CA1292442C - Port and elastic closure - Google Patents

Port and elastic closure

Info

Publication number
CA1292442C
CA1292442C CA000495010A CA495010A CA1292442C CA 1292442 C CA1292442 C CA 1292442C CA 000495010 A CA000495010 A CA 000495010A CA 495010 A CA495010 A CA 495010A CA 1292442 C CA1292442 C CA 1292442C
Authority
CA
Canada
Prior art keywords
closure
port
bore
tubular
sleeve
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 - Lifetime
Application number
CA000495010A
Other languages
French (fr)
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
Application granted granted Critical
Publication of CA1292442C publication Critical patent/CA1292442C/en
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • 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
    • A61J2205/00General identification or selection means
    • A61J2205/20Colour codes
    • 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
    • A61J2205/00General identification or selection means
    • A61J2205/70Audible labels, e.g. for pre-recorded info or messages

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)

Abstract

ABSTRACT OF THE DISCLOSURE

A port [12] and closure [10] assembly is provided. The closure [10] includes a sleeve member [32] and the port a rib member [34]. The sleeve member [32] having an inner circumference that is less than the outer circumference of the rib [34]. The port [12] and closure [10] cooperating to produce an audible signal when the closure [10] is removed from the port [12].

Description

~92~
- \

AN IMPROVED PORT AND ELASTIC CLOSURE

BACKGROUND OF THE INVENTION
.

This invention relates to a port and closure assembly. In particular, the present invention relates to a port and elastic closure for a medical solution container.
Typically, elongated ports are utilized to access solutions contained in flexible containers. As used herein, 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. To this end, the ports contain an open end that can receive a needle or other piercing means. In the medical field, these flexible containers may contain parenteral solutions, peritoneal solutions, and the like. An example of such a container is the ~'IAFLEX@ collapsible plastic container for parenteral solutions sold by Travenol Laboratories, Inc. of Deerfield, Illinois.
Fluids intended for intrabody administration must be sterile at the time of use to avoid the danger of introducing harmful ager,ts 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 medica'l technician prior to use. The problem of maintaining sterility is particularly acute at the port of the container where the fluid is accessed.
To guard against contamination a protective port c'losure is utilized with the port. One problem with the prior port closures is that they do not consistently provide an aseptic closure. Accordingly, user confidence with port and closure assemblies is not great.

~2g~29~ ~2 Thus, there is a need ~or an improved closure that overcomes the problems of the prior art.
SUMMARY_OF ~HE INVENTION
This invention provides a port and closure assembly for use on flexible containers designed to contain pharmaceutical and other medicinal solutions.
Tha 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. To this end, the sleeve of the closure is desi~ned to cooperate with a rib circumscribing the port to produce a snap when the closure is removed from the port.
Accordingly, it is an advantage of an aspect of the present invention to provide an elastic closure that produces an audible signal when it is removed from the tubular port and the partition wall of the tubular port is intact.
An advantage o~ an aspect of the present invention is that it provides an elastic closure that aseptically seals the port.
An advantage of an aspect of the present invention is that it provides an elastic closure that may be removed by the user with one hand.
An object of an aspect of the present invention is to provide an elastic closure that lends itself to mechanical assembly.
An advantage of an aspect of the present invention is that the closure includeæ rib~ that aid in the molding process of the closure.
An object of an aspect of the present invention is that it provides an outside wall structure o~ the port and a sleeve structure of the closure that cooperate to produce an audible signal when the closure is removed from the port.
Various aspects of the invention are as follows:
2~

2a A removable elastic closure Eor sealing the end of a tubular port with a partition wall located therein, comprising:
an elongated top member;
a guide member, the top member and guide member defining an inner bore;
a sleeve member surrounding the guide member having in an unstressed condition an inner circumference that is less than the outer circumference of a top portion of the tubular port thereby ~orming a hermetic seal for said port provided said partition wall is intact;
whereby upon removal of said elastic closure from said tubular port said hermetic seal is broken so as to produce an audible signal; and the guide member and inner bore cooperating to provide means for hampering the reinsertion of the elastic closure into the tubular port.

A port and closure assembly for a solution container comprising:
a tubular port for providing access to fluid within the solution container, the tubular port including an elongated bore, an outer wall defining the bore, a rib circumscribing the outer wall, and a partition wall located in the bore;
an elastomeric closure for removably sealing the tubular port, including a yuide member adapted to be received within the bore, and a sleeve for surrounding a portion of the outer wall of the tubular port so as to form a hermetic seal for said bore provided said partition wall is not pierced; and the sleeve having an inner circumference in an unstressed state that is less than the outer circumference of the rib member, the sleeve having fingers that extend below the rib when the closure seals the port, the fingers having an outer circumference that 2b is smaller than the outer circumference of a portion of the sleeve that circumscribes the rib when the closure seals the port, whereby upon removal of said closure from said tubular port said hermetic seal is bro~en so as to produce an audible signal in accordance with a Chinese fingers effect if the partition wall is not pierced.

A port and closure assembly for a solution container comprising:
a tubular port for providing access to fluid within the solution container including, an elongated bore, an outer wall defining the bore, a rib circumscribing the outer wall, and a partition wall for dividing the elongated bore into an upper and lower bore;
an elastomeric closure for removably sealing the tubular port, including a guide member adapted to be received within the upper bore, ~ripping means for grasping the elastomeric closure, and a sleeve for surrounding a portion of the outer wall thereby forming a hermetic seal for said upper bore provided said partition wall is intact, the sleeve having in an unstressed condition an inner circumference that is less than the outer circumference of the rib circumscribing the outer wall of the tubular port;
whereby upon removal of said closure from said tubular port said hermetic seal is broken so as to product an audible signal if the partition wall is intact.

Additional features and advantages are described in, and will be apparent from, the Detailed Description of the Presently Preferred Embodiments and from the drawings.

~2~ ~

BRIEF DESCRIPTION OF THE DRA~ IGS

Figure 1 illustrates a cross-sectional view of a preferred embodiment of the port and elastic closure of the present invention.
Figure 2 illustrates a cross-sectional view of another preferred embodiment of the port and elastic closure of the present invention.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

Figure 1 illustrates the closure 10 and port 12 of the present inven-tion. 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 1~ which is in fluid communication with a lower tubular bore 18 in the port 12. The port 12 includes a par-tition wall 20 that divides the lower tubular bore 18 from an upper tubular bore 21. 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 than 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 patien-ts 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 ~2~ ~

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.
In the preferred embodiment illustrated in Figure 2, the gripping member 26 includes a tubular bore 30. As illustrated, 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. Thus, 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 port 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. To this end, the sleeve member 32 has an inner circumference that is less than the outer circumference of the rib member 34. As illustrated in Figure 1, when the closure 10 seals the port 12, 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. When 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, To this end, the outward portion 37 and fingers 38~
cooperate with the rib member 34 to produce a "chinese fingers"

~z~

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.
Moreover, 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.
Preferably, 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 ~2~2 .

utilizes a walking beam in a form, fill, and seal packaginy apparatus.
It should be understood that various changes and modifications to the preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its attendant advantages. It is therefore intended that such changes and modifications be covered by the appended claims.

Claims (19)

1. A removable elastic closure for sealing the end of a tubular port with a partition wall located therein, comprising:
an elongated top member;
a guide member, the top member and guide member defining an inner bore;
a sleeve member surrounding the guide member having in an unstressed condition an inner circumference that is less than the outer circumference of a top portion of the tubular port thereby forming a hermetic seal for said port provided said partition wall is intact;
whereby upon removal of said elastic closure from said tubular port said hermetic seal is broken so as to produce an audible signal; and the guide member and inner bore cooperating to provide means for hampering the reinsertion of the elastic closure into the tubular port.
2. The elastic closure of Claim 1 wherein the guide member has an outer circumference in an unstressed condition that is less than the inner circumference of the tubular port.
3. The elastic closure of Claim 1 wherein the guide member has a greater length than the sleeve member.
4. The elastic closure of Claim 1 wherein the elongated top member includes at least one rib.
5. The elastic closure of Claim 1 wherein the elastic closure is constructed from an ethylene propylene rubber.
6. The elastic closure of Claim 5 wherein the elastic closure is constructed from a EPDM rubber.
7. A port and closure assembly for a solution container comprising:
a tubular port for providing access to fluid within the solution container, the tubular port including an elongated bore, an outer wall defining the bore, a rib circumscribing the outer wall, and a partition wall located in the bore;
an elastomeric closure for removably sealing the tubular port, including a guide member adapted to be received within the bore, and a sleeve for surrounding a portion of the outer wall of the tubular port so as to form a hermetic seal for said bore provided said partition wall is not pierced; and the sleeve having an inner circumference in an unstressed state that is less than the outer circumference of the rib member, the sleeve having fingers that extend below the rib when the closure seals the port, the fingers having an outer circumference that is smaller than the outer circumference of a portion of the sleeve that circumscribes the rib when the closure seals the port, whereby upon removal of said closure form said tubular port said hermetic seal is broken so as to produce an audible signal in accordance with a Chinese fingers effect if the partition wall is not pierced.
8. The port and closure assembly of Claim 7 wherein the guide member has a greater length than the sleeve member.
9. The port and closure assembly of Claim 7 wherein the elastomeric closure includes a gripping member.
10. The port and closure assembly of Claim 7 wherein the closure is constructed from an ethylene propylene rubber.
11. The port and closure assembly of Claim 7 wherein the inner circumference in unstressed condition of the sleeve member is less than the outer circumference of the outer wall of the tubular port.
12. The port and closure assembly of Claim 9 wherein the gripping member includes a tubular bore.
13. The port and closure assembly of Claim 10 wherein the closure is constructed from a EPDM rubber.
14. A port and closure assembly for a solution container comprising:
a tubular port for providing access to fluid within the solution container including, an elongated bore, an outer wall defining the bore, a rib circumscribing the outer wall, and a partition wall for dividing the elongated bore into an upper and lower bore;
an elastomeric closure for removably sealing the tubular port, including a guide member adapted to be received within the upper bore, gripping means for grasping the elastomeric closure, and a sleeve for surrounding a portion of the outer wall thereby forming a hermetic seal for said upper bore provided said partition wall is intact, the sleeve having in an unstressed condition an inner circumference that is less than the outer circumference of the rib circumscribing the outer wall of the tubular port;
whereby upon removal of said closure from said tubular port said hermetic seal is broken so as to product an audible signal if the partition wall is intact.
15. The port and closure assembly of Claim 14 wherein the gripping means includes a tubular bore.
16. The port and closure assembly of Claim 14 wherein the gripping means includes at least one rib member.
17. The port and closure assembly of Claim 14 wherein the closure is constructed from an ethylene propylene rubber.
18. The port and closure assembly of Claim 17 wherein the closure is constructed from a EPDM rubber.
19. The port and closure assembly of Claim 14 wherein the closure is color coded.
CA000495010A 1984-11-13 1985-11-12 Port and elastic closure Expired - Lifetime CA1292442C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US67085284A 1984-11-13 1984-11-13
US670,852 1984-11-13

Publications (1)

Publication Number Publication Date
CA1292442C true CA1292442C (en) 1991-11-26

Family

ID=24692156

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000495010A Expired - Lifetime CA1292442C (en) 1984-11-13 1985-11-12 Port and elastic closure

Country Status (6)

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

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 (en) * 1989-04-26 1990-10-29 Ken Heimreid CLOSURE DEVICE FOR CONTAINERS FOR ANY INFECTED LIQUIDS.
US20020104817A1 (en) * 2000-03-09 2002-08-08 Lasaitis Con A. Pull cap for a port of an administration assembly
DE102004027743A1 (en) * 2004-06-07 2006-01-05 Fresenius Medical Care Deutschland Gmbh Cap, in particular disinfection cap, peritoneal dialysis detection device, peritoneal dialysis bag set and its use
US20090105684A1 (en) 2007-10-23 2009-04-23 Baxter International Inc. Medication port for medical fluid container
DE102014223273A1 (en) * 2013-12-04 2015-06-11 Schaeffler Technologies AG & Co. KG protective cap

Family Cites Families (9)

* 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
US3554256A (en) * 1968-11-08 1971-01-12 Dave Champman Goldsmith & Yama Flexible intravenous container
JPS4910155U (en) * 1972-04-25 1974-01-28
JPS5061094A (en) * 1973-09-28 1975-05-26
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

Also Published As

Publication number Publication date
EP0203099B1 (en) 1989-06-14
ZA858569B (en) 1986-06-25
JPS62500704A (en) 1987-03-26
JPH0554790B2 (en) 1993-08-13
DE3571017D1 (en) 1989-07-20
EP0203099A4 (en) 1987-09-21
EP0203099A1 (en) 1986-12-03
WO1986002907A1 (en) 1986-05-22

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