CA1186284A - Flexible container with integral port and diaphragm - Google Patents

Flexible container with integral port and diaphragm

Info

Publication number
CA1186284A
CA1186284A CA000366710A CA366710A CA1186284A CA 1186284 A CA1186284 A CA 1186284A CA 000366710 A CA000366710 A CA 000366710A CA 366710 A CA366710 A CA 366710A CA 1186284 A CA1186284 A CA 1186284A
Authority
CA
Canada
Prior art keywords
container
diaphragm
tubular
ports
mold
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
CA000366710A
Other languages
French (fr)
Inventor
Mark E. Larkin
Leonard J. Meyer
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.)
Abbott Laboratories
Original Assignee
Abbott Laboratories
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 Abbott Laboratories filed Critical Abbott Laboratories
Application granted granted Critical
Publication of CA1186284A publication Critical patent/CA1186284A/en
Expired legal-status Critical Current

Links

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
    • A61J1/10Bag-type containers

Abstract

FLEXIBLE CONTAINER WITH INTEGRAL PORTS AND DIAPHRAGM
Abstract of the Disclosure A container for liquids, preferably sterile liquids comprises a hollow body constructed of plastic material having a plurality of tubular ports integrally formed and extending therefrom. Each port has a quantity of plastic material integrally formed as a diaphragm with-in the port so as to seal the container. In a preferred embodiment, at least one of the ports has a resealable septum sealed within it. The diaphragm is positioned be-tween the septum and the liquid within the container so as to prevent deterioration of the resealable septum caused by exposure to the liquid. Both the resealable septum and the diaphragm are constructed of a material which is pene-trable by a hypodermic needle for use in administering sterile solutions.

Description

~'he presen~ invention relates yenerally to containers for liquids, and in particular, to containers for liquid medicinal products, such as for example, intravenous solutions such as electrolytic or other solutions, plasma substitute solutions, anticoagulant solutions, blood or plasma and derivatives.
Plastic molded containers have found increasing acceptance in recent years and are used extensively throughout the packaging field due to the fact that they are relatively inexpensive, lighter in weight, durable and resist degradation from the liquids they contain. In the medical field, a particularly wide acceptance has been ! found for flexible containers used for dispensing liquids such as intravenous solutions. A continuing problem exists however in reducing the manufacturing costs of said containers. An additional problems has been the ¦ manufacture of such containers having a number of ports ¦ attached thereto for adding additional liquid to the container such as a medicament, or for filling the contai.ner itself prior to sterilization.
The following U.S. patents and applications are representative of several attempts at solving such problems:
¦ U.S. Patent.No. 3,589,422, granted June 29, 1971 - "Sealed Bag for Liquids" - David Bellamy, Jr.
et al.;
U.S. Patent No. 1,431,871 granted October 10, 1922 - "Bottle and Like Closing Device" - Edward ¦ ]3urnet;
I U.S. Patent No. 3,325,031 granted June 13, 1967 - "Bottles of Flexible Material for Medicinal Products" - J. L. G. Singier;
U.S. Patent No. 3,358,062 granted December 12, 1967 - "Molding Method for Making Sealed Articlas" -Jerome H. Lemelson:
U.S. Patent No. 3,919,374 granted November 11, 1975 - "Method for Blow Molding a Container Having an Auxiliary Component Formed as an Integral Part of It" - Henry Komendowski;
U.S. Patent No. 3,479,421 g.ranted November 18/ 1969 "Method of Molding Hollow Bodies" - Fritz Armbruster et al.;

~, ~
sb/h.

3~

U.S. Patent No. 3,705,931 granted December 12, 1972 "Method for Blow Molding and Compression Molding Thermoplastic Material" - Raymond C. Confer et al.;
U.S. Patent No. 3,742,9g5 granted July 3, 1973 "Blow Molded Article of Thermoplastic Material Having a Threaded Insert Therein" ~ Raymond C.
Confer et al.;
; U.S. Patent ~o. 3,805,986 granted April 23, 1974 - "Containers" - Jean Joseph Gaudin, U.S. Patent No. 3,810,503 granted May 14, 1974 - "Variable Volume Container for Fluids" -Dan Lewis, Jr. et al.;
.S. Patent No. 3,851rO29 granted November 26, 1974 - "Method for Molding and Sealing Thermoplastic Containers" - W. G. Cornett III, et al.;
U.S. Patent No. 3,936,264 granted February 3, 1976 - - "Apparatus for Blow Molding a Container With Breachable Sealing Members" - Walter G.
Cornett III~
U.S. Patent No. 4,049,033 granted September 20, 1977 - "Molded Collapsible Solution Container" -Philip G. Ralston, Jr.
Accordingly, it is an advantage of the present invention to provide a container for liquids which is low cost and easy to manufacture. It is an additional advantage of the invention to provide a contalner for sterile liquids which has a number of tubular ports integrally formed and extending therefrom during the same forming pxocess as the container itself.
An additional problem in this regard has been the injection of liquids through one of the tubular ports.
At -the present time resealable septums are commonly used in such ports. However the liquids within such containers usually have a deleterious effect upon such resealable sb/~

J

septums, which are usually construc-ted of a rubber ma-terial~
Accordin~ly it is an additional advantage of the invention to provide a container for liquids which has a ~iaphracJm integrally Eormed in each tubular poxt so as to separate the liquid contained within the container Erom the resealable septum within the tubular port, thereby preventing deterioration of the septum.
According to the present invention there is provided a container for liquids, the container including a hollow body formed of a plastic material with one or more tubular ports integrally formed from the plastic material of the hollow body and extending outwardly from the hollow body and defining an open orifice at the outer end thereoE.
Each of the ports has a quantity of the plastic material integrally formed as a diaphragm within the port at a distance inwardly from the open orifice and formed from the plastic material of the tubular port so as to seal the port.
At least one of the tubular ports contains a resealable septum member fixedly attached and sealed therein, the diaphragm being positioned between the resealable septum and liquid within the container so as to prevent deterioration of the resealable septum from exposure to the liquid. The resealable septum and the diaphragm are adapted for penetration by a hypodermic needle.
The resealable septum is preferably constructed of a rubber compound and is designed to reseal itself upon removal of the hypodermic needle.
In a disclosed embodiment of the invention, the resealable septum is positioned within the tubular port during formation of the container, so as to provide improved seal characteristics between the septum and the tubular port.
The container is blow-molded in the shape of a flexible bag, particularly adapted for dispensing sterile solutions. In such an embodiment, the bag is formed as a hollow body which is substantially tubular in shape, tapering a-t one end to a hanger portion and having at least one tubular port at a second end. The bag i5 adapted for hanging vertically and dispensing liquid from the container through the tubular port. Along these sama lines the shape of the container and the material selected ef~ectively cause the bag to collapse uniformly from top to bottom sb/p~

upon dispersal of -the liquid from -the container. Thus, the inventlon is particularly well ad~pted for use in sterilizable and sterility maintaining packa~ing. An additional means oE ensurincJ such sterility is the use of an overcap over each tubular port so as to prevent contamination of the port after sterili~ation and before penetration b~ a hypodermic needle.
The invention also comprises a method of manufacturing a flexible plastic container for sterile solutions having at least one tubular por-t integrally formed therein. Conventional blow-molding of a plastic material for sterile solutions comprises the steps of extruding a parison of heated plastic material into a mold having portions shaped as a hollow cavit~ and tubular ports. The parison is then blown into the shape of the mold. The present invention represents an improvement over conventional technology in the additional steps of inserting a pair of diaphra~m pins into the lower portion of the parison for each tub~llar port desired. In a preferred embodiment the diaphragm pins are coaxially aligned, one inside and one outside of the parison~ A
portion of the heated plastic material is squeezed into the portion of the mold shaped as each tubular port. Part of the heated plastic is retained across the opening of that portion of the mold shaped as a tubular port, thus forming a diaphragm isolating the port from the remainder of the container. The material is then cooled sufficiently to retain the shape of the mold, the diaphragm, and each of said ports. The diaphragm pins are then retracted and the container is removed from the mold.
An additional feature of the invention, in a specific embodiment of the invention, is the formation of the previously mentioned ports with resealable septums integrally formed therein. This is accomplished by affixing a septum to each diaphragm pin positioned outside the parison before insertion into the parison. A tubular port and diaphragm are then formed about each resealable septum.
The septum is then released from the diaphragm pin after cooling of the container.

sb/~"~

~-,3 One means of affixin~ the septum to the diaphragm pin is by using a point on the end of the pin which is adapted for punct~ring the septum su~iciently to affix and retain; it during the manufacturing process. This allows simplified, low cost manufacture. An additional feature of the invention is that by formation o the diaphragm in the tubular ports the container may be both blown, f illed and sealed within the mold in a sterile condition, (the sterile condition of the container during formation is caused by the heated condition of the plastic).

Brie Description of The Drawings FIGURE l of the drawings is a front view, par-tially cut-away, of a container for liquids formed as a hollow body having a pair of tubular ports integrally ~ormed and extending therefrom.
FIGURE 2 of the drawings is a front cut-away schematic view showing a prior art method of manufacturing a blow-molded container.
FIGURE. 3 of the drawirlgs is a front cut-away view of a method of manufacture of the container of FIGURE
1 showing in particular adjustable diaphragm pins for the formation of a diaphragm within the container.
FIGURE 4 of the drawings is a side cut-away view of the methocl of manufacture as shown in FIGURE 3.

Detailed Description of a Preferred Embodiment Whi.le this invention is susceptible of embodiment in many different forms, there is shown in the drawings and will ilerein be described in detail, several specific embodi-ments, with the understanding that the embodiments illu-strated are an exemplification o the principles of theinventionr and are not intended to limit the invention to the embodiments illustrated.
Container 10 for liquid 11 comprises a hollow body 12 formed of plastic material such as nolyethylene, polypropylene, polyvinylchloride or other commonly ~;nown plastics. Hollow body 12 has tubular ports 13 and 14 integrally formed and exten(1ing therefrom. Formed within tubular ports 13 and 14 are diaphragms 15 and 16 which seal ports 13 and 14 from hollow body 12 and correspondin~-ly seal liquid 11 from the atmosphere.
In a preferred embodiment tuhular ports 13 and 14 contain resealable septums 17 and 1~ which are ~ixably attached and sealed therein. Septurns 17 and 18 are ~ormed preferably o~ butyl rubber, silicone rubber, or other com-monly known elastomers. Diaphragms 15 and 16 a~e posi tioned between septums 17 and 18 and liquid 11 so as to prevent deterioration of septums 17 and 1~ from exposure to liquid 11. Septums 17 and 18 as well as diaphragms 15 and 16 are adapted for penetration by a hypodermic needle (not shown). In additional septums 17 and 18 are adapted to reseal themselves upon withdrawal of the hypodermic needle. In a preferred embodiment resealable septums 17 and 18 are positioned within tubular ports 13 and 14 dur-ing the formation of container 10 so as to provide improved sealing characteristics between septums 17 and 18 and tubu-lar ports 13 and 14. Thus, in a preferred embodiment con-tainer 10 is both sterilizable and sterility maintaining in order to contain sterile solutions. Along these same ; lines, in a preferred embodiment container 10 includes overcaps 19 and 20 affixed to tubular ports 13 and 14.
Overcap 19 is designed to cover orifice 21 of tubular port 13. Similarly, overcap 20 is desi~ned to cover orifice 22 of tubular port 14. One means for retaining overcaps 19 and 20 on tubular ports 13 and 14 is through the use of flanges 23 and 24 formed respectively on tubular ports 13 and 14. Overcaps 19 and 20 are formed of flexible thermo-plastic materials so as to snap over flanges 23 and 24 and thereby be retained on tubular ports 13 and 14. Thus attached overcaps 19 and 20 are sterility maintaining, but may be removed before insertion of a hypodermic needle by means of tabs 19A and 20A.
In a preferred embo~iment container 10 and hol-low body 12 are formed in a substantially tublJlar shape tapering to a hanger 25 at end 26. Tubular ports 13 and 14 are formed at end 27. As a result when container 10 is tlUn9 with hanger 25 in the uppermost position ports 13 and 14 below liquid 11 may be dispensed by ~ravity feed. In addition, hollow body 12 is constructed of material suE-ficiently elastic and is shaped so as to uniformly col~
lapse Erom hanger portion 25 downward. In order to ac-complish this, in a preferred embodiment, container 10 comprises a blow~molded bag constructed of such materials as plasticized polyvinylchloride polymers.
The invention also includes a method of manu-10 facturing flexible container 10.
As shown in FIGURE 2 of the drawings one con-ventional method of manufacturing a blow-~olded plastic container 100 comprises the steps of extruding a parison 101 of heated plastic material into a mold 102, blowing 15 the parison 101 into the shape of the mold 102 utilizing a blow pipe 103, cooling container l00 and removing it from mold 102. Also known in the art is the for~ation oE
tubular ports (not shown) extending from container 100.
Additionally taught in the prior art, as seen in U.S.
20 Patent 3,919,374 is the formation oE a tubular port in a blow-molding process in which a ruh~er plug is intro-duced into the tubular port during the blow-molding pro-cess and the tubular ports are Eorme-3 about the rubber plug .
The present invention represents an improvement over the prior art in that, as seen in FIGU~E 3 of the drawings, after container 10 is extruded as a parison oE
heated plastic material into a mold 102, diaphragm pins 201, 202, 203 and 204 are used for forming diaphragms 15 30 and 16. Pin 201 within container 10 is coaxially aligned to pin 202 outside container 10. Similarly pin 203 is coaxially aligned to pin 204. Pins 201 through 204 are used to squeeze end portion 27 of the plastic material at the bottom oE container 10 into sections 105 and 106 of 35 mold lQ2 which are shaped as tubular ports. A portion of the thermoplastic material is retaine-3 acros, openings 28 and 2~ which lead to tubular ports 13 and 14. This re-tainer3 plastic material forms diaphragms 15 and 16. Con tainer 10 is then cooled so as to retain the shape of forming mold 102. Diaphraa~ pins 201 through 204 are then re~oved from mold 102 and container lO is similarly removed from the mo-ld.
In a preferred embodiment, as seen in FIGt~RES
3 and 4, resealable septu~s 17 and 18 are affixed to diaphragm pins 202 and 204, and tub~lar ports 13 and 1 and diaphragms lS and 16 are then for~ed about reseal-able septums 17 and 18. Septums 17 and l~ are then re-leased from diaphragm pins 202 and 204 after cooling of container 10 and pins 202 and 204 are removed from tubular ports 13 and 14. Container lO is then removed from the mold. As seen in Fig. 3 diaphragm pins 202 and 204 contain points 205 and 206 which are used to affix septums 17 and 18 and retain them on a diaphragm ~ins 202 and 204~ Such lS fixation and insertion allows high speed manufacture of blow-molded containers such as container lO.
As further shown in FIGURE 4 of the drawings container lO may be formed using blow Fin 104 which is adapted either for blowing container lO into shape within the mold or may additionally be adapted for filling con-tainer lO with liquid ll while in the mold. ~low pin 104 ic then removed from container lO and the top portion of container lO is sealed using sealing knives 105 and 106 which seal the top portion 26 of container lO and in a Freferred embodiment also form hanger 25 proximate to to~
portion 26.
The foregoing description and drawings merely ex~lain and illustrate the invention, and the invention is not li~ited thereto, except in so far as the appended claims are so limited as those skilled in the art who have the disclosure before them will be able to ~ake modifica-tions and variations therein without departing from the scope of the invention.

Claims (11)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A container for liquids comprising: a hollow body formed of a plastic material; said hollow body having one or more tubular ports integrally formed from said plastic material of said hollow body and extending outwardly from the hollow body and defining an open orifice at the outer end thereof, each of said ports having a quantity of said plastic material integrally formed as a diaphragm within said port at a distance inwardly from said open orifice and formed from said plastic material of said tubular port so as to seal said port, at least one of said tubular ports containing a resealable septum member fixedly attached and sealed therein, said diaphragm being positioned between said resealable septum and liquid within said container so as to prevent deterioration of said resealable septum from exposure to said liquid; said resealable septum and said diaphragm being adapted for penetration by a hypodermic needle.
2. The invention according to Claim 1 in which said tubular port is formed about said resealable septum so as to provide improved sealability between said septum and said tubular port.
3. The invention according to Claim 1 in which said hollow body is substantially tubular in shape, tapering to a hanger portion at one end and having at least one of said tubular ports at a second end, said hollow body being adapted to substantially uniformly collapse from said hanger portion downward upon dispersal of said liquid from said container.
4. The invention according to Claim 1 in which said container comprises a blow-molded bag.
5. The invention according to Claim 1 in which said container is sterilizable and sterility maintaining.
6. The invention according to Claim 1 further including a plurality of overcap members affixed to and covering said tubular ports so as to prevent contamination of said ports,
7. The invention according to Claim 6 further including tab means attached to said overcap members for facilitating removal of said overcap members from said tubular ports.
8. An improved method of manufacturing a flex-ible plastic container for sterile solutions having a plurality of tubular ports integrally formed and extend-ing therefrom, comprising the steps of:
extruding a parison of heated plastic material into a mold having portions shaped as a hollow cavity and as tubular ports, and blowing said parison into the shape of said mold, the improvement comprising the steps of:
inserting a plurality of pairs of diaphragm pins into the lower portion of said container within said mold; each of said pair of pins being coaxially aligned to each other, one inside and one outside of said parison;
squeezing a portion of said heated plastic material between said pair of pins so as to form a dia-phragm across the opening to said portion of said mold shaped as a tubular port;
cooling said plastic material sufficiently to retain the shape of said mold of said diaphragm and of each of said ports;
removing said diaphragm pins; and removing said container from said mold.
9. The invention according to Claim 8 compris-ing the additional steps of:
filling said container while in said mold with said sterile solution;
heating a pair of oppositely disposed sealing knives proximate the top portion of said container;
compressing said top portion of said container between said sealing knives so as to seal said solution within said container in a sterile condition;
retracting said sealing knives; and removing said sterile container from said mold.
10. The invention according to Claim 8 includ-ing the additional steps of:
affixing a resealable septum to said diaphragm pins;
inserting said diaphragm pins and septum into said mold;
forming said tubular port and diaphragm about said resealable septum;
releasing said resealable septum from said diaphragm pin after said cooling of said container; and removing said diaphragm pin from said tubular port.
11. The invention according to Claim 10 in which said method comprises the additional step of penetrating said resealable septum with a pointed diaphragm pin suf-ficiently to affix and retain said resealable septum on said diaphragm pin.
CA000366710A 1979-12-26 1980-12-12 Flexible container with integral port and diaphragm Expired CA1186284A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US06/106,954 US4313904A (en) 1979-12-26 1979-12-26 Method of manufacturing a flexible container with integral ports and diaphragm
US106,954 1979-12-26

Publications (1)

Publication Number Publication Date
CA1186284A true CA1186284A (en) 1985-04-30

Family

ID=22314112

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000366710A Expired CA1186284A (en) 1979-12-26 1980-12-12 Flexible container with integral port and diaphragm

Country Status (9)

Country Link
US (1) US4313904A (en)
JP (2) JPS56100067A (en)
AU (1) AU547151B2 (en)
CA (1) CA1186284A (en)
DE (1) DE3048670C2 (en)
ES (2) ES8204370A1 (en)
FR (1) FR2472518B1 (en)
GB (1) GB2066210B (en)
IE (1) IE50413B1 (en)

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Also Published As

Publication number Publication date
JPS58216551A (en) 1983-12-16
AU547151B2 (en) 1985-10-10
US4313904A (en) 1982-02-02
ES498117A0 (en) 1982-05-01
FR2472518B1 (en) 1985-12-13
ES271839U (en) 1984-02-01
DE3048670C2 (en) 1985-04-25
JPS56100067A (en) 1981-08-11
AU6541880A (en) 1981-07-02
GB2066210A (en) 1981-07-08
ES271839Y (en) 1984-10-01
IE50413B1 (en) 1986-04-16
GB2066210B (en) 1983-03-02
FR2472518A1 (en) 1981-07-03
DE3048670A1 (en) 1981-09-10
ES8204370A1 (en) 1982-05-01
IE802722L (en) 1981-06-26

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