US3583460A - Sterile cover for fluid container port - Google Patents

Sterile cover for fluid container port Download PDF

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Publication number
US3583460A
US3583460A US844521A US3583460DA US3583460A US 3583460 A US3583460 A US 3583460A US 844521 A US844521 A US 844521A US 3583460D A US3583460D A US 3583460DA US 3583460 A US3583460 A US 3583460A
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US
United States
Prior art keywords
tube
sheath
cover
seal
peelable
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
US844521A
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English (en)
Inventor
Clifford Charles Faust
Sheldon Kavesh
Louis Lloyd Winokur
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.)
Union Carbide Corp
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Union Carbide 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 Union Carbide Corp filed Critical Union Carbide Corp
Application granted granted Critical
Publication of US3583460A publication Critical patent/US3583460A/en
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    • 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
    • Y—GENERAL 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
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S383/00—Flexible bags
    • Y10S383/906—Dispensing feature

Definitions

  • a sterile cover for a tubular port of a flexible plastic fluid container consists of a sheath of flexible film material disposed over the tubular port and peeiably sealed to the port. The port is exposed for use by peeling the sheath off the port and the sheath is thereafter discarded.
  • tubular ports of plastic film' containers are conventionally maintained in sterile condition by the use of a cover in the form of a sheath of thin plastic film completely enclosing the portion of tubular port which projects out of the container.
  • the sheath is sealed to the container. It is made either of a tubular film or of two strips of flat film sealed to each other around the tubular port. When use of the tubular port is desired, the end of the sheath is cut away to permit access to the port.
  • Another sheath has been proposed, which consists of two strips of plastic film disposed about the tubular port and permanently sealed to the container walls. The strips are pee lably sealed to each other around the tubular port projecting from the container. Each of the strips has a terminal portion extending outwardly beyond the peelable seal around the tubular port and beyond said tubular port to form an end tab for the sheath. Access to the tubular port is provided by grasping the end tabs and pulling them apart from each other until the peelable seal is broken and the tubular port is exposed.
  • a disadvantage of this sheath is that both hands are necessary to pull the end tabs apart, which means that another person or some kind of support must be provided to hold the container during the pulling operation.
  • FIG. 1 is a front view of a container having walls of flexible plastic material and two tubular ports, one of said ports being provided with a sterile cover according to one embodiment of the invention
  • FIG. 2 is an isometric view of an embodiment of a sheath of flexible film used to make the cover of the invention
  • FIG. 3 is a view similar to that of FIG. 2 of another embodiment of a sheath of flexible film used to make the cover of the invention
  • FIG. 4 is an enlarged perspective viewof the tubular port of FIG. 1 provided with the sterile cover;
  • FIG. 5 is an enlarged perspective view of another tubular port provided with a modified embodiment of the sterile cover illustrated in FIGS. 1 and 4;
  • FIG. 6 is a view similar to that of FIG. 5 of another tubular port provided with another modified embodiment of the sterile cover.
  • FIGS. 7 and 8 are enlarged, fragmentary cross-sectional views of a peelable destructible seal attaching a sterile cover to a port according to the invention.
  • a sterile cover for a tubular port of a container preferably has walls of plastic film material and the port is in the form of a tube, also preferably made of a plastic material.
  • the tube pro- 5 jects outwardly from the container and is attached to the inner surface of the walls of the container.
  • the cover of the invention comprises a sheath of flexible film material disposed over the outwardly projecting tube and enclosing at least the end portion of the outwardly projecting tube.
  • the sheath is hermetically sealed about the tube by at least one peelable circumferential seal to ensure preservation of the sterility of the end portion of the tube until removal of the sheath therefrom.
  • the sheath extends beyond the peelable, circumferential sterility seal to form free end tabs.
  • the tabs are folded back over the sterility seal and extend over the sheath beyond the end of the tube and of the sheath.
  • the cover may be removed by pulling the tabs with only one finger and the thumb of one hand, in a direction away from the container.
  • the peelable seal has another, essential function, i.e., it is so positioned about the tube that, upon pulling of the tabs, it initiates inversion of the sheath and further causes the sheath to be progressively inverted by offering a resistance to the pulling force during the peeling open operation.
  • FIG. 1 a container 10 for fluids such as are conventionally used in the storing and dispensing of blood, for example.
  • the container 10 has two walls, 12 and 14, made of a plastic film material.
  • I-Ioles I6 and 18 are provided in a sealed edge at one end of the container for suspending said container.
  • the container I0 has two tubular ports in the form of outwardly projecting tubes 20 and 22.
  • the tubes 20 and 22 are conventionally made of a thermoplastic material, heat sealed to the inner surface of the walls 12 and 14, and closed in a manner well known in the art.
  • the tube 20 has been provided with a sterile cover according to one embodiment of the invention.
  • the cover generally indicated at 24 comprises a single sheet 26 of flexible, thermoplastic film.
  • the sheet 26 is folded over itself, as shown in FIG. 2.
  • the contacting edges of the folded sheet are permanently heat sealed to each other by seals 28 and 30, to form a sheath 32 terminating in two free end tabs 34 and 36, shown
  • the inner wall of the sheath is sterile.
  • the sheath 32 has been disposed over the end portion of the tube 20.
  • the sheath 32 is sealed to the tube 20 by a plurality of peelable, heat seals 38, 39 and 40, extending transversely of the tube 20 and of the sheath 32.
  • the same peelable seals 38, 39 and 40 extend on the reverse side (not shown) of the cover and tube.
  • the seal 38 is the sterility seal, hermetically and circumferentially sealing the sheath 32 about the tube 20.
  • the seals 39 and 40 ensure the progressive inversion of the sheath which fits rather loosely over the tube 20.
  • the outer end of the tube which is the most critical part as far as sterility is concerned, is the last to be uncovered. Furthermore, the progressive inversion of the sheath prevents any contact, not only between the tube and the end tabs, but also between the tube and the peeled off sheath. Complete inversion of the sheath is not necessary but at least most of the sheath should invert prior to its removal from the tube.
  • the peelable, sterility seal 38 is also a destructible seal.
  • peelable seal means a seal between two elements, for instance, sheath and tube, which can be progressively broken or separated without affecting the integrity of the elements and which preferably cannot be reformed.
  • a destructible seal as used herein means a seal which in addition to being incapable of being reformed displays visible and/or tactile evidence of having been broken. The combined characteristics of these two types of seal are important in the cover of the invention which is employed to maintain and ensure the sterility of a tube until it is ready for use.
  • one or more of the other peelable seals may be sterility seals or destructible seals if desired.
  • the peelable seals 39 and/or 40 may be destructible.
  • the manner of producing peelable, destructible heat seals is referred to below.
  • FIG. 3 illustrates another embodiment of the sheath 32 of the invention, wherein said sheath is made of two separate sheets of a flexible film which are sealed to each other along their edges by a permanent seal 29.
  • the sheath 32 could be formed of a flexible tube with one end of said tube closed by a permanent seal, or in any other manner known to those skilled in the art, starting either from a tubular film or from a flat film.
  • FIG. 5 a modified embodiment of the closure 24 illustrated in FIG. 4.
  • the sheath 32 is sealed to the tube by a peelable, destructible, circumferential sterility seal 38 and by a plurality oftransverse, closely spaced, peelable seals 41, 42 and 43, similar peelable seals optionally extending on the opposite side of the cover in juxtaposed or staggered relationship with respect to the seals 41, 42 and 43.
  • the end tabs 36 and 34 are sealed to each other at their extremities, to facilitate gripping thereof by the user. This last feature is also optional.
  • the number of peelable seals varies according to the length and width of the sheath and the size and length of the tube protected by said sheath.
  • circumferential seal there could be only one very broad, circumferential seal, or a multiplicity of circumferential seals distributed over the length of the sheath.
  • the number and position of the peelable seals are not critical as long as they provide for the essential characteristics of the invention, i.e., a sterile seal between the sheath and the tube, and a progressive inversion of the sheath while said seal is peeled open and destroyed during removal of the sterile cover from the tube.
  • FIG. 6 shows a further modified embodiment of the cover of the invention, wherein the sheath 32 is attached to the tube by a peelable, destructible, circumferential sterility seal 38 and is peelably attached to the tube 20 by a longitudinal, peelable seal 44 and by another similar seal on the opposite side of the sheath and tube (not shown).
  • FIGS. 7 and 8 illustrate in enlarged section an example of a peelable, destructible seal according to the invention.
  • the tube 20 is a polyethylene tube
  • the sheath 32 is a laminate made of a polyethylene terephthalate film having one surface thereof coated with a layer 33 of ethylene-vinyl acetate copolymer, the coated surface of the sheath being in contact with the tube 20.
  • the sheath 32 is attached to the tube 20 by a peelable, destructible seal 35 obtained by heat sealing the sheath 32 and its coating 33 to the tube 20.
  • the ethylenevinyl acetate intermediate layer being peelably heat-scalable to both the polyethylene tube and the polyethylene terephthalate film provides a particularly suitable material for the destructible seal of the invention.
  • the peelable seal 35 is broken apart and destroyed, while the polyethylene terephthalate film from which the sheath is made retains its integrity. This destruction of the peelable seal, together with the inversion of the intact sheath,
  • a peelable, destructible seal may be obtained by using a sheath made of an ionic cross-linked polymer film such as the ethylene-monocarboxylic acid copolymer films described in US. Pat. No. 3,264,272 and heat sealing said sheath to a tube made of an olefin polymer such as polyethylene or polypropylene.
  • satisfactory peelable, destructible seals may be obtained by heat-sealing a sheath made of a low density polyethylene to a tube made of a high density polyethylene.
  • the sheath 32 is made of dimensionally stable thermoplastic film.
  • the sheath may also be a tight fitting sheath made by heat shrinking a thermoplastic film about the tube, or made from an elastic film.
  • heat-shrinkable thermoplastic films are polyethylene, polypropylene, vinyl chloride-vinyl acetate copolymer films which have been suitably oriented.
  • elastic films are polyurethane, polybutadiene, polyisoprene, butadiene-styrene copolymers and ethylene-propylene copolymer films. These examples are only illustrative since heat-shrinkable and elastic films are well known to those skilled in the art.
  • the seals along the edges of the sheath 32 are not permanent seals, but should be peelable and, if desired, destructible seals because of the nature of the material from which the sheath is made, in order to obtain progressive inversion and destruction of the sheath during removal of the cover from the tube.
  • the apparent structure of the sterile cover of these further embodiments is very similar to that of the cover of the preceding embodiments, with the difference that only one circumferential, peelable, destructible seal is necessary to seal the sheath about the tube, such as seal 38 of FIGS. 4 to 6, in order to preserve the sterility of the cover.
  • the sterile cover of the invention has been more particularly described in connection with certain specific materials, the invention is not limited thereto. Any flexible film material may be used to make the sterile cover of the invention as long as it permits the production of a sheath peelably sealed about a sterile tube by peelable seals which bring about the progressive inversion of the sheath during its removal from the tube.
  • the cover of the invention when used with a vinyl tube, the cover of the invention may be made of a vinyl film and heat sealed to the tube with peelable and, if desired, destructible seals.
  • the expression vinyl used herein refers to the vinyl and vinylidene film-forming polymers and copolymers containing at least 50 percent by weight of poly(vinyl chloride) or poly(vinylidene chloride).
  • Particularly effective peelable, destructible seals in the case of a vinyl tube provided with a vinyl cover according to the invention have been obtained by coating a vinyl chloride-vinyl acetate film with a layer of ethylene-vinyl acetate copolymer and heat sealing a sheath made of said film to the vinyl tube as shown in FIG. 7. Satisfactory peelable, destructible seals could also be obtained by use of suitable adhesives.
  • a sterile cover for a tube of plastic material which comprises a sheath of flexible film material disposed over and sealed about said tube by at least one peelable seal closing said sheath about said tube, said sheath having free end tabs extending about said tube, the seal being so positioned and the end tabs so constructed and arranged that when said tabs are pulled said peelable seal is progressively opened, said sheath is progressively inverted, and said inverted sheath is removed from said tube.
  • a cover as claimed in claim 2 in which the tube is made of an olefin polymer and the sheath is made of a film obtained from a material selected from the group consisting of ethylene terephthalate polymer and a vinyl polymer, said film having a surface thereof in contact with the tube coated with a layer of ethylene-vinyl acetate copolymer.
  • a sterile cover for a tube of plastic material which cover comprises a sheath of flexible film material disposed over and sealed about said tube by at least one peelable seal closing said sheath about said tube, said sheath having a free end portion extending about said tube, the seal being so positioned and the end portion so constructed and arranged that when said end portion is pulled said peelable seal is progressively opened, said sheath is progressively inverted, and said inverted sheath is removed from said tube.

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  • 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)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • External Artificial Organs (AREA)
  • Packages (AREA)
US844521A 1969-07-24 1969-07-24 Sterile cover for fluid container port Expired - Lifetime US3583460A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US84452169A 1969-07-24 1969-07-24

Publications (1)

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US3583460A true US3583460A (en) 1971-06-08

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US844521A Expired - Lifetime US3583460A (en) 1969-07-24 1969-07-24 Sterile cover for fluid container port

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US (1) US3583460A (da)
JP (1) JPS4933156B1 (da)
AR (1) AR192398A1 (da)
BE (1) BE753838A (da)
BR (1) BR7020794D0 (da)
CA (1) CA954085A (da)
CH (1) CH517027A (da)
DK (1) DK127576B (da)
FR (1) FR2060056B1 (da)
GB (1) GB1325041A (da)
NL (1) NL152454B (da)
SE (1) SE407011B (da)
ZA (1) ZA705058B (da)

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3865411A (en) * 1973-03-29 1975-02-11 Union Carbide Corp Sterile connector for conduits
US3909910A (en) * 1973-03-29 1975-10-07 Union Carbide Corp Method of joining the ends of two conduits together in a sterile manner
US4023607A (en) * 1974-06-07 1977-05-17 Automaticon A/S Polyethylene urine bag with tube
US4066556A (en) * 1976-10-28 1978-01-03 Johnson & Johnson Fluid filter and method of making same
US4119128A (en) * 1977-02-18 1978-10-10 Marilyn Bishop Tamperproof sterile port cover and method of making same
US4596554A (en) * 1985-04-19 1986-06-24 Dastgeer Ghulam M Colo-rectal evacuator
US4946432A (en) * 1986-05-21 1990-08-07 Baxter International Inc. Device for sealing and perforating a thermoplastic film
US5161581A (en) * 1991-05-28 1992-11-10 Scheetz Kenneth S Protective plumbing sleeve
US5391163A (en) * 1992-01-31 1995-02-21 Inpaco Corporation Pouch for administering medical fluids
US5564591A (en) * 1994-02-25 1996-10-15 Inpaco Corporation Beverage container having sealed integral dispensing means
US20100294693A1 (en) * 2009-05-22 2010-11-25 Fenwal, Inc. Containers and components thereof for use in the medical industry and methods to manufacture the same
US20130324883A1 (en) * 2011-09-07 2013-12-05 Michael J. Vaillancourt Protective Cover Assembly for a Needle Assembly
WO2017165779A1 (en) * 2016-03-24 2017-09-28 Icahn School Of Medicine At Mount Sinai Injection port protector
USD812761S1 (en) * 2016-07-14 2018-03-13 Karl Storz Gmbh & Co. Kg Sterile cover

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE412697B (sv) 1978-09-13 1980-03-17 Gambro Dialysatoren Anslutningsnippel for blodpasar eller liknande
US4510115A (en) * 1982-11-03 1985-04-09 Baxter Travenol Laboratories, Inc. Method for forming layered thermoplastic articles

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2145705A (en) * 1936-10-16 1939-01-31 Anaconda Wire & Cable Co Cushion cap for insulated cables
US3205889A (en) * 1962-07-23 1965-09-14 Abbott Lab Parenteral fluid container and port structure
US3276447A (en) * 1963-10-07 1966-10-04 Baxter Don Inc Flexible tubing clamp

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2104031A (en) * 1935-04-10 1938-01-04 Graber Christian Lee Container
US2997043A (en) * 1954-08-17 1961-08-22 Becton Dickinson Co Protective cannula sheath
FR1142421A (fr) * 1955-11-25 1957-09-18 Fenwal Lab Perfectionnements aux fermetures étanches pour récipients à fluides

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2145705A (en) * 1936-10-16 1939-01-31 Anaconda Wire & Cable Co Cushion cap for insulated cables
US3205889A (en) * 1962-07-23 1965-09-14 Abbott Lab Parenteral fluid container and port structure
US3276447A (en) * 1963-10-07 1966-10-04 Baxter Don Inc Flexible tubing clamp

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3865411A (en) * 1973-03-29 1975-02-11 Union Carbide Corp Sterile connector for conduits
US3909910A (en) * 1973-03-29 1975-10-07 Union Carbide Corp Method of joining the ends of two conduits together in a sterile manner
US4023607A (en) * 1974-06-07 1977-05-17 Automaticon A/S Polyethylene urine bag with tube
US4066556A (en) * 1976-10-28 1978-01-03 Johnson & Johnson Fluid filter and method of making same
US4119128A (en) * 1977-02-18 1978-10-10 Marilyn Bishop Tamperproof sterile port cover and method of making same
US4596554A (en) * 1985-04-19 1986-06-24 Dastgeer Ghulam M Colo-rectal evacuator
US4946432A (en) * 1986-05-21 1990-08-07 Baxter International Inc. Device for sealing and perforating a thermoplastic film
US5161581A (en) * 1991-05-28 1992-11-10 Scheetz Kenneth S Protective plumbing sleeve
US5391163A (en) * 1992-01-31 1995-02-21 Inpaco Corporation Pouch for administering medical fluids
US5564591A (en) * 1994-02-25 1996-10-15 Inpaco Corporation Beverage container having sealed integral dispensing means
US20100294693A1 (en) * 2009-05-22 2010-11-25 Fenwal, Inc. Containers and components thereof for use in the medical industry and methods to manufacture the same
US8622213B2 (en) 2009-05-22 2014-01-07 Fenwal, Inc. Containers and components thereof for use in the medical industry and methods to manufacture the same
US9539174B2 (en) 2009-05-22 2017-01-10 Fenwal, Inc. Containers and components thereof for use in the medical industry and methods to manufacture the same
US20130324883A1 (en) * 2011-09-07 2013-12-05 Michael J. Vaillancourt Protective Cover Assembly for a Needle Assembly
US8905944B2 (en) * 2011-09-07 2014-12-09 Vlv Associates, Inc. Protective cover assembly for a needle assembly
WO2017165779A1 (en) * 2016-03-24 2017-09-28 Icahn School Of Medicine At Mount Sinai Injection port protector
US11207515B2 (en) 2016-03-24 2021-12-28 Icahn School Of Medicine At Mount Sinai Injection port protector
USD812761S1 (en) * 2016-07-14 2018-03-13 Karl Storz Gmbh & Co. Kg Sterile cover

Also Published As

Publication number Publication date
DK127576B (da) 1973-12-03
ZA705058B (en) 1971-04-28
GB1325041A (en) 1973-08-01
FR2060056A1 (da) 1971-06-11
BR7020794D0 (pt) 1973-01-30
NL7010938A (da) 1971-01-26
JPS4933156B1 (da) 1974-09-05
SE407011B (sv) 1979-03-12
CA954085A (en) 1974-09-03
FR2060056B1 (da) 1974-02-01
CH517027A (fr) 1971-12-31
AR192398A1 (es) 1973-02-21
NL152454B (nl) 1977-03-15
DE2036606A1 (de) 1971-04-08
BE753838A (fr) 1971-01-25

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