EP0203099B1 - Elastischer verschluss für eine öffnung - Google Patents

Elastischer verschluss für eine öffnung Download PDF

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Publication number
EP0203099B1
EP0203099B1 EP85905380A EP85905380A EP0203099B1 EP 0203099 B1 EP0203099 B1 EP 0203099B1 EP 85905380 A EP85905380 A EP 85905380A EP 85905380 A EP85905380 A EP 85905380A EP 0203099 B1 EP0203099 B1 EP 0203099B1
Authority
EP
European Patent Office
Prior art keywords
closure
port
assembly
bore
wall
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
EP85905380A
Other languages
English (en)
French (fr)
Other versions
EP0203099A4 (de
EP0203099A1 (de
Inventor
Thomas A. Fowles
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.)
Baxter International Inc
Original Assignee
Baxter International Inc
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 Baxter International Inc filed Critical Baxter International Inc
Publication of EP0203099A1 publication Critical patent/EP0203099A1/de
Publication of EP0203099A4 publication Critical patent/EP0203099A4/de
Application granted granted Critical
Publication of EP0203099B1 publication Critical patent/EP0203099B1/de
Expired legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J2205/00—General identification or selection means
    • A61J2205/20—Colour codes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J2205/00—General identification or selection means
    • A61J2205/70—Audible labels, e.g. for pre-recorded info or messages

Definitions

  • This invention relates to a port and closure assembly.
  • the present invention relates to a port and elastic closure for a medical solution container.
  • elongated ports are utilized to access solutions contained in flexible containers.
  • the term ports includes, without limitation, fitments, valves, and other means for accessing a container.
  • the ports function as injection sites or means for accessing the solution in the flexible container.
  • the ports contain an open end that can receive a needle or other piercing means.
  • these flexible containers may contain parenteral solutions, peritoneal solutions, and the like.
  • An example of such a container is the Viaflex @ collapsible plastic container for parenteral solutions sold by Travenol Laboratories, Inc. of Deer- field, Illinois.
  • Fluids intended for intrabody administration must be sterile at the time of use to avoid the danger of introducing harmful agents into the body. Accordingly, the container must be able to house the solution so that the solution is maintained and extracted under sterile conditions. This requires not only that the container and its contents be in a sterile sealed condition at the time of receipt by the user, but also that no contamination of the contents occur when the container is opened by a physician, nurse, or medical technician prior to use.
  • the problem of maintianing sterility is particularly acute at the port of the container where the fluid is accessed.
  • This invention provides a port and closure assembly for use on flexible containers designed to contain pharmaceutical and other medicinal solutions.
  • the closure is designed to hermetically seal the port and cooperates with the port to produce an audible signal when the closure is removed from the port.
  • the sleeve of the closure is designed to cooperate with a rib circumscribing the port to produce a snap when the closure is removed from the port.
  • Another advantage of the present invention is that it provides an elastic closure that aseptically seals the port.
  • a further advantage of the present invention is that it provides an elastic closure that may be removed by the user with one hand.
  • An additional object of the present invention is to provide an elastic closure that lends itself to mechanical assembly.
  • a still further advantage of the present invention is that the closure includes ribs that aid in the molding process of the closure.
  • US-A-3994412 discloses a port and closure assembly for a solution container comprising a tubular port for providing access to fluid within the container, the port having an elongate bore, an outer wall defining the bore and a piercable wall closing the bore, and an elastic closure sealing the port and comprising an elongate top member, a guide member receivable in the bore and a sleeve member surrounding the guide member and engagable around the outer wall of the port.
  • the present invention is characterised in that the piercable wall is located within the bore, the sleeve member has, in an unstressed condition, an inner circumference less than the outer circumference of the portion of the outer wall with which the sleeve engages, the outer wall has an outwardly projecting rib with which the sleeve engages and the construction is such that an audible snap is produced as the sleeve is released from the rib during removal of the closure, but only if the piercable wall has not been pierced.
  • US-A-3554256 discloses a port having an overmolded closure wherein the closure extends over a rib on the outer wall of the port.
  • FIG. 1 illustrates the closure 10 and port 12 of the present invention.
  • the port 12 extends from a solution container 14 and functions to provide a means of accessing the solution container.
  • the solution container 14 includes an opening 16 which is in fluid communication with a lower tubular bore 18 in the port 12.
  • the port 12 includes a partition wall 20 that divides the lower tubular bore 18 from an upper tubular bore 21.
  • the partition wall 20 In order to access the container 14, and thereby the solution contained therein, the partition wall 20 must be broken or pierced. Typically, a needle or other sharp instrument is utilized to pierce the partition wall 20 and thereby access the fluid contained within the solution container 14.
  • the closure 10 functions to seal the opening 22 in the port 12. This is necessary to ensure that an aseptic environment is present within the upper tubular bore 21. If the upper tubular bore 21 is not maintained as an aseptic environment, when the partition wall 20 is pierced the fluid will be contaminated thereby introducing harmful agents into the patient's body.
  • the closure 10 includes a guide member 24 that is designed to be received within the upper tubular bore 21.
  • the guide member 24 has an outer circumference that is less than the inner circumference of the upper tubular bore 21. Accordingly, when the guide member 24 is received within the upper tubular bore 21 a friction fit is not necessarily created.
  • the closure 10 includes a gripping member 26 that provides an area for the user to grip when it is desired to remove the closure 10 from the port 12.
  • the gripping member 26 is an elongated member that may include a rib 28. Although one rib 28 is shown, a greater or lesser number of such ribs may be located on the gripping member 26. The ribs 28 also function to aid in the molding process.
  • the gripping member 26 includes a tubular bore 30.
  • the tubular bore 30 may extend for substantially the entire length of the closure 10.
  • the tubular bore 30 provides a closure 10 that is difficult to reinsert into the port 12 after it has been removed.
  • a tamper evident closure 10 is provided. This provides a closure 10 that allows the user to be assured that the aseptic environment within the upper tubular bore 21 of the pore 12 has not been violated.
  • the closure 10 includes a sleeve member 32.
  • the sleeve member 32 is designed to cooperate with a rib member 34 located on the outer wall 36 of the tubular port 12.
  • the sleeve member 32 has an inner circumference that is less than the outer circumference of the rib member 34.
  • the sleeve member 32 surrounds the rib member 34. Because of the circumferences of the sleeve member 32 and the rib member 34, a portion 37 of the sleeve member extends outwardly around the rib.
  • the sleeve 32 seals the port 12 the sleeve 32 further includes fingers 38 that extend downwardly from the rib 34.
  • the sleeve member 32 and rib member 34 cooperate to produce an audible signal when the closure 10 is removed from the fitment 12 and the partition wall 20 has not been broken or pierced.
  • the outward portion 37 and fingers 38 cooperate with the rib member 34 to produce a "chinese fingers" effect producing an audible snap when the closure 10 is removed from the port 12 and the partition wall 20 has not been violated.
  • the audible signal provides not only an easy method of determining whether the partition wall 20 has been violated but also produces a positive psychological effect to the user and the patient.
  • the audible signal indicates to the doctor or nurse utilizing the solution container 14, and the patient who is to receive the solution, that the hermetic seal between the closure 10 and the port 12 has just been broken.
  • the sleeve member 32 and rib member 34 cooperate so that the closure 10 may be removed from the port 12 through the use of only one hand.
  • This provides a more readily usable closure 10 in that typically the nurse or doctor is only able to utilize one hand to remove the closure.
  • the closure 10 is also user evident and does not require detail instructions.
  • the closure 10 is constructed from an ethylene propylene rubber.
  • the ethylene propylene rubber provides a closure 10 that has properties similar to closures constructed from natural rubber.
  • the preferred ethylene propylene rubber is EPDM.
  • the closure 10 may be color coded. To expedite the identification of the solution contained in the solution container 14, the closure 10 may be colored red, green, blue or other color that identifies to the user the solution in the container.
  • the closure 10 is compression molded, and the port 12 is injection molded. After the parts are molded, the closure 10 is fitted into the port 12. The closure 10 and port 12 assembly may then be steam sterilized. It is also possible to sterilize the closure 10 and the port 12 through bulk radiation sterilization and other methods known in the art.
  • the closure 10 provides a closure and port assembly that lends itself to mechanical assembly easily. To this end, the closure 10 provides a solid, nontacky surface that cooperates well with fitment attaching apparatus of packaging machines.
  • An example of such an apparatus is the heat seal press head that utilizes a walking beam in a form, fill, and seal packaging apparatus.

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)
  • Closures For Containers (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Claims (9)

1. Eine Öffnungs- und Schließanordnung für einen Lösungsbehälter mit einem rohrförmigen Öffnungsdurchgang (12) für den Zugang zu der Flüssigkeit innerhalb des Behälters, wobei der Öffnungsdurchgang eine langgestreckte Bohrung (18, 21), eine äußere, die Bohrung definierende Wand und eine aufbrechbare, die Bohrung verschließende Wand (20) umfaßt, und mit einem elastischen Verschluß (10), der zur Abdichtung des Öffnungsdurchgangs dient und der ein langgestrecktes Kopfteil (26), ein in die Bohrung (18, 21) einführbares Führungsteil und ein Hülsenteil (32) aufweist, welches sich um das Führungsteil herumerstreckt und eng an der äußeren Wand der Durchgangsöffnung anliegt, dadurch gekennzeichnet, daß die aufbrechbare Wand innerhalb der Bohrung liegt, daß das Hülsenteil (32) in spannungsfreiem Zustand einen Innenumfang aufweist, der kleiner ist als der Außenumfang des Abschnitts (36) der äußeren Wand, an der die Hülse anliegt, und daß die äußere Wand eine nach außen vorspringende Rippe (34) aufweist, mit welcher die Hülse zusammenwirkt und deren Konstruktion so ist, daß ein hörbares Schnappen erzeugt wird, wenn die Hülse bei der Entfernung des Verschlusses (10) von der Rippe freikommt, jedoch nur dann, wenn die aufbrechbare Wand (20) noch nicht aufgebrochen ist.
2. Anordnung nach Anspruch 1, wobei das Führungsteil in spannungsfreiem Zustand einen Außenumfang aufweist, der kleiner ist als der Innenumfang der rohrförmigen Durchgangsöffnung.
3. Anordnung nach Anspruch 1 oder 2, wobei das Führungsteil eine größere Länge besitzt als das Hülsenteil.
4. Anordnung nach einem der vorangehenden Ansprüche, wobei das langgestreckte Kopfteil eine innere Bohrung (30) umfaßt.
5. Anordnung nach einem der vorangehenden Ansprüche, wobei das langgestreckte Kopfteil mindestens ein Griffelement (28) aufweist.
6. Anordnung nach Anspruch 5, wobei das Griffelement eine Rippe (28) ist.
7. Anordnung nach einem der vorangehenden Ansprüche, wobei der Verschluß aus einem Ethylen-Propylengummi hergestellt ist.
8. Anordnung nach Anspruch 7, wobei der Verschluß aus EPDM-Gummi hergestellt ist.
9. Anordnung nach einem der vorangehenden Ansprüche, wobei der Verschluß farbcodiert ist.
EP85905380A 1984-11-13 1985-10-29 Elastischer verschluss für eine öffnung Expired EP0203099B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US67085284A 1984-11-13 1984-11-13
US670852 1984-11-13

Publications (3)

Publication Number Publication Date
EP0203099A1 EP0203099A1 (de) 1986-12-03
EP0203099A4 EP0203099A4 (de) 1987-09-21
EP0203099B1 true EP0203099B1 (de) 1989-06-14

Family

ID=24692156

Family Applications (1)

Application Number Title Priority Date Filing Date
EP85905380A Expired EP0203099B1 (de) 1984-11-13 1985-10-29 Elastischer verschluss für eine öffnung

Country Status (6)

Country Link
EP (1) EP0203099B1 (de)
JP (1) JPS62500704A (de)
CA (1) CA1292442C (de)
DE (1) DE3571017D1 (de)
WO (1) WO1986002907A1 (de)
ZA (1) ZA858569B (de)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4779997A (en) * 1987-04-27 1988-10-25 Baxter Travenol Laboratories, Inc. Closure for a port and closure assembly
US4903855A (en) * 1988-11-25 1990-02-27 Baxter International Inc. Closure and port assembly
US4892222A (en) * 1988-11-25 1990-01-09 Baxter International Inc. Port assembly for a container
NO891734L (no) * 1989-04-26 1990-10-29 Ken Heimreid Anordning ved lukke for beholdere for eventuelt infisertevaesker.
US20020104817A1 (en) * 2000-03-09 2002-08-08 Lasaitis Con A. Pull cap for a port of an administration assembly
DE102004027743A1 (de) * 2004-06-07 2006-01-05 Fresenius Medical Care Deutschland Gmbh Kappe, insbesondere Desinfektionskappe, Detektionsvorrichtung für die Peritonealdialyse, Beutelset für die Peritonealdialyse und dessen Verwendung
US20090105684A1 (en) 2007-10-23 2009-04-23 Baxter International Inc. Medication port for medical fluid container
EP2881642B2 (de) * 2013-12-04 2024-05-22 Schaeffler Technologies AG & Co. KG Schutzkappe

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3554256A (en) * 1968-11-08 1971-01-12 Dave Champman Goldsmith & Yama Flexible intravenous container
FR2245539A1 (en) * 1973-09-28 1975-04-25 Crinospital Spa Safety stopper for sterile solution bottles - consists of tube inserted into neck of bottle and annular section cap

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2907489A (en) * 1956-10-17 1959-10-06 American Flange & Mfg Disposable vent plug
US3105613A (en) * 1960-05-09 1963-10-01 Baxter Don Inc Blood container
JPS4910155U (de) * 1972-04-25 1974-01-28
US3994412A (en) * 1976-03-11 1976-11-30 Abbott Laboratories Tamperproof breakaway port
US4046276A (en) * 1976-07-14 1977-09-06 Baxter Travenol Laboratories, Inc. Port protector cap for a container
US4303067A (en) * 1980-01-21 1981-12-01 American Hospital Supply Corporation Medical liquid bag having an improved additive port
US4484916A (en) * 1982-01-20 1984-11-27 American Hospital Supply Corporation Medical solution container and port construction

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3554256A (en) * 1968-11-08 1971-01-12 Dave Champman Goldsmith & Yama Flexible intravenous container
FR2245539A1 (en) * 1973-09-28 1975-04-25 Crinospital Spa Safety stopper for sterile solution bottles - consists of tube inserted into neck of bottle and annular section cap

Also Published As

Publication number Publication date
CA1292442C (en) 1991-11-26
WO1986002907A1 (en) 1986-05-22
JPH0554790B2 (de) 1993-08-13
EP0203099A4 (de) 1987-09-21
JPS62500704A (ja) 1987-03-26
ZA858569B (en) 1986-06-25
EP0203099A1 (de) 1986-12-03
DE3571017D1 (en) 1989-07-20

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