U.S. patent number 3,921,630 [Application Number 05/445,836] was granted by the patent office on 1975-11-25 for thermoplastic bottle with controlled lateral collapse and method of dispensing liquid therefrom.
This patent grant is currently assigned to American Hospital Supply Corporation. Invention is credited to Charles J. McPhee.
United States Patent |
3,921,630 |
McPhee |
November 25, 1975 |
Thermoplastic bottle with controlled lateral collapse and method of
dispensing liquid therefrom
Abstract
A collapsible oval thermoplastic bottle that accurately measures
the volume of sterile medical liquid dispensed without inletting
air into the bottle. The bottle contains a sterile liquid and a
constant mass of sterile gas above the liquid. A rigid oval base
and a rigid oval shoulder of the bottle cooperate with a flexible
oval side wall of the bottle to "control the lateral collapse" of
the bottle. This "controlled collapse" redistributes the constant
mass of gas within the bottle to maintain portions of the side wall
at the liquid level in space relationship for accurate volumetric
readings against calibrations on the bottle. A 1 liter collapsible
bottle has an accuracy of .+-.30 ml., which accuracy is equivalent
to that of a rigid glass bottle of the same size.
Inventors: |
McPhee; Charles J. (Sylmar,
CA) |
Assignee: |
American Hospital Supply
Corporation (Evanston, IL)
|
Family
ID: |
23770378 |
Appl.
No.: |
05/445,836 |
Filed: |
February 26, 1974 |
Current U.S.
Class: |
604/530; 215/231;
222/107; 604/257; 128/DIG.24; 604/251; 215/373; 215/900; 215/399;
215/DIG.3; 215/382 |
Current CPC
Class: |
A61J
1/05 (20130101); Y10S 215/90 (20130101); Y10S
128/24 (20130101); Y10S 215/03 (20130101); A61J
2200/76 (20130101) |
Current International
Class: |
A61J
1/00 (20060101); A61M 005/14 () |
Field of
Search: |
;128/214R,214D,214.2,272,DIG.24 ;222/92,107 ;53/22
;215/1C,1A,231 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Dawson, Tilton, Fallon &
Lungmus
Claims
I claim:
1. A "closed" system for administering medical liquid comprising
the combination of a substantially transparent thermoplastic bottle
with "controlled lateral collapse" for accurately measuring the
volume of liquid dispensed without inletting air into the bottle,
which bottle includes a rigid oval base adapted to support the
bottle in a longitudinally upright position on a flat surface
during storage; a rigid oval shoulder with a non-air-inletting
dispensing outlet therethrough at an opposite end of the bottle; a
laterally flexible generally oval side wall integrally connected to
the base and shoulder and having a cross-section with a transverse
major axis and transverse minor axis, said transverse major axis
remaining generally constant in length at various locations along
the bottle's length, and said transverse minor axis becoming
progressively shorter as the minor axis proceeds from the oval
shoulder to the oval base along the bottle's length; volumetric
calibrations on the side wall; a sterile medical liquid initially
filling the bottle between 50 and 95% of its internal capacity, and
sterile air occupying the remaining portion of the internal
capacity of the bottle immediately prior to dispensing from the
bottle to provide a level upper surface of the liquid for measuring
against the calibration; said bottle having opposed portions of the
side wall that progressively deflect inwardly along its minor axis
toward each other as liquid is drained by gravity from the outlet,
which side wall portions are maintained at spaced relationships
until the liquid's upper surface has descended below said side wall
portions for accurate measurement of the liquid's upper surface
against the calibrations; said rigid oval base having a centrally
located recess therein; a hinged thermoplastic hanger integrally
formed with the bottle and foldably retained within this recess
during storage; a series of protruding feet on the rigid oval base
for supporting the bottle on a flat surface during storage; said
thermoplastic bottle having a medication additive port closed off
by a puncturable resealable rubber diaphragm; a tubular adapter
connected to the bottle and surrounding the dispensing outlet; a
puncturable diaphragm closing off the tubular adapter; a tubular
spike of an administration set wedgingly secured in the tubular
adapter; a flexible conduit connected to the spike at one end and
extending to a lower dispensing end of the conduit; and an enlarged
drip chamber connected in series with the administration set.
2. A method of administering to a patient medical liquid that has a
visible upper surface and occupies between 50 and 95% of the
internal capacity of a volumetrically calibrated substantially
transparent thermoplastic bottle, the remaining volume of said
bottle above said surface being occupied by sterile gas, said
bottle having a rigid oval base, a rigid oval shoulder defining an
outlet, and a flexible oval side wall connected between the base
and shoulder, which side wall has a major axis and a minor axis,
said method including the steps of
supporting the bottle in an outlet downward position; collapsing
the oval side wall inwardly along the minor axis as liquid is
gravity drained without inletting air into the bottle; contacting
opposed portions of the oval side wall at ends of its minor axis
above the visible upper surface of the liquid in the bottle when
the bottle is hung in its outlet downward position; and
progressively flattening the bottle by increasing the longitudinal
length of contact between the opposed sections of the side wall
above the descending upper surface of the liquid in the bottle
until the volume of the partially collapsed bottle is equal to or
less than the original space above said liquid prior to said
collapsing step whereby substantially all the liquid can be
dispensed without inletting air into the bottle, and with an
accurate volumetric reading of the liquid's visible upper surface
from the bottle's calibrations.
3. The method of claim 2, where the method also includes connecting
the dispensing outlet to a tubular administration set to form a
closed system of the bottle and administration set.
4. The method of claim 3, wherein the thermoplastic bottle is of 1
liter size and calibrated between 0 and 1000 ml. and the collapse
is carried out to provide a volumetric accuracy in a closed system
of .+-.30 ml.
5. the method as set forth in claim 2, wherein the bottle's side
walls are sufficiently deformed by the inward flexure so that after
dispensing its liquid contents and air is allowed to enter the
bottle, the bottle does not return to its original shape, and
thereby occupies less space than originally for convenient
disposal.
6. A liquid administration bottle having a substantially rigid base
at one end thereof and a substantially rigid shoulder with a
dispensing outlet at the other end thereof, wherein the improvement
comprises
said dispensing outlet including tubular port means defining an
inner surface sealingly engagable with the outer surface of a
hollow spike of a medical administration set for forming an
airtight seal therewith and for placing said bottle and set in flow
communication; a removable bacteria-tight sealing member secured to
said tubular port means; said bottle having a tubular wall
extending longitudinally between said base and shoulder, which wall
has longitudinally 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, which liquid has an
upper surface, and an amount of sterile gas above said liquid,
which has has a volume at dispensing pressures and temperatures
that is equal to or greater than said reduced volume capacity of
said bottle, whereby, substantially all of the liquid may be
drained from the inverted bottle under the influence of gravity
without inletting any additional gas into the bottle.
7. The bottle of claim 6 wherein said liquid is a sterile
parenteral solution occupying 50 to 95% of the bottle's uncollapsed
volume; said gas above said liquid being sterile air.
8. The bottle of claim 6 wherein said tubular wall of said bottle
has portions that contact each other only above the upper surface
of said liquid and substantially below said rigid base of the
bottle when said bottle is inverted and gravity drained.
9. The bottle of claim 6 in which said tubular wall is
substantially transparent and has volumetric calibrations.
10. The bottle of claim 9 wherein said tubular wall is calibrated
from 0 to 1,000 ml; said rigid base and shoulder coacting with said
flexible tubular wall to control the collapse of said bottle from
its uncollapsed condition to said partially collapsed condition to
provide a calibration accuracy within .+-. 30 ml over the 0 to
1,000 ml range.
11. The bottle of claim 6 wherein said tubular wall has a thickness
between 0.010 and 0.035 inches (0.25 and 0.94 mm) and has an oval
cross-sectional shape with a major transverse axis substantially
greater than the minor transverse axis thereof.
12. The bottle of claim 11 in which said tubular wall has generally
parallel longitudinally-extending portions at the ends of said
major transverse axis.
13. The bottle of claim 11 wherein said tubular wall has
longitudinally-extending portions at the ends of its minor
transverse axis that converge in a direction from said shoulder
towards said base.
14. The bottle of claim 6 wherein said shoulder has a thickness
between 0.040 and 0.060 inches (1.0 and 1.5 mm), has an oval shape,
and has portions that slope towards the bottle's base.
15. The bottle of claim 6 wherein said base has a thickness between
0.060 and 0.090 inches (1.5 and 2.3 mm) and has an oval shape.
16. The bottle of claim 6 wherein said bottle has a pair of flex
ribs, each with a thickness between 0.008 and 0.015 inches (0.21
and 0.40 mm), near said base.
17. The bottle of claim 6 wherein said bottle has a pair of
gripping flanges near said shoulder.
18. The bottle of claim 6 wherein said bottle is steam sterilizable
at 240.degree. to 260.degree.F (116.degree. to 127.degree.C) and is
of a propylene-ethylene copolymer.
19. A closed system for administering liquid which includes a
bottle having a substantially rigid base and a substantially rigid
shoulder with a dispensing outlet, wherein the improvement
comprises
said bottle having a tubular wall extending longitudinally between
said base and said shoulder; said wall having longitudinal columnar
rigidity for supporting the bottle upright on its base and having
limited lateral flexibility permitting partial, but not total,
collapse of the bottle to a reduced volume capacity; said bottle
containing a measured amount of liquid having an upper surface
intermediate the base and shoulder and also containing above said
surface an amount of sterile gas having a volume at dispensing
pressures and temperatures that is equal to or greater than said
reduced volume capacity of said bottle, whereby, substantially all
of said liquid can drain by gravity from said bottle when the same
is inverted without inletting any additional gas into said bottle;
and a tubular administration set connected to said outlet, with
said combined bottle and administration set forming the closed
system.
20. The system of claim 19 wherein the administration set has a
lower dispensing end that is 7 to 72 inches (17.9 to 183 cm) below
said upper surface of said liquid in said bottle during gravity
dispensing of said liquid.
21. A closed system for administering liquid which includes a
bottle having a substantially rigid base and a substantially rigid
shoulder with a dispensing outlet, wherein the improvement
comprises
said bottle having a tubular wall extending longitudinally between
said base and said shoulder; said wall having longitudinal columnar
rigidity for supporting the bottle upright on its base and having
limited lateral flexibility permitting partial, but not total,
collapse of the bottle to a reduced volume capacity; said bottle
containing a measured amount of liquid having an upper surface
intermediate the base and shoulder and also containing above said
surface an amount of sterile gas having a volume at dispensing
pressures and temperatures that is equal to or greater than said
reduced volume capacity of said bottle, whereby, substantially all
of said liquid can drain by gravity from said bottle when the same
is inverted without inletting any additional gas into said bottle;
and a tubular administration set connected to said outlet, with
said combined bottle and administration set forming the closed
system; said gas having a volume at dispensing pressures and
temperatures less than the total of the volume of said
administration set plus said reduced volume capacity of said
bottle, whereby, said administration set is prevented from being
completely drained of liquid by gravity during an administration
procedure.
22. The system of claim 21 wherein said limited lateral flexibility
of said tubular wall and said rigidity of said base and shoulder,
by permitting only partial collapse of said bottle, produce in
combination with said liquid a slight negative pressure within said
bottle within the range of 0.2 to 2.0 psi (0.014 to 0.14
kg/cm.sup.2) below atmospheric pressure as said bottle is gravity
drained.
23. A liquid administration bottle having a substantially rigid
base and a substantially rigid shoulder with a dispensing outlet,
wherein the improvement comprises
a generally transparent volumetrically calibrated oval tubular wall
with a major transverse axis and a minor transverse axis; said oval
wall extending longitudinally between said base and shoulder and
having longitudinal columnar rigidity for supporting the bottle
upright on its base; said wall also having limited lateral
flexibility along its minor axis permitting partial, but not total,
collapse of the bottle to a reduced volume capacity, with opposed
portions of the tubular wall contacting each other; said bottle
containing a measured amount of liquid occupying 50 to 95% of the
bottle's uncollapsed volume; said liquid having an upper surface
and a sterile gas occupying the remaining volume of the bottle
above said surface; said gas having a volume at dispensing
pressures and temperatures that is equal to or greater than said
reduced volume capacity of said bottle; said rigidity and oval
configurations of said base, shoulder, and tubular wall, combined
with the proportions of liquid and gas in said bottle, controlling
the collapse of the bottle when the same is inverted and gravity
drained so that said opposed portions of said tubular wall contact
each other only above the upper surface of said liquid; whereby,
said bottle may be gravity drained of substantially all of the
liquid therein without inletting any additional gas into said
bottle.
24. A medical liquid administration bottle having a substantially
rigid base at one end thereof and a substantially rigid shoulder
with a dispensing outlet at the other end thereof, wherein the
improvement comprises
said dispensing outlet including tubular port means defining an
inner surface sealingly engagable with the outer surface of a
hollow spike of a medical administration set for forming an
air-tight seal therewith and for placing said bottle and set in
flow communication; a substantially transparent body extending
longitudinally between said base and shoulder; said outlet in said
shoulder being capable of dispensing liquid from said bottle under
the influence of gravity, without the concurrent entry of air, when
the bottle is supported and drained in inverted position; said
bottle being filled completely with a sterile gas and an infusable
sterile liquid, which liquid has an upper surface visible through
said transparent body; said body having opposite wall portions is
filled and capable of flexing inwardly to engage each other at a
point of initial contact intermediate said base and shoulder as
said bottle is inverted and drained; the volume of gas in said
bottle exceeding the volume of the space in said bottle between
said base and said point of initial contact when said opposite wall
portions have flexed into engagement; and a graduated scale
extending longitudinally along said body; whereby, the upper
surface of the liquid as it is drained from said bottle is disposed
below the point of initial contact between said opposite wall
portions and may be read directly from the scale through the
substantially transparent body of the bottle; said body having
limited longitudinal columnar rigidity permitting partial, but not
total, collapse of said bottle to a state of reduced volume
capacity; said gas within the uncollapsed bottle having a volume
equal to or greater than said reduced volume capacity, whereby,
substantially all of the bottle's liquid contents can be drained by
gravity without inletting any additional gas into said bottle.
Description
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
volumeric 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 be 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 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 are the
variable teardrop shapes the bags form as they collapse. When the
flexible 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.
SUMMARY 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.
The applicant's bottle is of a thermoplastic material and an oval
base at one end, an oval shoulder with a dispensing outlet at an
opposite end, and a thin flexible oval side wall 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
administration, 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 surface. This
maintains the liquid's upper surface in a level condition and
readily visible for accurately reading against the volumetric
calibrations through its entire descent as the bottle empties. As
the bottle partially collapses to dispense its entire liquid
contents, the sterile air occupies pockets tht form at the base and
shoulder portions of the bottle.
THE DRAWINGS
FIG. 1A is a side elevational view of the flexible bag of the prior
art shown in its storing position;
FIGS. 1B, 1C, and 1D are side elevational views of the prior art
flexible bag showing it suspended for dispensing;
FIG. 2A is a side elevational view of a prior art rigid glass
bottle showing it in storing position;
FIGS. 2B, 2C, and 2D are side elevational views of the rigid glass
bottle of the prior art showing it suspended for dispensing;
FIG. 3A is a side elevational view of the applicant's thermoplastic
bottle in storing position:
FIG. 3B is a side elevational view of applicant's bottle suspended
for dispensing;
FIG. 3C is applicant's bottle with approximately one-half of its
contents dispensed;
FIG. 3D is a side elevational view of applicant's bottle with
approximately three-fourths of its contents dispensed;
FIG. 3E is a side elevational view of applicant's bottle connected
with an administration set forming a "closed system";
FIG. 4 is a front elevational view of a first embodiment of
applicant's bottle as it is supplied to the hospital;
FIG. 5 is a side elevational view of the bottle of FIG. 4;
FIG. 6 is a sectional view taken along line 6--6 of FIG. 4;
FIG. 7 is a sectional view taken along line 7--7 of FIG. 4;
FIG. 8 is a sectional view taken along line 8--8 of FIG. 4;
FIG. 9 is a top plan view of the bottle of FIG. 4;
FIG. 10 is a bottom plan view of the bottle of FIG. 4;
FIG. 11 is a front elevational view of a second embodiment of
applicant's bottle which has a more sloping shoulder configuration
than the first embodiment;
FIG. 12 is a side elevational view of the bottle of FIG. 11;
FIG. 13 is a front elevational view of the bottle of FIG. 11
suspended for dispensing and showing the sloping shoulder
feature;
FIG. 14 is a side elevational view of the bottle of FIG. 4 showing
a pouring container outlet opening;
FIG. 15 is an enlarged sectional view of the bottle of FIG. 12 with
an outlet system for connecting to a parenteral liquid
administration set;
FIG. 16 is an enlarged sectional side elevational view of the
bottle of FIG. 15 showing it suspended from its rigid base and
connected to a parenteral liquid administration set;
FIG. 17 is an enlarged sectional view of the FIG. 16 bottle showing
it with approximately one-half of its contents dispensed;
FIG. 18 is an enlarged sectional view of FIG. 16 bottle showing it
with approximately three-fourths of its contents dispensed;
FIG. 19 is an enlarged fragmentary view of the upper and lower
lefthand corners of the bottle shown in FIG. 16;
FIG. 20 is an enlarged exploded view of a closure system designed
for connection with a parenteral liquid administration set; and
FIG. 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, FIGS. 1A through 1D represent the
prior art of flexible thermoplastic bags used for dispensing either
intravenous solutions or blood. As shown in FIG. 1A, the flexible
bag 1 has a dispensing spout 2 at one end and a base 3 at an
opposite end. One of the main disadvantages of the flexible bag is
that it has no definite shape. The bag is limp and difficult to
handle and will not support itself upright on its own base.
The flexible bag shown in dispensing position in FIGS. 1B through
1D have been used primarily for dispensing blood. With blood, the
bag is normally filled with one pint (approximately one-half 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. For instance, from a 1 liter bottle a physician might
want to administer 350 ml. This is why volumetric accuracy is
extremely important in intravenous solution therapy.
FIG. 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 FIG. 1A, the rigid
glass bottle supports itself upright on its base and retains its
shape. In FIG. 2B the rigid glass bottle is hung from a bail 7, for
dispensing liquid to a patient through a tube 8.
In FIG. 2C, the liquid from bottle 4 is approximately one-third
administered. In FIG. 2D the liquid is nearly two-thirds
administered.
During administration of liquid from the right glass bottle 4 an
air-inletting system 9 replenishes the volume of liquid dispensed
with air. In FIG. 2C this is illustrated by bubbles entering the
interior of the bottle and floating upwardly. In an air-inletting
system as in FIGS. 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 that 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 shortcoming 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 FIG. 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. Integrally connected to this rigid
shoulder and base, and extending therebetween is a thin, flexible,
generally oval side wall 12. In FIG. 3A the bottle maintains its
shape and supports itself upright on rigid base 11. It will support
itself as shown in FIG. 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 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 FIG. 3B is not an air-inletting system as in
FIG. 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 form 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 FIG. 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 continue to deflect inwardly until essentially all of the
liquid is dispensed by gravity from the bottle. As shown in FIG.
3E, the bottle is connected to an an administration set for
dispensing through a "closed system" from the bottle through the
set and to the patient. In FIG. 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 FIG. 3E, the upper surface
of the liquid in the bottle is 7 to 72 inches (17.8 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 0.125 inch (3.3 mm) thick. A 10%
increase or decrease in the wall thickness changes the internal
diameter 0.025 inch (0.67 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 thermoplastic
bottle with an oval wall with a thickness of from 0.010 to 0.035
inch (0.25 to 0.94 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.
FIG. 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 11. 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 my co-pending application entitled "Three Barrier Closure System
for Medical Liquid Container" Ser. No. 445,834, filed Feb. 26,
1974, or a non-vented cap as described in a co-pending application
entitled, "Frangible Closure System for Medical Liquid Container
and Method of Making Same" Ser. No. 338,685, filed Mar. 7, 1973,
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
side. These ribs help strengthen the rigidity of the bottle is this
area and also provide finger grips to keep the bottle from slipping
out of the hand of the nurse or physician.
Volumetric calibrations 30a and 30b are shown in FIGS. 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.
FIGS. 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 FIG. 4. The
oval wall has marginal zones at the left and right sides of FIG. 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 is these figures shows the bottle of FIGS. 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 FIG. 4 the bottle
appears to have parallel sides and in FIG. 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
FIG. 4. The flex ribs do not extend across these columnar support
sections.
In FIG. 9 there is a top plan view of FIG. 4 showing the cap 21 and
flange 20. From this view of the rigid shoulder 10 is shown to be
generally oval in shape.
FIG. 10 is a bottom plan view of the bottle of FIG. 4 which
illustrates the hinged hanger 25 integrally formed with the bottle
and being held within recess 24 that extends along the bottle's
minor axis. Four feet are shown here, but a different number could
be used if desired. Representative feet are indicated at 22 and
23.
FIGS. 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 from the bottle. The shoulder 10 in the first
embodiment is not substantially crowned along the minor axis but is
generally perpendicular to the bottle's longitudinal axis. See
FIGS. 4 and 5. In the second embodiment the bottle shoulder 41
slopes away from the neck at a steep slope of approximately
45.degree. from the longitudinal axis at both its major and minor
axis to give a generally conical shoulder as shown in FIGS. 11 and
12. The purpose for this sloping neck is shown in FIG. 13. When the
bottle of the second embodiment is canted as much as 30.degree.
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 FIG. 12. However, the bottle
of the second embodiment functions in a "controlled collapse" in
the same manner as in the first embodiment. FIG. 13 illustrates the
bottle of the second embodiment used for dispensing intervenous
solution in a "closed system".
FIG. 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 characteristics.
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 embodiment bottle is illustrated in FIG. 14.
Substantially enlarged sectional views of the bottle of the second
embodiment used for administering parenteral liquids in a "closed
system" are shown in FIGS. 15, 16, 17 and 18. In FIG. 15 the outer
cap 21 has been removed to expose two tubular ports 50 and 51. Port
50 is adapted to receive and form 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 perpendicular tubular
port without damaging the foil seal with the other tubular port. At
the bottom end of the container of FIGS. 15 the hinged hanger 44 is
shown tucked into a recess.
When the container of FIG. 15 is supplied to the hospital it has an
upper liquid surface of 54 of liquid 55. It is important that there
is a gas, such as air within the bottle 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. Exceptionally 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 FIGS. 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 of the bottle of
this invention.
In FIG. 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 FIG. 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 FIG. 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 wall portions. This is so
that a level, readable liquid surface 54 is maintained throughout
the entire descent path of the liquid. If 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 (0.014 to 14 Kg/cm.sup.2) 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 21/2%). However, this is not significant because
the bottle can be calibrated to take into account this slight
increase in gas volume within the bottle. Temperatures 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.degree. to 80.degree. F
(18.3.degree. to 26.7.degree. 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 FIG. 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 FIG. 18 the walls will collapse 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 FIGS. 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 of 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. When 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 administration
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 administering 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 the set.
FIG. 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 FIG. 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 of air
pocket 60 as the liquid drains. The flex ribs in a 1 liter bottle
can be from 0.008 to 0.015 inch (0.21 to 0.40 mm) thick. The oval
wall can be from 0.010 to 0.035 inch (0.35 inch (0.25 to 0.94 mm)
thick. Although there is an overlap of thickness ranges the flex
rib will be always have a thinner portion than remaining portions
of the oval wall of a particular bottle. For instance, an oval wall
of 0.012 inch (0.32 mm) might have a flex rib of 0.009 inch (0.23
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 FIG. 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 level 54 below the contact
area of wall portion 58 and 59 (FIG. 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 FIG. 19 is
sufficiently rigid to support the bottle upright on a flat
surface.
Two dispensing outlets for the bottle are shown in FIGS. 20 and 21.
In FIG. 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 cap 42 of FIG. 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
(FIG. 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 could be used for a pouring
container as shown in FIG. 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) manufacturing costs are greatly reduced in
producing these two types of bottles.
The bottle of this invention can be made of a propylene-ethylene
copolymer thermoplastic material. The bottle is blowmolded as a
homogenous unit that includes the rigid base, rigid shoulder and
collapsible oval sidewall. Preferably the rigid shoulder is between
0.040 and 0.060 inch (1.0 to 1.5 mm) thick and the rigid base is
between 0.060 and 0.090 inch (1.5 to 2.3 mm) thick. The flexible
side wall is from 0.010 to 0.35 inch (0.25 to 0.94 mm) thick. When
such bottle is filled with liquid and air and sealed it can then be
steam sterilized at 240.degree. to 260.degree. F (116.degree. to
127.degree. 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.
* * * * *