EP0175529A1 - Récipient exempt de dispositif de perforation - Google Patents

Récipient exempt de dispositif de perforation Download PDF

Info

Publication number
EP0175529A1
EP0175529A1 EP85306369A EP85306369A EP0175529A1 EP 0175529 A1 EP0175529 A1 EP 0175529A1 EP 85306369 A EP85306369 A EP 85306369A EP 85306369 A EP85306369 A EP 85306369A EP 0175529 A1 EP0175529 A1 EP 0175529A1
Authority
EP
European Patent Office
Prior art keywords
container
insert member
protrusion
wall
flexible
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.)
Granted
Application number
EP85306369A
Other languages
German (de)
English (en)
Other versions
EP0175529B1 (fr
Inventor
William J. Schnell
James A. Fitzgerald
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
Baxter Travenol Laboratories 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, Baxter Travenol Laboratories Inc filed Critical Baxter International Inc
Priority to AT85306369T priority Critical patent/ATE40944T1/de
Publication of EP0175529A1 publication Critical patent/EP0175529A1/fr
Application granted granted Critical
Publication of EP0175529B1 publication Critical patent/EP0175529B1/fr
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

Definitions

  • This application relates to an improved container having flexible plastic walls, for sterile solutions or the like.
  • Flexible plastic solution containers are used in great quantities in the medical field for holding sterile solution for intravenous use, blood, sterile washing solutions, peritoneal dialysis solutions and the like.
  • Typical designs of flexible containers include the Viaflex O containers for intravenous solutions and the Dianeal b peritoneal dialysis solution containers sold by Travenol Laboratories, Inc.
  • Conventional flexible plastic containers carry tubular ports at one end which are proportioned to receive a spike connector of an administration set.
  • the spike connector passes into a tubular port passing through a diaphragm into flow communication with the solution contents of the container.
  • the Entri-Pak container of Biosearch Medical Products, Inc. of 5omerville, New Jersey is an aluminum foil-plastic laminated bag of enteral feeding diet material, with a projecting, flexible-wallea protrusion.
  • the protrusion seals a tube which is closed with a membrane.
  • the tube passes through the bag wall for communication with the bag interior.
  • the outer end of the protrusion is torn away to expose the outer end of the tube, which may then be spiked with the spike connector of an administration set.
  • flexible plastic containers are provided which are highly susceptible to inexpensive, automated manufacture, and which may be free of outwardly protruding tubular access ports which must be preformed and sealed to the container during the manufacturing operation.
  • a container defining a flexible wall.
  • Means for sealingly receiving a puncture member through the wall are present, comprising an insert member positioned within the container.
  • the insert member defines an aperture for sealingly receiving the puncture member after penetration through the wall.
  • the aperture provides flow communication between the container interior and a puncture member received in the aperture.
  • the aperture is a bore extending through the insert member.
  • the puncture member As the puncture member passes into the aperture, it typically causes an annular portion of the container wall to deform or stretch into a position between the puncture member and the aperture wall, where the annular portion can be sealingly locked and seated between the connected puncture member and aperture wall. Thus, leakage can be prevented.
  • the container wall may define a flexible-walled protrusion communicating with the rest of the container through a relatively narrow neck portion, to permit flow communication between the protrusion and the rest of the container.
  • the insert member is advantageously captured or retained in the protrusion, to provide it with a fixed location without the need to seal it to the inner wall of the container.
  • the container may also carry removable tape means on the outer surface of the flexible wall.
  • the tape means may be applied to the container prior to sterilization, so that the tape means may be removed, when use of the container is desired, to expose a clean, typically sterile surface for puncturing by the puncture member. Thus, no alcohol swab or the like may be required prior to the use of the device of this invention.
  • the container of this invention may be made from a pair of plastic sheets, or a large, extruded, flattened tubular plastic sheet, by appropriate peripheral heat sealing in a manner analogous to present commercial container manufacture techniques.
  • a plastic sheet may be folded over and then peripherally sealed together on all open sides to form the container.
  • the insert member may in this circumstance be simply placed between facing plastic sheets within the newly-formed container before the peripheral sealing operation, to provide a very efficient, cost effective manufacturing technique, since no separate application of port tubes is required.
  • blow molding or other techniques may be used to manufacture the container.
  • thermoplastic or other resilient materials may be used to make the container wall
  • one preferred material is DYPRO@ Z4650 polypropylene copolymer, sold by the Arco Chemical Company.
  • the plastic material used may, if desired, be about 0.01 inch thick and may optionally be a coextrusion of the above recited DYPRO plastic material as an inner layer, and polypropylene as an outer layer of the container wall.
  • the insert member may be made from a polypropylene material, for example having about 3 weight percent of copolymerized ethylene units in the formulation.
  • the insert member may comprise a pair of tubes in telescoping relation with each other and connected at one end, with the aperture as defined above being defined by the bore of the inner tube. This structure provides a certain desirable resilience to the insert member, and facilitates the seal formed between a puncture member and the aperture wall.
  • the insert member In the specific instance of DYPRO @ Z4650 copolymer, it is be desirable for the insert member to be made of a generally rigid material such as polypropylene as mentioned above. However, in other instances, for use with other resilient sheet materials, it may be desirable to use a softer, semiflexible insert member.
  • the aperture of the insert member may be proportioned to be of a diameter which is dependent upon the wall thickness of the facing plastic sheets, so that on penetration of the container wall by a puncture member, the annular portion of the container wall is formed by deformation and stretching into the desired sealing position between the puncture member and the aperture wall.
  • the various dimensions and proportions of the system may vary in accordance with frictional characteristics of the puncture member and insert member with the plastic of the container wall to optimize the formation of the desired deformed or stretched annular portion used for sealing between the connected puncture member and aperture wall. Additionally, one may adjust the sharpness of the puncture member to provide the desired results. For example, it may be desired to provide a sharp spike with a highly resilient material, coupled with materials that provide a rather high coefficient of friction. On the other hand, when using a bag wall material that is not very resilient, a duller spike may be desired in some instances, and one may wish to use materials that have a relatively lower coefficient of friction. On the other hand, a sharp spike may be used in this instance as well for facilitating access to the container.
  • Figure 1 is a plan view of a flexible, collapsible container, with a portion broken away, utilizing the invention of this application.
  • Container or bag 10 is made of a pair of overlying thermoplastic sheets 12, 14, which are heat sealed together.
  • a peripheral heat seal 16 is used.
  • the seal may be made by conventional radio frequency sealing processes if polyvinylchloride sheeting is used, or by a hot bar seal if polyolefin sheeting or the like is used.
  • the top of container 10 may carry other peripheral seals 18, and a corner hanger hole 20 for suspension of the container.
  • flexible-walled protrusion 22 is defined, being surrounded by the extension 24 of heat seal 16.
  • sheet 12 defines a portion of protrusion 22 which may be thermoformed in conventional manner to form a pocket 26.
  • Pocket 26 receives and holds insert member 28, which may be a molded plastic piece of a design shown in longitudinal section in Figure 3.
  • tape member 30 may be provided, adhering to an outer end of pocket 26 as shown in Figure 2.
  • Tape member 30 may be a known plastic foil tab which is sealed to bag 1C, defining a handle portion 32, so it can be manually removed to expose the surface of pocket 26 underneath foil tab 30. If foil tab 30 is applied and then bag 10 is radiation or steam sterilized, for example, removal of tab 30 can present a sterile surface to the user for application of a spike connector 34 to bag 10 to obtain access thereto.
  • insert member 28 may be a single, molded plastic piece comprising a pair of tubular portions 36, 38, joined together at one end 40 in telescoping relation.
  • the outer telescoping portion 36 serves as a good manual gripping member, so that one may hold protrusion 22 with the fingers, thus also gripping insert member 28.
  • One then may then manually advance spike 34, penetrating the wall of protrusion 22 to gain access to container 10.
  • Portions of the container wall 42 may be stretched to fold inwardly into bore 44 of insert member 28 as spike 34 penetrates bore 44, so that wall portions 42 provide an added sealing lip or ring to the connection system between spike 3 4 and insert member 28. Accordingly, liquid 46 in container 10 may pass through the lumen of spike 34 into an administration set or the like, for flow communication between the bag interior and the set to which spike 34 is attached.
  • the telescoping tube structure of insert member 28 provides a certain resilience to the tube 38 defining bore 44 which can improve the sealing characteristics of the insert member with spike 34. Also, less plastic is used, when compared with a solid piece insert member which does not define annular space 48.
  • FIG. 3 The illustration of Figure 3 is somewhat schematic.
  • the inner wall of tube 38 defining bore 44 will be commonly expected to contact the outer wall of spike 34, to provide improved sealing along most of its length.
  • the cut and folded-in portions 42 of the bag wall provide extra sealing, typically stretching insert member 2b outwardly a small amount to accommodate for their presence.
  • Figure 1 While the container of this invention may be made by blow molding or the like, the specific design of Figure 1 is contemplated to be made on a mass production basis by heat sealing together two overlapping continuous webs 50, 51 of plastic material to form the container walls 12, 14, respectively after inserting insert member 28 between webs 50, 51 in its desired position.
  • the two overlapping, continuous plastic webs 50, 51 shown in phantom lines represent the portion of continuous plastic web material (for example, a roll of material) that typically may be allocated to the manufacture of a single container. It can be seen that high efficiency of use can be obtainea, with excess portions of the plastic web material being typically trimmed away by an automatic trimmer as part of the manufacturing process.
  • an adjacent bag on the production line may be defined in continuous webs 50, 51 with its flexible-walled protrusion 22 facing bag 10 and occupying the area indicated by reference numeral 52, for further economy of manufacturing.
  • the heat seals 16 at the respective ends of container 10 are formed to be in angular relationship other than 90°to the lateral heat seals 16 of the edges of webs 50, 51.
  • protrusion 22 is the lowest point of container 10, so that all liquid will pass into protrusion 22 and thus out of spike 34. Even if container 10 is held perpendicular to the ground for draining, the slight downward slope of the lower end seal line 16 will assure that all liquid passes into protrusion 22.
  • protrusion 22 may be placed at a centered location of container 10 at the lower end thereof, and hanger hole 20 may also be centered.
  • Container 10a once again is made by peripheral heat sealing along seal lines 16a, 16b to form a generally diamond-shaped container.
  • Flexible walled protrusion 22a may be of substantially similar design to protrusion 22, and may contain an insert member 28a which may be of similar design to insert member 28.
  • Inner heat seal 54 is provided at the top of the container to separate its contents from hangar hole 56.
  • this design provides particular efficiency, in providing a very low scrap rate from a continuous web of overlapping plastic sheets 58 from which container 10a may be maae. This may be accomplished by providing that peripheral seal lines 16b, which are nonparallel to the edges 60 of plastic webs 58, are not perpendicular to such edges 60, but define an angle with them of typically 35° to 70°, i.e. an acute angle. It can be seen that a very low scrap rate of web material to be trimmed away from the container is provided by this configuration, since other containers 10a can be formed in portions 61 of overlapping web material 58.
  • the two side walls of container 64 may be formed by folding a web along fold line 66 at the end of protrusion 62, and forming peripheral heat seals 68 with insert member 70 inside.
  • Insert member 70 is shown to define bore 72 extending from end to end thereof, and also to define a pair of opposed, lateral projections 74 to facilitate manual gripping of the insert member by the user within flexible-walled protrusion 62.
  • Protrusion 76 may be defined by a peripheral heat seal line 78 which passes across its end, but such heat seal line does not interfere with a spike connection because of the novel shape of insert member 80 carried in protrusion 76.
  • Insert member 80 may be a block of plastic which may be smaller or flatter in its depth than its width or length, and defines a bore 82 passing generally diagonally through it as shown, so that the connecting spike will penetrate the bag wall at a position spaced from seal line 78.
  • FIG. 7 another flexible-walled protrusion 84 for a flexible, collapsible bag is disclosed.
  • the two sides of the bag are folded along fold line 86 at the end of protrusion 84, and then sealed together by peripheral seal lines 88.
  • Insert member 90 trapped within protrusion 84, may be roughly triangular in shape as shown, and defines a bore 92 extending therethrough. As shown, the area of insert member 90 adjacent one end 94 of the aperture is transversely enlarged relative to the area 96 of insert member 90 adjacent the other end. This triangular configuration facilitates the use of a more tightly fitting, generally triangular, flexible-walled protrusion.
  • molded insert member 98 is disclosed, being capable of fitting in a flexible-walled collapsible bag of any desired design, either captured in a protrusion, or loosely in the bag, or adhered to the inner bag wall.
  • Aperture or bore 100 is provided to receive a connecting spike penetrating through the bag wall, while various ribs 102, 104 are provided for ease of manually gripping the device through the bag wall.
  • FIG. 11 and 12 another design of container 105 is disclosed, comprising a pair of thermoplastic sheets lying one on top of the other and sealed together with a peripheral heat seal 106.
  • Relatively narrow neck portion 108 is defined by part of heat seal 106 in a centered position on the container.
  • Insert member 98 which may be of the design of Figures 8 to 10, is carried within neck portion 108 in a manner analogous to the previous embodiments, so that bore 100 extending through insert member 98 faces the end wall 109 of neck portion 108 to receive a puncture member in a manner similar to that previously described.
  • Neck portion 108 may carry an offset portion 111 made by a thermotorming step or the like, so that a spike 34 can pass through end wall 109 without interference by peripheral heat seal 106.
  • Wall lU9 may carry removable tape portion 113, if desired, similar in structure and function to tape member 30.
  • flexible container 105 may have an open end 114 to serve as a temporary filling port when bag 105 is delivered to a filling machine. Thereafter, a subsequent heat seal line 116 may be applied as shown to seal off the bag, and an appropriate hangar hole may be punched into the plastic material 118 outside of the seal lines 106, 116 for hanging of the container.
  • the flexible containers of this invention may be made by mass production techniques as described above, with significant cost savings over the puncturable, collapsible containers of the prior art. At the same time, they provide great convenience, reliability, and facility of use, particularly as containers for enteral feeding, blood or its components, or dialysis, parenteral, or washing solutions. They may be manufactured in a continuous form, fill and seal manufacturing process if desired.

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Housing For Livestock And Birds (AREA)
  • Sampling And Sample Adjustment (AREA)
  • External Artificial Organs (AREA)
  • Devices For Use In Laboratory Experiments (AREA)
  • Bag Frames (AREA)
EP85306369A 1984-09-14 1985-09-09 Récipient exempt de dispositif de perforation Expired EP0175529B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT85306369T ATE40944T1 (de) 1984-09-14 1985-09-09 Anstechteilfreier behaelter.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US65040084A 1984-09-14 1984-09-14
US650400 1984-09-14

Publications (2)

Publication Number Publication Date
EP0175529A1 true EP0175529A1 (fr) 1986-03-26
EP0175529B1 EP0175529B1 (fr) 1989-03-01

Family

ID=24608747

Family Applications (1)

Application Number Title Priority Date Filing Date
EP85306369A Expired EP0175529B1 (fr) 1984-09-14 1985-09-09 Récipient exempt de dispositif de perforation

Country Status (5)

Country Link
EP (1) EP0175529B1 (fr)
JP (1) JPS6173660A (fr)
AT (1) ATE40944T1 (fr)
CA (1) CA1247053A (fr)
DE (1) DE3568395D1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0326599A4 (en) * 1987-08-03 1990-09-26 Baxter International Inc. (A Delaware Corporation) Collapsible container and method of filling
EP0633034A1 (fr) * 1993-06-12 1995-01-11 B. Braun Melsungen Ag Jeu de perfusion
EP0665026A3 (fr) * 1993-12-30 1995-09-20 Braun Melsungen Ag Dispositif de dialyse.

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2958401A1 (fr) * 2010-04-01 2011-10-07 Braun Medical Sas Dispositif de prelevement d'un echantillon de liquide d'une poche souple
JP6230575B2 (ja) * 2015-08-11 2017-11-15 上田製袋株式会社 凍結保存用バッグ、および凍結保存用バッグに対する生体組織の封入方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2949712A (en) * 1955-01-18 1960-08-23 American Hospital Supply Corp Liquid packaging method
US3030952A (en) * 1956-12-24 1962-04-24 Baxter Don Inc Solution administration device and method of forming the same
US3177870A (en) * 1960-11-10 1965-04-13 Abbott Lab Secondary administration system
CH399297A (de) * 1959-12-02 1966-03-31 Pantaplast Ges Mit Beschraenkt Verpackung aus thermoplastischem Schlauch- oder Folienmaterial, die mit einer Auslauftülle versehen ist
GB1104359A (en) * 1966-07-28 1968-02-28 Kathleen Henfrey Improvements in and relating to containers formed of plastics material

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2949712A (en) * 1955-01-18 1960-08-23 American Hospital Supply Corp Liquid packaging method
US3030952A (en) * 1956-12-24 1962-04-24 Baxter Don Inc Solution administration device and method of forming the same
CH399297A (de) * 1959-12-02 1966-03-31 Pantaplast Ges Mit Beschraenkt Verpackung aus thermoplastischem Schlauch- oder Folienmaterial, die mit einer Auslauftülle versehen ist
US3177870A (en) * 1960-11-10 1965-04-13 Abbott Lab Secondary administration system
GB1104359A (en) * 1966-07-28 1968-02-28 Kathleen Henfrey Improvements in and relating to containers formed of plastics material

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0326599A4 (en) * 1987-08-03 1990-09-26 Baxter International Inc. (A Delaware Corporation) Collapsible container and method of filling
EP0633034A1 (fr) * 1993-06-12 1995-01-11 B. Braun Melsungen Ag Jeu de perfusion
EP0665026A3 (fr) * 1993-12-30 1995-09-20 Braun Melsungen Ag Dispositif de dialyse.

Also Published As

Publication number Publication date
CA1247053A (fr) 1988-12-20
ATE40944T1 (de) 1989-03-15
DE3568395D1 (en) 1989-04-06
EP0175529B1 (fr) 1989-03-01
JPS6173660A (ja) 1986-04-15

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