
and a hollow cylindrical portion of reduced diameter extending
beyond the seal. A vial having a stoppered opening and a hollow
cylindrical portion of reduced diameter extending beyond the
stopper. A double-ended cannula is slidably received in the reduced
portions of the barrel and the vial for perforating the seal and
the stopper to communicate with and between the interiors of the
syringe and the vial. A support on the cannula is removably engaged
with the reduced portion of the barrel. An elongated tubular sheath
extends between and is slidably supported upon the cannula support
and the reduced portion of the vial.
Inventors: |
Killinger; Fred M. (Portage,
MI) |
Assignee: |
The Upjohn Company (Kalamazoo,
MI)
|
Family
ID: |
22791673 |
Appl.
No.: |
05/212,592 |
Filed: |
December 27, 1971 |
Current U.S.
Class: |
604/413 |
Current CPC
Class: |
A61M
5/28 (20130101); A61J 1/2096 (20130101); A61J
1/2051 (20150501); A61M 5/283 (20130101); A61J
1/2013 (20150501); A61J 1/201 (20150501) |
Current International
Class: |
A61J
1/00 (20060101); A61M 5/28 (20060101); A61j
005/00 (); A61m 005/32 () |
Field of
Search: |
;128/272,216,218N,218NV,215,221,218M |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: McGowan; J. C.
Attorney, Agent or Firm: Woodhams, Blanchard and Flynn
Claims
The embodiments of the invention in which an exclusive property or
privilege is claimed are defined as follows:
1. A device for storing and administering a medicament,
comprising:
syringe means including a barrel having an elongated sleevelike end
portion of reduced diameter, said end portion of reduced diameter
having a discharge opening therethrough communicating with the
interior of said barrel;
perforable seal means blocking said discharge opening, said seal
means being spaced inwardly from the outer end of said discharge
opening as defined adjacent the free end of said reduced diameter
end portion;
vial means defining a chamber therein and having an elongated
sleevelike part of reduced diameter, said sleevelike part having a
flow opening therethrough communicating with said chamber;
perforable stopper means blocking said flow opening, said
perforable stopper means being spaced inwardly of said opening from
the outer end thereof as defined adjacent the free end of said
sleevelike part;
elongated double ended cannula means extending between said syringe
means and said vial means, said cannula means having one end
portion thereof loosely but slidably disposed within said reduced
diameter end portion, the other end portion of said cannula means
being loosely but slidably disposed within said reduced diameter
sleevelike part;
support means disposed in surrounding relationship to said cannula
means and fixedly secured thereto at a location disposed between
the ends thereof, said support means including a portion disposed
in snug, slidable, telescopic engagement with said reduced diameter
end portion;
releasable detent means coacting between said portion of said
support means and said reduced diameter end portion for resisting
movement of said cannula means relative to said syringe means;
removable tubular sheath means surrounding said cannula means and
extending between said syringe means and said vial means for
connecting same together, said sheath means including a first
annular end portion having first and second sleevelike parts of
different diameters disposed in surrounding relationship to said
barrel and said reduced diameter end portion, respectively, and
disposed in snug slidable engagement therewith;
said sheath means including a second annular end portion having
first and second sleevelike parts of different diameters disposed
in surrounding relationship to said reduced diameter part and said
vial means, respectively, and disposed in snug slidable engagement
therewith, whereby said sheath means can be slidably disconnected
from both said vial means and said syringe means; and
releasable detent means coacting between said reduced diameter part
and said sheath means for resisting movement of said sheath means
relative to said vial means.
Description
BACKGROUND OF THE INVENTION
This invention relates in general to a device for storing and
administering medicaments and, more particularly, to a type thereof
including a sealed syringe holding a diluent, a sealed vial holding
a medicament and interconnecting means for holding the syringe and
vial together and for effecting selective communication between
said syringe and said vial, whereby said diluent can be mixed with
said medicament and thereafter administered to a patient by a
cannula which is attached to the syringe and is part of the
connecting means.
Persons familiar with preparation and use of parenteral medicaments
have long been aware of the fact that certain medicaments tend to
lose their effectiveness rather soon after they are mixed with a
diluent in preparation for administration. Thus, they must be
stored in a dry or non-liquid condition and then mixed with a
diluent, preferably just before the medicament is administered to a
patient. Obviously, any other procedure would risk an incorrect
dosage of the medicament.
In the past, it has been common practice to furnish separate vials
of dry medicament and diluent and to use a conventional syringe for
transferring the diluent from one vial to another for the purpose
of mixing the two in order to administer the medicament. This
arrangement involves the risk of contamination, the risk of an
improper dose and even the risk of mixing the wrong ingredients,
where the administration of the medicament must be made by
unskilled persons.
Numerous attempts have been made to solve the foregoing problems as
by furnishing syringes and/or vials connected together so that the
supply and the administration means are part of a package which is
more readily usable. However, the existing combinations or packages
involving a medicament and a diluent have not proven satisfactory,
heretofore, for a variety of reasons. For example, they have not
satisfactorily avoided contamination, they have been too delicate
for conventional storing and handling procedures, they have been
too susceptible to accidental actuation whereby the materials are
mixed too soon, and in general they have been almost as complicated
to operate as the previous devices which they were intended to
replace.
Accordingly, a primary object of this invention is the provision of
a syringe and vial assembly with a connecting structure
therebetween whereby the sterility of the diluent in the syringe
and the medicament in the vial are maintained during the mixing of
the diluent and the medicament and, at the same time, the cannula
for the syringe is shielded from contamination during the mixing
and up to the very moment of administration to a patient.
A further object of this invention is the provision of a syringe
and vial assembly, as aforesaid, in which injectable medicaments
can be safely stored for relatively long periods of time, as in
drug stores, clinics and doctor's offices, along with a suitable
diluent in a single package capable of mixing the diluent and
medicament without any likelihood of contaminating the injecting
needle, the diluent or the medicament.
A further object of this invention is the provision of an assembly,
as aforesaid, which is rugged so that it cannot be readily damaged
during shipment or storage, which is constructed so that accidental
mixing of the diluent and the medicaments is positively opposed and
yet wherein intentional mixing of the medicament and the diluent
can be effected safely, easily and quickly in preparation for
injection with the syringe by any person qualified to perform such
an injection.
Other objects and purposes of this invention will become apparent
to persons familiar with apparatus of this type upon reading the
following description and examining the accompanying drawings, in
which:
FIG. 1 is a side elevational view of a syringe and vial assembly
embodied in the invention.
FIG. 2 is an enlarged sectional view taken along the line II--II in
FIG. 1.
FIG. 3 is a sectional view similar to FIG. 2 and showing the parts
thereof in different operational positions.
FIG. 4 is an enlarged fragment of FIG. 3.
FIG. 5 is a sectional view taken along the line V--V of FIG. 2.
FIG. 6 is a sectional view taken along the line VI--VI of FIG.
2.
FIG. 7 is a fragment of FIG. 2 showing a modified structure.
For convenience in description, the terms "upper", "lower" and
words of similar import will have reference to the syringe and vial
assembly or parts thereof as appearing in FIGS. 1 and 2. The terms
"inner", "outer" and derivatives thereof will have reference to the
geometric center of the assembly and major components thereof.
SUMMARY OF THE INVENTION
The objects and purposes of the invention, including those set
forth above, have been met by providing a syringe and vial assembly
including a sealed syringe containing a diluent, a sealed vial
containing a medicament, which may be liquid or dry, and a
connection structure which includes a cannula and extends between
and is supported upon the sealed ends of the syringe and the vial.
The connection structure is arranged so that the sharpened ends of
the cannula can be held spaced from the seal over the open end of
the syringe and the stopper closing the vial. However, by effecting
relative movement of the vial and syringe toward each other, the
cannula pierces the seal and the stopper, thereby communicating
with and between the interiors of the syringe and the vial.
Accordingly, the diluent can be moved through the cannula from the
syringe into the vial after which the medicament is dissolved in
the diluent and thereafter returned to the syringe by actuating the
plunger thereof in the reverse direction. The syringe and cannula
are now removed from the outer sheath of the connecting structure
so that the cannula is exposed and can be injected into the patient
for administering the dissolved medicament.
DETAILED DESCRIPTION
The syringe and vial assembly 10 (FIGS. 1 and 2) is comprised of a
syringe 11 connected to a vial 12 by an intermediate structure 13.
The syringe 11 has a barrel 16 and plunger 17 which may be of
conventional structure. The lower open end portion 18 of the barrel
16 is of reduced diameter and is covered by a seal 19 which is held
in place by the integral enlarged portion 22 of the sleeve 23 which
is preferably fabricated from metal. The sleeve 23 has a shoulder
24 which forms part of the enlarged portion 22 and presses the seal
19 firmly against the lower end of the barrel 16.
A cannula 26, which is sharpened on both ends, has a hub 27 rigidly
secured thereto and spaced from both ends thereof. A tubular
cannula support 28 has one end thereof secured to the hub 27 which
it concentrically encircles. The remainder of the tubular support
28 is spaced radially outwardly from the cannula and projects
toward the upper end thereof. The tubular support 28 has an
integral flange 29 at its upper end. The hub 27 may be made from
metal or plastic and the tubular support 28 is preferably
fabricated from plastic. In some circumstances, the hub 27 may be
integral with and part of the tubular support 28.
The lower end portion of the sleeve 23 (FIG. 2) and the upper
portion of the tubular support 28 have interfacing deformations,
such as annular ridges 32 and 33, respectively, by which the spaced
relationship between the upper end of the cannula 26 and the seal
19 is determined. This spaced position is shown in FIG. 2. By
moving the tubular support 28, hence the cannula 26, upwardly, the
ridge 33 on the tubular support 28 is moved upwardly from between
the two lowermost ridges 32 on the sleeve 23 until said ridge 33
moves past the uppermost ridge 32A, during which the seal 19 is
penetrated by the cannula 26. The ridge 32A and the ridge 33 hold
the cannula in the penetrating position.
The vial 12 has an open end 36 which is covered by a flanged
stopper 37 which is in turn held in place by the enlarged lower
portion 38 of the sleeve 39. That is, the sleeve 39 has an integral
shoulder 42 which bears downwardly against the stopper 37 thereby
holding it tightly against the upper end 36 of the vial 12.
A substantially cylindrical sheath 43 (FIG. 2) extends from the
enlarged portion 22 of sleeve 23 to the enlarged portion 38 of
sleeve 39. Said sheath 43 has a central cylindrical opening 44, the
upper portion of which is sleeved snugly but slidably upon the
tubular support 28. Said sheath has an upper enlarged opening 46
with an inside diameter approximately equal to the outside diameter
of the enlarged portion 22 of sleeve 23. Said upper opening 46 is
also slightly larger than the flange 29 at the upper end of the
tubular support 28. Thus, as the sheath 43 is moved upwardly
relative to the syringe 11, the engagement between the flange 29
and the shoulder 47 at the lower end of the upper opening 46 act to
move the tubular support 28, hence the cannula 26, upwardly with
the sheath 43. At the same time, the enlarged portion 22 is
received downwardly into the opening 46.
The lower end of the central opening 44 (FIG. 3) has an annular
ridge 48 which coacts with annular ridges 49 on the sleeve 39. In
this case, there are three ridges 49, two near the upper end of the
sleeve and one near the lower end. The ridge 48 is located between
the ridges 49 when the lower end of the cannula 26 is spaced from,
or at least is not penetrating through, the stopper 37. The sheath
43 can be moved downwardly relative to the sleeve 39 into a
position where the ridge 48 is below the lowermost ridge 49A, at
which time the cannula 26 penetrates completely through the stopper
37 as shown in FIG. 3. Also, during this movement, the enlarged
portion 38 on the sleeve 39 is slidably but snugly moved upwardly
into the enlarged opening 52 at the lower end of the sheath 43 and
coaxial with the central opening 44.
OPERATION
The assembly and operation of the syringe and vial assembly (FIG.
1), to which this application applies, will be apparent to skilled
persons upon reading the foregoing description. However, for
convenience, such assembly and operation will now be summarized
briefly.
In assembly, the vial 12 will be filled with a medicament, which
may be a liquid or a dry powdery material produced by evaporative
procedures. The stopper 37, which is held in place by the sleeve
39, will be unperforated.
The syringe 11 will contain a liquid and have a plunger 17 (FIG. 1)
at its upper end. The sleeve 23 (FIG. 2) will hold the seal 19
which is also unperforated The cannula support 28, which is secured
to the cannula 26 through the hub 27, will be mounted upon the
lower end of the sleeve 23 so that the ridge 33 near the upper end
of the interior wall of the tubular support 28 is located between
the two ridges at the lower end of the sleeve 23. In this position,
the cannula will be spaced from the seal 19.
The sheath 43 is now sleeved upwardly over the cannula 26 and the
tubular support 28 until the shoulder 47 engages the flange 29. At
the same time, the upper end of the sheath 43 will preferably
slightly overlap the enlarged portion 22 of the sleeve 23. The
sheath 43 and syringe barrel 16 can now be simultaneously manually
engaged in one hand while the vial 12 is engaged in the other hand
and the sleeve 39 on the vial 12 is slidably inserted first into
the enlarged opening 52 at the lower end of the sheath and then
into the lower end of the central opening 44. This sliding
connection will be terminated when the ridge 48 on the wall
defining the central opening 44 is located between the ridges 49 on
the sleeve 39. At this time, the lower end of the sheath 43 will be
preferably telescoped slightly over the enlarged portion 38 of the
sleeve 39.
The assembly 10 is now in condition for shipment and/or storage as
long as desired. While the diluent has been disclosed in the
syringe and the medicament in the vial, this situation can be
reversed.
When it becomes desirable to administer the medicament in the vial,
the vial and syringe are either simultaneously or sequentially
urged toward the sheath so that the cannula perforates and extends
completely through the seal 19 and stopper 37, thereby
communicating with and between the chambers within the barrel 16
and the vial 12 as illustrated in FIG. 3. The plunger 17 is now
moved downwardly within the barrel 16 whereby the liquid within the
barrel is transferred through the cannula into the vial.
By a gentle shaking action, the powdered or liquid material within
the vial is mixed with the diluent from the syringe. The assembly
10 is now inverted from its FIG. 1 position and the plunger 17 is
pulled downwardly whereby the mixture of diluent and medicine is
transferred back into the syringe.
The sheath 43 and vial 12 are now moved downwardly away from the
syringe and the tubular cannula support 28 so that the lower end of
the cannula 26 is exposed, as appearing in FIG. 4. The cannula will
remain in position with respect to the syringe due to the
interengagement of the ridges on the sleeve 23 with the ridge on
the tubular support 28. That is, the upper ridge 32A will be under
the ridge 33 and the lower ridges 32 may be somewhat embedded in
the interior wall of the tubular support 28. The medicine can now
be administered to the patient in a perfectly normal and
conventional manner.
In a modified construction, the ridge 33 in FIG. 3 on the tubular
support 28 may be replaced with one or more annular grooves 55
(FIG. 4) into which the ridges 32 are selectively and removably
received.
In a further modification, the stopper 37 of FIG. 2 may be replaced
by the stopper 56 (FIG. 7) in which the lower end of cannula 26 is
embedded to seal the end thereof.
Although particular preferred embodiments of the invention have
been disclosed in detail for illustrative purposes, it will be
recognized that variations or modifications of the disclosed
apparatus, including the rearrangement of parts, lie within the
scope of the present invention.
* * * * *