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EP0943348A2 - Dispositif de contrÔle d'écoulement de fluide pour un récipient pour fluides médicaux - Google Patents

Dispositif de contrÔle d'écoulement de fluide pour un récipient pour fluides médicaux Download PDF

Info

Publication number
EP0943348A2
EP0943348A2 EP99250073A EP99250073A EP0943348A2 EP 0943348 A2 EP0943348 A2 EP 0943348A2 EP 99250073 A EP99250073 A EP 99250073A EP 99250073 A EP99250073 A EP 99250073A EP 0943348 A2 EP0943348 A2 EP 0943348A2
Authority
EP
European Patent Office
Prior art keywords
fluid
container
closure device
medical fluid
medical
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.)
Withdrawn
Application number
EP99250073A
Other languages
German (de)
English (en)
Other versions
EP0943348A3 (fr
Inventor
Glynn Clements
Ralph B. Sizemore
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.)
Cryovac LLC
Original Assignee
Cryovac LLC
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 Cryovac LLC filed Critical Cryovac LLC
Publication of EP0943348A2 publication Critical patent/EP0943348A2/fr
Publication of EP0943348A3 publication Critical patent/EP0943348A3/fr
Withdrawn legal-status Critical Current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

Definitions

  • the present invention relates generally to an apparatus for controlling the flow of fluids and, more specifically, to such apparatus used in connection with a medical fluid container for closing the container and for receiving an external connector to transfer fluid from the container to a patient.
  • Medical fluid containers e.g., medical solution bottles or pouches such as I.V. bags, include at least one initially-closed outlet port through which fluid held within the container passes in order to administer the fluid to a patient.
  • the outlet port typically referred to as a "spike port” for reasons that will become apparent, is generally affixed to a short length of "connector tubing" that is integral with the container and which extends through a wall, seam, or other portion of the container to allow a desired medical fluid (e.g., a saline or dextrose solution) to be both injected into the container and subsequently removed from the container during administration of the fluid to a patient.
  • the outlet port is affixed to the connector tube after the container has been filled with medical fluid and serves to control, i.e., enable or prevent, the flow of fluid through the connector tube as desired.
  • the outlet port remains in a sealed-closed position during shipping and storage of the medical container in such a manner as to ensure the sterility of the packaged medical fluid.
  • This is generally accomplished by a rupturable membrane that is integral with the outlet port and which prevents any fluid flow out of the container and through the port until the membrane is ruptured.
  • An “administration set” is generally used to rupture the membrane and administer the medical fluid to a patient.
  • the administration set includes a connector or "spike,” which is a device having an internal channel therein and capable of rupturing and being held by the membrane in the outlet port, a length of administration tubing connected to the spike at one end of the tubing, and an I.V. needle or catheter connected to the administration tube at the other end.
  • the spike, administration tubing, and needle are in fluid communication with one another so that, once the spike punctures the membrane in the outlet port, fluid from within the medical fluid container flows, either by gravity or with the aid of an in-line pump or pressure cuff applied to the outside of the container, out of the container, through the connector tube, outlet port, and administration set, and into a patient via the needle or catheter which is inserted into a vein or other part of the patient's body.
  • the outlet port preferably includes a secure cover for fully enclosing the rupturable membrane within the outlet port to maintain the sterility of the membrane during shipment and storage of the container. While many conventional outlet ports include a cover, such covers do not fully cover or enclose the membrane within the outlet port so that dust, dirt, and other contaminates are allowed to come into contact with the membrane during shipment or storage. Other available outlet ports fully enclose the membrane, but the cover is difficult to remove, often requiring a sharp instrument to remove the cover. Accordingly, it would be desirable for an medical container outlet port to have a secure yet easily removable cover.
  • an outlet port Another desired feature in an outlet port would be for the cover to be re-positionable and permanently attached to the outlet port so that the medical fluid container can be re-closed after removal of the administration set.
  • the cover When the contents of the container have been fully dispensed and it is necessary to attach the administration set to a fresh container, some residual amount of fluid remains in the previously used container. In other instances, it is necessary to cease dispensation of the fluid after only a portion of the fluid has been used. In either case, i.e., after the contents of the container have been fully or partially dispensed, it is necessary to remove the administration set and dispose of the used container.
  • a medical fluid container with a re-closure feature would greatly facilitate the disposal/change-over process without spillage of the used container by allowing the used container to be quickly re-closed to prevent spillage of residual fluid. The used container could then be quickly and easily disposed of without spillage at the convenience of the medical worker.
  • outlet ports for medical fluid containers
  • the outlet port must be able to withstand retort sterilization conditions.
  • a sterilization process prior to sending it to the end user, e.g., a hospital.
  • sterilization is conducted by retorting the container in an autoclave at about 250°F for periods of 15 to 30 minutes. Steam is generally used as the heat-transfer medium.
  • the outlet ports must be able to endure the high temperatures which are encountered during retort sterilization without deterioration or deformation.
  • the outlet port will form a secure bond, i.e., a heat-weld, with the connector tube at this time so that other bonding techniques, such as solvent or adhesive bonding, are not necessary.
  • a secure bond i.e., a heat-weld
  • other bonding techniques such as solvent or adhesive bonding
  • outlet ports are formed from materials other than polyvinylchloride (PVC), since PVC has been found to possess undesirable properties for use as in medical applications. For example, plasticizer can migrate from the PVC and into the fluid contained within the container so that the fluid may become contaminated by potentially toxic material. A question has also arisen concerning whether PVC itself is adequately chemically neutral to medical fluids. It also been found that PVC becomes brittle at relatively low temperatures.
  • PVC polyvinylchloride
  • a fluid-flow control apparatus comprising:
  • the fluid-flow control apparatus can be used in various applications in which a primary and secondary closure would be advantageous, such as, e.g., as the outlet port for a medical fluid container wherein the primary closure includes a rupturable membrane and the secondary closure includes a re-positionable lid or cap which also serves as a cover to protect the primary closure.
  • a primary and secondary closure would be advantageous, such as, e.g., as the outlet port for a medical fluid container wherein the primary closure includes a rupturable membrane and the secondary closure includes a re-positionable lid or cap which also serves as a cover to protect the primary closure.
  • Such an outlet port comprising a fluid-flow control apparatus in accordance with the present invention overcomes the shortcomings of conventional outlet ports.
  • the cover is re-positionable and permanently attached to the outlet port so that the medical fluid container can be re-closed after removal of the administration set to thereby prevent spillage of residual medical fluid.
  • the second closure device is optionally capable of assuming a loosely-closed position to provide a secure yet easily removable cover to prevent contamination of the first closure device (membrane) during shipping and storage.
  • the outlet port can be formed by injection molding from non-PVC materials such as polyolefins, e.g., polypropylenes or polyethylenes, as a single part. Not only is this a simple and economical manufacturing technique, but the proper selection of suitable polymeric materials as discussed below allows the outlet port to withstand retort-sterilization conditions and to form a secure bond, i.e., a heat-weld, with the connector tube of the medical fluid container during sterilization. In this manner, other bonding techniques, such as solvent or adhesive bonding, are not necessary.
  • FIG. 1 shows a container 10 in accordance with the present invention for a medical fluid 12.
  • Container 10 may be any suitable container for medical fluids such as a rigid bottle or a flexible pouch.
  • the container is a flexible pouch.
  • the container is made from a flexible polyolefin film, e.g., in accordance with U.S. Patent No. 5,695,840, the disclosure of which is hereby incorporated herein by reference.
  • Any desired medical fluid 12 can be packaged in container 10, e.g., medical solutions such as dextrose or saline solutions or medical emulsions such as lipid emulsions.
  • container 10 is in the form of an I.V. pouch and is suspended from I.V.
  • connector tube 16 is bonded to and integral with container 10 and is used to introduce medical fluid 12 into and subsequently drain the fluid 12 out of container 10.
  • the connector tube 16 is preferably formed from a polymeric material, such as, e.g., that disclosed in U.S. Patent No. 4,948,643, and may be heat-welded into the container, e.g., in accordance with U.S. Patent Nos. 5,324,233 or 5,484,375. The disclosures of each of the foregoing three U.S. patents are hereby incorporated herein by reference.
  • FIGS. 4-8 illustrate outlet port 18 in greater detail.
  • outlet port 18 is preferably a fluid-flow control apparatus comprising a primary closure 20 and a secondary closure 22.
  • Primary closure 20 includes a connector means 24 for connecting to and fluidly communicating with medical fluid container 10 or other fluid source (i.e., where the fluid-flow control apparatus is used in other applications), and also a first closure device 26 for preventing fluid flow through the connector means but capable of being opened to enable fluid flow.
  • First closure device 26 preferably comprises a rupturable membrane affixed to connector means 24 such that fluid 12 is prevented from flowing through the connector means until the membrane is ruptured. This will be explained in more detail below.
  • Connector means 24 can be any suitable device or mechanism capable of making a mechanical and fluid connection with a fluid source so that the outlet port/fluid-flow control apparatus 18 is able to control the flow of fluid from the fluid source.
  • connector means 24 is a tubular member adapted to engage with and be held by the inside of connector tube 16 of container 10.
  • the inner diameter of connector tube 16 and the outer diameter of connector means 24 are such that connector tube 16 holds the connector means 24 securely therein via a pressure fit.
  • connector means 24 is also or instead connected to the connector tube 16 via a heat-weld, preferably formed during retort-sterilization of the container 10 after outlet port 18 has been attached to the connector tube.
  • the connector tube 16 and connector means 24 are preferably formed from materials that are capable of welding (fusing) together under the application of heat as applied during retort-sterilization.
  • suitable materials include, e.g., polypropylene homopolymer or copolymer, ethylene homopolymer or copolymer, and blends of the foregoing materials. This eliminates the extra and possibly contaminating steps of using solvent or adhesive bonding to secure the outlet port to the container.
  • connector tube 16 is not a required component of container 10. Rather, it is simply a convenient means for facilitating the attachment of outlet port 18 to the container via connector means 24. If desired, connector means 24 can be configured to be connected to the container in a different manner, e.g., by being directly heat-welded to the container such as by heat-welding in-between the two film sheets comprising container 10.
  • Secondary closure 22 includes a housing 28, a second closure device 30, and means 32 for attaching second closure device 30 to housing 28.
  • Housing 28 is connected to primary closure 20 and in fluid communication therewith when first closure device 26 is opened.
  • Second closure device 30 is re-positionable and movable in relation to housing 30 between a closed position as shown in FIGS. 1, 3, 5-6 and 8 to prevent fluid flow through the housing, and an open position as shown in FIGS. 2, 4, and 7 to enable fluid flow through the housing.
  • the second closure device 30 is capable of assuming a tightly-closed position as shown in FIGS. 3 and 6, and a loosely-closed position, as shown in FIGS. 1 and 5, which is intermediate between the tightly-closed and open positions.
  • Closure device 30 may be of any suitable form or shape.
  • the closure device 30 is a lid or cap-like structure of a size and shape corresponding to that of outer portion 29 of housing 28 to allow the closure device to be received and held securely within portion 29 of housing 28 as shown. In this manner, closure device 30 and housing 28 cooperatively form a closure that is sufficient to prevent fluid flow through the housing.
  • the fluid-flow control apparatus of the present invention will now be described in further detail in connection with its preferred use as an outlet port for a medical fluid container.
  • medical fluid container 10 is un-opened, un-used, and has just been placed on I.V. pole 14 prior to administering medical fluid 12 to a patient (not shown).
  • the container 10 is thus in the same condition as it was in after retort-sterilization and during shipping and storage.
  • both the first closure device 26 and the second closure device 30 of outlet port/fluid-flow control apparatus 18 are in closed positions. More specifically, the second closure device 30 is in the loosely-closed position as shown more clearly in FIG. 5.
  • first closure device 26 prevents medical fluid 12 from exiting container 10 via connector tube 16 while second closure device 30 prevents dust, dirt, and other contaminates from coming into contact with first closure device 26, thereby maintaining the sterility of closure device 26.
  • the device 30 is retorted, shipped, and stored in a loosely-closed position as shown in FIGS. 1 and 5.
  • the closure device 30 is retained in the loosely-closed position by providing the closure device with a plurality of radially-extending ribs 33 (see FIGS. 7 and 9) at the leading portion 34 of device 30.
  • the ribs 33 truncate a spaced distance "d" from main portion 35 of closure device 30.
  • housing 28 includes a lip 36 at the outer end 29 thereof. In this manner, when closure device 30 is moved to the loosely-closed position as shown most clearly in FIG. 5, ribs 33 interlock with lip 36 to secure the closure device in that position.
  • the housing 28 and leading portion 34 of closure device 30 are formed from polymeric materials that form a slight tack-weld with one another during the heat of retort-sterilization to provide an extra measure of closure.
  • the interlocking of ribs 33 with lip 36 and/or tack-welding thereof preferably retains the closure device 30 within housing 28 with a sufficiently low force that a medical worker can readily move the device 30 to the open position as desired.
  • tab 37 be included on device 30 to assist the medical worker in opening the device 30 by providing a surface under which to place a thumb or finger.
  • Tab 37 and protrusion 38 preferably also act as "stops" to prevent closure device from being inserted too far into housing 28 when the closure device is subsequently moved to the tightly-closed position as illustrated in FIG. 6.
  • ribs/lip interlocking configuration as presently illustrated is merely one means for retaining the closure device 30 in a loosely-closed position.
  • ribs 33 alone without a corresponding lip 36 may often be sufficient, particularly when the container 10 is to be retort-sterilized immediately after the container is filled with fluid to thereby cause a tack-weld between the ribs and the housing.
  • a number of other configurations are also possible and the present invention is not intended to be limited to any particular one.
  • Administration set 40 is positioned for insertion into container 10.
  • the administration set includes a "spike" connector 42, a length of administration tubing 44 fluidly connected to the spike connector at one end 46 of the tubing 44, and an I.V. needle or catheter 48 fluidly connected to the administration tube 44 at the other end 50.
  • the needle or catheter 48 is inserted into a patient (not shown) for delivery of fluid 12 thereto. All components of the administration set are in fluid communication with one another.
  • Fluid-flow control apparatus/outlet port 18 is preferably adapted to engage and hold an external connector for transfer of fluid 12 from container 10 and into the external connector. As shown in FIG. 2, this is preferably accomplished when first closure device 26 is a rupturable membrane.
  • the spike connector 42 is preferably a device having an internal channel 54 therein and capable of rupturing and being held by the membrane or first closure device 26 after the second closure device 30 has been moved to the open position as shown.
  • spike connector 42 is inserted into housing 28 of outlet port 18, through membrane/first closure device 26 which ruptures when sufficient pressure is exerted by the sharpened end 52 of spike 42, and into the connector means 24 of outlet port 18 and connector tube 16 of container 10.
  • first closure device 26 preferably maintains sufficient compressive force against the spike 42 to hold it in the position shown in FIG. 2. In this manner, with both first and second closure devices 26 and 30 are opened, fluid 12 flows from container 10, through administration tube 44 via spike connector 42 in fluid communication therewith, and into a patient via I.V. needle 48.
  • FIGS. 3 and 6 After the medical fluid 12 has been fully or partially dispensed from container 10, the administration set 40 is removed, i.e., spike connector 42 is pulled out of outlet port 18, and the container is disposed. As indicated in FIG. 3, membrane/first closure device 26 has been ruptured.
  • the second closure device 30 of outlet port 18 is re-positionable and can be moved to a closed position as shown in order to re-close the container. Since the outlet port 18 will, in most instances, not need to be subsequently reopened, the closure device 30 can be moved to the more secure, tightly-closed position as shown in FIGS. 3 and 6.
  • attachment means 32 ensures that the closure device 30 is not unintentionally discarded or misplaced so that the device is readily available for closure of outlet port 18 at the convenience of the medical worker.
  • the attachment means 32 can be any suitable device or mechanism that allows the closure device 30 to be freely movable and re-positionable between the various open and closed positions shown in the Figures. Means 32 should, for example, allow closure device 30 to be opened sufficiently as to not interfere with the insertion of spike connector 42 into outlet port 18.
  • Various hinge-like structures that pivotally join the closure device 30 with housing 28, for example, would be suitable.
  • a preferred structure is a flexible, polymeric hinge as shown.
  • the fluid-flow control apparatus in accordance with the present invention may be formed from any desired and suitable material and may be made by any suitable process.
  • the fluid-flow control apparatus is preferably a single, molded part formed from a polymeric material, e.g., by an injection molding process.
  • Preferred polymeric materials include polypropylene homopolymer or copolymer, ethylene homopolymer or copolymer, and blends of the foregoing materials.
  • a preferred polypropylene copolymer is propylene/ethylene copolymer.
  • Preferred polyethylenes are ethylene/alpha-olefin copolymers, including both heterogeneous ethylene/alpha-olefins (i.e., made by conventional Ziegler-Natta catalysis) and homogeneous ethylene/ alpha-olefins (i.e., made by single-site (e.g., metallocene) catalysis).
  • Blends of polypropylene homopolymer or propylene/ethylene copolymer with ethylene/alpha-olefin copolymer are also preferred. If such a blend is employed, the polypropylene component preferably ranges from about 70 to about 99 weight percent while the ethylene/alpha-olefin copolymer ranges from about 30 to about 1 weight percent.

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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)
  • Closures For Containers (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
EP99250073A 1998-03-16 1999-03-11 Dispositif de contrôle d'écoulement de fluide pour un récipient pour fluides médicaux Withdrawn EP0943348A3 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US39705 1979-05-17
US3970598A 1998-03-16 1998-03-16

Publications (2)

Publication Number Publication Date
EP0943348A2 true EP0943348A2 (fr) 1999-09-22
EP0943348A3 EP0943348A3 (fr) 2000-06-07

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP99250073A Withdrawn EP0943348A3 (fr) 1998-03-16 1999-03-11 Dispositif de contrôle d'écoulement de fluide pour un récipient pour fluides médicaux

Country Status (3)

Country Link
EP (1) EP0943348A3 (fr)
CA (1) CA2265200A1 (fr)
ZA (1) ZA992077B (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112955191A (zh) * 2018-03-08 2021-06-11 弗莱克斯有限公司 具有屏障移除的灭菌流体路径

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4948643A (en) 1989-01-23 1990-08-14 W. R. Grace & Co.-Conn. Flexible medical solution tubing
US5324233A (en) 1992-09-09 1994-06-28 W. R. Grace & Co.-Conn. Method and apparatus for sealing fitment tubes into pouches
US5695840A (en) 1995-03-22 1997-12-09 W. R. Grace & Co.-Conn. Films for medical solution pouches

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3633586A (en) * 1970-04-30 1972-01-11 David S Sheridan Sterile technique tube end closure and syringe adaptor
IT8034810V0 (it) * 1980-01-22 1980-01-22 Lena Paolo Contenitore sintetico a sacca per sangue umano e sue frazioni, soluzioni perfusionali, soluzioni dialitiche e per liquidi alimentari e chimici in genere
US4484351A (en) * 1983-05-23 1984-11-20 Union Carbide Corporation Non-glass chemical container
JPH02502976A (ja) * 1988-01-25 1990-09-20 バクスター、インターナショナル、インコーポレイテッド あらかじめスリットした注射部位および先細カニューレ
US4963132A (en) * 1988-11-11 1990-10-16 Gibson Roger M Capped fluidic connector

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4948643A (en) 1989-01-23 1990-08-14 W. R. Grace & Co.-Conn. Flexible medical solution tubing
US5324233A (en) 1992-09-09 1994-06-28 W. R. Grace & Co.-Conn. Method and apparatus for sealing fitment tubes into pouches
US5484375A (en) 1992-09-09 1996-01-16 W. R. Grace & Co.-Conn. Method & apparatus for sealing fitment tubes into pouches
US5695840A (en) 1995-03-22 1997-12-09 W. R. Grace & Co.-Conn. Films for medical solution pouches

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112955191A (zh) * 2018-03-08 2021-06-11 弗莱克斯有限公司 具有屏障移除的灭菌流体路径

Also Published As

Publication number Publication date
ZA992077B (en) 1999-09-27
EP0943348A3 (fr) 2000-06-07
CA2265200A1 (fr) 1999-09-16

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