Note: Descriptions are shown in the official language in which they were submitted.
~0460~3
BACKGROUND
Sterile medical liquid, such as a parenteral solution
or blood, is commonly infused into a patient's vein from a
container hanging above the patient. The sterile liquid flows
by gravity through a tubular administration set connected at
one end to the container and at an opposite end to a venous
needle in the patient.
Sterile parenteral solutions, such as 5% dextrose, normal
saline, etc. are frequently supplied to the hospitals in sealed,
sterilized containers. These containers are basically of two
types --rigid glass bottles, or flexible bags. Such containers
come in various sizes such as 1/4, 1/2, 1 and 2 liters, with
the 1 liter size being the most commonly used for intravenous
therapy. Both types of containers have disadvantages because
of their particular structure.
A volumetrically calibrated glass bottle gives an accurate
volumetric reading of +30 ml. of the actual volume of liquid
in a 1 liter bottle because a rigid glass bottle retains its
shape and maintains an upper surface of the liquid that can
easily read against the calibrations. However, before liquid
can drain from a rigid glass bottle there must be an air-inletting
system into the bottle so air can replace the dispensed liquid.
Typical air inletting systems include an air tube extending
into the bottle or a filtered air vent that bubbles air into
the bottle through its liquid contents. Because of the air
inletting requirements these systems are called "open" systems.
A flexible bag does not require an air-inletting system
because its walls can collapse as liquid is dispensed. Such
a system is called a "closed" system. A "closed" system is
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1046~13
much preferred over an "open" system because there is no requirement for air
tubes, filters, etc.
Despite its advantage as a "closed" system the flexible bag has
other serious disadvantages. First the flexible bag is limp making it
difficult to handle. Also the bag will not effectively support itself
upright on its own base. Another disadvantage with a flexible bag is its
inaccurate volume measurements. A flexible bag has an uncontrolled collapse
and when volumetrically calibrated can give a volumetric reading that
it is in error as much as +200 ml. from the actual volume of liquid in
a 1 liter flexible bag. A factor contributing to these inaccurate
volumetric readings is that the bags are all printed with the same
calibrations but collapse differently. This causes great errors in
volumetric readings from the calibrations.
To summarize, the rigid glass bottle has the disadvantage of
requiring an open-air inletting system to replace a dispensed liquid.
The flexible bag has disadvantages of being limp and difficult to handle,
and also has an uncontrolled collapse which makes for inaccurate volumetric
readings of the dispensed liquid.
S~ RY OF THE INVENTION
In the present invention an improved thermoplastic bottle
has been provided that overcomes the above disadvantages of both the rigid
glass bottle and the flexible bag. The thermoplastic bottle of this
invention has a structure that ~1) supports the bottle upright on its
rigid base, (2) causes a "controlled lateral collapse" of the bottle when
dispensing to give volumetric accuracy equivalent to that of a rigid
glass bottle, and (3) dispenses its entire liquid contents through a
"closed" system, while a gas within the bottle is redistributed throughout
the bottle to occupy pockets that form at upper and lower ends of the
bottle.
Thus the invention provides a liquid administration bottle
6~13
having a substantially rigid base and a substantially rigid shoulder with
a dispensing outlet, at an end opposite the base wherein the improvement
compr:Lses: a tubular wall extending longitudinally between the base and
the shoulder of the bottle which wall has longitudinal columnar rigidity
for supporting the bottle upright on its base and has limited lateral
flexibility permitting partial, but not total, collapse of the bottle when
the same is inverted and gravity drained to a reduced volume capacity;
said bottle containing a measured amount of liquid having an upper surface
and an amount of sterile gas above the liquid, which gas has a volume at
dispensing pressures and temperatures that is equal to or greater than
the reduced volume capacity of the bottle, whereby substantially all of
the liquid may be drained from the inverted bottle without inletting any
additional gas into the bottle.
The preferred bottle is of a thermoplastic material and has
an oval base at one end, an oval shoulder with a dispensing outlet at an
opposite end, and a thin flexible side wall of oval cross-sectional shape
extending between the base and shoulder. This thin flexible oval side wall
extending between the base and shoulder has a major axis and a minor axis.
The base and shoulder are substantially more rigid than the flexible side
wall and the bottle can be suspended from its rigid base without collapse
of this base. Inside the bottle is a sterile liquid occupying 50~ to 95
of the bottle's volume with a sterile air space above the liquid. When
the thermoplastic bottle is hung from its rigid base with its outlet
downward as in intravenous aa~instration, liquid draining by gravity
causes the thin flexible oval side wall to deflect inwardly along its
minor axis. The rigid oval shoulder and base prevent opposed portions
of the side wall from contacting each other at the liquid's upper sur-
face. This maintains the liquid's upper surface in a level condition
and readily visible for accurately reading against the volumetric cali-
~ _ 4 _
1046~)13
brations through its entire descent as the bottle empties. As the bottlepartially collapses to di6pense its entire liquid contents, the sterile
air occupies pockets that form at the base and shoulder portions of the
bottle.
THE DRA~INGS
Figure lA i6 a slde elevational view of the flexible
bag o the prior art shown in its 6toring position;
~ -4a-
104~;~13
1 Figures lB, lC, and lD are side elevational views of
the prior art flexible bag showing it suspended for dispensing;
Figure 2A is a side elevational view of a prior art
rigid glass bottle showing it in storing position;
Figures 2B, 2C, and 2D are side elevational views of
the rigid glass bottle of the prior art showing it suspended
for dispensing;
Figure 3A is a side elevational view of the applicant's
thermoplastic bottle in storing position;
Figure 3~ is a side elevational view of applicant's
bottle suspended for dispensing;
Figure 3C is applicant's bottle with approximately 1/2
of its contents dispensed;
Figure 3D is a side elevational view of applicant's
bottle with approximately 3/4 of its contents dispensed;
Figure 3E is a side elevational view of applicant's
bottle connected with an administration set forming a "closed
system";
Figure 4 is a front elevational view of a first embodi-
ment of applicant's bottle as it is supplied to the hospital;
Figure 5 is a side elevational view of the bottle ofFigure 4;
Figure 6 is a sectional view taken along line 6-6 of
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1046~13
1 Figure 4;
Figure 7 is a sectional view taken along line 7-7 of
Pig1lre 4;
Figure 8 is a sectional view taken along line 8-8 of
Figure 4;
Figure 9 is a top plan view of the bottle of Figure
4;
Figure 10 is a bottom plan view of the bottle of Figure
4;
Figure 11 is a ront elevational view of a second embodi-
ment of applicant's bottle which has a more sloping shoulder
configuration than the first embodiment;
Figure 12 is a side elevational view of the bottle of
Figure 11;
Figure 13 is a front elevational view of the bottle
of Figure 11 suspended for dispensing and showing the sloping
shoulder feature;
Figure 14 is a side elevational view of the bottle of
Figure 4 showing a pouring container outlet opening;
Figure 15 is an enlarged sectional view of the bottle
of Figure 12 with an outlet system for connecting to a parenteral
liquid administration set;
1046(~13
1 Figure 16 is an enlarged sectional side elevational
view of the bottle of Figure 15 showing it suspended from its
rigid base and connected to a parenteral liquid administration
seti
Figure 17 is an enlarged sectional view of the Figure
16 bottle showing it with approximately 1/2 of its contents
dispensed;
Figure 18 is an enlarged sectional view of Figure 16
bottle showing it with approximately 3/4 of its contents dispensed;
Figure 19 is an enlarged fragmentary view of the upper
and lower lefthand corners of the bottle shown in Figure 16;
Figure 20 is an enlarged exploded view of a closure
system designed for connection with a parenteral liquid administra-
tion set; and
Figure 21 is an enlarged exploded view of a closure
system for dispensing liquid from the applicant's thermoplastic
bottle by pouring.
DETAILED DESCRIPTION
With reference to these drawings, Figures lA through
lD represent the prior art of flexible thermoplastic bags used
for dispensing either intravenous solutions or blood. As shown
in Figure lA, the flexible bag has a dispensing spout 2 at
one end and a base 3 at an opposite end. One of the main disadvan-
tages of the flexible bag is that it has no definite shape.
The bag is limp and difficult to handle and will not support
- 7 -
- 1046Q13
1 itself upright on its own base.
The flexible bag shown in dispensing position in Figures
lB through lD have been used primarily for dispensing blood.
With blood, the bag is normally filled with one pint (approximately
1/2 liter) and the entire contents of the blood bag dispensed
at one time to a patient. The accuracy of the blood bag's
liquid contents is usually controlled by weighing the blood
bag when collecting blood from a donor. Thus, blood bags do
not need to be accurately calibrated.
With intravenous solutions, such as 5% dextrose, normal
saline, etc., the physician often desires to administer less
than the full contents of the container or to know how much
has been administered. Por instance, rom a 1 liter bottle
a physician might want to administer 350 ml. This is why volume-
teric accuracy is extremely important in intravenous solution
therapy.
Figure 2A shows the second type of prior art medical
liquid container which is a rigid glass bottle. Here, rigid
glass bottle 4 has a dispensing closure system 5 at one end
and a supporting base 6 at an opposite end. Unlike the flexible
bag of Figure lA, the rigid glass bottle supports itself upright
on its base and retains its shape. In Figure 2B the rigid
glass bottle is hung from a bail 7, for dispensing liquid to
a patient through a tube 8.
In Figure 2C, the liquid from bottle 4 is approximately
1/3 administered. In Figure 2D the liquid is nearly 2/3 admin-
istered.
During administration of liquid from the rigid glass
bottle 4 an air-inletting system 9 replenishes the volume of
-- 8
6013
1 liquid dispensed with air. In Figure 2C this is illustrated
by bubbles entering the interior of the bottle and floating
upwardly. In an air-inletting system as in Figures 2B through
2D, extensive and often expensive air inletting systems are
required. It is much preferred to have a "closed" collapsible
system that does not require any air inletting system.
In the past it has been believed than an air-inletting
rigid bottle was required to provide volumetric accuracy of
+30 ml. in a 1 liter bottle. A 1 liter flexible bag might
be as inaccurate as +200 ml. or require tedious impractical
techniques to improve the accuracy.
The shortcomings of the prior art containers are, the
limp handling characteristics and volumetric inaccuracy of
the flexible bag and the air-inletting requirement of a rigid
bottle. These problems are overcome with applicant's "controlled
collapse" bottle. Applicant's thermoplastic bottle shown in
Figure 3A is a blow-molded thermoplastic bottle with a rigid
shoulder 10 at one end and a rigid base 11 at an opposite end.
The rigid shoulder has a dispensing outlet therethrough. Integral-
ly connected to this rigid shoulder and base, and extendingtherebetween is a thin, flexible, generally oval side wall
12. In Figure 3A the bottle maintains its shape and supports
itself upright on rigid base 11. It will support itself as
shown in Figure 3A whether the bottle contains liquid or is
empty.
When applicant's bottle is supplied to a hospital it
contains more than 50% liquid, and the bottle's oval wall is
sufficiently transparent for observation of an upper surface
of liquid within the bottle. Preferably the container has
between 50% and 95% of its total internal capacity filled with
g
1046S~13
1 liquid, and a constant mass of sterile air occupies the remaining
volume. This air phase is large enough to provide a liquid
upper surface 14 for volumetric readings when dispensing begins.
As liquid is dispensed from this "collapsible" bottle it flows
through an administration set 15. Protrusion 16 shown in Figure
3B is not an air-inletting system as in Figure 2C above. Instead,
protrusion 16 has a passage sealed by a puncturable, resealable
resilient rubber pad through which additive medication can
be injected with a hypodermic syringe into the "closed" system
for administering to the patient. As soon as the hypodermic
syringe or other additive device is withdrawn the rubber pad
reseals so that no atmospheric air can enter the bottle.
As liquid is dispensed from the bottle, opposed portions
17 and 18 of the oval wall deflect inwardly. These portions
17 and 18 always remain spaced apart until the upper surface
14 of the liquid has descended below these portions. When
wall portions 17 and 18 do contact, as in Figure 3D, the liquid
level 14 is below such portions and still maintains a level
surface for accurate volumetric measurement against volumetric
calibrations of the bottle. After wall portions 17 and 18
do contact the remaining portions of oval wall 12 containue
to deflect inwardly until essentially all of the liquid is
dispensed by gravity from the bottle. As shown in Figure 3E,
the bottle is connected to an administration set for dispensing
through a "closed system" from the bottle through the set and
to the patient. In Figure 3E an administration set includes
a flexible tube which has a tubular rigid spike at an upper
end and a rigid adapter with a venous needle at a lower end
of the tube. The administration set also includes an enlarged
drip chamber and a roller clamp. When connected as shown in
Figure 3E, the upper surface of the liquid in the bottle is
- 10 -
1046~13
1 7 inches to 72 inches (17.8 cm to 193 cm) above the lower end
of the administration set to establish a liquid head.
A very important feature of applicant's "controlled
collapse" bottle is the extreme accuracy that was unexpectedly
found which can be maintained from one bottle to the next in
the manufacture of these bottles. It has been found that the
volumetric accuracy in a 1 liter bottle with "controlled collapse"
gives a repeatable reading of +30 ml. from one bottle to the
next. This is equivalent to the repeatable volumetric accuracy
of +30 ml. in rigid glass bottles. The reason glass bottles
have this variance in volume accuracy is because of the thickness
of the glass bottle wall which is approximately .125 inch (3.3
mm) thick. A 10% increase or decrease in the wall thickness
changes the internal diameter .025 inch (.67 mm) and it is
the internal dimensions that control the bottle's volumetric
accuracy. During manufacture the glass bottle is internally
expanded by pressure against a mold contacting its outer surface.
There is no mold forming its inner surface and hence the variance.
Also, internal glass bumps or thickened portions that sometimes
are found in a glass bottle affect its volumetric accuracy.
The applicant's bottle is an extremely thin walled thermo-
plastic bottle with an oval wall with a thickness of from .010
inch to .035 inch (.25 mm to .94 mm). A 10% variance in applicant's
wall thickness has a much lesser effect on its internal volume
than the glass bottle above. Numerous bottles have been tested
and show very reliable repeatability in the volumetric accuracy.
This accuracy in applicant's bottle has been within +30 ml.
for a series of 1 liter bottles. In some cases it has been
even more accurate and in the range of +20 ml. readings for
a series of 1 liter bottles.
- 11 -
1046(~13
Figure 4 shows a front elevational view of a first embodiment of
the applicant's bottle which has a generally oval side wall 12 integrally
connected to a rigid shoulder 10 and a rigid base ll. At an upper end of
the bottle is a neck flange 20 to which is secured a removable cap 21. Cap
21 can be either a vented cap as described in U.S. patent 3,904,060 entitled
"Three Barrier Closure System for Medical Liquid Container: granted
9 September 1975, or a non-vented cap as described in U.S. patent 3,923,182
entitled, "Frangible Closure System for Medical Liquid Container and Method
of Making Same: granted 2 December 1975 and invented by Pradip Choksi. At
a lower end of the~bottle is a series of supporting feet represented by
numerals 22 and 23. Also within a recess 24 of the base is a hinged hanger
25 integrally formed with the bottle. At an upper portion of the bottle
is an external rib 26 on one side of the bottle and an external rib 27
on an opposite ~ide. These ribs help strengthen the rigidity of the
bottle in this area and also provide finger grips to keep the bottle from
slipping out the hand of the nurse or physician.
Volumetric calibrations 30a and 30b are shown in Figure 4 and 5
along the wall section of the oval bottle. Calibration 30a is a "fill
mark" for measurement when filling the bottle in its upright position.
If desired, calibration 30a could be replaced with a full scale calibration
along the bottle so the amount of liquid in the less-than-full bottle can
be determined with the bottle upright. Calibrations 30b are for measurement
when the bottle is inverted and liquid is dispensed. It is these
calibrations 30b that are critical for the accurate volume measurement
during dispensing. Located between calibrations 30a and 30b is a
flexible label 28 with the bottle's contents and directions for use.
- 12 -
1046Q13
1 Figures 6, 7 and 8 are cross-sectional views taken through
the bottle's oval wall along lines 6-6, 7-7, and 8-8 of Figure
4. The oval wall has marginal zones at the left and right
sides of Figure 4 that merge at relatively sharp transverse
cross-sectional curvatures predisposing the body for folding
along said zones as the bottle collapses. As shown, the bottle
has a major axis 31 that is approximately twice the length
of minor axis 32. A cross-section of the bottle in these figures
shows the bottle of Figures 4 and 5 to have generally parallel
sides at ends of the major axis 31 but a generally decreasing
length of minor axis 32 from a top portion of the oval side
wall to a bottom portion. Thus, in Figure 4 the bottle appears
to have parallel sides and in Figure 5 the sides converge inwardly
from top to bottom causing the bottle to have a more flattened
oval configuration adjacent its bottom end. Also adjacent
the bottom end of the bottle are opposed thin flex ribs 33
and 34 that extend across ends of the minor axis along only
a portion of the bottle's periphery. Adjacent ends of the
flex ribs 33 and 34 and extending above the flex ribs are columar
support sections of the oval wall that are generally parallel
to the bottle's longitudinal axis and prevent the longitudinal
collapse of the bottle at the flex ribs when the bottle is
sitting upright as in Figure 4. The flex ribs do not extend
across these columnar support sections.
In Figure 9 there is a top plan view of Figure 4 showing
the cap 21 and flange 20. From this view the rigid shoulder
10 is shown ~o be generally oval in shape.
Figure 10 is a bottom plan view of the bottle of Figure
4 which illustrates the hinged hanger 25 integrally formed with the
bottle and being held within recess 24 that extends along the
- 13 -
1046~)13
1 bottle's minor axis. Four feet are shown here, but a different
number could be used if desired. Representative feet are indica-
ted at 22 and 23.
Figures 11 and 12 show respectively a front elevational
view and a side elevational view of a second embodiment of
the bottle. Here the bottle has a generally oval side wall
40 which is connected to a rigid shoulder 41 and a rigid base
42. As in the first embodiment there is a cap 43, a hinged
hanger 44, and supporting feet represented by 45 and 46. The
main difference between the first and second embodiments of
the bottle is in the shoulder structure. In the first embodiment
shoulder 10 is substantially crowned along the major axis to
slope relative to the longitudinal axis as shoulder 10 extends
outwardly rom the bottle. The shoulder 10 in the first embodi-
ment is not substantially crowned along the minor axis but
is generally perpendicular to the bottle's longitudinal axis.
See Figures 4 and 5. In the second embodiment the bottle shoulder
41 slopes away from the neck at a steep slope of approximately
45 from the longitudinal axis at both its major and minor
axis to give a generally conical shoulder as shown in Figures
11 and 12. The purpose for this sloping neck is shown in Figure
13. When the bottle of the second embodiment is canted as
much as 30 from the vertical it will still dispense its entire
liquid content. No liquid is retained in an outer portion
of the shoulder. Also, the bottle of the second embodiment
has a slightly more converging taper along its minor axis as
shown in Figure 12. However, the bottle of the second embodiment
functions in a "controlled collapse" in the same manner as
in the first embodiment. Figure 13 illustrates the bottle
of the second embodiment used for dispensing intravencus solution
in a "closed system".
- 14 -
iO4~:13
1 Figure 14 shows how the bottle designed for a "closed
system" has a structure of its shoulder, base and oval wall
that can be used as a pouring container with a different outlet.
Despite its collapsibility the bottle has very fine handling
ch~lracteristics. When the bottle is used as a pouring container
a threaded screw cap can be provided beneath cap 21. Both
caps would be removed for pouring. While either the first
or second embodiment bottle could be modified at its outlet
structure for use as a pouring container, only the first embodi-
ment bottle is illustrated in Figure 14.
Substantially enlarged sectional views of the bottle
of the second embodiment used for administering paTenteral
liquids in a "closed system" are shown in Figures 15, 16, 17
and 18. In Figure 15 the outer cap 21 has been removed to
expose two tubular ports 50 and 51. Port 50 is adapted to
receive and orm a liquid tight joint with a spike of parenteral
solution administration set. Port 51 has a punctural resealable
rubber diaphragm 52 through which additive medication can be
injected. Sealing off both of these ports is a peelable, metal-
thermoplastic laminate foil that protect their sterility.This foil designated as 53 is peeled off immediately before
use. In the drawings foil 53 is shown with a cut between the
two tubular ports 50 and 51. This structure is preferred because
each portion of the foil can be easily peeled from its perpendicu-
lar tubular port without damaging the foil seal with the other
tubular port. At the bottom end of the container of Figures
15 the hinged hanger 44 is shown tucked into a recess.
When the container of Figure 15 is supplied to the hos-
pital it has an upper liquid surace of 54 of liquid 55. It
is important that there is a gas, such as air within the bottle
- 15 -
l046al3
1 to establish the liquid measuring level. This gas could also
be an inert gas or mixtures of inert gases. Preferably, the
air occupies between 5 and 50% of the container capacity. Excepti-
onally fine results have been obtained in volumetric accuracy
with air occupying approximately 30% of the container's volume
when dispensing begins. This air space can be partially filled
with additive liquid medication injected into tubular port 51
immediately before dispensing, however, there must be a volume
of gas, such as air in the container when dispensing begins.
This air will be redistributed within the container so that
the readings on calibrations shown most clearly in Figures 4
and 11 are accurate. Since air is neither added nor removed
from the container after dispensing begins, there is a constant
mass of air in the container during dispensing and collapse
o~ the bottle of this invention.
In Figure 15 the outer closure 43 has been removed and
foil 53 is ready to be peeled back from tubular outlet 50 for
connecting to an administration set. Such administration set,
shown as 57, has been connected in Figure 16 and the bottle
inverted and hung from its hanger 44 on support 56. At this
point the volumetric reading will indicate that the 1 liter
bottle has 1,000 ml. (~30 ml.).
As liquid is dispensed the liquid surface 54 will descend
and opposed portions 58 and 59 of the oval side wall that lie
along the minor axis will deflect inwardly. See Figure 17.
This occurs as the liquid is dispensed through a closed system.
However, as the side wall portions deflect inwardly the generally
oval rigid base 42 and generally oval rigid shoulder 41 retain
a spaced relationship between wall portions 58 and 59 until
the liquid level 54 has descended below a contact area of these
- 16 -
10~6~13
1 wall portions. This is so that a level, readable liquid surface
54 is maintained throughout the entire descent path of the liquid.
I~ the walls had uncontrolled collapse it would be possible
to have them pinch together below the liquid surface 54 causing
serious volumetric reading errors.
As the liquid is draining from the bottle, the liquid
head causes a slight vacuum to form in the bottle, and this
slight vacuum is 0.2 to 2.0 psi (.014 to 0.14 Kg/cm2) below
the atmospheric pressure outside the bottle, and this causes
the side wall to deflect inwardly. This slight vacuum causes
the gas in the bottle to expand slightly (about 2 1/2%). However,
this is not significant because the bottle can be calibrated
to take into account this slight increase in gas volume within
the bottle, Temperature normally does not affect the volume
of the gas because the temperature inside and outside the bottle
are normally the same when dispensing, ie. room temperature
at 65 F to 80 F (18.3 C to 26.7 C). Prior to dispensing
the bottle has an uncollapsed internal volume; and as liquid
dispenses, the bottle assumes a partially collapsed internal
volume. This partially collapsed volume is from 10% to 80%
of the bottle's uncollapsed volume.
The side wall portions 58 and 59 have come in contact
with each other in Figure 18. However, the liquid level 54
is below this contact area and a pocket formed at the bottle
shoulder is large enough to hold the bottle's remaining liquid
contents. Although wall sections 58 and 59 have contacted each
other they are not totally sealed off. Thus, air pockets 60
and 61 are in communication with each other and can balance
the air mass in the container. As the liquid 55 continues to
drain from the bottle shown in Figure 18 the walls will collapse
- 17 -
1~46~3
1 against each other and the contact area will longitudinally
expand closer to the rigid base 42 and closer to the rigid shoulder
41. When the liquid 55 is completely dispensed the bottle will
have a very flat configuration except for rigid base 42 and
rigid shoulder 41. Applicant's thermoplastic bottle requires
no vacuum for completely emptying. The sequence of draining
as shown through Figures 16, 17 and 18 occurs with a conventional
gravity dispensing administration set. The slight vacuum within
the bottle created by gravity dispensing is opposed by a flexure
resistance of the tubular side wall. When the wall will collapse
no further, this flexure resistance is in equilibrium with the
slight vacuum within the bottle. The volume of gas in the bottle
at this slight vacuum is equal to or exceeds the combined volumes
o the two pockets so that liquid can completely empty from
the bottle.
Once the bottle has emptied, the administration set
can be disconnected, which provides an opening into the bottle.
~hen the administration set is disconnected, the side walls
will remain partially collapsed, and will not return to their
uncollapsed shape. This gives the bottle a shape that is easy
to handle, and occupies less space than the original uncollapsed
bottle when disposing of the bottle.
Another important feature of the invention is that the
gas in the bottle at the vacuum created during gravity dispensing
of the liquid through a "closed system" of the bottle and admin-
istration set has a volume less than the combined internal volume
of the closed system. Thus, the gas volume tends to hold some
liquid in the administration set as a safeguard against adminis-
tering air into a patient. This air volume will even hold liquid
in the set after a venous needle has been removed from such
patient, and there is no longer a venous back pressure into
- 18 -
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1 the set.
Figure 19 shows a greatly enlarged sectional fragmentary
view of the junctures of the flexible oval sidewall with rigid
base 42 and with the rigid shoulder 41. These fragmentary sections
are taken from the upper left-hand area and the lower left-hand
area of Figure 16. The flexible oval side wall indicated as
70 is integrally connected to rigid base 42 through a thin flex
rib 71. This flex rib 71 appears on the external surface of
the bottle as a laterally extending bulged rib adjacent the
indented recess for hanger 44. This thinned rib section 71
protrudes outwardly from collapsible wall 70 and it is thinner
than wall 70. The purpose of flex rib 71, and the like rib on
an opposite side of the bottle, is to aid in flexing wall 70
relative to rigid base 42. This helps to cause additional flex
adjacent to base 42 to diminish the capacity to air pocket 60
as the liquid drains. The flex ribs in a 1 liter bottle can
be from .008 inch to .OlS inch (.21 mm to .40 mm) thick. The
oval wall can be from .010 inch to .035 inch (.25 mm to .94
mm) thick. Although there is an overlap of thickness ranges
the flex rib will always have a thinner portion than remaining
portions of the oval wall of a particular bottle. For instance,
an oval wall of .012 inch (.32 mm) might have a flex rib of
.009 inch (.23 mm) thick. In addition to its thinner wall section,
the arcuate cross-sectional shape of the flex rib also aids
in its increased flexibility.
At a lower section of Figure 19 the rigid shoulder 41
is joined to flexible wall 70 at a juncture 72. There is no
thin flex rib at 72 as there is at 71. This is so the wider
portion of the bottle adjacent to dispensing outlet will remain
open for receiving a substantial quantity of liquid and lower
- 19 -
10461~3
1 level 54 below the contact area of wall portion 58 and 59 (Figure
18). The bottle has a structure which encourages the bottle
to collapse adjacent rigid base 42 and permits the air in the
bottle to be redistributed in the bottle for lowering the upper
surface of the liquid below a contact point of the walls as
liquid is dispensed. Despite this "controlled lateral collapse"
during a gravity liquid drain this laterally flexible bottle
structure shown in Figure 19 is sufficiently rigid to support
the bottle upright on a flat surface.
Two dispensing outlets for the bottle are shown in Figures
20 and 21. In Figure 20 the dispensing outlet includes tubular
ports 50 and 51. Tubular port 51 is closed off by a puncturable
resealable rubber pad 52. A peelable foil 53 is sealed across
the outer end of both of these tubular sections, and the foil
53 is preferably severed between tubular ports 50 and 51 for
convenient independent removal from each tubular section. Fitting
over the tubular ports 51 and 52 is a removable closure 43.
This closure can have a frangible portion 86 that is sealed
to flange 76 of the bottle. The outlet structure beneath outer
2~ cap 42 of Figure 20 is specifically for administering parenteral
solutions through a "closed" system that includes an administration
set.
The same bottle of this invention has sufficient rigidity
for use as a "pouring container". When used as a pouring container
an alternate outlet system is provided on the bottle. Here
the bottle (Figure 21) includes a flange 80 surrounded by a
threading dispensing outlet 81. Fitting over this outlet is
a threaded inner cap 82. There is also an outer cap 83 with
a frangible portion 87 sealed to flange 80 of the bottle. With
this optional closure system the container of applicant's invention
- 20 -
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1 could be used for a pouring container as shown in Figure 14.
By providing a bottle with a common body structure that is usable
both for an intravenous solution bottle and also for a pouring
bottle (depending on the particular outlet structure used) manufac-
turing costs are greatly reduced in producing these two types
~f bottles.
The bottle of this invention can be made of a propylene-
ethylene copolymer thermoplastic material. The bottle is blow-
molded as a homogenous unit that includes the rigid base, rigid
shoulder and collapsible oval sidewall. Preferably the rigid
shoulder is between .040 inch and .060 inch (1.0 mm to 1.5 mm)
thick and the rigid base is between .060 inch and .090 inch
(1.5 mm to 2.3 mm) thick. The flexible side wall is from .010
inch to .035 inch (.25 mm to .94 mm) thick. When such bottle
is filled with liquid and air and sealed it can then be steam
sterilized at 240 P to 260 F (116 C to 127 C)
In the foregoing specification, specific embodiments
have been used to illustrate 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.
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