U.S. patent number 3,923,183 [Application Number 05/338,662] was granted by the patent office on 1975-12-02 for container for medical liquid with separable outer and inner closures.
This patent grant is currently assigned to American Hospital Supply Corporation. Invention is credited to Pradip V. Choksi, Roy B. Steidley.
United States Patent |
3,923,183 |
Choksi , et al. |
December 2, 1975 |
Container for medical liquid with separable outer and inner
closures
Abstract
A thermoplastic bottle for sterile medical liquids with a
dispensing outlet closed off by an inner closure. An outer closure
in the form of a thermoplastic cap overlies the inner closure.
During steam sterilization at 240.degree. to 260.degree. F
(116.degree. to 127.degree. C) the outer cap deflects inwardly
against the inner cap to force the inner cap into a tighter seal
against the bottle. This outer cap includes external left-handed
threads and has a lateral frangible brim fused to the thermoplastic
bottle. A threaded jacking ring is screwed onto the outer cap and
with a counterclockwise motion acts to (1) fracture the cap's
external brim and (2) separate the outer cap from the sealed inner
cap.
Inventors: |
Choksi; Pradip V. (North
Hollywood, CA), Steidley; Roy B. (Seal Beach, CA) |
Assignee: |
American Hospital Supply
Corporation (Evanston, IL)
|
Family
ID: |
23325607 |
Appl.
No.: |
05/338,662 |
Filed: |
March 7, 1973 |
Current U.S.
Class: |
215/251;
215/DIG.3; 215/45; 215/399; 215/48; 215/901; 215/46; 215/384 |
Current CPC
Class: |
A61J
1/05 (20130101); B65D 51/18 (20130101); B65D
2203/04 (20130101); B65D 2251/0015 (20130101); B65D
2501/0081 (20130101); B65D 2251/0078 (20130101); Y10S
215/901 (20130101); Y10S 215/03 (20130101) |
Current International
Class: |
A61J
1/00 (20060101); B65D 51/18 (20060101); B65d
041/62 (); B65d 051/18 () |
Field of
Search: |
;215/42,46A,1C,DIG.3,37R,251 ;220/27 ;401/132,133 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Ross; Herbert F.
Attorney, Agent or Firm: Barger; Larry N. Merrick; Robert
T.
Claims
We claim:
1. A container and double closure system for storing and dispensing
sterile liquids, which includes a blow molded thermoplastic
container with a dispensing outlet, an inner closure, an outer cap,
and a jacking ring, the container and outer cap forming a unit
having a transverse abutment means surrounding the outlet wherein
the improvement comprises:
an said inner closure being secured to the container to close off
the outlet and form a hermetically sealed unit but is openable for
dispensing; said outer cap being a separately formed injection
molded thermoplastic outer cap with a longitudinal axis, said outer
cap having both a thin frangible section and externally exposed
threads, and said outer cap is sealed to the container proximate
the abutment means with an annular bacteria-tight bond with the
threads of the outer cap being in axial alignment with the abutment
means, said jacking ring being internally threaded and threadingly
disposed on the outer cap to guide it toward the abutment means for
exerting a pressure against the abutment means to axially pry the
outer cap apart at its frangible section.
2. The combination as set forth in claim 1, wherein the outer cap
has an integral external brim that is heat fused to the
thermoplastic container.
3. The combination as set forth in claim 1 wherein the external
threads on the outer cap are left-handed.
4. The combination as set forth in claim 1 wherein the inner
closure includes a transverse wall permanently sealed to the
container, said transverse wall including openable means for
connecting to an intravenous administration set.
5. The combination as set forth in claim 4 wherein the openable
means includes a thin pierceable diaphragm.
6. The combination as set forth in claim 4 wherein the transverse
wall includes a puncturable resealable section for injecting
additive medications.
7. The combination as set forth in claim 6 wherein the puncturable
resealable section includes a rubber diaphragm.
8. The combination as set forth in claim 1, wherein the abutment
means is a flange on the container and the outer cap has a
frangible brim with an outer annular portion fused to the flange
and an inner annular portion unfused to the flange and a weakened
fracturable line between the fused and unfused portions.
9. The combination as set forth in claim 1 wherein the outer cap
and container are both of propylene-ethylene copolymer
thermoplastic material.
10. A container and double closure system for storing and
dispensing sterile medical liquids, which includes a thermoplastic
bottle that has a tubular neck with a longitudinal axis, a
dispensing outlet, and an integral external flange on the bottle
neck, wherein the improvement comprises:
an inner closure secured to the bottle to close off the outlet and
form a hermetically sealed unit, said inner closure having at least
a portion that is openable for dispensing; said bottle's neck
flange having a top sealing surface lying in a plane generally
perpendicular to the neck's longitudinal axis; a separately formed
thermoplastic outer cap with a longitudinal axis and including a
top wall, a depending skirt and a thin frangible brim integrally
formed with a lower end portion of this skirt, said brim having a
thickness of between .005 inch and .050 inch, said frangible brim
being heat fused to the top sealing surface of the bottle's neck
flange at an annular fusion joint along an outer portion of the
frangible brim, said brim having an annular inner portion that is
unfused to the flange to provide a weakened fracture line between
the fused and unfused annular portions; external left-handed
threads on the outer cap, which threads are in a predetermined
alignment with said flange; and a rigid annular jacking ring having
internal left-handed threads which threadingly intermesh with the
threads of the outer cap, said annular jacking ring adapted to
rotate in a counterclockwise direction for both fracturing the
outer cap at said weakened line and thereafter removing the
combined jacking ring and outer cap from the sealed inner closure
and bottle combination with a rotational lifting motion.
Description
BACKGROUND
Sterile medical liquids such as 5% dextrose, normal saline, sterile
water, etc., are often bottled and sterilized by manufacturers and
then shipped to hospitals. When ready for use these bottles are
opened to dispense sterile irrigating liquids to a surgical wound,
or to deliver intravenous liquid into a patient's vein.
A very critical portion of these sterile medical liquid containers
is their closure system which protects the dispensing outlet of
these containers. Such a closure system must maintain the sterility
of the dispensing outlet.
It has been proposed in the past to use double closure systems in
which an outer closure fits over and protects a sterile inner
closure of the container. In some situations it is desirable to
separately remove the outer closure from the inner closure. Then in
a subsequent step all or part of the sterile inner closure can be
removed to dispense the sterile medical liquid from the container.
Sometimes the inner closure is replaceable or reclosable when only
a portion of the bottle's contents are dispensed.
While these previous double closure systems with an outer closure
separable from the inner closure performed the primary function of
protecting the sterility of the dispensing outlet, they were often
hard to open. This was because the outer closure required some
unusual hand movements and an unusual sequence of steps that the
nurse or physician had to remember.
SUMMARY OF THE INVENTION
This invention provides an improved double closure system with a
separately removable outer cap that fits over an inner cap. When
steam sterilized the outer cap deflects inwardly to urge the inner
cap into a tighter seal with the bottle. The closure both protects
the sterility of the dispensing outlet, and is also easy to open. A
counterclockwise motion of a special jacking ring fractures the
outer cap at a frangible brim which is hermetically sealed to the
bottle. The combined jacking ring and outer cap are then removed
from the inner closure. To a nurse or physician, this is an
extremely simple motion. They are accustomed to this motion because
it is commonly used for opening various household containers such
as toothpaste, jars of food, etc. No special series of pushing,
pulling, sliding steps, etc., need be remembered.
The special double closure system with separable outer cap is
better understood with reference to the attached drawings.
THE DRAWINGS
FIG. 1 is a front elevational view of the container and first
embodiment of the closure system of our invention as it is sealed
and stored at a hospital ready for use;
FIG. 2 is an exploded perspective view of the various elements of
the closure system of the first embodiment used for a pouring
container;
FIG. 3 is an enlarged sectional view of the pouring container
closure of FIG. 2 with the closure elements assembled;
FIG. 4 is a further enlarged sectional view of the left side
portion of FIG. 3 showing the frangible brim section of the outer
cap before fracturing;
FIG. 5 is an enlarged sectional view similar to FIG. 4 but showing
the frangible brim after fracture;
FIG. 5a is an enlarged sectional view of a right side portion of
another embodiment of the invention showing the jacking ring having
a closed top;
FIG. 6 is an enlarged exploded perspective view of a second
embodiment of the double closure system of this invention showing
an inner closure adapted to connect with an intravenous
administration set; and
FIGS. 7 to 10 illustrate the sequence of steps of opening the
pouring container illustrated in FIG. 3.
DETAILED DESCRIPTION
With reference to these drawings, FIG. 1 shows a blowmolded
thermoplastic bottle 1 with a closure system generally indicated at
2 at its upper end. At its lower end is a supporting base 3 with an
indented center portion 4. A hinged hanger 5 fits within indented
portion 4 for suspending the container upside down if desired. An
indented waist section 6 provides a convenient grippable portion of
the bottle.
The closure system of the bottle is shown in much greater detail in
FIG. 2. Here the bottle 1 is shown with a threaded tubular neck 7
surrounded by a pouring lip 8. In this first embodiment of the
invention, the container is generally referred to as a "pouring
container." The sterile medical liquid contained within the bottle
1 is simply poured into a surgical wound for flushing, etc. Since
the pouring lip 8 becomes touched by liquid poured from the bottle,
it is extremely important to have a very reliable closure
system.
The closure system fitting onto the tubular neck includes two caps.
One cap is an internally threaded screw cap 9 that is received on
threaded neck 7 and forms an annular inner hermetic seal with this
neck. The other is an outer cap 10 that fits over the inner cap and
includes a top wall 11 and a depending skirt 12 with external
threads 13. At a lower end of outer cap 10 is a laterally extending
frangible brim 14. This brim is .005 to .050 inch (0.13 to 1.3
millimeters) thick, and is fused to a flange 15 of the bottle. The
fusion joint between the frangible brim 14 and flange 15 forms an
annular outer hermetic seal. Thus, there are two annular hermetic
seals in this closure system.
The uppermost element in FIG. 2 is a threaded jacking ring 16. This
jacking ring includes a knurled or grooved outer surface 17 for
easy gripping. Internally of the annular jacking ring 16 are
integral left-handed threads 18. When the closure of FIG. 2 is
assembled, the threads 18 intermesh with the left-handed threads 13
of the outer cap. Thus, counterclockwise rotation of the jacking
ring 16 relative to the outer cap screws the jacking ring
downwardly on the outer cap.
FIG. 3 is an enlarged sectional view showing the jacking ring 16,
the outer cap 10 and the inner cap 9 assembled on the dispensing
neck 7. Here the inner cap 9, with a top wall 20 and a depending
skirt 21, has internal right-handed threads 22 that engage
right-handed 23 of the dispensing neck. At a top of the dispensing
neck 7 is a pouring lip 8. The top wall 20 of the inner cap 9
includes an integral deformable rib 25 that compressingly engages
this pouring lip 8. This forms the annular inner hermetic seal.
Even if the bottle is turned upside down, the sterile liquid
confined within bottle 1 will not seep past this inner hermetic
seal.
To maintain this inner hermetic seal it is very important that rib
25 be very tightly squeezed against lip 8 of the container neck.
The screw threads 22 of the inner cap exert this squeezing
pressure. It has also been found that additional downward pressure
on the inner cap makes an even tighter seal at rib 25. This can be
done by including a top 27 on the jacking ring that pushes
downwardly on the outer cap's top wall which in turn pushes on the
inner cap's top wall to increase the pressure at rib 25. FIG. 5a
illustrates this.
The added pressure on rib 25 can also be accomplished in a steam
autoclave. When a bottle closure such as shown in FIG. 3 is steam
autoclaved the pressure in the autoclave forces top wall 11 of the
outer closure to deflect downwardly and firmly press on the inner
cap. This increases the sealing force at rib 25 during autoclaving.
Thus, the added pressure on rib 25 can be applied with a jacking
ring that has no closed top.
The outer closure 10 with its top wall 11 and depending skirt 12
has integral external threads 13 and a frangible brim 14. This
frangible brim 14 is at a lower end of the outer cap and externally
protrudes in a plane generally perpendicular to a common
longitudinal axis 29 through dispensing neck 7 and outer cap 10.
The frangible brim has an outer annular portion 30 that is fusion
bonded to a top surface of lateral flange 15 on the bottle. The top
surface of this flange 15 lies in a plane generally perpendicular
to longitudinal axis 29.
FIG. 4 shows an enlarged fragmentary sectional view of the annular
fused zone 30 along an outer portion of frangible brim 14. There is
also an inner annular band 31 that remains unfused to the flange
15. This unfused portion 31 joins the fused portion 30 at a
weakened fracturable line 32 extending around the frangible brim.
As rotated counterclockwise a lower end surface 33 of the jacking
ring contacts the frangible brim. The jacking ring has a sharp
inner edge of its bottom surface that helps concentrate the
downward forces adjacent fracturable line 32. Further clockwise
movement of the jacking ring 16 as shown in FIG. 5 pulls the outer
cap upwardly until the frangible brim 14 fractures at fracturable
line 32. When this happens the combined jacking ring 17 and outer
closure 10 can be removed from the inner cap. This is because there
is a slight annular space between inner cap skirt 21 and outer cap
skirt 12 so there is no substantial frictional engagement between
the outer cap and the inner cap. Therefore if the outer cap is
further rotated after the fracture at 32, then the outer cap will
not loosen the inner cap.
Once the outer cap has been fractured with the jacking ring and
lifted therefrom, the inner cap can be unscrewed in a separate step
with a counterclockwise rotational movement. This inner cap can
then be replaced on the threaded neck of the container if
desired.
In FIG. 6 there is shown a second embodiment of our invention. Here
a container 40 is shown with a neck 41 surrounded by a flange 42.
There is no threaded screw cap on neck 41. Instead, in this
embodiment there is a transverse wall member 43 permanently sealed
to neck 41. If desired, wall member 43 can include a depending
skirt 44 that is fused or otherwise bonded to neck 41.
This transverse wall 43 has an openable portion for gaining access
to its sterile liquid contents. The openable portion can be a
puncturable diaphragm 45, adapted to be broken by a pointed spike
of a sterile intravenous administration set. Internally the
puncturable diaphragm 45 is a tubular gripping member (not shown)
for hermetically sealing against such a spike. A puncturable
resealable rubber diaphragm 45 for adding additional medicaments
can be secured to the wall member 43.
Fitting over the inner closure of the second embodiment of FIG. 6
is an outer cap 48. This cap includes a skirt with left-handed
threads 49 and a frangible brim 50 that is bonded to flange 42 of
the bottle. The outer cap structure is similar to the outer cap in
the first embodiment of FIG. 3. There is also a threaded jacking
ring 51 with internal left-handed threads 52 as in the first
embodiment.
FIGS. 7 to 10 show the method of opening the double closure system
of this invention. In these figures, the first embodiment is shown.
In FIG. 7 the first step is to rotate the annular jacking ring 16
counterclockwise to tighten it down against the frangible brim 14
that has been bonded to flange 15. Usually the jacking ring is
closely spaced to frangible brim 14 so the downward motion is
imperceptible to the nurse or physician. To them, they are simply
unscrewing the cap in a normal manner.
In FIG. 8 continued counterclockwise movement of the jacking ring
16 causes a strain at the frangible brim. This fractures the
frangible brim at an annular fracture line. When this happens, the
combined jacking ring and outer cap are lifted from the inner cap 9
as shown in FIG. 9. Since the inner cap 9 and outer cap 10 have a
slight space therebetween, rotation of the outer cap does not
loosen the inner cap. In a separate step the inner cap 9 is removed
by a counterclockwise unscrewing motion. Then the container in FIG.
10 is ready for pouring.
The procedure as shown above in FIGS. 7 through 9 is identical for
the second embodiment container. However, with the second
embodiment container the inner cap is not unscrewed. Instead, an
intravenous administration set is connected to the inner cap.
In opening procedures for both of these containers the manual
motions are extremely simple. The nurse or physician is accustomed
to turning a cap by turning it in a counterclockwise direction. The
operator need not be concerned with the inner workings, the
fracturing stresses, etc., that are created by this simple motion.
Thus, this invention creates a closure system that is both easy to
open and provides a separately removable outer cap and an inner cap
that form double sterility protecting closures.
In the two embodiments shown, very good results have been obtained
when the bottle is blow-molded of a polyallomer thermoplastic that
is a propylene-ethylene copolymer, and the outer caps of both
embodiments are injection-molded of the same propylene-ethylene
copolymer material. Such a material is marketed by Eastman Chemical
Company under the name of Tenite. Using the same material for both
the outer cap and the bottle aids in the heat fusion joint at the
frangible brim. The inner cap of the first embodiment, the inner
cap of the second embodiment, and the jacking ring of either
embodiment can be made of suitable thermoplastic material.
In the foregoing specification and drawings specific embodiments
have been used to describe the invention. However, it is understood
by those skilled in the art that certain modifications can be made
to these embodiments without departing from the spirit and scope of
the invention.
* * * * *