U.S. patent number RE29,062 [Application Number 05/587,151] was granted by the patent office on 1976-12-07 for intravenous container mixing assembly.
This patent grant is currently assigned to IMS Limited. Invention is credited to Robert W. Ogle.
United States Patent |
RE29,062 |
Ogle |
December 7, 1976 |
Intravenous container mixing assembly
Abstract
A device for the mixing and administration of intravenous fluid
comprising a cylindrical vial having an open end and a closed end,
an inwardly extending integral annular ring within the vial and
forming part of the walls of the vial intermediate said open and
closed ends. A tippable center septum seals on the annular ring. An
imperforate stopper is provided in the open end of the vial. The
vial is adapted to contain two liquids or a liquid and a dry
material in separated state. A non-opaque drip meter having a fluid
outlet at one end and a fluid inlet is provided, the inlet
comprising a tubular member terminating within the drip meter
whereby drops can be visually observed at the end of the tubular
member through the drip meter. Extending from the drip meter is a
solid or hollow elongated rigid spike having an enlarged base
adjacent the drip meter, the spike terminating in a point at its
other end. A filtered air inlet is positioned in proximity to the
base of the spike, a passage and filter are associated with the
spike or base for admitting filtered air into the vial. A fluid
passage runs through the base and has one end adjacent the spike at
the exterior of the base and the other end communicates with the
tubular member. The spike is adapted to puncture the stopper and
tip the septum whereby the contents of the vial can be mixed
without contamination from the exterior and the fluid contents of
the vial can flow through the fluid passage and the drip meter
while filtered air passes into the vial.
Inventors: |
Ogle; Robert W. (Newport Beach,
CA) |
Assignee: |
IMS Limited (S. El Monte,
CA)
|
Family
ID: |
23169189 |
Appl.
No.: |
05/587,151 |
Filed: |
June 16, 1975 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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195886 |
Nov 4, 1971 |
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830311 |
Jun 4, 1969 |
3674028 |
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Reissue of: |
302783 |
Nov 1, 1972 |
03858580 |
Jan 7, 1975 |
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Current U.S.
Class: |
604/91; 222/81;
604/414 |
Current CPC
Class: |
A61J
1/2093 (20130101); A61M 5/1409 (20130101); A61M
5/162 (20130101); A61M 2005/1623 (20130101); A61J
1/2041 (20150501); A61J 1/2075 (20150501); A61J
1/2082 (20150501) |
Current International
Class: |
A61M
5/162 (20060101); A61M 5/14 (20060101); A61J
1/00 (20060101); A61M 005/16 () |
Field of
Search: |
;128/218M,272,221,DIG.28,214R,214C,214.2,215 ;215/6 ;206/47A
;222/81 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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1,071,557 |
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Mar 1954 |
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FR |
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1,225,859 |
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Jul 1960 |
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FR |
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66,274 |
|
Mar 1956 |
|
FR |
|
Primary Examiner: Yasko; John D.
Attorney, Agent or Firm: Wills, Green & Mueth
Parent Case Text
This application is a continuation-in-part of Application Ser. No.
195,886, filed Nov. 4, 1971, which was a divisional application of
Application Ser. No. 830,311, filed June 4, 1969 and now issued as
U.S. Pat. No. 3,674,028.
Claims
I claim:
1. A novel device for the administration of intravenous fluids
which comprises a cylindrical fluid container having an open end
and a closed end, an imperforate stopper in said open end, an
annular inwardly projecting ring within said container, a tippable
center septum abutting said ring, a non-opaque drip meter having a
fluid outlet at one end and a fluid inlet, said inlet comprising a
tubular member terminating within said drip meter whereby drops can
be visually observed at the end of said tubular member through said
drip meter, extending from said drip meter an elongated rigid spike
having an enlarged base adjacent said drip meter, said spike
terminating in a point at its other end, said other end extending
into said container, a filtered air inlet positioned in proximity
to the base of said spike, means for admitting filtered air into
said container, a fluid passage running through said base and
having one end adjacent the spike at the exterior of said base so
that essentially all of the fluid within said container can drain
out by gravity through said fluid passage, and the other end of
said fluid passage communicating with said tubular member, the
point of said spike being adapted to puncture said stopper and tip
said septum whereby contents of said container can be mixed without
contamination from the exterior and the fluid contents can flow
through said fluid passage and drip meter while filtered air passes
into said vial.
2. A novel device for the administration of intravenous fluids
which comprises a cylindrical fluid vial having an open end and a
closed end, an imperforate stopper in said open end, an annular
inwardly projecting ring within said vial, a tippable center septum
abutting said ring, a non-opaque drip meter having a fluid outlet
at one end and a fluid inlet, said inlet comprising a tubular
member terminating within said drip meter whereby drops can be
visually observed at the end of said tubular member through said
drip meter, extending from said drip meter an elongated rigid solid
spike having an enlarged base adjacent said drip meter, said solid
spike terminating in a point at its other end, said other end
extending into said container, a filtered air inlet positioned in
proximity to the base of said solid spike, means for admitting
filtered air into said container, a fluid passage running through
said base and having one end adjacent the solid spike at the
exterior of said base so that essentially all of the fluid within
said container can drain out by gravity through said fluid passage,
and the other end of said fluid passage communicating with said
tubular member, the point of said solid spike being adapted to
puncture said stopper and tip said septum whereby contents of said
vial can be mixed without contamination from the exterior and the
fluid contents can flow through said fluid passage and drip meter
while filtered air passes into said vial.
3. The device of claim 2 wherein said solid spike is offset from
the centerline of said vial.
4. The device of claim 2 wherein said septum has a centrally domed
surface facing said stopper.
5. The device of claim 2 wherein said drip meter has an external
flange which abuts said end stopper.
6. The device of claim 2 wherein said end stopper is
non-reciprocating.
7. The device of claim 2 wherein said chamber adjacent said closed
end is shorter than the diameter of said septum.
8. The device of claim 7 wherein said septum has a plurality of
rings sealing on the walls of said vial.
9. The device of claim 1 wherein said spike is hollow and has a
central internal passage which communicates with said filtered air
inlet. .Iadd. 10. A novel device for the administration of
intravenous fluids which comprises a fluid container having an open
end and a closed end, an imperforate stopper in said open end, said
container having two coaxial cylindrical compartments, a tippable
center septum separating said compartments, a non-opaque drip meter
having a fluid outlet at one end and a fluid inlet, said inlet
comprising a tubular member terminating within said drip member
whereby drops can be visually observed at the end of said tubular
member through said drip meter, extending from said drip meter an
elongated rigid spike having an enlarged base adjacent said drip
meter, said spike terminating in a point at its other end, said
other end extending into said container, a filtered air inlet
positioned in proximity to the base of said spike, means for
admitting filtered air into said container, a fluid passage running
through said base and having one end adjacent the spike at the
exterior of said base so that essentially all of the fluid within
said container can drain out by gravity through said fluid passage,
and the other end of said fluid passage communicating with said
tubular member, the point of said spike being adapted to puncture
said stopper and tip said septum whereby contents of said container
can be mixed without contamination from the exterior and the fluid
contents can flow through said fluid passage and drip meter while
filtered air passes into said vial..Iaddend.
Description
BACKGROUND OF INVENTION
Various intravenous solution sets are known in the prior art. In
general, these devices involve the drip meter assembly which has a
sharp puncturing member at its upper end for piercing the stopper
of a bottle of intravenous solution. The puncturing member normally
has associated therewith an air inlet and a fluid outlet. Many
medicaments must be stored and packaged in a dry or lyophilized
state, and require reconstitution with a liquid diluent just prior
to use. Heretofore, the reconstitution of such materials for
administration in an intravenous set required the nurse or
technician to make one or more transfers of diluent in an open and
uncontrollable manner. This procedure carries with it the grave
risk of bacterial contamination. It also creates the chance of a
mistake occurring as the result of a mix-up of solution bottles.
The present invention is basically concerned with eliminating these
problems and hazards by providing a closed system in which the
solid medicament and its diluent can be packaged under strict
sterile conditions at the factory, and reconstituted at the time of
use without the necessity of the medicament becoming contaminated
during a transfer operation. It is believed that this invention
involves a major advance in the art of administering intravenous
solutions.
SUMMARY OF THE INVENTION
Briefly, this invention comprises a novel device for the mixing and
administration of intravenous fluid comprising a cylindrical vial
having an open end and a closed end, an inwardly extending integral
annular ring within said vial and forming part of the walls of said
vial intermediate said open and closed ends, a tippable center
septum sealing on said annular ring, an imperforate stopper in said
open end, said vial being adapted to contain two liquids or a
liquid and a dry material in separated state, a non-opaque drip
meter having a fluid outlet at one end and a fluid inlet, said
inlet comprising a tubular member terminating within said drip
meter whereby drops can be visually observed at the end of said
tubular member through said drip meter, extending from said drip
meter a solid or hollow elongated rigid spike having an enlarged
base adjacent said drip meter, said spike terminating in a point at
its other end, a filtered air inlet positioned in proximity to the
base of said spike, means associated with said spike or base for
admitting filtered air into said vial, a fluid passage running
through said base and having one end adjacent the spike at the
exterior of said base and the other end communicating with said
tubular member, said spike being adapted to puncture said stopper
and tip said septum whereby the contents of the vial can be mixed
without contamination from the exterior and the fluid contents of
said vial can flow through said fluid passage and said drip meter
while filtered air passes into said vial.
It is an object of my invention to provide a novel device for the
administration of intravenous fluids.
More particularly, it is an object of this invention to provide a
novel device which is adapted for the administration and
reconstitution of medicament in a completely closed system.
Another object of this invention is to provide a novel device for
the packaging and administration of medicament for intravenous use
which during storage is maintained in separated condition, viz, two
liquids or a liquid and a dry material.
These and other objects and advantages of this invention will be
apparent from the detailed description which follows.
DESCRIPTION OF PREFERRED EMBODIMENTS
Turning to the drawing:
FIG. 1 shows one embodiment of the drip meter and spike of this
invention.
FIG. 2 is a top view of the device of FIG. 1.
FIG. 3 is a bottom view of the device of FIG. 1.
FIG. 4 shows, in side sectional view, one embodiment of the vial,
center septum and end stopper of this invention.
FIG. 5 is a plan view of the end stopper of the vial of FIG. 4.
FIG. 6 shows, in sectional view, the parts of FIGS. 1-5 in
partially assembled condition.
FIG. 7 is a sectional view of the parts of FIGS. 1-5 in fully
assembled condition.
FIG. 8 is a sectional view of another embodiment of this
invention.
Considering the drawings in greater detail, the cylindrical vial 10
has an open end 12 and a closed end 14. The center septum 16 is
positioned just above and abuts the integral annular ring 18. Below
ring 18 is chamber 20 which contains a dry or lyophilized
medicament 22. The septum 16 has four sealing rings 24, 26, 28 and
30 which form a seal on the inside walls of the vial 10. A chamber
32 for liquid or diluent 34 is provided between septum 16 and the
end stopper 36. The end stopper 36, unlike septum 16, is
non-reciprocating; that is, it is not slidable downwardly within
vial 10, such movement being prevented by shoulders 38 which
overlay and may seal upon the ends of vial 10.
The drip meter 40 has an outlet 42 provided with tubing 44 normally
intended to carry the intravenous solution to the patient in
conventional fashion. The drip meter 40 is normally non-opaque;
that is, transparent or translucent so that drops of fluid may be
observed and/or counted. The drip meter 40 has a fluid inlet
comprising a tubular member 46 which terminates within the
non-opaque drip meter. In FIGS. 1-7, the rigid spike 48 is solid
and has an enlarged base 50 adjacent the drip meter 40. The spike
48 has a point 52 at one end. The opening 54 in base 50
communicates with air opening 56. The opening 56 is normally
provided with cotton 58 or other filtering material intended to
entrap any airborne particulate matter or bacteria in the entering
air. The fluid passage 60 runs through the base 50 and functions as
a downcomer for fluid. the lower end of passage 60 communicates
with the tubular member 46.
In use, the parts shown in FIGS. 1 and 2 are made up beginning as
in FIG. 6 and concluding as in FIG. 7 whereby the spike 48 tips the
center septum 16, allowing mixing and reconstitution to occur. The
flange 62 is brought up flush with the exterior of stopper 36 so
that passage 60 is in fluid communication with the fluid contents
of the vial 10. The spike 48 is long enough to reach and tip septum
16 at or prior to the time the flange 62 is flush with stopper
36.
FIG. 8 shows another embodiment of this invention wherein the vial
64, annular ring 66, center septum 68 and end stopper 70 have the
structure previously described. The drip meter 72 has an outlet 74
provided with tubing 76 and a fluid inlet comprising the tubular
member 78. In this embodiment, the rigid spike 80 is hollow and has
a central opening 82 and a scarf or point 84 at one end. The
opening 82 communicates with the air opening 86. The fluid passage
88 runs through the base 90 and communicates with tubular member
78. In this embodiment the point 84 is above the initial fluid
level in the vial 64 when the parts are fully assembled. Thus, the
entering air is discharged at point 84, above the fluid level in
the vial. This effectively reduces the risk of contamination of the
fluid by the incoming air. Also, in FIG. 8 the septum 68 has a
centrally domed surface 92 which facilitates the tipping of the
septum by the spike 80. The domed surface is particularly desirable
where the spike is centrally disposed in the vial rather than
offset from the centerline of the vial as shown in the
drawings.
It is to be noted that the tipping action afforded by the annular
ring and septum, allows the chamber adjacent the closed end of the
vial to be smaller than the diameter of the septum. In other words,
by providing for tipping action, this chamber can be substantially
reduced in length since it does not receive the septum in length.
This function reduces glass usage and saves space.
Preferably, the end stopper has a circular area bridged by a thin
imperforate diaphragm 94. The diaphragm is readily punctured by the
point of the spike.
Having fully described the invention, it is intended that it be
limited only by the scope of the appended claims.
* * * * *