U.S. patent number 3,828,779 [Application Number 05/314,705] was granted by the patent office on 1974-08-13 for flex-o-jet.
This patent grant is currently assigned to IMS Limited. Invention is credited to Robert Water Ogle.
United States Patent |
3,828,779 |
Ogle |
August 13, 1974 |
FLEX-O-JET
Abstract
A device for the introduction of liquid medication into a
flexible bag for the administration of intravenous solutions. The
device comprises an elongated generally cylindrical hollow tubular
member having an open end and a closed end, a boss extending from
the closed end, carried by the boss a cannula having a sharpened
outer end, and a rigid sheath surrounding the cannula and carried
by the boss. The sheath serves to limit the advancement of the
cannula into an orifice having a diameter greater than that of said
cannula. A thrust portion is provided within the tubular member and
a fluid passage extends longitudinally through the center of the
thrust portion. The lower end of the fluid passage communicates
with the upper end of the cannula. A cylindrical vial having a
resilient stopper in its open end seals on the inside walls of the
vial. There are threads on the thrust portion and cooperating
threads on the stopper adapted to be interlocked, whereby the plug
can be interlocked with the thrust portion.
Inventors: |
Ogle; Robert Water (Newport
Beach, CA) |
Assignee: |
IMS Limited (Wilmington,
DE)
|
Family
ID: |
23221085 |
Appl.
No.: |
05/314,705 |
Filed: |
December 13, 1972 |
Current U.S.
Class: |
604/413 |
Current CPC
Class: |
A61J
1/2089 (20130101); A61M 5/1409 (20130101); A61J
1/1475 (20130101); A61J 1/2096 (20130101); A61J
1/10 (20130101); A61J 1/201 (20150501); A61J
1/2013 (20150501); A61M 5/2429 (20130101) |
Current International
Class: |
A61J
1/00 (20060101); A61M 5/14 (20060101); A61J
1/05 (20060101); A61M 5/24 (20060101); A61j
005/00 (); A61m 005/32 () |
Field of
Search: |
;128/221,272,215,214.2,214C,214F,214D,218D,218N,216 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
236,947 |
|
Dec 1961 |
|
AU |
|
1,373,027 |
|
Aug 1964 |
|
FR |
|
1,082,035 |
|
Jun 1954 |
|
FR |
|
1,446,357 |
|
Jun 1966 |
|
FR |
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: McGowan; J. C.
Attorney, Agent or Firm: Mueth; Joseph E.
Claims
I claim:
1. The combination of a flexible bag for intravenous solution,
extending from the top of said bag, an additive-receiving flexible
tube-like orifice and an outlet adapted to lead to an intravenous
solution set, and a device for the introduction of liquid
medication into said flexible bag comprising an elongated generally
cylindrical hollow tubular member having an open end and a closed
end, a boss extending from said closed end, carried by the boss a
cannula having a sharpened outer end, a rigid cylindrical sheath of
fixed length surrounding said cannula and affixed to said boss,
said sharpened outer end extending slightly beyond the free end of
said sheath, said orifice having a diameter greater than that of
said cannula, said sharpened outer end being received in said
flexible tube-like orifice and said sheath engaging said orifice to
limit the advancement of said cannula into the orifice; within said
tubular member, a thrust portion, a fluid passage extending
longitudinally through the center of said thrust portion, the lower
end of said fluid passage communicating with the upper end of said
cannula, a cylindrical vial having a resilient stopper in its open
end sealing on the inside walls of said vial, interlocking means on
said thrust portion and cooperating interlocking means on said
stopper, whereby upon interlocking of said plug with said thrust
portion said vial is first held in an assembled but non-operating
position and upon further interlocking of said plug with said
cylindrical member, said plug is adapted to be pierced by said
fluid passage and said fluid passage communicated with said vial
without the application of substantial axial pressure on said plug
and said plug is locked securely to said cylindrical member to
permit aspiration upon withdrawal of said vial or to permit
expulsion of the contents of said vial upon exertion of pressure on
said vial.
2. The combination of claim 1 wherein the sheath has two portions
of different diameter, the outer portion having a diameter greater
than the outside diameter of said orifice and the inner portion
having a diameter less than the outside diameter of said orifice
whereby an annular shoulder is provided at the junction of said
portions which abuts the outer end of said orifice, said orifice
having a lateral imperforate diaphragm which is pierced by said
sharpened outer end when said shoulder and outer end of said
orifice are in contact.
Description
BACKGROUND OF THE INVENTION
The present invention is concerned with a device which is useful
for the addition of medicinal solutions to flexible intravenous
solution bags. Various devices have been proposed for these
purposes. In general, the devices involve the use of metal
conventional syringes. The problems are several. First, medication
for addition to intravenous solution bags is frequently of high
concentration, much too high for direct injection into the patient.
Thus, the packaging of concentrated medication in a syringe
presents the hazard of mistaken use, viz, direct injection rather
than dilution by addition to the intravenous solution. Secondly,
the orifice or inlet on the typical intravenous solution bag is
flexible as is the bag itself. The insertion of an ordinary syringe
into the orifice tube can result in the puncturing of the orifice
tube and/or bag unless great care is observed. The present
invention effectively overcomes these problems in the art.
SUMMARY OF THE INVENTION
Briefly, the present invention comprises a device for the
introduction of liquid medication into a flexible bag for the
administration of intravenous solutions which comprises an
elongated generally cylindrical hollow tubular member having an
open end and a closed end, a boss extending from said closed end,
carried by the boss a cannula having a sharpened outer end, a rigid
sheath surrounding said cannula and carried by said boss, said
sheath serving to limit the advancement of the cannula into an
orifice having a diameter greater than that of said cannula; within
said tubular member a thrust portion within said tubular member, a
fluid passage extending longitudinally through the center of said
thrust portion, the lower end of said fluid passage communicating
with the upper end of said cannula, a cylindrical vial having a
resilient stopper in its open end sealing on the inside walls of
said vial, interlocking means on said thrust portion and
cooperating interlocking means on said stopper, whereby upon
interlocking of said plug with said thrust portion said vial is
first held in an assembled but non-operating position and upon
further interlocking of said plug with said cylindrical member,
said plug is adapted to be pierced by said fluid passage and said
fluid passage with said vial without the application of substantial
axial pressure on said plug and said plug is locked securely to
said cylindrical member to permit aspiration upon withdrawal of
said vial or to permit expulsion of the contents of said vial upon
exertion of pressure on said vial.
This invention also includes the combination of a flexible bag for
intravenous solution having an additive-receiving orifice and an
outlet adapted to lead to an intravenous solution set, and a device
for the introduction of liquid medication into said flexible bag
comprising an elongated generally cylindrical hollow tubular member
having an open end and a closed end, a boss extending from said
closed end, carried by the boss a cannula having a sharpened outer
end, a rigid sheath surrounding said cannula and carried by said
boss, said orifice having a diameter greater than that of said
cannula, said sharpened outer end being received in said orifice
and said sheath engaging said orifice to limit the advancement of
said cannula into the orifice; within said tubular member, a thrust
portion within said tubular member, a fluid passage extending
longitudinally through the center of said thrust portion, the lower
end of said fluid passage communicating with the upper end of said
cannula, a cylindrical vial having a resilient stopper in its open
end sealing on the inside walls of said vial, interlocking means on
said thrust portion and cooperating interlocking means on said
stopper, whereby upon interlocking of said plug with said thrust
portion said vial is first held in an assembled but non-operating
position and upon further interlocking of said plug with said
cylindrical member, said plug is adapted to be pierced by said
fluid passage and said fluid passage communicated with said vial
without the application of substantial axial pressure on said plug
and said plug is locked securely to said cylindrical member to
permit aspiration upon withdrawal of said vial or to permit
expulsion of the contents of said vial upon exertion of pressure on
said vial.
It is an object of the present invention to provide a novel device
for the packaging of medication.
More particularly, it is an object of the present invention to
provide for the packaging of medication in a disposable device.
Still another object of the present invention is to provide a
disposable device for use in the addition of medication to
intravenous solution bags.
These and other objects and advantages of the invention will be
apparent from the more detailed description which follows taken in
conjunction with the accompanying drawings.
Further, the device of the present invention includes a significant
safety feature. Additives for intravenous solutions actually
contain medication in a concentration unsuitable for direct
injection into the human body. In fact, many of these additives are
fatal if directly injected. The sheath on the device of this
invention prevents the accidental injection of the concentrated
medication into the body. The sharpened cannula end of this
invention also prevents coring of the rubber diaphragm on the
intravenous solution bag. Coring results in bits of rubber falling
into the solution which can result in the injection of this
dangerous blood clotting material into the patient.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Turning to the drawings:
FIG. 1 shows a perspective view of a conventional intravenous
solution bag.
FIG. 2 is a partial side view of the bag in FIG. 1.
FIG. 3 is a sectional view of the upper portion of the bag of FIG.
1 taken along the line 3--3 in FIG. 2.
FIG. 4 shows, in assembled form, the bag of FIG. 1 in relationship
to the novel syringe having a sheath.
FIG. 5 shows a sectional view of the novel syringe of the present
invention in disassembled form.
FIG. 6 is an enlarged partial sectional view of the combination
shown in FIG. 4.
FIG. 7 shows, in assembled form, the use of the intravenous
administration bag after the addition of FIG. 4 has been
completed.
Turning to the drawings in greater detail, the holder of FIGS. 4-6
comprises a generally cylindrical hollow thrust portion 10 having
an open end 12 and a closed end 14. The cylindrical vial 16 has a
resilient stopper 18 in its open end sealing on the inside walls of
the vial 16. The stopper 18 generally, although not necessarily,
has a thin imperforate central diaphragm portion. The stopper 18 is
provided with an externally threaded projection 20 thereon. The
thrust portion 10 has a needle 22 therein and a boss 24 on its
exterior from which cannula 26 extends. The cannula 26 has a
sharpened outer end 28. The sheath 30 is carried by boss 24 and
surrounds cannula 26. The sheath 30 terminates short of the
sharpened outer end 28 of cannula 26. The sheath 30 has an offset
or shoulder 32 which functions as further hereinafter described.
Thrust portion 10 may be surrounded by holder 34.
The upper end of needle 22 has a sharp terminal portion 38. The
thurst portion 10 may have internal threads 40 in proximity to its
upper end, the threads on the projection 20 and the threads 40
being adapted when made up to cause said sharp terminal portion 38
of the needle 22 to puncture said stopper 18. When the projection
20 is made up with threads 40, the stopper 18 functions as a piston
to expel the contents of the vial 16 through needle 22 as said vial
16 is advanced with respect to said thrust portion 10.
The flexible intravenous solution bag 42 usually has a heat-sealed
peripheral portion 44 and a solution-containing zone 46. The bag
also has a flexible orifice or inlet tube 48 and an outlet tube 50
which leads to a conventional intravenous solution administration
set 52. The inlet tube and outlet tubes are provided with
imperforate diaphragms 54 and 56, respectively, and removable caps
or closures 58 and 60, respectively.
In operation, caps 58 and 60 are removed, the cannula 26 and sheath
30 are positioned as shown in FIG. 6, that is, the offset or
shoulder 32 limits the advancement of cannula into tube 48 so that
the sharpened end 28 of cannula 26 pierces diaphragm 54 but the
inside of shoulder 32 engages the outer end 62 of tube 48, limiting
the advancement of the cannula 26 within tube 48. The flat surface
of the shoulder 32 also serves to maintain the cannula 26 in a
parallel or longitudinal relationship with respect to the inside
walls of tube 48, thereby reducing the possibility of the sharpened
end 28 piercing the side of tube 48. By limiting the advancement of
the cannula 26 in tube 48 there is no chance that the sharpened end
28 can pierce the solution-containing zone 46. Thus, the escape of
solution and the introduction of contaminated hospital air into the
system are prevented.
With the parts as shown in FIG. 4, the vial is normally first
withdrawn slightly to aspirate from the bag into the vial
approximately that volume of air corresponding to the volume of
additive medication in the vial. Then, the contents of the vial are
expressed into the bag. The purpose of such aspiration is to
prevent rupture of the bag due to over-pressurization.
As will be understood by those skilled in the art, once the
contents of vial 16 have been transferred to zone 46, the bag 42 is
then hung up as shown and connected to the patient via set 52, as
shown in FIG. 7.
Having fully described the invention it is intended that it be
limited only by the lawful scope of the appended claims.
* * * * *