U.S. patent number 3,872,867 [Application Number 05/358,693] was granted by the patent office on 1975-03-25 for wet-dry additive assembly.
This patent grant is currently assigned to The Upjohn Company. Invention is credited to Fred M. Killinger.
United States Patent |
3,872,867 |
Killinger |
March 25, 1975 |
Wet-dry additive assembly
Abstract
A pair of vials each having a perforable seal closing an opening
in one end thereof and a hollow cylindrical portion of reduced
diameter adjacent the seal. A double-ended cannula is slidably
receivable into the reduced end portions of the vials for
perforating the seals to communicate with and between the interiors
of the vials. A support on the cannula is removably engageable with
the reduced portion on one of the vials. An elongated tubular
sheath extends between and is slidably supported upon the cannula
support and upon both of the vials.
Inventors: |
Killinger; Fred M. (Portage,
MI) |
Assignee: |
The Upjohn Company (Kalamazoo,
MI)
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Family
ID: |
26846635 |
Appl.
No.: |
05/358,693 |
Filed: |
May 9, 1973 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
149321 |
Jun 2, 1971 |
3788369 |
|
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212592 |
Dec 27, 1971 |
3826260 |
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Current U.S.
Class: |
604/413; 141/329;
206/219 |
Current CPC
Class: |
A61J
1/2089 (20130101); A61J 1/2013 (20150501); A61J
1/2065 (20150501); A61J 1/201 (20150501) |
Current International
Class: |
A61J
1/00 (20060101); A61j 001/00 () |
Field of
Search: |
;128/DIG.28,272,218M,218NV,218R,218N,215,216,221,218D,218DA |
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
Parent Case Text
This application is a Continuation-in-Part of patent applications
Ser. No. 149,321, filed June 2, 1971, now U.S. Pat. No. 3,788,369
and entitled "APPARATUS FOR TRANSFERRING LIQUID BETWEEN A CONTAINER
AND A FLEXIBLE BAG," and Ser. No. 212,592, filed Dec. 27, 1971, now
U.S. Pat. No. 3,826,260 entitled "VIAL AND SYRINGE COMBINATION."
Claims
The embodiments of the invention in which an exclusive property or
privilege is claimed are defined as follows:
1. A double vial assembly for storing a medicament, comprising:
first vial means defining a chamber therein and having a first
elongated sleevelike end portion of reduced diameter, said first
sleevelike end portion having a first flow opening therethrough for
providing the only communication with said chamber;
perforable seal means blocking said first opening, said seal means
being spaced inwardly from the outer end of said first opening as
defined adjacent the free end of said first sleevelike end
portion;
second vial means defining a chamber therein and having a second
elongated sleevelike end portion of reduced diameter, said second
sleevelike end portion having a second flow opening therethrough
for providing the only communication with said chamber in said
second vial means;
perforable stopper means blocking said second flow opening, said
perforable stopper means being spaced inwardly of said second
sleevelike opening from the outer end thereof as defined adjacent
the free end of said second end portion;
elongated double ended cannula means extending between said first
and second vial means, said cannula means having one end portion
thereof loosely but slidably disposed within said first sleevelike
end portion, the other end portion of said cannula means being
loosely but slidably disposed within said second sleevelike end
portion;
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 second
sleevelike end portion;
releasable detent means coacting between said portion of said
support means and said second sleevelike end portion for resisting
movement of said cannula means relative to said second vial
means;
removable tubular sheath means surrounding said cannula means and
extending between said first and second 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 first
sleevelike end portion and said first vial means, 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 second sleevelike end portion
and said second vial means, respectively, and disposed in snug
slidable engagement therewith, whereby said sheath means can be
slidably disconnected from both said first and second vial
means;
and
means, including releasable detent means, coacting between said
first sleevelike end portion and said sheath means for resisting
relative movement of said sheath means toward said first vial
means.
2. An assembly according to claim 1, wherein said second vial means
has the chamber thereof maintained under a pressure which is
substantially below atmospheric pressure.
3. An assembly according to claim 1, wherein said means coacting
between said first sleevelike end portion and said sheath means
includes an intermediate sleeve member snugly and slidably disposed
within the first sleevelike part of said sheath means, said
intermediate sleeve member being slidably disposed on and
surrounding said first sleevelike end portion, and said releasable
detent means coacting between said first sleevelike end portion and
said intermediate sleeve member.
4. An assembly according to claim 1, wherein said first and second
sleevelike end portions are of substantially the same diameter,
wherein the said first sleevelike part associated with the first
annular end portion and the first sleevelike part associated with
the second annular end portion are of the same diameter and are
connected to one another to form an intermediate tubular portion of
uniform diameter, said support means including a sleevelike support
member disposed within said intermediate tubular portion and
positioned in surrounding relationship to said second sleevelike
end portion, and said means coacting between said first sleevelike
end portion and said sheath means including an intermediate sleeve
member snugly and slidably disposed within the intermediate tubular
portion of said sheath means and disposed in surrounding
relationship to said first sleevelike end portion.
Description
BACKGROUND OF THE INVENTION
This invention relates in general to a device for storing and
supplying additives or medicaments and, more particularly, to a
type thereof including one sealed vial holding a diluent, another
sealed vial holding an additive or medicament and interconnecting
means for holding the vials together and for effecting selective
communication between said vials, whereby said diluent can be mixed
with said additive and thereafter fed into a passageway, such as a
tube connected to a patient by a cannula for intravenous
feeding.
Persons familiar with the preparation and use of parenteral
additives or medicaments have long been aware of the fact that
certain additives, for example, tend to loose 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
additive is supplied, for example, to an intravenous bottle.
In the past, it has been common practice to furnish separate vials
of dry additive 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 additive. This
arrangement involves the risk of contamination, the risk of
improper dose and even the risk of mixing the wrong ingredients
where the administration of additive must be handled by unskilled
persons.
Numerous attempts have been made to solve the foregoing problems as
by furnishing syringes and vials connected together so that the
supply and administration means are part of a package which is more
readily usable. However, the previous combinations or packages
involving an additive 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
and delicate to operate as the devices which they were intended to
replace.
Accordingly, a primary object of this invention is the provision of
a double vial assembly with a connecting structure between the
vials whereby the sterility of the diluent and the additive or
medicament in the vials is maintained prior to and during the
mixing of the diluent with the additive and, at the same time, the
cannula for the administration of the solution is shielded from
contamination during the mixing and up to the very moment of
insertion into the intravenous system or bottle.
A further object of this invention is the provision of a double
vial assembly, as aforesaid, in which injectable additives or
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 additive without any likelihood of contaminating the needle,
the diluent or the additive.
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 additive is positively opposed and,
yet, wherein intentional mixing of the additive and the diluent can
be effected safely, easily and quickly in preparation for supplying
of the solution by any person capable of following simple
instructions.
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 double vial assembly
embodying 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 exploded view of the structure appearing in FIG.
2.
FIG. 5 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 double 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 an assembly including one
sealed vial containing a diluent, another sealed vial containing an
additive or medicament, which may be liquid or dry, and a
connection structure that includes a sheath and a cannula which
extend between and are supported upon the sealed ends of the two
vials. The connection structure is arranged so that the sharpened
ends of the cannula can be held spaced from, or slightly embedded
in, the seals over the open ends of the vials. By effecting
relative movement of the vials toward each other, the cannula
pierces the seals and thereby communicates with and between the
interiors of the vials. The additive vial is under vacuum or the
diluent vial is pressurized to effect movement of the diluent from
its vial through the cannula into the additive vial after which the
additive is dissolved in the diluent by gently shaking the
assembly. The diluent vial and sheath are now removed from the
assembly so that the cannula is exposed and can be injected into an
intravenouos system or bottle which is also under vacuum.
DETAILED DESCRIPTION
The double vial assembly 10 (FIGS. 1 and 2) is comprised of a vial
11 connected to a similar or identical vial 12 by an intermediate
structure 13. The vial 11 has a chamber 16, and the lower open
mouth portion 18 thereof is of reduced diameter and is covered by a
seal 19 which may be a resilient, flanged stopper. The seal 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
flange 25 of the seal 19 firmly against the lower end of the vial
16.
The vial 12 has an open mouth 36 which is covered by a seal, such
as the 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
flange of the stopper 37 thereby holding it tightly against the
upper end 36 of the vial 12.
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 lower end thereof. The tubular support 28 has an
integral flange 29 at its lower 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 upper end portion of the sleeve 39 (FIG. 4) and the lower
portion of the tubular support 28 have interferring deformations,
such as annular ridges 32 and 33, respectively, by which the spaced
relationship between the lower end of the cannula 26 and the seal
37 is determined. This spaced position is shown in FIG. 2. By
moving the tubular support 28, hence the cannula 26, downwardly,
the ridge 33 on the tubular support 28 is moved downwardly from
between the two uppermost ridges 32 on the sleeve 23 until said
ridge 33 moves past the lowermost ridge 32A, during which the seal
37 is penetrated by the cannula 26. The ridge 32A and the ridge 33
hold the cannula in the penetrating position.
A substantially cylindrical sheath 43 (FIG. 4) 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
lower portion of which is sleeved snugly but slidably upon the
tubular support 28. Said sheath has a lower enlarged opening 46
with an inside diameter approximately equal to the outside diameter
of the enlarged portion 38 of sleeve 39. Said lower opening 46 is
also slightly larger than the flange 29 at the lower end of the
tubular support 28. Thus, as the sheath 43 is moved downwardly
relative to the vial 12, the engagement between the flange 29 and
the shoulder 47 at the upper end of the lower opening 46 act to
move the tubular support 28, hence the cannula 26, downwardly with
the sheath 43. At the same time, the enlarged portion 38 is
slidably received upwardly into the opening 46 in snug engagement
with the lower part of sheath 43 defining the peripheral wall of
the opening 46.
A flanged sleeve 45 is snugly disposed in the upper end of the
central opening 44 (FIG. 3). Said sleeve has an annular ridge 48
which coacts with annular ridges 49 on the sleeve 23. In this case,
there are three ridges 49, two near the lower end of the sleeve and
one near the upper end. The ridge 48 is located between the ridges
49 when the upper end of the cannula 29 is spaced from, or at least
is not penetrating through, the stopper 19. The sheath 43 can be
moved upwardly relative to the sleeve 23 into a position where the
ridge 48 is above the uppermost ridge 49A, at which time the
cannula 26 penetrates completely through the stopper 19. Also,
during this movement, the enlarged portion 22 on the sleeve 23 is
slidably but snugly moved downwardly into the enlarged opening 52
at the upper end of the sheath 43 and coaxial with the central
opening 44.
OPERATION
The operation of the double vial assembly (FIG. 1), to which this
application applies, will be apparent to skilled persons upon
reading the foregoing description. However, for convenience, such
operation will now be summarized briefly.
In preparation, the vial 12 will be filled with a medicament, which
may be a liquid or a dry powdery material produced by evaporative
procedures, and the pressure in the vial 12 will preferably be
reduced (that is, less than atmospheric). The stopper 37, which is
held in place by the sleeve 39, will be unperforated, and the vial
11 may be pressurized.
The vial 11 will contain a liquid and 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 upper end of the sleeve 39 so that the ridge 33
near the lower end of the interior wall of the tubular support 28
is located between the two ridges 32 near the upper end of the
sleeve 39. In this position, the cannula will be spaced from the
seal 37.
The sheath 43 is now sleeved downwardly over the cannula 26 at the
tubular support 28 until the shoulder 47 engages the flange 29. At
the same time, the lower end 46 of the sheath 43 will preferably
slightly overlap the enlarged portion 38 of the sleeve 39, which
portion 38 surround the vial mouth 36. The sheath 43 and vial 12
can now be simultaneously manually engaged in one hand while the
vial 12 is engaged in the other hand and the sleeve 23 on the vial
11 is slidably inserted first into the enlarged opening 52 at the
upper end of the sheath and then into the sleeve 45 in the upper
end of the central opening 44. This sliding connection will be
terminated when the ridge 48 on the wall defining the opening
through the sleeve 45 is located between the ridges 49 on the
sleeve 23. At this time, the upper end of the sheath 43 will be
preferably telescoped slightly over the vial mouth 18, as by
engaging the enlarged portion 22 of the sleeve 23.
The assembly 10 is now in condition for shipment and/or storage as
long as desired. While the diluent has been disclosed in the upper
vial 11 and the medicament in the lower vial 12, this situation can
be reversed. Also, it will be seen that the flanged sleeve 45 can
be an integral part of the sheath 43.
When it becomes desirable to administer the medicament in the vial
12, the two vials 11 and 12 are either simultaneously or
sequentially urged toward the sheath so that the cannula perforates
and extends completely through the seals 19 and 37, thereby
communicating with and between the chambers within the two vials.
The diluent in vial 11 will now move downwardly due to the
differential pressure through the cannula into the vial 12.
By a gentle shaking action, the powdered or liquid material within
the lower vial 12 is mixed with the diluent from the upper vial 11.
If the mixed diluent and additive must be administered at once, the
sheath 43 and vial 11 are moved upwardly away from the vial 12 and
the tubular cannula support 28 so that the upper end of the cannula
26 is exposed. The cannula will remain in position with respect to
the vial 12 due to the interengagement of the ridges on the sleeve
39 with the ridge on the tubular support 28. That is, ridge 33 will
be under the ridge 32A and the upper ridges 32 may be somewhat
embedded in the interior wall of the tubular support 28. The
cannula 26 is inserted downwardly into an intravenous bottle, for
example, in which the pressure is reduced so that the liquified
additive is withdrawn from the vial 12 through the cannula 26 and
into the I.V. bottle.
In a modified construction, the stopper 37 of FIG. 3 may be
replaced by the stopper 56 (FIG. 5) having an upward extension 57
into 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.
* * * * *