CA1046013A - Thermoplastic bottle with controlled lateral collapse and method of dispensing liquid therefrom - Google Patents

Thermoplastic bottle with controlled lateral collapse and method of dispensing liquid therefrom

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Publication number
CA1046013A
CA1046013A CA217,210A CA217210A CA1046013A CA 1046013 A CA1046013 A CA 1046013A CA 217210 A CA217210 A CA 217210A CA 1046013 A CA1046013 A CA 1046013A
Authority
CA
Canada
Prior art keywords
bottle
liquid
base
shoulder
oval
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA217,210A
Other languages
French (fr)
Other versions
CA217210S (en
Inventor
Charles J. Mcphee
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
American Hospital Supply Corp
Original Assignee
American Hospital Supply Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by American Hospital Supply Corp filed Critical American Hospital Supply Corp
Application granted granted Critical
Publication of CA1046013A publication Critical patent/CA1046013A/en
Expired legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00General characteristics or adaptations
    • A61J2200/70Device provided with specific sensor or indicating means
    • A61J2200/76Device provided with specific sensor or indicating means for fluid level
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00Surgery
    • Y10S128/24Medical-surgical bags
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S215/00Bottles and jars
    • Y10S215/03Medical
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S215/00Bottles and jars
    • Y10S215/90Collapsible wall structure

Landscapes

  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

ABSTRACT OF THE DISCLOSURE

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 coop-erate 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 spaced 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.

Description

~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
- 2 - ~

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 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 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 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 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.

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.

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 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".

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 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 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 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 1046~13 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 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 1046~13 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.

Claims (20)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:
1. A liquid administration bottle having a substantially rigid base and a substantially rigid shoulder with a dispensing outlet, at an end opposite the base wherein the improvement comprises:
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.
2. The bottle of claim 1, Wherein the improvement further comprises that the dispensing outlet includes tubular port means defining an inner surface sealingly engagable with the outer surface of a hollow spike of a medical administra-tion set for forming an airtight seal therewith and for placing said bottle and set in flow communication; and a removable bacteria-tight sealing mem-ber secured to said tubular port means.
3. The bottle of claim 2, wherein said liquid is a sterile parenteral solution occupying 50 - 95% of the bottle's uncollapsed volume; said gas above said liquid being sterile air.
4. The bottle of claim 2 wherein said tubular wall of said bottle has portions that contact each other only above the upper surface of of said liquid and substantially below said rigid base of the bottle when said bottle is inverted and gravity drained.
5. The bottle of claim 2 in which said tubular wall is substantially transparent and has volumetric calibrations.
6. The bottle of claim 5 wherein said tubular wall is calibrated from 0 to 1,000 ml; said rigid base and shoulder coacting with said flex-ible 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.
7. The bottle of claim 2 wherein said tubular wall has a thick-ness 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.
8. The bottle of claim 7 in which said tubular wall has generally parallel longitudinally-extending portions at the ends of said major transverse axis.
9. The bottle of claim 7 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.
10. The bottle of claim 2 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.
11. The bottle of claim 2 wherein said base has a thickness between 0.060 and 0.090 inches (1.5 and 2.3 mm) and has an oval shape.
12. The bottle of claim 2 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.
13. The bottle of claim 2 wherein said bottle has a pair of gripping flanges near said shoulder.
14. The bottle of claim 2 wherein said bottle is steam steri-lizable at 240° to 260°F (116° to 127°C) and is of a propylene-ethylene copolymer.
15. 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 setforming the closed system.
16. The system of claim 15 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.
17. 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 administra-tion 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 adminis-tration set is prevented from being completely drained of liquid by gravity during an administration procedure.
18. The system of claim 17 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/cm2) below atmospheric pressure as said bottle is gravity drained.
19. 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 tubular wall of oval cross-sectional shape with a major transverse axis and a minor transverse axis; said 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 in-verted and gravity drained so that said opposed portions of said tubular wall contact each other only above the upper sur-face of said liquid; whereby, said bottly may be gravity drained of substantially all of the liquid therein without inletting any additional gas into said bottle.
20. A "closed" system for administering medical liquid com-prising 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 longitu-dinally upright position on a flat surface during storage; a rigid oval shoulder with a non-air-inletting dispensing outlet therethrough at an op-posite end of the bottle; a laterally flexible side wall integrally connected to the base and shoulder and being oval in 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 becom-ing 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 por-tions 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 the 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.
CA217,210A 1974-02-26 1974-12-31 Thermoplastic bottle with controlled lateral collapse and method of dispensing liquid therefrom Expired CA1046013A (en)

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US445836A US3921630A (en) 1974-02-26 1974-02-26 Thermoplastic bottle with controlled lateral collapse and method of dispensing liquid therefrom

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US (1) US3921630A (en)
JP (1) JPS50118888A (en)
AR (1) AR201642A1 (en)
BE (1) BE825117A (en)
BR (1) BR7500745A (en)
CA (1) CA1046013A (en)
CH (1) CH582093A5 (en)
DE (1) DE2502310A1 (en)
EG (1) EG11580A (en)
ES (1) ES433993A1 (en)
FR (1) FR2261781B1 (en)
GB (1) GB1483553A (en)
IN (1) IN143639B (en)
IT (1) IT1026409B (en)
PH (1) PH11706A (en)
TR (1) TR19086A (en)
ZA (1) ZA7535B (en)

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FR2261781B1 (en) 1981-11-27
AU7706074A (en) 1976-07-01
BE825117A (en) 1975-05-29
DE2502310A1 (en) 1975-08-28
TR19086A (en) 1978-05-01
BR7500745A (en) 1975-12-02
CH582093A5 (en) 1976-11-30
FR2261781A1 (en) 1975-09-19
EG11580A (en) 1977-08-15
US3921630A (en) 1975-11-25
ZA7535B (en) 1976-01-28
IN143639B (en) 1978-01-07
AR201642A1 (en) 1975-03-31
IT1026409B (en) 1978-09-20
JPS50118888A (en) 1975-09-17
ES433993A1 (en) 1976-11-16
PH11706A (en) 1978-05-24
GB1483553A (en) 1977-08-24

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